Midazolam B. Braun

PACKAGE LEAFLET: INFORMATION FOR THE USER

Midazolam B. Braun 1 mg/ml injection/infusion solution

midazolam
Generic medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Midazolam B. Braun is and what it is used for
2. What you need to know before using Midazolam B. Braun
3. How to use Midazolam B. Braun
4. Possible side effects
5. How to store Midazolam B. Braun
6. Contents of the pack and other information

1. What Midazolam B. Braun is and what it is used for

Midazolam B. Braun is a short-acting medicine used to induce
sedation (a deeply relaxed state of calm, drowsiness, or sleep) and to relieve anxiety and
muscle tension. Its active substance, midazolam, belongs to a group of substances
called benzodiazepines.
This medicine is used for:

• conscious sedation (a calm or drowsy state while awake but very relaxed) during medical procedures or interventions in adults and children,
• sedation of adults and children in intensive care units,
• anaesthesia in adults, used alone or in combination with other medicines,
• premedication (to induce relaxation, calmness, and drowsiness before anaesthesia) in adults and children

2. What you need to know before using Midazolam B. Braun

Do not use Midazolam B. Braun

• if you are allergic (hypersensitive) to midazolam, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe respiratory problems and require midazolam for conscious sedation.

Warnings and precautions
Inform your doctor or pharmacist before using Midazolam B. Braun.
You will be closely monitored while receiving this medicine. Your doctor will also ensure
that all necessary equipment and medicines for emergency treatment and resuscitation are available.
Your doctor will pay particular attention and may carefully adjust the dose if:

• you are over 60 years of age
• you have a long-term illness (such as respiratory, renal, hepatic, or cardiac problems)
• you are debilitated (you have an illness that makes you feel very weak, exhausted, and lacking energy)

Before receiving this medicine, inform your doctor if:

• you have severe myasthenia gravis (a neuromuscular disease causing muscle weakness)
• you regularly drink large amounts of alcohol or have had alcohol-related problems in the past
• you regularly use drugs or have used them in the past

If you receive this medicine for a prolonged period, you may:

• become tolerant to midazolam. This means the medicine becomes less effective and no longer works for you,
• become dependent on the medicine and experience withdrawal symptoms (see 'If you stop using Midazolam B. Braun' in section 3). Midazolam will cause a gap in your memory starting from the time of administration. The duration depends on the dose you receive. If you are discharged from hospital or outpatient clinic after a surgical or diagnostic procedure, ensure that someone accompanies you home.

Children
Children must be closely monitored. For children under 6 months of age, this includes monitoring of respiration and oxygen levels.
It is particularly important to inform the doctor if the child has a cardiovascular disease (heart problems). The child will be carefully monitored and the dosage carefully adjusted.
Other medicines and Midazolam B. Braun
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
A large number of medicines can affect the action of midazolam, increasing its effect, prolonging its duration, or both.
In particular, inform your doctor if you are taking the following medicines:

• tranquillisers (for anxiety or to help you sleep)
• hypnotics (to help you sleep)
• sedatives (to calm or sedate you)
• antidepressants (medicines for depression)
• painkillers
• antihistamines (used to treat allergies)
• medicines to treat fungal infections (ketoconazole, voriconazole, fluconazole, itraconazole)
• macrolide antibiotics (erythromycin, clarithromycin)
• cimetidine or ranitidine (medicines for treating stomach ulcers)
• diltiazem (used to treat high blood pressure)
• protease inhibitors (medicines for treating HIV) such as saquinavir
• atorvastatin (used to treat high cholesterol)
• rifampicin (used to treat mycobacterial infections such as tuberculosis)
• St John's wort (herbal remedy)

Midazolam B. Braun with food, drinks and alcohol
Do not drink alcoholic beverages when receiving midazolam, as alcohol can unpredictably intensify the effect of this medicine. This could cause serious adverse effects on breathing, heart function, and circulation.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, you will be given midazolam only if your doctor considers it absolutely necessary for your treatment.
If you are breastfeeding, stop breastfeeding for 24 hours after midazolam administration.
Driving and using machines
Do not drive or operate tools or machinery until you have fully recovered from the effects of midazolam. Your doctor will advise you when it is safe to resume such activities.
This medicine may cause drowsiness, memory loss, or affect your concentration and coordination. Ensure that someone is available to accompany you home after discharge.
Midazolam B. Braun contains sodium
This medicine contains 3.5 mg of sodium (the main component of table/cooking salt) per millilitre. This corresponds to 0.2% of the maximum daily recommended sodium intake in an adult diet.

