Flumazenil Kabi 0,1 mg/ml roztvur do vstzhikivani

Leaflet accompanying the packaging: information for the user

Flumazenil Kabi 0.1 mg/ml

Solution for injection,
Concentrate for solution for infusion
Flumazenil

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Flumazenil Kabi and what is it used for
• 2. Important information before using Flumazenil Kabi
• 3. How to use Flumazenil Kabi
• 4. Possible side effects
• 5. How to store Flumazenil Kabi
• 6. Contents of the packaging and other information

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

Flumazenil Kabi is an antidote used to completely or partially reverse the central sedative effects of benzodiazepines (a specific group of drugs with sedative, hypnotic, muscle relaxant, and anxiolytic properties).
Therefore, Flumazenil Kabi is used to wake up patients after certain diagnostic tests or in intensive care when patients need to be given sedatives.
Flumazenil is also used in the diagnosis and treatment of benzodiazepine poisoning or overdose.
Flumazenil Kabi is also used in children (over 1 year of age) to wake them up from sleep induced by a medical procedure, by administering a benzodiazepine.

2. Important information before using Flumazenil Kabi

When not to use Flumazenil Kabi

• If the patient is allergicto flumazenil or any of the other ingredients of this medicine (listed in section 6).
• In cases where benzodiazepines are given in life-threatening situations(e.g., regulation of intracranial pressure or severe seizures).
• In cases of mixed poisoningwith benzodiazepines and certain other antidepressant drugs (so-called tricyclic and tetracyclic antidepressants, such as imipramine, clomipramine, mirtazapine, or mianserin). The toxicity of these drugs may be masked by the protective effect of benzodiazepines. In case of significant overdose of antidepressants, do not use Flumazenil Kabi to reverse the effects of benzodiazepines.

Warnings and precautions

Before starting treatment, discuss it with your doctor or nurse.

• In case of no awakeningafter administration of Flumazenil Kabi, consider other reasons, as Flumazenil Kabi specifically reverses the effects of benzodiazepines.
• When using Flumazenil Kabi at the end of surgery to wake up the patient, do not administer it until the effect of muscle relaxants has worn off.
• Since the duration of action of flumazenil is usually shorter than that of benzodiazepines, sedation may return. The patient should be closely monitored, possibly in an intensive care unit, until the effects of flumazenil have worn off.
• In cases of treatment with high doses of benzodiazepines and/or long-term (chronic) treatment with benzodiazepines in the weeks preceding the administration of flumazenil, avoid rapid injectionof large doses of flumazenil (greater than 1 mg), as this may lead to the occurrence of withdrawal symptoms(see section 4).
• 4. Possible side effects).
• In cases of long-termtreatment with high doses of benzodiazepines, carefully weigh the benefits of using Flumazenil Kabi against the risk of withdrawal symptoms.
• Children who have previously been given midazolamfor sedation should be closely monitored in intensive care units for at least 2 hours after administration of Flumazenil Kabi, as sedative effects or respiratory difficulties may return. In cases where other benzodiazepines were used for sedation, adjust the observation time according to the expected duration of their action.
• In patients with epilepsytreated with benzodiazepines for a long time, it is not recommended to administer flumazenil, as it may cause seizures.
• Seizures or other toxic side effects may be more severe in cases of mixed poisoning (e.g., benzodiazepine and tricyclic antidepressant poisoning).
• In cases of severe brain injury(and/or unstable intracranial pressure), caution is advised, as Flumazenil Kabi may lead to increased intracranial pressure.
• It is not recommended to use Flumazenil Kabi to treat benzodiazepine dependenceor withdrawal symptomsafter stopping benzodiazepines.
• In cases of a history of panic attacks, Flumazenil Kabi may cause new attacks.
• In cases of alcohol or drug dependence, the risk of developing tolerance to benzodiazepines and dependence on them may be higher.
• In cases of liver function disorders, the elimination of the drug may be delayed.

Children

• Flumazenil Kabi is used in children only to reverse sedation. There is insufficient data on other indications. This also applies to children under 1 year of age.

Flumazenil Kabi and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
When using Flumazenil Kabi in case of accidental overdose, consider that the toxic effects of other psychotropic drugs (especially tricyclic antidepressants, such as imipramine) used concurrently may increase as the effects of benzodiazepines wear off.
No interaction between flumazenil and other centrally acting depressant drugs has been observed.

Flumazenil Kabi with alcohol

No interaction between flumazenil and ethanol has been observed.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Due to insufficient experience, Flumazenil Kabi should be used during pregnancy only when the benefitto the patient outweighs the potential riskto the unborn child. There are no contraindications to the use of Flumazenil Kabi during pregnancy in emergency situations.
There is no data on the penetration of flumazenil into human milk. Therefore, breastfeeding should be discontinued for 24 hoursafter administration of Flumazenil Kabi.

Driving and using machines

After receiving Flumazenil Kabi to reverse the sedative effects of benzodiazepines, do not drive vehicles, operate machines, or engage in other activitiesthat require physical or mental effort for at least 24 hours, as the sedative effects of benzodiazepines may return.

