Flumazenil Kabi 0.1 mg / ml solution for injection., Fresenius Flumazenil 0.1 mg / ml solution for injection – patient leaflet, side effects, dosage

1. What Flumazenil is an

Flumazenil is a counterage or partial reversal of the ce benzodiazepines (specific gr muscle relaxing and anxiolyt It may therefore be used in after certain diagnostic tes been held under sedative c be used for the diagnosis a overdose with benzodiazep

Flumazenil is also used in c old) to wake them up after ‘benzodiazepine’ medicine medical procedure.

2. What you need to kno

Do not use Flumazenil

• if you are allergic (hy

  of the other ingredien

• if benzodiazepines ha

  control a potentially example control of pr

  and other information

  d what it is used for

  nt (antidote) for the complete ntral sedative effects of

  oup with sedative, sleep inducing, ic properties).

  anaesthesia to wake you up ts or in intensive care if you have onditions. Flumazenil may also nd treatment of intoxications or ines.

  hildren (more than 1 year they have been given a

  to make them sleepy during a

  w before you use Flumazenil

  persensitive) to flumazenil or any ts (listed in section 6).

  ve been administered to you to life-threatening situation (for essure in the brain or a serious

  epileptic seizure).

• in mixed intoxication

  certain types of other tricyclic and tetracycli Clomipramine, Mirtaz of these antidepressants benzodiazepine effects. a significant overdos Flumazenil must not benzodiazepine effe

Warnings and precautio

• If you do not wake u

  administered, another because Flumazenil spe benzodiazepines.

• If Flumazenil is admini

  operation to wake y the effects of muscle

• As the action of flum

  of benzodiazepines, s will be closely observ unit until the effects

• If you have received h

  (chronic) treatment w

  s with benzodiazepines and antidepressants (so called c antidepressants like Imipramine, apine or Mianserin). The toxicity can be masked by protective If you are showing signs of e of these antidepressants, be used to reverse

  cts.

  ns

  p after Flumazenil is

  reason for this will be considered cifically reverses the effects of

  stered to you at the end of your ou up, it should not be given until relaxants have gone away. azenil is usually shorter than that edation may possibly recur. You ed, possibly in the intensive care of flumazenil have gone away. igh dose and/or long-term ith benzodiazepines, at any

  time within the weeks prec administration, rapid inject flumazenil (more than 1 mg this may cause withdrawal

  1. 4. Possible side effects).

  • If you have been treated for

    doses of benzodiazepines, of Flumazenil should be car risk of withdrawal symptom

  • In children previously sedate

    These children should be clo care units for at least 2 ho of Flumazenil because rep difficulty with breathin

    sedation by other benzodia must be adjusted according duration.

  • If you are epileptic and hav

    treatment for a long period

    eding flumazenil ion of high doses of ) should be avoided since symptoms (see section long periods with high the advantages of the use efully weighed against the s.

    d with midazolam. sely observed in intensive urs after administration eated sedation or g can occur. In case of zepines, the monitoring to their expected e received benzodiazepine of time, the administration ion of flumazenil is not recomm cause seizures.

  • Seizures or other toxic effec

    cases of mixed drug overdo benzodiazepines and cyclic

  • If you have serious brain in

    pressure in your brain) care w can cause an increased pre

  • As Flumazenil is not recomm

    benzodiazepine-dependen benzodiazepines-withdra

  • If you have experienced p

    Flumazenil can cause new

  • If you are dependent on alc

    have a higher risk of benzo dependence.

  • if your liver is not working

    elimination can be delayed

Children

• Children should only receive Fl

  sedation. There are unsuffi indications. The same applie age of 1 year

Other medicines and Flumaze

Tell your doctor if you are taking other medicines, including medic prescription.

ended as flumazenil can ts can be more severe in se (e.g. intoxication with antidepressents)

jury (and/or instable illl be taken as Flumazenil ssure in your brain. ended for the treatment of ce or for the treatment of wal-symptoms.

anic attacks in the past attacks.

ohol or medicines as you diazepine tolerance and well flumazenil

.

umazenil after deliberate cient data for any other s for children below the nil

or have recently taken any ines obtained without a

When using Flumazenil in cases of has to be taken into account that t psychotropic medicinal products (e anti-depressants like Imipramine) t increase with the subsidence of the Interaction with other central ner has not been observed.

