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| ID | THPP_ID | Therapeutic Name | Sequence | Molecular Weight | Chemical Formula | Isoelectric Point | Hydrophobicity | Melting Point | Half Life | Description | Disease/Indication | Pharmacodynamics | Mechanism of Action | Toxicity | Metabolism | Absorption | Volume of Distribution | Clearance | Categories | Patent Number | Date of Issue | Date of Expiry | Drug Interaction | Target | Brand Name | Company | Brand Description | Prescribed for | Chemical Name | Formulation | Physical Appearance | Route of Administation | Recommended Dosage | Contraindication | Side Effects | Useful Links 1 | Useful Links 2 | Remarks |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 10038 | Th1007 | Leuprolide | >Th1007_Leuprolide PHWSYLLR | 1209.398 | C59H84N16O12 | NA | 0.1 | NA | Approximately 3 hours | Leuprolide is a synthetic 9 residue peptide analog of gonadotropin releasing hormone belonging to the class of drugs called hormones or hormone antagonists. It is used to treat advanced prostate cancer, uterine fibroids and endometriosis (under investigation for possible use in the treatment of mild to moderate Alzheimer's disease). | To treat prostate cancer, endometriosis, uterine fibroids and premature puberty. | Leuprolide is a luteinizing hormone agonist that results in suppression of testicular or follicular steroidogenesis thus used in the palliative treatment of advanced prostate cancer. | Leuprolide binds to the gonadotropin releasing hormone receptor and acts as an efficient inhibitor of gonadotropin secretion. | Subcutaneous administration of 250 to 500 times the recommended human dose in rats, expressed on a per body weight basis, resulted in dyspnea, decreased activity, and local irritation at the injection site. There is no evidence at present that there is a | Primarily degraded by peptidase (instead of cytochrome P450 enzymes). | Bioavailability by subcutaneous administration is comparable to that by intravenous administration. | 27 L [intravenous bolus administration to healthy male volunteers] | Excretion in urine, 8.34 L/hour [healthy male receiving a 1-mg IV bolus] | Adrenal Cortex Hormones, Agents Causing Muscle Toxicity, Amino Acids, Peptides, and Proteins, Antineoplastic Agents, Antineoplastic Agents, Hormonal, Antineoplastic and Immunomodulating Agents, Drugs causing inadvertant photosensitivity, Drugs that are Mainly Renally Excreted, Endocrine Therapy, Fertility Agents, Fertility Agents, Female, Gonadotropin Releasing Hormone Receptor Agonist, Gonadotropin Releasing Hormone Receptor Agonists, Gonadotropin-releasing hormone agonist, Gonadotropins, Hormones and Related Agents, Hyperglycemia-Associated Agents, Hypothalamic Hormones, Moderate Risk QTc-Prolonging Agents, Nerve Tissue Proteins, Neuropeptides, Oligopeptides, Peptides, Photosensitizing Agents, Pituitary Hormone-Releasing Hormones, Proteins, QTc Prolonging Agents, Reproductive Control Agents | NA | NA | NA | NA | Gonadotropin-releasing hormone receptor | Eligard | Atrix Labs/QLT In | Atrix Labs/QLT In | Eligard is used to treat the symptoms of prostate cancer in men. | 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate | ELIGARD is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. One syringe contains the ATRIGEL De | Suspension | Subcutaneous Injection | 7.5mg-1 injection/month, 22.5mg-1 injection per 3 month, 30mg-1 injection per 4 month, 45 mg- 1 injection every 6 month. | Hypersensitivity and pregnancy | Rare pain or unusual sensations in your back; numbness, weakness, or tingly feeling in your legs or feet; muscle weakness or loss of use; loss of bowel or bladder control; or liver problems - nausea, upper stomach pain, itching, tired feeling, loss of apetite. | Link | NA | NA |
| 10382 | Th1060 | Insulin, porcine | >Th1060_Insulin,_porcine GIVEQCCTSICSLYQLENYCN | 5795.6 | C257H387N65O76S6 | 5.39 | 0.218 | NA | 0.03 hours | Insulin isolated from pig pancreas. Composed of alpha and beta chains, processed from pro-insulin. Forms a hexameric structure. | For the treatment of type I and II diabetes mellitus. | Insulin is used in the treatment of type I and type II diabetes. The primary activity of insulin is the regulation of glucose metabolism. In muscle and other tissues (except the brain), insulin causes rapid transport of glucose and amino acids intracellularly. It also promotes anabolism, and inhibits protein catabolism. In the liver, insulin promotes the uptake and storage of glucose in the form of glycogen, inhibits gluconeogenesis, and promotes the conversion of excess glucose into fat. | Insulin binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor is able to autophosphorylate and phosphorylate numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. These activated proteins, in turn, lead to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC) which play a critical role in metabolism. | NA | Insulin is predominantly cleared by metabolic degradation via a receptor-mediated process. | NA | NA | NA | Alimentary Tract and Metabolism, Amino Acids, Peptides, and Proteins, Blood Glucose Lowering Agents, Cytochrome P-450 CYP1A2 Inducers, Cytochrome P-450 CYP1A2 Inducers (strength unknown), Cytochrome P-450 Enzyme Inducers, Drugs Used in Diabetes, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Insulin, Insulin, Short-Acting, Insulins and Analogues for Injection, Fast-Acting, Pancreatic Hormones, Peptide Hormones, Peptides, Proteins | NA | NA | NA | NA | Interferon alpha/beta receptor 2,Interferon alpha/beta receptor 1 | vetsulin | Intervet Inc (Merck Animal Health) | Intervet Inc (Merck Animal Health) | vetsulin (porcine insulin zinc suspension) is indicated for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs and cats with diabetes mellitus | NA | purified porcine insulin 40 IU (35% amorphous and 65% crystalline), Zinc (as chloride) 0.08 mg, Sodium acetate trihydrate 1.36 mg, Sodium chloride 7.0 mg, Methylparaben (preservative) 1.0 mg, pH is adjusted with hydrochloric acid and/or sodium hydroxide. | Vetsulin is supplied as a sterile injectable suspension in multidose vials containing 10 mL of 40 IU/mL porcine insulin zinc suspension. Vials are supplied in cartons of one, 10 mL vial. | Subcutaneous Injection | In dogs: The initial recommended vetsulin dose is 0.5 IU insulin/kg body weight. Initially, this dose should be given once daily concurrently with, or right after a meal; In Cats:The initial recommended dose in cats is 1 to 2 IU per injection. The injections should be given twice daily at approximately 12 hour intervals. | Dogs and cats known to have a systemic allergy to pork or pork products should not be treated with vetsulin. vetsulin is contraindicated during periods of hypoglycemia. | In dogs: Clinical signs of hypoglycemia were generally mild in nature (described as weakness, lethargy, stumbling, falling down, and/or depression, hematuria, vomiting, diarrhea, pancreatitis, non-specific hepatopathy/pancreatitis, development of cataracts, and urinary tract infections. In Cats: omiting, lethargy, diarrhea, decreased appetite/anorexia, pancreatitis, dermal events, respiratory disease, urinary tract disorder, renal disease, dehydration, weight loss, polydipsia, polyuria, behavioral change, and ocular discharge/conjunctivitis. | Link | NA | NA |
