ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 [Version 8, 10/2012] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Seite 1 von 13

2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suspension and solvent for suspension for injection for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance per dose: to PFU * live cell associated Marek`s Disease virus strain CVI 988 BP Host system: SPF chicken embryo fibroblasts *PFU = plaque forming units Excipients: For a full list of excipients, see section PHARMACEUTICAL FORM Suspension and solvent for suspension for injection. 4. CLINICAL PARTICULARS 4.1 Target species Chickens 4.2 Indications for use, specifying the target species For active immunisation of chickens against Marek`s disease to reduce mortality and lesions caused by the disease. Onset of immunity: 6 days Duration of immunity: 52 weeks 4.3 Contraindications None 4.4 Special warnings Maternally derived antibodies (MDA) may interfere with the development of an immune response. In case of a recent field infection or of the vaccination of the parent flock leading to a high level of MDA in the chickens, the timing and/or frequency of the vaccination schedule must be reconsidered. Vaccination of ornamental and exhibition fowl is not recommended. 4.5 Special precautions for use Special precautions for use in animals Only healthy chickens should be vaccinated. The vaccine strain spreads. Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible species. Special precautions to be taken by the person administering the veterinary medicinal product to animals Personal protective equipment consisting of goggles and gloves must be worn. Personnel involved in administering the veterinary medicinal product have to wash and disinfect hands after handling the vaccine. Seite 2 von 13

3 This product is stored in liquid nitrogen. The operator should be aware of the general precautions to be taken when thawing and opening the ampoules, especially concerning the protective equipment mentioned above. Liquid nitrogen causes serious freeze burns by getting contact with the skin. When opening the ampoules, hold them as far away from your body as possible in order to avoid injuries in case an ampoule explodes. If liquid nitrogen comes into contact with the skin, immediately warm the affected area by immersion in water at 29 ± 1 C or by use of body heat. Usually, there will be considerable pain during warming. Seek medical advice if full function and feeling are not rapidly restored. 4.6 Adverse reactions (frequency and seriousness) None known 4.7 Use during pregnancy, lactation or lay Do not use in birds in lay and breeding birds. 4.8 Interaction with other medicinal products and other forms of interaction Do not mix this vaccine with substances other than AviPro DILUJECT BLUE for which compatibility has been demonstrated. Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with either AviPro SALMONELLA VAC E or AviPro SALMONELLA VAC T or AviPro SALMONELLA DUO or AviPro ND HB1 or AviPro IB H120. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product, except those mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 4.9 Amounts to be administered and administration route may be administered by injection of 0.2 ml (1 dose) subcutaneously or intramuscularly after dilution of the virus suspension with the solvent AviPro DILUJECT BLUE. The chickens may be immunized from the 1st day of life but it is recommended to vaccinate as early as possible after hatch. Preparation: Immediately prior to vaccination one ampoule (2,000 doses) of the virus suspension is quickly thawed in a water bath at 27 C. Immediately after thawing, the ampoule is opened and the virus suspension (2,000 doses) diluted in 400 ml of solvent. The solvent should be at room temperature (20 C to 25 C). The vaccine suspension should be well mixed avoiding the buildup of foam also during administration (e.g. with a magnetic stirrer) in order to achieve a homogeneous suspension. Once diluted and reconstituted, the vaccine should be used immediately. Administration: Administer by a single injection subcutaneously in the neck or intramuscularly in the leg each bird as soon as possible after hatching to avoid infection with MD field viruses Overdose (symptoms, emergency procedures, antidotes), if necessary A tenfold dose has been demonstrated to be safe Withdrawal period(s) Zero days. 5. IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: live virus vaccines for poultry, ATCvet code: QI01AD03 Seite 3 von 13

4 vaccine strain stimulates an active immune response against Marek s Disease in vaccinated chickens. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Antigen: medium traces, new-born calf serum and dimethyl sulfoxide. Solvent: disodium phosphate dehydrate, glucose monohydrate, potassium dihydrogen phosphate, dipotassium phosphate, sodium chloride, sucrose, enzymatic hydrolysate of casein and E131 patent blue V. 6.2 Incompatibilities Do not mix with any other veterinary medicinal product, except the solvent AviPro DILUJECT BLUE recommended for use with the product. 6.3 Shelf life Shelf-life of the veterinary medicinal product as packaged for sale (antigen): 24 months Shelf-life of the veterinary medicinal product as packaged for sale (solvent): 36 months Shelf-life after dilution or reconstitution according to directions: 2 hours 6.4. Special precautions for storage Vaccine: Store and transport frozen in liquid nitrogen at a temperature below -150 C. Solvent: Store below 25 C. Do not freeze Do not expose reconstituted vaccine to direct sunlight or heat. 6.5 Nature and composition of immediate packaging The vaccine is supplied in EP type I glass ampoules. The ampoules are heat sealed and contain 2000 doses of vaccine. The solvent is supplied in plastic bottles containing 400 ml. The bottles are closed with EP type I closure and sealed with aluminium caps. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities. 7. MARKETING AUTHORISATION HOLDER Lohmann Animal Health GmbH Heinz-Lohmann-Str Cuxhaven, Germany 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD/MM/YYYY}> <{DD month YYYY}> 10 DATE OF REVISION OF THE TEXT {MM/YYYY} or <month YYYY> PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. Seite 4 von 13

5 ANNEX III LABELLING AND PACKAGE LEAFLET Seite 5 von 13

6 A. LABELLING Seite 6 von 13

7 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {EP type I glass ampoules} 1. NAME OF THE VETERINARY MEDICINAL PRODUCT 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) Suspension 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 2000 doses 4. ROUTE(S) OF ADMINISTRATION IM / SC injection 5. WITHDRAWAL PERIOD 6. BATCH NUMBER Lot No.: 7. EXPIRY DATE EXP: 8. THE WORDS FOR ANIMAL TREATMENT ONLY Ad us vet Seite 7 von 13

