[Drug Name]

Generic Name: Group ACYW135 Meningococcal Polysaccharide Vaccine

English Name: Group ACYW135 Meningococcal Polysaccharide Vaccine

Chinese Pinyin: ACYW135 Qun Naomoyanqiujun Duotang Yimiao

[Constituents and [A1] ]Meningococcal Polysaccharide Vaccine Group ACYW135 is lyophilized[u2] preparation made from Group A, C, Y, W135 Neisseria meningitides culture by extracting and purifying the respective polysaccharide antigen, mixing and then adding in suitable stabilizer. The final product looks like a white crisp cake, and after reconstitution by adding the attached solvent, into a clear liquid.

Active ingredients: Group A, C, Y, W135 Neisseria meningitides capsule polysaccharide.

Excipient: lactose.

Solvent: sterile, non-pyrogenic PBS.

[Vaccination Subjects]

At present, the vaccine is only recommended to be used in high-risk population (children and adults) over 2 years of age in the following conditions:

(1) Travelers or inhabitants of high-risk regions of the serogroup A, C, Y and W135 Neisseria meningitis epidemic areas like Sub-Saharan Africa.

(2) Persons who do laboratory or vaccine production work and might come in contact with the serogroupA, C, Y and W135 Neisseria meningitis in the air.

(3) High-risk population in the serogroups Y and W135 Neisseria meningitis epidemic areas estimated by the national Ministry of Health and CDC according to the epidemiological survey.

[Function and Use]

The vaccine is used against the epidemic cerebrospinal meningitis caused by Neisseria meningitides serogroup A, C, Y and W135.

[Specifications]

Reconstituted as per labeled amount, each vial is 0.5ml, and 0.5ml for each human dose containing50μg of respective serogroup A, C, Y and W135 polysaccharide.

[Administration and Dosage]

(1) Reconstitute vaccine by adding the accompanying solvent into the vaccine to dissolve. Shake and inject immediately.

(2) The vaccine should be injected subcutaneously at deltoid insertion area of the lateral upper arm.

(3) Vaccinate a single 0.5ml dose before meningococcal epidemic season.

(4) Re-vaccination (recommended by foreign countries): one booster dose shall be given 2 ~3 years after the primary immunization to people who remain at risk of invasive meningococcal disease, especially to children who were younger than 4 years at the time of primary immunization. Though whether re-vaccination is necessary for older children and adults has not been determined, re-vaccination should be considered within 3~5 years after primary immunization in case that antibody levels rapidly decline within 2~3 years after vaccination.

There is no current information available on immune persistence and strengthening of immunization regarding this vaccine in clinical research.

[Adverse Reaction]

Local adverse reactions: maily is injection site pain, then redness, swell and itching.

Systemic adverse reactions: mainly is fever, then headache, fatigue, drowsiness, nausea, vomiting and diarrhea, loss of appetite, muscle pain and rashes. Most of the adverse reactions can be relieved spontaneously and will disappear within 72 hours following vaccination.

The adverse reactions to this vaccine evaluated in domestic clinical studies with 900 subjects have been categorized as follows. The observation period was within 4 weeks after vaccination.

[Contraindications]

The vaccine should not be administered to subjects with the following conditions:

(1) Allergic to the vaccine or any components of the vaccine.

(2) Inpiduals with epilepsy, brain disorders and a history of allergy.

(3) Kidney disease, heart disease, active tuberculosis patients and persons infected with HIV.

(4) Subjects suffering from acute infectious diseases and fever.

(5) Since no reproductive toxicity test was performed on experimental animals or pregnant women, effects on the fetus is unknown. Therefore, vaccination to the pregnant women is prohibited, especially those within the first trimester of pregnancy.

[Precautions]

(1)The vaccine should be used with caution in the following cases: Family and the inpidual has a history of seizures; patients with chronic disease, patients with a history of epilepsy, allergy sufferers, pregnant women and lactating women.

(2) Appropriate medical treatment and supervision must be available to manage possible rare adverse reactions following administration of the vaccine, such as epinephrine for first-aid of anaphylactic reaction. Observe for at least 30 minutes after vaccination.

(3) Prior to administration, inspect visually for cracks in the vial, loose stopper, or with abnormal appearance after reconstitution. If any of these conditions exist, the vaccine shall not be administered.

(4) Once reconstituted, the vaccine should be used up as per regulated dose. pided dosing is prohibited. In case of non-immediate use, storage time shall be no more than 30 minutes.

(5) Do not inject this product intradermally, intramuscularly or intravenously, for these three administration routes have not been evaluated for safety and efficacy by clinical research.

(6) To avoid the accumulation of the endotoxin level, the vaccine cannot be used with pertussis vaccine and typhoid vaccine at the same time.

(7) The vaccine may not elicit a protective immune response in subjects with immunodeficiency or person under going immunosuppressive therapies.

(8) The vaccine should not be used on those who have been infected with Neisseria meningitis, and cannot protect from cerebrospinal meningitis caused by other infections (incl. Neisseria meningitis group B).

(9) The short-term prophylaxis for infants and children younger than 2 years is not available, but it can provide short-term protection to infants older than 3 months against Neisseria meningitis group A.

(10) Just like other vaccines, vaccination with Meningococcal Polysaccharide Vaccine Group ACYW135 could not protect all susceptible inpiduals 100%.

(11) It is not known whether Meningococcal Polysaccharide Vaccine Group ACYW135 is excreted in human milk. Because many drugs are excreted in human milk, be cautious when administered to lactating woman.

[Storage]Store and ship at 2～8℃, protected from light.

[Packaging] Each single human dose contains 1 vial of lyophilized vaccine and 1 vial of solvent. 1dose/carton; 5 doses/carton.

[Shelf Life] 24 months

[Product Standard] YBS00342015

[Product License No.] GYZZ S20090011

[Manufacturer]

Name: Hualan Biological Bacterin Inc.

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

Zip code: 453003

Tel: 86-373-3559991

Fax: 86-373-3559911