Vetoquinol/DOLPAC Small dogs/european Renewal June 2011 SUMMARY OF PRODUCT CHARACTERISTICS

Size: px
Start display at page:

Download "Vetoquinol/DOLPAC Small dogs/european Renewal June 2011 SUMMARY OF PRODUCT CHARACTERISTICS"

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Austria Belgium Cyprus Malta Czech Republic Netherlands Greece Portugal Slovakia Hungary Slovenia Germany Finland France Luxembourg UK-Ireland-Italy Spain Poland Denmark Sweden Dolpac small dogs tablets Dolpac 2 comprimé Dolpac Tablets for Small Dogs Dolpac small dogs tablets for 1-6 kg Dolpac vet small dogs tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Active substances Oxantel Pyrantel Praziquantel Excipient to one 190 mg divisible tablet mg (equivalent to mg of oxantel embonate) 9.99 mg (equivalent to 28.8 mg of pyrantel embonate) mg Excipients For a full list of excipients, see section PHARMACEUTICAL FORM Tablet Pale yellow to yellow, elongated, divisible oblong tablet with breaking line; 4. CLINICAL PARTICULARS 4.1 Target species Dogs 4.2 Indications for use, specifying the target species For curative treatment of dogs harbouring mixed parasitic infestations with the following adult stages of nematode and cestode species: Nematodes: Toxocara canis Toxascaris leonina Ancylostoma caninum 1/10

2 Uncinaria stenocephala Trichuris vulpis Cestodes: Dipylidium caninum Taenia spp Echinococcus multilocularis Echinococcus granulosus 4.3 Contraindications See section Special warnings for each target species Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Fleas serve as intermediate hosts for one of the common tapeworms Dipylidium caninum. Tapeworm infestation may reoccur unless control of intermediate hosts (fleas) is undertaken. 4.5 Special precautions for use i) Special precautions for use in animals Roundworm and Hookworm infection: In some animals, Ancylostoma caninum and Toxocara canis may not be totally eradicated by the treatment, resulting in a continued risk of egg shedding into the environment. Follow-up examinations of the faeces are advisable and according to the results of these examinations, treatment with a nematodicidal product may be carried out if necessary. The product is not recommended for use in pups younger than two months old or weighing less than 1 kg. In debilitated or heavily infested animals, the product should be used only according to a benefit/risk assessment by the responsible veterinarian Do not use in animals with known hypersensitivity to any of the components of the product. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Some constituents of this product may cause allergic reactions or skin irritation. Avoid contact with the skin. People with known hypersensitivity to any of the ingredients should avoid contact with this product. Wash hands after use. In case of accidental ingestion, seek medical advice and show the package leaflet to the physician. 4.6 Adverse reactions (frequency and seriousness) Vomiting and diarrhoea may be observed following the treatment. Despite not being observed in studies performed with the product, anorexia can occur as it is a common adverse effect of products containing praziquantel. 4.7 Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use is not recommended during pregnancy and lactation. 4.8 Interaction with other medicinal products and other forms of interaction Do not use simultaneously with levamisole, piperazine or choline esterase inhibitors 4.9 Amounts to be administered and administration route The recommended dose rate is 20 mg oxantel / 5 mg pyrantel / 5 mg praziquantel per kg bodyweight, ie one tablet per 2 kg bodyweight in a single intake, by oral route. Administer the required number of tablets, according to bodyweight, orally, in a single administration. Preferably, dogs should be fasted prior to treatment. Food may be given one hour or more after treatment. 2/10

