PROPOSURE 10 MG/ML EMULSION FOR INJECTION FOR DOGS AND CATS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROPOFOL

Available from:

Cyton Biosciences Ltd

ATC code:

QN01AX10

INN (International Name):

PROPOFOL

Dosage:

10 Mg/Ml

Pharmaceutical form:

Emulsion for Injection

Prescription type:

VPO-Vet.Practitioner Only

Therapeutic group:

Canine, Feline

Therapeutic area:

Propofol

Therapeutic indications:

Anaesthetic/Analgesic

Authorization status:

Authorised

Authorization date:

2017-03-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Proposure 10 mg/ml emulsion for injection for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Propofol
10 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for injection.
White or almost white, homogenous emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
A short-acting, intravenous general anaesthetic with a short recovery
period. Intended for brief procedures lasting up to
five minutes.
For induction and maintenance of general anaesthesia by administration
of incremental doses to effect.
For induction of general anaesthesia, where maintenance is provided by
inhalation anaesthetic agents.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product is a stable emulsion.
Prior to use, the product should be inspected visually for absence of
visible droplets or extraneous foreign particles or
phase separation and discarded if present.
If the product is injected too slowly an adequate plane of anaesthesia
may not be achieved due to failure to reach the
appropriate threshold of pharmacological activity.
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