MIDAZOLAM 2MG/ML SOLUTION FOR INJECTION

Active substance: MIDAZOLAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

hameln

Midazolam 1 mg/ml Injection
Midazolam 2 mg/ml Injection
Midazolam 5 mg/ml Injection
Read all of this leaflet carefully before you are given this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms
are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or nurse.
Midazolam
In this leaflet:
1. What Midazolam is and what it is used for
2. Before you are given Midazolam
3. How Midazolam is given
4. Possible side effects
5. How to store Midazolam
6. Further information

1. WHAT MIDAZOLAM IS AND WHAT IT IS USED
FOR
Midazolam belongs to a group of medicines called
‘benzodiazepines’. Midazolam works quickly to make
you feel sleepy or to put you to sleep. It also makes you
calm and relaxes your muscles.
Midazolam is used in adults:
• as a general anaesthetic to put them to sleep or to keep
them asleep.
Midazolam is also used in adults and children:
• to make them feel calm and sleepy if they are in
intensive care. This is called ‘sedation’.
• before and during a medical test or procedure where
they are going to stay awake. It makes them feel calm
and sleepy. This is called ‘conscious sedation’.
• to make them feel calm and sleepy before they are
given an anaesthetic.

2. BEFORE YOU ARE GIVEN MIDAZOLAM
You must not be given Midazolam if:
• you are allergic (hypersensitive) to midazolam or any of
the other ingredients of this medicine (listed in Section
6: Further information).
• you are allergic to other benzodiazepine medicines,
such as diazepam or nitrazepam.
• you have severe breathing problems and you are going
to have Midazolam for ‘conscious sedation’.
You must not be given Midazolam if any of the above
applies to you. If you are not sure, talk to your doctor or
nurse before you are given this medicine.
Take special care with Midazolam
Check with your doctor or nurse before you are given
Midazolam if:
• you are over 60 years of age.
• you have a long term illness, such as breathing
problems or kidney, liver or heart problems.
• you have an illness that makes you feel very weak, run
down and short of energy.
• you have something called ‘myasthenia gravis’ where
your muscles are weak.
• you have ever had alcohol problems.
• you have ever had drug problems.
If any of the above applies to you (or you are not
sure), talk to your doctor or nurse before you are given
Midazolam.
If your child is going to be given this medicine:
• talk to your doctor or nurse if any of the above applies
to your child.
• in particular, tell your doctor or nurse if your child has
heart or breathing problems.
Taking other medicines
Please tell your doctor or nurse if you are taking or
have recently taken any other medicines. This includes
medicines that you buy without a prescription and herbal
medicines. This is because Midazolam can affect the way
some other medicines work. Also some other medicines
can affect the way Midazolam works.
In particular, tell your doctor or nurse if you are taking any
of the following medicines:
• Medicines for depression
• Hypnotic medicines (to help you sleep)
• Sedatives (to make you feel calm or sleepy)
• Tranquilliser medicines (for anxiety or to help you
sleep)
• Carbamazepine or phenytoin (these may be used for
fits or seizures)
• Rifampicin (for tuberculosis)
• Medicines for HIV called ‘protease inhibitors’ (such as
saquinavir)
• Antibiotics called ‘macrolides’ (such as erythromycin or
clarithromycin)
• Medicines to treat fungal infections (such as
ketoconazole, voriconazole, fluconazole, itraconazole,
posaconazole)

• Strong pain killers
• Atorvastatin (for high cholesterol)
• Anti-histamines (for allergic reactions)
• St John’s Wort (a herbal medicine for depression)
• Medicines for high blood pressure called ‘calcium
channel blockers’ (such as diltiazem)
If any of the above applies to you (or you are not
sure), talk to your doctor or nurse before you are given
Midazolam.
Drinking alcohol
Do not drink alcohol if you have been given Midazolam.
This is because it may make you feel very sleepy and
cause problems with your breathing.
Pregnancy and breast-feeding
Talk to your doctor before you are given Midazolam if you
are pregnant or think you may be pregnant. Your doctor
will decide if this medicine is suitable for you.
After you have been given Midazolam, do not breastfeed for 24 hours. This is because Midazolam may pass
into your breast milk.
Driving and using machines
After having Midazolam, do not drive or use tools or
machines until your doctor says you can.
This is because Midazolam may make you feel sleepy
or forgetful. It may also affect your concentration and coordination. This may affect you being able to drive or use
tools and machines. After your treatment, you must be
taken home by an adult who can look after you.
Important information about some of the ingredients
of Midazolam
Midazolam contains up to 3.47 milligrams of sodium
in each millilitre of solution. This should be taken into
consideration for patients on a controlled sodium diet.