3 Weight of dog Number of tablets 1 kg ½ From 1.1 to 2 kg 1 From 2.1 to 4 kg 2 From 4.1 to 6 kg 3 The tablet can be divided into equal halves. Dogs kept together or in kennels should be treated at the same time Overdose (symptoms, emergency procedures, antidotes), if necessary Administration of the product to healthy dogs at 5 times the recommended dosage for 6 consecutive weeks had no adverse consequences Withdrawal period(s) Not applicable. 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Praziquantel, combinations ATCvet Code: QP52AA51 ATC vet Code: QP52AA51 Praziquantel, combinations 5.1 Pharmacodynamic properties The product contains three active ingredients, pyrantel embonate, oxantel embonate and praziquantel. The spectrum of activity of the product is wide, directed towards gastro-intestinal roundworms (ascaris, whipworm and hookworms) and tapeworms. Pyrantel has a paralysing effect on roundworm muscles, by activating acetylcholine receptors. Its activity is more particularly directed against Toxocara canis, Toxascaris leonina, Uncinaria stenocephala and Ancylostoma caninum. Its activity against Trichuris vulpis is negligible. Oxantel is an m-oxyphenolic derivate of pyrantel, that has been developed for its activity against whipworms. Praziquantel leads to muscular contractions, paralysis and altered parasite tegument integrity. It is active against adults and larval stages of dog tapeworms, Echinococcus, Taenia and Dipylidium. 5.2 Pharmacokinetic particulars After oral administration, the absorption of oxantel embonate is negligible. Pyrantel is quickly absorbed but in small quantities (Tmax = 1.38 h, Cmax = µg/ml) and is very quickly eliminated. Praziquantel is quickly absorbed (Tmax = 1.28 h, Cmax = 0.4 µg/ml) and eliminated (elimination half-life 1.5 h). 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Dextrates Povidone K30 Sodium Lauryl sulphate Bacon flavour Crospovidone Sodium stearyl fumarate 6.2 Incompatibilities Not applicable 6.3 Shelf life Shelf-life of the veterinary medicinal product as packaged for sale: three years Discard any unused half tablet 6.4. Special precautions for storage 3/10

4 This veterinary medicinal product does not require any special storage conditions. 6.5 Nature and composition of immediate packaging Polyamide-aluminium-PVC/aluminium blister or polychlorotrifluoroethylene-pvc/aluminium blister strip of 10 tablets. Cardbox with 1 strip of 10 tablets Cardbox with 6 strips of 10 tablets Cardbox with 10 strips of 10 tablets Not all pack sizes may be marketed 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEW AL OF THE AUTHORISATION 10 DATE OF REVISION OF THE TEXT PROHIBITION OF SALE, SUPPLY AND/OR USE 4/10

5 OUTER PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Austria Belgium Cyprus Malta Czech Republic Netherlands Greece Portugal Slovakia Hungary Slovenia Germany Finland France Luxembourg UK-Ireland-Italy Spain Poland Denmark Sweden Dolpac small dogs tablets Dolpac 2 comprimé Dolpac Tablets for Small Dogs Dolpac small dogs tablets for 1-6 kg Dolpac vet small dogs tablets 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substances Oxantel mg (equivalent to mg of oxantel embonate) Pyrantel 9.99 mg (equivalent to 28.8 mg of pyrantel embonate) Praziquantel mg Excipient to one 190 mg divisible tablet 3. PHARMACEUTICAL FORM Tablet 4. PACKAGE SIZE Cardboard box with 1 strip of 10 tablets Cardboard box with 6 strips of 10 tablets Cardboard box with 10 strips of 10 tablets 5. TARGET SPECIES Dogs 6. INDICATIONS Not included 7. METHOD AND ROUTE OF ADMINISTRATION Oral route. Read the package leaflet before use. 8. WITHDRAWAL PERIOD Not applicable. 9. SPECIAL WARNINGS, IF NECESSARY Read the package leaflet before use 5/10

6 10. EXPIRY DATE EXP: Discard any unused half tablet. 11. SPECIAL STORAGE PRECAUTIONS This veterinary medicinal product does not require any special storage conditions. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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. 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 REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 16. MARKETING AUTHORISATION NUMBER(S) 17. MANUFACTURER S BATCH NUMBER Lot: 6/10

