Quadrivalent Influenza Vaccine, Inactivated of Hualan

Package Insert of Influenza Vaccine(Split Virion), Inactivated, Quadrivalent

Please read this instruction carefully and use under the guidance of physicians

 [Drug Name]

Generic Name: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

English Name: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

Chinese Pinyin: Sijia 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 inoculated in embryo eggs. After incubation, the virus liquid is 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. 0.5ml of the vaccine contains:

A/Guangdong-Maonan/SWL1536/2019(H1N1) pdm09-like virus…15μɡ HA

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

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

B/Phuket/3073/2013(B/Yamagata/16/88 lineage) -like virus………...15μɡ HA

Excipients: Na2HPO4, NaH2PO4, NaCl.

 [Vaccination Subjects]

The vaccine is approved for use in people aged 3 years old and above, especially in vulnerable people and high risk population for influenza complications, such as children, the elderly, the weak and people in influenza epidemic areas.

[Function and Use]

After vaccination, the vaccine can stimulate the body to produce the immunity of anti-influenza virus; it is used for preventing influenza caused by vaccine-related type of influenza virus.

[Specifications]

0.5ml per vial (syringe), 0.5ml human dose for each use, contains 15µg HA of each type of influenza strains.

[Administration and Dosages]

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

2. People vaccinate the vaccine before or during the influenza pandemic season for prevention. Adult, children aged 3 years old and above should be vaccinated one dose of vaccine (0.5ml).

[Adverse Reactions]

A total of 3,045 subjects aged 3 years old and above participate in two clinical studies of this product in China, of which 1,095 subjects receive at least one dose of this vaccine. The safety observation of this product system is from the beginning of vaccination to 30 days after the whole vaccination, and the long-term safety observation of most subjects is from 31 days to 180 days after the whole vaccination.

According to the classification of adverse reactions 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

Systemic adverse reaction

Very common: fever;

Occasional: headache, fatigue, nausea, vomiting, diarrhea, cough, allergy, muscle pain;

Local adverse reactions

Common: pain, swelling;

Occasional: red, induration, pruritus.

2.        Domestic clinical trials of similar products

Serious adverse reactions

Rare: anaphylactoid purpura.

3.        Foreign clinical trial and post-market monitoring of similar products

The safety data of foreign clinical trial of similar products are summarized as follows:

Systemic adverse reactions

Very common: myalgia, headache, fatigue, discomfort, arthralgia, gastrointestinal symptoms, lethargy, irritability, loss of appetite;

Common: chills, fever;

Local adverse reactions

Very common: pain, redness, swelling;

Occasional: induration and ecchymosis;

Serious adverse reactions

Rare: systemic anaphylaxis.

The safety data obtained from foreign post-market monitoring are summarized as follows:

Digestive system: abdominal pain or discomfort, swelling of the mouth, throat and/or tongue;

Blood and lymphatic system: enlarged lymph nodes;

Infection and invasive diseases: injection site cellulitis, pharyngitis, rhinitis, tonsillitis;

Nervous system: convulsion, encephalomyelitis, facial paralysis, Guillain-Barre syndrome, myelitis, neuritis, sensory abnormalities, syncope;

Respiratory system: asthma, bronchospasm, dyspnea;

Cardiovascular system: tachycardia, vasculitis;

Vestibular system of inner ear: vertigo

Skin system: angioedema, erythema, swelling, pruritus, Stevens-Johnson syndrome, sweating, urticaria;

Eyes: conjunctivitis, eye pain, redness, swelling and eyelid swelling;

Immune system: anaphylactic shock, anaphylactoid purpura, hypersensitivity reaction, and serum sickness.