Release 300 mg/ml, solution for injection

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Pentobarbital sodium

MAH:

WDT - Wirtschaftsgenossenschaft deutscher Tierarzte eG,

ATC_code:

QN51AA01

INN:

Pentobarbital sodium

dosage:

300 milligram(s)/millilitre

pharmaceutical_form:

Solution for injection

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Cats, Cattle, Chickens, Dogs, Guinea pigs, Hamsters, Mink, Non Food Animals, Non food-producing horses, Other Birds, Pigs, Rabbi

therapeutic_area:

pentobarbital

therapeutic_indication:

Neurological Preparations

authorization_status:

Authorised

authorization_date:

2008-10-24

SPC

Health Products Regulatory Authority
27 August 2019
CRN00934R
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Release 300 mg/ml, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
​
ACTIVE SUBSTANCE:
​
​
pentobarbital sodium
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300 mg
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EXCIPIENTS:
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​
patent blue V
​
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
A clear, blue solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, ponies, cattle, swine, dogs, cats, minks, polecats, hares,
rabbits, guinea pigs, hamsters, rats, mice, chicken, pigeons,
birds, snakes, tortoises, lizards, frogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For euthanasia in animals.
4.3 CONTRAINDICATIONS
Do not use in animals intended for human or animal consumption.
Do not use for anaesthetic purposes.
Do not use for intracoelmic injection in chelonia as the time to death
may be unnecessarily prolonged compared with
intravenous administration.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Carcasses of animals euthanised with this product should be disposed
of in accordance with national legislation.
Carcasses of animals euthanised with this product should not be fed to
other animals due to the risk of secondary intoxication.
The intraperitoneal route of administration may cause a prolonged
onset of action with an increased risk of adverse effects
noted in 4.6. Prior sedation is advisable.
The intrapulmonary route of administration may cause a prolonged onset
of action with an increased risk of adverse effects
noted in 4.6 and should be reserved for cases where other routes of
administration are not possible. Prior sedation is
mandatory before this route of administration is employed.
When euthanasia of poikilotherms is undertaken, the animal must be
maintained at its preferred optimum temperature,
otherwise efficacy may be unreliable. Species appropriate measures
(e.g. pithing) should be taken to ensure that euthanasia is
complete in