Rubavax-M 0.5 ml (IM/SC Injection)

Indications

• Simultaneous immunization against Rubavax-M
• For persons older than 8 months

Composition

• Contains live attenuated Measles virus (Long-47 strain)
• Contains live attenuated Rubella virus (RA27/3 strain)
• Preparation grown in chicken embryo cell cultures
• Rubella virus grown in human diploid cell
• Each 0.5 ml contains live, attenuated measles virus USP≥ 1000 CCID50
• Each 0.5 ml contains live, attenuated rubella virus USP ≥1000 CCID50

Description

• Live, attenuated virus vaccine
• Vaccination against measles (rubeola) and rubella (German measles)
• Sterile lyophilized vaccine
• Prepared from live, attenuated strains of CAM-70 Rubavax-M virus
• Prepared from live, attenuated strains of Wistar RA 27/3 Rubella virus
• Propagated on chicken embryo fibroblast (CEF) cell substrate
• Grown on human diploid cell culture
• Lyophilized vaccine is a light yellow compact crystalline plug/powder
• Reconstituted vaccine varies from clear pale yellow to pinkish yellow solution

Dosage & Administration

• Single dose of 0.5 ml vaccine given by deep subcutaneous injection
• EPI schedule for measles-rubella vaccine

Contraindications

• Allergic to any ingredient in the vaccine
• Suffering from acute or severe chronic diseases
• Pregnant women
• Immune deficiency or receiving immunosuppressive therapy
• Suffering from encephalopathy, uncontrolled epilepsy, or other progressive neurological diseases

Side Effects

• Pain and tenderness at the injection site
• Transient fever reaction
• Mild rash within 12 days after vaccination
• Severe fever reaction
• Allergic rash within 72 hours after vaccination
• Anaphylactic shock within 1 hour after vaccination
• Anaphylactoid purpura
• Thrombocytopenia purpura
• Arthritis, pain, and swelling of large joints in adults

Pregnancy & Lactation

• Pregnancy category C
• Avoid pregnancy for 3 months following vaccination
• Caution for nursing women

Precautions & Warnings

• Avoid use if vaccine bottle has cracks, unclear labels, or abnormal appearance after reconstitution
• Prepare for emergency use in case of severe allergic reaction
• Observe recipients for at least 30 minutes after injection
• Delay vaccination with immune globulin by at least 3 months
• Vaccinate with an interval of at least 1 month from other attenuated live vaccines
• Avoid use in the epidemic season
• Avoid pregnancy within at least 3 months after injection
• Freezing is prohibited

Therapeutic Class

• Vaccines
• Anti-sera
• Immunoglobulin

Storage Conditions

• Store at +2°C to +8°C
• Transportation should also be at +2°C to +8°C
• Do not freeze
• Protect from light
• Discard vaccine if frozen

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