البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
MICONAZOLE NITRATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE
EUROMAR LTD
SUSPENSION
MICONAZOLE NITRATE 23 MG/ML; PREDNISOLONE ACETATE 5 MG/ML; POLYMYXIN B SULFATE 5500 IU/ML
DERMAL, OTIC
Required
ELANCO ANIMAL HEALTH, ELI LILLY REGIONAL OPERATIONS GMBH, AUSTRIA
Surolan is used in dogs and cats for the treatment of otitis and skin infections caused by fungi, yeasts, gram-negative and gram-positive bacteria. Ear mites.
2018-07-08
CONSUMER PACKAGE INSERT FOR VETERINARY MEDICINAL PRODUCT THE MEDICINE IS DISPENSED WITH A VETERINARIAN'S PRESCRIPTION ONLY FOR ANIMAL USE ONLY 1. NAME OF THE VETERINARY MEDICINAL PRODUCT: Surolan Veterinary Suspension drops 2. ACTIVE INGREDIENTS: Each 1 ml contains: Miconazole nitrate 23mg Prednisolone acetate 5mg Polymixin B sulfate 0.5293mg (5500I.U.) 3. WHAT IS THE MEDICINAL PRODUCT INTENDED FOR: Surolan is used in dogs and cats for the treatment of otitis and skin infections caused by fungi, yeast, gram-negative and gram-positive bacteria, ear mites (Otodectes cynotis). THERAPEUTIC GROUP: Miconazole nitrate: Antifungal from the Imidazole family Prednisolone acetate: Synthetic corticosteroid Polymixin B sulfate: Antibiotics 4. CONTRAINDICATIONS Do not use in animals with perforated ear drums since Polymyxin B is known to be a potential ototoxic agent. . Do not use in cases of known hypersensitivity to the active substances or to any of the excipients. . 5. SIDE EFFECTS Deafness and impaired hearing (mainly in elderly dogs) have been reported very rarely. If this occurs, treatment should be stopped. Decreased hearing or deafness is generally temporary in nature. Prolonged use of topical steroids can cause skin discoloration and delay wound healing. The conventional adverse effects of corticosteroids can occur (disturbance of biochemical parameters, such as increased cortisol and hepatic enzyme levels). 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 serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. Side effects can be repor اقرأ الوثيقة كاملة
Page 1 of 6 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Surolan Veterinary 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MG/ML ACTIVE SUBSTANCES: Miconazole Nitrate 23 Prednisolone Acetate 5 Polymyxin B Sulfate 0.5293 For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops suspension and cutaneous suspension. White suspension 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Surolan is used in dogs and cats for the treatment of otitis and skin infections caused by fungi, yeasts, gram negative and gram positive bacteria. ear mites 4.3 CONTRAINDICATIONS Do not use in animals with perforated ear drums since Polymyxin B is known to be a potential ototoxic agent. Do not use in cases of known hypersensitivity to the active substances or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES As the product is a prescription only medicine, treatment should be closely supervised by a veterinary practitioner. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Page 2 of 6 For external use only. Due to the likely variability (temporal, geographical) in the emergence of bacterial resistance to polymyxin B, bacteriological sampling and sensitivity testing (antibiogram) is recommended during treatment. If there is overgrowth of resistance bacteria and/or fungi, treatment with this product should be discontinued and treatment with an appropriate alternative should be initiated. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals Do not handle the product if you are allergic to the ingredients in the product. Accidental spillage on the skin should be washed off immediately with soap and water. Wash hands after use. Corticosteroids may produce irreversible effects in the skin. They can be absorbed and may have harmful effects, especially with frequent and extensive contact or in pregnancy. Always wear single use disposable gloves whe اقرأ الوثيقة كاملة