Semintra 4 mg/ml Oral Solution for Cats

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Telmisartan

Διαθέσιμο από:

Boehringer Ingelheim Vetmedica Gmbh

Φαρμακολογική κατηγορία (ATC):

QC09CA07

INN (Διεθνής Όνομα):

Telmisartan

Φαρμακοτεχνική μορφή:

Oral solution

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Cats

Θεραπευτική περιοχή:

Miscellaneous

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2013-02-13

Αρχείο Π.Χ.Π.

Issued: July 2023
AN:01478/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Semintra 4 mg/ml oral solution for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Telmisartan
4 mg
EXCIPIENTS:
Benzalkonium chloride
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to yellowish viscous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduction of proteinuria associated with chronic kidney disease (CKD)
in cats.
Treatment of systemic hypertension in cats
4.3
CONTRAINDICATIONS
Do not use during pregnancy or lactation (see also section 4.7).
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Issued: July 2023
AN:01478/2022
Page 2 of 8
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The safety and efficacy of telmisartan for the management of systemic
hypertension above 200 mmHg has not been investigated.
4.5
SPECIAL PRECAUTIONS FOR USE
i). Special precautions for use in animals
The safety and efficacy of telmisartan has not been tested in cats
under the age
of 6 months.
It is good clinical practice to monitor the blood pressure of cats
receiving the
veterinary medicinal product which are under anaesthesia.
Due to the mode of action of the veterinary medicinal product,
transient
hypotension may occur. Symptomatic treatment, e.g. fluid therapy,
should be
provided in case of any clinical signs of hypotension. The dosage of
telmisartan
should be reduced if systolic blood pressure (SBP) is consistently
lower than
120 mmHg or if there are concurrent signs of hypotension.
As known from substances acting on the Renin-Angiotensin-Aldosterone
System (RAAS), a slight decrease in red blood cell count may occur.
Red blood
cell count should be monitored during therapy.
Substances acting on the RAAS may lead to a reduction in glomerular
filtration
rate and worsening renal function in cats wi