מדינה: גרמניה
שפה: אנגלית
מקור: HMA (Heads of Medicines Agencies)
ramipril 1.25 mg
aniMedica GmbH
QC09AA05
Tablet
ramipril
Dogs
2012-01-19
1 PACKAGE LEAFLET Prilocard 1.25 mg 2.5 mg, 5 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 and manufacturer for the batch release: aniMedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany. 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Prilocard 1.25 mg 2.5 mg, 5 mg tablets for dogs. Active substance: ramipril. 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Prilocard 1.25mg tablets for dogs Each tablet contains: Active substance: ramipril 1.25mg Excipients: anhydrous lactose, glycerol dibehenate, sodium starch glycolate, sodium stearyl fumarate White round biconvex tablets, imprinted with 'B' on one side of the tablet and '48' on the other. Prilocard 2.5 mg tablets for dogs Each tablet contains: Active substance: ramipril 2.5mg Excipients: anhydrous lactose, glycerol dibehenate, sodium starch glycolate, sodium stearyl fumarate, yellow ferric oxide 0.40mg (E172) Light yellow capsule-shaped biconvex tablets scored on one side of the tablet and imprinted with 'B' and '49' on either side of the scoring line. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Prilocard 5 mg tablets for dogs Each tablet contains: Active substance: ramipril 5mg Excipients: anhydrous lactose, glycerol dibehenate, sodium starch glycolate, sodium stearyl fumarate, red ferric oxide 0.20mg (E172) Pink capsule-shaped biconvex tablets scored on one side of the tablet and imprinted with 'B' and '50' on either side of the scoring line. 2 The scoreline is only to facilitate breaking for ease of swallo קרא את המסמך השלם
_ _ _ _ _ _ _Page 1 of 7_ SUMMARY OF PRODUCT CHARACTERISTICS FOR PRILOCARD 2.5MG TABLETS FOR DOGS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Prilocard 2.5mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Prilocard 2.5 mg tablets for dogs Each tablet contains: Active substance: ramipril 2.5mg Excipients: yellow ferric oxide 0.40mg (E172) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. 2.5mg tablets Light yellow capsule-shaped biconvex tablets scored on one side of the tablet and imprinted with 'B' and '49' on either side of the scoring line. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. _ _ _ _ _Page 2 of 7_ 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For treatment of congestive heart failure (equivalent to New York Heart Association [NYHA] classes II, III and IV) caused by valvular insufficiency due to endocardiosis or cardiomyopathy. The preparation may if applicable be administered concomitantly with furosemide (diuretic) and/or the cardiac glycosides digoxin or methyl digoxin. Class Clinical symptoms II Fatigue, dyspnoea, cough etc. seen in normal activity. Ascites may occur at this stage. III Comfortable at קרא את המסמך השלם