Ziapam, 5 mg/ml, Solution for Injection for Cats and Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Diazepam

Available from:

Domes Pharma

ATC code:

QN05BA01

INN (International Name):

Diazepam

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Neurological Agent sedative

Authorization status:

Authorized

Authorization date:

2014-03-05

Summary of Product characteristics

Revised: November 2023
AN: 02182/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ZIAPAM, 5 mg/ml, solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
ACTIVE SUBSTANCE:
Diazepam ..................................... 5.0 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCT
Benzyl Alcohol (E1519)
15.7 mg
Benzoic Acid (E210)
2.5 mg
Sodium Benzoate (E211)
47.5 mg
Propylene Glycol
Ethanol (96 per cent)
Sodium hydroxide (for pH adjustment)
Water for injections
Solution for injection.
Greenish-yellow clear liquid .
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dog and cat
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the short term management of convulsive disorders and skeletal
muscle spasms of
central and peripheral origin.
As part of a pre-anaesthetic or sedation protocol.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Revised: November 2023
AN: 02182/2022
Page 2 of 6
Do not use in cases of severe hepatic disease.
3.4
SPECIAL WARNINGS
For intravenous use only.
Diazepam alone is less likely to be effective as a sedative when used
in animals that
are already excited. Diazepam can cause sedation and disorientation
and should be
used with caution in working animals, such as military, police or
service dogs.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
The product should be used with caution in animals with hepatic or
renal disease and in
debilitated, dehydrated, anaemic, obese, or geriatric animals.
The product should be used with caution in animals in shock, coma, or
with significant
respiratory depression.
The product should be used with caution in animals affected by
glaucoma.
It is not recommended to use diazepam for convulsive disorder control
in cats in c