3. How to use Midazolam B. Braun

Dosing:
Your doctor will determine the appropriate dose for you or your child, depending on the intended treatment and on your health condition or that of your child.
Midazolam B. Braun will be administered with a syringe (by injection) into a vein (intravenously) or into a muscle (intramuscularly). It may also be given diluted in a large volume of fluid through a cannula placed in a vein (by infusion).
Rectal administration via a special applicator is also possible, if injection or infusion is not feasible.
If you use more Midazolam B. Braun than you should
A doctor will administer this medicine to you. If you accidentally receive too much midazolam, you may become drowsy, confused, lethargic, or lose coordination. In case of severe intoxication, you may lose reflexes, develop low blood pressure, suffer from cardiorespiratory depression (slowed or interrupted breathing and heartbeat), and lose consciousness (coma).
Treatment of overdose primarily consists of monitoring vital functions (cardiac function, circulation, and respiration). You will receive appropriate supportive care, if necessary.
In case of severe intoxication, you may be given an antidote to counteract the effect of midazolam.
If you stop using Midazolam B. Braun
If you abruptly stop treatment after long-term use, you may experience symptoms such as:

• headaches,
• muscle pain,
• feelings of anxiety, tension, restlessness, confusion, or irritability,
• sleep-related problems (insomnia),
• mood changes,
• hallucinations (seeing or hearing things that do not exist),
• jerking movements (seizures).
  Your doctor will gradually reduce the dose of midazolam treatment towards the end to prevent these effects from occurring.
  If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported (frequency not known):
The following side effects can be serious. If you experience any of the following side effects,
inform your doctor immediately, who will stop administration of this medicine:

• Anaphylactic shock (life-threatening allergic reaction). Signs may include sudden skin reaction, itching or granular rash (urticaria), and swelling of the face, lips, tongue or other parts of the body. You may also experience shortness of breath, wheezing or breathing difficulties (bronchospasm)
• Heart attack (cardiac arrest). Signs may include chest pain that may spread to the neck and shoulders and down to the left arm, breathing problems or complications (sometimes these may stop breathing)
• Choking and sudden blockage of the airways (laryngospasm)

Life-threatening side effects are more likely to occur in adults over 60 years of age and in those who already have breathing difficulties or heart problems, especially if the injection is administered too quickly or at a high dose.
Other side effects:
Immune system problems:

• General allergic reactions (skin reactions, reactions of the cardiac and circulatory system)

Behavioural problems:

• Agitation
• Restlessness
• Hostility, anger outbursts or aggression
• Excitement
• Offensive behaviour

Muscle problems:

• Muscle spasms and tremors (involuntary shaking of muscles)

Mental and nervous system problems:

• Confusion
• Euphoria (a feeling of excessive happiness or excitement)
• Hallucinations (seeing or hearing things that are not real)
• Drowsiness and prolonged sedation
• Reduced attention
• Headache
• Dizziness
• Difficulty with muscle coordination
• Seizures in premature infants and newborns
• Temporary memory loss. The duration depends on how much midazolam you received. You may experience this after treatment. In isolated cases, this has lasted for a long time.
• Drug dependence
• Withdrawal symptoms, sometimes including seizures

Heart and circulation problems:

• Low blood pressure
• Slow heart rate
• Widening of blood vessels (vasodilation)

Breathing problems:

• Hiccups

Stomach, intestinal and mouth problems:

• Feeling unwell (nausea)
• Vomiting
• Constipation
• Dry mouth

Skin problems:

• Rash
• Urticaria (granular skin reactions)
• Itching

Effects at the site of administration:

• Redness
• Skin swelling
• Blood clots or pain

General:

• Tiredness (fatigue)

Injury, poisoning and procedural complications:

• Falls or bone fractures. This risk is increased in patients taking other sedatives (including alcohol) and in the elderly.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Midazolam B. Braun

Your doctor or pharmacist is responsible for the storage of this medicine.
They are also responsible for the proper disposal of any unused midazolam.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Chemical and physical stability has been demonstrated during use for 24 hours at room temperature and for 3 days at 5°C.
From a microbiological point of view, diluted solutions should be used immediately after preparation. If not used immediately, the storage times during use and the conditions prior to use are under the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the method of dilution excludes any risk of microbiological contamination.
Keep containers in the outer packaging to protect them from light.

6. Package contents and other information

What Midazolam B. Braun contains

• The active substance is midazolam (as midazolam hydrochloride). Each ml of Midazolam B. Braun contains 1 milligram of midazolam. A 5 ml vial contains 5 milligrams of midazolam. A 50 ml bottle contains 50 milligrams of midazolam. A 100 ml bottle contains 100 milligrams of midazolam.
• The excipients are sodium chloride, hydrochloric acid 10%, and water for injections.

Description of the appearance of Midazolam B. Braun and contents of the pack
Midazolam B. Braun is a clear, colourless solution. Midazolam B. Braun is available in:

• colourless glass vials of 5 ml, in packs of 10 vials;
• transparent polyethylene vials of 5 ml, in packs of 4, 10 or 20 vials;
• transparent polyethylene bottles of 50 ml and 100 ml, in packs of 10 bottles.
  Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Straße 1,
34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Tel. +49-5661-71-0
Fax: +49-5661-71-4567

Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1,
34212 Melsungen, Germany
B. Braun Medical, S.A.
Carretera de Terrassa 121,
08191 Rubí, Barcelona, Spain

This medicinal product is authorised in the Member States of the European Economic Area (EEA) under the following names:
Belgium Midazolam B. Braun 1 mg/ml
Czech Republic Midazolam B. Braun 1 mg/ml
Cyprus Midazolam B. Braun 1 mg/ml
Denmark Midazolam B. Braun 1 mg/ml
Estonia Midazolam B. Braun 1 mg/ml
France Midazolam B. Braun 1 mg/ml
Germany Midazolam B. Braun 1 mg/ml
Greece Midazolam B. Braun 1 mg/ml
Italy Midazolam B. Braun 1 mg/ml
Latvia Midazolam B. Braun 1 mg/ml
Lithuania Midazolam B. Braun 1 mg/ml
Luxembourg Midazolam B. Braun 1 mg/ml
Malta Midazolam B. Braun 1 mg/ml
Norway Midazolam B. Braun 1 mg/ml
Poland 1 mg/ml strength: Midazolam B. Braun
Portugal Midazolam B. Braun 1 mg/ml
Slovenia Midazolam B. Braun 1 mg/ml
Spain Midazolam B. Braun 1 mg/ml

This leaflet was last approved on

The following information is intended for healthcare professionals only:
Warnings
Paradoxical reactions
Paradoxical reactions such as agitation, involuntary movements (including tonic/clonic seizures and muscle tremors), hyperactivity, hostility, rage reaction, aggression, paroxysmal excitement and aggression have been reported with midazolam. These reactions may occur with high doses and/or when injection is administered rapidly. The highest incidence of these reactions has been reported in children and elderly patients.