| 10530 | Th1105 | Insulin aspart | >Th1105_Insulin_aspart GIVEQCCTSICSLYQLENYCN | 5825.8 | C256H381N65O79S6 | NA | NA | NA | 81 mins. SC injection | Recombinant (from S. cerevisiae),fast-acting insulin analogue. It contains a single amino acid substitution at position B28 where proline is replaced with aspartic acid. This results in a decreased hexamer formation and higher rate of absorption, compared to wild type insulin, following subcutaneous administration. | For the treatment of Type 1 or 2 diabetes mellitus. Should normally be used in conjunction with an intermediate or long-acting insulin. | Insulin is a natural hormone produced by beta cells of the pancreas. In non-diabetic individuals, a basal level of insulin is supplemented with insulin spikes following meals. Postprandial insulin spikes are responsible for the metabolic changes that occur as the body transitions from a postabsorptive to absorptive state. Insulin promotes cellular uptake of glucose, particularly in muscle and adipose tissues, promotes energy storage via glycogenesis, opposes catabolism of energy stores, increases DNA replication and protein synthesis by stimulating amino acid uptake by liver, muscle and adipose tissue, and modifies the activity of numerous enzymes involved in glycogen synthesis and glycolysis. Insulin also promotes growth and is required for the actions of growth hormone (e.g. protein synthesis, cell division, DNA synthesis). Insulin aspart is a rapid-acting insulin analogue used to mimic postprandial insulin spikes in diabetic individuals. The onset of action of insulin aspart is 10-15 minutes. Its activity peaks 60-90 minutes following subcutaneous injection and its duration of action is 4-5 hours. | Insulin aspart binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor autophosphorylates and phosphorylates numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. Activation of these proteins leads to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC), both of which play critical roles in metabolism and catabolism. In humans, insulin is stored in the form of hexamers; however, only insulin monomers are able to interact with IR. Substitution of the proline residue at B28 with aspartic acid reduces the tendency to form hexamers and results in a faster rate of absorption and onset of action and shorter duration of action. | Inappropriately high dosages relative to food intake and/or energy expenditure may result in severe and sometimes prolonged and life-threatening hypoglycemia. Neurogenic (autonomic) signs and symptoms of hypoglycemia include trembling, palpitations, sweating, anxiety, hunger, nausea and tingling. Neuroglycopenic signs and symptoms of hypoglycemia include difficulty concentrating, lethargy/weakness, confusion, drowsiness, vision changes, difficulty speaking, headache, and dizziness. Mild hypoglycemia is characterized by the presence of autonomic symptoms. Moderate hypoglycemia is characterized by the presence of autonomic and neuroglycopenic symptoms. Individuals may become unconscious in severe cases of hypoglycemia. | NA | Rapidly absorbed following subcutaneous administration (more so than regular human insulin). Furthermore, insulin aspart has a faster absorption, a faster onset of action, and a shorter duration of action than regular human insulin after subcutaneous injection. It takes 40 - 50 minutes to reach maximum concentration. When a dose of 0.15 U/kg body weight was injected in type 1 diabetes patients, the mean maximum concentration (Cmax) was 82 mU/L. The site of injection has no impact on extent or speed of absorption. | NA | 1.2 L/h/kg [healthy Caucasian male] | Hypoglycemic Agents and Antidiabetic Agents | US5618913 | 8-Apr-1997 | 7-Jun-2014 | NA | Insulin receptor,Insulin-like growth factor 1 receptor | NovoLog Mix 50/50 | Novo Nordisk | Novo Nordisk | NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with diabetes mellitus. | NA | NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) is a uniform, white, sterile suspension that contains insulin aspart (B28 asp regular human insulin analog) 100 Units/ml, 16 mg glycerol, 1.50 mg phenol, 1.72 mg metacreÂÂsol, 19.6 μg zinc, 1.25 mg disodium hydrogen phosphate dihydrate, 1.17 mg sodium chloride, and 0.23 mg protamine sulfate. NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) has a pH of 7.10 - 7.44. Hydrochloric acid or sodium hydroxide may be added to adjust pH | Uniform, white, sterile suspension that contains insulin aspart (B28 asp regular human insulin analog) | Subcutaneous | NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) should be administered within 15 minutes of meal initiation up to three times daily. It is intended only for subcutaneous injection into the abdominal wall, thigh, or upper arm. NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) should not be administered intravenously. | NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) or any of the excipients. | During clinical trials the overall adverse event profile of NovoLog Mix 50/50 was comparable to Novolin 70/30. Adverse events commonly associated with human insulin therapy include the following: Body as whole: allergic reactions, Skin and Appendages: Injection site reaction, lipodystrophy, pruritus, rash, Hypoglycemia | Link | NA | NA |
