PROPOFLO PLUS, 10 MG/ML, EMULSION FOR INJECTION FOR DOGS AND CATS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
12-05-2024
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Active ingredient:
PROPOFOL
Available from:
Abbott Laboratories Limited
ATC code:
QN01AX10
Dosage:
10 Mg/Ml
Pharmaceutical form:
Emulsion for Injection
Therapeutic group:
Anaesthetic/Analgesic
Therapeutic area:
Canine
Authorization date:
2012-04-27
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PropoFlo Plus, 10 mg/ml, emulsion for injection for dogs and cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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 dogs.
Do not use in animals with known hypersensitivity to the active substance or to any of the excipients.
Each ml contains:
ACTIVE SUBSTANCE:
Propofol
10 mg
EXCIPIENT:
Benzyl alcohol (E1519)
20 mg
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/04/2012_
_CRN 7011659_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
This product is a stable emulsion; discard the vial if phase separation is observed. Shake the vial gently but thoroughly
before withdrawing a dose.
If this product is injected very slowly, an
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