Flumazenil 0.1 Mg/Ml Solution For Injection
|
TEVA UK Ref: 231-30-87151-L LEA FLUMAZENIL 0.1mg/ml SOL FOR INJ 5ml TEVAH <GOD |
Version: 5 |
19 January 2016 |
S6Z speej 9 poo Bwjend
Flumazenil 0.1 mg/ml solution for injection
TPTTTI
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pharma code reads 295
The following information is intended for healthcare professionals only:
Posology and method of administration
Flumazenil should be administered intravenously by an anaesthetist or experienced physician.
Flumazenil may be administered as injection or as infusion and may be used concomitantly with other resuscitative measures. Adults:
Anaesthesia
The recommended starting dose is 0.2 mg administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further dose of 0.1 mg can be injected and repeated at 60-second intervals, 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's characteristics and the benzodiazepine used.
Intensive Care
The recommended starting dose is 0.2 mg administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further dose of 0.1 mg can be injected and repeated at 60-second intervals, up to a total dose of 2 mg.
If drowsiness recurs, an intravenous infusion of 0.1 - 0.4 mg/h may be useful.
The rate of infusion should be adjusted individually to achieve the desired level of consciousness.
If no clear effect on awareness and respiration is obtained after repeated dosing, it should be considered that the intoxication is not due to benzodiazepines.
Infusion should be discontinued every 6 hours to verify whether re-sedation occurs.
Older people:
In the absence of data on the use of flumazenil in older people, it should be noted that this population is generally more sensitive to the effects of medicinal products and should be treated with due caution.
Children above 1 year of age:
, For the reversal of conscious sedation induced with j benzodiazepines in children > 1 year of age, the recommended ; initial dose is 0.01 mg/kg (up to 0.2 mg) administered intravenously over 15 seconds. If the desired level of consciousness is not obtained after waiting an additional 45 seconds, further injection of 0.01 mg/kg may be administered (up to 0.2 mg) and repeated at 60 second intervals where necessary (a maximum of 4 times) to a maximum total dose of
0.05 mg/kg or 1 mg, whichever is lower. The dose should be individualised based on the patient's response. No data are available on the safety and efficacy of repeated administration of flumazenil to children for re-sedation.
Children under the age of 1 year:
There are insufficient data on the use of flumazenil in children under 1 year. Therefore flumazenil should only be administered in children under 1 year if the potential benefits to the patient outweigh the possible risk.
Patients with renal or hepatic impairment:
In patients with impaired hepatic function, the elimination of flumazenil may be delayed (see section 5.2) and therefore careful titration of dosage is recommended. No dosage adjustments are required in patients with renal impairment.
Instructions for use
After first opening the medicinal product should be used immediately.
When Flumazenil is to be used in infusion, it must be diluted prior to infusion. Flumazenil should only be diluted with sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution or 0.45% sodium chloride + 2.5% glucose.
Compatibility between Flumazenil and other solutions for injection has not been established.
Intravenous infusion solutions should be discarded after 24 hours.
Chemical and physical in-use stability of the diluted product has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Storage conditions
Keep the ampoule in the outer carton in order to protect from light. Do not refrigerate or freeze.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
Flumazenil 0.1 mg/ml solution for injection
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Flumazenil is and what it is used for
2. What you need to know before you use Flumazenil
3. How to use Flumazenil
4. Possible side effects
5. How to store Flumazenil
6. Contents of the pack and other information
OWHAT FLUMAZENIL IS AND WHAT IT IS USED FOR
Flumazenil is a counteragent (antidote) for the complete or partial reversal of the central sedative effects of benzodiazepines (specific group with sedative, sleep inducing, muscle relaxing and anxiolytic properties).
It may therefore be used in anaesthesia to wake you up after certain diagnostic tests or in intensive care if you have been held under sedative conditions. Flumazenil may also be used for the diagnosis and treatment of intoxications or overdose with benzodiazepines.
Flumazenil is also used in children (more than 1 year old) to wake them up after they have been given a benzodiazepine medicine to make them sleepy during a medical procedure.
WHAT YOU NEED TO KNOW BEFORE YOU USE FLUMAZENIL
Do not use Flumazenil
- if you are allergic to flumazenil or any of the other ingredients of this medicine (listed in section 6).
- if benzodiazepines have been administered to you to control a potentially life-threatening situation (for example control of pressure in the brain or a serious epileptic seizure).
- in mixed intoxications with benzodiazepines and certain types of other antidepressants (so called tricyclic and tetracyclic antidepressants like Imipramine, Clomipramine, Mirtazepine or Mianserin). The toxicity of these antidepressants can be masked by protective benzodiazepine effects. If you are showing signs of a significant overdose of these antidepressants, Flumazenil must not be used to reverse benzodiazepine effects.
Warnings and precautions
Talk to your doctor or pharmacist before using Flumazenil
- If you do not wake up after Flumazenil is administered, another reason for this will be considered because Flumazenil specifically reverses the effects of benzodiazepines.
