PETHIDINE Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Pethidine Hydrochloride 50mg/ml Solution for Injection.
Qualitative and quantitative composition
Each 1ml of solution contains 50mg of Pethidine Hydrochloride B.P..
Pharmaceutical form
Clear, colourless, sterile solution intended for parenteral administration to human beings.
Therapeutic indications
Pethidine hydrochloride may be used as an analgesic for the relief of moderate to severe pain including: obstetric analgesia; pre-operative medication and analgesia during anaesthesia; post-operative analgesia. ...
Posology and method of administration
Posology Adults The following single doses may be used and should not usually be repeated more frequently than four hourly; Subcutaneous or intramuscular injection: 25-100mg. Intravenous injection: 25-50mg. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use of pethidine should be avoided in patients with diabetic acidosis where there is danger of coma. In comatose ...
Special warnings and precautions for use
Pethidine is controlled under the Misuse of Drugs Act 1971 (Schedule 2). If the intravenous route is being used, pethidine should be given slowly in order to reduce the risk of adverse reactions. Extreme ...
Interaction with other medicinal products and other forms of interaction
Monoamine Oxidase Inhibitors The concurrent use of MAOIs (including moclobemide) is contra-indicated (see section 4.3) as they may result in CNS excitation or depression. Very severe reactions including ...
Pregnancy and lactation
Pregnancy There is inadequate evidence of safety in human pregnancy, but the drug has been in widely use for many years without apparent ill consequence. Animal studies have not shown any hazard. As with ...
Effects on ability to drive and use machines
Pethidine may impair the mental and/or physical abilities required for driving or for operating machinery. Patients should be advised accordingly and warned not to drive or to operate machines while taking ...
Undesirable effects
The information below lists reported adverse reactions, ranked using the following frequency classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 ...
Overdose
Symptoms Signs of acute overdosage may include respiratory depression, CNS depression with extreme somnolence progressing to incoordination, stupor or coma, convulsions, CNS stimulation, cyanosis, miosis, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics – Phenylpiperidine derivatives ATC code: NO2AB Pethidine is a synthetic opioid analgesic similar to morphine although less potent and shorter acting. Its analgesic ...
Pharmacokinetic properties
Pethidine is rapidly absorbed following intramuscular or subcutaneous injection, however, there are wide interindividual variations. It is widely distributed in the tissues with a volume of distribution ...
Preclinical safety data
No further relevant information other than that which is included with other sections of the Summary of Product Characteristics.
List of excipients
Sodium hydroxide B.P. Dilute hydrochloric acid B.P. Water for injections B.P.
Incompatibilities
There was loss of clarity when intravenous solutions of pethidine hydrochloride were mixed with those of aminophylline, amylobarbitone sodium, heparin sodium, methicillin sodium, morphine sulphate, nitrofurantoin ...
Shelf life
4 years. If only part used, discard the remaining solution.
Special precautions for storage
Do not store above 25°C. Keep in outer carton.
Nature and contents of container
1ml and 2ml clear glass ampoules, glass type 1 Ph. Eur. packed in cardboard cartons to contain 10 1ml or 10 2ml ampoules.
Special precautions for disposal and other handling
CD (2) For S/C., I/M., or I/V injection. Use as directed by the physician.
Marketing authorization holder
Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 12762/0596
Date of first authorization / renewal of the authorization
Date of first authorisation: 10/05/82 Date of renewal: 13/03/97
Date of revision of the text
January 2019
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