EUTHATAL solution for injection 200 mg in 1 ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pentobarbital sodium

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QN51AA01

INN (International Name):

Pentobarbital sodium

Dosage:

200 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Therapeutic area:

pentobarbital

Authorization status:

Authorised

Authorization date:

1995-10-01

Summary of Product characteristics

Health Products Regulatory Authority
07 December 2018
CRN008MPR
Page 1 of 4
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.
Health Products Regulatory Authority
07 December 2018
CRN008MPR
Page 2 of 4
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.
In the event of an acciden