| 10531 | Th1105 | Insulin aspart | >Th1105_Insulin_aspart GIVEQCCTSICSLYQLENYCN | 5825.8 | C256H381N65O79S6 | NA | NA | NA | 81 mins. SC injection | Recombinant (from S. cerevisiae),fast-acting insulin analogue. It contains a single amino acid substitution at position B28 where proline is replaced with aspartic acid. This results in a decreased hexamer formation and higher rate of absorption, compared to wild type insulin, following subcutaneous administration. | For the treatment of Type 1 or 2 diabetes mellitus. Should normally be used in conjunction with an intermediate or long-acting insulin. | Insulin is a natural hormone produced by beta cells of the pancreas. In non-diabetic individuals, a basal level of insulin is supplemented with insulin spikes following meals. Postprandial insulin spikes are responsible for the metabolic changes that occur as the body transitions from a postabsorptive to absorptive state. Insulin promotes cellular uptake of glucose, particularly in muscle and adipose tissues, promotes energy storage via glycogenesis, opposes catabolism of energy stores, increases DNA replication and protein synthesis by stimulating amino acid uptake by liver, muscle and adipose tissue, and modifies the activity of numerous enzymes involved in glycogen synthesis and glycolysis. Insulin also promotes growth and is required for the actions of growth hormone (e.g. protein synthesis, cell division, DNA synthesis). Insulin aspart is a rapid-acting insulin analogue used to mimic postprandial insulin spikes in diabetic individuals. The onset of action of insulin aspart is 10-15 minutes. Its activity peaks 60-90 minutes following subcutaneous injection and its duration of action is 4-5 hours. | Insulin aspart binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor autophosphorylates and phosphorylates numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. Activation of these proteins leads to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC), both of which play critical roles in metabolism and catabolism. In humans, insulin is stored in the form of hexamers; however, only insulin monomers are able to interact with IR. Substitution of the proline residue at B28 with aspartic acid reduces the tendency to form hexamers and results in a faster rate of absorption and onset of action and shorter duration of action. | Inappropriately high dosages relative to food intake and/or energy expenditure may result in severe and sometimes prolonged and life-threatening hypoglycemia. Neurogenic (autonomic) signs and symptoms of hypoglycemia include trembling, palpitations, sweating, anxiety, hunger, nausea and tingling. Neuroglycopenic signs and symptoms of hypoglycemia include difficulty concentrating, lethargy/weakness, confusion, drowsiness, vision changes, difficulty speaking, headache, and dizziness. Mild hypoglycemia is characterized by the presence of autonomic symptoms. Moderate hypoglycemia is characterized by the presence of autonomic and neuroglycopenic symptoms. Individuals may become unconscious in severe cases of hypoglycemia. | NA | Rapidly absorbed following subcutaneous administration (more so than regular human insulin). Furthermore, insulin aspart has a faster absorption, a faster onset of action, and a shorter duration of action than regular human insulin after subcutaneous injection. It takes 40 - 50 minutes to reach maximum concentration. When a dose of 0.15 U/kg body weight was injected in type 1 diabetes patients, the mean maximum concentration (Cmax) was 82 mU/L. The site of injection has no impact on extent or speed of absorption. | NA | 1.2 L/h/kg [healthy Caucasian male] | Hypoglycemic Agents and Antidiabetic Agents | NA | NA | NA | NA | Insulin receptor,Insulin-like growth factor 1 receptor | NovoLog Mix 70/30 | Novo Nordisk | Novo Nordisk | NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with diabetes mellitus. | NA | Inactive ingredients for the 10 mL vial are mannitol 36.4 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 19.6 μg/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, sodium chloride 0.58 mg/mL, and protamine sulfate 0.32 mg/mL. Inactive ingredients for the NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart rdna origin) FlexPen are glycerol 16.0 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 19.6 μg/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, sodium chloride 0.877 mg/mL, and protamine sulfate 0.32 mg/mL. NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart rdna origin) has a pH of 7.20 - 7.44. Hydrochloric acid or sodium hydroxide may be added to adjust pH. | NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart rdna origin) is a uniform, white, sterile suspension that contains insulin aspart 100 Units/mL. | Subcutaneous | NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is an insulin analog with an earlier onset and intermediate duration of action in comparison to the basal human insulin premix. The addition of protamine to the rapid-acting aspart insulin analog (NovoLog) results in insulin activity that is 30% short-acting and 70% long-acting. NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is typically dosed on a twice-daily basis (with each dose intended to cover 2 meals or a meal and a snack). The dosage of NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) must be individualized. The written prescription for NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) should include the full name, to avoid confusion with NovoLog (insulin aspart) and Novolin 70/30 (human premix). | NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) is contraindicated during episodes of hypoglycemia in patients with hypersensitivity to NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart (rdna origin)) or one of its excipients. | signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out. Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal) | Link | NA | NA |
| 10662 | Th1140 | Insulin,isophane | >Th1140_Insulin,isophane GIVEQCCTSICSLYQLENYCN | 5808 | C257H383N65O77S6 | 9 | NA | 81 °C | Systemic insulin disposition (apparent terminal half-life) following oral inhalation of 4 to 48 units of human insulin was 120-206 minutes. | Recombinant (E.coli derived), Intermediate-acting insulin to improve glycemic control. It consists of a crystalline suspension of human insulin with protamine and zinc, which results in an intermediate-acting insulin with a slower onset of action and longer duration of activity compared to regular human insulin. | Used to improve glycemic control in patients with type 1 or type 2 diabetes mellitus. | When 0.3 Units/kg of NPH insulin was subcutaneously administered, the onset of action was approximately 0.8 hours. The duration of action was 13.2 hours. The peak activity of NPH insulin occurs 4-6 hours post-dose. Compared to insulin glargine, NPH insulin has a quicker onset of action and shorter duration of action. | The primary activity of insulin is the regulation of glucose