Atipazole 5 mg/ml Solution for Injection for Dogs and Cats

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: VMD (Veterinary Medicines Directorate)

Thành phần hoạt chất:

Atipamezole Hydrochloride

Sẵn có từ:

Vetpharma Animal Health, S.L

Mã ATC:

QV03AB90

INN (Tên quốc tế):

Atipamezole Hydrochloride

Dạng dược phẩm:

Solution for injection

Loại thuốc theo toa:

POM-V - Prescription Only Medicine – Veterinarian

Nhóm trị liệu:

Cats, Dogs

Khu trị liệu:

Neurological Agent

Tình trạng ủy quyền:

Authorized

Ngày ủy quyền:

2013-10-23

Đặc tính sản phẩm

Revised: August 2018
AN: 01963/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ATIPAZOLE 5 mg/ml Solution for injection for dogs and cats
Atipamezole hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
ACTIVE SUBSTANCE:
Atipamezole .................................................4.27 mg
(as atipamezole hydrochloride 5.0 mg)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218) ............1.0 mg
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Solution for Injection.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In
dogs
and
cat:
reversal
of
the
sedative
effects
of
medetomidine
and
dexmedetomidine
Revised: August 2018
AN: 01963/2017
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients. Do not use in breeding animals.
Do not use in animals suffering from hepatic or renal or cardiac
diseases.
See also section 4.7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
After administration of the product, the animals should be allowed to
rest in a
quiet
place.
During
the
recovery
phase,
animals
should
not
be
left
unattended. Make sure the animal has regained a normal swallowing
reflex
before any food or drink is offered.
Due to different dosing recommendations caution should be taken using
the
product off label in animals other than the target species.
If other sedatives different than (dex)medetomidine are administered,
it must
be taken into account that the effects of these other agents are
likely to
persist after the reversal of the effects of (dex)medetomidine.
Atipamezole does not reverse the effect of ketamine, which can cause
seizures in dogs and cause cramps in cats when used alone. Do not
administer
atipamezole
within
30-40
minutes
of
prior
administration
of
ketamine.
ii)
S