Flumazenil Kabi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) in a 5 ml ampoule, which means the medicine is considered "sodium-free".
This medicine contains 37 mg of sodium (a major component of common salt) in each 10 ml ampoule.
This corresponds to 1.9% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Flumazenil Kabi

Flumazenil Kabi is administered by intravenous injection(into a vein) or diluted in intravenous infusion(over a longer period).
Flumazenil is administered by an anesthesiologist or an experienced doctor. Flumazenil can be used concurrently with other resuscitation procedures.
This medicine is intended for single use only. Unused solution should be discarded.
Before use, the solution should be inspected. It can only be used if it is clear, colorless, and free of impurities.
The recommended dose is:

Patients with renal or hepatic impairment

In patients with hepatic impairment, the elimination of flumazenil may be delayed, and therefore, careful dosingis recommended.
There is no need to adjust dosesin patients with renal impairment.

Children

Children over 1 year of age

Reversal of sedation

Method of administration:

Intravenous injection of a dose of 0.01 mg/kg body weight (up to 0.2 mg) administered over 15 seconds. If an adequate level of consciousness is not achieved within 45 seconds, the dose can be repeated. If necessary, injections can be repeated every 60 seconds (up to 4 times), with a maximum dose of 0.05 mg/kg body weight or 1 mg, whichever is smaller.

Children under 1 year of age

There is insufficient data on the use of Flumazenil Kabi in children under 1 year of age. Therefore, Flumazenil Kabi should be administered to children under 1 year of age only when the potential benefitsto the patient outweigh the potential risks.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.
Information intended for healthcare professionals can be found in one of the sections below.

4. Possible side effects

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

Very common (occurring in more than 1 in 10 patients):

Nausea.

Common (occurring in less than 1 in 10 patients but more than 1 in 100 patients):

Allergic reactions (hypersensitivity reactions), anxiety (after rapid injection, does not require treatment), emotional instability, sleep disorders (insomnia), drowsiness, dizziness, headache, agitation (after rapid injection, does not require treatment), involuntary tremors or twitching, dry mouth, abnormal rapid and deep breathing (hyperventilation), speech disorders, subjective skin sensations (e.g., cold, heat, tingling, pressure, etc.) without stimulation (paresthesia), double vision, strabismus, increased tear production, palpitations (after rapid injection, does not require treatment), flushing, low blood pressure when changing position from lying to standing, transient increased blood pressure (after awakening), vomiting, hiccups, sweating, fatigue, pain at the injection site.

Uncommon (occurring in less than 1 in 100 patients but more than 1 in 1,000 patients):

Fear (after rapid injection, does not require treatment), seizures (in patients with epilepsy or severe liver failure, mainly after long-term treatment with benzodiazepines or in cases of mixed poisoning - see section 2. Warnings and precautions), abnormal hearing, slow or fast heart rate, premature ventricular contraction, breathing difficulties (dyspnea), cough, nasal congestion, chest pain, chills (after rapid injection, does not require treatment).

Frequency not known (cannot be estimated from available data):

Withdrawal symptoms (see below), panic attacks (in patients with a history of panic attacks), abnormal crying, agitation, aggressive behavior, severe allergic reactions (anaphylactic reactions).
In cases of long-term treatment with benzodiazepines, flumazenil may cause withdrawal symptoms, such as tension, agitation, anxiety, emotional instability, hallucinations, involuntary tremors or twitching, and seizures.
Usually, side effects in childrendo not differ significantly from side effects in adult patients. In cases where Flumazenil Kabi is used to wake up a child from sedation, cases of excessive crying, agitation, and aggressive reactions have been reported.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Flumazenil Kabi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after: EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
The medicine is intended for single use only.
Shelf life after first opening the packaging: the medicine should be used immediately.
Shelf life after dilution: 24 hours.
Chemical and physical stability has been demonstrated after dilution for 24 hours at 25°C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the user is responsible for the storage conditions during use and before use. This period should not normally exceed 24 hours at 2-8°C, unless the dilution was performed in controlled and validated aseptic conditions.
Do not use this medicine if the solution is not clear and free of impurities.
Any unused solution should be disposed of in accordance with local regulations.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Flumazenil Kabi contains

The active substance of the medicine is flumazenil.
Each milliliter contains 0.1 mg of flumazenil.
Each 5 ml ampoule contains 0.5 mg of flumazenil.
Each 10 ml ampoule contains 1.0 mg of flumazenil.
Other ingredientsare: acetic acid, sodium chloride, disodium edetate, sodium hydroxide, 1N solution, water for injections.

What Flumazenil Kabi looks like and contents of the packaging

Flumazenil Kabi is a clear and colorless solution for injection and concentrate for solution for infusion in colorless glass ampoules.
Available pack sizes:
5 or 10 ampoules containing 5 ml of solution for injection, in a cardboard box.
5 or 10 ampoules containing 10 ml of solution for injection, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstraße 36
A-8055 Graz
Austria
To obtain more detailed information, contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:22.03.2021
-------------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:
Detailed storage conditions for the medicine are described in section 5. How to store Flumazenil Kabi.

Kabi.

If flumazenil is to be administered in infusion, it must be diluted first.
Flumazenil should be diluted only with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), or sodium chloride 4.5 mg/ml (0.45%) + glucose 25 mg/ml (2.5%).
Compatibility of flumazenil with other solutions for injection has not been established.
The medicine must not be mixed with other medicines except those mentioned in this section.
More information on dosing can be found in section 3 of this leaflet.