Trivalent Influenza Vaccine

Package insert of Influenza Vaccine (Split Virion), Inactivated

[Drug Name]

Generic Name: Influenza Vaccine (Split Virion), Inactivated

English Name: Influenza Vaccine (Split Virion), Inactivated

Chinese Pinyin: Liugan Bingdu Liejie Yimiao

[Constituents and Characters]

The vaccine is prepared from influenza virus type A and B prevalent strains recommended by WHO. The virus strains are propagated in embryonated chicken eggs. After incubation, the virus suspensions in allantoic cavities are harvested. The vaccine is prepared by inactivation, concentration, purification and splitting. The vaccine is a slightly opalescent liquid.

Active ingredients: Hemagglutinin of prevalent strains of influenza virus in current year. The vaccine 0.5ml contains:

A/Guangdong-Maonan/SWL1536/2019 (H1N1) pdm09-like virus ...15μɡ hemagglutinin

A/Hong Kong, S.A.R., China/2671/2019 (H3N2)-like virus………………………...15μɡ hemagglutinin

B/Washington/02/2019 (B/Victoria lineage)-like virus……………..15μɡ hemagglutinin

Excipients: Na2HPO4, NaH2PO4, NaCl.

[Vaccination Subjects]

The vaccine is approved for use in vulnerable people and high risk population for inf1uenza complications, such as children over 3 years of age, the elderly, the weak and people in influenza epidemic areas.

[Function and Use]

It is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine for prophylaxis of the Influenza caused by the contained vaccine strain.

[Specifications]

This vaccine per single human dose is 0.5ml in syringe containing not lower than 15µg HA for each virus strain.

[Administration and Dosages]

(1)   Intramuscularly inject the vaccine in the region of the deltoid muscle of the upper arm.

(2)   Persons 3 years of age and older should vaccinate with a single dose of 0.5 ml before or during the flu epidemic season.

[Adverse Reactions]

As with all other vaccines, adverse reactions may occur after vaccination.

According to the classification of adverse reactions rate recommended by The Council for International Organizations of Medical Sciences (CIOMS): very common (≥ 10%), common (1%-10%, including 1%), occasional (0.1%-1%, including 0.1%), rare (0.01%-0.1%, including 0.01%), very rare (<0.01%), as described below:

1、Clinical trial and post-marketing monitoring

1.1Clinical trial

Systemic adverse reaction

Very common: fever.

Common: fatigue, cough, crying.

Occasional: allergic reaction, eating disorder, nausea, vomiting, diarrhea.

Local adverse reaction

Common: redness, swelling.

Occasional: pain, pruritus, burning sensation.

1.2Post-marketing monitoring

Systemic adverse reaction

Very common: fever.

Very rare: fatigue, nausea, vomiting, dizziness, chest tightness, headache, arthralgia, cough, diarrhea, allergic reaction, allergic purpura, convulsions, anaphylactic shock, palpitations, rash, nasal obstruction, chills, crying (children).

Local adverse reaction

Common: redness, swelling.

Occasional: induration.

Very rare: pain, pruritus, erythema, swelling, angioedema, lymphadenectasis.