Telmitraxx 4 mg/ml Oral Solution for Cats

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Telmisartan

Διαθέσιμο από:

Alfasan Nederland B.V.

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:

2023-07-21

Αρχείο Π.Χ.Π.

Issued: July 2023
AN: 02993/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Telmitraxx 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
Disodium edetate
1.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear and colourless to yellow solution practically free from
particles.
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).
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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.
Issued: July 2023
AN: 02993/2021
Page 2 of 6
It is good clinical practice to monitor the blood pressure of cats
receiving
telmisartan 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.
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 with severe kidney disease. The safety and efficacy of
telmisartan in
such patients has not been investigated. When using this veterinary
medicinal
product in cats with severe kidney disease, it is advisable to monitor
renal
function (plasma creatinine concentration).
ii). Special precautions to be take