ALFAXAN 10 mg/ml solution for injection for dogs and cats

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Alfaxalone

זמין מ:

Jurox (Ireland) Limited

קוד ATC:

QN01AX05

INN (שם בינלאומי):

Alfaxalone

כמות:

10 milligram(s)/millilitre

טופס פרצבטיות:

Solution for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

איזור תרפויטי:

alfaxalone

מצב אישור:

Authorised

תאריך אישור:

2008-05-16

מאפייני מוצר

Health Products Regulatory Authority
01 October 2020
CRN009V7G
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
ALFAXAN 10 mg/ml solution for injection for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Alfaxalone 10 mg/ml
For a 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 and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an induction agent prior to inhalation anaesthesia in dogs and cats
. 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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
During recovery, it is preferable that animals are not handled or
disturbed. This may lead to paddling, minor muscle twitching
or movements that are more violent. While better avoided, such
reactions are clinically insignificant.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Appropriate analgesia should be provided in cases where procedures are
anticipated to be painful.
The safety of the veterinary medicinal product in animals less than 12
weeks of age 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.
Especially when using higher doses of the veterinary medicinal
product, a dose-dependent respiratory depression may occur.
Oxygen and/or intermittent positive pressure ventilation should be
administered to counteract the threatening
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