【Product Instruction】Anflu (Influenza) (Syringe)

Revised: 12 November, 2010
INFLUENZA VACCINE (SPLIT VIRION), INACTIVATED
【INSTRUCTION】
 

【NAME OF THE MEDICAL PRODUCT】

Generic Name: Influenza Vaccine (Split Virion), Inactivated
Trade Name: Anflu®

【COMPOSITION AND DESCRIPTION】

Anflu® is derived from the influenza virus recommended by WHO, which is cultured in chicken embryo, followed by harvest, inactivation, purification and disruption. Finally, a slightly opalescent suspension with no foreign particles is obtained.
Active ingredients:

Pediatric dosage is 0.25 ml/dose, including the antigens:

  7.5 μg haemagglutinin of A/California/7/2009
  7.5 μg haemagglutinin of A/Victoria/210/2009
  7.5 μg haemagglutinin of B/Brisbane/60/2008

Adult dosage is 0.50 ml/dose, including the antigens:

  15 μg haemagglutinin of A/California/7/2009
  15 μg haemagglutinin of A/Victoria/210/2009
  15 μg haemagglutinin of B/Brisbane/60/2008
Excipients include sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and water for injection.
No preservative in Anflu®.

【TARGET GROUPS FOR VACCINATION】

Vaccination is recommended for the susceptible person and those having high risk of associated complications, such as children aged over 6 months, senior citizens, weakling and those who are in influenza epidemic areas.

【THERAPEUTIC INDICATION】

Anflu® can induce body to generate immunoreaction against influenza virus and can be used for prevention of infection caused by influenza virus.

【STRENGTH】

Each package contains 0.25 ml or 0.5 ml liquid. Single dose of 0.25 ml is for children aged from 6 months to 3 years, containing 7.5 μg haemagglutinin per type of influenza virus strain. Single dose of 0.5 ml is for adult and children aged over 3 years, containing 15 μg haemagglutinin per type of influenza virus strain.

【ADMINISTRATION AND DOSAGE】

(1)Intramuscular injection on deltoid.
(2)Adults and children above 36 months are administered one 0.5ml dose; Children between 6 to 36 months are administered two times, each time 0.25ml dose with the interval of 4 weeks.

【ADVERSE REACTIONS】

Common adverse reactions:
(1)Normally, within 24 hours after vaccination, some local reactions happen at the site of injection: redness, swelling, pain, tenderness, itching and induration; or some systematical reactions: fever, dizziness, shivering, fatigue, sweating, myalgia, arthralgia, pruritus, rash and headache. These reactions usually disappear within one or two days without treatment.
(2)Some reaction of fever could happen after vaccination, which will disappear within a short period without any treatment.
Rare adverse reactions:
(1)Some influenza symptoms and generalmalaise could happen after vaccination, which will disappear without any treatment.
(2)Serious fever reaction: take some physical and medical treatments to avoid hyperpyretic convulsion.
Extremely rare adverse reactions:
(1)Anaphylactic erythra: Urticaria could happen within 72 hours after vaccination, which needs medical treatment of antianaphylaxis.
(2)Allergic purpura: need medical treatment, such as corticosterone for antianaphylaxis. It could induce the associated anaphylactoid purpura nephritis, APN, if no properly treatment.
(3)Anaphylactic shock: could happen within one hour after vaccination, which need first-aidmeasures such as the injection of adrenalin.

【CONTRAINDICATION】

This product is forbidden to use for the groups below:
(1)People who is allergic to any component of vaccine, including excipients, formaldehyde, disruption reagent, Triton X-100, gentamycin and ovalbumin.
(2)People who suffers acute diseases, serious chronic disease, acute paroxysm of any chronic disease, cold and fever.
(3)Women during pregnancy
(4)People who has un-controlled epilepsy or other nervous system disease, and guillain-barre syndrome

【PRECAUTIONS】

(1)This product should be used with caution for people who or whose family has the history of convulsion or epilepsia, chronic disease and allergy symptoms.
(2)Do not use the product in the case that there is any crack in the container, the vaccine is degenerative, or there is big mass that can not be disappeared by shaking.
(3)This product should be used immediately after open.
(4)Adrenalin and other first aid medicine should be prepared at the vaccination place, in case of serious allergy reaction. The people after vaccination should not leave until 30 minutes after vaccination.
(5)Application of immunosuppressors may decrease or inhibit immunization reactions. People administrated globulin should be vaccinated the vaccine 1 month later.
(6)People who has any reaction of nervous system after the vaccination of this product, is not able to be vaccinated again.
(7)Must not be frozen.
(8)Administration must not be via vascular route.
(9)This product should be stored at places out of the reach by children.
(10)Shake before use.
(11)Anflu should not be mixed with other vaccines in the same container.
(12)Please seek medical advice if:
    You have defected immune function.
    Ask, the advice of your doctor or pharmacist before using any medicine.
    Medical advice should be followed on whether or not to get vaccination during pregnancy. Lactation is not a contraindication of this product.

【STORAGE】

Store and transport between +2℃ and +8℃, protected from light. Do not freeze.

【PACKAGE】

Pre filled syringe or vial. The package unit is one syringe or one vial.

【SHELF LIFE】

12 months

【AUTHORIZATION NUMBER】

Junior: Guo Yao Zhun Zi S20053055
Adult: Guo Yao Zhun Zi S20053056

【MANUFACTURER】

SINOVAC BIOTECH CO., LTD.
Add:PKU BioCity, No. 39 Shangdi Xi Rd, Haidian District Beijing
Postal code:100085
Tel:86-10-82890088
Fax:86-10-62966910
http://www.sinovac.com
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Add: No. 39 Shangdi Xi Road, Haidian District, Beijing, P.R.C. 100085 Supported by elongtian