Procare 1% w/v emulsion for injection
Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
26-01-2013
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Active ingredient:
propofol 1 %
Available from:
Norbrook Laboratories Limited
ATC code:
QN01AX10
Pharmaceutical form:
Emulsion for injection
Therapeutic group:
propofol
Therapeutic area:
Cats, Dogs
Authorization date:
2012-06-27
Summary of Product characteristics
Revised: November 2012
AN: 00907/2012
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINCAL PRODUCT
Procare 10 mg/ml Emulsion for Injection for Cats and Dogs (UK)
Vetofol 10 mg/ml Emulsion for Injection for Cats and Dogs (FR, IT, IE)
Vetofol vet. 10 mg/ml Emulsion for Injection for Cats and Dogs (SE)
Norfol (NO, DK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Propofol
10.0mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Emulsion for injection.
A white homogeneous emulsion with no appearance of visible droplets or
extraneous foreign particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The veterinary medicinal product is a short-acting, intravenous, general
anaesthetic for procedures of short duration, lasting up to 5 minutes:
For the induction and maintenance of general anaesthesia using
incremental doses to effect,
For the induction of general anaesthesia where maintenance is provided by
inhalation anaesthetics.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active substance or
to any of the excipients.
Revised: November 2012
AN: 00907/2012
Page 2 of 6
4.4
SPECIAL WARNINGS
The product is a stable emulsion; discard the vial if phase separation is
observed. If the product is injected very slowly, an inadequate plane of
anaesthesia can occur.
4.5
SPECIAL PRECAUTIONS FOR
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