PropoFlo Plus 10mg/ml Emulsion for Injection
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
07-09-2013
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Active ingredient:
propofol 0 g/ml
Available from:
Abbot Laboratories Ltd
ATC code:
QN01AX10
Pharmaceutical form:
Emulsion for injection
Therapeutic group:
propofol
Therapeutic area:
Cats, Dogs
Authorization date:
2012-03-21
Summary of Product characteristics
Revised: March 2013
AN: 01360/2012
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PropoFlo Plus, 10 mg/ml, emulsion for injection for dogs and cats (UK & IE)
PropoVet Multidose 10 mg/ml emulsion for injection for cats and dogs (AT, BE, DK,
ES, FI, FR, IS, LU, NL, NO, PT & SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Propofol, 10 mg/ml
EXCIPIENT(S):
Benzyl alcohol (E1519), 20 mg/ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
A white emulsion with no evidence of phase separation
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The veterinary medicinal product is indicated for therapeutic use in dogs and cats as
a short-acting, intravenous general anaesthetic with a short recovery period:
For procedures of short duration, lasting up to approximately 5 minutes.
For induction of general anaesthesia where maintenance is provided by inhalation
anaesthetic agents.
For induction and short-term maintenance of general anaesthesia by administration
of incremental doses of the product to effect for approximately half an hour (30
minutes), not to exceed the total dose stated in section 4.3.
Revised: March 2013
AN: 01360/2012
Page 2 of 7
4.3 CONTRAINDICATIONS
Do not use for prolonged infusion (see section 4.5).
Do not exceed a total dose in one anaesthetic episode of 24 mg/kg (2.4 ml/kg) of
propofol in cats or
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