8 PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS {BOTTLE / BOX} 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AviPro DILUJECT BLUE, solvent for cell associated Lohmann vaccines 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES List of substances: disodium phosphate dehydrate, glucose monohydrate, potassium dihydrogen phosphate, dipotassium phosphate, sodium chloride, sucrose, enzymatic hydrolysate of casein and E131 patent blue V. 3. PHARMACEUTICAL FORM Solution for manufacturing a suspension 4. PACKAGE SIZE 400 ml 5. TARGET SPECIES Target species: Chickens. 6. INDICATION(S) Not applicable 7. METHOD AND ROUTE(S) OF ADMINISTRATION Method and route of administration: Subcutaneous or intramuscular injection. 8. WITHDRAWAL PERIOD Withdrawal period: Zero days. 9. SPECIAL WARNING(S), IF NECESSARY Special warnings: Read the package leaflet before use. 10. EXPIRY DATE EXP 11. SPECIAL STORAGE CONDITIONS Storage conditions: Store below 25 C. Do not freeze. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Not applicable 13. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable FOR ANIMAL TREATMENT ONLY. 14. THE WORDS KEEP OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Seite 8 von 13

9 Lohmann Animal Health GmbH Heinz-Lohmann-Str. 4, D Cuxhaven, Germany 16. MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/ MANUFACTURER S BATCH NUMBER BATCH Seite 9 von 13

10 B. PACKAGE LEAFLET Seite 10 von 13

11 PACKAGE LEAFLET Suspension and solvent for suspension for injection for chickens 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder, and manufacturer responsible for the batch release: Lohmann Animal Health GmbH Heinz-Lohmann-Str. 4, D Cuxhaven, Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Suspension and solvent for suspension for injection for chickens 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance per dose: to PFU * live cell associated Marek`s Disease virus strain CVI 988 BP Host system: SPF chicken embryo fibroblasts *PFU = plaque forming units Excipients: Medium traces, new-born calf serum, dimethyl sulfoxide, disodium phosphate dehydrate, glucose monohydrate, potassium dihydrogen phosphate, dipotassium phosphate, sodium chloride, sucrose, enzymatic hydrolysate of casein and E131 patent blue V. 4. INDICATION(S) For active immunisation of chickens against Marek`s disease to reduce mortality and lesions caused by the disease. Onset of immunity: within 6 days Duration of immunity: 52 weeks. 5. CONTRAINDICATIONS None 6. ADVERSE REACTIONS None known If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Chickens 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Administer AviPro MD Maris from the first day of life by subcutaneous or intramuscular injection of 0.2 ml (1 dose) after dilution of the virus suspension with the solvent AviPro Diluject Blue. 9. ADVICE ON CORRECT ADMINISTRATION Preparation: Seite 11 von 13

12 Quickly thaw one ampoule (2,000 doses) of the virus suspension in a water bath at 27 C immediately prior to vaccination. Open the ampoule immediately after thawing, and dilute the virus suspension (2,000 doses) in 400 ml of solvent. The solvent should be at room temperature (20 C to 25 C). Mix the vaccine suspension well avoiding the build-up of foam also during administration (e.g. with a magnetic stirrer) in order to achieve a homogeneous suspension. Once diluted and reconstituted, the vaccine should be used immediately. Administration: Administer a single injection subcutaneously in the neck or intramuscularly in the leg each bird as soon as possible after hatching to avoid infection with MD field viruses. 10. WITHDRAWAL PERIOD Zero days 11. SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children. Vaccine: Storage and transport frozen in liquid nitrogen at a temperature below -150 C. Solvent: Storage below 25 C. Do not freeze Do not expose the vaccine suspension ready for use to direct sunlight or heat. Do not use after the expiry date stated on the label after EXP. Shelf-life after dilution or reconstitution according to directions: 2 hours 12. SPECIAL WARNING(S) Maternally derived antibodies (MDA) may interfere with the development of an immune response. In case of a recent field infection or of the vaccination of the parent flock leading to a high level of MDA in the chicks, the timing and/or frequency of the vaccination schedule must be reconsidered. Do not use in birds in lay and breeding birds. A tenfold dose has been demonstrated to be safe. Special precautions for use in animals Only healthy chickens should be vaccinated. The vaccine strain spreads. Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible species. Special precautions to be taken by the person administering the veterinary medicinal product to animals Always wear personal protective equipment consisting of goggles and gloves. Personnel involved in administering the veterinary medicinal product should wash and disinfect hands after handling the vaccine. This product is stored in liquid nitrogen. The operator should be aware of the general precautions to be taken when thawing and opening the ampoules, especially concerning the protective equipment mentioned above. Liquid nitrogen causes serious freeze burns by getting contact with the skin. When opening the ampoules, hold them as far away from your body as possible in order to avoid injuries in case an ampoule explodes. Seite 12 von 13

13 If liquid nitrogen comes into contact with the skin, immediately warm the affected area by immersion in water at 29 ± 1 C or by use of body heat. Usually, there will be considerable pain during warming. Seek medical advice if full function and feeling are not rapidly restored. Interactions Do not mix this vaccine with substances other than AviPro DILUJECT BLUE for which compatibility has been demonstrated. Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed either AviPro SALMONELLA VAC E or AviPro SALMONELLA VAC T or AviPro SALMONELLA DUO or AviPro ND HB1 or AviPro IB H120. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product, except those mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED xxx 15. OTHER INFORMATION xxx Seite 13 von 13