Handling
The medicinal product must be used immediately after opening.
Stability after dilution according to instructions:
Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and for 3 days at 5 °C.
From a microbiological standpoint, diluted solutions should be used immediately after preparation. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and will normally not exceed 24 hours at 2 to 8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Refer to the Summary of Product Characteristics for instructions on dilution, incompatibilities and prescribing information.
The product is supplied in a single-dose container. Any unused content of opened vials must be discarded immediately.
Use only if the solution is clear and transparent and the vial is intact.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Midazolam B. Braun 5 mg/ml injectable solution/for infusion

midazolam
Generic medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Midazolam B. Braun is and what it is used for
2. What you need to know before using Midazolam B. Braun
3. How to use Midazolam B. Braun
4. Possible side effects
5. How to store Midazolam B. Braun
6. Contents of the pack and other information

1. What Midazolam B. Braun is and what it is used for

Midazolam B. Braun is a short-acting medicine used to induce
sedation (a deeply relaxed state of calm, drowsiness, or sleep) and to relieve anxiety and
muscle tension. Its active substance, midazolam, belongs to a group of substances
called benzodiazepines.
This medicine is used for:

• conscious sedation (a calm or drowsy state in which the patient is awake but very relaxed) during medical examinations or procedures in adults and children,
• sedation of adults and children in intensive care units,
• anaesthesia in adults, used alone or in combination with other medicines,
• premedication (to induce relaxation, calmness, and drowsiness before anaesthesia) in adults and children

2. What you need to know before using Midazolam B. Braun

Do not use Midazolam B. Braun

• if you are allergic (hypersensitive) to midazolam, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe respiratory problems and require midazolam for conscious sedation.

Warnings and precautions
Inform your doctor or pharmacist before using Midazolam B. Braun.
You will be closely monitored while receiving this medicine. Your doctor will also ensure
that all necessary equipment and medicines for emergency treatment and resuscitation are available.
Your doctor will pay particular attention and may carefully adjust the dose if:

• you are over 60 years of age
• you have a long-term illness (such as respiratory, renal, hepatic, or cardiac problems)
• you are debilitated (have an illness that makes you feel very weak, exhausted, and lacking in energy)

Before receiving this medicine, inform your doctor if:

• you have severe myasthenia gravis (a neuromuscular disease causing muscle weakness)
• you regularly drink large amounts of alcohol or have had alcohol-related problems in the past
• you regularly use drugs or have used them in the past

If you receive this medicine for a prolonged period, you may:

• become tolerant to midazolam. This medicine becomes less effective and no longer works for you,
• become dependent on the medicine and experience withdrawal symptoms (see 'If you stop using Midazolam B. Braun' in section 3).

Midazolam will cause a gap in your memory starting from the time of administration.
The duration depends on the dose you receive. If you are discharged from hospital or outpatient clinic
after a surgical or diagnostic procedure, ensure that someone accompanies you home.
Children
Children must be closely monitored. For children under 6 months of age, this includes monitoring of breathing and oxygen levels.
It is particularly important to inform the doctor if the child has a cardiovascular disease (heart problems). The child will be carefully monitored and the dosage carefully adjusted.
Other medicines and Midazolam B. Braun
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
A large number of medicines can affect the action of midazolam, increasing its effect or prolonging its duration, or both.
In particular, inform your doctor if you are taking the following medicines:

• tranquillisers (for anxiety or to help you sleep)
• hypnotics (to help you sleep)
• sedatives (to calm or put you to sleep)
• antidepressants (medicines for depression)
• painkillers
• antihistamines (used to treat allergies)
• medicines to treat fungal infections (ketoconazole, voriconazole, fluconazole, itraconazole)
• macrolide antibiotics (erythromycin, clarithromycin)
• cimetidine or ranitidine (medicines for stomach ulcer treatment)
• diltiazem (used to treat high blood pressure)
• protease inhibitors (medicines for the treatment of HIV) such as saquinavir
• atorvastatin (used to treat high cholesterol)
• rifampicin (used to treat mycobacterial infections such as tuberculosis)
• St John's wort (herbal remedy)

Midazolam B. Braun with food, drinks and alcohol
Do not drink alcoholic beverages while receiving midazolam, as alcohol may intensify the effect of
this medicine in an uncontrolled way. This could cause serious adverse effects on
respiration, cardiac function, and circulation.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
If you are pregnant, you will receive midazolam only if your doctor considers it absolutely
necessary for your treatment.
If you are breastfeeding, stop breastfeeding for 24 hours following midazolam administration.
Driving and using machines
Do not drive or operate tools or machinery until you are fully awake from the effects of midazolam. Your doctor
will advise you when you may resume such activities.
This medicine may make you sleepy, cause memory loss, or affect your concentration
and coordination. Ensure that someone is available to accompany you home after discharge.
Midazolam B. Braun contains sodium
This medicine contains 2.2 mg of sodium (the main component of table/cooking salt) per millilitre. This corresponds to 0.1% of the maximum daily recommended sodium intake in an adult's diet.

