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Injection III
Our range of products include remestyp 1.0 injection, remicade injection, reopro 10 mg injection, varilrix injection, zavedos 5mg injection and pneumo 23 vacc 0.5ml injection.
Remestyp 1.0 Injection
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Product Details:
| Dose | 5ml-10ml, 1ml-5ml |
| Injectable Form | Solution |
| Application | Anti Infective & Common Disease Medicines |
| Injection Site | Intramuscular, Intravenous |
| Packaging Type | Glass Bottle |
| Medicine Type | Allopathic |
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Remicade Injection
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Product Details:
| Brand | Remicade |
| Strength / Dose | 100 mg |
| Manufacturer | Janssen |
| Packaging type | Vial |
| Composition | Infliximab 100mg/10ml |
| Treatment | Arthritis |
| Dosage Form | Injection |
| Grade | Medicine grade |
Rheumatoid arthritis, psoriasis, ankylosing spondylitis, psoriatic arthritis.
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Reopro 10 Mg Injection
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Product Details:
| Dose | 1ml-5ml |
| Injectable Form | Solution |
| Application | Analgesics and Pain Relief Medicines, Anti Infective & Common Disease Medicines |
| Injection Site | Intramuscular, Intravenous |
| Packaging Type | Glass Bottle |
| Packaging Size | 10 mg |
| Medicine Type | Allopathic |
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Varilrix Injection
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Product Details:
| Injectable Form | Solution |
| Application | Anti Infective & Common Disease Medicines |
| Dose | 1ml-5ml |
| Injection Site | Intravenous, Intramuscular |
| Packaging Type | Glass Bottle |
| Medicine Type | Allopathic |
| Usage | Clinical, Hospital |
| Form | Injection |
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Zavedos 5Mg Injection
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Product Details:
| Packaging Size | 5 mg |
| Application | Anti Infective & Common Disease Medicines |
| Injection Site | Intravenous |
| Packaging Type | Glass Bottle |
| Medicine Type | Allopathic |
| Injectable Form | Solution |
| Dose | 1ml-5ml |
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Pneumo 23 Vacc 0.5Ml Injection
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AVENTIS PASTEUR
"PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine consisting of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).7
PNEUMOVAX 23 is a clear, colorless solution. Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative. The vaccine is used directly as supplied. No dilution or reconstitution is necessary."
PNEUMONIA VACCINE
"PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine consisting of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).7
PNEUMOVAX 23 is a clear, colorless solution. Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative. The vaccine is used directly as supplied. No dilution or reconstitution is necessary."
PNEUMONIA VACCINE
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Pneumovax Injection
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WYETH LEDERLE
"NEUMOVAX * 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine for intramuscular or subcutaneous injection. It consists of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae, including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in the United States. (See Table 1.) The 23-valent vaccine accounts for at least 90% of pneumococcal blood isolates and at least 85% of all pneumococcal isolates from sites which are generally sterile as determined by ongoing surveillance of U.S. data.
*Registered trademark of MERCK & CO., Inc.
PNEUMOVAX 23 is manufactured according to methods developed by the MERCK Research Laboratories. Each 0.5 mL dose of vaccine contains 25 µg of each polysaccharide type dissolved in isotonic saline solution containing 0.25% phenol as preservative. "
PNEUMONIA VACCINE
"NEUMOVAX * 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine for intramuscular or subcutaneous injection. It consists of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae, including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in the United States. (See Table 1.) The 23-valent vaccine accounts for at least 90% of pneumococcal blood isolates and at least 85% of all pneumococcal isolates from sites which are generally sterile as determined by ongoing surveillance of U.S. data.
*Registered trademark of MERCK & CO., Inc.
