Infanrix Hexa

/ GSK

The primary vaccination schedule consists of three doses in the first 6 months of life and can start from the age of 2 months. As vaccination schemes vary from country to country, the schedule for each country may be used in accordance with the different national recommendations.
To ensure long term protection, a booster dose is recommended for DTP and Hib in the second year of life. Further booster doses with Hib after the age of 2 years are generally not recommended.

Active immunization of all infants from 2 months to 7 years of age against diphtheria, tetanus, pertussis (DTP) and Hib.

Known hypersensitivity to any of the components of the substance or patients that have shown previous hypersensitivity, severe febrile illness, acute infection.

It is good clinical practice that vaccination should be preceded by a review of medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination. If any of the following events occur in temporal relation to receipt of DTPcontaining vaccines, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks, particularly since these events are not associated with permanent sequelae.
The following events were previously considered contra-indications for DTPw and can now be considered general precautions:
Temperature of  40.5 C within 48 hours of vaccination, not due to another identifiable cause. Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination. Persistent, inconsolable crying lasting  3 hours, occurring within 48 hours of vaccination. Convulsions with or without fever, occurring within 3 days of vaccination.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine. For this reason, the vaccinee should remain under medical supervision for 30 minutes after immunisation. This product should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects As with all diphtheria, tetanus and pertussis vaccines, the vaccine should be administered by deep intramuscular injection and preferably at alternate sites for each injection. Excretion of capsular polysaccharide antigen in the urine has been described following receipt of Hib vaccines, and therefore antigen detection may not have a diagnostic value in suspected Hib disease within 1-2 weeks of vaccination. This product should under no circumstances be administered intravascularly. A history of febrile convulsions, a family history of convulsive fits, a family history of SIDS and a family history of an adverse event following This product do not constitute contra-indications. Human Immunodeficiency Virus (HIV) infection is not considered as a contraindication. Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.

Body as a whole: Very common: unusual crying. Common: fever (38.0 rectal).
Central and peripheral nervous system: Very common: restlessness.
Gastrointestinal system: Very common: diarrhoea, loss of appetite. Common: vomiting.
Psychiatric: Very common: somnolence.
For full details see prescribing information.

This product can be administered either simultaneously or at any time before or after a different inactivated or live vaccine.
Different injectable vaccines should always be administered at different injection sites. As with other vaccines it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immunologic response may not be achieved. can be administered either simultaneously or at any time before or after a different inactivated or live vaccine. Different injectable vaccines should always be administered at different injection sites. As with other vaccines it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immunologic response may not be achieved.  can be administered either simultaneously or at any time before or after a different inactivated or live vaccine. Different injectable vaccines should always be administered at different injection sites. As with other vaccines it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immunologic response may not be achieved.
For full details see prescribing information.

Fertility: No data available.
Pregnancy: As This product is not intended for use in adults, adequate human data on use during pregnancy and adequate animal reproduction studies are not available.
Lactation: As This product is not intended for use in adults, adequate human data on use during lactation and adequate animal reproduction studies are not available.

Occasional reports of overdose have been received.  Overdose has not resulted in ill effect.