metabolism. Insulin promotes glucose and amino acid uptake into muscle and adipose tissues, and other tissues except brain and liver. It also has an anabolic role in stimulating glycogen, fatty acid, and protein synthesis. Insulin inhibits gluconeogenesis in the liver. Insulin binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor is able to autophosphorylate and phosphorylate numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. These activated proteins, in turn, lead to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC) which play a critical role in metabolism and catabolism | NA | NA | NA | NA | NA | Hypoglycemic Agents and Antidiabetic Agents | NA | NA | NA | NA | Insulin receptor | Novolin N | Novo Nordisk | Novo Nordisk | Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, | NA | Novolin N in an InnoLet disposable prefilled insulin syringe. Novolin N is commonly known as NPH, Human Insulin Isophane Suspension (recombinant DNA origin). The concentration of this product is 100 units of insulin per milliliter. It is a cloudy or milky suspension of human insulin with protamine and zinc. The insulin substance (the cloudy material) settles at the bottom of the insulin reservoir, therefore, the Novolin N InnoLet (nph, human insulin isophane suspension 3 ml disposable prefilled syringe) must be rotated up and down so that the contents are uniformly mixed before a dose is given | Novolin N InnoLet (nph, human insulin isophane suspension 3 ml disposable prefilled syringe) | Subcutaneous | 0.5 U/kg/day SC (Type 1 Diabetes Mellitus), 0.5-1 units/kg/day in divided doses (Type 2 Diabetes Mellitus) | Tell your doctor or pharmacist if you have any medical conditions, pregnant, planning to become pregnant, or are breast-feeding; taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement; allergies to medicines, foods, or other substances; drink alcoholic beverages or smoke; heart problems (eg, heart failure); kidney or liver problems; nerve problems; adrenal, pituitary, or thyroid problems; or diabetic ketoacidosis; use 3 or more insulin injections per day; if you are fasting, have high blood sodium levels, or are on a low-salt (sodium) diet. Some MEDICINES MAY INTERACT with insulin isophane vials. Tell your health care provider if you are taking any other medicines, especially any of the following: Beta-blockers, Angiotensin-converting enzyme, (ACE) inhibitors, Thiazolidinediones Corticosteroids . | insulin allergy, Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms of low blood sugar may include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin isophane. | Link | NA | NA |
| 10664 | Th1142 | Obinutuzumab | NA | 146100 | C6512H10060N1712O2020S44 | NA | NA | NA | 28.4 days | Humanized monoclonal antibody used along with chlorambucil for the treatment of chronic lymphocytic leukemia. It was approved by the FDA in November 2013 and is marketed under the brand name Gazyva. It carries a black box warning of fatal Hepatitis B Virus (HBV) reactivation and fatal Progressive Multifocal Leukoencephalopathy (PML). | Obinutuzumab is used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia. | Obinutuzumab is more potent than rituximab in depleting B-cells, antitumor activity, and tumor regression. | In contrast to rituximab, which is a classic type I CD20 antibody, obinutuzumab binds to type II CD20 antibodies. This allows obinutuzumab to have a much higher induction of antibody-dependant cytotoxicity and a higher direct cytotoxic effect than the classic CD20 antibodies. | The most serious toxicities observed with obinutuzumab are Hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML). HBV reactivation can occur with all anti-CD20 antibodies and can result in hepatic failure, fulminant hepatitis, and death. PML occurs as a result of JC virus infection and can be fatal as well. Other common but less serious adverse reactions include infusion reactions (pre-treat with glucocorticoids, acetaminophen, and anti-histamine to prevent this), neutropenia, thrombocytopenia, and Tumor Lysis Syndrome (TLS) (pre-treat patients, especially with a high lymphocyte count and/or a high tumor burden, with anti-hyperuricemics and hydration). It is also recommended to NOT administer live virus vaccinations prior to or during obinutuzumab treatment. | Obinutuzumab is not metabolized by the liver. | Obinutuzumab is administered intravenously, so its absorption is 100%. | Obinutuzumab has a volume of distribution of about 3.8 L. | The clearance of obinutuzumab is 0.09L/day. | Antineoplastic Agents | NA | NA | NA | NA | B-lymphocyte antigen CD20 | Gazyva | Genentech | Genentech | chronic lymphocytic leukemia (CLL) | NA | GAZYVA is supplied at a concentration of 25 mg/mL in 1000 mg single use vials. The product is formulated in 20 mM L-histidine/L-histidine hydrochloride, 240 mM trehalose, 0.02% poloxamer 188. The pH is 6.0. | GAZYVA is produced by mammalian cell (CHO) suspension culture. GAZYVA is a sterile, clear, colorless to slightly brown, preservative free liquid concentrate for intravenousadministration. | Intravenous infusion | Each dose of GAZYVA is 1000 mg, administered intravenously, with the exception of the first infusions in cycle 1, which are administered on day 1 (100 mg) and day 2 (900 mg). | NA | Hepatitis B reactivation, Progressive multifocal leukoencephalopathy, Infusion reactions, Tumor lysis syndrome, Infections, Neutropenia, Thrombocytopenia. | Link | NA | NA |
| 10669 | Th1146 | Lucinactant | >Th1146_Lucinactant KLLLLKLLLLKLLLLKLLLLK | 2470.2 | C126H238N26O22 | NA | NA | NA | NA | A new synthetic peptide containing surfactant for intratracheal use. It contains sinapultide, a novel, hydrophobic, 21-amino acid peptide (leucine and lysine repeating units, KL4 peptide) designed to mimic human surfactant protein-B (SB-P). It specifically mimics the C-terminal amphipathic helical domain of this protein. It also consists of phospholipids (dipalmitoylphosphatidylcholine, DPPC and palmitoyloleoyl phosphatidylglycerol,POPG) and a fatty acid (palmitic acid). It is completely devoid of animal-derived components. FDA approved it on March 6, 2012. | Intended for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. | Lucinactant is a new synthetic surfactant containing a protein that mimics human surfactant protein-B, is effective at preventing respiratory distress syndrome (RDS) and related complications in preterm infants. Lucinactant has been shown to have antiinflammatory properties, is resistant to proteolytic degradation and oxidation, and has no potential