Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and pet rabbits

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Alfaxalone

Dostupné z:

Jurox (UK) Limited

ATC kód:

QN01AX05

INN (Medzinárodný Name):

Alfaxalone

Dávkovanie:

10 milligram(s)/millilitre

Forma lieku:

Solution for injection

Typ predpisu:

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Terapeutické skupiny:

Cats, Dogs, Rabbits

Terapeutické oblasti:

alfaxalone

Terapeutické indikácie:

Neurological Preparations

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2018-04-27

Súhrn charakteristických

Health Products Regulatory Authority
27 April 2018
CRN000VGT
Page 1 of 10
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and
pet rabbits
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
ACTIVE SUBSTANCE:
​
Alfaxalone
​10 mg
​
EXCIPIENTS:
​
​
Ethanol
​150 mg
Chlorocresol
​1 mg
​
Benzethonium chloride
​0.2 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear colourless solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats and pet rabbits
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an induction agent prior to inhalation anaesthesia in dogs, cats
and pet rabbits.
As a sole anaesthetic agent for the induction and maintenance of
anaesthesia for the
performance of examination or surgical procedures in dogs and cats.
4.3 CONTRAINDICATIONS
Do not use in combination with other intravenous anaesthetic agents.
Do not use on animals with hypersensitivity to the active substance or
any other
excipients.
Health Products Regulatory Authority
27 April 2018
CRN000VGT
Page 2 of 10
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The analgesic properties of alfaxalone are limited, therefore
appropriate
peri-operative analgesia should be provided in cases where procedures
are
anticipated to be painful.
4.5 SPECIAL PRECAUTIONS FOR USE
(i) Special precautions for use in animals
The safety of the veterinary medicinal product in animals less than 12
weeks of age
(dogs and cats) and 16 weeks of age (rabbits) has not been
demonstrated.
Transient post induction apnoea frequently occurs, particularly in
dogs – see section
4.6 for details. In such cases, endotracheal intubation and oxygen
supplementation
should be employed. Facilities for intermittent positive pressure
ventilation should be
available. In order to minimise the possibility of apnoea, administer
the veterinary
medicinal product by slow intravenous injection and not as a rapid
dose.
In rabbits, oxygenation pr