GlaxoSmithKline – Hepatitis Vaccines (2009)

About

Ambirix: Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Engerix-B: Hepatitis B Vaccine (Recombinant).
Fendrix: Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Havrix: Hepatitis A vaccine, inactivated.
Hepatyrix: Hepatitis A (inactivated, adsorbed) and Typhoid Polysaccharide vaccine.
Twinrix: Combined hepatitis A (inactivated virus) and hepatitis B vaccine (genetically derived surface antigen).

Hepatitis

Hepatyrix
– Hepatitis A (inactivated) and Typhoid Polysaccharide vaccine (adsorbed).
– 25 micrograms of the Vi polysaccharide antigen, part of the typhi (Ty2 strain) bacterium that causes typhoid fever.
– 1440 ELISA units of hepatitis A viral protein.
– Excipients: Sodium chloride, Water for injections.

Ambirix (2007)
– First authorisation: August 2002.
– Latest renewal: September 2007.
– Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
– 2 injections within 12 months, used in infants, children and adolescents from 1 year.
– Cannot completely prevent infections with hepatitis A or B viruses, even after received both doses.
– Former formulation: Thiomersal and preservative containing vaccine.
– Active substances: Hepatitis A virus (inactivated), 720 ELISA Units, produced on human diploid (MRC-5) cells and adsorbed on aluminium hydroxide, hydrated 0.05 milligrams Al3+; Hepatitis B surface antigen, 20 micrograms, produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology and adsorbed on aluminium phosphate 0.4 milligrams Al3+.
– Excipients: Sodium chloride and water for injections.
– Evaluation of pharmacokinetic properties is not required for vaccines.
– Side effects during clinical trials: Pain or discomfort at the injection site or redness; Tiredness; Irritability; Headache; Loss of appetite; Swelling at the injection site; Fever (more than 38°C); Drowsiness; Stomach and digestive complaints waste; Itchy or blistering, swelling of the eyes and face,
difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness; Flu-like symptoms, including chills, and muscle and joint pains; Fits, dizziness, pins and needles, multiple sclerosis, disease of the nerves of the eye, loss of sensation in, or of the ability to move some parts of the body, severe headache with stiff neck, disruption of the normal brain functions; Faints; Inflammation of some blood vessels; Feeling or being sick, loss of appetite, diarrhoea and stomach pains; Abnormal laboratory liver test results; Swelling of the glands; Bleeding or bruising more easily than normal due to a drop in a type of blood cell called platelets.
– Postmarketing Experience: Abnormal liver function tests; Thrombocytopenia, thrombocytopenic purpura, lymphadenopathy; Syncope, dizziness, paresthesia, convulsions; Nausea, vomiting, diarrhoea, abdominal pain; Rash, pruritis, urticaria; Decreased appetite; Hypotension; Flu-like symptoms, fatigue; Allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness like disease; Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), encephalitis, encephalopathy; Optic neuritis; Erythema exsudativum multiforme; Meningitis; Vasculitis.

Engerix-B
– Purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus.
– Culture media: Yeast or yeast extract.
– Excipients: Aluminum Hydroxide, Phosphate Buffers, Thimerosal, Yeast Protein.
– Pediatric/Adolescent: Each 0.5-mL dose contains 10 mcg of hepatitis B surface antigen
adsorbed on 0.25 mg aluminum as aluminum hydroxide, sodium chloride (9 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 0.71 mg/mL).
– Adult: Each 1-mL adult dose contains 20 mcg of hepatitis B surface antigen adsorbed on 0.5 mg aluminum as aluminum hydroxide, sodium chloride (9 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 0.71 mg/mL).
– Dosing Schedules: 1st dose; 2nd dose, 1 month later; 3rd dose, 6 months after 1st dose.
– Not evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
– Animal reproduction studies not conducted.
– Not known whether can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
– Not known whether is excreted in human milk.
– Adverse Reactions: Dizziness, headache; Fever (>37.5°C), injection site erythema, injection site induration, injection site swelling; Upper respiratory tract illnesses; Lymphadenopathy; Anorexia; Agitation, insomnia; Somnolence, tingling; Flushing, hypotension; Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting; Erythema, petechiae, pruritus, rash,
sweating, urticaria; Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck; Chills, influenza-like symptoms, injection site ecchymosis, injection site pain, injection site pruritus, irritability, malaise, weakness.
– Postmarketing Reports: Herpes zoster, meningitis; Thrombocytopenia; Allergic reaction, anaphylactoid reaction, anaphylaxis. Arthralgia/arthritis (usually transient), fever, and
dermatologic reactions such as urticaria, erythema multiforme, ecchymoses, and erythema
nodosum; Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, paresthesia, Guillain-Barré syndrome and Bell’s palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis; Conjunctivitis, keratitis, visual disturbances; Earache, tinnitus, vertigo; Palpitations, tachycardia; Vasculitis; Apnea, bronchospasm including asthma-like symptoms; Dyspepsia; Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura; Arthritis, muscular weakness; Injection site reaction; Abnormal liver function tests.

