Solupam 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:

Dechra Regulatory B.V.

ATC code:

QN05BA01

INN (International Name):

Diazepam

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

diazepam

Authorization date:

2019-03-29

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Solupam 5 mg/ml solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml 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)
Sodium Benzoate (E211)
Propylene Glycol
Ethanol (96 per cent)
Water for injections
Clear, yellow-green solution , pH 6.2-7.2
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs and cats.
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.
Do not use in cases of severe hepatic disease.
3.4
SPECIAL WARNINGS
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 case of chronic
poisoning by pesticides (chlorpyrifos) as the toxicity of these
organophosphates may be potentiated.
Paradoxical reactions (including excitation, a disinhibiting effect
and aggression) may be observed if
diazepam is used as a sole agent, therefore avoid the u