3. How to use Midazolam B. Braun

Dosing:
Your doctor will determine the correct dose for you or your child, depending on the treatment required and on your or your child's health condition.
Midazolam B. Braun will be administered with a syringe (by injection) into a vein (intravenously) or into a muscle (intramuscularly). It may also be given diluted in a large volume of fluid through a cannula placed in a vein (by infusion).
Rectal administration via a special applicator may also be possible if injection or infusion is not feasible.

If you use more Midazolam B. Braun than you should
A doctor will administer this medicine to you. If you accidentally receive too much midazolam, you may become drowsy, confused, lethargic, or lose coordination. In case of severe intoxication, you may lose reflexes, develop low blood pressure, suffer from cardiorespiratory depression (slowed or interrupted breathing and heartbeat), and lose consciousness (coma).
Treatment of overdose primarily consists of monitoring vital functions (cardiac function, circulation, and respiration). You will receive appropriate supportive measures, if necessary.
In case of severe intoxication, you may be given an antidote to counteract the effect of midazolam.

If you stop using Midazolam B. Braun
If you abruptly stop treatment after long-term use, you may experience symptoms such as:

• headaches,
• muscle pain,
• feelings of anxiety, tension, restlessness, confusion, or bad mood (irritability),
• sleep-related problems (insomnia),
• mood changes,
• hallucinations (seeing or hearing things that are not real),
• jerking movements (seizures).

Your doctor will gradually reduce the dose of midazolam treatment until it is completely discontinued, in order to prevent these effects.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported (frequency not known):
The following side effects can be serious. If you experience any of the following side effects,
inform your doctor immediately, who will stop administration of this medicine:

• Anaphylactic shock (a life-threatening allergic reaction). Signs may include sudden skin reaction, itching or granular rash (urticaria), and swelling of the face, lips, tongue or other parts of the body. You may also experience shortness of breath, wheezing or breathing difficulties (bronchospasm)
• Heart attack (cardiac arrest). Signs may include chest pain that may spread to the neck and shoulders and down the left arm, breathing problems or complications (sometimes these may stop breathing)
• Choking and sudden blockage of the airways (laryngospasm)

Life-threatening side effects are more likely to occur in adults over 60 years of age and in those who already have difficulty breathing or have heart problems, especially if the injection is administered too quickly or at a high dose.
Other side effects:
Immune system problems:

• General allergic reactions (skin reactions, reactions of the cardiac and circulatory system) Effects on behaviour
• Agitation
• Restlessness
• Hostility, anger outbursts or aggression
• Excitement
• Offensive behaviour

Muscle problems:

• Muscle spasms and tremors (involuntary shaking of muscles)

Mental and nervous system problems:

• Confusion
• Euphoria (a feeling of excessive happiness or excitement)
• Hallucinations (seeing or hearing things that are not real)
• Drowsiness and prolonged sedation
• Reduced attention
• Headache
• Dizziness
• Difficulty with muscle coordination
• Seizures in premature infants and newborns
• Temporary memory loss. The duration depends on how much midazolam you received. You may experience this after treatment. In isolated cases, this has lasted for a long period.
• Drug dependence
• Withdrawal symptoms, sometimes including seizures

Heart and circulatory problems:

• Low blood pressure
• Slow heartbeat
• Widening of blood vessels (vasodilation)

Breathing problems:

• Hiccups

Stomach, intestinal and mouth problems:

• Feeling unwell (nausea)
• Vomiting
• Constipation
• Dry mouth

Skin problems:

• Rash
• Urticaria (granular skin reactions)
• Itching

Effects at the site of administration:

• Redness
• Skin swelling
• Blood clots or pain

General:

• Tiredness (fatigue)

Injury, poisoning and procedural complications:

• Falls or bone fractures. This risk is increased in patients taking other sedatives (including alcohol) and in elderly patients.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Midazolam B. Braun

Your doctor or pharmacist is responsible for the storage of this medicine. They are also responsible for the proper disposal of any unused midazolam.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Chemical and physical stability during use has been demonstrated for 24 hours at room temperature and for 3 days at 5°C.
From a microbiological standpoint, diluted solutions should be used immediately after preparation. If not used immediately, storage times and conditions prior to use are under the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the dilution method excludes any risk of microbiological contamination.
Keep containers in the outer packaging to protect them from light.

6. Package contents and other information

What Midazolam B. Braun contains

• The active substance is midazolam (as midazolam hydrochloride). Each ml of Midazolam B. Braun contains 5 milligrams of midazolam.
  o 1 vial of 1 ml therefore contains 5 milligrams of midazolam
  o 1 vial of 3 ml therefore contains 15 milligrams of midazolam
  o 1 vial of 10 ml therefore contains 50 milligrams of midazolam
• The excipients are sodium chloride, hydrochloric acid 10%, and water for injections

Description of the appearance of Midazolam B. Braun and package contents
Midazolam B. Braun is a clear, colourless solution. Midazolam B. Braun is available in:
o colourless glass vials of 1 ml, in packs of 10 vials
o colourless glass vials of 3 ml, in packs of 10 vials
o colourless glass vials of 10 ml, in packs of 5 or 10 vials
o transparent polyethylene vials of 10 ml, in packs of 4, 10 or 20 vials

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Straße 1,
34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Tel. +49-5661-71-0
Fax: +49-5661-71-4567

Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1,
34212 Melsungen, Germany
B. Braun Medical, S. A.
Carretera de Terrassa 121,
08191 Rubí, Barcelona, Spain

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Belgium Midazolam B. Braun 5 mg/ml
Czech Republic Midazolam B. Braun 5 mg/ml
Cyprus Midazolam B. Braun 5 mg/ml
Denmark Midazolam B. Braun 5 mg/ml
Estonia Midazolam B. Braun 5 mg/ml
France Midazolam B. Braun 5 mg/ml
Germany Midazolam B. Braun 5 mg/ml
Greece Midazolam B. Braun 5 mg/ml
Italy Midazolam B. Braun 5 mg/ml
Latvia Midazolam B. Braun 5 mg/ml
Lithuania Midazolam B. Braun 5 mg/ml
Luxembourg Midazolam B. Braun 5 mg/ml
Malta Midazolam B. Braun 5 mg/ml
Norway Midazolam B. Braun 5 mg/ml
Poland 5 mg/ml strength: Midazolam B. Braun
Portugal Midazolam B. Braun 5 mg/ml
Slovenia Midazolam B. Braun 5 mg/ml
Spain Midazolam B. Braun 5 mg/ml

This leaflet was last approved on

The following information is intended for healthcare professionals only:

Warnings
Paradoxical reactions
Paradoxical reactions such as agitation, involuntary movements (including tonic/clonic seizures and muscle tremors), hyperactivity, hostility, rage reaction, aggressiveness, paroxysmal excitement and aggression have been reported with midazolam. These reactions may occur with high doses and/or when injection is administered rapidly. The highest incidence of these reactions has been reported in children and elderly patients.

Handling
The medicinal product must be used immediately after opening.
Stability after dilution according to instructions:
Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and for 3 days at 5 °C.
From a microbiological standpoint, diluted solutions should be used immediately after preparation. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and will normally not exceed 24 hours at 2–8 °C, unless dilution has been performed under controlled and validated aseptic conditions.
Refer to the Summary of Product Characteristics for instructions on dilution, incompatibilities and prescribing information.
The product is supplied in a single-dose container. Any unused content of opened vials must be immediately discarded.
Use only if the solution is clear and transparent and the vial is intact.