Telmitraxx 4mg/ml oral solution for cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Telmisartan

Available from:

Alfasan Nederland B.V

ATC code:

QC09CA07

INN (International Name):

Telmisartan

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

telmisartan

Authorization date:

2023-08-04

Summary of Product characteristics

1
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 PRODUC
t
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.
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.
2
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
creatini