Pethidine Injection BP 50mg/ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PETHIDINE HYDROCHLORIDE

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

N02AB; N02AB02

INN (International Name):

PETHIDINE HYDROCHLORIDE

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Phenylpiperidine derivatives; pethidine

Authorization status:

Not marketed

Authorization date:

1996-12-13

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pethidine Injection BP 50mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 50 mg of pethidine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless to pale yellow solution, free from visible
particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pethidine is a narcotic analgesic with similar actions to morphine.
Relief of moderate to severe pain.
As a premedication.
Obstetric analgesia.
Enhancement of analgesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults
_For moderate or severe pain._
Normal single dose (usually not to be repeated more often than 4
hourly)
_For obstetric analgesia._
By intramuscular or subcutaneous injection repeated 1 – 3 hours
later.
50 - 100 mg.
Maximum of 400mg in 24 hours.
_As a premedication._
By intramuscular or subcutaneous injection
25 - 100mg
(one hour prior to the operation)
_For the enhancement of analgesia._
By slow intravenous injection.
10 – 25mg as required.
By intramuscular or subcutaneous injection
25 – 100
mg.
By slow intravenous injection
25 – 50
mg.
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Elderly or debilitated patients.
Initial doses should not exceed 25mg as this group of patients may be
especially sensitive to the central depressant
effec