Isemid

Land: Europäische Union

Sprache: Englisch

Quelle: EMA (European Medicines Agency)

Wirkstoff:

Torasemide

Verfügbar ab:

CEVA Santé Animale

ATC-Code:

QC03CA04

INN (Internationale Bezeichnung):

Torasemide

Therapiegruppe:

Dogs

Therapiebereich:

High-ceiling diuretics, Sulfonamides, plain

Anwendungsgebiete:

For treatment of clinical signs related to congestive heart failure in dogs, including pulmonary oedema.

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2019-01-09

Gebrauchsinformation

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET
ISEMID 1 MG CHEWABLE TABLETS FOR DOGS (2.5-11.5 KG)
ISEMID 2 MG CHEWABLE TABLETS FOR DOGS (> 11.5-23 KG)
ISEMID 4 MG CHEWABLE TABLETS FOR DOGS (> 23-60 KG)
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Ceva Santé Animale
10, av. de La Ballastière
33500 Libourne
France
Manufacturer responsible for batch release:
Ceva Santé Animale
ZI Très le Bois
22600 Loudéac
France
Ceva Santé Animale
Boulevard de la Communication,
Zone autoroutière
53950 Louverne
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Isemid 1 mg chewable tablets for dogs (2.5-11.5 kg)
Isemid 2 mg chewable tablets for dogs (> 11.5-23 kg)
Isemid 4 mg chewable tablets for dogs (> 23-60 kg)
torasemide
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each chewable tablet contains:
ACTIVE SUBSTANCE:
Isemid 1 mg
1 mg of torasemide
Isemid 2 mg
2 mg of torasemide
Isemid 4 mg
4 mg of torasemide
The tablets are brown coloured, oblong shaped, chewable and can be
divided into halves.
4.
INDICATION(S)
For treatment of clinical signs related to congestive heart failure in
dogs, including pulmonary
oedema.
18
5.
CONTRAINDICATIONS
Do not use in cases of renal failure.
Do not use in cases of dehydration, hypovolaemia or hypotension.
Do not use concomitantly with other loop diuretics.
Do not use in cased of hypersensitivity to the active substance or to
any of the excipients.
6.
ADVERSE REACTIONS
In a clinical field study, renal insufficiency, a transient increase
in renal blood parameters,
haemoconcentration and alterations in electrolyte levels (chloride,
sodium, potassium, phosphorus,
magnesium, calcium) were very commonly observed.
The following clinical signs were observed commonly: episodic
gastrointestinal signs such as
vomiting and diarrhoea, dehydration, polyuria, polydipsia, urinary
incontinence, anorexia, weight loss
and lethargy.
Other effects consistent with the

Fachinformation

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Isemid 1 mg chewable tablets for dogs (2.5-11.5 kg)
Isemid 2 mg chewable tablets for dogs (> 11.5-23 kg)
Isemid 4 mg chewable tablets for dogs (> 23-60 kg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
ACTIVE SUBSTANCE:
Isemid 1 mg
1 mg of torasemide
Isemid 2 mg
2 mg of torasemide
Isemid 4 mg
4 mg of torasemide
EXCIPIENTS:
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Chewable tablet.
Oblong brown scored tablets. The tablet can be divided into halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of clinical signs related to congestive heart failure in
dogs, including pulmonary
oedema.
4.3
CONTRAINDICATIONS
Do not use in cases of renal failure.
Do not use in cases of dehydration, hypovolaemia or hypotension.
Do not use concomitantly with other loop diuretics.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The initial/maintenance dose may be temporarily increased when
pulmonary oedema becomes more
severe, i.e. reaching alveolar oedema state (see section 4.9).
_ _
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In dogs presenting with acute pulmonary oedema requiring emergency
treatment, the use of injectable
medicinal products should be considered first before commencing oral
diuretic therapy.
Renal function (measurement of blood urea and creatinine as well as
urine protein: creatinine (UPC)
ratio), hydration status and serum electrolytes status should be
monitored prior to and during treatment
3
at very regular intervals according to the benefit-risk assessment
performed by the responsible
veterinarian (see sections 4.3 and 4.6 of the SPC). The diuretic
response to torasemide may increase
over time upon repeated dosing, particularly at doses greater than 0.2
mg/kg/day; therefore more
fre