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Injection II
Providing you the best range of lg hyal medicine, granocyte, levemir, luveris, mencevax acwy and havpur with effective & timely delivery.
Lg Hyal Medicine
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Product Details:
| Dose | 1ml-5ml, 5ml-10ml |
| Injectable Form | Solution |
| Application | Analgesics and Pain Relief Medicines, Anti Infective & Common Disease Medicines |
| Injection Site | Intravenous, Intramuscular |
| Packaging Type | Glass Bottle |
| Medicine Type | Allopathic |
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Granocyte
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Product Details:
| Grade standard | Medicine Grade |
| Application | Anti-Infective |
| Packaging Type | Bottles |
| API Form | Liquid |
| Dosage Form | Injection |
| Type of Medicines | Allopathic |
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Levemir
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NOVO NORDISK
"LEVEMIR (insulin detemir [rDNA origin] injection) is a sterile solution of insulin detemir for use as a subcutaneous injection. Insulin detemir is a long-acting (up to 24-hour duration of action) recombinant human insulin analog. LEVEMIR is produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.
Insulin detemir differs from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been attached to the amino acid B29. Insulin detemir has a molecular formula of C267H402O76N64S6 and a molecular weight of 5916.9. It has the following structure:
Figure 1: Structural Formula of insulin detemir
View Enlarged Table"
INSULIN DIABETES
"LEVEMIR (insulin detemir [rDNA origin] injection) is a sterile solution of insulin detemir for use as a subcutaneous injection. Insulin detemir is a long-acting (up to 24-hour duration of action) recombinant human insulin analog. LEVEMIR is produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.
Insulin detemir differs from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been attached to the amino acid B29. Insulin detemir has a molecular formula of C267H402O76N64S6 and a molecular weight of 5916.9. It has the following structure:
Figure 1: Structural Formula of insulin detemir
View Enlarged Table"
INSULIN DIABETES
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Luveris
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MERCK SERONO
"Luveris® (lutropin alfa for injection) is a sterile lyophilized powder composed of recombinant human luteinizing hormone, r-hLH. r-hLH is a heterodimeric glycoprotein consisting of two non-covalently linked subunits (designated α and β) of 92 and 121 amino acids, respectively. The carbohydrate chain attachment to the r-hLH protein core occurs via N- but not O-linkage. The N-glycosylation sites are Asn-52 and Asn-78 for the α–subunit and Asn-30 for the β–subunit. The β-chain has an N-glycosylation site and its structure and glycosylation pattern are very similar to that of pituitary-derived hLH.
Slideshow: Vaccination Safety: Your Questions Answered
Vaccination Safety: Your Questions Answered
The production process involves expansion of genetically modified Chinese Hamster Ovary (CHO) cells from an extensively characterized cell bank into large scale cell culture processing. Lutropin alfa is secreted by the CHO cells directly into the cell culture medium that is then purified using a series of chromatographic steps. The biological activity of lutropin alfa is determined using the Van Hell Bioassay described in the British Pharmacopoeia. The in vivo biological activity is determined using a house standard properly calibrated against the relevant international standard.
Luveris® is a sterile, lyophilized powder, which after reconstitution with Sterile Water for Injection, USP, is intended for subcutaneous (sc) administration. Each vial of Luveris® contains 82.5 IU lutropin alfa, 48 mg sucrose, 0.83 mg dibasic sodium phosphate dihydrate, 0.052 mg monobasic sodium phosphate monohydrate, 0.05 mg polysorbate 20, and 0.1 mg L-methionine. Phosphoric acid and/or sodium hydroxide are used to adjust the pH. After reconstitution with 1 mL of enclosed diluent, the product will deliver 75 IU of recombinant human lutropin alfa. The pH of the reconstituted solution is 7.5 to 8.5.
Therapeutic Class: Infertility"
FERTILITY HORMONE
"Luveris® (lutropin alfa for injection) is a sterile lyophilized powder composed of recombinant human luteinizing hormone, r-hLH. r-hLH is a heterodimeric glycoprotein consisting of two non-covalently linked subunits (designated α and β) of 92 and 121 amino acids, respectively. The carbohydrate chain attachment to the r-hLH protein core occurs via N- but not O-linkage. The N-glycosylation sites are Asn-52 and Asn-78 for the α–subunit and Asn-30 for the β–subunit. The β-chain has an N-glycosylation site and its structure and glycosylation pattern are very similar to that of pituitary-derived hLH.
