Medical Influenza Vaccine(Split Virion)

 influenza Vaccine (Split Virion), Inactivated

[Eligibles]

Susceptible individuals and persons liable to be afflicted with the associated complications, such as children, elderly persons and individuals in the epidemic area.

[Function and use]

The product can induce immunity against influenza virus in recipients following immunization. It is used to prevent the infections of the prevalent strains of influenza viruses.

[Description]

The influenza vaccine (split virion) is a preparation made from the WHO recommended prevalent strains of influenza virus type A and type B which are grown separately in embryonated chicken eggs. After incubation, the virus suspensions in allantoic cavities are harvested. The vaccine is prepared by inactivation, concentration, purification and disruption of the virus. It is a slightly milky-white liquid, containing thimerosal as a preservative.

Active constituent: Influenza haemagglutinin derived from each of prevalent influenza virus strains in that very year. (The name of each of virus strains and the content of haemagglutinin shall be included. )

Subsidiary materials: All the components of subsidiary materials approved shall be listed.

[Specifications]

0. 25 ml or 0.5 ml per container.  0.25 ml per single human dose (used for children aged between 6 months and 3 years) .shall contain 7.5 μg of influenza haemagglutinin of each influenza virus strain. 0.5 ml per single human dose (used for adult and children aged above 3 years) shall contain 15 μg of influenza haemagglutinin of each influenza virus strain.

[Contraindications]

(l) Subjects with known allergic reaction to some components of the vaccine, including subsidiary

materials, formaldehyde, chemicals used for virus desruption and antibiotics.

(2) Subjects with acute diseases, severe chronic diseases, and chronic diseases at acute attack stage

or fever.

(3) Pregnant women.

(4) Subjects with uncontrolled epilepsy, other progressive diseases of nervous system or a history of Guillain-Barre syndrome;

[Precautions]

(1) The vaccine shall be administered with caution to the subjects with family or individual history of convulsion and those with chronic diseases, history of epilepsy and allergic diathesis.

(2) Do not use the vaccine if the container shows abnormalities, such as crack, illegible label, exceeding expiry date or turbidity.

(3) The vaccine shall be administered immediately after the container is opened.

(4) Adrenaline should be available for first aid in case of severe anaphylactic reactions. The recipients shall be observed for at least 30 minutes on site following injection.

(5) The immunization with this vaccine should be deferred for at least 3 months following administration of immunoglobulin to avoid the influence on immune effect.

(6) Revaccination should be prohibited if any reactions of nervous system would occur after injection.

(7) Freezing is strictly forbidden.

[Storage]

Store and ship the product at 2-8℃ , protected from light.

[Packaging]

The approved packaging requirements shall apply.

[Validity period]

12 months.    

[Feature]

Taking the most advanced influenza producing technology, virus splitting, purification, control tests and specifications are in accordance with WHO standard.

Good vaccine quality, satisfied immunity results, ideal immnunogenicity, high seroconversion rate, anti-body increasing time, all are above the standards set by European Union.

Special advise: the vaccine should be injected annually.

1. For adult use in vial and persons aged above 3.

2. For adult use in pre-filled syringe and persons aged above 3.

3. For paediatric use in vial aged between 6 months and 35 months.

4. For paediatric use in pre-filled-syringe aged between 6 months and 35 months.

 

1.influenza vaccine                                                      

2.split virion                                                                 

3.WHO recommended strains                                   

4.against influenza virus