PENTAXIM Powder and suspension for suspension for injection (2021)
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Περιεχόμενα
1. Name of the medicinal product
PENTAXIM, powder and suspension for suspension for injection in prefilled syringe Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine and Haemophilus type b conjugate ...
2. Qualitative and quantitative composition
After reconstitution one dose (0.5 ml) contains: Diphtheria toxoid<sup>(1)(2)*</sup>: ≥ 30 I.U Tetanus toxoid<sup>(1)(2)**</sup>: ≥ 40 I.U Bordetella pertussis antigens: Pertussis toxoid<sup>(1)</sup> ...
3. Pharmaceutical form
Powder and suspension for suspension for injection. PENTAXIM is made up of a syringe prefilled with a cloudy, whitish, sterile suspension and a vial of white powder.
4.1. Therapeutic indications
This vaccine is indicated in the joint prevention of diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellulitis, ...
4.2. Posology and method of administration
Posology Pentaxim must be used in accordance with official recommendations. Primary vaccination: 3 injections given at an interval of one month, i.e. according to the official schedule, at the age of 2, ...
4.3. Contraindications
Hypersensitivity:to any of the active substances of PENTAXIM, to any of the excipients, to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during the manufacturing process and which may be ...
4.4. Special warnings and precautions for use
The immunogenicity of PENTAXIM may be reduced by immunosuppressive treatment or immunodeficiency. It is then recommended to wait until the end of the treatment or disease before vaccinating. Nevertheless, ...
4.5. Interaction with other medicinal products and other forms of interaction
This vaccine can be administered simultaneously with the M-M-RVAXPRO vaccine or with the HBVAXPRO vaccine, but in two separate sites. Interference with laboratory tests Since the Hib capsular polysaccharide ...
4.6. Pregnancy and lactation
Not applicable. PENTAXIM is intended for paediatric use only.
4.7. Effects on ability to drive and use machines
Not applicable. PENTAXIM is intended for paediatric use only.
4.8. Undesirable effects
The adverse events are ranked under headings of frequency using the following convention: Very common: ≥10%, Common: ≥1% and <10%, Uncommon: ≥0.1% and <1%, Rare: ≥0.01% and <0.1%, Very rare: <0.01%, Not ...
4.9. Overdose
Not documented.
5.1. Pharmacodynamic properties
<b>VACCINE AGAINST DIPHTHERIA, TETANUS, PERTUSSIS AND POLIOMYELITIS AND INFECTIONS CAUSED BY HAEMOPHILUS INFLUENZAE TYPE b.</b> <b>Pharmacotherapeutic group:</b> BACTERIAL AND VIRAL VACCINES, COMBINED ...
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional acute toxicity, repeat dose toxicity and local tolerance studies.
6.1. List of excipients
Concerning the adsorbent, see Section 2. Suspension for injection: Medium 199 Hanks without phenol red [complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other substances ...
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
3 years. The vaccine must be administered immediately after reconstitution.
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. For storage conditions of the reconstituted medicinal product, see Sections 6.3.
6.5. Nature and contents of container
Powder in vial (type I glass) equipped with a stopper (chlorobutyl) + 0.5 mL of suspension in prefilled syringe (type I glass) equipped with a plunger-stopper (bromobutyl or chlorobutyl or bromochlorobutyl). ...
6.6. Special precautions for disposal and other handling
For syringes without attached needles, the needle must be fitted firmly to the syringe, rotating it by a one-quarter turn. Reconstitute the solution by injecting the suspension of the combined diphtheria, ...
7. Marketing authorization holder
SANOFI PASTEUR, 14 Espace Henry Vallée, 69007 Lyon, France
8. Marketing authorization number(s)
MA No.: 19523
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 23/04/2004 Date of renewal of the authorization: unlimited, starting from 08/04/2011
10. Date of revision of the text
25/10/2021
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