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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Propofol

Available from:

Dechra Regulatory B.V.

ATC code:

QN01AX10

INN (International Name):

Propofol

Dosage:

10.0 milligram(s)/millilitre

Pharmaceutical form:

Emulsion for injection/infusion

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

propofol

Authorization status:

Authorised

Authorization date:

2019-06-28

Summary of Product characteristics

Health Products Regulatory Authority
03 April 2020
CRN009P7K
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Propodine 10 mg/ml emulsion for injection/infusion for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE:
​
​
Propofol
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10.0 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Emulsion for injection/infusion.
White or almost white homogeneous emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
- General anaesthesia for diagnostic or surgical procedures of short
duration, lasting up to five minutes.
- Induction and maintenance of general anaesthesia.
- Induction of general anaesthesia where maintenance is provided by
inhalation anaesthetic agents.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
This product is a stable emulsion. Prior to use, the product should be
inspected visually for the absence of visible droplets or
extraneous foreign particles and discarded if present. Do not use if
evidence of phase separation remains after gentle shaking.
If the product is injected too slowly, an inadequate plane of
anaesthesia can occur, due to failure to reach the appropriate
threshold of pharmacological activity.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
During induction of anaesthesia, mild hypotension and transient apnoea
may occur.
If the product is injected too rapidly, cardiopulmonary depression may
occur (apnoea, bradycardia, hypotension).
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 recommended. It is
advisable to administer supplemental oxygen during maintenance of
anaesthesia.
Caution s