Havrix
– Culture media: Human diploid tissue culture, MRC-5.
– Excipients: Aluminum Hydroxide, Amino Acids, Formaldehyde or Formalin, MRC-5, Cellular Protein, Neomycin Sulfate, 2-Phenoxyethanol, Phosphate Buffers, Polysorbate.

Twinrix
– Sterile suspension of inactivated hepatitis A virus (strain HM175) propagated in MRC-5 cells, and combined with purified surface antigen (HBsAg) of the hepatitis B virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus, in synthetic media containing inorganic salts, amino acids, dextrose, and vitamins. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation.
– Contains the antigenic components used in producing Havrix and Engerix-B, for persons 18 years of age or older.
– Culture media: Human diploid tissue culture (MRC-5), yeast or yeast extract.
– Excipients: Aluminum Hydroxide, Aluminum Phosphate, Amino Acids, Dextrose, Formaldehyde or Formalin, Inorganic Salts, MRC-5 Cellular Protein, Neomycin Sulfate, 2-Phenoxyethanol, Phosphate Buffers, Polysorbate 20, Thimerosal.
– 1.0-mL dose of vaccine contains 720 ELISA Units of inactivated hepatitis A virus and
15 20 mcg of recombinant HBsAg protein.
– 1 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, Water for Injection, traces of formalin (not more than 0.1 mg), and residual MRC-5 cellular proteins (not more than 2.5 mcg).
– Neomycin sulfate, an aminoglycoside antibiotic, is included in the cell growth media; only trace amounts (not more than 20 ng) remain following purification.
– Primary immunization for adults consists of 3 doses, given on a 0, 1, and 6-month schedule. Alternatively, a 4-dose schedule, given on days 0, 7 and 21 to 30 followed by a booster dose at month 12 may be used.
– As with any vaccine, vaccination may not protect 100% of recipients.
– Not evaluated for carcinogenic potential, mutagenic potential, or potential for impairment of fertility.
– Healthcare providers are encouraged to register pregnant women in the GlaxoSmithKline vaccination pregnancy registry.
– Not known whether is excreted in human milk.
– Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
– As with any vaccine, broad use could reveal adverse events not observed in clinical trials.
– Postmarketing Reports: Herpes zoster, meningitis; Thrombocytopenia, thrombocytopenic purpura; Allergic reaction, anaphylactoid reaction, anaphylaxis, serum sickness–like syndrome days to weeks after vaccination including arthralgia/arthritis (usually transient), fever, urticaria, erythema multiforme, ecchymoses, and erythema nodosum; Bell’s palsy, convulsions, encephalitis, encephalopathy, Guillain-Barré syndrome, hypoesthesia, myelitis, multiple sclerosis, neuritis, neuropathy, optic neuritis, paralysis, paresis, transverse myelitis; Conjunctivitis, visual disturbances; Earache, tinnitus; Palpitations, tachycardia; Vasculitis; Bronchospasm including asthma-like symptoms, dyspnea; Dyspepsia; Hepatitis, jaundice; Alopecia, angioedema, eczema, erythema multiforme, erythema nodosum, hyperhydrosis, lichen planus; Arthritis, muscular weakness; Chills, injection site reaction, malaise; Abnormal liver function tests.

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