for transmitting animal-derived diseases. Lucinactant has proven safe and effective in the prevention of RDS in preterm infants and as a treatment for MAS in full-term infants and for adult ARDS. | Pulmonary surfactant is a lipoprotein complex that is produced naturally in the lungs, where it lines the alveolar epithelium and serves to reduce surface tension, which facilitates alveoli expansion and allows gas exchange. Human surfactants contain phospholipids, predominantly dipalmitoylphosphatidylcholine (DPPC), in addition to surfactant proteins A, B, C and D. Surfactant is also a physical barrier to inhaled particle and noxious agents, enhances particle clearance, is involved in host defense against infection and possesses antiinflammatory properties. Several serious respiratory disorders have been associated with a loss or lack of endogenous surfactant. Lucinactant was designed to mimic the essential endogenous human surfactant protein B (SP-B). | Most common adverse reactions associated with the use of lucinactant are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption. | NA | NA | NA | NA | Pulmonary surfactants | US5407914 | 18-04-1995 | 17-11-2013 | NA | NA | Surfaxin | Discovery Laboratories, Inc. | Discovery Laboratories, Inc. | To prevent respiratory distress syndrome (RDS) in premature infants at high risk for RDS. It reduces the incidence of RDS at 24 hours and mortality due to RDS. | NA | Intratracheal Suspension: 8.5 mL suspension in a glass vial. Each mL contains 30 mg phospholipids [22.50 mg dipalmitoylphosphatidylcholine (DPPC) and 7.50 mg palmitoyloleoyl-phosphatidylglycerol, sodium salt (POPG, Na)], 4.05 mg palmitic acid (PA), and 0.862 mg sinapultide. | Suspension | Intratracheal administration | The recommended dose of surfaxin is 5.8 mL per kg birth weight. Up to 4 doses of surfaxin can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours. | None | Administration-related oxygen desaturation and bradycardia | Link | NA | NA |
| 10690 | Th1154 | OspA lipoprotein | >Th1154_OspA_lipoprotein MKKYLLGIGLILALIACKQNVSSLDEKNSVSVDVPGGMKVLVSKEKNKDGKYDLMATVDNVDLKGTSDKNNGSGILEGVKADKSKVKLTVADDLSKTTLEVLKEDGTVVSRKVTSKDKSTTEAKFNEKGELSEKTMTRANGTTLEYSQMTNEDNAAKAVETLKNGIKFEGNLASGKTAVEIKEGTVTLKREIDKNGKVTVSLNDTASGSKKTASWQESTSTLTISANSKKTKDLVFLTNGTITVQNYDSAGTKLEGSAAEIKKLDELKNALR | 27743.1 | C1198H2012N322O422S2 | 6.72 | -0.652 | NA | 1.2 Hrs (Mammalian reticulocytes,in vitro) | Vaccine against Lyme disease that contains lipoprotein OspA, an outer surface protein of Borrelia burgdorferi sensu stricto ZS7, as expressed by Escherichia coli. Lipoprotein OspA is a single polypeptide chain of 257 amino acids with lipids covalently bonded to the N terminus. It is conjugated with alum (aluminum hydroxide) as an adjuvant. | For prophylactic treatment of Lyme Disease | OspA lipoprotein is a single polypeptide chain of 270 amino acids. It is a vaccination used to prevent Lyme Disease. | OspA lipoprotein, an outer surface protein of the bacteria Borrelia burgdorferi sensu stricto ZS7, is used to stimulate the production of specific antibodies against B. burgdorferi. It is used as a vaccination against Lyme Disease, a disease carried by ticks. | NA | NA | NA | NA | NA | Vaccines | NA | NA | NA | NA | Toll-like receptor 2 | Lymerix | SmithKline Beecham | SmithKline Beecham | YMErix (lipoprotein outer surface a vaccine) is indicated for active immunization against Lyme disease in individuals 15 to 70 years of age. | NA | Each 0.5 mL dose of vaccine consists of 30 mcg of lipoprotein OspA adsorbed onto 0.5 mg aluminum as aluminum hydroxide adjuvant. Each dose of the vaccine preparation contains 10 mM phosphate buffered saline and 2.5 mg of 2-phenoxyethanol, a bacteriostatic agent. | LYMErix (lipoprotein outer surface a vaccine) is supplied as a sterile suspension | Intramuscular Injection | Primary immunization against Lyme disease consists of a 30 mcg/0.5 mL dose of LYMErix (lipoprotein outer surface a vaccine) given at 0, 1 and 12 months. | LYMErix (lipoprotein outer surface a vaccine) is contraindicated in people with known hypersensitivity to any component of the vaccine. | Hyperntension, Diarrhea, Arthritis, Backpain, Depression, Sinusitis, Rashes, Headache, Dizziness, Depression, Fever, Fatigue. | Link | NA | NA |
| 10692 | Th1156 | Abarelix | >Th1156_Abarelix XXXSYNLXPA | 1416.063 | C72H95ClN14O14 | NA | NA | NA | 13.2 ± 3.2 days | Synthetic decapeptide antagonist to gonadotropin releasing hormone (GnRH). It is marketed by Praecis Pharmaceuticals as Plenaxis. Praecis announced in June 2006 that it was voluntarily withdrawing the drug from the market. | For palliative treatment of advanced prostate cancer. | Used in the palliative treatment of advanced prostate cancer. Abarelix is a luteinizing hormone agonist that results in suppression of testicular or follicular steroidogenesis | Abarelix binds to the gonadotropin releasing hormone receptor and acts as a potent inhibitor of gonadotropin secretion | NA | NA | NA | NA | NA | Anti-Testosterone Agents | US5968895 | 19-10-1999 | 12-Nov-2016 | Tacrolimus, Thiothixene, Toremifene, Trimipramine, Voriconazole, Vorinostat, Ziprasidone, Zuclopenthixol- All above drugs cause Additive QTc Prolongation and increases the risk of severe ventricular arrythmias | Gonadotropin-releasing hormone receptor | Plenaxis | Speciality european pharma | Speciality european pharma | Plenaxis is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia. | Abarelix is chemically described as acetyl-D-β-naphthylalanyl-D-4-chlorophenylalanyl- D-3-pyridylalanyl-L-seryl-L-N-methyl-tyrosyl-D-asparagyl-L-leucyl-L-N(ε)-isopropyllysyl- L-prolyl-D-alanyl-amide. | The single-dose vial contains 113 mg of anhydrous free base abarelix peptide (net) supplied in an abarelix CMC complex. This complex also contains 19.1 to 31 mg of CMC. After the vial is reconstituted with 2.2 mL of 0.9% sodium chloride injection | Abarelix for injectable suspension is supplied as a white to off-white sterile dry powder | Intramuscular Injection | The recommended dose of Plenaxis is 100 mg administered intramuscularly to the buttock on Day 1, 15, 29 (week 4) and every 4 weeks thereafter. | Plenaxis is not indicated in women or pediatric patients. In addition, Plenaxis may cause fetal harm if administered to a pregnant woman. | Diarrhea, Dizziness, Flushing of Skin, Headache, Constipation, Sleep Disturbance | Link | NA | NA |