PNEUMOVAX 23 is manufactured according to methods developed by the MERCK Research Laboratories. Each 0.5 mL dose of vaccine contains 25 µg of each polysaccharide type dissolved in isotonic saline solution containing 0.25% phenol as preservative. "
PNEUMONIA VACCINE
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Primacor Injection
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SANOFI AVENTIS
"PRIMACOR™ 3003 Copolymer is an ethylene acrylic acid copolymer which has been specifically designed by Dow for use as an adhesive or sealant layer in extrusion coating and extrusion lamination. PRIMACOR 3003 Copolymer exhibits: Excellent draw-down and edge stability Excellent organoleptic properties Excellent toughness and strength Outstanding environmental stress crack and product resistance Excellent hot-tack and sealability Adhesion to paper, paperboard, metals and polyethylenes Insensitivity to moisture"
PNEUMONIA VACCINE
"PRIMACOR™ 3003 Copolymer is an ethylene acrylic acid copolymer which has been specifically designed by Dow for use as an adhesive or sealant layer in extrusion coating and extrusion lamination. PRIMACOR 3003 Copolymer exhibits: Excellent draw-down and edge stability Excellent organoleptic properties Excellent toughness and strength Outstanding environmental stress crack and product resistance Excellent hot-tack and sealability Adhesion to paper, paperboard, metals and polyethylenes Insensitivity to moisture"
PNEUMONIA VACCINE
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Proleukin Injection
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CHIRON NOVARTIS
"nterleukin -2 (aldesleukin, [Proleukin®]) is a cytokine with the following immune-modulating effects: enhancement of lymphocyte mitogenesis and cytotoxicity, induction of lymphocyte-
activated (LAK) cells and natural killer (NK) cells, and induction of gamma production. U.S. Food and Drug Administration (FDA)-approved labeled indications include the treatment of metastatic renal cell carcinoma and metastatic malignant melanoma. Other oncologic applications of IL-2 monotherapy are being actively investigated, principally as a technique
to maintain remission or eliminate minimal residual disease in patients with a variety of malignancies, including most prominently leukemias, but also including lymphomas and other solid tumors such as neuroblastoma and breast cancer. IL-2 has also been used post-autologous bone marrow transplantation as an immunotherapeutic technique to maintain remission and reduce the relapse rate. In HIV -infected patients, there is a reduced endogenous production of IL-2 and a defect in IL -2 receptor expression, respon sible in part for the characteristic reduction in CD4 counts. Exogenous IL-2, in conjunction with antiretroviral therapy, has been investigated as atechnique to increase CD4 counts, preserve immune function and hopefully decrease the incidence of opportunistic infections. It has been proposed that IL-2 in conjunction with combination antiretroviral therapy may be a useful approach for purging HIV from the latently infected CD4 cells. IL-2 has also been investigated as a component of a variety of combinat ion therapies, for example in combination with alpha in the treatment of metastatic renal cell cancer and metastatic melanoma. IL-2 can be administered by subcutaneous injection (low-dose therapy) or into a vein (intermediate or high
-dose thera py), either intermittently as a bolus or quick injection, or as a continuous treatment over a defined period of time"
ONCOLOGY
"nterleukin -2 (aldesleukin, [Proleukin®]) is a cytokine with the following immune-modulating effects: enhancement of lymphocyte mitogenesis and cytotoxicity, induction of lymphocyte-
activated (LAK) cells and natural killer (NK) cells, and induction of gamma production. U.S. Food and Drug Administration (FDA)-approved labeled indications include the treatment of metastatic renal cell carcinoma and metastatic malignant melanoma. Other oncologic applications of IL-2 monotherapy are being actively investigated, principally as a technique
to maintain remission or eliminate minimal residual disease in patients with a variety of malignancies, including most prominently leukemias, but also including lymphomas and other solid tumors such as neuroblastoma and breast cancer. IL-2 has also been used post-autologous bone marrow transplantation as an immunotherapeutic technique to maintain remission and reduce the relapse rate. In HIV -infected patients, there is a reduced endogenous production of IL-2 and a defect in IL -2 receptor expression, respon sible in part for the characteristic reduction in CD4 counts. Exogenous IL-2, in conjunction with antiretroviral therapy, has been investigated as atechnique to increase CD4 counts, preserve immune function and hopefully decrease the incidence of opportunistic infections. It has been proposed that IL-2 in conjunction with combination antiretroviral therapy may be a useful approach for purging HIV from the latently infected CD4 cells. IL-2 has also been investigated as a component of a variety of combinat ion therapies, for example in combination with alpha in the treatment of metastatic renal cell cancer and metastatic melanoma. IL-2 can be administered by subcutaneous injection (low-dose therapy) or into a vein (intermediate or high
-dose thera py), either intermittently as a bolus or quick injection, or as a continuous treatment over a defined period of time"
ONCOLOGY
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Retavase Injection
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PDL BIOPHARMA
CARDIOVASCULAR - ACUTE MYOCARDIAL INFARCTION
CARDIOVASCULAR - ACUTE MYOCARDIAL INFARCTION
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Solumedro/1000Mg Injection
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PFIZER
"SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid, which contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.
