Universal reference book for medicines
Product name: TWINRIX ® (TWINRIX)

Active substance: hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (adsorbed)

Type: Vaccine for the prevention of hepatitis A and B

Manufacturer: GlaxoSmithKline Biologicals (Belgium)
Composition, form of production and packaging
Suspension for injection
homogeneous, whitish color, when standing, a clear colorless supernatant and a white precipitate are formed.

0.5 ml

inactivated hepatitis A virus 360 units ELISA

purified recombinant major surface antigen of hepatitis B virus (HBsAg) 10 μg

[PRING] aluminum 0.45 mg (including aluminum phosphate - 0.4 mg and aluminum hydroxide - 0.05 mg sorbents), 2-phenoxyethanol 0.5 mg (preservative), sodium chloride, water d / and, amino acids (mixture), formaldehyde, Neomycin sulfate (trace amounts), polysorbate-20.

The inactivated hepatitis A virus is adsorbed on aluminum hydroxide, the recombinant hepatitis B surface antigen is on aluminum phosphate.

1 dose (0.5 ml) - glass syringes (1) - blisters (1) - packs of cardboard.

1 dose (0.5 ml) - glass syringes (1) in the package with 1 needle - blisters (1) - cardboard packs.

1 dose (0.5 ml) - glass syringes (1) in the package with 2 needles in the caps - blisters (1) - cardboard packs.

1 dose (0.5 ml) - glass syringes (5) - blisters (2) - packs of cardboard.

1 dose (0.5 ml) - glass syringes (5) - blisters (2) complete with 5 needles in strips (2) - cardboard packs.

1 dose (0.5 ml) - glass syringes (5) - blisters (2) complete with 5 needles in strips (4) - cardboard packs.

Suspension for injection homogeneous, whitish color, when standing, a clear colorless supernatant and a white precipitate are formed.

1 ml

inactivated hepatitis A virus 720 UD ELISA

purified recombinant basic surface antigen of hepatitis B virus (HBsAg) 20 μg

[PRING] aluminum 0.45 mg (including aluminum phosphate - 0.4 mg and aluminum hydroxide - 0.05 mg sorbents), 2-phenoxyethanol 0.5 mg (preservative), sodium chloride, water d / and, amino acids (mixture), formaldehyde, Neomycin sulfate (trace amounts), polysorbate-20.

The inactivated hepatitis A virus is adsorbed on aluminum hydroxide, the recombinant hepatitis B surface antigen is on aluminum phosphate.

1 dose (1 ml) - glass syringes (1) - blisters (1) - packs of cardboard.

1 dose (1 ml) - glass syringes (1) in the package with 1 needle - blisters (1) - cardboard packs.

1 dose (1 ml) - glass syringes (1) in the package with 2 needles in the caps - blisters (1) - cardboard packs.

1 dose (1 ml) - glass syringes (5) - blisters (2) - packs of cardboard.

1 dose (1 ml) - glass syringes (5) - blisters (2) complete with 5 needles in strips (2) - cardboard packs.

1 dose (1 ml) - glass syringes (5) - blisters (2) complete with 5 needles in strips (4) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

The inactivated hepatitis A and B vaccine is a mixture of inactivated hepatitis A virions (strain HM175) grown in diploid human MCR-5 culture and purified recombinant hepatitis B surface antigen, obtained by genetic engineering from S. cerevisiae.

Tweenrix induces the formation of specific antibodies to the hepatitis A virus (anti-HAV) and to the hepatitis B virus (anti-HBs) in 2-4 weeks.
after vaccination. A specific humoral response with the formation of anti-HAV antibodies develops in 100% of vaccinated at the end of the course of triple vaccination (0-1-6 months), i.e.1 month after the third dose. A specific humoral response producing antibodies to anti-HBs develops in approximately 99% of adults and 100% of children 1 month after completion of the three-time vaccination (0-1-6 months), i.e. 1 month after the third dose.
When using an emergency vaccination program (0-7-21 days) in adults with the introduction of a fourth dose at 12 months, seroprotective levels of anti-HBs antibodies appear after 82% and 82% of vaccinees at weeks 1 and 5, respectively, after the third dose;
a month after the introduction of the fourth dose - in 100% of the vaccinated. Anti-HAV antibodies after administration of the third dose are observed in 100% and 99.5% of patients vaccinated at 1 and 5 weeks, respectively, and 100% - one month after the fourth dose.
In a long-term clinical study, it has been established that anti-HAV and anti-HBs antibodies after vaccination start in most vaccinated adults and children persist for 60 and 48 months, respectively.

The kinetics of the reduction in the concentration of anti-HAV and anti-HBs antibodies after the administration of Twinrich is similar to the kinetics of antibody titre reduction after vaccination with monovalent vaccines.

INDICATIONS

- prevention of hepatitis A and B in children aged 12 months, adolescents and adults;

- chronic liver diseases (including carriage of the hepatitis C virus), with the exception of chronic hepatitis B.

DOSING MODE

Twinbrush can not be administered iv!
The vaccine is intended for in / m introduction to the deltoid muscle region or antero-lateral thigh region in young children. In people with thrombocytopenia or bleeding of another etiology, the vaccine can be administered sc.
Before using the vaccine, it is necessary to visually check for foreign particles and shake the well well, to obtain an opaque suspension of whitish color.
If the vaccine does not comply with the above description or contains foreign matter, it should be destroyed. Twinnings can not be mixed in one syringe with other vaccines.
Vaccination schedules

The recommended single dose for adults and adolescents over 16 years is 1.0 ml, for children and adolescents under 16 years - 0.5 ml.

