国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
benazepril hydrochloride, pimobendan
Elanco GmbH
QC09BX90
benazepril, pimobendan
Dogs
ACE inhibitors, combinations
For the treatment of congestive heart failure due to atrioventricular valve insufficiency or dilated cardiomyopathy in dogs.
Revision: 4
Authorised
2015-09-08
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: FORTEKOR PLUS 1.25 MG/2.5 MG TABLETS FOR DOGS FORTEKOR PLUS 5 MG/10 MG TABLETS 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: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany Manufacturer responsible for batch release: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs pimobendan/benazepril hydrochloride 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains ACTIVE SUBSTANCES: pimobendan benazepril hydrochloride FORTEKOR PLUS 1.25 mg/2.5 mg tablets 1.25 mg 2.5 mg FORTEKOR PLUS 5 mg/10 mg tablets 5 mg 10 mg EXCIPIENTS: iron oxide brown E172 FORTEKOR PLUS 1.25 mg/2.5 mg tablets 0.5 mg FORTEKOR PLUS 5 mg/10 mg tablets 2 mg The tablets are bilayered, oval, white and light brown, and can be divided into halves along the score line. 4. INDICATION(S) For the treatment of congestive heart failure due to atrioventricular valve insufficiency or dilated cardiomyopathy in dogs. FORTEKOR PLUS is a fixed dose combination and should only be used in patients whose clinical signs are successfully controlled by administration of the same doses of the individual components (pimobendan and benazepril hydrochloride) given concurrently. 18 5. CONTRAINDICATIONS Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis. Do not use in cases of hypotension (low blood pressure), hypovolemia (low blood volume), hyponatremia (low blood sodium levels) or acute renal (kidney) failure. Do not use in pregnant or lactating dogs (see section “SPECIAL WARNINGS"). Do not use in cases of hypersensitivity to pimobendan, to benazepril hydrochloride or to any ingredient of the tablets. 6. ADVERSE REACTIONS Pimobendan: A moderate positive chronotropic effect and vomit 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCES: pimobendan benazepril hydrochloride FORTEKOR PLUS 1.25 mg/2.5 mg tablets 1.25 mg 2.5 mg FORTEKOR PLUS 5 mg/10 mg tablets 5 mg 10 mg EXCIPIENTS: iron oxide brown (E172) FORTEKOR PLUS 1.25 mg/2.5 mg tablets 0.5 mg FORTEKOR PLUS 5 mg/10 mg tablets 2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. White and light brown oval bilayer tablets with a score line on both sides. The tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of congestive heart failure due to atrioventricular valve insufficiency or dilated cardiomyopathy in dogs. FORTEKOR PLUS is a fixed dose combination and should only be used in patients whose clinical signs are successfully controlled by administration of the same doses of the individual components (pimobendan and benazepril hydrochloride) given concurrently. 4.3 CONTRAINDICATIONS Do not use in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic or pulmonary stenosis). Do not use in cases of hypotension, hypovolaemia, hyponatremia or acute renal failure. Do not use during pregnancy and lactation (see section 4.7). Do not use in cases of hypersensitivity to the active substances or to any of the excipients. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals In cases of chronic kidney disease, it is recommended to check the dog’s hydration status before starting therapy, and to monitor its plasma creatinine and blood erythrocyte counts during therapy. As pimobendan is metabolised in the liver, the product 完全なドキュメントを読む