100 mg Plain - Vials containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone, also 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate dried. SOLU-CORTEF 100 mg plain does not contain diluent (see DOSAGE AND ADMINISTRATION, Preparation of Solutions)."
"SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid, which contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.
100 mg Plain - Vials containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone, also 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate dried. SOLU-CORTEF 100 mg plain does not contain diluent (see DOSAGE AND ADMINISTRATION, Preparation of Solutions)."
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Stamaril Injection
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SANOFI PASTEUR
"Each 0.5mL dose of reconstituted vaccine from the freeze-dried product contains an
injectable suspension in stabiliser of the attenuated 17 D strain of yellow fever virus. The
virus has been propagated in specific pathogen-free chick embryos, in particular free from
avian leucosis viruses. Each dose contains not less than 1000 mouse LD 50 units.
Other ingredients: Stabilising medium: 16.0 mg lactose, 8.0 mg sorbitol, 833 mcg L-histidine hydrochloride, 362 mcg L-alanine, 1.6 mg sodium chloride, 54 mcg potassium chloride, 598 mcg sodium phosphate-dibasic dodecahydrate, 63 mcg potassium phosphate-monobasic, 39 mcg calcium chloride, 29mcg magnesium sulfate. Diluent: 0.4% sodium chloride solution. STAMARIL
® has been manufactured in a facility approved by the World Health Organization. The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. "
"Each 0.5mL dose of reconstituted vaccine from the freeze-dried product contains an
injectable suspension in stabiliser of the attenuated 17 D strain of yellow fever virus. The
virus has been propagated in specific pathogen-free chick embryos, in particular free from
avian leucosis viruses. Each dose contains not less than 1000 mouse LD 50 units.
Other ingredients: Stabilising medium: 16.0 mg lactose, 8.0 mg sorbitol, 833 mcg L-histidine hydrochloride, 362 mcg L-alanine, 1.6 mg sodium chloride, 54 mcg potassium chloride, 598 mcg sodium phosphate-dibasic dodecahydrate, 63 mcg potassium phosphate-monobasic, 39 mcg calcium chloride, 29mcg magnesium sulfate. Diluent: 0.4% sodium chloride solution. STAMARIL
® has been manufactured in a facility approved by the World Health Organization. The manufacture of this product includes exposure to bovine materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. "
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Tritanrix Injection
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GSK
QUADRIVALENT VACCINE
QUADRIVALENT VACCINE
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Typhim Injection
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SANOFI PASTEUR
yphim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Pasteur SA, for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S. typhi Ty2 strain. The organism is grown in a semisynthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fattyacid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection.
TYPHOID VACCINE
yphim Vi®, Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Pasteur SA, for intramuscular use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S. typhi Ty2 strain. The organism is grown in a semisynthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process. The capsular polysaccharide is precipitated from the concentrated culture supernatant by the addition of hexadecyltrimethylammonium bromide, and the product is purified by differential centrifugation and precipitation. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg) used for the inactivation of the bacterial culture. The potency of the purified polysaccharide is assessed by molecular size and O-acetyl content. Phenol, 0.25%, is added as a preservative. The vaccine contains residual polydimethylsiloxane or fattyacid ester-based antifoam. The vaccine is a clear, colorless solution. Each dose of 0.5 mL is formulated to contain 25 mcg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7 ± 0.3), 4.150 mg of Sodium Chloride, 0.065 mg of Disodium Phosphate, 0.023 mg of Monosodium Phosphate, and 0.5 mL of Sterile Water for Injection.
