Somulose Solution for Injection

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Secobarbital sodium; Cinchocaine Hydrochloride

Предлага се от:

Dechra Regulatory B.V.

АТС код:

QN05CB02

INN (Международно Name):

Secobarbital sodium; Cinchocaine Hydrochloride

дозиране:

400/25 milligram(s)/millilitre

Лекарствена форма:

Solution for injection

Вид предписание :

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична област:

barbiturates in combination with other drugs

Статус Оторизация:

Authorised

Дата Оторизация:

2006-10-06

Данни за продукта

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Somulose solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCES:
Secobarbital Sodium (Quinalbarbitone Sodium)
400 mg
Cinchocaine Hydrochloride
25 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
Clear, slightly straw coloured viscous solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, cats, horses and cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For euthanasia in dogs, cats, horses and cattle only.
4.3
CONTRAINDICATIONS
The combination product must not be used for anaesthesia, it is
non-sterile.
When used in horses or cattle do not use the carcass for animal
consumption.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Non-vascular administration may delay onset of effect, cause pain and
result in excitement.
Rarely, horses may show resistance to euthanasia and prior use of
sedation should be
considered in each case (see also under section 4.9). It is always
advisable to have an
alternative method of euthanasia available.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Care should be taken not to excite the animal. The dose is to be
administered intravenously
only (see also under section 4.9).
It is strongly recommended that carcasses of animals euthanased with
Somulose are
incinerated.
Special precautions to be taken by the person administering the
veterinary medicinal product
to animals
Somulose is a potent drug which is highly toxic to man. Extreme care
should be taken to avoid
accidental self-injection. Use an intravenous catheter instead of a
needle whenever possible.
Wear suitable protective gloves when handling the product. Wash off
splashes from skin and
eyes immediately. Wash hands after use.
Due to the rapid onset of action of secobarbitone if accidentally
self-administered, this product
should only be administered in the presence of an assistant/other
individual.
Once the required dose