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[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/Victoria/2570/2019 (H1N1)pdm09-like virus...............................15μɡ hemagglutinin

A/Darwin/9/2021 (H3N2)-like virus………………………...............15μɡ hemagglutinin

B/Austria/1359417/2021 (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.

[Contraindications]

(1) Subjects with known hypersensitivity reactions to any components of the vaccine, including eggs, excipients, formaldehyde, Triton X-100.

(2) Subjects who have acute illness, severe chronic diseases, acute exacerbation of chronic disease and fever.

(3) Pregnant women.

(4) Subjects with a diagnosis of uncontrolled epilepsy or other nervous system progressive disease, and history of Guillain-Barre Syndrome.

[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.

2.Domestic clinical trials of similar product

Common Adverse Reactions:

(1) Pain, tenderness, redness, swelling, and pruritus at the injection site may appear in a few subjects within 24 hours post-vaccination. Normally it will disappear in two or three days.

(2) A few subjects would have transient fever after vaccination, but it will disappear without treatment in a short period.

Rare Adverse Reactions:

(1) Transient cold symptoms and general malaise may occur, but will vanish without special treatment.

(2) Severe febrile reaction: Physical method and symptomatic treatment should be adopted to avoid febrile convulsion.

Very rare Adverse Reactions:

(1) Anaphylactoid dermatitis: Hives may appear within 72 hours post-vaccination. In this case, anti-anaphylactic treatment should be given immediately.

(2) Anaphylactoid purpura: Cortisol should be given immediately for anti-anaphylactic treatment to people who have anaphylactoid purpura post vaccination. Anaphylactic purpura nephritis may complicate if the anaphylactoid purpura could not timely treated or properly treated.

(3) Anaphylactic shock: may occur within 1 hour after vaccination. Adrenaline should be available for first aid in case of severe anaphylactic reactions.

3.Summary of Foreign Clinical Trials and Post-marketing Monitoring of Similar Products:

3.1. Data Collected from Clinical Trials:

Common local reactions: pain, tenderness, swelling, induration, pruritus.

Common systemic adverse reactions: fever, muscle pain, headache, discomfort, fatigue, diarrhea, loss of appetite, nausea and vomiting, irritability

3.2. Data Collected from Post-marketing Monitoring

(1) Blood and lymphatic system diseases: thrombocytopenia and lymphadenopathy.

(2) Immune system diseases: anaphylaxis or immediate anaphylaxis, including anaphylactic shock and serum disease.

(3) Nervous system disorders: such as neuralgia, paresthesia, (shortly after vaccination) dizziness, convulsions (including febrile convulsion), facial paralysis, brachial plexus neuropathy, syncope, cerebrospinal meningitis, encephalopathy, neuritis or neuropathy, myelitis and Guillain-Barre Syndrome.

(4) Vascular diseases: vasculitis (possibly related to transient renal involved).

(5) Respiratory, chest and mediastinal diseases: dyspnea, pharyngitis and rhinitis.

(6) Skin and subcutaneous tissue diseases: pruritus, urticaria and rash.

(7) General diseases and symptoms caused: fever, pain, weak/fatigue, limb pain, chest pain, cellulitis and swelling in injection site, influenza-like symptoms.

[Precautions]

(1) The vaccine should be administered with caution in individuals with a history of

convulsions, chronic disease, epilepsy or allergies.

(2) If either of these conditions exists, the vaccine should not be administered. Any leakage of container or illegible label or any clumps not dispersed after shaking in the container.

(3) Use immediately once the container is opened.

(4) The vaccine should be used within the shelf life stated on the label.

(5) Adrenaline should be available for first aid in case of severe anaphylactic reactions. The recipients should take a rest for at least 30 minutes on site after vaccination.

(6) Revaccination is prohibited if any neurological reaction occurs after vaccination.

(7) Subjects treated with immunoglobulin shall defer for at least one month for the vaccination with this vaccine.

(8) Immunocompromised subjects or those who have any questions before use should consult and comply with the medical advice.

(9) Do not be freezed or partially used.

(10)  Intravenous injection of the vaccine is strictly contraindicated.

 [Drug Interactions]

Should the vaccine be administered simultaneously with another injectable vaccine(s), the vaccine(s) would be administered at different injection sites.

Immunosuppressive therapies may influence the immune response to influenza. Consult the healthcare provider to prevent possible interactions with other drugs.

[Storage] Store and ship at 2-8°C, protected from light.

[Packaging] Prefilled syringe, packaged with bromobutyl rubber stopper.

1 syringe per carton. 2 syringes per carton.

[Shelf Life] 12 months

[Product Standard]YBS05042019 and Chinese Pharmacopoeia (volume Ⅲ,2015 edition)

[Product License No.] GYZZ S20083016

[Marketing Authorization Holder]

Hualan Biological Bacterin Inc.               

Address: Jia No.1-1, Hualan Ave., Xinxiang, Henan, China

[Manufacturer]

Hualan Biological Bacterin Inc.                

Address: Jia No.1-1, Hualan Ave., Xinxiang, Henan, China

Tel: 86-373-3519991

Fax: 86-373-3519991

Post Code: 453003