TYPHOID VACCINE
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Vaxigrip Injection
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SANOFI PASTEUR
"2014 Season 1 CONSUMER MEDICINE INFORMATION VAXIGRIP ® Inactivated Influenza Vaccine (Split Virion) BP What is in this leaflet This leaflet answers some common questions about VAXIGRIP. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you or your child having VAXIGR IP against the benefits they expect it will have. If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist. Keep this leaflet. You may need to read it again. What VAXIGRIP is used for
VAXIGRIP is a vaccine used to help prevent influenza (‘flu’) especially in people who have a high risk of getting complications. New types of influenza virus can appear each year hence vaccination is recommended every year for anyone who wishes to reduce their chance of becoming ill with the flu. Annual vaccination against influenza is particularly recommended for the following individuals: 1. All people over the age of 65 years 2. People under 65 years of age with: Heart disease Lung disease - asthma that require regular preventative therapy; other chronic lung disease with impaired lung function Diabetes Kidney disorder Cancer Other conditions – diseases that require treatment with medicines that reduce natural immunity, HIV, children on long-term therapy 3. Pregnant women Influenza vaccination is recommended for any pregnant women who are beyond the first trimester of pregnancy i.e. those who will be in the second or third trimester of "
FLU VACCINE
"2014 Season 1 CONSUMER MEDICINE INFORMATION VAXIGRIP ® Inactivated Influenza Vaccine (Split Virion) BP What is in this leaflet This leaflet answers some common questions about VAXIGRIP. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you or your child having VAXIGR IP against the benefits they expect it will have. If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist. Keep this leaflet. You may need to read it again. What VAXIGRIP is used for
VAXIGRIP is a vaccine used to help prevent influenza (‘flu’) especially in people who have a high risk of getting complications. New types of influenza virus can appear each year hence vaccination is recommended every year for anyone who wishes to reduce their chance of becoming ill with the flu. Annual vaccination against influenza is particularly recommended for the following individuals: 1. All people over the age of 65 years 2. People under 65 years of age with: Heart disease Lung disease - asthma that require regular preventative therapy; other chronic lung disease with impaired lung function Diabetes Kidney disorder Cancer Other conditions – diseases that require treatment with medicines that reduce natural immunity, HIV, children on long-term therapy 3. Pregnant women Influenza vaccination is recommended for any pregnant women who are beyond the first trimester of pregnancy i.e. those who will be in the second or third trimester of "
FLU VACCINE
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Venofer Injection
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ALTANA PHARMA
"Venofer (iron sucrose injection, USP), an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: [Na2Fe5O8(OH) •3(H2O)]n •m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Venofer is available in 10 mL single-use vials (200 mg elemental iron per 10 mL), 5 mL single-use vials (100 mg elemental iron per 5 mL), and 2.5 mL single-use vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and has a pH of 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
ONCOLOGY
"Venofer (iron sucrose injection, USP), an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: [Na2Fe5O8(OH) •3(H2O)]n •m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Venofer is available in 10 mL single-use vials (200 mg elemental iron per 10 mL), 5 mL single-use vials (100 mg elemental iron per 5 mL), and 2.5 mL single-use vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and has a pH of 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
ONCOLOGY
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Vitrimix Kv Iv Injection
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FRESENIUS KB INDIA
INTRAVENOUS AMINO ACIDS + MINERALS
INTRAVENOUS AMINO ACIDS + MINERALS
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Methylprednisolone Injection
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Product Details:
| Brand Name | Solu Medrol |
| Manufacturer | Pfizer Ltd |
| Dose | 500 mg |
| Packaging Type | Vials |
| Packaging Size | 1 ml |
| Composition | Methylprednisolone 500 mg |
| Usage/Application | As steroid and anti inflammatory drug |
| Form | Injection |
"SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone.
