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PACKAGE LEAFLET: INFORMATION FORTHE USER    D00522

Midazolam 5mg/ml Solution for injection or infusion

Midazolam Hydrochloride

In this leaflet:

1.    What Midazolam is and what it is used for

2.    Before Midazolam is given

3.    Flow Midazolam will be given

4.    Possible side effects

5.    Flow to store Midazolam solution for injection or infusion

6.    Further information

1.    What Midazolam is and what it is used for

Midazolam is one of a group of medicines known as benzodiazepines. Benzodiazepines are sedatives, meaning that they are used to relax you and help you to sleep.

Midazolam Injection is used to help you feel relaxed and to help you sleep before and during an operation. It can also calm you during an operation where you are not asleep. It may also be used to help patients in intensive care units to relax.

2.    Before Midazolam is given

You should not be given Midazolam:

•    If you are allergic or hypersensitive to Midazolam or other or to any of the ingredients in the product.

•    If you have severe breathing difficulties or problems with your lungs

Take special care with Midazolam if:

•    you have severe or moderate breathing difficulties

•    you are over 60 years of age

•    it is to be given to children, especially those suffering heart or blood vessel problems (cardiovascular)

•    you have severe kidney problems

•    you have problems with your heart or have a heart condition

•    you have a history of alcohol or drug abuse or have liver disease

•    you have a condition called 'myasthesia gravis'

•    You are debilitated (have an illness that makes you feel very weak, run down and short of energy).

•    You are pregnant or think you may be pregnant (see 'Pregnancy and breast-feeding').

If any of the above applies to you, please tell your doctor.

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TECHNICAL INFORMATION    D00522

Taking other medicines:

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes:

•    Antifungal medicines such as Itraconazole, fluconazol, voriconazole, ketoconazole or posaconazole

•    Medicines to reduce blood pressure such as verapamil or diltiazem

•    Medicines to treat high cholesterol, such as Atorvastatin

•    Medicines to treat mycobacteria infections such as tuberculosis (rifampicin)

•    Antibiotics prescribed by your doctor such as erythromycin or clarithromycin

•    HIV medications such as saquinavir ritonavir, indinavir, nelfinavir and amprenavir

•    Drugs that depress the central nervous system (cause drowsiness) such as phenytoin or carbamazepine

•    Alcohol or drugs containing alcohol

•    General anaesthetics (given by inhalation)

•    Strong painkillers

•    The herbal medicine St. Johns Wort

If you are in any doubt please tell your doctor about any medication you are taking.

Pregnancy and breast-feeding:

This medicine should not be used during pregnancy unless your doctor feels it is necessary.

Midazolam passes in low amounts into breast milk. Nursing mothers are advised to stop breast-feeding for 24 hours following administration of midazolam

Please speak to your doctor if you are pregnant, trying to become pregnant or are breast-feeding.

Driving and using machinery:

This medicine may adversely affect your ability to drive or use machines. You should not drive a vehicle or operate a machine until completely recovered. Your physician should decide when these activities may be resumed. It is recommended that you are accompanied when returning home after you are discharged from hospital.

Important information about some of the ingredients of Midazolam

Midazolam injection is essentially'sodium free'as it contains less than 1 mmol sodium (23mg) per ampoule.

3. How Midazolam is given

Adults and the elderly.

Midazolam Injection will be given to you by a doctor or nurse slowly in a vein (intravenous) either as a continuous infusion or intermittent bolus injection or into a muscle. Your doctor will decide the correct dosage for you as this would be dependent on your general physical condition, age, weight and your response to treatment and whether other medicines are needed at the same time.

Children

The precise dose and route of administration must be decided by a doctor qualified in the treatment of children.

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Midazolam 5mg/ml Solution for injection or infusion

Midazolam Hydrochloride

The following information is intended for medical or healthcare professionals only:

Incompatibilities

The product should not be mixed with other medicinal products apart from 5% Glucose Intravenous Infusion BP, Sodium Chloride Intravenous Infusion BP or 0.18% Sodium Chloride and 4% Glucose Intravenous Infusion BP

Standard Dosage

Indication	Adults <60 years	Adults 60 years+/debilitated or seriously ill	Children
Conscious sedation	IV Initial dose: 2-2.5mg Titration doses: Img Total dose: 3.5-7.5mg	IV Initial dose: 0.5-1 mg Titration doses: 0.5-1 mg Total dose: <3.5mg	IV in patients 6 months-5 years Initial dose: 0.05-0.1 mg/kg Total dose: <6mg IV in patients 6-12 years Initial dose: 0.025-0.05mg/kg Total dose: < lOmg Rectal>6 months 0.3-0.5mg/kg IM 1-15 years 0.05-0.15mg/kg
Anaesthesia premedication	IV T2mg repeated IM 0.07-0.1 mg/kg	IV Initial dose 0.5mg Slow uptitration as needed IM 0.025-0.05mg/kg	Rectal> 6 months 0.3-0.5mg/kg IM 1-15 years 0.08-0.2mg/kg
Anaesthesia induction	IV 0.15-0.2mg/kg (0.3-0.35 mg/k( without premedication)	IV 0.1-0.2mg/kg (0.15-0.3 mg/kg without premedication)

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