Composition, form of production and packaging
Suspension for the / m introduction is whitish in color, cloudy.
1 dose
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, 2 types of 8 ED antigen D
poliomyelitis virus inactivated, 3 types of 32 ED antigen D
Auxiliary substances: aluminum hydroxide - 0.3 mg, Hanks Hanks environment 199 * - 0.05 ml, formaldehyde - 12.5 mg, phenoxyethanol - 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
1 dose (0.5 ml) - glass syringes (1) - packings, cell planimetric (1) - packs cardboard.
Lyophilizate for the preparation of a suspension for the / m introduction of white color, homogeneous.
1 dose
polysaccharide Haemophilus influenzae B, conjugated with tetanus toxoid 10 Ојg
Excipients: sucrose - 42.5 mg, trometamol - 0.6 mg.
1 dose - vials of glass (1) - packings of cellular (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Vaccine for the prevention of diphtheria, tetanus, pertussis, poliomyelitis and diseases caused by Haemophilus influenzae type b.
INDICATIONS
Prevention in children from 3 months of age .:
- Diphtheria;
- tetanus;
- pertussis;
- poliomyelitis;
- Invasive infection caused by Haemophilus influenzae type b (meningitis, septicemia, etc.).
DOSING MODE
The vaccine is given intramuscularly at a dose of 0.5 ml, the recommended place of administration is the middle third of the anterolateral lateral surface of the thigh.Do not administer intradermally or intravenously. Before administration, it must be ensured that the needle does not penetrate into the blood vessel. For a package with two separate needles, the needle should be tightly fixed before turning the vaccine, rotating it a quarter of a turn relative to the syringe. To prepare the vaccine, after completely removing the plastic colored cap from the vial, completely enter the suspension for intramuscular injection (vaccine for the prevention of diphtheria, tetanus, pertussis and poliomyelitis) through the needle from the syringe into the vial with lyophilizate (vaccine for the prevention of infection caused by Haemophilus influenzae type b) .
Shake the vial without removing the syringe from it, and wait until the lyophilisate is completely dissolved (no more than 3 minutes). The resulting suspension should be cloudy and have a whitish hue. The vaccine should not be used in case of discoloration or presence of foreign particles. The vaccine thus prepared should be completely injected into the same syringe. Ready vaccine should be entered immediately.
Vaccination course Pentaxime consists of 3 injections of one dose of vaccine (0.5 ml) at intervals of 1 -2 months, starting at 3 months of age. Revaccination is carried out.
Vaccination course Pentaxim consists of 3 injections of one dose of vaccine (0.5 ml) at intervals of 1-2 months, starting at 3 months of age. Revaccination is performed by administering 1 dose of Pentaxim at the age of 18 months of life.
In accordance with the National Calendar of preventive vaccinations of the Russian Federation, 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; Revaccination is carried out once at the age of 18 months.
If the schedule of vaccination is not met, subsequent intervals between the administration of the next dose of the vaccine do not change, including the interval before the 4th (revaccinating) dose of -12 months
If the first dose of Pentaxim was administered at the age of 6-12 months, the second dose is administered 1.5 months after the first, and as a 3rd dose administered 1.5 months after the second, a vaccine should be used to prevent diphtheria, tetanus; pertussis and poliomyelitis, initially presented in a syringe (i.e., without dilution of the lyophilizate in the vial (Hlb)). As a revaccinating (4th dose), the usual dose of Pentaxime (with dilution of lyophilizate (Hlb)) is used.
If the first dose of Pentaxim is administered at the age after 1 year of life, then the vaccine for the prevention of diphtheria, tetanus, pertussis and poliomyelitis, initially presented in a syringe, without dilution of lyophilizate should be used for the 2 nd, 3 rd and 4 th (revaccinating) dose in the vial (Hlb).