The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6α, 11β), and the molecular weight is 496.53. The structural formula is represented below:
SOLU-MEDROL® (methylprednisolone sodium succinate) Structural Formula Illustration
Methylprednisolone sodium succinate is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly.
SOLU-MEDROL is available in preservative and preservative-free formulations:"
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Dantrolene Sodium Injection
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Product Details:
| Dose/Strength | 20 mg |
| Packaging Type | Glass Ampoules |
| Brand | Dantrium |
| Dosage Form | Injection |
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Priorix Injection
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GSK
"PRIORIX is a live virus vaccine for immunisation against measles, mumps and rubella.
PRIORIX is a sterile lyophilised mixed preparat ion containing the attenuated Schwarz measles
virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Each virus strain is separately obtained by propagation in either chick embryo tissue cultures (mumps and measles) or MRC5 human diploid cells (rubella).
PRIORIX is presented as a white to slightly pink pellet for reconstitution with sterile Water for
Injection diluent. Each 0.5mL dose of the reconstituted vaccine contains not less than 10 3.0
CCID 50 (cell culture infectious dose 50%) of the Schwarz measles, not less than 10 3.7 CCID
50 of the RIT 4385 mumps and not less than 10 3.0 CCID 50 of the Wistar RA 27/3 rubella virus strains. The three virus strains are mixed prior to lyophilisation. The lyophilised vaccine also contains lactose, neomycin sulphate, amino acids and sorbitol and mannitol as stabilisers. The manufacture of this product includes exposur e to bovine derived materials. No evidence
exists that any case of vCJD (consider ed to be the human form of bovine spongiform
encephalopathy) has resulted from the administration of any vaccine product.
PRIORIX meets the World Health Organisation requirements for manufacture of biological
substances and for measles, mumps and rubella vaccines and combined vaccines (live" MUMPS, MEASLES, RUBELLA VACCINE
"PRIORIX is a live virus vaccine for immunisation against measles, mumps and rubella.
PRIORIX is a sterile lyophilised mixed preparat ion containing the attenuated Schwarz measles
virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Each virus strain is separately obtained by propagation in either chick embryo tissue cultures (mumps and measles) or MRC5 human diploid cells (rubella).
PRIORIX is presented as a white to slightly pink pellet for reconstitution with sterile Water for
Injection diluent. Each 0.5mL dose of the reconstituted vaccine contains not less than 10 3.0
CCID 50 (cell culture infectious dose 50%) of the Schwarz measles, not less than 10 3.7 CCID
50 of the RIT 4385 mumps and not less than 10 3.0 CCID 50 of the Wistar RA 27/3 rubella virus strains. The three virus strains are mixed prior to lyophilisation. The lyophilised vaccine also contains lactose, neomycin sulphate, amino acids and sorbitol and mannitol as stabilisers. The manufacture of this product includes exposur e to bovine derived materials. No evidence
exists that any case of vCJD (consider ed to be the human form of bovine spongiform
encephalopathy) has resulted from the administration of any vaccine product.
