Twinrix (hepatitis A virus inactivated) suspension for injections 1 ml. syringe

$99.00

The TWINRIX ™ Vaccines is indicated for the vaccination of unvaccinated children (1 year of age and older), adolescents, and adults for the prevention of hepatitis A and B.

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Description

Storage
active substances: 1 dose (1 ml) contains:
hepatitis A virus (inactivated) 1.2 720 units ELISA hepatitis B virus surface antigen 20 μg 20 μg
1 produced on human diploid cells MRC-5 2 adsorbed on aluminum hydroxide hydrated with 0.05 mg of Al3 + 3 produced on yeast culture cells Saccharomyces cerevisiae 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 culture of human MRC5 cells. HBsAg is obtained by genetic engineering in yeast cell culture.
Pharmacotherapeutic group
Viral vaccines. Combination vaccine for the prevention of hepatitis. ATX code J07B C20.
Immunological and biological properties
Pharmacodynamics
TWINRIX ™ induces immunity against hepatitis A and B viruses by stimulating the synthesis of specific anti-HAV and anti-HBs antibodies.
Children from 1 year to 15 years
In clinical trials involving individuals aged 1 to 15 years, seroconversion for anti-HAV 1 month after the first dose of the vaccine was 99.1%, 6 months after the second dose (seventh month) – 100% . Seroconversion for anti-HBs 1 month after the first dose was 74.2%, 6 months after the second dose (seventh month) – 100%. The level of seroprotection for anti-HBs (titers ≥ 10 mIU / ml) in these terms was 37.4% and 98.2%, respectively.
In a clinical study in adolescents 12 – 15 years, with the introduction of the twelfth month of the second dose of the vaccine, the level of seropositivity after 1 month for anti-HAV was 99.0%, for anti-HBs – 99.0%, seroprotection was 97.0% .
In a comparative study involving adolescents using a two-dose vaccination schedule compared to an alternative vaccination schedule (three-dose vaccine containing 360 units of ELISA inactivated virus HA and 10 μg HBsAg at a dose of 0.5 ml), the level of seroprotection for anti-HBs before The dose of TWINRIX к was lower than with the three-dose regimen. However, as shown at the end of vaccination (in the seventh month), the quality of immunization did not decrease.
Antibodies to anti-HAV and anti-HBs, according to relevant studies, persist after administration of the vaccine TWINRIX ™ (according to the scheme 0, 6 months) for at least 10 years. After 10 years, the level of seropositivity for anti-HAV antibodies was 100% for both groups of patients, aged 1 to 11 years and aged 12 to 15 years after primary vaccination. During the same period, the level of seroprotection for anti-HBs was 77.3% and 85.9%, respectively. A study in patients 12 to 15 years of age at the time of primary vaccination showed that the immune response to both antigens was the same as after three injections of a vaccine containing 360 units of ELISA inactivated HAV and 10 μg of surface antigen. HBsAg at a dose of 0.5 ml.
During long-term six-year follow-up of patients aged 12 to 15 years at the time of primary vaccination, the level of seropositivity for anti-HAV antibodies was 100% both when using the scheme 0, 6 months, and when using the scheme 0, 12 months. Seroprotection levels for anti-HBs antibodies were 84.8% and 92.9%, respectively.