7 PACKAGE LEAFLET 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing Authorisation holder Manufacturer for the batch release: VETOQUINOL MAGNY VERNOIS F LURE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Austria Belgium Cyprus Malta Czech Republic Netherlands Greece Portugal Slovakia Hungary Slovenia Germany Finland France Luxembourg UK-Ireland-Italy Spain Poland Denmark Sweden Dolpac small dogs tablets Dolpac 2 comprimé Dolpac Tablets for Small Dogs Dolpac small dogs tablets for 1-6 kg Dolpac vet small dogs tablets 3. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each tablet contains Active substances Oxantel Pyrantel Praziquantel Excipient to one 190 mg divisible tablet mg (equivalent to mg of oxantel embonate) 9.99 mg (equivalent to 28.8 mg of pyrantel embonate) mg 7/10

8 4. INDICATIONS For curative treatment of dogs harbouring mixed parasitic infestations with the following adult stages of nematode and cestode species: Nematodes: Cestodes: Toxocara canis Toxascaris leonina Ancylostoma caninum Uncinaria stenocephala Trichuris vulpis Dipylidium caninum Taenia spp Echinococcus multilocularis Echinococcus granulosus 5. CONTRAINDICATIONS See paragraph Special warnings 6. ADVERSE REACTIONS Vomiting and diarrhoea may be observed following the treatment. Despite not being observed in studies performed with the product, anorexia can occur as it is a common adverse effect of products containing praziquantel. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Dogs. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION The recommended dose rate is 20 mg oxantel / 5 mg pyrantel / 5 mg praziquantel per kg bodyweight, ie one tablet per 2 kg bodyweight in a single intake, by oral route. Administer the required number of tablets, according to bodyweight, orally, in a single administration. Preferably, dogs should be fasted prior to treatment. Food may be given one hour or more after treatment. Weight of dog Number of tablets 1 kg ½ From 1.1 to 2 kg 1 From 2.1 to 4 kg 2 From 4.1 to 6 kg 3 The tablet can be divided into equal halves. Dogs kept together or in kennels should be treated at the same time. 9. ADVICE ON CORRECT ADMINISTRATION None. 10. WITHDRAWAL PERIOD Not applicable. 11. SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children. This veterinary medicinal product does not require any special storage conditions. Do not use after the expiry date which is stated on the carton after EXP Discard any unused half tablet. 8/10

9 12. SPECIAL WARNINGS Special warnings for each target species Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Fleas serve as intermediate hosts for one of the common tapeworms Dipylidium caninum. Tapeworm infestation may reoccur unless control of intermediate hosts (fleas) is undertaken. Special precautions for use in animals Roundworm and Hookworm infection: In some animals, Ancylostoma caninum and Toxocara canis may not be totally eradicated by the treatment, resulting in a continued risk of egg shedding into the environment. Follow-up examinations of the faeces are advisable and according to the results of these examinations, treatment with a nematodicidal product may be carried out if necessary. The product is not recommended for use in pups younger than two months old or weighing less than 1 kg. In debilitated or heavily infested animals, the product should be used only according to a benefit/risk assessment by the responsible veterinarian. Do not use in animals with known hypersensitivity to any of the components of the product. Special precautions to be taken by the person administering the veterinary medicinal product to animals Some constituents of this product may cause allergic reactions or skin irritation. Avoid contact with the skin. People with known hypersensitivity to any of the ingredients should avoid contact with this product. Wash hands after use. In case of accidental ingestion, seek medical advice and show the pack age leaflet to the physician. Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use is not recommended during pregnancy and lactation. Interaction with other medicinal products and other forms of interaction Do not use simultaneously with levamisole, piperazine or choline esterase inhibitors Overdose (symptoms, emergency procedures, antidotes), if necessary Administration of the product to healthy dogs at 5 times the recommended dosage for 6 consecutive weeks had no adverse consequences. 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 meas ures should help to protect the environment. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 15. OTHER INFORMATION Cardbox with 1 strip of 10 tablets Cardbox with 6 strips of 10 tablets Cardbox with 10 strips of 10 tablets Not all pack sizes may be marketed. 9/10

