Suspension for the / m introduction 0.5 ml (1 dose)
surface antigen of hepatitis B virus 10 Ојg
diphtheria toxoid 5 units.
tetanus toxoid 5 units.
Excipients: aluminum hydroxide (from 0.35 to 0.55 mg), merthiolate (15 to 35 Ојg), formaldehyde (not more than 50 Ојg).
0.5 ml (1 dose) - ampoules (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
The vaccine is a combination of aluminum hydroxide adsorbed on the recombinant yeast surface antigen of the hepatitis B virus (HBsAg) and the diphtheria and tetanus toxoid purified from ballast proteins.
The composition of 1 dose (0.5 ml): 5 flocculating units (Lf) of diphtheria toxoid, 5 units of tetanus toxoid binding (EC), 10 Ојg HBsAg, 0.35 to 0.55 mg aluminum hydroxide (Al +3 ), preservative - 35 Ојg and not more than 50 Ојg of formaldehyde.
The preparation is a homogeneous suspension of a yellowish white color without foreign inclusions, separated when standing on a transparent supernatant and a loose sediment that completely breaks when shaken.
INDICATIONS
Prevention of hepatitis B, diphtheria and tetanus in persons aged 6 to 19 years. The vaccine is used:
- in the course of vaccination in previously not vaccinated against diphtheria, tetanus and hepatitis B;
- with planned age-related revaccination against diphtheria and tetanus in previously not vaccinated against hepatitis B.
DOSING MODE
The vaccine is given in / m in the deltoid muscle in a dose of 0.5 ml.
SC administration of the drug and the introduction of the gluteus muscle is not recommended because of a decrease in the effectiveness of the hepatitis component and the possibility of strengthening local reactions.
Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.
Primary vaccination of children older than 6 years and adolescents not previously vaccinated against diphtheria, tetanus and hepatitis B is performed three times according to the scheme: 1 dose on the selected day, 2 dose after 1-1.5 months, 3 dose 6-7 months after first dose.
If it is necessary to increase the intervals, the vaccination should be carried out as soon as possible, determined by the state of health of the vaccinated person.Subsequent revaccinations against diphtheria and tetanus are carried out in accordance with the vaccination calendar.
Revaccination of persons against diphtheria and tetanus, previously not vaccinated against hepatitis B, is carried out once, followed by the completion of the vaccine course with hepatitis B vaccine at the age-related dosage.
The preparation is not suitable for use in ampoules with broken integrity, lack of marking, with changing physical properties (discoloration, presence of unbreakable flakes), expired shelf life, improper storage.
Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. The drug in the opened ampoule is not subject to storage.
The introduction of the drug is registered in the prescribed registration forms with the indication of the serial number, expiration date, manufacturer, date of introduction, the nature of the reaction to the administration of the drug.
SIDE EFFECT
A part of the vaccinated in the first two days can develop short-term general (temperature increase, malaise, joint and muscle pain, dizziness) and local (soreness, hyperemia, swelling) reactions. In extremely rare cases, allergic reactions (Quincke's edema, hives, polymorphic rash), slight exacerbation of allergic diseases can develop.
Given the possibility of developing allergic reactions of immediate type in particularly sensitive individuals, vaccinated people should be provided with medical supervision for 30 minutes.
Vaccination sites should be provided with anti-shock therapy.
CONTRAINDICATIONS
- strong and unusual reactions to previous administration of ADS-toxoid and / or hepatitis B vaccine: temperature above 40 В° C, edema, hyperemia over 8 cm in diameter at the site of administration, and allergic reactions to baker's yeast and other components of the vaccine. Vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases.
With mild forms of acute respiratory viral infection, acute intestinal diseases and other vaccinations are carried out after the disappearance of clinical symptoms.
Patients with chronic diseases are vaccinated after achieving complete or partial remission.
Immunodeficiencies, HIV infection, as well as supporting course therapy, incl. steroid hormones and psychopharmaceuticals, are not contraindications to vaccination.
In order to identify contraindications, the doctor (paramedic at the FAP) on the day of vaccination is interviewing parents and examining the vaccinated with mandatory thermometry. When vaccinating adults, preliminary selection of persons to be vaccinated is possible with their subsequent interviewing by a medical worker who performs vaccination on the day of vaccination.
PREGNANCY AND LACTATION
It is not recommended to use this medication during pregnancy and during breastfeeding, because safety in the course of controlled clinical trials has not been studied.
APPLICATION FOR CHILDREN
According to indications from 6 years.
SPECIAL INSTRUCTIONS
Persons with neurological changes are vaccinated after excluding the progression of the process.
Patients with allergic diseases are vaccinated 2-4 weeks after the end of exacerbation, while stable manifestations of the disease (localized skin conditions, hidden bronchospasm, etc.) are not contraindications to vaccination, which can be performed against the background of appropriate therapy.
Impact on the ability to drive vehicles and manage mechanisms
Not installed.
OVERDOSE
Cases of overdose are not established.
DRUG INTERACTION
Vaccinations with the ADS-M-Hep B vaccine can be administered concomitantly with other vaccines of the national calendar of preventive vaccinations (with the exception of BCG vaccine) or 1 month after vaccination against other infections.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
Shelf life of the vaccine is 3 years. The drug with expired shelf life is not subject to application.
Storage conditions. At a temperature of 2 В° to 8 В° C in accordance with SP 3.3.2.1248-03. Keep out of the reach of children. Freezing is not allowed.
Conditions of transportation. At a temperature of 2 В° to 8 В° C In accordance with SP 3.3.2.1248-03. Freezing is not allowed.
The information is provided for your information, do not self-medicate, it is dangerous for your health.
