COMPOSITION

Meningococcal BC vaccine is a purified outer membrane complex of serogroup B and capsular polysaccharide of serogroup C meningococcus, adsorbed onto aluminum hydroxide. The vaccine contains 0.01% thiomersal as preservative, phosphate and sodium chloride.

Each 0.5 ml dose contains:
– Outer membrane protein of serogroup B meningococcus ……….. 50 µg *
– Capsular polysaccharide of serogroup C meningococcus ………… 50 µg **
– Aluminum hydroxide gel ………………………………………….. 2.0 mg
– Thiomersal ………………………………………………………….. 0.05 mg
– Sodium chloride …………………………………………………….. 4.25 mg
– Phosphates ………………………………………………………….. 0.5 mg
– Water for injection ………………………………………………….. q.s.

Quantified as total protein content (Lowry).
** Quantified as total sialic acid content.

Dosage form: Suspension for injection.

INDICATIONS
VA-MENGOC-BC® is indicated for active immunization against meningococcal meningitis caused by serogroups B and C.

PRESCRIPTION ONLY MEDICINE

– Vaccine is indicated for individuals from 6 months to 45 years of age, and for those living in epidemic areas or traveling to such areas.
– Recommended for people living in community groups such as childcare centers, boarding schools, military barracks, prisons, areas of high population density, or communities with reported cases of serogroup B and C meningococcal infections.

CONTRAINDICATIONS

– Hypersensitivity to any component of the vaccine.
– Contraindicated in cases of fever, acute infections, progressive allergic conditions, and decompensated chronic diseases.
– Rarely, if serious adverse reaction occurs after the first dose, the second dose is contraindicated.

PRECAUTIONS

– Keep out of reach of children.
– Read instructions carefully before use.
– Never administer intravenously.
– Opened vials must be stored protected from light at 2–8°C and used within 24 hours.
– The manufacturer is not responsible for any consequences due to failure to comply with recommended use and storage instructions.
– Do not use expired vaccine.
– Caution in patients with thrombocytopenia or coagulation disorders as bleeding may occur following intramuscular injection.

WARNING

– After vaccination, recipients must remain under observation for 30 minutes before resuming normal activities.
– Adrenaline solution 1/1000 must be readily available in case of anaphylactic reaction.

DRUG INTERACTIONS

– Immunocompromised patients and/or those receiving immunosuppressive therapy (corticosteroids, antimetabolites, or recent immunoglobulin administration) may have reduced immune response. Vaccination should be postponed.

PREGNANCY AND LACTATION

– Not recommended during pregnancy and lactation.
– May only be used in these groups if epidemiological risk is high. Risk/benefit should be carefully considered.

EFFECTS ON DRIVING AND OPERATING MACHINERY

– No reports of impairment of driving or operating machinery one hour after vaccination.

ADVERSE REACTIONS

– No serious adverse reactions have been reported in most vaccinees in large-scale field trials and post-marketing studies in Cuba and other countries.
– Local reactions such as pain, erythema, and induration at the injection site are usually mild, occur within 24 hours, and resolve within 72 hours. More severe local reactions may rarely occur. These are similar to reactions with other adsorbed vaccines.
– Systemic reactions may include fever ≥ 38°C, rarely lasting more than 2 days. Rare cases of fever ≥ 39°C have been reported with rapid onset.
– Other systemic symptoms may include malaise, headache, and drowsiness.
– Both local and systemic reactions are generally milder after the second dose.
– The vaccine does not cause disease or typical symptoms of meningococcal meningitis.

DOSAGE

– Primary vaccination schedule consists of 2 doses of 0.5 ml each, 6–8 weeks apart. The second dose is mandatory to achieve protection.
– Indicated for individuals aged 6 months to 45 years.
– Booster doses are not required once the 2-dose primary schedule is completed.
– During mass campaigns, revaccination may include individuals without documented prior vaccination.

INSTRUCTIONS FOR USE

– Administer VA-MENGOC-BC® intramuscularly, preferably in the deltoid muscle, under strict aseptic conditions.
– In young children where the deltoid is underdeveloped, inject into the anterolateral thigh.
– As the gel may precipitate, gently shake the vial before withdrawing into syringe to ensure homogeneity.

STORAGE

– Store at 2°C–8°C (DO NOT FREEZE).
– Protect from physical factors such as light and strong radiation.

SHELF LIFE
36 months from date of manufacture.

PRESENTATION
Single-dose vial 0.5 ml. Box of 10 vials.