Mencevax ACWY. 1 Name of the medicinal product Mencevax ACWY.

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1 Mencevax ACWY 1 Name of the medicinal product Mencevax ACWY. 2 Qualitative and Quantitative Composition Mencevax ACWY is a lyophilized, preparation of purified polysaccharides from Neisseria meningitidis (meningococcus) of serogroup A, C, W 135 and Y. Mencevax ACWY meets the World Health Organisation requirements for biological substances and for meningococcal meningitis vaccines. Each 0.5 ml dose of the reconstituted vaccine contains 50 µg of each of the polysaccharide serogroups A, C, W 135 and Y. 3 Pharmacuetical form Lyophilised powder for reconstitution with solution for injection. 4 Clinical particulars 4.1 Therapeutic indications Mencevax ACWY is indicated for the active immunization of adults and children over 14 years of age against meningococcal meningitis caused by meningococci of serogroups A, C, W 135 and Y. The vaccine is particularly recommended for subjects at risk, for example those living in or visiting areas where the disease is epidemic or highly endemic. It is also recommended for subjects living in closed communities and close contacts of patients with disease caused by meningococci of serogroups A, C, W 135 and Y. It may also be used in individuals with terminal complement component deficiency, proferdin deficiency and functional or actual splenectomy 4.2 Posology and method of administration Posology The recommended dose of the vaccine must be administered. One immunizing dose of the reconstituted vaccine is contained in 0.5 ml. Method of administration Mencevax ACWY is for subcutaneous use only. Mencevax ACWY should under no circumstances be administered intravenously. 4.3 Contra-indications Mencevax ACWY should not be administered to subjects with known hypersensitivity to any component of the vaccine or to subjects having shown signs of hypersensitivity after previous administration of Mencevax ACWY

2 4.4 Special warnings and special precautions for use As with other vaccines, the administration of Mencevax ACWY should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contra-indication for immunization. Mencevax ACWY gives no protection against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W 135 and Y. If administered to subjects with impaired immune responses, the vaccine may not induce an effective response. The seroconversion rate of children vaccinated under the age of two years is lower for the serogroup C and to a lesser extent for the serogroup W 135 and Y. However, the seroconversion rate for the serogroup A is acceptable in children from the age of 6 months onwards. As with all injectable vaccines, appropriate medical treatment should always be readily available for treatment in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccine should remain under medical supervision for 30 minutes after immunization. As with all vaccination, a solution of 1:1000 adrenalin should be available for injection should an anaphylactic reaction occurs. Mencevax vaccine should not under any circumstances be injected by the intravenous route. 4.5 Interaction with other medicaments and other forms of interaction Mencevax ACWY can be administered at the same time as other vaccines. Different injectable vaccines should always be administered at a different injection site. 4.6 Pregnancy and lactation Adequate human data on use during pregnancy and lactation and adequate animal reproduction studies are not available. On theoretical grounds, avoiding the administration of Mencevax ACWY is prudent unless there is a substantial risk of infection. 4.7 Effects on ability to drive and use machines 4.8 Undesirable effects Mencevax ACWY may cause erythema, slight induration and tenderness or pain at the site of injection. Extremely rarely, headache, fatigue, fever, allergic reactions, including anaphylactoid reactions and somnolence have been reported. Miscellaneous neurological reactions have been reported very rarely although a causal relationship to Mencevax vaccine has not been established. 4.9 Overdose

3 5 Pharmacological properties 5.1 Pharmacodynamic properties Mencevax ACWY induces bactericidal antibodies against meningococci of the serogroups A, C, W 135 and Y. Administration of a single 0.5 ml dose of Mencevax ACWY elicits a significant bactericidal antibody response against meningococci of serogroups A, C, W 135 and Y in about 95% of subjects. Polysaccharide A is known to be immunogenic in infants from the age of six months. The seroconversion rate of children vaccinated under the age of two years is lower for the serogroup C and to a lesser extent for the serogroups W 135 and Y. 5.2 Pharmacokinetik properties Evaluation of pharmacokinetic is not required for vaccines 5.3 Preclinical safety data 6 Pharmaceutical particulars 6.1 List of excipients Vaccine: lactose Diluent: Sterile saline solution (and phenol for multidose presentations). 6.2 Incompatibilities Mencevax ACWY should not be mixed with other vaccines. 6.3 Shelf life The expiry date of the vaccine is indicated on the label and on packaging. When stored under prescribed conditions of temperatures between +2 o C and +8 o C, the shelf life is two years. After reconstitution, the vaccine should be injected promptly or kept in a refrigerator. If it is not use within eight hours, it should be discarded because of the risk of contamination. It is recommended to protect the reconstituted vaccine from direct sunlight. 6.4 Special precautions for storage The lyophilized vaccine should be stored in a refrigerator between +2 o C and +8 o C or in a freezer. The diluent can be stored at ambient temperature. When supplies of Mencevax ACWY are distributed from a central cold-store, it is good practice to arrange transport under refrigerated conditions, particularly in hot climates. If the lyophilized vaccine has been accidentally exposed to high temperatures not exceeding the

4 time and temperature limits indicated below, the expiry date no longer applies: it should preferably either be used immediately or stored at 20 o C. If it is thought that the thermal stability limits have been exceeded, the lyophilized vaccine should be discarded or, if economically justified, be re-tested for potency before use. - Additional information on the stability The following experimental data give an indication of the stability of the vaccine and are not recommendations for storage (see under special precautions for storage). Mencevax ACWY is stable for at least 6 months when storage at +22 o C. At a temperature of +45 o C, it retains its potency for at least 3 months and for 1 week at +60 o C. The reconstituted vaccine is stable for 1 month when kept at +4 o C and for at least 1 week at +25 o C and about 4 days when kept at +37 o C. 6.5 Nature and contents of container Mencevax ACWY is presented as a white pellet in a glass vial. The sterile diluent for the monodose presentation is clear and colourless and presented in a glass vial or ampoule. The sterile diluent for the multidose presentation (which contains phenol) can show a slight cloudiness and/or pink coloration and is presented in a glass vial. 6.6 Instruction for use, handling The vaccine should be inspected visually for any foreign particulate matter and/or other coloration prior to administration. In the event of either being observed, discard the vaccine. Mencevax ACWY must be reconstituted by adding the entire contents of the supplied container of diluent to the vaccine vial. The vaccine pellet should be completely dissolved in the diluent. Mencevax is a trademark. Reg. No. HARUS DENGAN RESEP DOKTER Imported by P.T. SmithKline Beecham Pharmaceuticals Bogor, Indonesia Manufacturer Glaxo SmithKline, Biologicals s.a Rue de I Institut 89,B-1330 Rixensatt Belgium

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