MIDAZOLAM 5MG/ML SOLUTION FOR INJECTION

Active substance: MIDAZOLAM

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D00522

Midazolam 5mg/ml
Solution for injection or infusion
Midazolam Hydrochloride
Read all of this leaflet carefully before you start using this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• 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.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Midazolam is and what it is used for
Before Midazolam is given
How Midazolam will be given
Possible side effects
How to store Midazolam solution for injection or infusion
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.

TECHNICAL INFORMATION

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 1mmol 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.
Continued overleaf

If you are given too much Midazolam:
As this medicine will be given to you whilst you are in hospital it
is unlikely that you will be given too little or too much, however,
tell your doctor, nurse or pharmacist if you have any concerns.

• Rush and itching
• Muscle tremor
If any of the side effects get serious, or you notice any side effects
not listed in the leaflet, please tell your doctor or pharmacist.

If you stop taking Midazolam
During prolonged treatment with Midazolam, physical
dependence may develop. Suddenly stopping the treatment may
be accompanied by withdrawal symptoms. The following
symptoms may occur: headaches, muscle pain, anxiety, tension,
restlessness, confusion, irritability, rebound insomnia (unable to
sleep), mood changes, hallucinations and convulsions. Since the
risk of withdrawal symptoms is greater after suddenly stopping
treatment, it is recommended to stop doses gradually.

5. How to store Midazolam

4. Possible side effects

Your doctor or pharmacist is responsible for storing Midazolam
injection. They are also responsible for disposing of any unused
Midazolam. You should not be given Midazolam injection after
the expiry date which is stated on the carton and ampoule. The
expiry date refers to the last date of the month
Keep out of the reach and sight of children.
This medicinal product does not require any special temperature
storage conditions
Keep the container in the outer carton in order to protect from
light.
Your doctor or nurse should not use this product if the solution is
discoloured.

Like all medicines Midazolam can cause side effects, although not
everybody gets them.

6. Further Information

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

If any of the following symptoms occur contact your doctor or
nearest accident and emergency department immediately.
These are symptoms of a serious allergic reaction.
• skin irritation or rash including redness, itchiness and
swelling
Other side effects
• drowsiness
• prolonged sedation (sleepiness),
• reduced alertness or confusion,
• euphoria (state of excitement),
• hallucinations,
• fatigue,
• headache,
• dizziness,
• ataxia (reduced control of limb movements),
• amnesia (memory loss)
• agitation,
• hyperactivity,
• hostility,
• rage,
• aggressiveness,
• convulsions (muscle tightening and relaxing)
• nausea,
• vomiting,
• hiccups,
• coughing,
• constipation,
• dry mouth
• chest pain or problems with your heart,
• heart failure,
• changes in heart rate
• breathing difficulties, such as spasm of the airway tract
• stopping breathing
• Swelling or pain on injection site
• Blood clots at the site of injection
• Addiction
• Low blood pressure

What Midazolam contains
The active ingredient is Midazolam (as hydrochloride).
Each 2ml of solution for injection or infusion contains 10mg
midazolam (as the hydrochloride).
Each 3ml of solution for injection or infusion contains 15mg
midazolam (as the hydrochloride).
The other ingredients are water for injections, dilute hydrochloric
acid, sodium chloride and sodium hydroxide
Each ml of solution for injection contains 5mg of Midazolam (as
the hydrochloride).
What Midazolam looks like and contents of the pack:
Midazolam solution for Injection is a clear colourless solution,
filled in clear glass ampoules
The medicine is supplied to your pharmacist or doctor in packs of
10 clear glass ampoules (2ml and 3ml).
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals,
Bampton Road,
Harold Hill,
Romford,
RM3 8UG,
United Kingdom.
Product Licence Number (s):
PL 00156/0123 PA 361/21/1
For any information about this medicine, please contact the
Marketing Authorisation Holder, details provided above.
This leaflet was approved in: 10/2010

D00522

PACKAGE LEAFLET: INFORMATION FOR THE USER

D00522

Midazolam 5mg/ml
Solution for injection or infusion
The following information is intended for medical or healthcare
professionals only:
Standard Dosage

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

Indication

Adults<60 years

Adults 60 years+/debilitated
or seriously ill

IV
Initial dose: 2-2.5mg
Titration doses: 1mg
Total dose: 3.5-7.5mg

IV
Initial dose: 0.5-1mg
Titration doses: 0.5-1mg
Total dose: <3.5mg

IV in patients 6 months-5 years
Initial dose: 0.05-0.1mg/kg
Total dose: <6mg
IV in patients 6-12 years
Initial dose: 0.025-0.05mg/kg
Total dose: < 10mg
Rectal>6 months
0.3-0.5mg/kg
IM 1-15 years
0.05-0.15mg/kg

IV
Intermittent doses of
0.03-0.1 mg/kg or continuous
infusion of 0.03-0.1 mg/kg/hr

Sedation in ICU

IV
Loading dose: 0.03-0.3 mg/kg in increments of 1-2.5mg
Maintenance dose: 0.03-0.2mg/kg/hr

Children

Conscious sedation

Sedative component in
combined anaesthesiA

Anaesthesia premedication

Anaesthesia induction

IV
1-2mg repeated
IM
0.07-0.1mg/kg

IV Initial dose 0.5mg
Slow uptitration as needed
IM 0.025-0.05mg/kg

IV
0.15-0.2mg/kg (0.3-0.35 mg/kg
without premedication)

Rectal> 6 months
0.3-0.5mg/kg
IM 1-15 years
0.08-0.2mg/kg

IV
0.1-0.2mg/kg (0.15-0.3 mg/kg
without premedication)
Continued overleaf

Special precautions for disposal of a used medicinal product
or waste materials derived from such medicinal product and
other handling of the product

IV
Lower doses than
recommended for
adults<60 years
IV in neonates<32 weeks
gestational age
0.03 mg/kg/hr
IV in neonates>32 weeks and
children up to 6 months
0.06 mg/kg/hr
IV in patients>6 months
Loading dose: 0.05-0.2mg/kg
Maintenance dose:
0.06-0.12mg/kg/h

Diluted product should be discarded if not used within 24 hours.
Do not use the product if the solution is discoloured

Midazolam Injection is for single use only.
Discard any unused contents.
The product should be used immediately after opening.
Midazolam Injection is stable, both physically and chemically, for
up to 24 hours at 2°C-8°C when mixed aseptically with 500 ml
infusion fluids containing Dextrose 4% with Sodium Chloride
0.18%, Dextrose 5% or Sodium Chloride 0.9%.

D00522

Midazolam Hydrochloride

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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