- Approval Id
- 93c24f031efde0a2
- Drug Name
- AFLUNOV SUSPENSION FOR INJECTION 0.5ML IN PRE-FILLED SYRINGE
- Product Name
- AFLUNOV SUSPENSION FOR INJECTION 0.5ML IN PRE-FILLED SYRINGE
- Approval Number
- SIN14400P
- Approval Date
- 2013-08-29
- Registrant
- SEQIRUS PTE. LTD.
- Licence Holder
- SEQIRUS PTE. LTD.
- 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>Posology:</p>
<p><u>Adults and elderly (18 years of age and above):</u><br>
Individuals 18 years and older: Two 0.5 mL doses administered with an interval of at least 21 days between doses.
<p>In the event of an officially declared influenza pandemic due to H5N1 virus, persons previously vaccinated with one or two doses of AFLUNOV® that contained HA antigen derived from a different clade of the same influenza subtype as the pandemic influenza strain may receive a single dose of adjuvanted H5N1 pandemic vaccine instead of two doses that are required in previously unvaccinated individuals (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>Paediatric population:</u><br>
There is limited experience in children between 6 months and 17 years of age (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>Method of administration</u><br>
Immunisation should be carried out by intramuscular injection into the deltoid muscle.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Active immunisation against H5N1 subtype of Influenza A virus.<br>
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/2005 (H5N1)-like strain (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>AFLUNOV® should be used in accordance with official recommendations.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (ovalbumin from eggs, kanamycin and neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and hydrocortisone) of this vaccine.<br>
However, in a pandemic situation caused by the strain included in this vaccine, it may be appropriate to give this vaccine to individuals with a history of anaphylaxis as defined above, provided that facilities for resuscitation are immediately available in case of need.</p>
- Atc Code
- J07BB02
- Atc Item Name
- influenza, inactivated, split virus or surface antigen
- Pharma Manufacturer Name
- SEQIRUS PTE. LTD.
