Vaccine for the prevention of diphtheria, pertussis a, polio, tetanus and infections Haemophilus Influenzae | Pentaxim (vaccine) lyophilisate d / pr. suspensions for w / mouse. enter 1 dose 0.5 ml vials 1 pc.

Latin name

Pentaxim

Release form

Suspension for i / m color.

Packaging

1 dose (0.5 ml) - glass syringes (1) - contour cell packaging (1) - packs of cardboard.

Pharmacological action of

Vaccine for the prevention of diphtheria, tetanus, pertussis, poliomyelitis and diseases caused by Haemophilus influenzae type b.

Indications

Prevention in children starting at 3 months of age: diphtheria

tetanus

pertussis

polio

invasive infection caused by Haemophilus influenzae type b (meningitis, septicemia.

Contraindications

progressive encephalopathy, with or without seizures

encephalopathy that developed within 7 days after the administration of any vaccine containing Bordetella pertussis

antigens, a strong reaction that developed after a previous temperature increase of 48 hours up to 40 РC and above, prolonged unusual crying syndrome, febrile or afebrile convulsions, hypotonic-hyporeactive syndrome

allergic reaction, developed after the previous introduction of the vaccine for the prevention of diphtheria, tetanus, pertussis, polio and the vaccine for the prevention of infection caused by Haemophilus influenzae type b

diseases, accompanied by fever, acute manifestations of an infectious disease or an exacerbation of a chronic disease. In these cases, vaccination should be postponed until the

has recovered, the confirmed systemic hypersensitivity reaction to any ingredient in the vaccine, as well as glutaraldehyde, neomycin, streptomycin and polymyxin B.

Caution: if a child has a history of febrile seizures not associated with previous vaccination, after the body temperature of the vaccinated for 48 hours after vaccination and, with its increase, regularly use antipyretic (antipyretic) drugs throughout this period.

Special instructions

Pentaxim does not form immunity against infection caused by other serotypes of Haemophilus influenzae, as well as against meningitis of a different etiology.

The doctor must be informed of all cases of adverse reactions, including those not listed in this manual. Before each vaccination, in order 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 immediate family (in particular, allergic), cases of side effects on previous vaccines. The doctor should have the medicines and tools necessary for the development of a hypersensitivity reaction.

Immunosuppressive therapy or a condition of immunodeficiency may cause a weak immune response to the vaccine. In these cases, it is recommended that vaccination be postponed until the end of such therapy or remission of the disease. However, for people with chronic immunodeficiency (e.g. HIV infection), vaccination is recommended, even if the immune response may be weakened.

For thrombocytopenia and other bleeding disorders, the vaccine should be administered with caution because of the risk of bleeding with i / m injection.

If you have a history of Guillain-BarrГ© syndrome or brachial neuritis in response to a vaccine containing tetanus toxoid, Pentaxim vaccination decisions must be carefully reasoned. As a rule, in such cases, it is justified to complete the primary immunization (if less than 3 doses are administered).

Composition

1 dose

diphtheria toxoid? 30 IU

tetanus toxoid? 40 IU

toxoid pertussis 25 mcg

hemagglutinin filamentous 25 mcg

poliomyelitis virus inactivated, type 1 40 D D sigen antigen

poliomyelitis virus inactivated, 2 types 8 IU D antigen

poliomyeld virus 3 antigelomid HANKS Hanks 199 * medium - 0.05 ml, formaldehyde - 12.5 mg, phenoxyethanol - 2.5 ?l, acetic acid or sodium hydroxide - up to pH 6.8-7.3, water d / i - up to 0.5 ml.

* - does not contain phenol red

Side effects

Local: soreness (usually expressed by a short cry at rest or with mild pressure in the injection area) redness and hardening at the injection site (in 0.1-1% of cases -> 5 cm in diameter). These reactions may develop within 48 hours after vaccination.

General: increase in body temperature:> 38 РC - with a frequency of 1-10%> 39 РC - with a frequency of 0.1-1% rarely (0.01-0.1%) - over 40 РC. (Rectal temperature was evaluated, as a rule, it is 0.6-1.1 РC higher than axillary (axillary).)

Also irritability, drowsiness, sleep disturbances, anorexia, diarrhea, vomiting, less often, prolonged crying were noted.

In very rare (<0.01%) cases, rash, urticaria, febrile and afebrile convulsions, hypotension and hypotonic-hyporeactive syndrome, anaphylactic reactions (facial swelling, Quincke's edema, shock) were noted

Rarely, after administration of vaccines containing the HIb component, there were cases of edema of one or both lower extremities (with a predominance of edema on the extremities where the vaccine was introduced). Mostly, edema was observed during the first few hours after the initial vaccination. These reactions were sometimes accompanied by fever, soreness, prolonged crying, cyanosis or discoloration of the skin, less often reddening, petechiae or transient purpura, fever, rash. These reactions took place on their own within 24 hours without any residual effects, they are not associated with any adverse events on the part of the heart and respiratory system.

Very rarely, after the administration of vaccines containing the acellular pertussis component, there have been cases of severe reactions (more than 5 cm in diameter) at the injection site, including edema spreading over one or both joints. These reactions appeared 24-72 hours after the vaccine was administered and could be accompanied by redness, an increase in skin temperature at the injection site, or sensitivity or pain at the injection site. These symptoms disappeared on their own within 3-5 days without any additional treatment. It is believed that the likelihood of developing such reactions increases depending on the number of administrations of the acellular pertussis component, this probability is greater after the 4th and 5th doses of such a vaccine. The company has data that, after administration of other vaccines containing tetanus toxoid, Guillain-Barré syndrome and brachial nerve neuritis were observed.

Drug Interactions

With the exception of immunosuppressive therapy, there is no reliable data on the possible mutual effects when used with other drugs, including other vaccines.

The doctor should be informed about the introduction of any other drug (including over-the-counter) to the child recently or at the same time as the vaccination.

Storage Conditions

Store in a refrigerator (2 to 8 РC). Do not freeze.

Keep out of the reach and sight of children.

Term hodnosty

3 years



prescription

Dosage form

solution for injection

Sanofi Pasteur S.A., France