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  • Pediacel
    / Medici


    Active Ingredient *

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    0.5 ml

    not in the basket chart

    Related information


    Dosage

    Pediacel may be administered as 4 dose series starting as early as 2 months of age with 3 doses at an interval of 2 months between each dose, followed by a booster dose approximately 6 to 12 months after the third dose.
    See prescribing information for full details.


    Indications

    Primary immunization of infants from the age of 2 months and in children up to 6 years of age (prior to their 7th birthday) against diphtheria, tetanus, pertussis, poliomyelitis and invasive H. influenzae type b disease.


    Contra-Indications

    Known systemic hypersensitivity reaction to any component. Encephalopathy within 7 days of previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause. Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy. Not to be administered to children under 2 months or children 7 years of age or older.


    Special Precautions

    The parent or guardian should be questioned concerning any symptoms and/or signs of an adverse reaction after a previous dose of vaccine. Vaccines that contain Hib antigen do not provide protection against infections with other types of H. influenzae, or against meningitis of other origin. Under no circumstances can the tetanus protein contained in conjugate vaccines containing tetanus toxoid as protein carrier be used to replace the usual tetanus vaccination. SIDS has occurred in infants following administration of DTaP vaccines. Should not be administered by intravascular injection; the needle does not penetrate a blood vessel. Intradermal or subcutaneous routes of administration are not to be utilized. Should not be administered into the buttocks. Granuloma or sterile abscess at the injection site has been reported with a product containing the same antigens. Vaccination should be postponed in cases of acute or febrile disease. However, a disease with low-grade fever should not usually be a reason to postpone vaccination. If any of the following events occur within the specified period after administration of a whole-cell pertussis vaccine or a vaccine containing an acellular pertussis component, the administration should be based on careful consideration of potential benefits and possible risks: Temperature of or above 40.5 C within 48 hours, not attributable to another identifiable cause; Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours; Persistent crying lasting 3 hours or more within 48 hours; Convulsions with or without fever within 3 days. Should not be administered to persons with any bleeding disorders, such as hemophilia or thrombocytopenia, unless the potential benefits outweigh the risk of administration. If Guillain-Barre syndrom (GBS) occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to vaccinate should be based on careful consideration of potential benefits and possible risks. For infants or children at higher risk for seizures than the general population, an appropriate antipyretic may be administered.
    Pregnancy and lactation: Should not be administered.


    Side Effects

    Very common: Injection site tenderness, swelling, redness, fever (>38 degrees Celsius), crying, eating less, fussiness, less active.
    Common: Diarrhea, vomiting.
    See prescribing information for full details.

     


    Drug interactions

    Immunosuppressive treatments may interfere with the development of the expected immune response.
    See prescribing information for full details.


    Manufacturer
    Sanofi Pasteur
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