Medication info

Pediatric Agripal Pre-filled Syringe (Influenza Surface Antigen Vaccine)

Prescription medication
Ingredient · strength
Purified Inactivated Influenza Virus Antigen A [A/California/7/2009,NYMC-181(H1N1)]›7.5μg / 1 prefilled syringePurified Inactivated Influenza Virus Antigen A [A/Hong Kong/4801/2014, NYMC X-263B(H3N2)]›7.5μg / 1 prefilled syringePurified Inactivated Influenza Virus Antigen B [B/Brisbane/60/2008, wild type]›7.5μg / 1 prefilled syringe
Manufacturer / importer
씨에스엘코리아(유)
Appearance
Pre-filled syringe containing a clear liquid preparation
Packaging
10 pre-filled syringes/box [pre-filled syringe (0.25 mL)]
Approval status
Active

MFDS item code 201103138 · Approved 2011.05.12

Summary

Main use
Prevention of influenza disease caused by influenza A and B viruses
Who uses it
Adults · Children
Adult dosage
Administer the same dose as a single intramuscular injection once a year.
Children's dosage
For ages 6-35 months: administer 0.25 mL as a single intramuscular injection. However, infants and young children under 3 years who have not previously been infected with influenza or vaccinated should receive 2 doses spaced at least 4 weeks apart in the first year of vaccination.

Ingredients

Importer
씨에스엘코리아(유)

Efficacy & effects

Prevention of influenza disease caused by influenza A and B viruses

View approved original text

This vaccine is used for children aged 6 months to under 35 months to prevent influenza disease caused by influenza A and B viruses.

Dosage and Administration

Adult dosage

Administer the same dose as a single intramuscular injection once a year.

Children's dosage

For ages 6-35 months: administer 0.25 mL as a single intramuscular injection. However, infants and young children under 3 years who have not previously been infected with influenza or vaccinated should receive 2 doses spaced at least 4 weeks apart in the first year of vaccination.

Precautions

This drug must have the health status of the vaccinee carefully checked before vaccination. In particular, it should not be administered to patients with fever, severe nutritional disorders, cardiovascular, renal, or liver disease in an acute phase or whose symptoms have worsened, acute respiratory illness, or active infectious disease. Furthermore, individuals with allergies to any components of this drug or those who have experienced severe allergic reactions from this drug in the past should avoid administration, as should those who have had adverse reactions following vaccination. Patients who have experienced convulsions within the past year or those who have had neurological disorders after receiving influenza vaccines should also be cautious. Patients with chronic cardiovascular, respiratory conditions, or diabetes may have worsening of their conditions due to influenza infection, so careful judgment is required during vaccination. This drug may cause side effects such as headache, sweating, muscle pain, joint pain, fever, malaise, chills, fatigue, and redness or swelling at the injection site, all of which typically resolve naturally within 1-2 days. Rarely, serious side effects such as thrombocytopenia, lymphadenopathy, allergic reactions, neurological abnormalities, and skin rashes may occur; any of these symptoms should prompt immediate consultation with medical staff. Acute allergic reactions like anaphylaxis may occur after vaccination, so medical staff should be prepared for rapid emergency response. This drug should not be injected intravascularly, and the injection site is recommended to be the lateral aspect of the upper arm, which should be disinfected before administration. On the day of vaccination and the following day, rest should be observed, and the injection site should be kept clean; if abnormal symptoms such as high fever or convulsions arise, the hospital should be visited immediately. Patients in an immunocompromised state may not exhibit adequate immune responses after this vaccination, requiring attention. In addition, different injection sites should be used for vaccinations combined with other vaccines, and immune response may be reduced in individuals receiving immunosuppressive therapy. This drug should be stored in a refrigerated environment (2-8°C), avoiding freezing and should be kept away from light. Before use, it should be brought to room temperature, shaken well to confirm it is in a clear liquid state, and it should not be used if discoloration or particulates are noted. Care should be taken as freezing may alter quality, and it is important to ensure the needle does not enter the vascular system. Unused medication should be disposed of properly according to relevant regulations.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylaxis
  • severe thrombocytopenia
  • neuritis
  • encephalitis
  • Guillain-Barre syndrome
  • angioedema
  • and vasculitis.

Mild side effects

Headache, sweating, muscle pain, joint pain, fever, malaise, chills, fatigue, redness at the injection site, swelling, pain, petechiae, induration, reactions similar to soft tissue reactions at the injection site, swelling at the injection site, pruritus, nonspecific rash, vasculitis, neuralgia, sensory disturbances, febrile convulsions, syncope, and presyncope.

Not everyone experiences these, and they can vary from person to person.

Storage

This drug must be stored in a sealed container to prevent exposure to air and light. Additionally, the temperature should be maintained between 2 and 8 degrees Celsius and care should be taken to avoid freezing. Proper storage will help maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Pre-filled syringe containing a clear liquid preparation

Package unit

10 pre-filled syringes/box [pre-filled syringe (0.25 mL)]

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.