10 BLISTER 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Austria Belgium Cyprus Malta Czech Republic Netherlands Greece Portugal Slovakia Hungary Slovenia Germany Finland France Luxembourg UK-Ireland-Italy Spain Poland Denmark Sweden Dolpac small dogs tablets Dolpac 2 comprimé Dolpac Tablets for Small Dogs Dolpac small dogs tablets for 1-6 kg Dolpac vet small dogs tablets 2. NAME OF THE MARKETING AUTHORISATION HOLDER 3. EXPIRY DATE EXP: 4. BATCH NUMBER Lot: 5. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only. 10/10

SUMMARY of PRODUCT CHARACTERISTICS

SUMMARY of PRODUCT CHARACTERISTICS SUMMARY of PRODUCT CHARACTERISTICS 1. Name of the veterinary medicinal product HELM-EX Flavour Tablets 2. Qualitative and quantitative composition Each tablet contains: Active ubstances Praziquantel 50.0

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Prazitel Plus XL Tablets For Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substances: Praziquantel

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Veloxa Forte Chewable Tablets for Dogs (in Greece and Hungary) Veloxa 175/504/525 mg Chewable Tablets for Dogs (in Denmark,

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT ZANTEL 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: Per tablet Praziquantel 50.0 mg Fenbendazole 500.0 mg

More information

Tablet. A light-brown to brown, meat flavoured, bone shaped tablet scored on both sides that can be divided into halves.

Tablet. A light-brown to brown, meat flavoured, bone shaped tablet scored on both sides that can be divided into halves. 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Drontal Dog Tasty Bone 150/144/50 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active Substances: 150 mg Febantel 50 mg Pyrantel

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Drontal Plus XL Flavour Tablets for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Febantel Pyrantel

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Prazitel Plus XL Tablets For Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substances: Praziquantel

More information

Treatment of mixed infections by nematodes and cestodes of the following species:

Treatment of mixed infections by nematodes and cestodes of the following species: 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Drontal Tasty Bone Multi-worm XL 525/504/175 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active Substances 525 mg febantel 175

More information

SUMMARY of PRODUCT CHARACTERISTICS (SPC)

SUMMARY of PRODUCT CHARACTERISTICS (SPC) 1. Name of the veterinary medicinal product Cestal Plus flavour tablets ad us. vet. active substances: praziquantel pyrantel pamoate fenbendazole SUMMARY of PRODUCT CHARACTERISTICS (SPC) 2. Qualitative

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Prazical Plus XL Tablets For Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substances: Praziquantel

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CESTEM Flavoured tablets for large dogs [UK, IT, DE, AT, BE, NL, LU, ES, PL, BG, CY, CZ, EE, EL, HU, LT, LV, PT, RO, SK, SI]

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Zantel Cat and Dog Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances (per tablet): Praziquantel Fenbendazole

More information

CAZITEL FLAVORED ALLWORMER FOR DOGS

CAZITEL FLAVORED ALLWORMER FOR DOGS CAZITEL FLAVORED ALLWORMER FOR DOGS For use in dogs only. Do not use on cats or rabbits. For use on puppies and dogs from 2 weeks of age. INDICATION Multi spectrum intestinal wormers for puppies and adult

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Credelio 56 mg chewable tablets for dogs (1.3 2.5 kg) Credelio 112 mg chewable tablets for dogs (>2.5 5.5 kg) Credelio

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 [Single-dose pipettes] 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Profender 30 mg/7.5 mg spot-on solution for small cats Profender 60 mg/15 mg spot-on solution

More information

SUMMARY OF PRODUCT CHARACTERISTICS. Cephacare flavour 50 mg tablets for cats and dogs. Excipients: For a full list of excipients, see section 6.1.

