- Approval Id
- 23e68bfc9848ab44
- Drug Name
- INFANRIX IPV+HIB VACCINE
- Product Name
- INFANRIX IPV+HIB VACCINE
- Approval Number
- SIN10988P
- Approval Date
- 1999-06-25
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><strong>Posology</strong></p>
<p>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 maintained between subsequent doses.</p>
<p>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.</p>
<p><strong>Method of administration</strong></p>
<p><em><strong>Infanrix-IPV+Hib</strong></em> is for <strong>deep</strong> intramuscular injection, in the anterolateral thigh.</p>
<p>It is preferable that each subsequent dose is given at alternate sites.</p>
<p><em><strong>Infanrix-IPV+Hib</strong></em> 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.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>Indications</strong></p>
<p><em><strong>Infanrix-IPV+Hib</strong></em> is indicated for active immunisation in infants from the age of 2 months against diphtheria, tetanus, pertussis, poliomyelitis and <em>Haemophilus influenzae</em> type b.</p>
<p><em><strong>Infanrix-IPV+Hib</strong></em> is also indicated as a booster dose for children who have previously been immunised with diphtheria, tetanus, pertussis (DTP), polio and Hib antigens.</p>
<p><em><strong>Infanrix-IPV+Hib</strong></em> does not protect against diseases caused by other types of <em>Haemophilus influenzae</em> nor against meningitis caused by other organisms.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p><em><strong>Infanrix-IPV+Hib</strong></em> should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, inactivated polio or Hib vaccines.</p>
<p><em><strong>Infanrix-IPV+Hib</strong></em> is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine.</p>
- Atc Code
- J07CA06
- Atc Item Name
- diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
