Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
【 **Dosage and administration**】 Following dose is administered via intramuscular injection, and same dose is repeated once annually. 1. 3 through 8 years of age: 0.5mL as a single injection. 2. 9 years of age and older: 0.5mL as a single injection. For children below 9 years of age who have not been previously vaccinated or infected, a second dose should be administered after an interval of at least 4 weeks.
INTRAMUSCULAR
Medical Information
【 **Indications**】 Active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine, for adults and children 3 years of age and older. The use of SKYCellflu Quadrivalent® should be based on official recommendations.
Under 【 **Precautions for use**】 **1\. Do not administer SKYCellflu Quadrivalent® to the following individuals.** If deemed necessary after a medical interview and visual inspection, examine the subject’s health condition further using methods such as auscultation and percussion. Do not administer the vaccine to subjects with following conditions. As an exception, the vaccine may be administered to subjects who are at risk of possible influenza infection and determined to have no likelihood of developing serious disabilities due to the administration of the vaccine. 01. Hypersensitivity reaction to active ingredient and/or any other ingredient (including formalin) in SKYCellflu Quadrivalent® 02. Febrile disease or acute infection 03. History of severe hypersensitivity reaction and/or convulsive symptom to previous influenza vaccination 04. History of Guillain-Barre syndrome or other neurological disorder within 6 weeks of previous influenza vaccination 05. Fever 06. Cardiovascular disease, renal disease, or hepatic disease in acute, exacerbation, or active phase 07. Acute respiratory disease or other active infection 08. History of anaphylaxis reaction to any ingredient in SKYCellflu Quadrivalent® 09. History of suspected allergic reaction, including systemic rash, to previous vaccination 10. Other medical conditions that are diagnosed to be inappropriate for administration of SKYCellflu Quadrivalent® vaccine.
J07BB02
influenza, inactivated, split virus or surface antigen
Manufacturer Information
aj biologics pte. ltd.
SK bioscience Co., Ltd. (L House)
Active Ingredients
Influenza virus (NH) A/Guangdong-Maonan/SWL1536/2019, CNIC-1909 (H1N1)
15mcg/0.5ml
Documents
Package Inserts
SKYCELLFLU QUADRIVALENT PREFILLED SYRINGE PI.pdf
Approved: April 9, 2021