SUMMARY OF PRODUCT CHARACTERISTICS. Cephacare flavour 50 mg tablets for cats and dogs. Excipients: For a full list of excipients, see section 6.1. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cephacare flavour 50 mg tablets for cats and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS page 1 of 7 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Panacur PetPaste 187.5 mg/g oral paste for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g oral

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ophtocycline 10 mg/g eye ointment for dogs, cats and horses (AT, BE, BG, CY, CZ, EL, ES, HR, HU, IE, IT, LU, NL,

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NexGard 11 mg chewable tablets for dogs 2-4 kg NexGard 28 mg chewable tablets for dogs > 4-10 kg NexGard 68 mg chewable

More information

United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS (Reference Member State) MUTUAL RECOGNITION PROCEDURE

United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS (Reference Member State) MUTUAL RECOGNITION PROCEDURE United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS (Reference Member State) MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Distocur 34 mg/ml Oral suspension for cattle. Distocur.vet 34 mg/ml Oral suspension for cattle. (DK, NO, SE) 2.

More information

1.3.1 Milbemycin oxime + Praziquantel SPC, Labeling and Package Leaflet GB

1.3.1 Milbemycin oxime + Praziquantel SPC, Labeling and Package Leaflet GB ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS SmPCPIL095728_1 04.07.2017 Updated: 04.07.2017 Page 1 of 17 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Milquantel 2.5 mg/25 mg tablets for small dogs and puppies

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Milpro 16 mg/40 mg film-coated tablets for cats Milpro Vet. 16 mg/40 mg film-coated tablets for cats (IT, DK) 2. QUALITATIVE

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrobactin 250 mg tablets for dogs and cats (AT, BE, BG, CY, CZ, DE, EL, ES, FR, HR, HU, IE, IT, LU, NL, PT, RO,

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates

More information

[Version 8, 10/2012] SUMMARY OF PRODUCT CHARACTERISTICS

[Version 8, 10/2012] SUMMARY OF PRODUCT CHARACTERISTICS [Version 8, 10/2012] SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Curofen 50 mg/g Premix for Medicated Feeding Stuff for Pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

More information

SUMMARY OF PRODUCT CHARACTERISTICS. Milprazon 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg

SUMMARY OF PRODUCT CHARACTERISTICS. Milprazon 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Milprazon 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS Revised: May 2016 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Milpro 12.5 mg/125 mg film-coated tablets for dogs Milpro Vet. 12.5 mg/125 mg film-coated tablets for dogs

More information

SUMMARY OF PRODUCT CHARACTERISTICS. Milprazon 2.5 mg/25 mg Tablets for Small Dogs and Puppies Weighing At Least 0.5 kg

SUMMARY OF PRODUCT CHARACTERISTICS. Milprazon 2.5 mg/25 mg Tablets for Small Dogs and Puppies Weighing At Least 0.5 kg SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Milprazon 2.5 mg/25 mg Tablets for Small Dogs and Puppies Weighing At Least 0.5 kg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RONAXAN 20mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance : Doxycycline (as doxycycline

More information

United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE

United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Milbactor

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS AN: 01695/2015 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Milbemax Tablets for small dogs and puppies 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:

More information

[Version 7.2, 12/2008] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

[Version 7.2, 12/2008] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS [Version 7.2, 12/2008] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RABORAL V-RG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 1 dose: Active substance: -

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MILBEMAX Film-coated tablets for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substances:

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fiprex CAT 52.5 mg spot-on solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pipette (0.7 ml) contains:

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrobactin 500 mg tablets for dogs and cats (AT, BE, BG, CY, CZ, DE, EL, ES, FR, HR, HU, IE, IT, LU, NL, PL, PT, RO, SI,

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NOSEDORM 5 mg/ml Solution for injection for dogs and cats [DE, ES, FR, PT] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each

More information

LABELLING AND PACKAGE LEAFLET

LABELLING AND PACKAGE LEAFLET LABELLING AND PACKAGE LEAFLET 1 A. LABELLING 2 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MILTEFORAN 20 mg/ml oral solution for dogs miltefosine 2.

