Acecare 2 mg/ml Solution for Injection for Dogs and Cats

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Acepromazine maleate

Dostępny od:

Ecuphar NV

Kod ATC:

QN05AA04

INN (International Nazwa):

Acepromazine maleate

Dawkowanie:

2 milligram(s)/millilitre

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Dziedzina terapeutyczna:

acepromazine

Status autoryzacji:

Authorised

Data autoryzacji:

2016-07-15

Charakterystyka produktu

Health Products Regulatory Authority
30 August 2021
CRN00CH1L
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Acecare 2 mg/ml Solution for Injection for Dogs and Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains
ACTIVE SUBSTANCE:
​
​
Acepromazine
​
2 mg
​
(as acepromazine maleate
​
2.71 mg)
​
EXCIPIENTS:
​
​
Phenol (as preservative)
​
3 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and Cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Anaesthetic Premedication: Following acepromazine administration, the
amount of anaesthetic necessary to induce anaesthesia
is considerably reduced. This reduction is approximately one-third of
a suitable induction agent.
Tranquilisation: Acepromazine tranquilisation (ataraxy) involves a
modification of temperament which is not associated with
hypnosis, narcosis or marked sedation. This is achieved with low doses
of acepromazine.
Sedation: At higher dose rates acepromazine is a sedative.
4.3 CONTRAINDICATIONS
Do not use in pregnant animals.
Do not use on a long term basis in individual animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Acepromazine is hypotensive. Particular care should therefore be taken
in hypovolaemic animals; rehydration should precede
acepromazine administration.
Acepromazine may cause hypothermia due to depression of the
thermoregulatory centre and peripheral vasodilation.
In some dogs, particularly Boxers and other short-nosed breeds,
spontaneous fainting or syncope may occur due to sinoatrial
block caused by excessive vagal tone. An attack may be precipitated by
an injection of acepromazine, so a low dose should be
used.
Where there is a history of this type of syncope, or if it is
suspected because of excessive sinus arrhythmia, it may be
advantageous to control the