Adults and adolescents over 16 years of age
In persons over 16 years of age, with 3 doses of TWINRIX ™, immune protection against hepatitis A and B was formed within 2 to 4 weeks. Clinical studies have shown that 1 month after the first dose, anti-HAV vaccines were found in approximately 94%, and 1 month after the third dose (ie the seventh month) in 100% of those vaccinated. Anti-HBs appeared in 70% of the vaccine after the first dose and in 99% of the vaccine after the third dose.
In adults, on immunization schedule 0, 7, 21 days plus the fourth dose at 12 months, the level of seroprotection against anti-HBV is 1 and 5 weeks after the third dose of 82% and 85%, respectively. One month after the fourth dose, all vaccinated develop a protective level of seroprotection against anti-HBV. At 1 and 5 weeks after the third dose, seroconversion for anti-HAV was 100% and 99.5%, respectively, and reached 100% 1 month after the fourth dose in all vaccinated subjects.
In a clinical study in adults over 40 years of age, seropositivity levels for anti-HAV antibodies and seroprotection levels for hepatitis B after TWINRIX Р vaccination at 0, 1, 6 months were similar to those seen with monovalent vaccines. hepatitis A and B separately.
Seroprotection levels for hepatitis B 7 and 48 months after the first dose of TWINRIX ™ were 92% and 57%, respectively, compared with 80% and 40% after administration of the monovalent hepatitis B vaccine, manufactured by GlaxoSmithKline, containing 20 μg of antigen, and 71% and 27%, respectively, after administration of another licensed monovalent hepatitis B vaccine containing 10 μg of antigen. In all groups, anti-HBs antibody concentrations decreased with increasing age and body weight of patients. In men, antibody concentrations were lower than in women.
Seropositivity levels for anti-HAV antibodies 7 and 48 months after the first dose of TWINRIX ™ were 97% (for both groups 7 and 48 months) compared with 99% and 94% after administration of the monovalent hepatitis A vaccine, manufactured by GlaxoSmithKline, and 99% and 96% after administration of another licensed monovalent hepatitis A vaccine.
To assess immune memory, patients received an additional dose of the same vaccine 48 months after the first dose of TWINRIX ™ as part of the primary vaccination course. One month after administration of this dose in 95% of patients, the concentration of anti-HBV antibodies was 10 mIU / ml and above, and the geometric mean concentrations (SGC) increased 179 times (SGC = 7233.7 mIU / ml), indicating immune memory.
In two long-term studies in adults aged 17 to 43 years, 15 years after primary vaccination with TWINRIX ™, it was found that anti-HAV seropositivity rates reached 100% for both studies and anti-HBs seroprotection rates were 89.3% and 92.9%, respectively (n = 56). It was shown that the dynamics of reducing the levels of anti-HAV and anti-HBs was similar to that observed with the use of appropriate monovalent vaccines. Pharmacokinetics
Evaluation of pharmacokinetic properties is not required for vaccines.
Indication
TWINRIX ™ 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 можна should not be administered to individuals with known hypersensitivity to any component or neomycin, or to individuals who develop signs of hypersensitivity after the first administration of TWINRIX ™ or monovalent vaccines for the prevention of hepatitis A and B. As with other vaccines, Twinrix ™ should be delayed in persons with acute fever-related illnesses.
Interaction with other drugs and other types of interactions.
The effect of co-administration of TWINRIX ™ and specific immunoglobulins against hepatitis A or B viruses is unknown. However, co-administration of monovalent vaccines for the prevention of hepatitis A and B with specific immunoglobulins had no effect on seroconversion, although this may lead to the appearance of antibodies in slightly reduced titers.

Clinical studies have shown that TWINRIX ™ can be administered during the second year of life at the same time as vaccines for the prevention of diphtheria, tetanus, pertussis (acellular component), poliomyelitis (inactivated), Haemophilus influenzae type b (DTPa or IPV). with a combined vaccine for the prevention of measles, rubella and mumps. In these clinical trials, the vaccine was administered to different parts of the body.
Although co-administration of TWINRIX ™ with other vaccines has not been specifically studied, it can be assumed that there will be no interaction with different syringes and injections into different parts of the body.
Patients receiving immunosuppressive therapy and patients with immune system defects cannot be expected to achieve an adequate immune response.
Method of application and dosage
The recommended dose for children (1 year and older), adolescents and adults – 1.0 ml.
Primary vaccination schedule:
Children from 1 year to 15 years

The standard course of primary vaccination with TWINRIX ™ includes the administration of two doses, the first of which is administered on the selected day, the second – between the sixth and twelfth month 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 the Twinrix ™ vaccine consists of three doses. The first dose is administered on the selected day, the second – a month later, and the third – 6 months after the first dose.
In exceptional cases, adults who are going on a trip in 1 month or later 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 scheme, it is recommended to administer the fourth dose of the vaccine 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 adults with the TWINRIX ва vaccine according to the scheme 0, 1, 6 months, it was found that specific antibodies persist for up to 15 years after completion of vaccination.
Titers of anti-HAV and anti-HBs after the course of primary vaccination are within the range characteristic of monovalent vaccines. After immunization of adult patients with the TWINRIX vaccine, the dynamics of the decrease in antibody titers is similar to that observed with 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 IU / liter.
Hepatitis А

