देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: VMD (Veterinary Medicines Directorate)
Lufenuron, Milbemycin Oxime (A3 and A4)
Elanco Europe Ltd
QP54AB51
Lufenuron, Milbemycin Oxime (A3 and A4)
Film-coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Insect Growth Regulator
Expired
2014-06-23
Revised: November 2016 AN: 01048/2016 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PROTECT FLEA AND WORM TREATMENT TABLETS FOR MEDIUM DOGS 11.5 mg/ 230 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCES Milbemycin oxime 11.5 mg Lufenuron 230.0 mg Excipient: Titanium dioxide (E171) 3.7 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets White, pentagonal, biconvex, bevel-edged, coated tablets with “GLG” on one side and “CGV” on the reverse. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Protect Flea and Worm Treatment is used for the prevention of fleas (_Ct. felis, _ _Ct. canis_, preadult stages), and for the concurrent prevention of heartworm (elimination of L3/L4 larval stages of _Dirofilaria immitis) _and/or treatment of adult stages of gastrointestinal nematodes such as hookworms (_Ancylostoma _ _caninum)_, roundworms (_Toxocara canis) _and whipworms (_Trichuris vulpis_). 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance, to the adjuvants or to any of the excipients. Revised: November 2016 AN: 01048/2016 Page 2 of 6 4.4 SPECIAL WARNINGS Ideally, tablets are administered on the same day each month. If an interval is greater than 6 weeks, treatment should be resumed immediately and be continued at monthly intervals and, in case of heartworm prevention, a veterinarian should be consulted. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals In heartworm risk regions_, _or in case it is known that a dog has been travelling to and from heartworm risk regions, before commencing Protect Flea and Worm Treatment, as with any other heartworm preventive, a veterinary consultation is advised to exclude the presence of any concurrent infestation of _Dirofilaria immitis_. In the case of a positive diagnosis, adulticidal therapy is indicated before administering Pr पूरा दस्तावेज़ पढ़ें