\n\n0.1 mg \/ ml injection solution
flumazenil<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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.
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Children<\/strong> Tell your doctor if you are taking, have recently taken, or might take any other medicines. There is no known interaction between ethanol and flumazenil.<\/p>\n\n\n\n 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<\/strong> to you is expected to outweigh the potential risks<\/strong> 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<\/strong> after flumazenil treatment is recommended.<\/p>\n\n\n\n You can not drive a car<\/strong>, use machines<\/strong> 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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. Flumazenil Fresenius Kabi is given as an intravenous injection<\/strong> (into a blood vessel) or as an intravenous infusion<\/strong> (over a long period of time).<\/p>\n\n\n\n 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. Recommended dosage:<\/p>\n\n\n\n Patients with renal or hepatic impairment:<\/strong> Renal impairment does not <\/strong>require dose adjustment.<\/strong> Use in children:<\/strong> Children under 1 year<\/strong><\/p>\n\n\n\n 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<\/strong> of the drug is expected to exceed the potential risks<\/strong> to the child. If you have any further questions on the use of this product, ask your doctor or pharmacist. Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common (may affect more than 1 user in 10)<\/strong><\/p>\n\n\n\n Nausea Common (may affect up to 1 in 10 users)<\/strong><\/p>\n\n\n\n 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)<\/strong><\/p>\n\n\n\n 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)<\/strong><\/p>\n\n\n\n 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<\/strong> Such symptoms<\/strong> are a state of tension, restlessness, anxiety, mood swings, confusion, hallucinations, involuntary tremors and tremors, and convulsions. Normally, no different adverse reactions were<\/strong> of children<\/strong> differ greatly from those in adults. Abnormal crying, agitation, and aggressive reactions have been reported when flumazenil was used to wake anesthetized children. Keep this medicine out of the sight and reach of children. 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.<\/p>\n\n\n\n The active substance is flumazenil. 1 ml contains 0.1 mg of flumazenil. The other ingredients are disodium edetate, concentrated acetic acid, sodium chloride, 4% sodium hydroxide solution, water for injections.<\/p>\n\n\n\n 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: Not all pack sizes may be marketed.<\/p>\n\n\n\n <\/p>\n\n\n\n Manufacturer:<\/em> This medicinal product is authorized under the European Economic Area under the names:<\/strong> 0.1 mg \/ ml injection solution
<\/p>\n\n\n\nOther medicines and Flumazenil Fresenius Kabi<\/h2>\n\n\n\n
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.<\/p>\n\n\n\nFlumazenil Fresenius Kabi with alcohol<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Flumazenil Fresenius Kabi contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use Flumazenil Fresenius Kabi<\/h2>\n\n\n\n
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.
<\/p>\n\n\n\nAdults:<\/strong><\/td><\/tr> Anesthetic<\/strong><\/td> Intensive care<\/strong><\/td><\/tr> Dose<\/strong><\/td><\/tr><\/thead> Introductory dose:0.2 mg intravenously (in a vein) for 15 seconds.<\/td> Introductory dose:0.3 mg intravenously (in a vein) for 15 seconds.<\/td><\/tr> 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.<\/td> 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.<\/td><\/tr> The usual dose is 0.3-0.6 mg, but the dose may vary from patient to patient depending on the benzodiazepine used.<\/td> If the patient becomes unconscious again, a second bolus injection may be given. An intravenous infusion of 0.1\u20110.4 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.<\/td><\/tr> <\/td> Infusion one can be given in addition to the maximum injection dose of 2 mg<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
In patients with hepatic impairment, elimination of flumazenil from the body may be slower than normal and therefore careful dosing is recommended.<\/strong>
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<\/p>\n\n\n\nChildren and adolescents (from 1 year)<\/strong><\/td><\/tr> For cancellation of intentional anesthesia<\/strong><\/td><\/tr> Dose:<\/strong><\/td><\/tr> 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.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
<\/p>\n\n\n\n
For information intended for healthcare professionals, see the corresponding section below.<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\n5. How to store Flumazenil Fresenius Kabi<\/h2>\n\n\n\n
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 \u00b0 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 \u00b0 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 \u00b0 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.
<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
<\/p>\n\n\n\n
One ampoule of 5 ml contains 0.5 mg of flumazenil.
One 10 ml ampoule contains 1.0 mg of flumazenil.
<\/p>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
<\/p>\n\n\n\n
Pack of 5 or 10 ampoules of 5 ml solution
Pack of 5 or 10 ampoules of 10 ml solution
<\/p>\n\n\n\n
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
AT-8055 Graz
Austria<\/p>\n\n\n\n
<\/p>\n\n\n\nAustria<\/td> Flumazenil Kabi 0.1 mg\/ml solution for injection and concentrate for infusion<\/td><\/tr> Germany<\/td> Flumazenil Kabi 0.1 mg\/ml solution for injection and concentrate for infusion<\/td><\/tr> Denmark<\/td> Flumazenil Fresenius Kabi<\/td><\/tr> Spain<\/td> Flumazenil Fresenius Kabi 0.1 mg\/ml injectable<\/td><\/tr> Hungary<\/td> Flumazenil Kabi 0.1 mg\/ml injectable injection<\/td><\/tr> Ireland<\/td> Flumazenil 0.1 mg \/ ml Solution for Injection<\/td><\/tr> Italy<\/td> Flumazenil Kabi 0.1 mg \/ ml, inoperable solution<\/td><\/tr> Netherlands<\/td> Flumazenil Kabi 0.1 mg \/ ml solution for injection<\/td><\/tr> Norway<\/td> Flumazenil Fresenius Kabi 0.1 mg\/ml solution for injection<\/td><\/tr> Poland<\/td> Flumazenil Kabi 0.1 mg\/ml orodispersible drug<\/td><\/tr> Portugal<\/td> Flumazenil Fresenius Kabi 0.1 mg\/ml injectable solution<\/td><\/tr> UK<\/td> Flumazenil Kabi 0.1 mg\/ml Solution for Injection<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"
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