ALFENTANIL Solution for injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Alfentanil 5 mg/ml solution for injection.
Qualitative and quantitative composition
Each 1 ml of Alfentanil 5 mg/ml solution for injection contains: Alfentanil hydrochloride 5.44 mg, equivalent to 5.0 mg alfentanil base Excipient with known effect: This medicine contains less than 1 mmol ...
Pharmaceutical form
Solution for Injection. The product is a clear and colourless solution.
Therapeutic indications
Alfentanil 5 mg/ml solution for injection is a potent opioid analgesic with a very rapid onset of action. It is indicated for analgesia and suppression of respiratory activity in mechanically ventilated ...
Posology and method of administration
At the proposed doses, Alfentanil 5 mg/ml solution for injection has no sedative activity. Therefore supplementation with an appropriate hypnotic or sedative agent is recommended. Admixture is not advisable ...
Contraindications
Hypersensitivity to the active substance, to other opioids, or to any of the excipients listed in section 6.1. Obstructive airway disease or respiratory depression if not ventilating. Concurrent administration ...
Special warnings and precautions for use
Warnings Following administration of Alfentanil 5 mg/ml solution for injection, a fall in blood pressure may occur. The magnitude of this effect may be exaggerated in the hypovolaemic patient or in the ...
Interaction with other medicinal products and other forms of interaction
Drugs modifying the effect of alfentanil Sedative medicines such as benzodiazepines or related drugs The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases ...
Pregnancy and lactation
Pregnancy Although no teratogenic or acute embryotoxic effects have been observed in animal experiments, insufficient data are available to evaluate any harmful effects in humans. Consequently, it is necessary ...
Effects on ability to drive and use machines
No studies on the effects of alfentanil on the ability to drive and use machines have been performed. However, where early discharge is envisaged patients should be advised not to drive or operate machinery ...
Undesirable effects
Adverse Reactions The most frequently reported Adverse reactions (incidence ≥10%) are: nausea and vomiting. Undesirable effects listed below in Table 1 have been reported in clinical trials (1157 subjects) ...
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
Pharmacotherapeutic group: opioid anaesthetics ATC code: N01AH02 (Alfentanil) In humans, alfentanil at therapeutic doses has no detrimental effects on myocardial performance. The cardiovascular stability ...
Pharmacokinetic properties
Alfentanil is a synthetic opioid with µ-agonist pharmacological effects. After bolus injections ranging from 2.4 to 125 micrograms/kg, plasma levels in man decay triexponentially with a terminal half life ...
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 Sodium hydroxide Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6.
Shelf life
<u>Shelf-life before first opening:</u> 3 years. <u>Shelf-life after dilution:</u> Chemical and physical in-use stability of the dilutions (see section 6.6) has been demonstrated for 48 hours. From the ...
Special precautions for storage
No special precautions for storage.
Nature and contents of container
Clear glass ampoules (Ph Eur Type I, one point cut) containing 5 mg/1 ml. Original pack containing 5 or 10 ampoules of 1 ml each.
Special precautions for disposal and other handling
Alfentanil 5 mg/ml solution for injection should be diluted with sodium chloride intravenous infusion BP, glucose intravenous infusion BP, or compound sodium lactate intravenous infusion BP (Hartmanns ...
Marketing authorization holder
hameln pharma plus gmbh, Langes Feld 13, D-31789, Hameln, Germany
Marketing authorization number(s)
PL 25215/0006
Date of first authorization / renewal of the authorization
24/11/2010
Date of revision of the text
09/07/2018
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