| 10734 | Th1169 | Beractant | NA | NA | NA | NA | NA | NA | 20–30 h. | Beractant is a pulmonary surfactant made from natural bovine lung extract. | Beractant is indicated for Respiratory Distress Syndrome (RDS) in premature infants. | Endogenous pulmonary surfactant lowers surface tension on alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. Deficiency of pulmonary surfactant causes Respiratory Distress Syndrome (RDS) in premature infants. SURVANTA replenishes surfactant and restores surface activity to the lungs of these infants. | In vitro, SURVANTA reproducibly lowers minimum surface tension to less than 8 dynes/cm as measured by the pulsating bubble surfactometer and Wilhelmy Surface Balance. In situ, SURVANTA restores pulmonary compliance to excised rat lungs artificially made surfactantdeficient. In vivo, single SURVANTA doses improve lung pressure-volume measurements, lung compliance, and oxygenation in premature rabbits and sheep. | NA | In surfactant-deficient premature rabbits and lambs, alveolar clearance of radio-labelled lipid components of beractant is rapid. Most of the dose becomes lung-associated within hours of administration, and the lipids enter endogenous surfactant pathways of reutilization and recycling. Limited animal experiments have not found effects of beractant on endogenous surfactant metabolism. | Beractant is administered directly to the target organ, the lungs, where biophysical effects occur at the alveolar surface. | NA | NA | Alveolar Surface Tension Reduction,Bradycardia-Causing Agents,Complex Mixtures,Pulmonary Surfactants,Respiratory System Agents,Surface-Active Agents,Surfactant Activity | NA | NA | NA | Bretylium may increase the bradycardic activities of Beractant; Beractant may increase the bradycardic activities of Ceritinib; Esmolol may increase the bradycardic activities of Beractant; Beractant may increase the bradycardic activities of Ivabradine; Beractant may increase the atrioventricular blocking (AV block) activities of Lacosamide; Octreotide may increase the bradycardic activities of Beractant; Ruxolitinib may increase the bradycardic activities of Beractant; Tofacitinib may increase the bradycardic activities of Beractant. | NA | Survanta | Abb Vie Inc. | Abb Vie Inc. | SURVANTA is indicated for prevention and treatment (“rescueâ€Â) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA significantly reduces the incidence of RDS, mortality due to RDS and air leak complications. | NA | 25 mg/mL | Suspension | endotracheal | Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg). | NA | pale skin; slow heartbeat; breathing that stops; urinating less than usual; or blood in the urine; noisy breathing; feeding or bowel problems; or bleeding around the endotracheal tube. | NA | NA | NA |
| 10735 | Th1169 | Beractant | NA | NA | NA | NA | NA | NA | 20–30 h. | Beractant is a pulmonary surfactant made from natural bovine lung extract. | Beractant is indicated for Respiratory Distress Syndrome (RDS) in premature infants. | Endogenous pulmonary surfactant lowers surface tension on alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. Deficiency of pulmonary surfactant causes Respiratory Distress Syndrome (RDS) in premature infants. SURVANTA replenishes surfactant and restores surface activity to the lungs of these infants. | In vitro, SURVANTA reproducibly lowers minimum surface tension to less than 8 dynes/cm as measured by the pulsating bubble surfactometer and Wilhelmy Surface Balance. In situ, SURVANTA restores pulmonary compliance to excised rat lungs artificially made surfactantdeficient. In vivo, single SURVANTA doses improve lung pressure-volume measurements, lung compliance, and oxygenation in premature rabbits and sheep. | NA | In surfactant-deficient premature rabbits and lambs, alveolar clearance of radio-labelled lipid components of beractant is rapid. Most of the dose becomes lung-associated within hours of administration, and the lipids enter endogenous surfactant pathways of reutilization and recycling. Limited animal experiments have not found effects of beractant on endogenous surfactant metabolism. | Beractant is administered directly to the target organ, the lungs, where biophysical effects occur at the alveolar surface. | NA | NA | Alveolar Surface Tension Reduction,Bradycardia-Causing Agents,Complex Mixtures,Pulmonary Surfactants,Respiratory System Agents,Surface-Active Agents,Surfactant Activity | NA | NA | NA | Bretylium may increase the bradycardic activities of Beractant; Beractant may increase the bradycardic activities of Ceritinib; Esmolol may increase the bradycardic activities of Beractant; Beractant may increase the bradycardic activities of Ivabradine; Beractant may increase the atrioventricular blocking (AV block) activities of Lacosamide; Octreotide may increase the bradycardic activities of Beractant; Ruxolitinib may increase the bradycardic activities of Beractant; Tofacitinib may increase the bradycardic activities of Beractant. | NA | Survanta | Abbvie Corporation | Abbvie Corporation | SURVANTA is indicated for prevention and treatment (“rescueâ€Â) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA significantly reduces the incidence of RDS, mortality due to RDS and air leak complications. | NA | 25 mg | Suspension | intratracheal | Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg). | NA | pale skin; slow heartbeat; breathing that stops; urinating less than usual; or blood in the urine; noisy breathing; feeding or bowel problems; or bleeding around the endotracheal tube. | NA | NA | NA |
| 10838 | Th1201 | Poractant alfa | NA | NA | NA | NA | NA | NA | Studied in adult and newborn rabbits, the half-life in the lungs was found to be 25 and 67 respectiv | Poractant alfa is a pulmonary surfactant marketed as Curosurf in the United States and Canada. It is used to treat Respiratory Distress Syndrome (RDS) in premature infants with an endogenous pulmonary surfactant deficiency. Poractant alfa is an extract of natural porcine lung surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight proteins (surfactant associated proteins SP-B and SP-C). The phospholipid content of the extract consists primarily of phosphatidylcholine and dipaImitoylphosphatidylcholine. Poractant alfa is a creamy white suspension of this extract in 0.9% sodium chloride solution. It contains no preservatives. | Poractant alfa is indicated for the treatment of Respiratory Distress Syndrome (RDS) in premature infants. | Poractant alfa improved lung compliance, pulmonary gas exchange and survival in preterm rabbits. | Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli in the lungs, thus stabilizing them against