PRIORIX meets the World Health Organisation requirements for manufacture of biological
substances and for measles, mumps and rubella vaccines and combined vaccines (live" MUMPS, MEASLES, RUBELLA VACCINE
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Rabipur Injection
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CHIRON VACCINES
"RABIPUR ® Product Information AUSTR 100582 Page 1 of 13 Version 2.0 RABIPUR ® Inactivated Rabies Virus Vaccine DESCRIPTION RABIPUR ® is an inactivated rabies virus vaccine, derived from the fixed -virus strain, Flury LEP. The virus is propagated in aPurified Chick Embryo Cell
(PCEC) culture, inactivated using - propiolact one and purified viacentrifugation. It is supplied in a single - dose presentation consisting of a vial containing lyophilised powder (vaccine component), accompanied by an ampoule of diluent (Water for Injections). Each 1.0mL dose of the reconstituted vaccine contains no less than 2.5IU of inactivated rabies virus, in accordance with the World Health Organisation requirements. Each 1.0mL dose of the reconstituted vaccine also contains the following excipients: trometamol (3.5mg), sodium chloride (4.5mg) , disodium edetate (0.25mg), monopotassium glutamate (0.9mg), polygeline (10.5mg), sucrose (60mg) and water for injections (1.0mL). The quantities of each excipient (excluding water for injection) will vary dependent on virus concentration in the harvested material. The neomycin, chlortetracycline and amphotericin B are used in the manufacturing process of this vaccine and may be present in trace amounts. The manufacture of this product includes exposure to bovine derived materials. No evide nce exists that any case of vCJD (considered to be the human form of bovine spongiform encephalitis) has resulted from the administration of any vaccine product"
RABIES VACCINE
"RABIPUR ® Product Information AUSTR 100582 Page 1 of 13 Version 2.0 RABIPUR ® Inactivated Rabies Virus Vaccine DESCRIPTION RABIPUR ® is an inactivated rabies virus vaccine, derived from the fixed -virus strain, Flury LEP. The virus is propagated in aPurified Chick Embryo Cell
(PCEC) culture, inactivated using - propiolact one and purified viacentrifugation. It is supplied in a single - dose presentation consisting of a vial containing lyophilised powder (vaccine component), accompanied by an ampoule of diluent (Water for Injections). Each 1.0mL dose of the reconstituted vaccine contains no less than 2.5IU of inactivated rabies virus, in accordance with the World Health Organisation requirements. Each 1.0mL dose of the reconstituted vaccine also contains the following excipients: trometamol (3.5mg), sodium chloride (4.5mg) , disodium edetate (0.25mg), monopotassium glutamate (0.9mg), polygeline (10.5mg), sucrose (60mg) and water for injections (1.0mL). The quantities of each excipient (excluding water for injection) will vary dependent on virus concentration in the harvested material. The neomycin, chlortetracycline and amphotericin B are used in the manufacturing process of this vaccine and may be present in trace amounts. The manufacture of this product includes exposure to bovine derived materials. No evide nce exists that any case of vCJD (considered to be the human form of bovine spongiform encephalitis) has resulted from the administration of any vaccine product"
RABIES VACCINE
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Trimovax Injection
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SANOFI PASTEUR
MUMPS, MEASLES, RUBELLA VACCINE
MUMPS, MEASLES, RUBELLA VACCINE
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Twinrix Injection
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GSK
"TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] is a bivalent vaccine containing the antigenic components used in producing HAVRIX® (Hepatitis A Vaccine) and ENGERIX-B® [Hepatitis B Vaccine (Recombinant)]. TWINRIX is a sterile suspension for intramuscular administration that contains inactivated hepatitis A virus (strain HM175) and noninfectious hepatitis B virus surface antigen (HBsAg). The hepatitis A virus is propagated in MRC-5 human diploid cells and inactivated with formalin. The purified HBsAg is obtained by culturing genetically engineered Saccharomyces cerevisiae yeast cells, which carry the surface antigen gene of the hepatitis B virus. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation.
A 1-mL dose of vaccine contains 720 ELISA Units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum in the form of aluminum phosphate and aluminum hydroxide as adjuvants, amino acids, sodium chloride, phosphate buffer, polysorbate 20, and Water for Injection. From the manufacturing process each 1-mL dose of TWINRIX also contains residual formalin (not more than 0.1 mg), MRC-5 cellular proteins (not more than 2.5 mcg), neomycin sulfate (an aminoglycoside antibiotic included in the cell growth media; not more than 20 ng) and yeast protein (no more than 5%).
TWINRIX is available in vials and prefilled syringes. The tip caps of the prefilled syringes may contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. TWINRIX is formulated without preservatives."
