ALFAXAN 10 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
16-09-2016
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Aktivna sestavina:
ALFAXALONE
Dostopno od:
Jurox (UK) Limited
Koda artikla:
QN01AX05
INN (mednarodno ime):
ALFAXALONE
Odmerek:
10 Mg/Ml
Farmacevtska oblika:
Solution for Injection
Tip zastaranja:
VPO-Vet.Practitioner Only
Terapevtska skupina:
Canine, Feline
Terapevtsko območje:
Alfaxalone
Terapevtske indikacije:
Neurological Preparations
Status dovoljenje:
Authorised
Datum dovoljenje:
2008-05-16
Lastnosti izdelka
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. As a sole anaesthetic agent for the induction and maintenance of
anaesthesia for the performance of examination or surgical procedures.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 01/09/2016_
_CRN 7024443_
_page number: 1_
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 vet
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