collapse under transpulmonary pressures. A deficiency of pulmonary surfactant in premature infants allows surface tension to increase to the point where sections of lung collapse and respiratory distress syndrome (RDS) develops. Poractant alfa lowers minimum surface tension to less than or equal to 4 mN/m. This compensates for the lack of endogenous surfactant and restores adequate surface activity to the lungs | Studies on the carcinogenicity or reproductive effects of poractant alfa have not been conducted. Mutagenicity assays were negative. In the case of an overdose with poractant alfa where there are clear clinical effects on the infant's respiration, ventilation, or oxygenation, it is recommended that as much of the solution be aspirated as possible and the infant be managed with supportive measures. Fluid and electrolyte balances should be monitored closely in this case. | No studies on the metabolism of poractant alfa have been performed in humans. One small study in rabbits did find that poractant alfa may be degraded by macrophages and that it may, in part, be recycled in the alveoli in a similar manner to endogenous lung surfactant. | Poractant alfa is administered directly to the site of action in the lungs via endotracheal tube. It very rapidly adsorbs to the air-liquid interface to form a stable surfactant monolayer. No studies on absorption of poractant alfa have been performed in humans. | No studies on the distribution of poractant alfa have been performed in humans. | No studies on clearance of poractant alfa have been performed in humans. | Pulmonary Surfactants | NA | NA | NA | Bretylium, Ceritinib, Esmolol, Ivabradine, Lacosamide, Octreotide, Ruxolitinib, Tofacitinib | NA | Curosurf | Chiesi USA, Inc | Chiesi USA, Inc | CUROSURF® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS. | NA | 80 mg/mL | Suspension | endotracheal | The initial recommended dose is 2.5 mL/kg birth weight (see Table 1), administered as one or two aliquots depending upon the instillation procedure. | NA | Curosurf (poractant alfa) Suspension is a pulmonary surfactant used to treat Respiratory Distress Syndrome (RDS) in premature infants. Curosurf reduces mortality and pneumothoraces (collapsed lung) associated with RDS. Common side effects of Curosurf include slow heart rate, low blood pressure, endotracheal tube blockage, and low blood oxygen levels. Many side effects are associated with premature birth. | Link | NA | NA |
| 10849 | Th1212 | Insulin Pork | >Th1212_Insulin_Pork GIVEQCCTSICSLYQLENYCN | 5795.6 | C257H387N65O76S6 | 5.39 | 0.218 | NA | NA | Insulin isolated from pig pancreas. Composed of alpha and beta chains, processed from pro-insulin. Forms a hexameric structure. | For the treatment of type I and II diabetes mellitus. | Insulin is used in the treatment of type I and type II diabetes. The primary activity of insulin is the regulation of glucose metabolism. In muscle and other tissues (except the brain), insulin causes rapid transport of glucose and amino acids intracellularly. It also promotes anabolism, and inhibits protein catabolism. In the liver, insulin promotes the uptake and storage of glucose in the form of glycogen, inhibits gluconeogenesis, and promotes the conversion of excess glucose into fat. | Insulin binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor is able to autophosphorylate and phosphorylate numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. These activated proteins, in turn, lead to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC) which play a critical role in metabolism. | NA | Insulin is predominantly cleared by metabolic degradation via a receptor-mediated process. | NA | NA | NA | Alimentary Tract and Metabolism,Amino Acids, Peptides, and Proteins,Blood Glucose Lowering Agents,Cytochrome P-450 CYP1A2 Inducers,Cytochrome P-450 CYP1A2 Inducers (strength unknown),Cytochrome P-450 Enzyme Inducers,Drugs Used in Diabetes,Hormones,Hormones, Hormone Substitutes, and Hormone Antagonists,Insulin,Insulin, Short-Acting,Insulins and Analogues for Injection, Fast-Acting,Pancreatic Hormones,Peptide Hormones,Peptides,Protein Precursors,Proteins | NA | NA | NA | NA | Insulin receptor,Insulin-like growth factor 1 receptor | Iletin II | Lilly | Lilly | NA | NA | 100 units/mL (U-100) | sterile suspension | Subcutaneous | NA | NA | NA | Link | NA | NA |
| 10868 | Th1229 | Hepatitis A Vaccine | NA | NA | NA | NA | NA | NA | Evaluation of pharmacokinetic properties is not required for vaccines. | Two types of HAV vaccines are currently available internationally: 1. Formaldehyde-inactivated vaccines: Inactivated HAV vaccines are used in most countries. Monovalent inactivated HAV vaccines are available in paediatric dose (0.5 ml) for children aged 1 year to 15 years, and in adult dose (1 ml). 2. Live attenuated vaccines (based on H2 or LA-1 HAV strains): These vaccines are manufactured and used mainly in China and India. Inactivated hepatitis A vaccines are safe and highly effective. Traditionally, a two-dose schedule is recommended, particularly in travellers at substantial risk of contracting hepatitis A and in immunocompromised individuals. However, in healthy individuals, comparable effectiveness has been achieved with a single dose. The Chinese live attenuated hepatitis A vaccines have been shown to be safe and highly protective (95%) against clinical infection for at least 3 years. Among the adverse effects from Hepatitis A vaccine injection are fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the injection site and malaise. Anorexia and nausea could be possible side effects. | Hepatitis A vaccine is indicated for active immunization against disease caused by hepatitis A virus (HAV). It is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. HAVRIX® will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low to intermediate prevalence of hepatitis A, immunization with HAVRIX® is particularly recommended in subjects who are, or will be, at increased risk of infection such as: * Travelers: Persons traveling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the Mediterranean basin, the Middle East, Central and South America. * Armed Forces: Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor have an increased risk of HAV infection. Active immunization is indicated for these individuals. * Persons for whom Hepatitis A is an Occupational Hazard: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, and food handlers, among others. * Persons for whom there is an Increased Risk of Transmission of