FLUMAZENIL Solution for Injection 0.1 Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
FLUMAZENIL
Available from:
B. Braun Melsungen AG
Dosage:
0.1 Mg/Ml
Pharmaceutical form:
Solution for Injection
Authorization date:
2007-11-09
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flumazenil 0.1 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.1 mg flumazenil.
1 ampoule with 5 ml contains 0.5 mg flumazenil.
1 ampoule with 10 ml contains 1 mg flumazenil.
Excipient: Sodium 3.7 mg / ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
concentrate for solution for infusion
clear colourless solution
pH 3.9 – 5.0
4 CLINICAL PARTICULARS
4.1 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:
In anaesthesia
-
Termination of hypnosedative effects in general anaesthesia induced and/or
maintained with benzodiazepines in hospitalized patients.
-
Reversal of benzodiazepine sedation in short-term diagnostic and therapeutic
procedures in ambulatory patients and hospitalized patients.
In intensive care situations
-
For the specific reversal of the central effects of benzodiazepines, in order to restore spontaneous respiration.
-
For diagnosis and treatment of intoxications or overdose with only or mainly benzodiazepines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Flumazenil should be administered intravenously by an anaesthetist or experienced physician.
Flumazenil may be administered as injection or as infusion (For instructions on dilution of the product before
administration, see section 6.6).
Flumazenil may be used concomitantly with other resuscitative measures.
IRISH MEDICINES BOARD
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_Date Printed 14/03/2012_
_CRN 2103765_
_page number: 1_
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