Slideshow: Vaccination Safety: Your Questions Answered
Vaccination Safety: Your Questions Answered
The production process involves expansion of genetically modified Chinese Hamster Ovary (CHO) cells from an extensively characterized cell bank into large scale cell culture processing. Lutropin alfa is secreted by the CHO cells directly into the cell culture medium that is then purified using a series of chromatographic steps. The biological activity of lutropin alfa is determined using the Van Hell Bioassay described in the British Pharmacopoeia. The in vivo biological activity is determined using a house standard properly calibrated against the relevant international standard.
Luveris® is a sterile, lyophilized powder, which after reconstitution with Sterile Water for Injection, USP, is intended for subcutaneous (sc) administration. Each vial of Luveris® contains 82.5 IU lutropin alfa, 48 mg sucrose, 0.83 mg dibasic sodium phosphate dihydrate, 0.052 mg monobasic sodium phosphate monohydrate, 0.05 mg polysorbate 20, and 0.1 mg L-methionine. Phosphoric acid and/or sodium hydroxide are used to adjust the pH. After reconstitution with 1 mL of enclosed diluent, the product will deliver 75 IU of recombinant human lutropin alfa. The pH of the reconstituted solution is 7.5 to 8.5.
Therapeutic Class: Infertility"
FERTILITY HORMONE
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Mencevax Acwy
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GSK
"DESCRIPTION Mencevax ACWY is a lyophilized preparation of purified polysaccharides f
rom Neisseria meningitidis (meningococcus) of groups A, C,W-135 and Y.
It is presented as a white pellet in a glass vial together with a separate vial of clear, colourless, sterile saline solvent. When reconstituted with the solvent supplied the vaccine is ready for subcutaneous injection. Each 0.5 mL dose of reconstituted vaccine contains 50 micrograms
of each of the polysaccharide of groups A, C,W-135, and Y . Other ingredients The reconstituted vaccine also contains 12.6 mg of sucrose, 4.5 mg of s trometamol and water for injections to 0.5mL"
MENINGITIS VACCINE
"DESCRIPTION Mencevax ACWY is a lyophilized preparation of purified polysaccharides f
rom Neisseria meningitidis (meningococcus) of groups A, C,W-135 and Y.
It is presented as a white pellet in a glass vial together with a separate vial of clear, colourless, sterile saline solvent. When reconstituted with the solvent supplied the vaccine is ready for subcutaneous injection. Each 0.5 mL dose of reconstituted vaccine contains 50 micrograms
of each of the polysaccharide of groups A, C,W-135, and Y . Other ingredients The reconstituted vaccine also contains 12.6 mg of sucrose, 4.5 mg of s trometamol and water for injections to 0.5mL"
MENINGITIS VACCINE
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Havpur
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Product Details:
| Packaging Type | Sachet |
| Dose/Strength (ex. 1 mg or 1 ml) | 1mg/ml |
| Packaging Size | 10 ml |
| Usage | Clinical, Hospital |
| Generic | Inactivated Hepatitis A viral vaccine |
| Grade | Medicine grade |
| Form | Injection |
"HAVpur - Pharmacology: Provides active immunization against hepatitis A.
Indication: Active immunization of patients 12 mo of age and older against disease caused by hepatitis A virus.
VAQTA is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus in persons 2 years of age and older. Primary immunization should be given at least 2 weeks prior to expected exposure to HAV.
Individuals who are or will be at increased risk of infection by HAV include:
TRAVELERS
Persons traveling to areas of higher endemicity for hepatitis A. These areas include, but are not limited to, Africa, Asia (except Japan), the Mediterranean basin, Eastern Europe, the Middle East, Central and South America, Mexico, and parts of the Caribbean. Current CDC (Centers for Disease Control and Prevention) advisories should be consulted with regard to specific locales.
MILITARY PERSONNEL
PEOPLE LIVING, IN, OR RELOCATING TO, AREAS OF HIGH ENDEMICITY
CERTAIN ETHNIC AND GEOGRAPHIC POPULATIONS THAT EXPERIENCE CYCLIC HEPATITIS A EPIDEMICS SUCH AS:
Native peoples of Alaska and the Americas.
