Hepatitis B vaccine, recombinant

Composition

Each ml of hepatitis B recombinant vaccine contains 20 µg hepatitis B surface antigen (HBs-Ag) with ≥ 95% purity, obtained fromPichia pastorisas a yeast host and preserved with 0.05 mg thiomersal.

Dosage Form

Injectable white, slightly opalescent suspension.

Multi dose vial of 20 µg/ml (100 µg of HBs-Ag in 5 ml of the suspension).

Pharmacological Information

The vaccine produces high antibody titers against HBs-Ag. After three properly administered doses of the vaccine, 90% of healthy young adults and 95% of infants, children, and adolescents develop protective antibodies and subsequent immunity to HBV infection.

Dosage & Administration

-Usual dose: Three doses, first dose at initial visit, then one month and six months after the first dose, for a total of three doses (2 doses at 1 month interval, followed by a third dose 6  months after the first dose in birth date).

-Adults and children above 10 years of age: three doses of 1 ml (20 µg) and neonates and children up to 10 years of age: three doses of 0.5 ml (10 µg).

-Neonates born from  HBs-Ag positive mothers: within twelve hours after birth (preferably) or within seven days after birth, then one month, two months & twelve months after the first dose, for a total of four doses .

-Booster doses: Booster doses are not routinely recommended for persons with normal immune systems.

Administration Route

The vaccine should be administered by intramuscular (IM) or deep subcutaneous injection. However, for persons with blood clotting disorders (e.g. hemophiliac) or thrombocytopenia, the vaccine should be administered subcutaneously. The deltoid muscle is the recommended site for immunization of adults & adolescents. For infants & young children, the anterolateral aspect of the thigh muscle is the recommended site.

Vaccination Recommendations

          •        The vial should be well shaken before use, avoiding the formation of foam.

          •        The vaccine should not be diluted.

          •        It should not be administered intravenously or interadermally.

          •        Like other injectable biological products, keep epinephrine vial in reach while vaccination, to be used in the case of anaphylactic reaction.

          •        The vaccine should not be injected in the gluteal region, as the immunogenicity of the vaccine is substantially lowered.

Clinical Information and Indications

Hepatitis B vaccine is utilized for active immunization against HBV infection and prevention of its potential consequences such as acute or chronic hepatitis, liver cirrhosis and primary carcinoma. Vaccination can prevent the hepatic failure and infection due to delta viroid. This vaccine must be applied routinely to all newborns. It is specially recommended for the following high risk population groups as well:

-Health care personnel who may be exposed to the virus by means of blood, blood products, employees in medical facilities,

students in medical and nursing schools in contact with patients.

-Persons who have kidney disease or who undergo blood dialysis. Persons with blood clotting disorders (e.g. hemophiliacs), nephropathies, cirrhosis, who receive hemodialysis or plasmapheresis. Hemodialysis patients and patients with early renal failure before requiring hemodialysis.

-International travelers who will live or work for six months or more in areas with intermediate or high levels of chronic HBV infection, like South East Asia.

-Household members and sex partners of persons with positive chronic HBV infection.

-Patients and staff of live-in facilities and day-care programs for the disabled persons receiving social services, persons living in institutions and community homes, and the staff of these institutions.

-Prisoners and other prison employees, soldiers and other military personnel on active duty, fire

department personnel and embalmer morticians.

-Persons diagnosed recently with a sexually transmitted disease (STD), illegal drug users, and persons at the risk of sexual contamination (i.e., homosexual and bisexual males, including those with HIV infection, heterosexual persons with multiple partners, and persons with more than one sex partner in a six-month period).

-Donors or acceptors who will undergo elective surgery with sufficient time for seroconversion.

-Receptors of transplanted organs.

-Persons who usually use tattoos on their body.

Warnings

This vaccine protects only against infection with subtypes of HBV (and indirectly against hepatitis D virus infection). Immunization with this vaccine is not an indication for hepatitis caused by other hepatitis virus or by other viruses known to infect liver. Because of the long incubation period of HBV, unrecognized infection may be present at the time of immunization; the vaccine may not prevent hepatitis B in already infected patients.

Routine vaccination in the immune-deficient patients will not produce optimum antibody titer; thus, revaccination is recommended. Post-vaccination testing is not necessary after routine vaccination of infants, children, adolescents or adults except for high risk or immune-deficient persons.

Side Effects

Along with its desired effects, this vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur, they may need medical attention and consult with your doctor.

Common side effects are soreness, redness or pain at the injection site. Other systemic reactions are unusual tiredness or weakness, aches or pain in joints, fever, headache, welts and blurred vision or other vision changes, diarrhea or abdominal cramp, vertigo and nausea. Rare symptoms of allergic reaction are difficulty in breathing or swallowing, skin rash, hives, itching especially of feet or hands, reddening of skin especially around ears, swelling of eyes, face, or inside of nose.

Contraindications

Persons with feverish states due to a moderate or severe infectious disease should postpone receiving the vaccine until their conditions improved. Vaccination with hepatitis B vaccine is contraindicated for persons who previously had anaphylactic responses to a dose of the vaccine. Persons who are allergic to yeast should not receive this vaccine.

Pregnancy and Lactation

The effect of the HBs-Ag on fetal development has not been assessed. However, hepatitis B recombinant vaccine is recommended for pregnant women at risk of hepatitis B infection (FDA pregnancy category C). It is not known whether hepatitis B vaccine passes into the breast milk. However, the vaccine is not expected to cause problems in nursing babies.

Drug Interactions

Taking other medicinal products or vaccines should be done under supervision of doctor. This vaccine can be administered (using separate body sites and separate syringes) concurrently with polysaccharide vaccines (e.g., Haemophilus b vaccine, meningococcal and pneumococcal polyvalent vaccine), Influenza virus vaccine, diphtheria toxoid, tetanus toxoid and pertusis vaccine, live viral vaccines such as measles, mumps and rubella vaccines, poliovirus vaccines, immune globulins and inactivated vaccines (except cholera, typhoid (parenteral) and plague vaccines). It is recommended that cholera, typhoid (parenteral) and plague vaccines are administered on separate occasions.

Storage Conditions & Shelf Life

Store between +2°C to +8°C (in refrigerator). Do not freeze. The shelf life in this condition is 2 years after production date.

Keep the product out of reach of children.

Packaging

Each multidose vial contains 5 ml hepatitis B vaccine (5ml/vial).