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

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Alfaxalone

Dostopno od:

Zoetis Belgium S.A.

Koda artikla:

QN01AX05

INN (mednarodno ime):

Alfaxalone

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

alfaxalone

Datum dovoljenje:

2008-05-16

Lastnosti izdelka

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 hypoxaemia/hypercapnea.
This should be particularly
important in risky anaesthetic cases and whenever the anaes