Rapifen 500 micrograms/ml solution for injection or infusion (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Janssen-Cilag Ltd |
|---|---|
| Διεύθυνση | 50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG |
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Name of the medicinal product
Rapifen.
Qualitative and quantitative composition
Each ml of Rapifen contains alfentanil hydrochloride 544 micrograms, equivalent to 500 micrograms alfentanil base.
Pharmaceutical form
Aqueous injection.
Therapeutic indications
As an analgesic supplement for use before and during anaesthesia. It is indicated for: Short procedures and outpatient surgery. Procedures of medium and long duration when given as a bolus followed by ...
Posology and method of administration
For intravenous administration. Rapifen by the intravenous route can be administered to both adults and children. The dosage of Rapifen should be individualised according to age, bodyweight, physical status, ...
Contraindications
Obstructive airways disease or respiratory depression if not ventilating. Concurrent administration with monoamine oxidase inhibitors or within 2 weeks of their discontinuation. Administration in labour ...
Special warnings and precautions for use
Warnings Following administration of Rapifen, a fall in blood pressure may occur. The magnitude of this effect may be exaggerated in the hypovolaemic patient or in the presence of concomitant sedative ...
Interaction with other medicinal products and other forms of interaction
Potential for Rapifen to affect other medicinal products In combination with alfentanil, the blood concentrations of propofol are 17% higher than in the absence of alfentanil. The concomitant use of alfentanil ...
Pregnancy and lactation
Although no teratogenic or acute embryotoxic effects have been observed in animal experiments, insufficient data are available to evaluate any harmful effects in man. Consequently, it is necessary to consider ...
Effects on ability to drive and use machines
Where early discharge is envisaged, patients should be advised not to drive or operate machinery for the 24 hours following administration.
Undesirable effects
Adverse Drug Reactions The most frequently reported ADRs (incidence ≥10%) are: nausea and vomiting. Undesirable effects listed below in Table 1 have been reported in clinical trials (1157 subjects) and/or ...
Overdose
The manifestations of alfentanil overdose are generally an extension of its pharmacological action, which include the following: Action Bradycardia Anticholinergics such as atropine or glycopyrrolate. ...
Pharmacodynamic properties
The analgesic potency of Rapifen is one quarter that of fentanyl. The duration of action of Rapifen is one third that on an equianalgesic dose of fentanyl and is clearly dose-related. Its depressant effects ...
Pharmacokinetic properties
Alfentanil is a synthetic opioid with µ-agonist pharmacological effects. After bolus injections ranging from 2.4 to 125 µg/kg, plasma levels in man decay triexponentially with a terminal half life of approximately ...
Preclinical safety data
Preclinical effects observed were only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
List of excipients
Sodium chloride Water for injection
Incompatibilities
See Dosage and dosage schedules.
Shelf life
5 years.
Special precautions for storage
Store in a controlled drug store. This medicinal product does not require any special storage conditions.
Nature and contents of container
Colourless glass one-point-cut ampoules (PhEur, Type I). Pack size: packs of 10 2 ml ampoules; packs of 5 and 10 10 ml ampoules.
Special precautions for disposal and other handling
For single use only. Discard any unused contents.
Marketing authorization holder
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UK
Marketing authorization number(s)
PL 0242/0091
Date of first authorization / renewal of the authorization
27 July 1983/30 March 2004
Date of revision of the text
11 July 2012