Flumazenil with alcohol

There is no known interaction betw

Pregnancy, breast-feeding and

If you are pregnant or breast-fe pregnant or are planning to hav or pharmacist for advice before

Because of insufficient experien Flumazenil should only be used is higher than the potential risk The administration of Flumazen contraindicated in an emergenc

It is not known whether flumaze milk. Therefore it is recommend hours after administration of Flu

an accidental overdose it he toxic effects of other specially tricyclic aken concurrently, may benzodiazepine effect. vous system depressants een ethanol and flumazenil.

fertility eding, think you may be e a baby, ask your doctor taking this medicine.

ce during pregnanacy if the advantage for you for the unborn baby. il during pregnancy is not y situation.

nil is excreted in breast ed not to breast-feed 24 mazenil

Driving and using machi

After receiving Flumazenil effects of benzodiazepines machinery or engage in a demanding activity for at possibly recur.

Flumazenil contains sod

This medicinal product con mg / 5 ml ampoule size or solution for injection. To b patients on a controlled so

3. How to use Flumazen

Flumazenil is administered a vein) or diluted as intrave period).

Flumazenil will be given by physician. Flumazenil may resuscitative measures. This medicinal product is f solution should be discarde inspected visually prior to u solution is clear, colourless

nes

for the reversal of the sedative you must not drive a car, operate ny other physically or mentally least 24 hours since sedation may

ium chloride

tains 3.7 mg sodium per ml (18.5 37 mg / 10 ml ampoule size) e taken into consideration by dium diet.

il

as intravenous injection (into nous infusion (over a longer

your anaesthetist or experienced be used at the same time as other

or single use only. Any unused d. The solution should be se. It should only be used if the and practically free from particles.

The recommended dose is

Anaesthesia

Dos

Starting dose:

0.2 mg administered intravenously over a perio of 15 seconds.

A further dose of 0.1 mg can be injected and

repeated at 60 second intervals, if required level of consciousness is not obtain within 60 seconds, up to a maximum dose of 1.0 mg. The usual dose required lies between 0.3 and 0.6 mg, but may deviate depending on the patient characteristics and the benzodiazepine used.

described as follows:

Adults

Intensive Care

age level:

d

Starting dose:

0.3 mg administered intravenously over a period of 15 seconds.

ed

A further dose of 0.1 mg can be injected and repeated at 60 second intervals, if required level of consciousness is not obtained within 60 seconds, up to a maximum dose of 2.0 mg.

s

If drowsiness recurs a second bolus injection may be

administered. An intravenous infusion of 0.1- 0.4 mg/h has also been shown useful. The dosage and rate of infusion should be adjusted individually to achieve the desired level of consciousness

The infusion can be given additionally to the maximum

dose of 2 mg by injection.

Patients with renal (kidney) or impairment

In patients with impaired liver fun flumazenil may be delayed and t of dosage is recommended.

No dosage adjustments are req impaired kidney function.

Use in Children

Children above 1

Reversal of delibe

Dosage le

The recommended initial dose to 200 micrograms), administe seconds. If the desired level of co after waiting an additional 45 of 10 micrograms//kg may be micrograms) and repeated at 6 necessary (a maximum of 4 time of 50 micrograms/kg or 1 mg, w

Children under the age of 1 ye

hepatic (liver)

ction, the elimination of herefore careful titration uired in patients with year of age rate sedation vel:

is 10 micrograms/kg (up red intravenously over 15 nsciousness is not obtained seconds, further injection administered (up to 200 0 second intervals where

1. s) to a maximum total dose hichever is lower.

ar

There are insufficient data on the children under 1 year. Therefore F be administered in children unde benefits to the patient outweigh

If you have any further questions ask your doctor or pharmacist. For information intended for heal see accordant section below.

4. Possible side effects

Like all medicines, this medicine c although not everybody gets the

Very common (may affect mor

Nausea

Common (may affect up to 1 i

hypersensitivity reactions (allergic (after rapid injection, not requirin lability, having problems in initiati (insomnia), feeling sleepy (somno agitation (after rapid injection, no unvoluntary trembling or quiverin abnormal rapid and deep respirat speech disorder, subjective cutan cold, warmth, tingling, pressure,

use of Flumazenil in lumazenil should only r 1 year if the potential the possible risk.

on the use of this product, thcare professionals please an cause side effects, m.

e than 1 in 10 people)

n 10 people)

reactions), anxiety g treatment), emotional ng and maintaining sleep lence), vertigo, headache, t requiring treatment), g (tremor), dry mouth, ion (hyperventilation), eous sensations (e.g. etc.) in the absence of stimulation (paresthesia), doub (squinting), lacrimation (producti heart palpitations (after rapid inje treatment), reddening of the skin pressure on transition from lying increased blood pressure (on awa sweating, fatigue, injection site p

le vision, strabismus on of tear fluid) increased, ction, not requiring (flushing), low blood to standing, transient king), vomitting, hiccup, ain

mazenil 0.1 mg/ml

Solution for Inject

PACKAGE LEAFLET: INFO

RMATION FOR THE USER

Uncommon (may affect

Fear (after rapid injection, convulsions (in patients suf liver insufficiency, mainly a benzodiazepines or mixed warnings and precautions) heart rate, premature beat difficulty breathing (dyspn chest pain, shivering (after treatment).

