Dolethal 200 mg/ml Solution for Injection for dogs and cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pentobarbital sodium

Available from:

Vetoquinol Ireland Limited

ATC code:

QN51AA01

INN (International Name):

Pentobarbital sodium

Dosage:

200 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

pentobarbital

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

1990-10-01

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dolethal 200 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS:
ACTIVE SUBSTANCE:
Pentobarbital Sodium
200
mg
EXCIPIENT:
Benzyl Alcohol
0.0104
ml
Cochineal Red A (E124)
0.01
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A red aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Euthanasia of dogs and cats.
4.3
CONTRAINDICATIONS
Not for anaesthetic use.
Not for use in animals intended for animal or human consumption.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
It may be necessary to increase the dose for older animals weighing
more than 10 kg.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Any volume administered outside the vein will reduce the efficacy of
the dose.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Lethal to humans.
Particular care should be taken to avoid accidental exposure to the
product.
To avoid accidental spraying of the product in the face and eyes, care
should be taken during the
injection to ensure the pressure on the syringe is not too great.
Wear suitable protective gloves and glasses when handling the product.
Avoid accidental self-
administration and self-injection.
In the case of accidental self-administration (injection, ingestion,
skin absorption), seek URGENT
medical attention, advising medical services of barbiturate poisoning.
In the case of accidental contact with eyes, irrigate eyes immediately
with flowing cold or tepid water.
In the case of contact with skin, wash immediately with water and then
thoroughly with soap and
water.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not relevant.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For intraveno