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Hepatitis B Vaccine (Recombinant) (Recombivax Hb)

Trade Name : RECOMBIVAX HB

Merck Sharp & Dohme Corp.

INJECTION, SUSPENSION, VACCINE

Strength 5 ug/.5mL

HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hepatitis B Vaccine (Recombinant) (Recombivax Hb) which is also known as RECOMBIVAX HB and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 5 ug/.5mL per ml. Read more

Hepatitis B Vaccine (Recombinant) (Recombivax Hb) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • RECOMBIVAX HB[Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older.
  • RECOMBIVAX HB is a vaccine indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in predialysis and dialysis patients 18 years of age and older. ()
  • For intramuscular administration. See for subcutaneous administration in persons with hemophilia.
  • RECOMBIVAX HB should be administered as soon as possible after being removed from refrigeration .
  • RECOMBIVAX HB
  • RECOMBIVAX HB Dialysis Formulation
  • RECOMBIVAX HB is a sterile suspension available in the following presentations:
  • RECOMBIVAX HB DIALYSIS FORMULATION is a sterile suspension available in the following presentation:
  • RECOMBIVAX HB is a sterile suspension available in the following presentations:
  • RECOMBIVAX HB Dialysis Formulation is a sterile suspension available in the following presentation:
  • Do not administer RECOMBIVAX HB to individuals with a history of severe allergic or hypersensitivity reactions (, anaphylaxis) after a previous dose of any hepatitis B-containing vaccine or to any component of RECOMBIVAX HB, including yeast .
  • Severe allergic or hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of RECOMBIVAX HB, including yeast. (, )
  • The vial stopper, the syringe plunger stopper, and tip cap contain dry natural latex rubber which may cause allergic reactions in latex-sensitive individuals. ()
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including RECOMBIVAX HB, to infants born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination. ()
  • In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively.
  • In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. ()
  • In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
  • Do not mix RECOMBIVAX HB with any other vaccine in the same syringe or vial. ()
  • No data
  • RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is a sterile suspension of non-infectious subunit viral vaccine derived from HBsAg produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories.
  • The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast containing the gene for the subtype of HBsAg. The fermentation process involves growth of on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. Each dose contains less than 1% yeast protein. The vaccine produced by the Merck method has been shown to be comparable to the plasma-derived vaccine in terms of animal potency (mouse, monkey, and chimpanzee) and protective efficacy (chimpanzee and human).
  • The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products.
  • RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in three formulations. n
  • Pediatric/Adolescent Formulation (Without Preservative),
  • Adult Formulation (Without Preservative),
  • Dialysis Formulation (Without Preservative),
  • All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains <15 mcg/mL residual formaldehyde. The vaccine is of the subtype.
  • RECOMBIVAX HB has been shown to elicit antibodies to hepatitis B virus as measured by ELISA.
  • Antibody concentrations u226510mIU/mL against HBsAg are recognized as conferring protection against hepatitis B infection.{2}
  • Infection with hepatitis B virus can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Chronically infected persons are at increased risk for cirrhosis and hepatocellular carcinoma.
  • RECOMBIVAX HB has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility .
  • No data
  • No data
  • No data
  • Information for Vaccine Recipients and Parents/Guardians
  • Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • The trademarks depicted herein are owned by their respective companies.
  • Copyright u00a9 1986-2020 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-v232-i-2002r442
  • NDC 0006-4981-00n n
  • HEPATITIS B VACCINE [RECOMBINANT]RECOMBIVAX HBn
  • PEDIATRIC/ADOLESCENT
  • Preservative Free
  • This package contains 10 single-dose vials. Each 0.5 mL vial contains 5 mcg of hepatitis B surface antigen on an aluminum hydroxide adjuvant. Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast containing the gene for the subtype of HBsAg. This Product Contains No Preservatives.
  • Rx only
  • NDC 0006-4093-0210 Single-Dose 0.5-mL Syringes
  • HEPATITIS B VACCINE[RECOMBINANT]RECOMBIVAX HBn
  • PEDIATRIC/ADOLESCENT FORMULATION
  • Preservative Free
  • This package contains 10 single-dose syringes. Each 0.5-mL syringe contains 5 mcg of hepatitis B surface antigen adjuvanted with amorphous aluminum hydroxyphosphate sulfate.
  • Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast n containing the gene for the subtype of HBsAg.
  • This Product Contains No Thimerosal.n- Rx only
  • NDC 0006-4995-001 Single-dose10 mcg/1 mL Vial
  • HEPATITIS BVACCINE[RECOMBINANT]RECOMBIVAX HBn
  • ADULTFORMULATION
  • Preservative Free
  • 1 mL contains 10 mcg of hepatitis B surface antigen adjuvanted with amorphous aluminum hydroxyphosphate sulfate.
  • Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast n containing the gene for the n subtype of HBsAg.
  • This Product Contains No Thimerosal.
  • Rx only
  • NDC 0006-4094-0210 Single-Dose 1.0-mL Syringes
  • HEPATITIS B VACCINE [RECOMBINANT]RECOMBIVAX HBn
  • ADULT FORMULATION
  • Preservative Free
  • This package contains 10 single-dose syringes. Each 1.0-mL syringe contains 10 mcg of hepatitis B surface antigen adjuvanted with amorphous aluminum hydroxyphosphate sulfate.
  • Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast n containing the gene for the subtype of HBsAg.
  • This Product Contains No Thimerosal.n- Rx only
  • tttttttNDC 0006-4992-001 Single-dose40 mcg/1 mL Vial tttttt
  • HEPATITIS B VACCINE [RECOMBINANT]RECOMBIVAX HBn
  • DIALYSIS FORMULATION
  • Preservative Free
  • 1 mL contains 40 mcg of hepatitis B surface antigen adjuvanted with amorphous aluminum hydroxyphosphate sulfate.
  • Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast n containing the gene for the n subtype of HBsAg.
  • This Product Contains No Thimerosal.
  • Rx only

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