Pentaxim
Pentaxim: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Special instructions
- 8. Use in childhood
- 9. Drug interactions
- 10. Analogs
- 11. Terms and conditions of storage
- 12. Terms of dispensing from pharmacies
- 13. Reviews
- 14. Price in pharmacies
Latin name: Pentaxim
ATX code: J07CA06
Active ingredient: diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous hemagglutinin, poliomyelitis viruses (1, 2, 3 types) inactivated
Manufacturer: Sanofi Pasteur S. A. (Sanofi Pasteur, SA) (France)
Description and photo update: 2018-04-07
Prices in pharmacies: from 1249 rubles.
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Pentaxim is a drug used for complex vaccination for the prevention of diphtheria, pertussis, tetanus, poliomyelitis, as well as diseases caused by Haemophilus influenzae type b.
Release form and composition
The dosage form of the drug Pentaxim is a kit including a lyophilisate for preparing a suspension for intramuscular (intramuscular) administration and a suspension for intramuscular administration:
- lyophilisate: homogeneous in composition, white; the vaccine reconstituted from the lyophilisate is an opaque, whitish liquid that separates upon settling into a white precipitate and a colorless liquid, which are easily resuspended by shaking;
- suspension for intramuscular administration: turbid, whitish suspension.
In a cardboard box 1 closed cell package with 1 dose of lyophilisate in a glass bottle and 1 dose of suspension (0.5 ml) in a glass syringe with a capacity of 1 ml, with a fixed needle or without a needle; Syringe packs without a fixed needle contain 2 separate sterile needles.
The content of active components in the suspension for i / m administration, per 1 dose (0.5 ml):
- tetanus toxoid - ≥ 40 international units (IU);
- diphtheria toxoid - ≥ 30 IU;
- filamentous hemagglutinin - 25 mcg;
- pertussis toxoid - 25 mcg;
- inactivated poliomyelitis virus type 1 - 40 IU of D-antigen;
- inactivated poliomyelitis virus type 2 - 8 units of D-antigen;
- inactivated poliomyelitis virus type 3 - 32 units of D-antigen.
Auxiliary components of the suspension: aluminum hydroxide - 0.3 mg; formaldehyde - 12.5 mcg; Hanks medium 199 (not containing phenol red) - 0.05 ml; phenoxyethanol - 2.5 μl; acetic acid / sodium hydroxide - up to pH 6.8–7.3; water for injection - up to 0.5 ml.
The composition of the lyophilisate (Hlb) for preparing a suspension for intramuscular administration, for 1 dose:
- active ingredient: Haemophilus influenzae type b polysaccharide, conjugated with tetanus toxoid - 10 μg;
- auxiliary components: sucrose - 42.5 mg; trometamol - 0.6 mg.
Antibiotics (neomycin, streptomycin, polymyxin B) are necessary in the vaccine manufacturing process, but are not present in measurable amounts in the final product.
Production conditions of Pentaxim comply with GMP (Good Manufacturing Practice) requirements.
Pharmacological properties
Pentaxim is a vaccine for diphtheria and tetanus, adsorbed, acellular pertussis, inactivated poliomyelitis, infections caused by Haemophilus influenzae type b conjugated. It belongs to the pharmacotherapeutic group of MIBP - medical immunobiological drugs, and is designed to create immunity to the listed diseases.
Indications for use
According to the instructions, Pentaxim is recommended for primary immunization and revaccination of children from 3 months of age against poliomyelitis, pertussis, diphtheria, tetanus, invasive infection caused by Haemophilus influenzae type b (meningitis, septicemia, etc.).
Contraindications
Absolute contraindications:
- progressive encephalopathy (with or without seizures);
- encephalopathy that develops within 7 days after any vaccination with Bordetella pertussis antigens;
- a strong response (within 48 hours) to a previous vaccination with a pertussis component: prolonged unusual crying syndrome, hyperthermia with body temperature up to 40 ° C and above, febrile / afebrile convulsions, hypotonic-hyporeactive episode;
- an allergic reaction caused by a previous vaccination to prevent polio, pertussis, diphtheria, tetanus, and Haemophilus influenzae type b infections;
- diseases accompanied by an increase in body temperature, exacerbation of infectious or chronic diseases (vaccination must be postponed until recovery);
- confirmed systemic allergic reaction to any component of Pentaxim, as well as polymyxin B, neomycin, glutaraldehyde, streptomycin.
