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

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: VMD (Veterinary Medicines Directorate)

Veiklioji medžiaga:

Diazepam

Prieinama:

Dechra Regulatory BV

ATC kodas:

QN05BA01

INN (Tarptautinis Pavadinimas):

Diazepam

Vaisto forma:

Solution for injection

Recepto tipas:

POM-V - Prescription Only Medicine – Veterinarian

Farmakoterapinė grupė:

Cats, Dogs

Gydymo sritis:

Neurological Agent sedative

Autorizacija statusas:

Authorized

Leidimo data:

2019-02-20

Prekės savybės

Revised: June 2023
AN: 01587/2022
Page 1 of 6
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.
Revised: June 2023
AN: 01587/2022
Page 2 of 6
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 (includin