- Approval Id
- c4186e22e58957bf
- Drug Name
- NIMENRIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Product Name
- NIMENRIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Approval Number
- SIN14534P
- Approval Date
- 2014-04-03
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>4.2. Posology and method of administration</strong></p>
<p><u>Posology</u><br>
<strong>Nimenrix™</strong> should be used in accordance with available official recommendations.</p>
<img src="/TGIF/Nimenrix-Table1_260924.png" alt="Nimenrix Dosage Table 1" /><br><br>
<p><em>Previously vaccinated children from 12 months of age, adolescents and adults</em><br>
<strong>Nimenrix™</strong> may be given as a booster dose to individuals who have previously received primary vaccination with a conjugated or plain polysaccharide meningococcal vaccine (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><u>Special populations</u><br>
Individuals who have underlying conditions predisposing them to meningococcal infection due to anatomic or functional asplenia (such as sickle cell disease) may receive at least one dose of <strong>Nimenrix™</strong> (see sections 4.8 and 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Method of administration</u><br>
Immunisation should be carried out by intramuscular injection only.</p>
<p>In infants, the recommended injection site is the anterolateral aspect of the thigh.</p>
<p>In individuals from 1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle (see sections 4.4 and 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>For instructions on reconstitution of the medicinal product before administration, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong></p>
<p><strong>Nimenrix™</strong> is indicated for active immunisation of individuals from 6 weeks of age against invasive meningococcal diseases caused by <em>Neisseria meningitidis</em> groups A, C, W-135 and Y.</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong></p>
<p><strong>Nimenrix™</strong> should not be administered to subjects with hypersensitivity to the active substances or to any of the excipients contained in the vaccine (see sections 2 and 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- J07AH08
- Atc Item Name
- meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
- Company Detail Path
- /organization/pfizer-private-limited