The standard scheme of immunization (0-1-6 months) includes a triple injection of the vaccine with the introduction of a second one month after the first (2nd dose) and the third - 6 months after the first dose (dose 3).

In exceptional circumstances requiring rapid and simultaneous protection from hepatitis A and B (for example, a planned trip to a region endemic for hepatitis A and B a month or more after the first vaccination), adults are given an emergency vaccination schedule of 0-7-21 days.
When applying this scheme, a fourth vaccination is required 12 months after the first.
A full course of vaccination is recommended to begin, carry out and complete with the Twinrix vaccine.
It is not recommended to replace the Twinrix vaccine with any other during the course.
If it is necessary to revaccinate against hepatitis B, after carrying out the full Twoxycus vaccination schedule, any monovalent vaccine can be used.

SIDE EFFECT

In controlled vaccine trials
Twinbricks were most often recorded: pain, redness, swelling at the injection site.
In comparative studies it was shown that the incidence of undesirable reactions to Twinrichs is comparable to that of monovalent vaccines.

The undesirable reactions listed below are grouped according to organ systems and frequency of occurrence: very often (? 10%), often (from? 1% to <10%), sometimes (from? 0.1% to <1%), rarely (from? 0.01% to <0.1%), very rarely, including individual messages (<0.01%).

Systemic adverse reactions may develop in response to vaccination.

On the part of the body as a whole: very often - a feeling of fatigue;
often - headache, weakness; sometimes - a fever.
From the digestive system: often - nausea;
sometimes - vomiting.
In the case of an emergency vaccination scheme, the common symptoms occurred at the same frequency as when using the standard regimen, with the exception of a headache, the frequency of reports about which increased.
The introduction of the fourth dose was not accompanied by previously undescribed undesirable phenomena or an increase in their frequency.
According to post-registration data
the following undesirable reactions were recorded.
On the part of the body as a whole: very rarely - the flu-like syndrome (fever, chills, headache, myalgia, arthralgia), allergic reactions (including anaphylactoid and anaphylactic reactions and whey), fatigue.

From the cardiovascular system: very rarely - syncope, lowering blood pressure.

From the central nervous system and peripheral nervous system: very rarely - dizziness, paresthesia, convulsions.

On the part of the digestive system: very rarely - nausea, vomiting, decreased appetite, diarrhea, abdominal pain, changes in functional liver tests.

From the hemopoietic system: very rarely - thrombocytopenia, thrombocytopenic purpura, lymphadenopathy.

Dermatological reactions: very rarely - rash, itching, hives.

Additional information on adverse reactions that have occurred with the use of monovalent vaccines, but not registered with the use of Twinrich.

From the side of the central nervous system and peripheral nervous system: very rarely - multiple sclerosis, optic neuritis, myelitis, Bell's paralysis, polyneuritis as Guillain-Barre syndrome, meningitis, encephalitis, encephalopathy.

Dermatological reactions: very rarely - exudative erythema multiforme.

From the cardiovascular system: very rarely - vasculitis.

CONTRAINDICATIONS

- hypersensitivity to any component of the vaccine and / or to baker's yeast;

- hypersensitivity reactions to previous administration of Twinrich or monovalent vaccines against hepatitis A and B.

The introduction of Twinrich should be delayed in persons with acute fever (including with exacerbation of chronic diseases).
Vaccination is carried out 1 month after recovery (onset of remission).
PREGNANCY AND LACTATION

Controlled clinical studies on the use of the Twinrix vaccine during pregnancy and during breastfeeding have not been conducted, as well as experimental studies of the effect of the drug on the reproductive function of animals.

SPECIAL INSTRUCTIONS

Twinbrush does not protect against hepatitis C and E and other infectious diseases of the liver.

Twinbricks are not recommended for emergency prevention of hepatitis B in case of accidental infection through the blood.

It is possible that during vaccination vaccinees may be in the incubation period of hepatitis A and B and it is not known whether the introduction of Twinrich will prevent the development of the disease in this case.

The effect of the vaccine in immunocompromised individuals has not been studied.
It is suggested that in patients with reduced immune status, the protective titer of antibodies against hepatitis A and B may not be achieved after a triple vaccination, so they may need to be revaccinated with the appropriate monovalent vaccine.
In connection with the possibility of development in rare cases of an anaphylactic reaction, the vaccinated should be under medical supervision for 30 minutes, and procedural rooms should be provided with anti-shock therapy.

OVERDOSE

So far, no cases of overdose have been reported.

DRUG INTERACTION

The interaction of twinnix with specific antibodies of anti-HAV and anti-HBs has not been studied.
However, the available data indicate that there is no effect on seroconversion with simultaneous use of monovalent hepatitis A or B vaccines and specific immunoglobulins, although it is possible that in some cases simultaneous administration of a vaccine and specific immunoglobulins can lead to a decrease in antibody titer.
The interaction of Twinrichs with other vaccines with their simultaneous use has not been studied, and therefore it is not recommended to introduce Twinrichs simultaneously with other vaccines.

It is assumed that in patients receiving immunosuppressant therapy (as in patients with a decreased immune status), an adequate immune response may not be achieved.

TERMS OF RELEASE FROM PHARMACY

Packaging containing 1 syringe is dispensed by prescription.

A package containing 10 syringes is supplied to medical and preventive institutions.

TERMS AND CONDITIONS OF STORAGE

The vaccine should be stored and transported at a temperature of 2 ° to 8 ° C;
Do not freeze. Shelf life - 3 years. Do not use after the expiration date printed on the package.
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