More information

SUMMARY OF PRODUCT CHARACTERISTICS. Active substance: cefalexin (as cefalexin monohydrate) mg

SUMMARY OF PRODUCT CHARACTERISTICS. Active substance: cefalexin (as cefalexin monohydrate) mg SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cefaseptin 750 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Active substance: cefalexin

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MILBEMAX Film-coated tablets for small cats and kittens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Active

More information

SUMMARY OF PRODUCT CHARACTERISTICS. NUFLOR 300 mg/ml solution for injection for cattle and sheep

SUMMARY OF PRODUCT CHARACTERISTICS. NUFLOR 300 mg/ml solution for injection for cattle and sheep SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NUFLOR 300 mg/ml solution for injection for cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocare 20 mg/ml solution for injection for cattle and pigs (UK, IE, FR) Odimar 20 mg/ml solution for injection for cattle

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NexGard 11 mg chewable tablets for dogs 2 4 kg NexGard 28 mg chewable tablets for dogs >4 10 kg NexGard 68 mg chewable

More information

Part II SUMMARY OF PRODUCT CHARACTERISTICS. Each tablet contains 25 mg Clindamycin (as Clindamycin Hydrochloride)

Part II SUMMARY OF PRODUCT CHARACTERISTICS. Each tablet contains 25 mg Clindamycin (as Clindamycin Hydrochloride) Clindacyl 25mg Tablets Vm 08007/4104 Part II SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CLINDACYL 25 MG TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet

More information

Summary of Product Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Enrotab 50 mg tablets for dogs

Summary of Product Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Enrotab 50 mg tablets for dogs Summary of Product Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotab 50 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance Enrofloxacin

More information

SUMMARY OF THE PRODUCT CHARACTERISTICS

SUMMARY OF THE PRODUCT CHARACTERISTICS 1 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Exflow 10 mg/g powder for use in drinking water for cattle (calves), pigs, chickens, turkeys and ducks Exflow Vet 10

More information

B. PACKAGE LEAFLET 1

B. PACKAGE LEAFLET 1 B. PACKAGE LEAFLET 1 PACKAGE LEAFLET NICILAN 400 mg/100 mg tablets for dogs 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT COXEVAC suspension for injection for cattle and goats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:

More information

For the treatment of mixed parasitic infections in cats caused by roundworms and tapeworms of the following species:

For the treatment of mixed parasitic infections in cats caused by roundworms and tapeworms of the following species: Printed from (http://www.noahcompendium.co.uk). (c) Copyright 2018. All Rights Reserved. Date: Wednesday, October 24, 2018 11:47 Bayer plc Telephone:0118 206 3000 Website:www.bayer.co.uk Email:animal.health@bayer.com

More information

SUMMARY OF PRODUCT CHARACTERISTICS. Bottle of powder: Active substance: ceftiofur sodium mg equivalent to ceftiofur...

SUMMARY OF PRODUCT CHARACTERISTICS. Bottle of powder: Active substance: ceftiofur sodium mg equivalent to ceftiofur... SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT WONDERCEF powder and solvent for solution for injection for horses not intended for the production of foods for human consumption.

More information

SUMMARY OF PRODUCT CHARACTERISTICS 1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS 1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS 1.B. SUMMARY OF PRODUCT CHARACTERISTICS 1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Lamox 800 mg/g powder for use in drinking water for chickens and pigs 2. QUALITATIVE

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HALOCUR 0.5 mg/ml oral solution for calves 2. Qualitative and quantitative composition Active substance Halofuginone

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis ColiClos suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vectra Felis 423 mg/42.3 mg spot-on solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AMPROLINE 400 mg/ml solution for use in drinking water for chickens and turkeys 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bravecto 112.5 mg chewable tablets for very small dogs (2-4.5 kg) Bravecto 250 mg chewable tablets for small dogs

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Intra Hoof-Fit Gel 40 mg/g + 40 mg/g gel for dairy cattle Intra Pasta 40 mg/g + 40 mg/g gel for dairy cattle Pecopro vet

