Medication info

Agripal S1 Pre-filled Syringe (Influenza Surface Antigen Vaccine)

Prescription medication
Ingredient · strength
Purified Inactivated Influenza Virus Antigen A [A/Singapore/GP1908/2015 IVR-180(H1N1)]›15μg / 1 prefilled syringePurified Inactivated Influenza Virus Antigen A [A/Hong Kong/4801/2014, NYMC X-263B(H3N2)]›15μg / 1 prefilled syringePurified Inactivated Influenza Virus Antigen B [B/Brisbane/60/2008, wild type]›15μg / 1 prefilled syringe
Manufacturer / importer
시퀴러스코리아(유)
Appearance
Pre-filled syringe containing a transparent liquid formulation
Packaging
10 pre-filled syringes/box [pre-filled syringe (0.5 mL)]
Approval status
Active

MFDS item code 199403134 · Approved 1994.06.03

Summary

Main use
Prevention of influenza disease caused by influenza virus types A and B
Who uses it
Adults · Children
Adult dosage
From age 9 and above, administer 0.5 mL as a single intramuscular injection. Repeat the same dosage annually.
Children's dosage
6-35 months: Administer 0.25 mL as a single intramuscular injection. Children aged 3-8 years: Administer 0.5 mL as a single intramuscular injection. In children under 9 years who have not previously been infected with influenza or received the vaccine.

Ingredients

Importer
시퀴러스코리아(유)

Efficacy & effects

Prevention of influenza disease caused by influenza virus types A and B

View approved original text

This vaccine is used to prevent influenza disease caused by influenza virus types A and B in children, adolescents, and adults aged 6 months or older.

Dosage and Administration

Adult dosage

From age 9 and above, administer 0.5 mL as a single intramuscular injection. Repeat the same dosage annually.

Children's dosage

6-35 months: Administer 0.25 mL as a single intramuscular injection. Children aged 3-8 years: Administer 0.5 mL as a single intramuscular injection. In children under 9 years who have not previously been infected with influenza or received the vaccine.

Precautions

The patient's health status must be thoroughly checked before administration of this vaccine. Individuals with fever or very poor nutritional status, patients with acute heart, kidney, or liver diseases, and those with acute respiratory diseases or other infectious diseases should not receive this vaccine. Additionally, individuals who have previously experienced allergic reactions to this vaccine, or are sensitive to specific components such as egg or chicken protein, should also avoid vaccination. Those who have had severe side effects from this vaccine in the past or have experienced allergy symptoms like fever or generalized rash within 2 days after administration should be cautious. Women who are pregnant or may become pregnant, and patients with chronic illnesses such as heart, respiratory, or diabetes need to make careful considerations before administration. This vaccine may cause side effects such as headache, sweating, myalgia, arthralgia, fever, fatigue, redness or pain at the injection site, which usually resolve spontaneously within 1-2 days. Rarely, thrombocytopenia, lymphadenopathy, severe allergic reactions, neurological issues, or severe swelling or pain at the injection site may occur, so immediate consultation with healthcare professionals is necessary in case of unusual symptoms. In case of severe allergic reactions such as anaphylaxis after administration, prompt appropriate treatment and observation are required. This vaccine should never be administered intravenously, and the injection site should be typically on the outer side of the arm and properly disinfected. It is essential to rest and keep the injection site clean on the day of administration and the following day, and immediate medical attention should be sought if symptoms such as high fever or convulsions occur. This vaccine may not provide sufficient immunity in immunocompromised patients. Reactions such as fainting or hyperventilation may occur due to tension or anxiety during injection, so precautions for such situations are necessary. If administered with other vaccines, side effects may be exacerbated; therefore, different injection sites should be used, and those receiving immunosuppressants may have diminished immune responses. There have been no reported cases of overdose, but caution should be exercised during administration, particularly after the second trimester of pregnancy, when the risk of influenza infection is high. Before use, the vaccine should be kept at room temperature to acclimate, and it should be well shaken to ensure it is a clear liquid; do not use if discoloration or foreign particles are present. Store in a sealed container to avoid exposure to air or light, protect from direct sunlight, and keep at a cool temperature between 2 and 8 degrees Celsius. Additionally, take care not to freeze the vaccine. Discard any remaining product according to regulations.

Side effects and when to seek care immediately

Serious side effects

Urticaria, thrombocytopenia, angioedema, allergic reactions causing shock, extensive swelling at the injection site, encephalitis, neuritis, Guillain-Barré syndrome, renal impairments associated with vasculitis, anaphylactic reactions

Mild side effects

  • Headache
  • sweating
  • myalgia
  • arthralgia
  • fever
  • malaise
  • chills
  • fatigue
  • redness at the injection site
  • swelling
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  • pain
  • petechiae
  • induration
  • lymphadenopathy
  • vasculitis
  • pruritus
  • nonspecific rash
  • neuralgia
  • sensory abnormalities
  • febrile seizures
  • fainting
  • and presyncope

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

Storage

This product should be stored in a sealed container to avoid exposure to air or light, protected from direct sunlight, and kept in a cool place at a temperature between 2 and 8 degrees Celsius. Additionally, care should be taken to avoid freezing the vaccine.

Appearance and packaging

Appearance

Pre-filled syringe containing a transparent liquid formulation

Package unit

10 pre-filled syringes/box [pre-filled syringe (0.5 mL)]

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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.