0.1 mg / ml solution for injection / infusion
flumazenil
What the Flumazenil Hamel is and what it is used for
Flumazenil Hameln is an antidote ( antidote ) used to completely or partially counteract the effects of benzodiazepines (medicines with sedative, sleep-inducing, muscle-relaxing, and anti-anxiety effects) on the central nervous system.
It can therefore be used to wake you up after you have been put to sleep for sampling or in connection with intensive care if you have been sedated (a state of calm, drowsiness, or sleep). Flumazenil Hameln can also be used to diagnose and treat poisoning or overdose caused by benzodiazepines.
The Flumazenil Hamel can also be used in children (older than 1 year) to wake the child when a drug with benzodiazepines has been given to make the child sleepy.
Flumazenil contained in the Flumazenil Hamel may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you get the Flumazenil Hamel
Do not use the Flumazenil hamel
The Flumazenil Hamel will be given to you under the close supervision of an anesthetist.
You should NOT get the Flumazenil Hamel
• if you are allergic (hypersensitive) to flumazenil or any of the other ingredients of this medicine (listed in section 6).
• if you are receiving benzodiazepines to treat a life-threatening condition such as increased pressure in the brain ( intracranial pressure ) or severe epileptic seizures.
Warnings and cautions
Talk to your doctor before receiving Flumazenil Hameln if you:
• has epilepsy and has been using benzodiazepines for a long time. Flumazenil Hameln can cause seizures.
• have liver problems.
• has or has had a serious head injury. The flumazenil Hamel can cause increased pressure in the brain.
• have been particularly anxious before an operation or have previously had anxiety.
• had panic attacks. Flumazenil Hameln can cause new attacks.
• have been treated with benzodiazepines for a long time or with high doses. Rapid injection of Flumazenil Hameln with a dose higher than 1 mg can then give rise to withdrawal symptoms.
• have been dependent on alcohol or other drugs, as the risk of developing benzodiazepine tolerance and benzodiazepine dependence is higher and thus also the risk of withdrawal symptoms. Your anesthesiologist will adjust the dose carefully.
Also, pay attention to the following
The Flumazenil Hamel only counteracts the effects of benzodiazepines.
• If lowering of consciousness or sedation is caused by another agent, the Flumazenil Hamel is unlikely to counteract it.
• Even if the Flumazenil Hamel is given to counteract drowsiness, you may find that the drowsiness returns within 24 hours after the Flumazenil Hamel is given. This is because the effect of benzodiazepines lasts longer than the effect of the Flumazenil Hamel. Therefore, you will be monitored, if possible in the intensive care unit, until all possible effects of benzodiazepines have subsided.
• If you are undergoing major surgery that causes a lot of pain, your anesthetist may keep you sedated.
The Flumazenil Hamel is not recommended for the treatment of benzodiazepine dependence or its symptoms.
If Flumazenil Hamel is given to wake you up after surgery, it should not be given until the effects of the muscle relaxants have disappeared.
Children
Children previously sedated with midazolam should be closely monitored in the intensive care unit for at least two hours after receiving the Flumazenil Hamel as the effect may recur and breathing difficulties may occur. If any other benzodiazepine has been used, the child should be monitored for the expected duration of action of the drug.
The flumazenil Hamel 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 drugs and Flumazenil hameln
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This information is needed so that your anesthesiologist can adjust your dose carefully.
Tell your doctor or nurse, in particular, if you are taking any of the following medicines:
• zopiclone and triazolopyridazine (used in the treatment of insomnia).
• benzodiazepines (e.g. diazepam , midazolam).
Tricyclic or tetracyclic antidepressants such as amitriptyline, nortriptyline, clomipramine, mirtazapine, mianserin, and imipramine.
When the Flumazenil Hamel is used to treat accidental overdose, it must be borne in mind that the effects of other psychotropic drugs (especially tricyclic antidepressants, such as imipramine) are taken concomitantly may increase as the effect of benzodiazepines decreases.
Pregnancy and breastfeeding
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.
The risk to the unborn fetus has not been established and therefore Flumazenil Hameln is not recommended during pregnancy if the expected benefit of the treatment does not clearly exceed any risks to the woman and the fetus, e.g. in a life-threatening or critical situation.
It is not known whether flumazenil is excreted in human milk. Therefore, breast-feeding should be discontinued for 24 hours after treatment with Flumazenil Hameln.
Driving and using machines
The effect of the Flumazenil Hamel does not last as long as that of benzodiazepines and therefore you may feel sleepy again. Do not drive or use any tools or machines within 24 hours of receiving the Flumazenil hamlet.
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.
The flumazenil Hamel contains sodium
This medicine contains 3.7 mg sodium (the main ingredient in table salt/table salt) per ml.
- Each 5 ml ampoule contains less than 1 mmol (23 mg) sodium, ie essentially ‘sodium-free’.
- Each 10 ml ampoule contains 37 mg of sodium . This corresponds to 2% of the maximum recommended daily sodium intake for adults.
How Flumazenil Hameln is given
The flumazenil Hamel is given intravenously (in the vein) either diluted or undiluted. The Flumazenil Hamel will be given to you under the close supervision of a physician experienced in anesthesia. The dose is adjusted individually and depends on your age, weight, how well your liver and kidneys are working and what you need the medicine for. Flumazenil Hameln can be used in combination with other drugs, which are used to bring someone back to consciousness.