More information

PART IB1 SUMMARY OF PRODUCT CHARACTERISTICS OCTACILLIN

PART IB1 SUMMARY OF PRODUCT CHARACTERISTICS OCTACILLIN PART IB1 SUMMARY OF PRODUCT CHARACTERISTICS OCTACILLIN 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Octacillin 800 mg/g powder for use in drinking water for chickens NL: Octacillin 800 mg/g poeder voor gebruik

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fiprex S 75 mg spot-on solution for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One pipette (1 ml) contains: Active

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS Revised: March 2011 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Strongid - P Paste 43.90% w/w 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Pyrantel Embonate 43.90

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Amphen 200 mg/g Granules for use in drinking water for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: Active

More information

Ubroseal Dry Cow 2.6 g intramammary suspension for cattle

Ubroseal Dry Cow 2.6 g intramammary suspension for cattle Health Products Regulatory Authority 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ubroseal Dry Cow 2.6 g intramammary suspension for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4g intramammary

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Rycarfa 100 mg tablets for dogs (BE, DE, ES, FR, IE, IT, NL, PT, UK) Rycarfa vet 100 mg tablets for dogs (DK, FI) Carprox

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS Page 1 of 18 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cardisure flavoured 10 mg Tablets For dogs (Austria, Belgium, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands,,

More information

4.5. Special precautions for use Special precautions to be taken by person administering the veterinary medicinal product to animals

4.5. Special precautions for use Special precautions to be taken by person administering the veterinary medicinal product to animals 1.B1. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AMOXYCOL Soluble Powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: Amoxicillin trihydrate 640.0

More information

Label (2 tab) - front panel Issue Date: Page: 1 of 14 The information above this line is not included in the label FOR ANIMAL TREATMENT ONLY

Label (2 tab) - front panel Issue Date: Page: 1 of 14 The information above this line is not included in the label FOR ANIMAL TREATMENT ONLY Label (2 tab) - front panel Issue Date: 30-8-00 Page: 1 of 14 FOR ANIMAL TREATMENT ONLY Bay-o-Pet DRONTAL Allwormer FOR LARGE DOGS Infopest Verified Controls all 11 gastrointestinal worms Active Constituents:

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Carofertin 10 mg/ml Emulsion for injection for cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BLUEVAC BTV8 suspension for injection for cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Selectan 300 mg/ml solution for injection for cattle and swine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Valbazen 100 mg/ml Total Spectrum Wormer 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Albendazole

More information

Veterinary Medicinal Product

Veterinary Medicinal Product Veterinary Medicinal Product Carprodyl Quadri 120 mg chewable tablets for dogs PART I B Pharmaceutical Form Chewable tablet Veterinary Medicinal Product Carprodyl Quadri 120mg chewable tablets for dogs

More information

LUTEOSYL(d)-Cloprostenol mg/ml Solution for injection for cattle and pigs

LUTEOSYL(d)-Cloprostenol mg/ml Solution for injection for cattle and pigs SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT In France, Germany, Hungary, Italy, Poland, Spain and The Netherlands; LUTEOSYL 0.075 mg/ml

More information

SUMMARY OF PRODUCT CHARACTERISTICS. Pentoject, Pentobarbitone Sodium 200 mg/ml Solution for Injection

SUMMARY OF PRODUCT CHARACTERISTICS. Pentoject, Pentobarbitone Sodium 200 mg/ml Solution for Injection SUMMARY OF PRODUCT CHARACTERISTICS Revised: June 2018 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pentoject, Pentobarbitone Sodium 200 mg/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Panacur AquaSol 200 mg/ml oral suspension for use in drinking water for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Acecare 2mg/ml Solution for Injection for Dogs and Cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Parofor 70 mg/g powder for use in drinking water, milk or milk replacer for pre-ruminant cattle and pigs. 2. QUALITATIVE

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Advantage 40 Spot-on solution for Cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Imidacloprid 40 mg/pipette

