SPC, UK: Rapifen 500 micrograms/ml solution for injection or infusion (2012)
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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 ...
Pharmaceutical form
Aqueous injection.
Therapeutic indications
As an analgesic supplement for use before and during anaesthesia. It is indicated for: Short procedures ...
Posology and method of administration
For intravenous administration. Rapifen by the intravenous route can be administered to both adults and ...
Contraindications
Obstructive airways disease or respiratory depression if not ventilating. Concurrent administration with ...
Special warnings and precautions for use
Warnings Following administration of Rapifen, a fall in blood pressure may occur. The magnitude of this ...
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 ...
Pregnancy and lactation
Although no teratogenic or acute embryotoxic effects have been observed in animal experiments, insufficient ...
Effects on ability to drive and use machines
Where early discharge is envisaged, patients should be advised not to drive or operate machinery for ...
Undesirable effects
Adverse Drug Reactions The most frequently reported ADRs (incidence ≥10%) are: nausea and vomiting. Undesirable ...
Overdose
The manifestations of alfentanil overdose are generally an extension of its pharmacological action, which ...
Pharmacodynamic properties
The analgesic potency of Rapifen is one quarter that of fentanyl. The duration of action of Rapifen is ...
Pharmacokinetic properties
Alfentanil is a synthetic opioid with µ-agonist pharmacological effects. After bolus injections ranging ...
Preclinical safety data
Preclinical effects observed were only at exposures considered sufficiently in excess of the maximum ...
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 ...
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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί
πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.