Vaccination should be performed with caution if there is a history of febrile seizures not associated with previous vaccination. In such patients, it is required to control body temperature for 48 hours after vaccination, and when it rises, regularly use antipyretic drugs.
Instructions for the use of Pentaxim: method and dosage
The Pentaxim vaccine is administered intramuscularly at a dose of 0.5 ml; children aged from six months to two years - in the area of the middle third of the anterolateral thigh, children over two years old - in the deltoid muscle of the shoulder. It is forbidden to administer the drug intravenously or intradermally. Before injecting the suspension, make sure that the needle does not enter the blood vessel, for which it is necessary to slightly pull the plunger back after inserting the needle and check the syringe for blood.
For the embodiment of the packaging with 2 needles embedded separately, before beginning the vaccine preparation requires tightly secure the needle by turning it a 1 / 4 turnover relative to the syringe. It is necessary to choose a needle in accordance with the thickness of the child's subcutaneous fat at the injection site.
Vaccine preparation:
- Remove the colored plastic cap from the lyophilizate bottle.
- Introduce a pre-shaken suspension for intramuscular administration (vaccine for the prevention of poliomyelitis, pertussis, diphtheria, tetanus) from a syringe through a needle into a vial with lyophilisate [vaccine for the prevention of infection caused by Haemophilus influenzae type b (Hlb)].
- Shake the vial without removing the syringe from it, wait until the lyophilisate is completely dissolved (no longer than 3 minutes).
- Visually evaluate the resulting suspension: it should be cloudy, but free from foreign particles, and have a whitish tint (otherwise the suspension is unusable).
- The finished suspension should be completely absorbed into the same syringe.
After preparation, the vaccine must be administered immediately.
Vaccination course Pentaxim: three injections of 1 dose (0.5 ml) with an interval of 1–2 months, starting from 3 months of age. Revaccination is carried out at the age of 18 months with the introduction of 1 dose of Pentaxim. That corresponds to the requirements of the National Calendar of Preventive Vaccinations of the Russian Federation: the course of vaccination for the prevention of poliomyelitis, pertussis, diphtheria, tetanus consists of 3 injections of the drug with an interval of 1.5 months (at 3; 4.5 and 6 months); revaccination is performed once every 18 months.
In case of violation of the vaccination schedule, the subsequent intervals between the next doses of the vaccine remain unchanged, including a break before the revaccination dose of 12 months.
When the first dose of Pentaxim is administered at the age of 6 to 12 months, the second, standardly prepared dose, is administered 1.5 months after the first, and for the 3rd dose, administered 1.5 months after the second, it is required to use the vaccine to prevent poliomyelitis, pertussis, diphtheria, tetanus, originally presented in a syringe, without diluting the lyophilisate (Hlb) in a vial. As the 4th (revaccination) dose, a standard dose of Pentaxim with a lyophilisate dilution (Hlb) is used.
When the first dose of Pentaxim is administered at the age of over 1 year, for the 2nd, 3rd and 4th (revaccination) doses, it is required to use the vaccine for the prevention of poliomyelitis, pertussis, diphtheria, tetanus, initially presented in a syringe, without diluting the lyophilisate (Hlb) in the vial.
Side effects
Adverse reactions that were observed when using Pentaxim vaccine for immunization:
- local, developing within 48 hours after vaccination: soreness at the injection site, usually expressed by a short cry at rest or with slight pressure; compaction and redness at the injection site of the suspension (in 0.1-1% of cases with a diameter of more than 5 cm);
- general: increase in body temperature: more than 38 ° C - with a frequency of 1-10%; more than 39 ° С - with a frequency of 0.1–1%; more than 40 ° С - with a frequency of 0.01–0.1% (indicators of rectal temperature are used, which, as a rule, are higher than the axillary by 0.6–1.1 ° С; sleep disturbances, drowsiness, irritability, anorexia, vomiting, diarrhea; less often - prolonged crying; in very rare cases (<0.01%) - urticaria, rash, febrile / afebrile convulsions, hypotension, hypotonic-hyporeactive syndrome, anaphylactic reactions (facial edema, Quincke's edema, anaphylactic shock).
