Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
emodepside, toltrazuril
Vetoquinol S.A.
QP52AX60
emodepside, toltrazuril
Dogs
Antiparasitic products, insecticides and repellents
For dogs, when mixed parasitic infections caused by roundworms and coccidia of the following species are suspected or demonstrated:Roundworms (nematodes)Toxocara canis (mature adult, immature adult, L4);Uncinaria stenocephala (mature adult);Ancylostoma caninum (mature adult).CoccidiaIsospora ohioensis complex;Isospora canis.Procox is effective against the replication of Isospora and also against the shedding of oocysts. Although treatment will reduce the spread of infection, it will not be effective against the clinical signs of infection in already infected animals.
Revision: 15
Authorised
2011-04-20
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: PROCOX 0.9 MG/ML + 18 MG/ML ORAL SUSPENSION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Vetoquinol S.A. Magny-Vernois 70200 Lure France Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324 24106 Kiel Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Procox 0.9 mg/ml + 18 mg/ml oral suspension for dogs emodepside / toltrazuril 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS 1 ml contains: ACTIVE SUBSTANCES: emodepside 0.9 mg toltrazuril 18 mg EXCIPIENTS: butylhydroxytoluene (E321; as antioxidant) 0.9 mg sorbic acid (E200; as preservative) 0.7 mg 4. INDICATIONS For dogs, when mixed parasitic infections caused by roundworms and coccidia of the following species are suspected or demonstrated: Roundworms (Nematodes): - _Toxocara canis_ (mature adult, immature adult, L4) - _Uncinaria stenocephala _(mature adult) - _Ancylostoma caninum _(mature adult) _ _ - _Trichuris vulpis_ (mature adult) Coccidia: - _Isospora ohioensis _complex 18 - _Isospora canis _ _ _ Treatment will reduce the spread of _Isospora_ infection but will not be effective against symptoms in already infected animals. 5. CONTRAINDICATIONS Do not use in dogs/puppies which are under 2 weeks of age or weigh less than 0.4 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 6. ADVERSE REACTIONS Slight and transient digestive tract disorders (e.g., vomiting or loose stools) may occur in very rare cases. 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 tr Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Procox 0.9 mg/ml + 18 mg/ml oral suspension for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCES: emodepside 0.9 mg toltrazuril 18 mg EXCIPIENTS: butylhydroxytoluene (E321; as antioxidant) 0.9 mg sorbic acid (E200; as preservative) 0.7 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension. White to yellowish suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For dogs, when mixed parasitic infections caused by roundworms and coccidia of the following species are suspected or demonstrated: Roundworms (Nematodes): - _Toxocara canis_ (mature adult, immature adult, L4) - _Uncinaria stenocephala _(mature adult) - _Ancylostoma caninum _(mature adult) - _Trichuris vulpis_ (mature adult) Coccidia: - _Isospora ohioensis _complex - _Isospora canis _ Procox is effective against the replication of _Isospora_ and also against the shedding of oocysts. Although treatment will reduce the spread of infection, it will not be effective against the clinical signs of infection in already infected animals. 4.3 CONTRAINDICATIONS Do not use in dogs/puppies which are under 2 weeks of age or weigh less than 0.4 kg. 3 Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS Procox is effective against the replication of coccidia and against the shedding of oocysts. Replication of the parasite damages the dog’s intestinal mucosa, which may cause enteritis. Therefore, treatment with Procox does not resolve clinical symptoms arising from mucosal damage (e.g. diarrhoea) that have arisen before treatment. In such cases supportive treatment may be necessary. Treatment against _Isospora _should aim to minimize the shedding of oocysts into the environment, thereby reducing the risk for reinfection in groups/kennels with known and recurring _Isospora_ infections. A pr Прочетете целия документ