SKYCellflu Special Precautions

Precautions for use: 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.
Administer SKYCellflu Quadrivalent with caution to the following individuals: 1) Pregnant women or women of child-bearing potential.
2) 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.
3) As with other intramuscular injection, patients with any bleeding disorder, such as hemophilia or thrombocytopenia, or patients on anticoagulant therapy should not receive SKYCellflu Quadrivalent unless the potential benefits outweigh 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.
General precautions: 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.
Antibody response may be insufficient in patients with inherited or iatrogenic immunodeficiency.
Influenza vaccine should be administered before influenza outbreaks. Vaccination may be delayed depending on epidemiological situation.
Influenza vaccine should be administered annually using a new vaccine composed with strains recommended each year.
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.