Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
ivermectin 1 mg/g
Le Vet B.V
QP54AA01
Ear gel
ivermectin
Cats Non Food
2012-01-16
1 _[Version 7.1, 10/2006] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Otimectin vet. 1 mg/g ear gel for cats (AT, BE, CZ, DE, EL, IE, FI, FR, IS, LT, NL, NO, PL, PT, SE, UK) Otimectin 1 mg/g ear gel for cats (ES, IT) Otimectin Vet. (DK) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE PER G: Ivermectin 1 mg EXCIPIENTS: For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Ear gel. Colourless to slightly yellow, slightly opalescent and viscous gel 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of ear mite (_Otodectes cynotis_) infestation in cats. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use if the tympanic membrane is perforated. Do not use if the tympanic membrane cannot be fully visualized. Do not use in cats with obstructed external ear canals due to chronic inflammation. Do not use in cats suffering from systemic disorders. 4.4 SPECIAL WARNINGS FOR THE TARGET SPECIES All the cats housed together should be treated simultaneously against O_todectes cynotis _infestation. Other receptive companion animals (dogs, ferrets) in the household should be treated as well with another suitable product when the presence of ear mite is detected and confirmed. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS In the absence of available information on safety the product should not be used on cats under 16 weeks of age. Care should be ta Read the complete document