Twinrix (hepatitis A, B virus) suspension for injections 1 ml. syringe №1

Description

Twinrix (hepatitis A, B virus) suspension for injections 1 ml. syringe №1

Composition

active substances: 1 dose (1 ml) contains:

hepatitis A virus (inactivated) (1,2) 720 units of ELISA

hepatitis B virus surface antigen (3,4) 20 mcg

1 is produced on human diploid cells MRC-5

2 adsorbed on aluminum hydroxide hydrated with 0.05 mg of Al3 +

3 produced in Saccharomyces cerevisiae yeast culture cells by recombinant DNA technology

4 adsorbed on aluminum phosphate 0.4 mg of Al3 +.

Excipients: aluminum hydroxide, aluminum phosphate, sodium chloride and water for injections.

Amino acids for injection, formaldehyde, neomycin sulfate, polysorbate-20 are present in trace amounts due to the production process.

Dosage form

Suspension for injection.

Main physicochemical properties: mixture of purified inactivated hepatitis A virus (HAV) and purified hepatitis B virus surface antigen (HBsAg), which are separately absorbed on aluminum hydroxide and aluminum phosphate. Hepatitis A virus is produced in diploid human MRC5 cell culture. HBsAg is genetically engineered in yeast cell culture.

Pharmacotherapeutic group

Viral vaccines. Combination vaccine for the prevention of hepatitis. ATX code J07B C20.

Pharmacological properties

Twinrix vaccine induces immunity against hepatitis A and B viruses by stimulating the synthesis of specific anti-HAV and anti-HBs antibodies.

Indication

Twinrix vaccine is indicated for the vaccination of unvaccinated children (1 year of age and older), adolescents and adults to prevent hepatitis A and B.

Contraindication

Twinrix should not be administered to individuals with known hypersensitivity to any component or neomycin, or to individuals who develop evidence of hypersensitivity after the first administration of Twinrix or monovalent hepatitis A and B vaccines. As with other vaccines, the administration of Twinrix should be delayed in persons with acute febrile illness.

Method of application and dosage

The recommended dose for children (1 year and older), adolescents and adults – 1.0 ml.

Primary vaccination schedule:

• children aged 1 to 15 years. The standard course of primary vaccination with Twinrix vaccine involves the administration of two doses, the first of which is administered on the selected day, the second between six and twelve months after the first dose. Protection against hepatitis B is formed after the second dose;
• adults and adolescents over 16 years of age. The standard course of primary vaccination with Twinrix vaccine consists of three doses. The first dose is administered on the chosen day, the second – a month later, and the third – 6 months after the first dose.

In exceptional cases, adults who are going to travel in 1 month or less and can not complete the initial vaccination according to the scheme 0, 1, 6 months, can be vaccinated according to the scheme 0, 7, 21 days. When using this regimen, it is recommended that a fourth dose of vaccine be given 12 months after the first dose.

The recommended vaccine regimens should be strictly adhered to. Once the primary vaccination course has been started, it should be completed using the same vaccine

Booster vaccination:

• based on long-term follow-up data in the vaccination of children aged 1 to 15 years with the Twinrix vaccine, it was found that specific antibodies persist for up to 15 years after vaccination;
• based on long-term follow-up data in the vaccination of adults with the Twinrix vaccine according to the scheme 0, 1, 6 months, it was found that specific antibodies persist for up to 20 years after vaccination.

Titers of anti-HAV and anti-HBs after the course of primary vaccination are within the range characteristic of monovalent vaccines. Thus, general recommendations for booster immunization can be provided based on experience with monovalent vaccines.

Hepatitis B

The need for a booster dose of hepatitis B vaccine has not been established in healthy subjects who have received a full course of primary vaccination. However, some official immunization programs provide for the introduction of a booster dose. In this case, these recommendations must be strictly followed.

For some categories of people at risk for hepatitis B virus infection (hemodialysis, immunodeficiency, etc.), it is necessary to constantly monitor the level of specific antibodies so that it is not below 10 mIU / ml.

Hepatitis A

To date, the need for a booster dose to immunocompetent individuals who give an immune response to the hepatitis A vaccine has not been established. It should be borne in mind that a sufficient level of immune protection can be provided by immunological memory. Recommendations for booster doses of the vaccine are based on the fact that a certain concentration of antibodies against hepatitis A virus is required to ensure an adequate level of protection.

If a booster dose is needed to prevent hepatitis A and B, the Twinrix vaccine may be used. Monovalent vaccines for the prevention of hepatitis A and B may be used for booster immunization of persons vaccinated with Twinrix vaccine.

The Twinrix vaccine is intended for intramuscular injection into the deltoid area of ​​the upper extremity in adults and older children. In children under three years of age, the vaccine is given into the anterolateral thigh.

Because intradermal and intramuscular injections into the gluteal muscle do not produce a sufficient response to the vaccine, this route of administration should not be used. In exceptional cases, Twinrix can be administered subcutaneously to patients with thrombocytopenia or coagulation disorders, as bleeding may occur after intramuscular administration. However, this route of administration of the vaccine may lead to a reduced immune response.

Instructions for use of the vaccine

During storage, a white precipitate with a clear colorless supernatant may be observed.

The vaccine should be resuspended before use. After re-suspension, the vaccine should become uniform, cloudy, white.

Steps for re-suspending the vaccine to obtain a homogeneous white slightly turbid suspension:

1. Hold the syringe upright in a closed hand.

2. Shake the syringe upside down and vice versa.

3. Repeat this step vigorously for at least 15 seconds.

4. Inspect the vaccine again:

• if the vaccine has the appearance of a homogeneous turbid white suspension, it is ready for use (the vaccine should not be transparent);
• if the vaccine does not yet look like a uniform turbid white suspension, shake the syringe upside down for at least another 15 seconds, then test again.

The vaccine should be inspected visually for any foreign particulate matter and / or abnormal appearance prior to administration. Do not use the vaccine if you have the above.

Any unused product or waste material should be disposed of in accordance with local requirements.

Children

Twinrix is indicated for the vaccination of unvaccinated children over 1 year of age.

Overdose

According to post-marketing surveillance, there have been reports of overdose following the use of Twinrix vaccine. The side effects observed with overdose were similar to those seen with conventional vaccination.

Side effects:

A) Adults and adolescents over 16 years of age:

• infections and invasions: upper respiratory tract infections;
• nervous system: headache, dizziness;
• gastrointestinal system: gastrointestinal symptoms, diarrhea, nausea;
• musculoskeletal system and connective tissue: myalgia;
• general disorders and administration site conditions: pain and redness at the injection site, fatigue, swelling at the injection site, reaction at the injection site (such as haematomas, pruritus, bruising), malaise, fever (≥ 37.5 ° C).

B) Children aged 1 to 15 years:

• nervous system: headache, drowsiness;
• gastrointestinal system: gastroenterological symptoms;
• metabolic and digestive disorders: loss of appetite;
• general disorders and administration site conditions: pain and redness at the injection site, fatigue, swelling at the injection site, fever;
• mental disorders: irritability.