Composition, form of production and packaging
Suspension for the / m introduction is whitish in color, cloudy.
Diphtheria toxoid-30 IU
tetanus toxoid 40 IU
Pertussis toxoid 25 mcg
haemagglutinin filamentosa 25 mcg
poliomyelitis virus inactivated, type 1 40 ED antigen D
poliomyelitis virus inactivated, type 2 8 ED antigen D
poliomyelitis virus inactivated, type 3 32 ED antigen D
[PRING] aluminum hydroxide - 0.3 mg, Hanks medium 199 * - 0.05 ml, formaldehyde - 12.5 mg, phenoxyethanol 2- - 2.5 Ојl, acetic acid or sodium hydroxide - up to pH 6.8-7.3, water d / u - up to 0.5 ml.
* - does not contain phenolic red
0.5 ml - syringes (1) with fixed needle - packs of cellular (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
The introduction of the drug in accordance with the approved scheme forms a specific immunity against pertussis, diphtheria, tetanus and poliomyelitis.
The immune response after the initial course of vaccination:
Researches of immunogenicity carried out in children of the 1st year of life who received a 3-fold immunization with Tetraczyme vaccine showed, starting from the 2nd month of life, that a protective antibody titer (> 0.01 IU / ml) was developed for all vaccinated (100%) to diphtheria and tetanus antigens.
For pertussis antigens, approximately 4% of the titers of antibodies to pertussis toxoid and filamentous hemagglutinin were observed in about 90% of children 1 to 2 months after the completion of the primary vaccination course. In connection with the lack of an empirically established serological criterion of protection, a 4-fold increase
titers of antibodies is considered a criterion for seroconversion.
At least 99.5% of children after immunization had titers of antibodies to type 1, 2 and 3 polioviruses exceeding level 5 (the inverse of serum neutralization dilution), considered to be protective against poliomyelitis.
Immune response after revaccination:
Immunogenicity studies conducted in children of the 2nd year of age who received a primary vaccination course in the form of 3 doses of the tetraxym vaccine demonstrated a high level of immune response to all components after the administration of the 4th dose (revaccination).
Studies conducted in children aged 12-24 months who received a primary immunization course with three doses of vaccines with a whole-cell pertussis component demonstrated that subsequent revaccination with Tetraczyme vaccine is safe and immunogenic for all components of the vaccine.
No pharmacokinetics studies have been performed.
- prevention of diphtheria, tetanus, pertussis, poliomyelitis in children, starting from 3 months of age.
Immediately before administration, shake to form a homogeneous whitish turbid suspension. The vaccine is given in / m in a dose of 0.5 ml, the recommended place of administration is the middle third of the anterolateral lateral surface of the thigh for children up to 24 months old and the deltoid shoulder muscle for older children.
Do not administer intradermally and / or iv. Before administration, it must be ensured that the needle does not penetrate into the blood vessel.
In accordance with the National Calendar of Prophylactic Inoculations, the vaccination course for the prevention of diphtheria, tetanus, pertussis and poliomyelitis consists of 3 injections of the drug at intervals of 1.5 months, at the age of 3, 4.5 and 6 months, respectively.
Revaccinations are performed after 12 months (at the age of 18 months) by administering a single dose of the vaccine.
If the vaccination schedule is not met, subsequent intervals between the introduction of the next dose of the vaccine do not change, including, the interval before the 4th (revaccinating) dose is 12 months. Further revaccination against poliomyelitis is carried out within the time frames stipulated by the National Calendar of preventive vaccinations. In all cases of violation of the vaccination schedule, the doctor should be guided by the National Calendar of preventive vaccinations.
Local reactions: soreness at the injection site; redness and compaction at the injection site more than 2 cm in diameter. These reactions can develop within 48 hours after vaccination and last for 48-72 hours, pass independently without any treatment. Very rarely there were cases of severe reactions (more than 5 cm in diameter) at the site of administration of the vaccine, incl. swelling that spreads through one or both joints. These reactions appeared 24-72 hours after the administration of the vaccine and disappeared independently for 3-5 days without any additional treatment. It is believed that the likelihood of developing such reactions increases depending on the number of injections of the acellular pertussis component, this probability is greater after the 4th and 5th dose of such a vaccine.
General reactions: increase in body temperature:> 38 В° C - with a frequency of 1-10%; > 39 В° РЎ - with a frequency of 0.1-1%; rarely (0.01-0.1%) - over 40 В° C. (The rectal temperature was evaluated, which, as a rule, is higher than axillary (axillary) by 0.6-1.1 В° C).
