- Approval Id
- 1d1862b88e3adbda
- Drug Name
- TRUMENBA SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML
- Product Name
- TRUMENBA SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML
- Approval Number
- SIN15634P
- Approval Date
- 2019-02-21
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- <p><strong>4.2. Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>Standard schedule for routine immunization: Administer 0.5 ml at 0 and 6 months.</p>
<p>Schedule for individuals at increased risk of invasive meningococcal disease: Administer 2 doses of 0.5 ml at least 1 month apart, followed by a third dose at least 4 months after the second dose.
</p>
<p><strong>Booster Dose</strong></p>
<p>A booster dose should be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Pediatric Population</strong></p>
<p>Safety and efficacy of Trumenba in children below the age of 10 years of age have not been established.</p>
<p><strong>Elderly</strong></p>
<p>Trumenba has not been studied in adults older than 65 years of age.</p>
<p><u>Method of administration</u></p>
<p>For intramuscular injection only. The preferred site for injection is the deltoid muscle of the upper arm.</p>
<p>Separate injection sites and different syringes must be used if more than one vaccine is administered at the same time.</p>
<p>There are no data available on the interchangeability of Trumenba with other meningococcal serogroup B vaccines to complete the vaccination series.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong></p>
<p>Trumenba is indicated in individuals 10 years and older for active immunization to prevent invasive meningococcal disease caused by <em>Neisseria meningitidis</em> serogroup B.</p>
<p>See section 5.1 for information on protection against specific serogroup B strains – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>Dosing of Trumenba should be determined taking into consideration the risk of invasive meningococcal B disease by each country or region. The use of this vaccine should be in accordance with official recommendations.</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong></p>
<p>Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.<br>
Severe allergic reaction (e.g., anaphylaxis) after any previous dose of Trumenba or to any component of this vaccine.</p>
- Atc Code
- J07AH09
- Atc Item Name
- meningococcus B, multicomponent vaccine
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
