0.1 mg / ml injection solution
flumazenil

1. What Flumazenil Fresenius Kabi is and what it is used for

Flumazenil Fresenius Kabi is used to completely or partially counteract the effects of benzodiazepines (medicines with sedatives, sleep-inducing, muscle-relaxing, and anti-anxiety effects) on the central nervous system. It can therefore be used to wake you up after sampling or after sedation in connection with intensive care.
Flumazenil can also be used in cases of overdose or poisoning caused by benzodiazepines.

Flumazenil Fresenius Kabi is also used in children (older than 1 year) to wake the child when a benzodiazepine medicine has been given to make the child sleepy during a medical procedure.

What you need to know before you use Flumazenil Fresenius Kabi

Do not use Flumazenil Fresenius Kabi

  • if you are allergic to flumazenil or any of the other ingredients of this medicine (listed in section 6).
  • if benzodiazepines have been used in the treatment of any life-threatening condition, such as in connection with increased pressure in the brain or a severe epileptic seizure.
  • if you show signs of an overdose of benzodiazepines with certain other antidepressants (so-called tri / tetracyclic antidepressants, such as clomipramine, imipramine, mirtazapine, or mianserin). The effect of benzodiazepines can mask the symptoms of intoxication with the above-mentioned antidepressants. If you show clear symptoms of overdose with these antidepressants, Flumazenil Fresenius Kabi should not be used to cancel the effect of benzodiazepines.

Warnings and cautions

  • if you do not wake up after receiving Flumazenil Fresenius Kabi. In that case, the unconsciousness is due to something else, because flumazenil is a substance that specifically cancels the action of benzodiazepines.
  • if Flumazenil Fresenius Kabi is given to wake you up after surgery. In this case, flumazenil should not be given until the effects of the muscle relaxants have completely disappeared.
  • Since the duration of action of flumazenil is generally shorter than the duration of action of benzodiazepines, the sedative effect of the sleeping pill may be repeated. Therefore, you will be closely monitored (possibly in the intensive care unit) until the effect of flumazenil has disappeared.
  • if you have received high doses and/or long-term treatment with benzodiazepines at any time in the weeks before flumazenil is given. Then the rapid injection s with high dose s (above 1 mg) flumazenil avoided since such can cause withdrawal symptoms (see section 4 Possible adverse s).
  • if you have been treated for a long time with a high dose of your benzodiazepine. In this case, the benefits of Flumazenil Fresenius Kabi should be carefully weighed against the risks of withdrawal symptoms.
  • to children previously sedated with midazolam. These children should be closely monitored in the intensive care unit for at least two hours after receiving Flumazenil Fresenius Kabi. The sedative effect of midazolam may recur and breathing difficulties may occur. If any other benzodiazepine has been used during anesthesia, the child should be monitored for the expected duration of action of the drug.
  • if you have epilepsy and have been using benzodiazepines for a long time. In these cases, the use of flumazenil is not recommended, as flumazenil may cause seizures.
  • Seizures or other symptoms of intoxication may be more severe with multiple drug overdoses at the same time (eg benzodiazepine intoxication and tricyclic antidepressants ).
  • if you have severe brain damage (and/or unstable pressure in the brain) as flumazenil may increase the pressure in the brain.
  • Flumazenil Fresenius Kabi is not recommended for the treatment of benzodiazepine dependence or withdrawal symptoms caused by benzodiazepines.
  • if you have ever had panic attacks before, Flumazenil Fresenius Kabi may cause new attacks.
  • if you are addicted to alcohol or sleeping pills because the risk of benzodiazepine intolerance and benzodiazepine dependence is higher.
  • if your liver is not working properly, the secretion of Flumazenil Fresenius Kabi may be delayed.

Children

  • Flumazenil Fresenius Kabi should be given to children only when the child has been intentionally put to sleep or given sedatives. There is insufficient information for other indications. The same applies to children under 1 year.

