UpCard
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
14-07-2020
Karatteristiċi tal-prodott
(SPC)
14-07-2020
Rapport ta 'Valutazzjoni Pubblika
(PAR)
06-08-2015
Ingredjent attiv:
Torasemide anhydrous
Disponibbli minn:
Vétoquinol SA
Kodiċi ATC:
QC03CA04
INN (Isem Internazzjonali):
Torasemide
Grupp terapewtiku:
Dogs
Żona terapewtika:
Sulfonamides, plain, High-ceiling diuretics
Indikazzjonijiet terapewtiċi:
For treatment of clinical signs, including oedema and effusion, related to congestive heart failure in dogs.
Sommarju tal-prodott:
Revision: 2
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2015-07-31
Fuljett ta 'informazzjoni
15
B.
PACKAGE LEAFLET
16
PACKAGE LEAFLET:
UPCARD 0.75 MG TABLETS FOR DOGS
UPCARD 3 MG TABLETS FOR DOGS
UPCARD 7.5 MG TABLETS FOR DOGS
UPCARD 18 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 responsible for batch
release:
Vetoquinol SA
Magny-Vernois
70200 Lure
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UpCard 0.75 mg tablets for dogs
UpCard 3 mg tablets for dogs
UpCard 7.5 mg tablets for dogs
UpCard 18 mg tablets for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each tablet contains:
UpCard 0.75 mg tablets for dogs
0.75 mg of torasemide
UpCard 3 mg tablets for dogs
3 mg of torasemide
UpCard 7.5 mg tablets for dogs
7.5 mg of torasemide
UpCard 18 mg tablets for dogs
18 mg of torasemide
UpCard 0.75 mg tablets are oblong white to off-white tablets with 1
break-line on each side. The
tablets can be divided into equal halves.
UpCard 3 mg, 7.5 mg and 18 mg tablets are oblong white to off-white
tablets with 3 break-lines on
each side. The tablets can be divided into equal quarters.
4.
INDICATION(S)
For treatment of clinical signs, including oedema and effusion,
related to congestive heart failure.
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
17
Do not use in cases of renal failure.
Do not use in cases of severe dehydration, hypovolaemia or
hypotension.
Do not use concomitantly with other loop diuretics.
6.
ADVERSE REACTIONS
Increase in renal blood parameters and renal insufficiency are very
commonly observed during
treatment.
As a result of the diuretic action of torasemide, haemoconcentration
and, very commonly, polyuria
and/or polydipsia are observed.
In case of prolonged treatment, electrolyte deficiency (including
hypokalaemia, hypochloraemia,
hypomagnesaemia) and dehydration may occur.
Gastrointestinal signs which include emesis, reduced or absent faeces
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UpCard 0.75 mg tablets for dogs
UpCard 3 mg tablets for dogs
UpCard 7.5 mg tablets for dogs
UpCard 18 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
UpCard 0.75 mg
0.75 mg of torasemide
UpCard 3 mg
3 mg of torasemide
UpCard 7.5 mg
7.5 mg of torasemide
UpCard 18 mg
18 mg of torasemide
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
UpCard 0.75 mg tablets: oblong white to off-white tablets with 1
break-line on each side. The tablets
can be divided into equal halves.
UpCard 3 mg, 7.5 mg and 18 mg tablets: oblong white to off-white
tablets with 3 break-lines on each
side. The tablets can be divided into equal quarters.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of clinical signs, including oedema and effusion,
related to congestive heart failure.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cases of renal failure.
Do not use in cases of severe dehydration, hypovolaemia or
hypotension.
Do not use concomitantly with other loop diuretics.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In dogs presenting in acute crisis with pulmonary oedema, pleural
effusion and/or ascites requiring
emergency treatment, the use of injectable drugs should be considered
first before commencing oral
diuretic therapy.
Renal function, hydration status and serum electrolytes status should
be monitored:
-
at treatment initiation
-
from 24 hours to 48 hours after treatment initiation
-
from 24 hours to 48 hours after dose change
-
in case of adverse events.
While the animal is on treatment, these parameters should be monitored
at very regular intervals
according to the benefit-risk assessment performed by the responsible
veterinarian
Aqra d-dokument sħiħ