Not known (frequency c available data)

Withdrawal symptoms (see with a history of panic reac aggressive reactions, severe

If you were treated for a lo flumazenil can induce wit symptoms are: tension, a lability, confusion, hallucin quivering (tremor) and con

In general the undesirabl differ much from that in a

up to 1 in 100 people)

not requiring treatment),

fering from epilepsy or severe fter long-term treatment with drug overdose (see section 2 , abnormal hearing, slow or rapid of your heart (extrasystole), oea), cough, nasal congestion, rapid injection, not requiring

annot be estimated from the

below); panic attacks (in patients tions); abnormal crying, agitation, allergic reactions (anaphylaxis).

ng period with benzodiazepines hdrawal symptoms. The gitation, anxiety, emotional ations, involuntary trembling or vulsions.

e effects in children do not dults. When using Flumazenil to

awaken a child from sedat and aggressive reactions h

Reporting of side effects

If you get any side effects, any possible side effects no also report side effects dire

United Kingdom

Yellow Card Scheme Website: www.mhra.gov.u

Ireland

HPRA Pharmacovigilance Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

By reporting side effects yo information on the safety

5. How to store Flumaze

Keep this medicine out of

ion, abnormal crying, agitation ave been reported.

talk to your doctor. This includes t listed in this leaflet. You can ctly (see details below).

k/yellowcard

u can help provide more of this medicine.

nil

the sight and reach of children.

Do not use this medicine a stated on the label and car last day of that month. Do not store above 25°C This medicinal product is f Shelf life after first openin be used immediately. Shelf life after dilution: 24 Chemical and physical in-u demonstrated for 24 hours From a microbiological poi used immediately. If not us times and conditions prior the user and would norma 2 to 8 °C, unless dilution h validated aseptic condition

Do not use this medicine if from particles.

Any unused solution shoul local requirements.

fter the expiry date which is ton. The expiry date refers to the

or single use only.

g: the medicinal product should

hours.

se stability has been

at 25°C.

nt of view, the product should be ed immediately, in-use storage to use are the responsibility of lly not be longer than 24 hours at as taken place in controlled and s.

the solution is not clear and free

d be discarded in accordance with

Do not throw away any medicines household waste. Ask your pharm medicines you no longer use. The protect the environment.

6. Contents of the pack and ot

What Flumazenil contains

The active substance is flumaze

Each millilitre contains 0.1 mg = 1 Each ampoule with 5 ml contains flumazenil.

Each ampoule with 10 ml contain micrograms flumazenil.

The other ingredients are disodi acid, sodium chloride, sodium hyd for injections.

What Flumazenil looks like and

Flumazenil is a clear and colourles and concentrate for solution for i

via wastewater or acist how to throw away se measures will help her information.

nil.

00 micrograms flumazenil. 0.5 mg = 500 micrograms s 1.0 mg = 1000 um edetate, glacial acetic roxide solution 4%, water contents of the pack s solution for injection nfusion in colourless glass ampoules.

Following packaging sizes are ava Carton boxes with 5 or 10 ampou solution.

Carton boxes with 5 or 10 ampou solution

Not all packaging sizes may be m

Marketing Authorisation Hold

Fresenius Kabi Limited

Cestrian Court, Eastgate Way, Ma Cheshire WA7 1NT

United Kingdom

This leaflet was last revised 05/20

ilable:

les containing 5 ml les containing 10 ml arked.

er and Manufacturer nor Park, Runcorn

16

The following information

Detailed storage condition When Flumazenil is to be u chloride 9 mg/ml (0.9% w/ (2.5% w/v) solution. Comp

This medicinal product mu

For further information on

is intended for healthcare professiona

s can be found in section 5. How to s sed in infusion, it must be diluted prior

1. v) solution, glucose 50 mg/ml (5% w/v atibility between flumazenil and other

st not be mixed with other medicinal

dosage instructions please see sectio

ls only:

tore Flumazenil.

to infusion. Flumazenil should only be ) or sodium chloride 4.5 mg/ml (0.45% solutions for injection has not been es

products except for those mentioned

n 3 of the Package Information Leafle

diluted with sodium w/v) + glucose 25 mg/ml tablished.

in this section.

t.