The first vaccination, the age of the child (the full drug Pentaxim is introduced). The second inoculation (1.5 months), is introduced: The third inoculation (after 1.5 months), is introduced: Revaccination (12 months), is introduced
up to 6 months full preparation Pentaxim full preparation Pentaxim full preparation Pentaxim
6-12 months full preparation Pentaxim Pentaxim without dilution of lyophilizate Hlb in the vial full preparation Pentaxim
after 12 months Pentaxim without dilution of lyophilizate Hlb in the pentaxim vial without dilution of lyophilisate IIIb in vial Pentaxime without dilution of lyophilizate Hlb in vial
In all cases of violation of the vaccination schedule, the doctor should be guided by the National Calendar of preventive vaccinations of the Russian Federation.
SIDE EFFECT
Local: soreness (usually expressed by a short crying at rest or with slight pressure in the area of ​​injection); redness and denseness at the injection site (in 0.1-1% of cases -> 5 cm in diameter). These reactions can develop within 48 hours after vaccination.
General: increased 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. (Rectal temperature was evaluated, as a rule, it is higher than axillary (axillary) by 0.6-1.1 В° C.)
Also noted irritability, drowsiness, sleep disturbances, anorexia, diarrhea, vomiting, less often - prolonged crying.
In very rare cases (<0.01%), rash, urticaria, febrile and afebrile convulsions, hypotension and hypotonic-hyporeactive syndrome, anaphylactic reactions (face swelling, Quincke's edema, shock)
Rarely, after the introduction of vaccines containing the HIb component, there have been cases of edema of one or both lower extremities (with the predominance of edema on the extremities to 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 often reddening, petechiae or transitory purpura, fever, rash. These reactions passed independently for 24 hours without any residual phenomena, they are not associated with any adverse events on the part of the heart and the respiratory system.
Very rarely, after the introduction of vaccines containing acellular pertussis component, there have been cases of pronounced reactions (more than 5 cm in diameter) at the site of administration of the vaccine, including swelling that spreads through one or both joints. These reactions appeared 24-72 hours after the administration of the vaccine and could be accompanied by redness, increased skin temperature at the injection site, sensitivity or pain at the injection site. These symptoms disappeared on their own 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. The company has data that after the introduction of other vaccines containing tetanus toxoid, Guillain-Barre syndrome and neural brachial neuritis were observed.
CONTRAINDICATIONS
- progressive encephalopathy, accompanied by cramps or without such;
- encephalopathy, developed within 7 days after the administration of any vaccine containing the antigens Bordetella pertussis;
- 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, febrile or afebrile convulsions, hypotonic hyporeactive syndrome;
- an allergic reaction that developed after the previous administration of the vaccine for the prevention of diphtheria, tetanus, pertussis, poliomyelitis and a vaccine to prevent infection caused by Haemophilus influenzae type 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;
- a confirmed systemic hypersensitivity reaction to any ingredient in the vaccine, as well as glutaraldehyde, neomycin, streptomycin, and polymyxin B.
With caution: if a child has a history of febrile seizures that are not associated with previous vaccination, the body temperature of the vaccine administered within 48 hours after vaccination should be monitored and, when it is increased, antipyretic (antipyretic) drugs should be used regularly throughout this period.
SPECIAL INSTRUCTIONS
Pentaxime does not form immunity against infection caused by other serotypes of Haemophilus influenzae, as well as against meningitis of a different etiology.
The physician should be informed of all cases of adverse reactions, including those 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 history of the patient and the next of kin (in particular, allergic), the incidence of side effects on previous vaccines. The physician should have the medicines and tools necessary for the development of a 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 Pentaxim should be carefully justified. As a rule, in such cases, the completion of primary immunization is justified (if less than 3 doses are administered).
DRUG INTERACTION
With the exception of immunosuppressive therapy, there is no reliable evidence of a possible mutual effect when used with other drugs, including other vaccines.
The doctor should be informed of the recent or concurrent vaccination with the introduction of any other medication (including over-the-counter drugs) to the child.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
Store 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.