Hepatitis A: e.g. homosexuals, persons with multiple sexual partners, abusers of injectable drugs, hemophiliac patients. * Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunization of close contacts is recommended. * Specific Population Groups known to have Higher Incidence of Hepatitis A: e.g. North American Indians, Inuits, recognized community-wide HAV epidemics. * Subjects with chronic liver disease or who are at risk of developing chronic liver disease e.g. Hepatitis B (HB) and Hepatitis C (HC) chronic carriers and alcohol abusers. | Elevation of Anti-Hepatitis A antibodies which gives protection against Hepatitis A infection. | The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined. | LD50 information for the hepatitis A vaccine is not readily available in the literature. The prescribing information for the inactivated Hepatitis A vaccine indicates that postmarketing reports of adverse effects following an overdose with the vaccine that were similar to those that are normally expected. This may include pain or redness at the injection site, headache, irritability, appetite loss, and other symptoms. Prescribing information also advises contacting the local poison control center in the case of an overdose.[L338] | NA | NA | NA | NA | Actively Acquired Immunity,Inactivated Hepatitis A Virus Vaccine,Vaccines | NA | NA | NA | NA | B-lymphocytes | Avaxim | Sanofi Pasteur Limited | Sanofi Pasteur Limited | AVAXIM is indicated for active immunisation against infection caused by hepatitis A virus in susceptible adults and adolescents of 16 years of age and above. | NA | Each 0.5 mL dose of sterile, whitish, cloudy suspension, contains 80 antigen units of inactivated hepatitis A virus. Nonmedicinal ingredients: aluminum hydroxide (expressed as aluminum): 0.15 mg; 2-phenoxyethanol: 2.5 µL; formaldehyde: 12.5 µg; polysorbate 80 in less than 750 µg; medium 199, water for injection up to: 0.5 mL; neomycin: trace amounts. | Suspension | Intramuscular | NA | Hypersensitivity to the active substance(s) or to any of the excipients. | diarrhea, drowsiness, fatigue, fever, generally feeling unwell, headache, irritability, loss of appetite, muscle or joint achiness, nausea or vomiting, pain and redness at the injection site, swelling or hard lump at the injection site, weakness might occur as side reaction | Link | NA | NA |
| 10869 | Th1229 | Hepatitis A Vaccine | NA | NA | NA | NA | NA | NA | Evaluation of pharmacokinetic properties is not required for vaccines. | Two types of HAV vaccines are currently available internationally: 1. Formaldehyde-inactivated vaccines: Inactivated HAV vaccines are used in most countries. Monovalent inactivated HAV vaccines are available in paediatric dose (0.5 ml) for children aged 1 year to 15 years, and in adult dose (1 ml). 2. Live attenuated vaccines (based on H2 or LA-1 HAV strains): These vaccines are manufactured and used mainly in China and India. Inactivated hepatitis A vaccines are safe and highly effective. Traditionally, a two-dose schedule is recommended, particularly in travellers at substantial risk of contracting hepatitis A and in immunocompromised individuals. However, in healthy individuals, comparable effectiveness has been achieved with a single dose. The Chinese live attenuated hepatitis A vaccines have been shown to be safe and highly protective (95%) against clinical infection for at least 3 years. Among the adverse effects from Hepatitis A vaccine injection are fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the injection site and malaise. Anorexia and nausea could be possible side effects. | Hepatitis A vaccine is indicated for active immunization against disease caused by hepatitis A virus (HAV). It is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. HAVRIX® will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low to intermediate prevalence of hepatitis A, immunization with HAVRIX® is particularly recommended in subjects who are, or will be, at increased risk of infection such as: * Travelers: Persons traveling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the Mediterranean basin, the Middle East, Central and South America. * Armed Forces: Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor have an increased risk of HAV infection. Active immunization is indicated for these individuals. * Persons for whom Hepatitis A is an Occupational Hazard: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, and food handlers, among others. * Persons for whom there is an Increased Risk of Transmission of Hepatitis A: e.g. homosexuals, persons with multiple sexual partners, abusers of injectable drugs, hemophiliac patients. * Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunization of close contacts is recommended. * Specific Population Groups known to have Higher Incidence of Hepatitis A: e.g. North American Indians, Inuits, recognized community-wide HAV epidemics. * Subjects with chronic liver disease or who are at risk of developing chronic liver disease e.g. Hepatitis B (HB) and Hepatitis C (HC) chronic carriers and alcohol abusers. | Elevation of Anti-Hepatitis A antibodies which gives protection against Hepatitis A infection. | The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined. | LD50 information for the hepatitis A vaccine is not readily available in the literature. The prescribing information for the inactivated Hepatitis A vaccine indicates that postmarketing reports of adverse effects following an overdose with the vaccine that were similar to those that are normally expected. This may include pain or redness at the injection site, headache, irritability, appetite loss, and other symptoms. Prescribing information also advises contacting the local poison control center in the case of an overdose.[L338] | NA | NA | NA | NA | Actively Acquired Immunity,Inactivated Hepatitis A Virus Vaccine,Vaccines | NA | NA | NA | NA | B-lymphocytes | Havrix | Dispensing Solutions, Inc. | Dispensing Solutions, Inc. | HAVRIX® is indicated for active immunization against disease caused by hepatitis A virus (HAV) | NA | Each 1-mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. It contains few excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). | Suspension | Intramuscular | Primary immunization for children and adolescents (12 months through 18 years of age) consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later. | Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX | Injection site hematoma, upper respiratory tract infections, Insomnia etc | Link | NA | NA |