OTHERS
Persons engaging in high-risk sexal activity (such as homosexually active males); users of illicit injectable drugs; residents of a community experiencing an outbreak of hepatitis A.
Hemophiliacs and other recipients of therapeutic blood products (see and ).
Persons who test positive for hepatitis C virus and have diagnosed liver disease.
Although the epidemiology of hepatitis A does not permit the identification of other specific populations at high risk of disease, outbreaks of hepatitis A or exposure to hepatitis A virus have been described in a variety of populations in which VAQTA may be useful:
Certain institutional workers (e.g., caretakers for the developmentally challenged)
Employees of child day-care centers
Laboratory workers who handle live hepatitis A virus
Handlers of primate animals that may be harboring HAV
PEOPLE EXPOSED TO HEPATITIS A
For those requiring both immediate and long-term protection, VAQTA may be administered concomitantly with IG.
Revaccination
See,.
Use With Other Vaccines
VAQTA may be given concomitantly at separate injection sites with typhoid and yellow fever vaccines. The GMTs for hepatitis A when VAQTA, typhoid and yellow fever vaccines were administered concomitantly were reduced when compared to VAQTA alone. Following receipt of the booster dose of VAQTA, the GMTs for hepatitis A in these two groups were observed to be comparable. (See, and,.)
The Advisory Committee on Immunization Practices has stated that limited data from studies conducted among adults indicate that simultaneous administration of hepatitis A vaccine with diphtheria, poliovirus (oral and inactivated), tetanus, oral typhoid, cholera, Japanese encephalitis, rabies, or yellow fever vaccine does not decrease the immune response to either vaccine or increase the frequency of reported adverse events. Studies indicate that hepatitis B vaccine can be administered with VAQTA without affecting immunogenicity or increasing the frequency of adverse events.
Use With Immune Globulin
For individuals requiring either post-exposure prophylaxis or combined immediate and longer-term protection (e.g., travelers departing on short notice to endemic areas), VAQTA may be administered concomitantly with IG using separate sites and syringes (see and ).
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Holoxan
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Product Details:
| Form Of Medicines | Gels |
| Application | Analgesics, Anti-Infective |
| Packaging Type | Bottles |
| Dosage Form | Injection |
| Type of Medicines | Allopathic |
| Grade standard | Medicine Grade |
"HOLOXAN (ifosfamide) New Zealand Data Sheet HOLOXAN Data Sheet 10 December 2013 Page 1 of 23 Baxter HOLOXAN Ifosfamide 500mg, 1g, 2g Powder for Injection FOR INTRAVENOUS USE ONLY
DESCRIPTION
HOLOXAN (sterile ifosfamide) is supplied as single-dose vials of 500mg, 1g, or 2g for reconstitution and administration by intrave nous injection/infusion. Ifosfamide is a chemotherapeutic agent related chemically to the nitrogen mustards and is a synthetic analogue of cyclophosphamide. Ifosfamide is 3-(2-chloroe thyl)-2-[(2-chloroethyl)amino]tetrahydro-2H-1,3,2- oxazaphosphorine 2-oxide. The molecular formula is C
7 H 15 CI 2 N 2 O 2 P and its molecular weight is 261.1. Its structural formula is: Ifosfamide is a white crystalline powder that is soluble in water"
ONCOLOGY
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Immunate 250Iu Inj
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BAXTER
"Human (Immunate) - Indication: Rabies vaccine and Hyper RAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. Hyper RAB S/D should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given.
Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S. Public Health Service Advisory Committee on Immunization Practices (ACIP).
"Human (Immunate) - Indication: Rabies vaccine and Hyper RAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. Hyper RAB S/D should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given.
Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S. Public Health Service Advisory Committee on Immunization Practices (ACIP).
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Kamrab 300Mcg Injection
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KAMADA LTD,
"We are able to supply a wide range of Vaccines and Biological products like Anti Toxins and Sera. We work with Multinational as well as WHO Prequalified Indian manufacturers for their Vaccines. We are able to offer the following products including anti rabies vaccine, oral polio vaccine, hepatitis b vaccine, vaccines and serum, influenza vaccine, meningitis vaccine, chicken pox vaccine etc.
