Summary of product characteristics As per Annexure C SUMMARY OF PRODUCT CHARACTERISTICS Doc. No. SPC/71108 Ver.1 1. NAME OF THE MEDICINAL PRODUCT. ANNEXURE C to MODULE I Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Pharma ingredient (API) i.e. Antigen Single Harvest of Measles, Single Harvest of Mumps, and Single Harvest of Rubella added at the time of formulation in vaccine serially, Measles not less than 1000 CCID 50 single human dose, Mumps not less than 5000 CCID 50 single human dose & Rubella not less than 1000 CCID 50 Single human dose as per the limit recommended as per I.P.2010/2014 and WHO TRS 840. Stabilizer containing gelatin is added half of the total formulation volume and based on the final calculation M199 is used as diluent. No preservative is added The final formula is as described below Material Name Spec. Single dose Qty. / dose Ten dose Qty. / dose Used as Active raw material Single harvest Measles I.P. 1000 CCID 50 1000 CCID 50 Antigen Single harvest Mumps I.P. 5000 CCID 50 5000 CCID 50 Antigen Single harvest Rubella I.P. 1000 CCID 50 1000 CCID 50 Antigen Excipients Stabilizer 176 I.P. 0.25 ml 0.125 ml Stabilizer Medium M199 I.P. q.s q.s Diluent 3. PHARMACEUTICAL FORM Drug Substance(s) Single Harvest of Measles, Mumps & Rubella Vaccine (Live) I.P. has been developed as per WHO TRS 840 and Indian pharmacopoeia 2010 / 2014. Page 1 of 6
Drug Product Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) Single dose & Multi dose has been developed as per WHO TRS 840 and Indian pharmacopoeia 2010 / 2014. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) is indicated for active immunization in children of 12 months to 10 years of age against Measles, Mumps and Rubella infections simultaneously. 4.2 Posology and method of administration Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) has to be diluted with the diluent provided before administration. Single dose of 0.5ml should be administered as subcutaneous injection in the antero-lateral aspect of thigh or the upper arm taking aseptic precautions. The diluent and reconstituted vaccine should be inspected visually for any foreign particulate matter and / or variation of physical aspects prior to administration. In the event of either being observed, discard the diluent or reconstituted vaccine. Steps for preparation: 1. Draw the diluent from the ampoule into a syringe 0.5ml for single-dose vial 5ml for multi-dose vial 2. Pierce the bung of the vial with the needle and gently inject the diluent into the vial 3. Detach the syringe, leaving the needle in vial bung. After 15 seconds remove the needle 4. Rotate the vial gently between your palms till the material dissolves. Avoid shaking the vial as this would cause frothing. 5. Withdraw 0.5 ml of the reconstituted solution into the syringe, now ready for administration 4.3 Contraindications Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) should not be administered during the following conditions: Page 2 of 6
History of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination Leukaemia, lymphomatoses and other Malignant diseases Severe febrile diseases Persons who are severely Immunocompromised as a result of congenital disease, HIV infection, advanced Leukaemia or lymphoma, serious malignant disease, or treatment with high-dose steroids, alkylating agents or anti-metabolites, or in persons who are receiving immunosuppressive therapeutic radiation History of febrile convulsions or impairment of CNS. History of known hypersensitivity to egg protein. 4.4 Special warnings and precautions for use The vaccine should be administered by subcutaneous route only. In rare cases anaphylactic shock may occur in susceptible individual and for such emergency 1:1000 adrenaline injection should be kept ready to be injected intramuscularly or subcutaneously. For treatment of severe anaphylaxis the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5ml of 1:1000 injections) given s/c or i/m. Single dose should not exceed 1 mg (1ml). For infants and children the recommended dose of adrenaline is 0.01mg/kg (0.01ml/kg of 1:1000 injections). Single paediatric dose should not exceed 0.5mg (0.5ml). The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be lifesaving. It should be used at the first suspicion of anaphylaxis. As with the use of all vaccines the vaccines should remain under observation for not less than 30 minutes for possibility of occurrence of rapid allergic reactions. Antihistaminics should also be available in addition to supportive measures such as oxygen inhalation. 4.5 Interaction with other medicinal products and other forms of interaction Immune globulin (IG) should not to be given concomitantly with Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried). Administration of immune globulins concomitantly with Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) may interfere with the expected immune response. Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin. Administration of measles, mumps or rubella antibody-containing blood products, including immune globulin preparations, should be avoided within 1 month after a dose of Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) unless considered to be essential. Page 3 of 6
If administration of other live virus vaccines is required, Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) should be given concomitantly at separate injection sites, or one month before or after administration of other live virus vaccines. It has been reported that live attenuated measles, mumps, and rubella virus vaccine may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or 4 to 6 weeks after vaccination with Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried). 4.6 Pregnancy and lactation Not recommended to be used in pregnant or lactating mothers. 4.7 Effects on ability to drive and use machines Not applicable. 4.8 Undesirable effects Adverse reactions commonly known to occur with Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) include: injection site erythema, injection site pain, injection site swelling and injection site bruising, fever (38.5 C or higher), morbilliform or other rash. Rarely, vaccination may lead to encephalitis, febrile seizures, orchitis and aseptic meningitis. 4.9 Overdose No case of overdose has been reported 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamics properties Not applicable 5.2 Pharmacokinetic properties Not applicable 5.3 Preclinical safety data Not applicable Page 4 of 6
6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Gelatin D-Sorbitol 6.2 Incompatibilities This product must not be mixed with other medicinal products. 6.3 Shelf life 2 Years 6.4 Special precautions for storage The Vaccine should be stored at a temperature between 2-8 C. Transportation should also be at 2-8 C. For Single Dose: - Use Immediately after Reconstitution. Protect from Light. For Multi dose: - Use within 6 hour after Reconstitution Do Not Freeze after Reconstitution Protect from Light. 6.5 Nature and contents of container Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) Single dose Container closure system 2R Amber Colour tubular glass Vial - USP Type 1 with 13 mm Bromo butyl slotted rubber stoppers and flips off seals. Measles, Mumps & Rubella Vaccine (Live) I.P. (Freeze Dried) Multi dose Container closure system 5ml Amber colour tubular glass Vial - USP Type 1 with 13 mm Bromo butyl slotted rubber stoppers and flip off seals. Page 5 of 6
6.6 Special precautions for disposal Any unused product or waste material should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION Cadila Healthcare Ltd Plot Survey No. 23, 25/P, 37, 40/P, 42 to 47 Opp. Ramdev Masala, Sarkhej- Bavla N.H. 8A, Village: Changodar, Taluka: Sanand, Dist. Ahmedabad 382 213 Phone: +91-2717- 664600 8. MARKETING AUTHORISATION NUMBER(S) G/28D/VAC/03 (Manufacturing License Form 28-D) 9. DATE OF FIRST AUTHORISATION License No. G/28D/VAC/03 in Form 28D issued dated on 05/08/2015 & Valid up to dated 04/08/2020 Page 6 of 6