Adults
The starting dose is usually 0.2 mg intravenously (in a vein) for 15 seconds. If your state of consciousness has not improved enough within 60 seconds, an additional dose of 0.1 mg may be given. This can be repeated every 60 seconds until you are awake enough. The maximum dose that can be given is 1 mg after anesthesia and 2 mg in intensive care.
The treatment is stopped every 6 hours to check if you fall back into consciousness.
Children older than 1 year
The starting dose is usually 0.01 mg/kg body weight (up to 0.2 mg) given intravenously over 15 seconds. If the state of consciousness is not sufficiently improved within 45 seconds, an additional dose of 0.01 mg/kg body weight (up to 0.2 mg) may be given. This can be repeated every 60 seconds, up to 4 times, to a maximum dose of 0.05 mg/kg body weight or a total of 1 mg, whichever is lower.
There is too little information on the use of Flumazenil Hameln in children under 1 year of age. Your doctor will decide if it is necessary to give Flumazenil Hameln to your child at this age.
Older
Elderly people are generally more sensitive to the effects of the Flumazenil Hamel and should therefore be treated with caution.
Patients with hepatic impairment
If you have liver problems, your doctor may give you a lower dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you experience any of the following side effects, tell your doctor or nurse immediately. The flumazenil Hamel can cause allergic reactions. Symptoms of allergic reactions include swelling of the face, lips, throat, or tongue, rash, and difficulty breathing.
The following side effects have been reported:
Very common (may affect more than 1 user in 10) :
– Nausea
Common (may affect up to 1 in 10 people) :
– allergic reactions,
– mood swings,
– insomnia,
– drowsiness,
– dizziness,
– headache,
– involuntary tremors and tremors,
– dry mouth,
– hyperventilation,
– disturbance of speech,
– sensation sensations in the skin (eg cold, heat, tingling, pressure, etc.) without external influences ( paresthesia ),
– double vision,
– skinning,
– increased tear flow,
– reddening of the skin,
– drop in blood pressure when getting up,
a short-term increase in blood pressure
– vomiting,
– hiccup,
– sweating,
injection site pain.
Common after rapid injection (does not require treatment):
– anxiety
– agitation (agitation)
– palpitations.
Uncommon (may affect up to 1 in 100 people):
– fear,
– seizures abnormal hearing,
– fast or slow heartbeat,
– extra heartbeat,
– shortness of breath,
– cough,
– nasal congestion,
– chest pain,
– chills.
Rare (may affect up to 1 in 1,000 people):
severe allergic reactions.
If you have been treated with high doses of benzodiazepines for a long time, Flumazenil Hameln may cause withdrawal symptoms. Such symptoms are tension, restlessness, anxiety, mood swings, confusion, hallucinations, dizziness, sweating, rapid heartbeat, involuntary tremors and tremors ( tremor ) and seizures, panic attacks, abnormal crying, agitation, and aggressive behavior.
Additional side effects are in children
Normally, the side effects in children do not differ much from those in adults. Abnormal crying, agitation, and aggressive behavior have been reported when the Flumazenil Hamel was used to wake anesthetized children.
5. How to store the Flumazenil hamel
- Keep this medicine out of the sight and reach of children.
- Do not store above 25 ° C. Do not freeze. Keep the vial are in the outer carton. Sensitive to light.
- The drug should be used immediately after opening.
- The unused solution from opened ampoules should be discarded.
- Do not use this medicine if you find that the solution is not clear and colorless.
- 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.
- 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.
- Shelf life after dilutionChemical and physical in-use stability data show that reconstituted solution is stable for 24 hours at 25 ° C. From a microbiological perspective, the product should be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user. This storage should normally not be longer than 24 hours at 2 – 8 ° C unless dilution has taken place under controlled and validated aseptic conditions.
6. Contents of the packaging and other information
Content declaration
- The active substance is flumazenil
- 1 ml solution for injection / infusion contains 0.1 mg flumazenil.
- 1 ampoule of 5 ml solution contains 0.5 mg flumazenil.
- 1 ampoule of 10 ml solution contains 1.0 mg flumazenil.
- The other ingredients are: disodium edetate, concentrated acetic acid, sodium chloride, sodium hydroxide (for pH adjustment), water for injections.
What the medicine looks like and the contents of the pack
Flumazenil Hameln is a clear and colorless solution in glass ampoules.
Cartons of 5 or 10 ampoules are 5 ml.
Cartons of 5 or 10 ampoules are 10 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holder of approval
for sale:
Hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany
Manufacturer
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
This medicinal product is authorized under the European Economic Area under the names:
Germany: Flumazenil-Hameln 0.1 mg/ml Solution for injection
Denmark: Flumazenil hameln
Finland: Flumazenil hameln 0.1 mg / ml injection / infusion test, liuos
Italy: Flumazenil hameln 0.1 mg / ml infusible or infusion solution
Netherlands: Flumazenil hameln 0.1 mg / ml, solution for injection / infusion
Norway: Flumazenil hameln 0.1 mg / ml solution for injection for infusion
United Kingdom: Flumazenil 100 micrograms / ml solution for injection / infusion