Instruction for use: Twinrix

Dosage form: Suspension for intramuscular administration

Active substance: Vaccinum ad prophylaxim hepatitidum epidemicarum A, B

ATX

J07BC20 Hepatitis vaccines in combination

Pharmacological group:

Vaccines, serums, phages and toxoids

Composition and release form

Suspension for intramuscular injection 0.5 ml

Inactivated hepatitis A virus, ELISA units 360

Purified recombinant basic surface antigen of hepatitis B virus (HBsAg) (dose for children) 10 μg

Auxiliary substances: aluminum hydroxide; Aluminum phosphate; formaldehyde; Neomycin sulfate; 2-phenoxyethanol; Polysorbate 20; sodium chloride; water for injections

In glass bottles of 0.5 ml; In a pack of cardboard 1, 10, 25 bottles or in glass syringes; In a pack of cardboard 10, 25 syringes.

Suspension for intramuscular injection 1 ml

Inactivated hepatitis A virus, ELISA units 720

Purified recombinant basic surface antigen of hepatitis B virus (HBsAg) (adult dose) 20 μg

Auxiliary substances: aluminum hydroxide; Aluminum phosphate; formaldehyde; Neomycin sulfate; 2-phenoxyethanol; Polysorbate 20; sodium chloride; water for injections

In glass bottles of 1 ml; In a pack of cardboard 1, 10, 25 bottles or in glass syringes; In a pack of cardboard 10, 25 syringes.

Pharmachologic effect

Mode action - immunostimulating.

Dosing and Administration

IM, preferably in the deltoid muscle region or anterolateral hip area in young children; SC, in people with thrombocytopenia and other diseases of the blood coagulation system.

Adults (16 years and over) are recommended a single dose of 1 ml.

The immunization schedule consists of 3 doses: the first one is administered on the selected day, the second one in a month, the third one after 6 months after the first dose. In emergency cases (when traveling to the hyperendemic region in a month or more after the first vaccination), if there is no possibility to carry out the scheme 0, 1, 6 months, then scheme 0, 7, 21 day is applied with the introduction of the 4th dose 12 months after 1 Th.

Children (from 1 year to 15 years inclusive), the recommended single dose - 0.5 ml. The immunization schedule consists of 3 doses: the first one is administered on the selected day, the second one in a month, the third one after 6 months after the first dose.

If the course of primary vaccination is initiated with the Twinrix vaccine, then it must also be completed with the Twinrix vaccine.

Revaccination against hepatitis B: the need for a revaccinating dose against hepatitis B in healthy individuals who have completed the primary vaccination course has not been established. For some categories of people at risk for hepatitis B (eg those on dialysis or with reduced immunity), the need for revaccination is determined by the presence of a protective antibody level ≥10 IU / L.

Revaccination against hepatitis A: the need for revaccination of persons with a positive response to hepatitis A vaccination has not been proven at this time. Protective properties in the absence of detectable antibodies are provided by immunological memory. In situations where a revaccinating dose is required against hepatitis A and B, Twinrix can be used or any monovalent vaccine can be used.

Before using the vaccine, it is necessary to visually check for foreign particles and shake well the vial or syringe to obtain an opaque white suspension. If the vaccine looks different or contains foreign particles, it should be destroyed.

Twinrix cannot be mixed in one syringe with other vaccines and injected IV.

Manufacturer

GlaxoSmithKline Bayolodikalz SA, Belgium.

Storage conditions of the drug Twinrix

At a temperature of 2-8 ° C (don’t freezing).

Keep out of the reach of children.

Shelf life of the drug Twinrix

3 years.

Do not use after the expiry date printed on the package.