Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
PETHIDINE HYDROCHLORIDE
Martindale Pharmaceuticals Ltd
N02AB; N02AB02
PETHIDINE HYDROCHLORIDE
100/2 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Phenylpiperidine derivatives; pethidine
Not marketed
1996-12-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pethidine Injection BP 100mg/2ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml ampoule contains 100 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). By intramuscular or subcutaneous injection 25 - 100 mg. By slow intravenous injection 25 - 50 mg. _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. Elderly or debilitated patients Initial doses should not exceed 25mg as this group of patients may be especially sensitive to the central depressant effect of the drug. Children I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _7_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _1_ _C_ _R_ _N_ _ _ _2_ _1_ _0_ _1_ _7_ _2_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ Прочитать полный документ