Bexepril 5 mg Film-coated tablet for dogs

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Benazepril hydrochloride

Sẵn có từ:

Chanelle Pharmaceuticals Manufacturing Limited

Mã ATC:

QC09AA07

INN (Tên quốc tế):

Benazepril hydrochloride

Liều dùng:

5 mg/tablet

Dạng dược phẩm:

Film-coated tablet

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Nhóm trị liệu:

Dogs

Khu trị liệu:

benazepril

Chỉ dẫn điều trị:

Cardiovascular

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2010-06-04

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bexepril 5 mg Film-coated tablet for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril
4.6 mg
(equivalent to Benazepril Hydrochloride 5mg)
EXCIPIENT:
Titanium Dioxide (E171)
0.9348 mg
Iron Oxide Yellow (E172)
0.0476 mg
Quinoline Yellow Aluminum Lake (E104)
0.0176mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
A round yellow biconvex tablet with break line on one side. The
tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs weighing more than 10 kg:
Treatment of congestive heart failure associated with, in particular,
dilated cardiomyopathy and/or mitral insufficiency.
4.3 CONTRAINDICATIONS
Do not use in any dog that has evidence of cardiac output failure due,
for example, to aortic stenosis.
Do not use in animals known to be hypersensitive to the active
substance or to any of the excipient(s).
See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_8_
_/_
_0_
_9_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_4_
_6_
_2_
_2_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxicity to the product has been observed in dogs
during clinical trials. How