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

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Alfaxalone

可用日期:

Jurox (Ireland) Limited

ATC代码:

QN01AX05

INN（国际名称）:

Alfaxalone

剂量:

10 milligram(s)/millilitre

药物剂型:

Solution for injection

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗领域:

alfaxalone

授权状态:

Authorised

授权日期:

2008-05-16

产品特点

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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