- If Flumazenil is administered to you at the end of your operation to wake you up, it should not be given until the effects of muscle relaxants have gone away. As the action of flumazenil is usually shorter than that of benzodiazepines, sedation may possibly recur. You will be closely observed, possibly in the intensive care unit until the effects of flumazenil have gone away.
- If you have received long-term (chronic) treatment with benzodiazepines, rapid injection of high doses of flumazenil (more than 1 mg) should be avoided since this may cause withdrawal symptoms.
- If you have been treated for long periods with high doses of benzodiazepines, the advantages of the use of Flumazenil should be weighed against the risk of withdrawal symptoms.
- In children previously sedated with Midazolam: These children should be closely observed in intensive care units for at least 2 hours after administration of Flumazenil because repeated sedation or difficulty with breathing can occur. In case of sedation by other benzodiazepines, the monitoring must be adjusted according to their expected duration.
- If you are epileptic and have received benzodiazepine treatment for a long period of time, the administration of flumazenil is not recommended as flumazenil can cause seizures.
- If you have serious brain injury (and/or instable pressure in your brain) care will be taken as Flumazenil can cause an increased pressure in your brain.
- As Flumazenil is not recommended for the treatment of benzodiazepine-dependence or for the treatment of benzodiazepines-withdrawal-symptoms.
- If you have experienced panic attacks in the past Flumazenil can cause new attacks.
- If you are dependent on alcohol or medicines as you have a higher risk of benzodiazepine tolerance and dependence.
- Children should only receive Flumazenil after deliberate sedation. There are insufficient data for any other indications. The same applies for children below the age of 1 year
Other medicines and Flumazenil
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 is because flumazenil can affect the way some other medicines work and because some other medicines can affect the way flumazenil works.
Flumazenil can alter the effect of medicines with a similar mechanism of action like zopiclone or triazolopyridazine (medicines used to help you sleep).
When using Flumazenil injection in cases of an accidental overdose it has to be taken into account that the toxic effects of
Pharma code reads 295
|
TEVA UK Ref: 231-30-87151-L LEA FLUMAZENIL 0.1mg/ml SOL FOR INJ 5ml TEVAH <GOD |
Version: 5 |
19 January 2016 |
other psychotropic medicinal products (especially tricyclic antidepressants like Imipramin) taken concurrently, may increase with the subsidence of the benzodiazepine effect.
Interaction with other central nervous system depressants has not been observed.
Pregnancy and breast-feeding
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.
Because of insufficient experience during pregnancy Flumazenil injection should only be used if the advantage for you is higher than the potential risk for the unborn baby. The administration of Flumazenil injection during pregnancy is not contraindicated in an emergency situation.
It is not known whether flumazenil is excreted in breast milk. Therefore it is recommended not to breast-feed 24 hours after administration of Flumazenil injection.
Driving and using machines
After receiving Flumazenil for the reversal of the sedative effects of benzodiazepines you must not drive a car, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours since sedation may possibly recur.
Important information about some of the ingredients of Flumazenil
This medicinal product contains 9.3 mg sodium chloride per ml (3.7 mg sodium per ml) (for 46.5 mg/ 5 ml ampoule size or 93 mg/10 ml ampoule size). To be taken into consideration by patients on a controlled sodium diet.
HOW TO USE FLUMAZENIL
Flumazenil is administered as intravenous injection (into a vein) or diluted as intravenous infusion (over a longer period). Flumazenil will be given by your anaesthetist or experienced physician. Flumazenil may be used at the same time as other resuscitative measures.
Your doctor will decide on a suitable dose for you. Doses vary and will depend on the procedure you have received and the level of sedation. Your bodyweight, age, general condition of health and your response to the drug will also influence the dose you receive.
Use in anaesthesia
The recommended starting dose for adults is 0.2 mg given by slow injection into a vein over 15 seconds. If the required level of consciousness is not obtained after 60 seconds, a further dose of 0.1 mg can be given. This dose can be repeated every 60 seconds until the desired level of consciousness is achieved, up to a maximum total dose of 1 mg. The usual dose is 0.3-0.6 mg.
Use in intensive care situations
The recommended starting dose for adults is 0.2 mg given by slow injection into a vein over 15 seconds. If the required level of consciousness is not obtained after 60 seconds, a further dose of 0.1 mg can be given. This dose can be repeated every 60 seconds until the desired level of consciousness is achieved, up to a maximum total dose of 2 mg.
- If you become drowsy again you may be given a slow, continuous injection (infusion) into a vein at a rate of 0.1-0.4 mg per hour until the correct level of consciousness is achieved.
- If after repeated doses there is no marked improvement in consciousness or independent breathing, your doctor will probably stop giving Flumazenil and use another method to raise your level of consciousness.
Use in children and adolescents
In case of children above 1 year of age, the,starting dose is 0.01 mg/kg body weight (up to 0.2 mg) administered intravenously over a period of 15 seconds. This dose can be repeated, if after a waiting period of 45 seconds the required level of consciousness is not obtained: a follow-up injection of 0.01 mg/Kg (up to 0.2 mg) may be administered.