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 1 suspension for injection for sheep and cattle. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose

More information

SUMMARY OF PRODUCT CHARACTERISTICS. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetrisulf powder for oral solution for chickens, turkeys and geese

SUMMARY OF PRODUCT CHARACTERISTICS. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetrisulf powder for oral solution for chickens, turkeys and geese SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetrisulf powder for oral solution for chickens, turkeys and geese 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One g contains:

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eurican Herpes 205 powder and solvent for emulsion for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AT, BE, CZ, EE, ES, FR, IE, IS, IT, LT, LU, LV, NO, PL, PT, RO, SE, SI, SK, UK: Genestran 75 micrograms/ml solution for injection

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT TAF SPRAY 28.5 mg/g Cutaneous Spray, Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g contains: Active substance: Thiamphenicol

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS Revised: May 2014 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrox Flavour 150 mg Tablets for dogs (United Kingdom, Austria, Belgium, Germany, Denmark, Greece, Ireland,

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DOXYPRIM 40% soluble powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Doxycycline hyclate 400.0 mg Excipients:

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Maprelin 75 µg/ml solution for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection

More information

FOR ANIMAL TREATMENT ONLY

FOR ANIMAL TREATMENT ONLY Hangsell card front panel (2 chew) Issue Date: 5/4/2011 Page: 1 of 11 FOR ANIMAL TREATMENT ONLY Each chew contains: 175 mg PRAZIQUANTEL 174.4 mg PYRANTEL as PYRANTEL EMBONATE 875 mg FEBANTEL Controls all

More information

FLOXYME 50 mg/ml SOLUTION FOR USE IN DRINKING WATER

FLOXYME 50 mg/ml SOLUTION FOR USE IN DRINKING WATER FLOXYME 50 mg/ml SOLUTION FOR USE IN DRINKING WATER 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FLOXYME 50 mg/ml SOLUTION FOR USE IN DRINKING WATER 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:

More information

Health Products Regulatory Authority

Health Products Regulatory Authority 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Genta 50 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substances Gentamicin sulphate equivalent to Gentamicin

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amfipen LA 100 mg/ml suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each ml contains:

More information

B. PACKAGE LEAFLET 1

B. PACKAGE LEAFLET 1 B. PACKAGE LEAFLET 1 PACKAGE LEAFLET FOR: Cadorex 300 mg/ml solution for injection for cattle, sheep and pigs 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT GALLIPRANT 20 mg tablets for dogs GALLIPRANT 60 mg tablets for dogs GALLIPRANT 100 mg tablets for dogs 2. QUALITATIVE

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS [Version 7.3.1, 11/2010] FINAL SPC, LABELLING AND PACKAGE LEAFLET ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CEVAC Clostridium Ovino suspension for injection

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MILBEMAX film-coated tablets for small cats and kittens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Active

More information

PARASITE TREATMENTS PROVEN PROTECTION FOR DOGS AND CATS

PARASITE TREATMENTS PROVEN PROTECTION FOR DOGS AND CATS PARASITE TREATMENTS PROVEN PROTECTION FOR DOGS AND CATS THIS IS WHY For pets and the families who love them Now, more than ever, pets are considered part of the family. But when parasites are involved,

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pro Penstrep Suspension for Injection for Cattle, Sheep and Pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:

More information

SUMMARY OF PRODUCT CHARACTERSITICS

SUMMARY OF PRODUCT CHARACTERSITICS SUMMARY OF PRODUCT CHARACTERSITICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eliminall 2.5 mg/ml cutaneous spray, solution for cats and dogs Exproline vet 2.5 mg/ml cutaneous spray, solution for cats

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flukiver 5% w/v Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Closantel (as Clostanel sodium)

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT IVOMEC Injection for Pigs 10 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substance: Ivermectin

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Advantage 40 mg feline and bunny Spot-on solution [UK] Advantage 40 mg Spot-on solution for Small Cats and Small Pet Rabbits

More information