* Oral Polio Vaccine
* Hepatitis B Vaccine
* Influenza Vaccine
* Anti Rabies Vaccine
* DPT Vaccine
* MMR Vaccine
* TD Vaccine
* Meningitis Vaccine
* Chicken Pox Vaccine
* Trivalent Vaccine, Quadrivalent Vaccines/ Pentavalent Vaccines etc."
RABIES IMMUNOGLOBULIN
"We are able to supply a wide range of Vaccines and Biological products like Anti Toxins and Sera. We work with Multinational as well as WHO Prequalified Indian manufacturers for their Vaccines. We are able to offer the following products including anti rabies vaccine, oral polio vaccine, hepatitis b vaccine, vaccines and serum, influenza vaccine, meningitis vaccine, chicken pox vaccine etc.
* Oral Polio Vaccine
* Hepatitis B Vaccine
* Influenza Vaccine
* Anti Rabies Vaccine
* DPT Vaccine
* MMR Vaccine
* TD Vaccine
* Meningitis Vaccine
* Chicken Pox Vaccine
* Trivalent Vaccine, Quadrivalent Vaccines/ Pentavalent Vaccines etc."
RABIES IMMUNOGLOBULIN
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Lymphoglobuline 100Mg Inj
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PASTEUR
IMMUNOSUPPRESANT / RENAL APLASTIC ANEMIA
IMMUNOSUPPRESANT / RENAL APLASTIC ANEMIA
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Meningococcal A+C
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SANOFI PASTEUR
"Menomune ® – A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, for subcutaneous use, is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis , Group A, Group C, Group Y and Group W-135. N meningitidis are cultivated with Mueller Hinton agar 1 and Watson Scherp 2
media. The purified polysaccharide is extracted from the Neisseria meningitidis cells and separated from the media by procedures which include centrifugation, detergent precipitation, alcohol precipitation, solvent or organic extraction and diafiltration. No preservative is
added during manufacture. The 0.78 mL vial of diluent contains sterile, preservative-free, pyrogen-free distilled water and is used for reconstitution of product supplied in 1 mL vials. The 6 mL vial of diluent contains sterile, pyrogen-free distilled water to which thimerosal (mercury derivative) 1:10,000 is added as a preservative. The 6 mL vial is for reconstitution of product supplied in 10 mL vials. After reconstitution with diluent as indicated on the label, the 0.5 mL dose is formulated to contain 50 μg of “isolated product” from each of Groups A, C, Y and W-135 in an isotonic sodium chloride solution. Each dose of vaccine is also formulated to contain 2.5 mg to 5 mg of lactose added as a stabilizer. 3 The vaccine when reconstituted is a clear colorless liquid. Potency is evaluated by measuring the molecular size of each polysaccharide component using a column chromatography method as standardized by the US Food and Drug Administration (FDA) and the World Health Organization (WHO) 4 for Meningococcal Polysaccharide Vaccine. THIS VACCINE CONFORMS TO THE WORLD HEALTH ORGANIZATION (WHO) REQUIREMENTS"
MENINGITIS VACCINE
"Menomune ® – A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, for subcutaneous use, is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis , Group A, Group C, Group Y and Group W-135. N meningitidis are cultivated with Mueller Hinton agar 1 and Watson Scherp 2
media. The purified polysaccharide is extracted from the Neisseria meningitidis cells and separated from the media by procedures which include centrifugation, detergent precipitation, alcohol precipitation, solvent or organic extraction and diafiltration. No preservative is
added during manufacture. The 0.78 mL vial of diluent contains sterile, preservative-free, pyrogen-free distilled water and is used for reconstitution of product supplied in 1 mL vials. The 6 mL vial of diluent contains sterile, pyrogen-free distilled water to which thimerosal (mercury derivative) 1:10,000 is added as a preservative. The 6 mL vial is for reconstitution of product supplied in 10 mL vials. After reconstitution with diluent as indicated on the label, the 0.5 mL dose is formulated to contain 50 μg of “isolated product” from each of Groups A, C, Y and W-135 in an isotonic sodium chloride solution. Each dose of vaccine is also formulated to contain 2.5 mg to 5 mg of lactose added as a stabilizer. 3 The vaccine when reconstituted is a clear colorless liquid. Potency is evaluated by measuring the molecular size of each polysaccharide component using a column chromatography method as standardized by the US Food and Drug Administration (FDA) and the World Health Organization (WHO) 4 for Meningococcal Polysaccharide Vaccine. THIS VACCINE CONFORMS TO THE WORLD HEALTH ORGANIZATION (WHO) REQUIREMENTS"
MENINGITIS VACCINE
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Metalyse
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BOEHRINGER INGELHEIM
"Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology,
using an established mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527
amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with
asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra - alanine substitution at amino acids 296 – 299 in the protease domain.
