- Approval Id
- ca39446c5315f980
- Drug Name
- FLUARIX TETRA SUSPENSION FOR INJECTION
- Product Name
- FLUARIX TETRA SUSPENSION FOR INJECTION
- Approval Number
- SIN14760P
- Approval Date
- 2015-03-23
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- <p><strong>3.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>Fluarix Tetra should be administered as a single 0.5 mL injection.</p>
<p>Children 6 months to less than 9 years, who have not previously been vaccinated against influenza should receive a second dose of 0.5 mL after an interval of at least 4 weeks.</p>
<p>Children aged <6 months:<br>
The safety and efficacy of Fluarix Tetra in children aged less than 6 months have not been established.</p>
<p>Vaccination should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).</p>
<p><u>Method of administration</u></p>
<p>Immunisation should be carried out by intramuscular injection.</p>
<p>Precautions to be taken before handling or administering the medicinal product.</p>
<p>For instructions for preparation of the medicinal product before administration, see <em>section 5.6</em> – <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>3.1 Therapeutic indications</strong></p>
<p>Fluarix Tetra is indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine (see <em>Pharmacodynamics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>The use of Fluarix Tetra should be based on official recommendations.</p>
- Contraindications
- <p><strong>3.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substances or to any of the excipients listed in <em>section 5.1</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em> or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate.</p>
<p>Immunisation should be postponed in patients with febrile illness or acute infection.</p>
- Atc Code
- J07BB02
- Atc Item Name
- influenza, inactivated, split virus or surface antigen
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
