EUTHATAL solution for injection 200 mg in 1 ml

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Pentobarbital sodium

Tillgänglig från:

Dopharma Research B.V.

ATC-kod:

QN51AA01

INN (International namn):

Pentobarbital sodium

Dos:

200 milligram(s)/millilitre

Läkemedelsform:

Solution for injection

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapiområde:

pentobarbital

Bemyndigande status:

Authorised

Tillstånd datum:

1995-10-01

Produktens egenskaper

Health Products Regulatory Authority
02 August 2019
CRN0097FP
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
EUTHATAL solution for injection 200 mg in 1 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
​
​
ACTIVE SUBSTANCE
Pentobarbital sodium
200
mg
​
​
​
EXCIPIENTS
Patent Blue V (E131)
0.01
mg
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Blue aqueous solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats and other small animals.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Euthanasia in dogs, cats and other small animals.
4.3 CONTRAINDICATIONS
Do not use for anaesthetic purposes.
Carcasses of animals, which have been euthanased with the product,
must not be used for animal consumption.
Do not administer by intramuscular route.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In some circumstances the intrathoracic or intracardiac routes of
administration may be used, but only as a last resort. The
choice of these routes should be made in the light of the attendant
difficulties and the unnecessary pain and distress to the
animal which could result. When it is anticipated that euthanasia may
be problematical (e.g. aggressive patients),
premedication with appropriate sedative is recommended.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In the event of accidental administration to an animal not presented
for euthanasia, measures such as artificial respiration,
administration of oxygen, and the use of analeptics are appropriate.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
In the case of accidental self-administration, seek urgent medical
attention, advising medical service of barbiturate poisoning.
Pentobarbital is a potent drug, which is toxic to man. Particular care
should be taken to avoid accidental ingestion and
self-injection.
Health Products Regulatory Authority
02 August 2019
CRN0097FP
Page 2 of 3
In the