The consequence of the administration of vaccines containing the Hlb component, in rare cases, may be edema of one / both lower extremities (edema prevails on the side of the vaccine administration), which is mainly observed after the primary vaccination within the first few hours, and is sometimes accompanied by prolonged crying, fever body, soreness, cyanosis / discoloration of the skin. Less commonly, redness, petechiae, or transient purpura with fever and rash are observed. The reactions go away on their own within 24 hours, without residual effects, including from the respiratory system and heart.
After vaccination with the acellular pertussis component, in very rare cases, there was a pronounced reaction at the injection site with a diameter of more than 5 cm (including up to edema spreading over one or both joints), appearing 24-72 hours after the drug was administered and accompanied in some cases by redness, increased skin temperature, increased sensitivity / soreness at the injection site. Within 3-5 days, these symptoms go away on their own without additional therapy. Presumably, the risk of developing such reactions increases in proportion to the number of injections of the acellular pertussis component; after the fourth and fifth vaccinations, this probability is greater.
There is evidence that Guillain-Barré syndrome and neuritis of the brachial nerve were observed as a result of the administration of other vaccines containing tetanus toxoid.
special instructions
Vaccination with Pentaxim does not produce immunity against infections caused by other serotypes of Haemophilus influenzae, as well as meningitis of other etiology.
It is required to inform the doctor about all episodes of adverse reactions, including instructions for the drug not included in the list. In order to prevent possible allergic and other possible reactions, before each vaccination, the doctor is obliged to clarify the child's health and immunization history, the history of him and his immediate family (in particular, allergic), side effects on previous vaccinations. During the procedure, medical personnel should have drugs and instruments that may be required for the development of a hypersensitivity reaction.
A state of immunodeficiency or immunosuppressive therapy can cause a weak immune response to the drug administration. In this case, vaccination is recommended to be postponed until the end of the course of therapy or until remission of the disease. But with chronic immunodeficiency, for example, HIV-infected children, vaccination is recommended even with a weakened immune response.
Thrombocytopenia and other bleeding disorders increase the risk of bleeding with intramuscular injection, such patients should be given the vaccine with caution.
A history of the development of brachial nerve neuritis or Guillain-Barré syndrome in response to any tetanus toxoid vaccine indicates the need for careful justification of the decision to vaccinate with Pentaxime. In such cases, it is usually justified to complete the primary immunization when less than three doses have been administered.
Pediatric use
In pediatric practice, vaccination with Pentaxim is carried out according to the recommended route of administration and dosage.
Drug interactions
There is no reliable data on the mutual influence of Pentaxim and other drugs (including other vaccines), with the exception of immunosuppressive substances / drugs.
It is necessary to inform the doctor about the introduction of any other medications (including over-the-counter) to the child, carried out recently or at the same time as vaccination.
Analogs
The analogue of Pentaxim is Infanrix Quinta.
Terms and conditions of storage
Store at 2–8 ° C (refrigerated). Keep out of the reach of children. Do not freeze.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Pentaxim
Most of the reviews about Pentaxim are positive. Parents who have chosen this drug to immunize their children claim that this vaccine is better purified than its counterparts, is well tolerated, easy to use (fewer injections required) and minimizes adverse reactions.
According to experts, Pentaxim almost to zero reduces the likelihood of developing vaccine-associated poliomyelitis (provoked by the use of a vaccine).
There are a few episodes of fever after vaccination, which is difficult to bring down.
As disadvantages, it is also indicated that in most cases the vaccination can only be done for a fee, and the price of the drug is high.
Price for Pentaxim in pharmacies
The approximate price for Pentaxim for 1 dose of vaccine (1 bottle of lyophilisate for preparation of suspension + 1 syringe of suspension) is 1,300 rubles.
Pentaxim: prices in online pharmacies
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Drug name Price Pharmacy |
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Pentaxime vaccine lyophilisate for preparation of suspension for intramuscular administration 1 pc. 1249 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
