Repose 500 mg/ml solution for injection

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Pentobarbital sodium

제공처:

Le Vet Beheer B.V.

ATC 코드:

QN51AA01

INN (국제 이름):

Pentobarbital sodium

복용량:

500 milligram(s)/millilitre

약제 형태:

Solution for injection

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

Cats, Cattle, Dogs, Hamsters, Horses, Mink, Pigs, Rabbits, Rodents, Sheep

치료 영역:

pentobarbital

치료 징후:

Neurological Preparations

승인 상태:

Authorised

승인 날짜:

2017-05-05

제품 특성 요약

1
_[Version 8.2,01/2021] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Repose 500 mg/ml solution for injection (AT, BE, BG, CY, CZ, EL, ES,
HR, HU, IE, IT, LU, MT,
PT, RO, SI, SK, UK)
Repose vet 500 mg/ml solution for injection (DK, FI, IS, NO, SE, EE,
LT, LV, PL)
Repose solution for injection (FR)
Euthasol 500 mg/ml solution for injection (NL)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Pentobarbital sodium
500 mg
(Equivalent to 455.7 mg pentobarbital)
EXCIPIENTS
Patent blue V (E131)
0.01 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, blue aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, cats, rodents, rabbits, cattle, sheep, goats, pigs, horses and
minks.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Euthanasia.
4.3
CONTRAINDICATIONS
Do not use for anaesthesia.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Intravenous injection of pentobarbital has the ability to cause
induction excitement in several species
of animal and adequate sedation should be applied if deemed necessary
by the veterinary surgeon. In
horses, cattle and pigs, premedication with an appropriate sedative is
mandatory to produce profound
sedation before euthanasia. Measures should be taken to avoid
perivascular administration (e.g. by
using an intravenous catheter).
In pigs, it was shown that there is a direct correlation between
restraint and level of excitation and
agitation. Therefore, injection in pigs should be done with the least
amount of restraint necessary.
Due to the difficulty of safe intravenous injections in pigs, adequate
sedation of the animal before IV
administration of pentobarbital is mandatory.
3
The intraperitoneal route of administration may cause a prolonged
onset of action with an increased
risk of induction excitement. Intraperitoneal administration must only
be used following appropriate
sedation. Measures should be taken to avoid administration into the
spl