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HSA Approval

Aflunov Suspension for Injection 0.5ml in Pre-filled syringe

SIN14400P

Aflunov Suspension for Injection 0.5ml in Pre-filled syringe

Aflunov Suspension for Injection 0.5ml in Pre-filled syringe

August 29, 2013

SEQIRUS PTE. LTD.

SEQIRUS PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSEQIRUS PTE. LTD.
Licence HolderSEQIRUS PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SUSPENSION

**4.2 Posology and method of administration** Posology: Adults and elderly (18 years of age and above): Individuals 18 years and older: Two 0.5 mL doses administered with an interval of at least 21 days between doses. 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Paediatric population: There is limited experience in children between 6 months and 17 years of age (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle.

INTRAMUSCULAR

Medical Information

**4.1 Therapeutic indications** Active immunisation against H5N1 subtype of Influenza A virus. 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). AFLUNOV® should be used in accordance with official recommendations.

**4.3 Contraindications** 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. 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.

J07BB02

influenza, inactivated, split virus or surface antigen

Manufacturer Information

SEQIRUS PTE. LTD.

Seqirus Vaccines Limited (Formulation, Fill/Finish, Primary & Secondary packaging)

Rovi Pharma Industrial Services, S.A. (Filling/Primary packaging)

Active Ingredients

Influenza virus surface antigens (haemagglutinin and neuraminidase) A/turkey/Turkey/1/05 (H5N1)-like strain used (NIBRG-23)

7.5 ug HA/0.5 ml

Documents

Package Inserts

Aflunov Suspension for Injection 0.5ml in Pre-filled syringe, PI.pdf

Approved: August 15, 2022

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Aflunov Suspension for Injection 0.5ml in Pre-filled syringe - HSA Approval | MedPath