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HSA Approval

INFLUVAC TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 ML

SIN15591P

INFLUVAC TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 ML

INFLUVAC TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 ML

December 4, 2018

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Licence HolderABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED

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: 0.5 ml. _Pediatric patients_ Children from 6 months to 17 years of age: 0.5 ml. Children less than 9 years of age, who have not previously been vaccinated with a seasonal influenza vaccine: a second dose of 0.5 ml should be given after an interval of at least 4 weeks. Infants less than 6 months of age: the safety and efficacy of Influvac® Tetra in infants have not been established. Method of Administration Immunization should be carried out by intramuscular or deep subcutaneous injection. The preferred sites for intramuscular injection are the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 6 months through 35 months of age, or the deltoid muscle in children from 36 months of age and adults. Precautions to be taken before handling or administrating the medicinal product: For instructions for preparation of the medicinal product before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.

SUBCUTANEOUS, INTRAMUSCULAR

Medical Information

**4.1. Therapeutic indications** Prophylaxis of influenza, especially those who run an increased risk of associated complications. Influvac® Tetra is indicated in adults and children from 6 months of age. The use of Influvac® Tetra should be based on official recommendations.

**4.3. Contraindications** Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin. Immunization shall be postponed in patients with febrile illness or acute infection.

J07BB02

influenza, inactivated, split virus or surface antigen

Manufacturer Information

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Abbott Biologicals B.V.

Abbott Biologicals B.V. (Weesp)

Active Ingredients

Influenza Virus (SH) A/Sydney/5/2021 (H1N1)pdm09-like strain (A/Sydney/5/2021, SAN-013)

15 micrograms HA/0.5ml

Influenza Virus (SH) A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/9/2021, SAN-010)

15 micrograms HA/0.5ml

Influenza Virus (SH) B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26)

15 micrograms HA/0.5ml

Influenza Virus (SH) B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type)

15 micrograms HA/0.5ml

Documents

Package Inserts

InfluvacTetra Suspension for Injection in pre-filled syringe PI.pdf.pdf

Approved: March 3, 2023

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INFLUVAC TETRA, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 ML - HSA Approval | MedPath