SKYCellflu Quadrivalent

Contraindication:
Do not administer the vaccine to individuals with following conditions. As an exception, the vaccine may be administered to individuals 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.

• Hypersensitivity reaction to active ingredient and/or any other ingredient (including formalin as a virus inactivating agent in the manufacturing process of drug substances) in SKYCellflu Quadrivalent.
• Febrile disease or acute infection.
• History of severe hypersensitivity reaction and/or convulsive symptom to previous influenza vaccination.
• History of Guillain-Barre syndrome or other neurological disorder within 6 weeks of previous influenza vaccination.
• Fever.
• Cardiovascular disease, renal disease, or hepatic disease in acute, exacerbation, or active phase.
• Acute respiratory disease or other active infection.
• History of anaphylaxis reaction to any ingredient in SKYCellflu Quadrivalent.
• History of suspected allergic reaction, including systemic rash, to previous vaccination.
• Other medical conditions that are diagnosed to be inappropriate for administration of SKYCellflu Quadrivalent vaccine.

Warning and Precaution:

• Pregnancy: safety and efficacy of SKYCellflu Quadrivalent has not been evaluated in pregnant women. Direct and/or indirect adverse effect related to reproduction and developmental toxicity was not observed in animal studies.
• Lactation: safety and efficacy of SKYCellflu Quadrivalent has not been evaluated in breastfeeding women.
• Patients with chronic cardiovascular or respiratory disease or patients with diabetes mellitus may experience significant exacerbation of existing disease upon influenza infection, and thus may receive vaccination with caution, as necessary.
• As with other intramuscular injection, patients with bleeding disorder such as hemophilia and thrombocytopenia or patients on anticoagulant therapy should not receive SKYCellflu Quadrivalent unless the potential benefit outweighs the risk of administration. If the decision is made to administer SKYCellflu Quadrivalent in such persons, it should be administered with caution to avoid the risk of hematoma formation following injection.
• Instruction should be provided to the vaccine recipient or caregiver to have a rest on the day of vaccination and next day, to maintain the injection site clean, and to immediately seek medical attention if symptoms such as fever and convulsion develop after vaccination.
• SKYCellflu Quadrivalent can prevent disease caused by influenza virus only, and does not prevent infection caused by other sources which show similar symptoms as influenza.
• As with other injectable vaccine preparations, appropriate emergency intervention should be prepared for potential anaphylaxis response after administration of the vaccine.
• Syncope may occur after or even before vaccination as a psychological reaction to injection needle. Appropriate measures should be taken to prevent injury from syncope.