Telmitraxx 4 mg/ml Oral Solution for Cats

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Telmisartan

متاح من:

Alfasan Nederland B.V.

ATC رمز:

QC09CA07

INN (الاسم الدولي):

Telmisartan

الشكل الصيدلاني:

Oral solution

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Cats

المجال العلاجي:

Miscellaneous

الوضع إذن:

Authorized

تاريخ الترخيص:

2023-07-21

خصائص المنتج

Issued: July 2023
AN: 02935/2021
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:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Benzalkonium chloride solution
0.1 mg
Maltitol
Hydroxyethylcellulose
Disodium edetate
1.0 mg
Water, purified
Sodium hydroxide
Hydrochloric acid, dilute
Clear and colourless to yellow solution practically free from
particles
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cats
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Reduction of proteinuria associated with chronic kidney disease (CKD).
3.3
CONTRAINDICATIONS
Do not use during pregnancy or lactation (see also section 3.7).
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
3.4
SPECIAL WARNINGS
None.
Issued: July 2023
AN: 02935/2021
Page 2 of 6
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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 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 vet