It is indicated to help protect your child against diphtheria, tetanus, pertussis, poliomyelitis and against invasive infections due to the Haemophilus influenzae type b bacterium (such as meningitis, blood poisoning, etc.) it is indicated in children from the age of 2 months. It does not protect against infections caused by other types of Haemophilus influenzae or against meningitis due to other micro-organisms.
Vaccines, Anti-sera & Immunoglobulin
This vaccine will be administered to your child by a healthcare professional. Posology The schedule should be chosen in accordance with current national recommendations: ? 2 injections with an interval of two months, one at the age of 2 and, one at the age of 4 months, followed by a booster injection at the age of 11 months. or ? 3 injections at an interval of one to two months from the age of 2 months, followed by a booster injection within the second year of life Method of administration Administration should be performed into a muscle, preferably in the anterolateral side of the thigh (middle third) in infants, and in the upper arm in children.
If your child is allergic (hypersensitive): - to any of the vaccine components (listed in Section 6 ?What PENTAXIM contains?) - to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during the manufacturing process and which may be present as traces). - to a pertussis vaccine (acellular or ?whole cell?), ? If your child had an allergic reaction after a previous injection of the same vaccine or a vaccine containing the same substances, ? if your child suffers from evolving encephalopathy (cerebral lesions), ? if your child suffered from encephalopathy (cerebral lesions) within 7 days of a previous dose of a pertussis vaccine (acellular or ?whole cells? pertussis), ? if your child has fever or a disease which occurred suddenly (acute disease), in this case it is preferable to postpone the vaccination.
Serious allergic reactions Serious allergic reactions, although very rare, may occur following vaccination, generally while the child is still present on the place where he/she was vaccinated. If any of the symptoms listed below occurs after you have left the place where your child was vaccinated, you must contact IMMEDIATELY a doctor or the emergency services. ? Swelling of the face (face oedema), sudden swelling of the face and neck (angioedema, Quincke?s oedema). ? Sudden and serious malaise with drop in blood pressure causing dizziness and loss of consciousness, accelerated heart rate associated with respiratory disorders (anaphylactic reaction and shock). Other side effects If your child experiences any of the following side effects listed below and it persists or gets serious, please contact your doctor or pharmacist. Very common reactions (may affect more than one in 10 children) ? Loss of appetite. ? Nervousness, irritability, abnormal crying. ? Somnolence. ? Vomiting. ? Injection-site redness (erythema), fever 38?C or higher, injection-site swelling (oedema), injection-site pain. Common reactions (may affect less than one in 10 children but more than one in 100 children) ? Diarrhoea ? Injection-site hardening (induration)
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
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