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VA-MENGOC-BC
Produced by the Instituto Finlay de Vacunas in Cuba, VA-MENGOC-BC is a complex vaccine comprising purified outer membrane vesicles of serogroup B and purified capsular polysaccharide of serogroup C meningococcus, adsorbed onto aluminum hydroxide gel. It is indicated for active immunization against Meningococcal disease caused by serogroups B and C. Its use is recommended for individuals from 6 months to 45 years old of aged, particularly in areas with a high risk of meningococcal disease transmission.
Vaccine information
Description
VA-MENGOC-BC vaccine is produced by Instituto Finlay de Vacunas – Cuba. The vaccine is a complex of purified outer membrane protein of group B meningococcal bacteria and polysaccharide of the envelope of group C meningococcal bacteria. VA-MENGOC-BC vaccine is effective in preventing meningitis caused by meningococcal bacteria. Bridge groups B and C, used for people from 6 months to 45 years old
COMPOSICION
The Meningococcal BC vaccine is a complex of purified outer membrane vesicles of serogroup B and purified capsular polysaccharide of serogroup C meningococcus, adsorbed onto Aluminium Hydroxide gel. The vaccine contains 0,01 % Thiomersal as preservative and also phosphates and Sodium Chloride.
Each 0,5 mL dose contains:
Outer membrane protein of meningococcus B………………………… 50 micrograms*
Capsular polysaccharide of meningococcus C…………………….. 50 micrograms**
Aluminium Hidroxide gel…………………………………………………………………………….. 2,0 mg
Thiomersal…………………………………………………………………………………………………. 0,05 mg
Sodium Chloride………………………………………………………………………………………… 4,25 mg
Phosphates………………………………………………………………………………………………… 0,05 mg
Water for injection……………………………………………………………………………………………… s.q.
* Quantified as total protein content (Lowry)
** Quantified as total Sialic Acid content
PHARMACEUTICAL FORM
Suspension for injection.
INDICATIONS
VA-MENGOC-BC® is indicated for active immunisation against Meningococcal disease caused by serogroups B and C. Its use is recommended in ages from three months on and residents in endemo-epidemic areas or travellers to those areas. It is also recommended for persons living in closed communities such as child-care centres, boarding schools, military camps, prisons, highly populated areas or any community where cases or carriers of meningococci of the serogroups B and C have been reported and, therefore, the population is exposed to the risk of contracting the disease.
CONTRAINDICATIONS
Should not be administered to persons with known hypersensitivity to any component of the vaccine. It is contraindicated in febrile conditions, acute infectious and allergic processes and unbalanced chronic diseases. Any severe reaction to first dose administration is rare, but this situation contraindicates a second dose administration.
PRECAUTIONS
VA-MENGOC-BC® should not be administered to pregnant women unless its use is considered necessary and justified due to a high epidemiological risk. In all vaccination centres, an adequate medicine (1/1000 Adrenaline solution), must be ready, should any anaphylactic reaction occur. Immunodeficient patients or those receiving immunodepressive treatment may not adequately respond to vaccination.
WARNINGS
The vaccine should never be administered by intravenous route. The correct handling and extraction by health care providers of one or several doses of the vaccine from a multidose flask guarantees the product’s quality. Therefore, once the vial is punctured, it must be kept protected from light and stored at a temperature of 2-8 °C; it should not be used after 24 hours. It is not the manufacturer’s responsibility the non-fulfillment of recommendatios for handling and preservation of the vaccine. This vaccine cannot be used after its expiry date.
ADVERSE REACTIONS
No serious adverse reactions have been observed in most of the vaccinees during a huge number of clinical trials and post-licensing studies conducted in Cuba and another countries. The expected local symptoms and signs reported were pain, erythema and induration, which were slight and had a variable frequency, appearing in the first 24 hours and tending to disappear 72 hours after vaccination. Local symptoms of greater intensity may appear in isolated cases. These local symptoms and signs are similar to those caused by other adsorbed vaccines. Among general symptoms, temperatures of 38 °C or more have been reported; they rarely last for more than two days. Cases of temperatures of 39 °C or more, which develops rapid and favourly, have been described with a lower frequency. General discomfort, headache and somnolence may appear. The incidence of local and general symptoms and signs tends to decrease after the second dose administration. In more than 40 millions of doses of VA-MENGOC-BC administered, the vaccine has shown an acceptable safety profile. This vaccine does not produce the disease or its major symptoms and signs.
POSOLOGY
The vaccination scheme consists of two doses of 0,5 mL each, with an optimal interval of six to eight weeks. The second dose is indispensable for achieving protection. This scheme is valid from three months of age onwards. In the experience of using this vaccine in a programmed way, no booster doses have been required. When using the vaccine in repeated specific campaigns, the use of booster doses is not excluded for those people who do not have a documented evidence of a previous vaccination with the two-dose scheme.
INSTRUCTIONS FOR USE
VA-MENGOC-BC® should be administered by deep intramuscular route, preferably in the deltoid region, observing sterility and aseptic standards. In children with very small deltoid muscles, the vaccine should be applied in the antero-lateral part of the thigh. Since the gel tends to sediment, gently shake the vial content before extracting each dose to guarantee correct homogenisation.
STORAGE
During its transportation and storage, the vaccine should be stored at 2 – 8 °C. (DO NOT FREEZE), avoiding exposure to physical agents like intense light radiation.
EXPIRATION DATE
The date printed on the vial label will be considered the expiration date.
PRESENTATION
Vials containing 1, 2, 5, 10 and 20 doses.
SANITARY MEDICAL REGISTRY IN THE CUBAN REPUBLIC
No. 1133
FINLAY INSTITUTE
Havana, Cuba
Edition date
July 2005
NOTICE
*** All complaints about this vaccine must be reported directly, with information about series number, expiration date and relevant evidence (if any) to the manufacturer: Company for Vaccines and Biological Production No.1 (VABIOTECH). Address: No. 1 Yersin, Pham Đinh Ho Ward, Hai Ba Trung District, Hanoi. Phone: +84-24-39717710
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