Cell culture is carried out in nutrient medium containing the antibiotic gentamicin (65 mg/L).
However, the presence of the antibiotic is not detectable in the final product (limit of detection is 0.67 μg/vial). METALYSE is a sterile, white to off - white, lyophilis ed powder for single intravenous bolus administration after reconstitution with sterile Water for Injections."
CARDIOVASCULAR - ACUTE MYOCARDIAL INFARCTION
"Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology,
using an established mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527
amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with
asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra - alanine substitution at amino acids 296 – 299 in the protease domain.
Cell culture is carried out in nutrient medium containing the antibiotic gentamicin (65 mg/L).
However, the presence of the antibiotic is not detectable in the final product (limit of detection is 0.67 μg/vial). METALYSE is a sterile, white to off - white, lyophilis ed powder for single intravenous bolus administration after reconstitution with sterile Water for Injections."
CARDIOVASCULAR - ACUTE MYOCARDIAL INFARCTION
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Minirin
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FERRING
"Minirin - Minirin is a man-made form of a hormone that occurs naturally in the pituitary gland. This hormone is important for many functions including blood flow, blood pressure, kidney function, and regulating how the body uses water.
Minirin is used to treat bed-wetting, central cranial diabetes insipidus, and increased thirst and urination caused by head surgery or head trauma.
Minirin may also be used for other purposes not listed in this medication guide.
Minirin is a hormone. It helps to control the symptoms of diabetes insipidus (""water diabetes"") where the body produces an abnormally large amount of urine. Minirin is also used to control excessive thirst and to reduce the production of an abnormally large amount of urine that occurs after a head injury or after certain types of surgery. Minirin can also be used to treat certain bleeding disorders. Minirin may also be used to test the ability of the body to dissolve blood clots that have formed.
Oral Cranial diabetes insipidus
Adult: Initially, 100 mcg tid adjusted according to response.
Maintenance: 100-200 mcg tid, up to 100-1200 mcg daily.
Child: Initially, 100 mcg tid adjusted according to response.
Maintenance: 100-200 mcg tid, up to 100-1200 mcg daily.
Oral Primary nocturnal enuresis
Adult: 200-400 mcg at bedtime.
Child: ≥5 yr: 200-400 mcg at bedtime. Nasal Cranial diabetes insipidus
Adult: 10-40 mcg daily as a single or divided doses.
Child: 3 mth-12 yr: 5-30 mcg daily. Nasal Diagnosis of diabetes insipidus
Adult: 20 mcg as a single dose.
Child: 20 mcg as a single dose. Nasal Renal function testing
Adult: 40 mcg as a single dose.
Child: 1-15 yr: 20 mcg and infants: 10 mcg. To be given as a single dose. Nasal Primary nocturnal enuresis
Adult: 20-40 mcg at bedtime.
Child: ≥5 yr: 20-40 mcg at bedtime. Nasal Nocturia associated with multiple sclerosis
Adult: 10-20 mcg at bedtime. Nasal Type I Von Willebrand's disease
Adult: 300 mcg; <50 kg: 150 mcg. Should be given within 2 hr before the surgery.
Parenteral Cranial diabetes insipidus
Adult: 1-4 mcg daily IM, SC or IV.
Child: 0.4 mcg IM, SC, or IV.
Parenteral Diagnosis of diabetes insipidus
Adult: 2 mcg as a single dose via SC/IM.
Child: 2 mcg SC/IM.
Parenteral Renal function testing
Adult: 2 mcg given as SC or IM inj.
Child: Infants: 0.4 mcg; children: 2 mcg. Dose to be given as SC or IM inj.
Intravenous Type I Von Willebrand's disease
"Minirin - Minirin is a man-made form of a hormone that occurs naturally in the pituitary gland. This hormone is important for many functions including blood flow, blood pressure, kidney function, and regulating how the body uses water.
Minirin is used to treat bed-wetting, central cranial diabetes insipidus, and increased thirst and urination caused by head surgery or head trauma.
