SUMMARY OF PRODUCT CHARACTERISTICS 1
1. NAME OF THE VETERINARY MEDICINAL PRODUCT BIOCOM P Vet, suspension for injection for minks (all MS except DK) BIOVAC-BP, suspension for injection for minks (DK) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml: Active ingredients: Inactivated Mink Enteritis Virus Types 1 and 2 1 PD80 * Clostridium botulinum Type C toxoid 40 PD80 * Inactivated Pseudomonas aeruginosa Serotypes: PAB*** Serotype 5 (Strains PA5G-485 and PA5M-485-P) PAB*** Serotype 6 (Strains PA6G-485, PA6M-485-JA, and PA6M-485-JB) PAB*** Serotype 7-8 (Strains PA7G-485 and PA7M-485-347) * PD 80 = Dose protecting at least 80% of the animals ** RP = Relative potency unit *** PAB= Pseudomonas aeruginosa bacterin Adjuvant: Aluminum hydroxide Excipients: Thimerosal 0.8-1.7 mg Al 0.1 ± 0.05 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection After shaking, the product is a yellowish homogeneous suspension without visible particles. 4. CLINICAL PARTICULARS 4.1 Target species Minks 2
4.2 Indications for use, specifying the target species For the active immunization of mink from an age of 6 weeks to reduce mortality and clinical symptoms caused by Mink Enteritis Virus Types 1 and 2, Clostridium botulinum Type C toxin, and Pseudomonas aeruginosa Serotypes 5, 6, and 7-8 (in accordance with the International Antigenic Typing Scheme (IATS)). Onset of immunity: 3 weeks. Duration of immunity: For Mink Enteritis and Type C botulism: 12 months. For Pseudomonas aeruginosa Serotypes 5, 6 and 7-8: 3 months. 4.3 Contraindications None. 4.4 Special warnings for each target species Vaccinate healthy animals only. Maternal antibodies may interfere with vaccination. If it is expected that maternal antibody titers are high, it is advised to postpone the vaccination (see section 4.9). 4.5 Special precautions for use Special precautions for use in animals: Not applicable. Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 Adverse reactions (frequency and seriousness) A local reaction of up to 5.0 cm in diameter is commonly observed at the injection site. This palpable reaction consists of subcutaneous swelling that may be palpated at the injection site and may last up to 6 months. Transient anorexia may uncommonly be observed. In rare cases an anaphylactic reaction may occur. Anaphylaxis may be treated with epinephrine. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports) 4.7 Use during pregnancy, lactation, or lay The safety of the veterinary medicinal product has not been established during pregnancy or lactation. 3
4.8 Interaction with other medicinal products and other forms of interaction No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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 Shake well before and regularly during use. Inject 1 ml subcutaneously under the loose skin of the armpit. Kits without maternal antibodies: Vaccinate at the age of 6 weeks or later. Kits with maternal antibodies: Vaccinate at the age of 10-12 weeks. Breeding animals: Re-vaccinate annually. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No information available. 4.11 Withdrawal period(s) Not applicable. 5. IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: mink enteritis virus / parvovirus + inactivated clostridium + inactivated pseudomonas ATC vet code: QI20CL01 Inactivated viral and bacterial vaccine to stimulate active immunity against Mink Enteritis Virus Types 1 and 2, Clostridium botulinum Type C, and Pseudomonas aeruginosa Serotypes 5, 6 and 7-8. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Citrate buffer (1 M), buffer containing citric acid and trisodium citrate dihydrate Antifoam, emulsion containing active silicone Thimerosal Water for injections 6.2 Major incompatibilities In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. 6.3 Shelf life 4
Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening the immediate packaging: Use immediately; do not store. 6.4 Special precautions for storage Store and transport refrigerated (2 C - 8 C). Do not freeze. Protect from direct sunlight. 6.5 Nature and composition of immediate packaging Polyethylene bottle containing 100 ml (100 doses), 250 ml (250 doses), or 500 ml (500 doses). The bottles are closed with a rubber stopper and sealed with an aluminum cap. Not all pack sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER United Vaccines Holding B.V. Molenweg 7 6612 AE Nederasselt The Netherlands Telephone: +31-(0)246221980 Fax: +31-(0)246221465 E-Mail: info@nfe.nl 8. MARKETING AUTHORISATION NUMBER(S) {NNNNN} 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorization: {DD/MM/YYYY} 10. DATE OF REVISION OF THE TEXT {DD/MM/YYYY} PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 5
LABELLING AND PACKAGE LEAFLET 6
LABELLING 7
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Polyethylene bottle 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BIOCOM P Vet, suspension for injection for minks (all MS except DK) BIOVAC-BP, suspension for injection for minks (DK) 2. STATEMENT OF ACTIVE SUBSTANCES Per dose (1 ml): Active ingredients: Inactivated Mink Enteritis Virus Types 1 and 2 1 PD80 * Clostridium botulinum Type C toxoid 40 PD80 * Inactivated Pseudomonas aeruginosa Serotypes: PAB*** Serotype 5 (Strains PA5G-485 and PA5M-485-P) PAB*** Serotype 6 (Strains PA6G-485, PA6M-485-JA, and PA6M-485-JB) PAB*** Serotype 7-8 (Strains PA7G-485 and PA7M-485-347) * PD80 = Dose protecting at least 80% of the animals ** RP = Relative potency unit *** PAB= Pseudomonas aeruginosa bacterin 3. PHARMACEUTICAL FORM Suspension for injection 4. PACKAGE SIZE 500 ml (500 doses) 250 ml (250 doses) 100 ml (100 doses) 5. TARGET SPECIES Minks 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 8. WITHDRAWAL PERIOD(S) 8
