Norofol 10mg/ml Emulsion for Injection for Cats and Dogs
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
22-08-2013
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Active ingredient:
propofol 1 % w/v
Available from:
Norbrook Laboratories Limited
ATC code:
QN01AX10
Pharmaceutical form:
Emulsion for injection
Therapeutic group:
propofol
Therapeutic area:
Cats, Dogs
Authorization date:
2010-09-29
Summary of Product characteristics
Revised: February 2011
AN: 01771/2009
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norofol 10mg/ml Emulsion for Injection for cats and dogs (UK, BG, CZ, LT, RO, SI, SK)
Vetofol 10mg/ml Emulsion for Injection for cats and dogs (AT, CY, EE, FI, DE, EL, LV,
PT, ES)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Propofol
10.0mg
Excipients
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:_
Norofol Injection is indicated for use in dogs and cats as 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 that are hypersensitive to the active substance or any of the
excipients.
Revised: February 2011
AN: 01771/2009
Page 2 of 6
4.4
_SPECIAL WARNINGS FOR EACH TARGET SPECIES:_
If Norofol Injection is injected very slowly, an inadequate plane of anaesthesia can
occur.
Shake the vial gently but thoroughly before
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