COMBINED HEPATITIS A + B VACCINE
"TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] is a bivalent vaccine containing the antigenic components used in producing HAVRIX® (Hepatitis A Vaccine) and ENGERIX-B® [Hepatitis B Vaccine (Recombinant)]. TWINRIX is a sterile suspension for intramuscular administration that contains inactivated hepatitis A virus (strain HM175) and noninfectious hepatitis B virus surface antigen (HBsAg). The hepatitis A virus is propagated in MRC-5 human diploid cells and inactivated with formalin. The purified HBsAg is obtained by culturing genetically engineered Saccharomyces cerevisiae yeast cells, which carry the surface antigen gene of the hepatitis B virus. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation.
A 1-mL dose of vaccine contains 720 ELISA Units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum in the form of aluminum phosphate and aluminum hydroxide as adjuvants, amino acids, sodium chloride, phosphate buffer, polysorbate 20, and Water for Injection. From the manufacturing process each 1-mL dose of TWINRIX also contains residual formalin (not more than 0.1 mg), MRC-5 cellular proteins (not more than 2.5 mcg), neomycin sulfate (an aminoglycoside antibiotic included in the cell growth media; not more than 20 ng) and yeast protein (no more than 5%).
TWINRIX is available in vials and prefilled syringes. The tip caps of the prefilled syringes may contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. TWINRIX is formulated without preservatives."
COMBINED HEPATITIS A + B VACCINE
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Typherix Injection
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GSK
"TYPHERIX Product Information 1 (8) Issue No. 5 1 TYPHERIX PRODUCT INFORMATION (Salmonella typhiVi polysaccharide) DESCRIPTION TYPHERIX is a colourless, sterile liquid containing the cell surface Vi polysaccharide extracted from Salmonella typhi Ty2 strain.
The production of Vi polysaccharide active ingredient involves fermentation of S.typhi bacteria followed by extraction/purification of the Vi polysaccharide. Traditional culture methods are used for fermentation of S.typhi. Each 0.5 ml dose of vaccine contains 25 μg of the Vi polysaccharide of Salmonella typhi in a sterile isotonic sodium chloride solution. TYPHERIX contains phenol (as preservative), and a phosphate buffer. The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. TYPHERIX meets the World Health Organisation (WHO) requirements for biological
substances and conforms with the European Pharmacopoeia monograph on Vipolysaccharide typhoid vaccines. No substance of human origin is used in its manufacture."
TYPHOID VACCINE
"TYPHERIX Product Information 1 (8) Issue No. 5 1 TYPHERIX PRODUCT INFORMATION (Salmonella typhiVi polysaccharide) DESCRIPTION TYPHERIX is a colourless, sterile liquid containing the cell surface Vi polysaccharide extracted from Salmonella typhi Ty2 strain.
The production of Vi polysaccharide active ingredient involves fermentation of S.typhi bacteria followed by extraction/purification of the Vi polysaccharide. Traditional culture methods are used for fermentation of S.typhi. Each 0.5 ml dose of vaccine contains 25 μg of the Vi polysaccharide of Salmonella typhi in a sterile isotonic sodium chloride solution. TYPHERIX contains phenol (as preservative), and a phosphate buffer. The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. TYPHERIX meets the World Health Organisation (WHO) requirements for biological
substances and conforms with the European Pharmacopoeia monograph on Vipolysaccharide typhoid vaccines. No substance of human origin is used in its manufacture."
