Diazedor 5 mg/ml solution for injection for dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diazepam

Available from:

Richter Pharma AG

ATC code:

QN05BA01

INN (International Name):

Diazepam

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

diazepam

Therapeutic indications:

Sedative

Authorization status:

Authorised

Authorization date:

2018-06-01

Summary of Product characteristics

Health Products Regulatory Authority
08 June 2018
CRN000V58
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Diazedor 5 mg/ml solution for injection for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains:
​
ACTIVE SUBSTANCE:
​
​
Diazepam
​
5.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless to greenish-yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cats and dogs:
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.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or to any of the
excipients.
Do not use in cases of severe hepatic disease.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES

For strict intravenous use.

Diazepam alone is less likely to be effective as a sedative when used
in
animals that are already excited.
Health Products Regulatory Authority
08 June 2018
CRN000V58
Page 2 of 6

Diazepam can cause sedation and disorientation and should be used with
caution in working animals, such as military, police or service dogs.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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 case
of chronic chlorpyrifos toxicosis as organophosphate's toxicity may be
potentiated.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
This product is a CNS depressant. Av