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MeningACon

Specification for A, C Meningococcal Polysaccharide Conjugate Vaccine

Drug Name
Generic name  A, C Meningococcal Polysaccharide Conjugate Vaccine
Brand name   MeningACon
English name  Meningococcal Group A&C Conjugate Vaccine
Chinese spelling  A  Qun  C  Qun  Naomoyanqiujun  Duotang  Jiehe  Yimiao
Ingredients and Description
MeningACon® is manufactured by conjugate of capsular polysaccharide antigens individually extracted from Neisseria meningitidis serogroups A, C fermentation fluid to tetanus toxoid. Then the conjugates are purified and are absorbed with aluminum hydroxide as adjuvant and prepared to this vaccine.
MeningACon vaccine is manufactured as an ivory-white, turbid liquid, which should not contain insoluble massive substance after shaking.
Inoculation objects
Infants and Children above the age of 3 months.
Indications and Usage
After administration, the organism can acquire humoral immune response. MeningACon is indicated for the prevention of invasive meningococcal disease including meningitis, pneumonia caused by Neisseria meningitidis serogroups A, C.
MeningACon is not indicated for the prevention of infections caused by microorganisms other than Neisseria meningitidis serogroups A and C. MeningACon is also not indicated for treatment diseases including meningitis, pneumonia caused by other factors.
Strength
Each dose consists of a 0.5mL suspension, which contains Neisseria meningitidis serpgroup A polysaccharide and C polysaccharide that are conjugated to tetanus toxoid 10g individually.
Dosage and administration
1.  Shake up before use.
2. Administer a 0.5 mL dose of A、C Meningococcal Polysaccharide Conjugate Vaccine by intramuscular injection to lateral deltoid attachment of the upper arm after skin degerming.
3. The following immunization procedures are recommended according to clinical study results available:
For children with 3-12 months age: make 3 times basic Immunology, inject another times after 1 month; Children with 1-2 years old: make 3 times basic Immunology, inject another times after 1 month; Children above 3 years old or adults, make 1 times basic Immunology.
Consistent protection period and administration dosage used in booster immunization are not determined.
Adverse reaction
Temporary fever and rash were reported occasionally. The main ADR were swelling and pain in the injection area and it can recover without any treatment. Hypersomnia and anxious were reported in a few children.
Contraindications
1. Do not administer to anyone with a history of a severe allergic reaction to MeningACon or any component of the vaccine, especially to tetanus toxoid .
2. Do not administer to anyone with epilepsy, ventilation, brain disorders.
3. Do not administer to anyone kidney disease, heart disease, HIV infection, and active tuberculosis.
4. Do not administer to anyone with acute infectious disease or fever.
Warnings and precautions
1. The vaccine is a white turbid liquid and may separate to layers due to long- term preservation, shake up before use.
2. Check carefully before use, if the stopper to the vials is loose or the liquid contains insoluble massive substance after shaking, the vaccine should not be used.
3. Injection needle should not prick blood vessel.  Do not inject via intravenous or intra-arterial injection.
4. Avoid inoculating while in fever or acute infection conditions.
5. Clinical study on concomitant administration with other vaccines is not conducted; no safety and immunogenicity data on drug interaction are available. Inoculation with other vaccines together should be avoided to affect immune effect.
Use before the expiration date marked on vial label.
Storage
store and transport in cool condition at 2~8℃.  Do not freeze.
package
vial(s)
Expiration date
 24 months
Executed standard
 A, C, Y, W135 meningococcal polysaccharide vaccine manufacturing and testing procedures (try out)
Approval Document No. GYZZS20070018
Manufacturer:
Beijing Luzhu biopharmaceutical Co., Ltd.,
No. 22 Tongji Beilu, Beijing Economic-technological Development Area, China.
Post code: 100176
Tel: 010-67870189
Fax: 010-67870318
Web: www.vaccine.com.cn