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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
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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.
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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
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