Propomitor 10 mg/ml emulsion for injection/infusion for dogs and cats

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Propofol

थमां उपलब्ध:

Orion Corporation

ए.टी.सी कोड:

QN01AX10

INN (इंटरनेशनल नाम):

Propofol

डोज़:

10 milligram(s)/millilitre

फार्मास्यूटिकल फॉर्म:

Emulsion for injection/infusion

प्रिस्क्रिप्शन प्रकार:

POM: Prescription Only Medicine as defined in relevant national legislation

चिकित्सीय क्षेत्र:

propofol

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2020-04-24

उत्पाद विशेषताएं

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Propomitor 10 mg/ml emulsion for injection/infusion for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Propofol
10 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION
IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Soya-bean oil, refined
100 mg
Egg phospholipids
Glycerol
Sodium hydroxide
Water for injections
Disodium edetate
White or almost white, homogenous emulsion for injection/infusions.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES

general anaesthesia for brief procedures lasting up to five minutes

induction and maintenance of general anaesthesia by administration of
incremental doses to
effect or as a constant rate infusion (CRI)

induction of general anaesthesia, where maintenance is provided by
inhalation anaesthetic
agents.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
The veterinary medicinal product is a stable emulsion. Prior to use,
the veterinary medicinal product
should be inspected visually for absence of visible droplets or
extraneous foreign particles or phase
separation, and discarded if present. Do not use if evidence of phase
separation remains after gentle
shaking.
2
If the veterinary medicinal 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.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
During induction of anaesthesia, mild hypotension and transient apnoea
may occur. When using the
veterinary medicinal product, facilities for the maintenance of a
patent airway, artificial ventilation
and oxygen enrichment must be available. Following induction of
anaesthesia, the use of an
endotracheal tube is