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 the administration of a booster dose of the vaccine are based on the fact that to ensure an adequate level of protection requires a certain concentration of antibodies to hepatitis A, which has been shown to persist for at least 10 years.
If a booster dose is required to prevent hepatitis A and B, the TWINRIX може vaccine may be used. Monovalent vaccines for the prevention of hepatitis A and B can be used for booster immunization of persons vaccinated with the TWINRIX І vaccine.
TWINRIX ™ is intended for intramuscular injection into the deltoid area of ​​the upper extremity in adults and older children. Children under three years of age are vaccinated in the anterolateral thigh.
Because an intradermal and intramuscular injection into the gluteal muscle does 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. Examine the vaccine again:
a) if the vaccine has the appearance of a homogeneous turbid white suspension, it is ready for use (the vaccine should not be transparent);
b) If the vaccine does not yet look like a homogeneous 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. If the above vaccine is not available.
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 (see sections “Indications”, “Method and Dosage”).
Overdose
According to post-marketing surveillance, there have been reports of overdose following the use of TWINRIX ва vaccine. The side effects seen with overdose were similar to those seen with regular vaccination.
Side effects

Clinical trial data.
Adults and adolescents over 16 years of age
The safety profile below is based on data obtained from vaccination of more than 6,000 people who received a standard 0, 1, 6 month vaccination schedule (n = 5683) or an accelerated – 0, 7, 21 day (n = 320). The most commonly reported local adverse reactions after administration of the vaccine according to the standard regimen at 0, 1, 6 months are pain and redness with a frequency of 37.6% and 17.0%, respectively. In two clinical trials in which the vaccine was administered on days 0, 7, and 21, general and local symptoms were reported with the same frequency as defined below. After the fourth dose received at 12 months, the frequency of general and local adverse reactions corresponded to the frequency observed after vaccination at 0, 7, 21 days.
In a comparative study, it was noted that the frequency of side effects after the use of the vaccine TWINRIX ™ does not differ from that when using monovalent vaccines.
Infections and invasions
Uncommon: upper respiratory tract infections.
Circulatory and lymphatic systems
Rare: lymphadenopathy.
Metabolic and digestive disorders
Rare: decreased appetite.
Nervous System
Very common: headache.
Uncommon: dizziness.
Rare: hyposthesia, paresthesia.
Vascular system
Rare: hypotension.
Gastrointestinal system
Common: gastrointestinal symptoms, diarrhea, nausea.
Rare: vomiting.
Skin and subcutaneous tissue
Rare: rash, itching.
Very rare: urticaria.
Musculoskeletal system and connective tissue
Uncommon: myalgia.
Rare: arthralgia.
General disorders and administration site conditions
Very common: pain and redness at the injection site, fatigue.
Common: swelling at the injection site, reaction at the injection site (such as bruising, itching, bruising), malaise.
Uncommon: fever (≥ 37.5 ° C).
Rare: flu-like symptoms, chills.
Children aged 1 to 15 years
778 children aged 1 to 15 years inclusive were involved in clinical trials, and 1,537 doses of vaccine were administered in a two-dose regimen.
Nervous System
Very common: headache.
Common: drowsiness.
Gastrointestinal system
Common: gastroenterological symptoms.
Metabolic and digestive disorders
Very common: loss of appetite.
General disorders and administration site conditions
Very common: pain and redness at the injection site, fatigue.
Common: swelling at the injection site, fever.
Mental disorders
Very common: irritability.
Post-marketing data.
Adults and adolescents 16 years of age and older
The following are adverse reactions reported with both TWINRIX ™ (administered at 0, 1, 6 months or 0, 7, 21 days) and monovalent vaccines for the prevention of hepatitis A or B, manufactured by GlaxoSmithKline ».
Infections and invasions
Meningitis.
Circulatory and lymphatic systems
Thrombocytopenia, thrombocytopenic purpura.
Immune system
Anaphylaxis, allergic reactions, including anaphylactoid reactions and serum-like reactions.
Nervous System
Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions.
Vascular disorders
Vasculitis.
Skin and subcutaneous tissue
Angioneurotic edema, red flat herpes, polymorphic erythema.
Musculoskeletal system and connective tissue
Arthritis, muscle weakness.
General disorders and administration site conditions
Feeling of pain, burning and burning at the injection site at the time of vaccination.
Children aged 1 to 15 years
The following adverse reactions were observed during post-marketing surveillance with a twin-dose immunization with TWINRIX к vaccine.
Immune system
Very rare: allergic reactions, including anaphylactic and anaphylactoid reactions.
Nervous System
Very rare: syncope or vasovagal injection reactions, hypoaesthesia.
Expiration date
36 months. The expiration date of the vaccine is indicated on the label and packaging.
Storage conditions
The vaccine should be stored at 2 to 8 ° C in a dark place. Keep out of reach of children.
Do not freeze. If the vaccine has been frozen, it should be discarded.