9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP {month/year} Once broached use immediately. 11. SPECIAL STORAGE CONDITIONS Store and transport refrigerated. Do not freeze. Protect from direct sunlight. 12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Dispose of waste material in accordance with local requirements. 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 United Vaccines Holding B.V. Molenweg 7 6612 AE Nederasselt The Netherlands Telephone: +31-(0)246221980 Fax: +31-(0)246221465 E-Mail: info@nfe.nl 16. MARKETING AUTHORISATION NUMBER(S) {NNNNN} 17. MANUFACTURER S BATCH NUMBER Lot {number} 9
PACKAGE LEAFLET 10
PACKAGE LEAFLET BIOCOM P Vet, suspension for injection for minks (all MS except DK) BIOVAC-BP, suspension for injection for minks (DK) 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: United Vaccines Holding B.V. Molenweg 7 6612 AE Nederasselt The Netherlands Telephone: +31-(0)246221980 Fax: +31-(0)246221465 E-Mail: info@nfe.nl Manufacturer responsible for batch release: C.F.E. Molenweg 7 6612 AE Nederasselt The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT BIOCOM P Vet, suspension for injection for minks (all MS except DK) BIOVAC-BP, suspension for injection for minks (DK) 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Per dose (1 ml): Active ingredients: Inactivated Mink Enteritis Virus Types 1 and 2 1 PD80 * Clostridium botulinum Type C toxoid 40 PD80 * Inactivated Pseudomonas aeruginosa Serotypes: PAB*** Serotype 5 (Strains PA5G-485 and PA5M-485-P) PAB*** Serotype 6 (Strains PA6G-485, PA6M-485-JA, and PA6M-485-JB) PAB*** Serotype 7-8 (Strains PA7G-485 and PA7M-485-347) * PD80 = Dose protecting at least 80% of the animals ** RP = Relative potency unit *** PAB= Pseudomonas aeruginosa bacterin Adjuvant: Aluminum hydroxide 0.8-1.7 mg Al 11
Excipients: Thimerosal 0.1 ± 0.05 mg 4. INDICATION(S) For the active immunization of mink from an age of 6 weeks to reduce mortality and clinical symptoms caused by Mink Enteritis Virus Types 1 and 2, Clostridium botulinum Type C toxin, and Pseudomonas aeruginosa Serotypes 5, 6, and 7-8 (in accordance with the International Antigenic Typing Scheme (IATS)). 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS A local reaction of up to 5.0 cm in size is commonly observed at the injection site. This reaction may be felt as swelling under the skin and may last up to 6 months. A lack or loss of appetite may uncommonly be observed for a short time. In rare cases a sudden and severe allergic reaction during which breathing may stop may occur. Reactions of this type may be treated with epinephrine. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports) If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. Alternatively, you can report via your national reporting system {national system details}. 7. TARGET SPECIES Minks 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Shake well before and regularly during use. Inject 1 ml into the fat under the loose skin of the armpit. Kits from unvaccinated mothers: Vaccinate at the age of 6 weeks or later. Kits from vaccinated mothers: Vaccinate at an age of 10-12 weeks. 12
Breeding animals: Re-vaccinate annually. 9. ADVICE ON CORRECT ADMINISTRATION After shaking, the product is a yellowish homogenous suspension without visible particles. Use sharp, sterile needles and a sterile injection gun or syringe. 10. WITHDRAWAL PERIOD Not applicable. 11. SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children. Store and transport refrigerated (2 C - 8 C). Do not freeze. Protect from direct sunlight. Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Shelf life after first opening the container: Use immediately; do not store. 12. SPECIAL WARNING(S) Special warnings for each target species: Vaccinate healthy animals only. Kits may be protected from infection due to the transfer of antibodies from the mother. This may interfere with vaccination. If this is expected, it is advised to delay the vaccination until the age of 10-12 weeks. Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Pregnancy and lactation: The safety of the vaccine has not been determined during pregnancy or lactation. Interaction with other medicinal products and other forms of interaction: No information is available on the safety and effectiveness of this vaccine when used with any other product. A decision to use this vaccine before or after any other product needs to be made on a case by case basis. Overdose (symptoms, emergency procedures, antidotes): No information available. Incompatibilities: This vaccine must not be mixed with any other product. 13
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. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED {DD/MM/YYYY} 15. OTHER INFORMATION The product is supplied in a polyethylene bottle containing 100 ml (100 doses), 250 ml (250 doses), or 500 ml (500 doses). The bottles are closed with a rubber stopper and sealed with an aluminum cap. Not all pack sizes may be marketed. For any information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder. 14