Infanrix-IPV + Hib

/ 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. An interval of at least 1 month should be respected between subsequent doses.
A booster dose is recommended in the second year of life with an interval of at least 6 months after completion of primary vaccination schedule.
Method of administration: INFANRIX IPV+ Hib is for deep intramuscular injection, in the anterolateral aspect of the thigh.
It is preferable that each subsequent dose is given into alternating limbs.
INFANRIX IPV +Hib should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes.
INFANRIX IPV+ Hib should under no circumstances be administered intravascularly.

INFANRIX- IPV+Hib is indicated for active immunisation in infants from the age of 2 months to 5 years, against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b.
INFANRIX IPV Hib is also indicated as a booster dose for children who have previously been immunised with DTP, polio and Hib antigens.
The Hib component of the vaccine does not protect against diseases due to other serotypes of Haemophilus influenzae nor against meningitis caused by other organisms.

Hypersensitivity to the active substances or to any of the excipients, polymyxin and polysorbate 80.
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio or Hib vaccines.
INFANRIX IPV+ Hib is contra-indicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine, including INFANRIX-IPV+Hib. Pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.
As with other vaccines, the administration of INFANRIX IPV+ Hib should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, however, is not a contraindication.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily
available in case of a rare anaphylactic event following the administration of the vaccine.
If any of the following events have occurred in temporal relation to receipt of any DTP-containing vaccine, the decision to give subsequent doses of vaccine containing a pertussis component should be carefully considered.
– Temperature of ≥ 40.0 °C (rectal) within 48 hours, 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.
See prescribing information for full details.

Infections and infestations Uncommon: upper respiratory tract infection
Blood and lymphatic system disorders Uncommon: lymphadenopathy
Metabolism and nutrition disorders Very common: appetite lost
Psychiatric disorders Very common: crying abnormal, irritability, restlessness
Nervous system disorders Very common: somnolence
Respiratory, thoracic and mediastinal disorders Uncommon: bronchitis, cough, rhinorrhoea
Gastrointestinal disorders Common: diarrhoea, vomiting
Skin and subcutaneous tissue disorders Uncommon: urticaria, rash.
Rare: pruritus, dermatitis
General disorders and administration site conditions Very common: fever (≥38.0°C), injection site reactions such as pain and redness, local swelling at the injection site (≤50 mm). Common: injection site reactions including induration, local swelling at the injection site (>50 mm). Uncommon: diffuse swelling of the injected limb, sometimes involving the adjacent joint, fever>39.5°C, fatigue.
See prescribing information for full details.

If INFANRIX IPV Hib is to be given at the same time as another injectable vaccine(s), the 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 response may not be achieved.

As INFANRIX IPV+ Hib is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available.

Some cases of overdose have been reported during post-marketing surveillance. Adverse events, when reported following overdosage, were similar to those observed after administration of the recommended dose of INFANRIX-IPV+Hib.