Semintra
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
14-01-2019
Charakterystyka produktu
(SPC)
14-01-2019
Sprawozdanie z oceny publicznego
(PAR)
25-06-2018
Składnik aktywny:
Telmisartan
Dostępny od:
Boehringer Ingelheim Vetmedica GmbH
Kod ATC:
QC09CA07
INN (International Nazwa):
telmisartan
Grupa terapeutyczna:
Cats
Dziedzina terapeutyczna:
Agents acting on the renin-angiotensin system, Angiotensin II antagonists, plain
Wskazania:
Reduction of proteinuria associated with chronic kidney disease (CKD).
Podsumowanie produktu:
Revision: 6
Status autoryzacji:
Authorised
Data autoryzacji:
2013-02-13
Ulotka dla pacjenta
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET:
SEMINTRA 4 MG/ML ORAL SOLUTION FOR CATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Semintra 4 mg/ml oral solution for cats
Telmisartan
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One ml contains:
Telmisartan
4 mg
Benzalkonium chloride
0.1 mg
Clear, colourless to yellowish viscous solution.
4.
INDICATION(S)
Reduction of proteinuria associated with chronic kidney disease (CKD)
in cats.
5.
CONTRAINDICATIONS
Do not use during pregnancy or lactation. See section “Pregnancy and
lactation”.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
6.
ADVERSE REACTIONS
The following mild and transient gastrointestinal signs have rarely
been observed in a clinical study
(in order of decreasing frequency): mild and intermittent
regurgitation, vomiting, diarrhoea or soft
faeces.
Elevated liver enzymes have been very rarely observed and values
normalised within a few days
following cessation of therapy.
Effects attributable to the pharmacological activity of the product
observed at the recommended
treatment dose included reductions in blood pressure and decreases in
red blood cell counts.
27
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treated displaying adverse
reactions)
-
common (more than 1 but less than 10 animals in 100 animals treated)
-
uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
-
rare (more than 1 but less than 10 animals in 10,000 animals treated)
-
very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
If you notice any side effects, even those not already listed in this
package leaflet or you t
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Semintra 4 mg/ml oral solution for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 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.
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
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 Semintra 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
3
patients has not been investigated. When using this product in cats
with severe kidney disease, it is
advisable to monitor renal function (plasma creatinine concentration).
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
In case of accidental ingestion, seek medical advice immediately and
show th
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