SKYCELLFLU QUADRIVALENT PREFILLED SYRINGE 0.5ML

【 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.

1. Hypersensitivity reaction to active ingredient and/or any other ingredient (including formalin) in SKYCellflu Quadrivalent®
2. Febrile disease or acute infection
3. History of severe hypersensitivity reaction and/or convulsive symptom to previous influenza vaccination
4. History of Guillain-Barre syndrome or other neurological disorder within 6 weeks of previous influenza vaccination
5. Fever
6. Cardiovascular disease, renal disease, or hepatic disease in acute, exacerbation, or active phase
7. Acute respiratory disease or other active infection
8. History of anaphylaxis reaction to any ingredient in SKYCellflu Quadrivalent®
9. 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.

【 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.