Minirin may also be used for other purposes not listed in this medication guide.
Minirin is a hormone. It helps to control the symptoms of diabetes insipidus (""water diabetes"") where the body produces an abnormally large amount of urine. Minirin is also used to control excessive thirst and to reduce the production of an abnormally large amount of urine that occurs after a head injury or after certain types of surgery. Minirin can also be used to treat certain bleeding disorders. Minirin may also be used to test the ability of the body to dissolve blood clots that have formed.
Oral Cranial diabetes insipidus
Adult: Initially, 100 mcg tid adjusted according to response.
Maintenance: 100-200 mcg tid, up to 100-1200 mcg daily.
Child: Initially, 100 mcg tid adjusted according to response.
Maintenance: 100-200 mcg tid, up to 100-1200 mcg daily.
Oral Primary nocturnal enuresis
Adult: 200-400 mcg at bedtime.
Child: ≥5 yr: 200-400 mcg at bedtime. Nasal Cranial diabetes insipidus
Adult: 10-40 mcg daily as a single or divided doses.
Child: 3 mth-12 yr: 5-30 mcg daily. Nasal Diagnosis of diabetes insipidus
Adult: 20 mcg as a single dose.
Child: 20 mcg as a single dose. Nasal Renal function testing
Adult: 40 mcg as a single dose.
Child: 1-15 yr: 20 mcg and infants: 10 mcg. To be given as a single dose. Nasal Primary nocturnal enuresis
Adult: 20-40 mcg at bedtime.
Child: ≥5 yr: 20-40 mcg at bedtime. Nasal Nocturia associated with multiple sclerosis
Adult: 10-20 mcg at bedtime. Nasal Type I Von Willebrand's disease
Adult: 300 mcg; <50 kg: 150 mcg. Should be given within 2 hr before the surgery.
Parenteral Cranial diabetes insipidus
Adult: 1-4 mcg daily IM, SC or IV.
Child: 0.4 mcg IM, SC, or IV.
Parenteral Diagnosis of diabetes insipidus
Adult: 2 mcg as a single dose via SC/IM.
Child: 2 mcg SC/IM.
Parenteral Renal function testing
Adult: 2 mcg given as SC or IM inj.
Child: Infants: 0.4 mcg; children: 2 mcg. Dose to be given as SC or IM inj.
Intravenous Type I Von Willebrand's disease
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Myozyme
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GENZYME
"MYOZYME (alglucosidase alfa), a lysosomal glycogen-specific enzyme, consists of the human enzyme acid α-glucosidase (GAA), encoded by the most predominant of nine observed haplotypes of this gene. MYOZYME is produced by recombinant DNA technology in a Chinese hamster ovary cell line. The MYOZYME manufacturing process differs from that for LUMIZYME®, resulting in differences in some product attributes. Alglucosidase alfa degrades glycogen by catalyzing the hydrolysis of α-1,4- and α-1,6- glycosidic linkages of lysosomal glycogen.
Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 daltons for the polypeptide chain, and a total mass of approximately 110 kilo Daltons, including carbohydrates. Alglucosidase alfa has a specific activity of 3 to 5 U/mg (one unit is defined as that amount of activity that results in the hydrolysis of 1 μmole of synthetic substrate per minute under the specified assay conditions). MYOZYME is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for reconstitution with 10.3 mL
Sterile Water for Injection, USP. Each 50 mg vial contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80, 9.9 mg sodium phosphate dibasic heptahydrate, 31.2 mg sodium phosphate monobasic monohydrate. Following reconstitution as directed, each vial contains 10.5 mL reconstituted solution and a total extractable volume of 10 mL at 5.0 mg/mL alglucosidase alfa. MYOZYME does not contain preservatives; each vial is for single use only." POMPE DISEASE
"MYOZYME (alglucosidase alfa), a lysosomal glycogen-specific enzyme, consists of the human enzyme acid α-glucosidase (GAA), encoded by the most predominant of nine observed haplotypes of this gene. MYOZYME is produced by recombinant DNA technology in a Chinese hamster ovary cell line. The MYOZYME manufacturing process differs from that for LUMIZYME®, resulting in differences in some product attributes. Alglucosidase alfa degrades glycogen by catalyzing the hydrolysis of α-1,4- and α-1,6- glycosidic linkages of lysosomal glycogen.
Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 daltons for the polypeptide chain, and a total mass of approximately 110 kilo Daltons, including carbohydrates. Alglucosidase alfa has a specific activity of 3 to 5 U/mg (one unit is defined as that amount of activity that results in the hydrolysis of 1 μmole of synthetic substrate per minute under the specified assay conditions). MYOZYME is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for reconstitution with 10.3 mL
Sterile Water for Injection, USP. Each 50 mg vial contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80, 9.9 mg sodium phosphate dibasic heptahydrate, 31.2 mg sodium phosphate monobasic monohydrate. Following reconstitution as directed, each vial contains 10.5 mL reconstituted solution and a total extractable volume of 10 mL at 5.0 mg/mL alglucosidase alfa. MYOZYME does not contain preservatives; each vial is for single use only." POMPE DISEASE
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Navelbine Injection
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PIERRE FABRE
"NAVELBINE (vinorelbine tartrate) is a semi-synthetic vinca alkaloid for intravenous injection. Chemically, vinorelbine tartrate is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(tartrate)] and has the following structure:
NAVELBINE® (vinorelbine tartrate) Structural Formula Illustration
C45H54N4O82C4H6O6 M.W. 1079.12.
NAVELBINE Injection is a sterile nonpyrogeinc aqueous solution. Each milliliter of solution contains 10 mg vinorelbine tartrate in Water for Injection. The pH of NAVELBINE Injection is approximately 3.5."
ONCOLOGY
"NAVELBINE (vinorelbine tartrate) is a semi-synthetic vinca alkaloid for intravenous injection. Chemically, vinorelbine tartrate is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(tartrate)] and has the following structure:
NAVELBINE® (vinorelbine tartrate) Structural Formula Illustration
C45H54N4O82C4H6O6 M.W. 1079.12.
NAVELBINE Injection is a sterile nonpyrogeinc aqueous solution. Each milliliter of solution contains 10 mg vinorelbine tartrate in Water for Injection. The pH of NAVELBINE Injection is approximately 3.5."
ONCOLOGY
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Oncaspar Injection
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ENZON
"ncaspar® (pegaspargase) is L-asparaginase (L-asparagine amidohydrolase) that is covalently conjugated to monomethoxypolyethylene glycol (mPEG). L-asparaginase is a tetrameric enzyme that is produced endogenously by E. coli and consists of identical 34.5 kDa subunits. Approximately 69 to 82 molecules of mPEG are linked to L-asparaginase; the molecular weight of each mPEG molecule is about 5 kDa. Oncaspar® activity is expressed in International Units. One International Unit of L-asparaginase is defined as the amount of enzyme required to generate 1 micromole of ammonia per minute at pH 7.3 and 37°C.
Oncaspar® is supplied as a clear, colorless, preservative-free, isotonic sterile solution in phosphate-buffered saline, pH 7.3. Each milliliter contains 750 ± 150 International Units of pegaspargase, dibasic sodium phosphate, USP (5.58 mg), monobasic sodium phosphate, USP, (1.20 mg) and sodium chloride, USP (8.50 mg) in water for injection, USP."
ONCOLOGY
"ncaspar® (pegaspargase) is L-asparaginase (L-asparagine amidohydrolase) that is covalently conjugated to monomethoxypolyethylene glycol (mPEG). L-asparaginase is a tetrameric enzyme that is produced endogenously by E. coli and consists of identical 34.5 kDa subunits. Approximately 69 to 82 molecules of mPEG are linked to L-asparaginase; the molecular weight of each mPEG molecule is about 5 kDa. Oncaspar® activity is expressed in International Units. One International Unit of L-asparaginase is defined as the amount of enzyme required to generate 1 micromole of ammonia per minute at pH 7.3 and 37°C.
Oncaspar® is supplied as a clear, colorless, preservative-free, isotonic sterile solution in phosphate-buffered saline, pH 7.3. Each milliliter contains 750 ± 150 International Units of pegaspargase, dibasic sodium phosphate, USP (5.58 mg), monobasic sodium phosphate, USP, (1.20 mg) and sodium chloride, USP (8.50 mg) in water for injection, USP."
ONCOLOGY
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SCHERING PLOUGH
HEPATITIS
HEPATITIS
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