Other medicines and Flumazenil Fresenius Kabi

Tell your doctor if you are taking, have recently taken, or might take any other medicines.
When flumazenil is used to treat accidental overdose, it must be borne in mind that other psychotropic drugs (especially tricyclic antidepressants, such as imipramine) taken concomitantly may increase the sedative effect of benzodiazepines. Interaction with other drugs that suppress the central nervous system has not been observed.

Flumazenil Fresenius Kabi with alcohol

There is no known interaction between ethanol and flumazenil.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

As the experience with Flumazenil Fresenius Kabi in pregnancy is insufficient, this medicine should be used only if the benefit to you is expected to outweigh the potential risks to the unborn baby. In case of emergency, flumazenil can also be used during pregnancy.

It is not known whether flumazenil is excreted in human milk. Therefore, a 24-hour break in breastfeeding after flumazenil treatment is recommended.

Driving and using machines

You can not drive a car, use machines or perform any physically or mentally demanding activity within 24 hours after you have received Flumazenil Kabi for the abolition of bensodiazepineffekter. Namely, there is a risk that the sedative effect of benzodiazepines will return.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Flumazenil Fresenius Kabi contains sodium

This medicine contains 3.7 mg sodium per ml solution for injection (18.5 mg / 5 ml ampoule and 37 mg / 10 ml ampoule ). This should be observed for patients following a low salt diet.

3. How to use Flumazenil Fresenius Kabi

Flumazenil Fresenius Kabi is given as an intravenous injection (into a blood vessel) or as an intravenous infusion (over a long period of time).

The preparation is given by an anesthetist or another physician experienced in this type of medicine. Flumazenil can be given at the same time as other medicines that are used to raise your awareness.
This preparation is for single use only. Any unused solution should be discarded. The solution must be inspected visually before use. Only a clear solution free of visible particles may be used.

Recommended dosage:

Adults:
Anesthetic Intensive care
Dose
Introductory dose:0.2 mg intravenously (in a vein) for 15 seconds. Introductory dose:0.3 mg intravenously (in a vein) for 15 seconds.
If the desired level of consciousness is not reached within 60 seconds, an additional dose of 0.1 mg may be given. If necessary, this additional dose can be repeated at intervals of 60 seconds; up to a maximum dose of 1.0 mg. If the desired level of consciousness is not reached within 60 seconds, an additional dose of 0.1 mg may be given. If necessary, this additional dose can be repeated at intervals of 60 seconds; up to a maximum dose of 2.0 mg.
The usual dose is 0.3-0.6 mg, but the dose may vary from patient to patient depending on the benzodiazepine used. If the patient becomes unconscious again, a second bolus injection may be given. An intravenous infusion of 0.1‑0.4 mg/hour has also been shown to be effective. The dose and infusion rate should be adjusted individually to achieve the desired degree of alertness.
  Infusion one can be given in addition to the maximum injection dose of 2 mg

Patients with renal or hepatic impairment:
In patients with hepatic impairment, elimination of flumazenil from the body may be slower than normal and therefore careful dosing is recommended.

Renal impairment does not require dose adjustment.

Use in children:

Children and adolescents (from 1 year)
For cancellation of intentional anesthesia
Dose:
The recommended initial dose is 10 micrograms/kg body weight (up to 200 micrograms) given intravenously over 15 seconds. If the desired level of consciousness is not reached within 45 seconds after injection, an additional 10 micrograms/kg (up to 200 micrograms) may be given. The additional dose can be repeated at 60-second intervals if necessary (maximum 4 times) to a maximum dose of 50 micrograms/kg or a total dose of 1 mg, whichever is the lower.

Children under 1 year

Sufficient experience with Flumazenil Fresenius Kabi in children under 1 year of age is not available. Flumazenil Fresenius Kabi should therefore be given to children under 1 year of age only if the benefit of the drug is expected to exceed the potential risks to the child.