Where necessary repeated injections at 60-second intervals (up to a maximum of 4 times) to a maximum dose of 0.05 mg/kg or 1 mg, depending on which is the lowest dose can be injected. There are insufficient data on the use of Flumazenil in children under 1 year. Therefore Flumazenil should only be administered in children under 1 year if the potential benefits to the patient outweigh the possible risk.
If you are older people or have a liver condition your dose of Flumazenil will be adjusted with particular care. No dose adjustment is required in patients with impaired kidney function.
If you use more Flumazenil than you should If you think you have been given too much Flumazenil, you should feel no ill effects, however, it would be wise to contact your doctor, pharmacist or hospital as quickly as possible.
If you stop using Flumazenil
Flumazenil treatment ends when you become fully conscious. However, because the effects of Flumazenil may wear off quickly and you may need repeat doses, you should remain under close medical supervision until all drowsiness has subsided.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Nervous system disorders
- Common:
- Uncommom:
Eye disorders
- Common:
Ear disorders
- Uncommon: Cardiac disorders
- Common:
- Uncommon:
Vascular disorders
- Common:
dizziness, headache, agitation (after rapid injection, not requiring treatment), unvoluntary trembling or quivering (tremor), dry mouth, abnormal rapid and deep respiration (hyperventilation), speech disorder, subjective cutaneous sensations (e.g. cold, warmth, tingling, pressure, etc.) in the absence of stimulation (paresthesia). convulsions (in patients suffering epilepsy or severe liver insufficiency, mainly after long-term treatment with benzodiazepines or multiple medicinal products abuse).
double vision, strabismus (squinting), lacrimation (production of tear fluid) increased.
abnormal hearing.
heart palpitations (after rapid injection, not requiring treatment).
slow or rapid heart rate, premature beat of your heart (extrasystole).
reddening of the skin, low blood pressure on transition from lying to standing, transient increased blood pressure (on awaking). Respiratory, chest and mediastinal disorders
- Uncommon: difficulty breathing, cough, nasal congestion,
chest pain.
Gastrointestinal disorders
- Very common: nausea
- Common: vomitting, hiccup
Skin and subcutaneous tissue disorders
- Common: sweating.
General disorders and administration site conditions
- Common: fatigue, injection site pain.
- Uncommon: shivering
If you were treated for a long period with benzodiazepines flumazenil can induce withdrawal symptoms. The symptoms are: tension, agitation, anxiety, confusion, hallucinations, involuntary trembling or quivering (tremor) and convulsions.
Additional side effects in children and adolescents In general the undesirable effects in children do not differ much from that in adults. When using Flumazenil injection to awaken a child from sedation, abnormal crying, agitation and aggressive reactions have been reported.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
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 label after EXP. The expiry date refers to the last day of that month.
Keep ampoules in the outer carton in order to protect from light. Do not refrigerate or freeeze.
This medicinal product is for single use only. After first opening the medicinal product should be used immediately. Any unused solution should be discarded. The solution should be inspected visually prior to use. It should only be used if the solution is clear, colourless and practically free from particles.
Chemical and physical in-use stability of the diluted product has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Do not use this medicine if you notice unclear solution and particles.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
T3
g
<D
■o
O
E
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is classified into the following categories:
Very common: Common: Uncommon: Rare
Very rare:
Not known:
may affect more than 1in 10 people may affect up to 1 in 10 people may affect up to 1 in 100 people may affects up to 1 in 1000 people may affects up to 1 in 10,000 people Frequency cannot be estimated from the available data
Immune system disorders
- Common: hypersensitivity reactions (allergic reactions).
Psychiatric disorders
- Common: Anxiety (after rapid injection, not requiring
treatment), strong emotional lability, having problems in initiating and maintaining sleep (insomnia), feeling sleepy (somnolence)
What Flumazenil contains
- The active substance is Flumazenil
- Each ml contains 0.1 mg flumazenil
1 ampoule with 5 ml contains 0.5 mg flumazenil
- 1 ampoule with 10 ml contains 1 mg flumazenil
- The other ingredients are sodium chloride, disodium edetate dihydrate, glacial acetic acid (E260), sodium hydroxide, hydrochloric acid and water for injections.
What Flumazenil looks like and contents of the pack
Flumazenil is a clear, almost colourless, solution for injection and concentrate for solution for infusion, free from foreign matter. This medicine is supplied as a ready to use injectable solution and comes in two sizes:
Pack sizes:
• 1 or 5 glass ampoules containing 5 ml solution packed in folded carton box
• 1 or 5 glass ampoules containing 10 ml solution packed in folded carton box
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG.
Manufacturer
Teva Pharmaceutical Works Private Limited Company, H-2100 Godollo, Tancsics Mihaly ut 82, Hungary This leaflet was last revised: May 2013 87151-L
PL 00289/1191 3-29119580/C
Pharma code reads 295