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

Issued: February 2019
AN: 01678/2017
Page 1 of 5
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
EXCIPIENT(S):
Benzyl Alcohol (E1519)
15.7 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Yellow-green, clear solution for injection, pH 6.2-7.2
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE 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.
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
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.
Issued: February 2019
AN: 01678/2017
Page 2 of 5
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
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
use of
diazepam alone