If you have any further questions on the use of this product, ask your doctor or pharmacist.
For information intended for healthcare professionals, see the corresponding section below.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 user in 10)

Nausea

Common (may affect up to 1 in 10 users)

Hypersensitivity reactions (allergic reactions), anxiety (after rapid injection, requires no treatment), mood swings, insomnia ( insomnia ), drowsiness ( somnolence ), dizziness, headache, agitation (after rapid injection, requires no treatment), involuntary tremors and tremors ( tremor ), dry mouth, abnormally fast and deep breathing (hyperventilation), speech disorders, skin symptoms (cold, heat, tingling, pressure, etc.) without external influences ( paresthesias ), double vision, squinting, increased tear flow, palpitations (after rapid injection, does not require treatment), reddening of the skin, drop in blood pressure when getting up, short-term increase in blood pressure (on waking up), vomiting, hiccups, sweating, fatigue, pain at the injection site.

Uncommon (may affect up to 1 in 100 people)

Fear (after rapid injection, no treatment required), convulsions (in patients suffering from epilepsy or severe hepatic impairment, mainly after long-term treatment with benzodiazepines or overdose of several drugs (see section 2 warnings and caution), abnormal hearing, fast or slow pulse, extra heartbeat (extrasystole), shortness of breath ( dyspnoea ), cough, nasal congestion, chest pain, chills (after rapid injection, requires no treatment).

No known frequency (cannot be estimated from the available data)

Withdrawal symptoms (see below), panic attacks (in patients who have previously had panic reactions), abnormal crying, agitation, aggressive reactions, severe allergic reactions.

If you have been taking benzodiazepines for a long time, flumazenil may cause withdrawal symptoms  Such symptoms are a state of tension, restlessness, anxiety, mood swings, confusion, hallucinations, involuntary tremors and tremors, and convulsions.

Normally, no different adverse reactions were of children differ greatly from those in adults. Abnormal crying, agitation, and aggressive reactions have been reported when flumazenil was used to wake anesthetized children.

5. How to store Flumazenil Fresenius Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
This medicine is for single use only.
Shelf life after opening: The preparation should be used immediately.
Shelf life after dilution: 24 hours.
The preparation is chemically and physically stable for 24 hours at 25 ° C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, in-use storage times and conditions before administration is the same as the user’s responsibility. In any case, these should not normally exceed 24 hours at 2-8 ° C, unless dilution has taken place under controlled and validated conditions.
Do not use this medicine if it is cloudy or contains particles.
Any unused product or waste material should be disposed of by local requirements.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is flumazenil.

1 ml contains 0.1 mg of flumazenil.
One ampoule of 5 ml contains 0.5 mg of flumazenil.
One 10 ml ampoule contains 1.0 mg of flumazenil.

The other ingredients are disodium edetate, concentrated acetic acid, sodium chloride, 4% sodium hydroxide solution, water for injections.

What the medicine looks like and the contents of the pack

Flumazenil Fresenius Kabi is a clear and colorless solution for injection and concentrates for solution for infusion in colorless glass ampoules.

The following pack sizes are available:
Pack of 5 or 10 ampoules of 5 ml solution
Pack of 5 or 10 ampoules of 10 ml solution

Not all pack sizes may be marketed.

Manufacturer:
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
AT-8055 Graz
Austria

This medicinal product is authorized under the European Economic Area under the names:

Austria Flumazenil Kabi 0.1 mg/ml solution for injection and concentrate for infusion
Germany Flumazenil Kabi 0.1 mg/ml solution for injection and concentrate for infusion
Denmark Flumazenil Fresenius Kabi
Spain Flumazenil Fresenius Kabi 0.1 mg/ml injectable
Hungary Flumazenil Kabi 0.1 mg/ml injectable injection
Ireland Flumazenil 0.1 mg / ml Solution for Injection
Italy Flumazenil Kabi 0.1 mg / ml, inoperable solution
Netherlands Flumazenil Kabi 0.1 mg / ml solution for injection
Norway Flumazenil Fresenius Kabi 0.1 mg/ml solution for injection
Poland Flumazenil Kabi 0.1 mg/ml orodispersible drug
Portugal Flumazenil Fresenius Kabi 0.1 mg/ml injectable solution
UK Flumazenil Kabi 0.1 mg/ml Solution for Injection

Muhammad Nadeem

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