PENTAXIM (SC Injection)

Indications

PENTAXIM is a vaccine. Vaccines are used to protect against infectious diseases. When PENTAXIM is injected, the body’s natural defenses develop a protection against those diseases. PENTAXIM 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.) PENTAXIM 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.

Therapeutic Class

Vaccines, Anti-sera & Immunoglobulin

Pharmacology

No data has found

Dosage & Administration

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.

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.

Interaction

In case the child should receive PENTAXIM simultaneously with other vaccines, please ask the doctor or pharmacist for more information. Inform the doctor or pharmacist if the child takes or has recently taken any other medicines, even those not prescribed.

Contraindications

If child is allergic (hypersensitive): to any vaccine components (see Description), 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 child had an allergic reaction after a previous injection of the same vaccine or a vaccine containing the same substances; if child suffers from evolving encephalopathy (cerebral lesions); if child suffered from encephalopathy (cerebral lesions) within 7 days of a previous dose of a pertussis vaccine (acellular or “whole cells” pertussis; if child has fever or a disease which occurred suddenly (acute disease), in this case it is preferable to postpone the vaccination.

Side Effects

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. Very common reactions (may affect more than one in 10 children): Loss of appetite; Nervousness, irritability, abnormal crying; Somnolence; Vomiting

Precautions

If your child has blood disorder such as a decrease in platelets (thrombocytopenia) or clotting disorders because of the risk of bleeding which may occur during intramuscular administration

If your child already presented with febrile convulsions, not related to a previous vaccine injection; in this case it is particularly important that temperature be monitored in the 48 hours following vaccination and that antipyretic treatment be regularly administered to help reduce fever, for 48 hours,

If your child experienced any of the following events after a previous administration of a vaccine (then the decision to give further doses of this pertussis-containing vaccine will be carefully evaluated):

  • Fever of 40°C or above within 48 hours of vaccination, not due to another identifiable cause.
  • Collapse or shock-like state with hypotonic-hyporesponsive episode (drop in energy) within 48 hours of vaccination.
  • Persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours of vaccination.
  • Convulsion with or without fever, occurring within 3 days of vaccination.

Storage Conditions

Store in a refrigerator (2°C-8°C). Do not freeze. Keep out of the reach and sight of children.

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