FLUMAZENIL Solution for injection or infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Flumazenil 100 micrograms/ml solution for injection/infusion.
Qualitative and quantitative composition
Each ml contains 100 micrograms flumazenil. 1 ampoule with 5 ml contains 500 micrograms flumazenil. 1 ampoule with 10 ml contains 1000 micrograms flumazenil. Excipient with known effect: This medicinal ...
Pharmaceutical form
Solution for injection/infusion. Clear colourless solution.
Therapeutic indications
Flumazenil is indicated for the complete or partial reversal of the central sedative effects of benzodiazepines. It may therefore be used in anaesthesia and in the intensive care in the following situations: ...
Posology and method of administration
Posology Adults Anaesthesia The recommended starting dose is 200 micrograms administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further ...
Contraindications
Hypersensitivity to flumazenil or to any of the excipients listed in section 6.1. Patients receiving benzodiazepines for control of a potentially life-threatening condition (e.g. control of intracranial ...
Special warnings and precautions for use
Use in children for other indications than reversal of conscious sedation is not recommended as no controlled studies are available. Until sufficient data are available, flumazenil should only be administered ...
Interaction with other medicinal products and other forms of interaction
Flumazenil reverses the central effects of benzodiazepines by means of competitive interaction at receptor level: the effects of non-benzodiazepine agonists acting via the benzodiazepine receptor, such ...
Fertility, pregnancy and lactation
Emergency use of flumazenil during pregnancy and lactation is not contraindicated. Pregnancy Flumazenil should only be used during pregnancy if the possible benefit to the patient outweighs the potential ...
Effects on ability to drive and use machines
Patients who have received flumazenil to reverse the effects of benzodiazepine sedation should be warned not to drive, to operate machinery or to engage in other activities demanding physical or mental ...
Undesirable effects
Any side-effects associated with Flumazenil usually subside rapidly without the need for special treatment. Frequency categories are defined using the following convention: Very common: ≥1/10 Common: ≥1/100 ...
Overdose
In cases of mixed-drug overdose, particularly with cyclic antidepressants, toxic effects (such as convulsions and cardiac dysrhythmias) may emerge with the reversal of benzodiazepine effects by flumazenil. ...
Pharmacodynamic properties
Pharmacotherapeutic group: All other therapeutic products, Antidotes ATC code: V03AB25 Flumazenil, an imidazobenzodiazepine, is a benzodiazepine antagonist which, by competitive interaction, blocks the ...
Pharmacokinetic properties
Distribution Flumazenil is a lipophilic weak base. Flumazenil is bound for approximately 50% to plasma proteins, from which two thirds are bound to albumin. Flumazenil is extensively divided over extra ...
Preclinical safety data
Late prenatal as well as per- and postnatal exposure to flumazenil induced both behavioural alterations and an increase of hippocampal benzodiazepine receptor density in the rat offspring. The effect of ...
List of excipients
Disodium edetate Glacial acetic acid Sodium chloride Sodium hydroxide for pH adjustment Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except for those mentioned in section 6.6.
Shelf life
Shelf life: 3 years. Shelf life after first opening: After first opening the medicinal product should be used immediately. Shelf life after dilution: Chemical and physical in-use stability has been demonstrated ...
Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the ampoules in the outer carton in order to protect from light.
Nature and contents of container
Carton boxes with 5 or 10 ampoules (glass Type I) containing 5 ml solution for injection/infusion. Carton boxes with 5 or 10 ampoules (glass Type I) containing 10 ml solution for injection/infusion. Not ...
Special precautions for disposal and other handling
This medicinal product is for single use only and any unused solution should be discarded. Please inspect the medicinal product visually. It should only be used if the solution is clear and practically ...
Marketing authorization holder
hameln pharma gmbh, Inselstraße 1, 31787, Hameln, Germany
Marketing authorization number(s)
PL 25215/0001
Date of first authorization / renewal of the authorization
20/09/2010
Date of revision of the text
01/04/2020
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