Other: irritability, drowsiness, sleep disturbances, decreased appetite, diarrhea, vomiting, less often - atypical or prolonged crying. In very rare cases (<0.01%), rash, urticaria, febrile and afebrile convulsions, hypotension and hypotonic-hyporeactive syndrome, anaphylactic reactions (facial edema, Quincke's edema, shock) were noted.
The company has data that after administration of other tetanus toxoid-containing vaccines (regardless of Tetraxime use), Guillain-Barre syndrome and neural brachial neuritis were observed in a number of cases.
In deeply premature infants (born at 28 weeks or earlier) within 2-3 days after vaccination, there may be cases of lengthening the time intervals between respiratory movements.
- progressive encephalopathy, accompanied by cramps or without such;
- encephalopathy, developed within 7 days after. previous administration of any vaccine containing Bordetella pertussis antigens;
- a strong reaction that developed within 48 hours after a previous vaccination with a vaccine containing a pertussis component: an increase in body temperature to 40 В° C or higher, a syndrome of prolonged unusual crying for 3 or more hours, febrile or afefril convulsions, hypotonic hyporeactive syndrome;
- an allergic reaction that developed after the previous administration of any vaccine to prevent diphtheria, tetanus, pertussis, poliomyelitis;
- confirmed allergic reaction to any ingredient in the vaccine, as well as glutaraldehyde, neomycin, streptomycin and polymyxin B;
- diseases accompanied by an increase in body temperature, acute manifestations of an infectious disease or exacerbation of a chronic disease. In these cases, vaccination should be postponed until recovery.
With caution: if a child has a history of febrile seizures that are not related to previous vaccination, the body temperature of the grafted body should be monitored within 48 hours after
inoculations and, with its increase, apply antipyretic (antipyretic) drugs during this period.
APPLICATION FOR CHILDREN
The vaccine is used in children from 3 months of age.
The physician should be informed of all cases of adverse reactions, incl. not listed in this manual. Before each vaccination, to prevent possible allergic and other reactions, the doctor should clarify the state of health, the history of immunization, the patient's history (in particular - allergic), the incidence of side effects on previous vaccine administrations. The physician should have the medicines and tools necessary for medical interventions in the development of the hypersensitivity reaction.
Immunosuppressive therapy or the state of immunodeficiency can cause a weak immune response to the administration of the vaccine. In these cases it is recommended to postpone the vaccination before the end of such therapy or remission of the disease. However, for people with chronic immunodeficiency (eg, HIV infection), vaccination is recommended even if the immune response can be weakened.
When thrombocytopenia and other disorders of blood clotting, the administration of the vaccine should be carried out with caution because of the risk of developing bleeding with a / m injection.
When developing a history of Guillain-Barre syndrome or neuritis of the brachial nerve in response to any vaccine containing tetanus toxoid, the decision to vaccinate with Tetracsim should be carefully justified. As a rule, in such cases, the completion of primary immunization is justified (if less than 3 doses are administered). The potential risk of developing apnea and the need to monitor breathing for 48-72 hours should be considered when conducting a primary course of immunization in deeply premature babies born at 28 weeks or earlier, especially those with
in the anamnesis signs of immaturity of the respiratory system. Since the immunization benefits of this group of children are high, vaccination should not be postponed or considered contraindicated.
Impact on the ability to drive vehicles and manage mechanisms
Not applicable, because is assigned to children.
Cases of overdose are unknown.
With the exception of immunosuppressive therapy, there is no reliable data on the possible mutual effects when used with other drugs.
The vaccine can be administered in a single syringe with a conjugated vaccine against the infection caused by Haemophilus influenzae type b (Act-HIB) (with the Act-HIB vaccine diluted directly by the Tetracsim vaccine) or concomitantly with the vaccine (in different parts of the body).
Rarely, with concomitant administration with vaccines containing the HIB component, edema of one or both lower limbs has been reported (in the case where two vaccines are administered by one syringe, with the predominant edema of the limb into which the vaccine was administered). Most edema was observed within the first few hours after the primary vaccination. These reactions were sometimes accompanied by an increase in body temperature, pain, prolonged crying, cyanosis or skin discoloration, less redness, petechiae or transitory purpura, fever, rash. These reactions passed independently for 24 hours without any residual phenomena, they were not associated with any adverse events on the part of the heart and respiratory system.
Tetracisim can be administered simultaneously with vaccines against measles-mumps, rubella, chicken pox, hepatitis B in different parts of the body.
The doctor should be informed of the recent or concurrent vaccination with the introduction of any other medication (including over-the-counter medication) to the child.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store the drug in the refrigerator (at a temperature of 2 В° to 8 В° C). Do not freeze. Keep out of the reach of children.
Shelf life - 3 years.
Do not use after the expiration date printed on the package.