SUMMARY OF PRODUCT CHARACTRISTICS

Transcription

1 1. NAME OF THE MEDICINAL PRODUCT Purified, Inactivated, Lyophilized Rabies Vaccine, Prepared on Vero Cells INDIRAB 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative Formula per dose of 0.5 ml (Single Dose & Multi Dose): S. No. Ingredient Monograph 1.0 Purified BPL Inactivated Rabies Virus (Prepared on Vero Cells, Pitman Moore strain of Rabies Virus) IP/BP 2.0 Thiomersal IP/BP/USP/EP 3.0 Maltose USP 4.0 Human Albumin USP/EP Quantitative Formula per dose of 0.5mL for Single Dose Vial & Multi dose: S. No. Ingredient Quantity per dose 1.0 Purified BPL Inactivated Rabies Virus (Prepared on Vero Cells, Pitman Moore strain of Rabies Virus) 2.5IU 2.0 Thiomersal 0.01% 3.0 Maltose 5%w/v 4.0 Human Albumin 1%w/v Page 1 of 6

2 3. PHARMACEUTICAL FORM INDIRAB is Lyophilized vaccine presented in single dose for intramuscular injection and multi-dose for intradermal injection. Category: Active Immunizing Agent. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications INDIRAB can be used for active immunization against Rabies infection by Intramuscular route and intradermal injection. 4.2 Posology and method of administration INDIRAB is recommended for the prevention of rabies in Pre-exposure and Postexposure subjects. The vaccination schedule should be adopted according to the category of exposure and the immune status of the subject. The recommended dose for intradermally is 0.1mL in each upper arm (over the left and right deltoids). The immunization schedule is 0day, 7day and 28day for Pre-exposure and 0Day, 3day, 7day and 28day for Post-exposure treatment. The recommended dose intramuscular is 0.5mL in deltoids in adults and in the anterolateral region of the thigh muscle in children. Do not inject in the gluteal region. The immunization schedule is 0day, 7day and 28day for Pre-exposure and 0day, 3day, 7day, 14day and 28day for Post-exposure treatment. 4.3 Contraindications INDIRAB must not be used in the following cases: Pre-exposure - It is preferable to postpone vaccination in severe febrile infection, acute disease, and progressive chronic disease. - Know hypersensitivity to any of the ingredients of the vaccine. Page 2 of 6

3 Post-Exposure - No contraindication for post-exposure vaccination in the case of bites by suspected and rabid animals, as rabies is a fatal disease. 4.4 Special warnings and precautions for use - Intradermal must be administrated by staff trained in this technique. - Vaccine vials should be stored between C after reconstitution and the total content should be used as soon as possible, at least within 8hours. - Do not inject by the intravascular route; make sure that the needle does not enter a blood vessel. - Immunoglobulin and rabies vaccine must not be mixed in the same syringe or injected at the same site. - Keep out of the reach of children. 4.5 Interaction with other medicinal products and other forms of interaction Corticosteroids and immune-suppressive treatment may interfere with antibody production and cause vaccine failure. In order to avoid possible interactions between several medicinal products any other ongoing treatment should be reported to doctor. If any contraindication exists, the risk of prophylactic vaccination should be weighed against those of a possible infection, and if necessary the vaccination should be carried out taking appropriate precautions. 4.6 Pregnancy and lactation Adequate human data on the use of vaccine during pregnancy or lactation and adequate animal reproductive studies are not available. It is recommended to postpone pre-exposure prophylaxis during pregnancy. For postexposure vaccination, pregnancy is not a contraindication, as rabies is a fatal disease. For the vaccination of subjects at a high risk of infection, the benefit/risk ratio must be assessed before administering the injection. During pregnancy and lactation, it is recommended to ask your doctor for advice before using the vaccine. Page 3 of 6

4 4.7 Effects on ability to drive and use machines Not Applicable. 4.8 Undesirable effects - Minor local reactions: pain, erythema, oedema, pruritus and induration at the injection point. - Systemic reactions: moderate fever, shivring, fainting, asthenia, headaches, dizziness, arthralgia, myalgis, gastrointestinal disorders (nausea, abdominal pains). - Exceptional cases of anaphylactic reactions are observed. 4.9 Overdose Not recommended. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Intradermal: Clinical trials in pre-bite (Healthy individuals) cases provided/demonstrated safety and immunogenicity of INDIRAB by intradermal route of admistration. The antibody titres were significantly greater than the protective titres of 0.5 IU/mL. No serious vaccine related adverse reactions were observed in any of the volunteers during clinical trials. The common reactions to vaccine were pain at the site of injection and fever in afew cases. Vaccine elicited adequate homologous antibody titers as compared to comparator vaccine. Intramuscular: Clinical trials in pre-bite (Healthy individuals) cases provided/demonstrated safety and immunogenicity of INDIRAB by intramuscular route of admistration. The antibody titres were significantly greater than the protective titres of 0.5 IU/mL. No serious vaccine related adverse reactions were observed in any of the volunteers during clinical trials. The common reactions to vaccine were pain at the site of injection and fever in a few cases. The test article INDIRAB administered intramuscularly to the Pre-bite subjects over a pre Page 4 of 6

5 schedule regimen. Vaccine elicited adequate homologous antibody titers as compared to comparator vaccine. 5.2 Pharmacokinetic properties Evaluation of Pharmacokinetic properties is not required for vaccines. 5.3 Preclinical safety data The expected toxicity symptoms for vaccine include local reaction at the site of injection, pyrogenicity, anaphylactic reactions. During repeat dose toxicity studies, the animals were observed daily for various clinical signs and none of the animals showed any clinical signs indicative of toxicity, viz. local reactions at the site of injection, pyrogenicity and anaphylaxis. Preclinical studies showed that the vaccine was non-toxic and safe. 6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients Human Serum Albumin, Maltose and Thiomersal. 6.2 Incompatibilities Not Applicable. 6.3 Shelf life Three years ( when stored at C) 6.4 Special precautions for storage Do not use the vaccine after expiry date. Vaccine vials should be stored between +2 o C to +8 o C. After reconstitution total content should be used within 8 hours. Do not freeze. Keep out of the reach of children. Page 5 of 6

6 6.5 Nature and contents of container - 2mL glass vial containg lyophilized Human rabies vaccine - 0.5mL of 0.3% Sodium Chloride solution (diluents) in glass ampoule. 6.5 Special precautions for disposal Discard the vaccine if particulate matter observed after reconstitution. 7. MARKETING AUTHORIZATION PREQUALIFICATION HOLDER Name of the Company: Bharat Biotech International Limited Address: Genome Valley, Shameerpet Mandal, Hyderabad, Andhra Pradesh, INDIA Phone No.: Fax No.: E. Mail: info@bharatbiotech.com Web: 8. MARKETING AUTHORIZATION NUMBER(S) 930/M3A/ DATE OF FIRST AUTHORIZATION / RENEWAL OF THE AUTHORIZATION 930/M3A/2008, dated 24/05/2008 Page 6 of 6