Actikor 5 mg Film-coated Tablets for Dogs

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Benazepril Hydrochloride

Tersedia dari:

Ecuphar NV

Kode ATC:

QC09AA07

INN (Nama Internasional):

Benazepril Hydrochloride

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Dogs

Area terapi:

Cardio Vascular ACE inhibitor

Status otorisasi:

Expired

Tanggal Otorisasi:

2011-07-28

Karakteristik produk

Revised: December 2016
AN: 01090/2015
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Actikor 5 mg Film-coated Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
ACTIVE SUBSTANCE:
Benazepril 4.6 mg (equivalent to 5 mg of benazepril hydrochloride).
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Yellow coloured, oval, biconvex, film-coated tablets with a breakline
on one side and plain on
the other side.
The tablets can be divided into two equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs weighing more than 5 kg:
Treatment of congestive heart failure associated with, in particular,
dilated cardiomyopathy or
mitral insufficiency.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or
acute renal failure.
Do not use in cases of cardiac output failure due to aortic stenosis
or pulmonary stenosis.
Do not use during pregnancy or lactation (section 4.7).
Revised: December 2016
AN: 01090/2015
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals

No evidence of renal toxicity to the veterinary medicinal product has
been observed in
dogs during clinical trials, however, as is routine in cases of
chronic kidney disease, it is
recommended to monitor plasma creatinine, urea and erythrocyte counts
during therapy.
Special precautions to be taken by the person administering the
veterinary medicinal product
to animals

ACE inhibitors have been found to affect the unborn child during
pregnancy in humans.
Pregnant women should take special care to avoid accidental exposure,
including hand-
to-mouth contact.

Wash hands after use.

Benazepril may cause hypotension after oral ingestion.

In case of ac