TYPHOID VACCINE
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Verorab Injection
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SANOFI PASTEUR
"VERORAB is a sterile powder and diluent for suspension for injection. Freeze-dried Powder
After reconstitution, 1 dose (0.5 mL) contains: Rabies virus*, Wistar rabies PM/WI 38 1503-3M strain (inactivated) ≥2.5 IU** * produced in VERO cells** quantity measured according to the in
ternational standard and the NIH test Maltose 52.5 mg Human serum albumin 2.5 mg BME medium† qsWater for injection qs † BME: Basal Medium Eagle: mixture of mineral salts, vitamins and amino-acids including L-Phenylalanine. Diluent - 0.4% sodium chloride solution Sodium chloride 2mg Water for injection qs 0.5mL VERORAB contains bovine serum albumin (not more than 50 nanogram per dose). The vaccine may contain undetectable traces of betapropiolactone, neomycin, streptomycin and polymixin B which are used during vaccine production. "
RABIES VACCINE
"VERORAB is a sterile powder and diluent for suspension for injection. Freeze-dried Powder
After reconstitution, 1 dose (0.5 mL) contains: Rabies virus*, Wistar rabies PM/WI 38 1503-3M strain (inactivated) ≥2.5 IU** * produced in VERO cells** quantity measured according to the in
ternational standard and the NIH test Maltose 52.5 mg Human serum albumin 2.5 mg BME medium† qsWater for injection qs † BME: Basal Medium Eagle: mixture of mineral salts, vitamins and amino-acids including L-Phenylalanine. Diluent - 0.4% sodium chloride solution Sodium chloride 2mg Water for injection qs 0.5mL VERORAB contains bovine serum albumin (not more than 50 nanogram per dose). The vaccine may contain undetectable traces of betapropiolactone, neomycin, streptomycin and polymixin B which are used during vaccine production. "
RABIES VACCINE
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Xigris Injection
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ELI LILLY
"Xigris (drotrecogin alfa (activated)) is a recombinant form of human activated protein C. An established human cell line possessing the complementary DNA for the inactive human protein C zymogen secretes the protein into the fermentation medium. Fermentation is carried out in a nutrient medium containing the antibiotic geneticin sulfate. Geneticin sulfate is not detectable in the final product. Human protein C is enzymatically activated by cleavage with thrombin and subsequently purified. Drotrecogin alfa (activated) is a serine protease with the same amino acid sequence as human plasma-derived activated protein C. Drotrecogin alfa (activated) is a glycoprotein of approximately 55 kilodalton molecular weight, consisting of a heavy chain and a light chain linked by a disulfide bond. Drotrecogin alfa (activated) and human plasma-derived activated protein C have the same sites of glycosylation, although some differences in the glycosylation structures exist.Xigris (drotrecogin alfa) is supplied as a sterile, lyophilized, white to off-white powder for intravenous infusion. The 5 and 20 mg vials of Xigris contain 5.3 mg and 20.8 mg of drotrecogin alfa (activated), respectively. The 5 and 20 mg vials of Xigris (drotrecogin alfa) also contain 40.3 and 158.1 mg of sodium chloride, 10.9 and 42.9 mg of sodium citrate, and 31.8 and 124.9 mg of "
SEVERE ADULT SEPSIS
"Xigris (drotrecogin alfa (activated)) is a recombinant form of human activated protein C. An established human cell line possessing the complementary DNA for the inactive human protein C zymogen secretes the protein into the fermentation medium. Fermentation is carried out in a nutrient medium containing the antibiotic geneticin sulfate. Geneticin sulfate is not detectable in the final product. Human protein C is enzymatically activated by cleavage with thrombin and subsequently purified. Drotrecogin alfa (activated) is a serine protease with the same amino acid sequence as human plasma-derived activated protein C. Drotrecogin alfa (activated) is a glycoprotein of approximately 55 kilodalton molecular weight, consisting of a heavy chain and a light chain linked by a disulfide bond. Drotrecogin alfa (activated) and human plasma-derived activated protein C have the same sites of glycosylation, although some differences in the glycosylation structures exist.Xigris (drotrecogin alfa) is supplied as a sterile, lyophilized, white to off-white powder for intravenous infusion. The 5 and 20 mg vials of Xigris contain 5.3 mg and 20.8 mg of drotrecogin alfa (activated), respectively. The 5 and 20 mg vials of Xigris (drotrecogin alfa) also contain 40.3 and 158.1 mg of sodium chloride, 10.9 and 42.9 mg of sodium citrate, and 31.8 and 124.9 mg of "
SEVERE ADULT SEPSIS
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