Flumazenil 500micrograms/5ml solution for injection ampoules

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Flumazenil

Tilgængelig fra:

Actavis UK Ltd

ATC-kode:

V03AB25

INN (International Name):

Flumazenil

Dosering:

100microgram/1ml

Lægemiddelform:

Solution for injection

Indgivelsesvej:

Intravenous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 15010700; GTIN: 5012617022479

Indlægsseddel

Flumazenil 0.5mg/5ml PIL - UK
item no: AAAC7774
print proof no: 2
origination date: 02.11.11
originated by: SA
revision date: 15.11.11
revised by: sa
dimensions: 148x570
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 07.11.11
supplier: Synthon
technically app. date: 15.11.11
min pt size:
TECHNICAL APPROVAL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.
t

,FFQ
UIJT
MFBøFU
:PV
NBZ
OFFE
UP
SFBE
JU
BHBJO

t

*G
ZPV
IBWF
BOZ
GVSUIFS
RVFTUJPOT
BTL
ZPVS
EPDUPS
PS

QIBSNBDJTU

t

5IJT
NFEJDJOF
IBT
CFFO
QSFTDSJCFE
GPS
ZPV
%P
OPU
QBTT

JU
PO
UP
PUIFST
*U
NBZ
IBSN
UIFN
FWFO
JG
UIFJS
TZNQUPNT

BSF
UIF
TBNF
BT
ZPVST

t

*G
BOZ
PG
UIF
TJEF
FòFDUT
HFUT
TFSJPVT
PS
JG
ZPV
OPUJDF
BOZ

TJEF
FòFDUT
OPU
MJTUFE
JO
UIJT
MFBøFU
QMFBTF
UFMM
ZPVS
EPDUPS

PS
QIBSNBDJTU

t

5IF
OBNF
PG
ZPVS
NFEJDJOF
JT
'MVNB[FOJM
TPMVUJPO
GPS

JOKFDUJPO
XIJDI
XJMM
CF
SFGFSSFE
UP
BT
A'MVNB[FOJM
PS

A'MVNB[FOJM
NHNM
4PMVUJPO
GPS
*OKFDUJPO
UISPVHIPVU

UIJT
MFBøFU

IN THIS LEAFLET:
1 WHAT FLUMAZENIL 0.1MG/ML SOLUTION
FOR INJECTION IS AND WHAT IT IS USED FOR
2 BEFORE YOU USE
3 HOW YOU USE
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE
6 FURTHER INFORMATION
1 WHAT FLUMAZENIL 0.1MG/ML SOLUTION FOR INJECTION IS
AND WHAT IT IS USED FOR
'MVNB[FOJM
NHNM
4PMVUJPO
GPS
*OKFDUJPO
DPOUBJOT
UIF
BDUJWF
JOHSFEJFOU

øVNB[FOJM
'MVNB[FOJM
CFMPOHT
UP
B
HSPVQ
PG
NFEJDJOFT
LOPXO
BT

CFO[PEJB[FQJOF
BOUBHPOJTUT


'MVNB[FOJM
JT
VTFE
UP
SFWFSTF
UIF
FòFDUT
PG
B
HSPVQ
PG
NFEJDJOFT
LOPXO

BT
CFO[PEJB[FQJOFT

XIJDI
BSF
VTFE
UP
DBVTF
EFFQ
TMFFQ
#Z
SFWFSTJOH
UIF

FòFDUT
PG
CFO[PEJB[FQJOFT

JU
BMMPXT
UIF
QBUJFOU
UP
CFDPNF
DPOTDJPVT
TP

UIBU
UIFZ
DBO
CSFBUIF
VOBJEFE



'MVNB[FOJM
DBO
CF
VTFE
UP
QBSUMZ
PS
DPNQMFUFMZ
SFWFSTF
UIF
FòFDUT
PG

CFO[PEJB[FQJOF
TFEBUJPO
BOE
HFOFSBM
BOBFTUIFTJB
BGUFS
NFEJDBM
UFTUT
BOE

PQFSBUJPOT
JO
UIF
IPTQJUBM
*U
JT
VTFE
PO
JOUFOTJWF
DBSF
QBUJFOUT
UP
CSJOH

BCPVU
VOBJEFE
CSFBUIJOH
*U
JT
BMTP
VTFE
UP
EJBHOPTF
BOE
USFBU
QBUJFOUT

XIP
IBWF
CFFO

Produktets egenskaber

OBJECT 1
FLUMAZENIL 0.1 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 28-Jun-2012 | Accord-UK Ltd
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: each ml of solution contains 3.8 mg sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear colourless solution.
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.
For the reversal of conscious sedation induced with benzodiazepines in
children > 1 year of age.
4.2 Posology and method of administration
Flumazenil must be administered intravenously by an anaesthesist or
doctor with experience in
anesthesiology. Flumazenil may be administered either undiluted or
diluted.
For dilution, see section 6.6.
It can be administered together with other reanimation measures.
Adults
_Anaesthesia_
The initial dose is 0.2 mg administered i.v. in 15 seconds. If the
desired degree of consciousness is not
obtained within 60 seconds, a second dose of 0.1 mg can be
administered. This may be repeated at 60-
second intervals where necessary, up to a total dose of 1.0 mg. Th