3. HOW MIDAZOLAM IS GIVEN
Midazolam will be given to you by a doctor or nurse. It will
be given to you in a place that has the equipment needed
to monitor you and to treat any side effects. This might
be a hospital, clinic or doctor’s surgery. In particular, your
breathing, heart and circulation will be monitored.
Midazolam is not recommended for use in infants and
babies under 6 months of age. However, if the doctor
feels that it is necessary, it can be given to an infant or
baby under 6 months who is in intensive care.
How Midazolam will be given to you
You will be given Midazolam in one of the following
ways:
• By slow injection into a vein (intravenous injection).
• Through a drip into one of your veins (intravenous
infusion).
• By injection into a muscle (intramuscular injection).
• Into your back passage (rectum).
How much Midazolam will be given to you
The dose of Midazolam varies from one patient to
another. The doctor will work out how much to give you. It
depends on your age, weight and general health. It also
depends on what you need the medicine for, how you
respond to treatment, and whether you are going to be
given other medicines at the same time.
After being given Midazolam
After your treatment, you must be taken home by an adult
who is able to look after you. This is because Midazolam
may make you sleepy or forgetful. It may also affect your
concentration and co-ordination.
If you are given Midazolam for a long time, such as in
intensive care, your body may start to get used to the
medicine. This means it may not work as well.
If you are given too much Midazolam
Your medicine will be given to you by a doctor or nurse.
This means it is unlikely that you will be given too much.
However, if you are given too much by mistake, you may
notice the following:
• Feeling sleepy and losing your co-ordination and
reflexes.
• Problems with speaking and unusual eye movements.
• Low blood pressure. This may make you feel dizzy or
light-headed.
• Slowing or stopping of your breathing or heart beat and
being unconscious (coma).
Long term use of Midazolam for sedation in intensive
care
If you are given Midazolam for a long time, the following
may happen:

--------------------------------------------------------------------------------------------------------------------

hameln

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

Midazolam 1 mg/ml Injection
Midazolam 2 mg/ml Injection
Midazolam 5 mg/ml Injection
This is a summary of the information regarding the
preparation of Midazolam 1 mg/ml, 2 mg/ml, 5 mg/ml
Injection.
It is important that you read the entire contents of this
guide prior to the preparation of this medicinal product.
Please refer to the Summary of Product Characteristics
for full prescribing and other information.

1. PRESENTATION
Midazolam 1 mg/ml is supplied as a clear and colourless
solution for injection in clear glass ampoules containing
2 ml, 5 ml or 10 ml.
Midazolam 2 mg/ml is supplied as a clear and colourless
solution for injection in clear glass ampoules containing
5 ml or 25 ml and in clear glass vials containing 50 ml.

xxxxx_42_10_PB_Midazolam 1_2 & 51 1

Midazolam 5 mg/ml is supplied as a clear and colourless
solution for injection in clear glass ampoules containing
1 ml, 2 ml, 3 ml, 5 ml, 10 ml or 18 ml.

2. PREPARATION
Dilution Instructions
This medicinal product must not be diluted with other
solutions for parenteral use than those mentioned
below.
With continuous intravenous infusion, midazolam
injection solution may be diluted in a ratio of 15 mg
midazolam to 100-1000 ml with one of the following
infusion solutions: 0.9% NaCl, 5% and 10% dextrose and
Ringer’s solution.

19.10.2010 10:56:43

5. How to store Midazolam

• It may start to work less well.
• You may become dependent on the medicine and get
withdrawal symptoms when you stop having it (see
“Stopping Midazolam” below).
Stopping Midazolam
If you are given Midazolam for a long time, such as in
intensive care, you may get withdrawal symptoms when
you stop being given the medicine. These include:
• Mood changes
• Fits (convulsions)
• Headache
• Muscle pain
• Problems with sleeping (insomnia)
• Feeling very worried (anxious), tense, restless,
confused or bad tempered (irritable).
• Seeing and possibly hearing things that are not really
there (hallucinations).
Your doctor will lower your dose gradually. This will help
to stop withdrawal symptoms from happening to you.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Midazolam can cause side effects,
although not everybody gets them. The following side
effects have been reported but their frequency is not
known and cannot be estimated from the available data.
Stop having Midazolam and see a doctor straight
away if you notice any of the following side effects.
They can be life-threatening and you may need
urgent medical treatment
• A severe allergic reaction (anaphylactic shock). The
signs may include a sudden rash, itching or lumpy
rash (hives) and swelling of the face, lips, tongue or
other parts of the body. You may also have shortness
of breath, wheezing or trouble breathing.
• Heart attack (cardiac arrest). The signs may include
chest pain.
• Breathing problems, sometimes causing the breathing
to stop.
• Muscle spasm around the voice box, causing choking.

• Your doctor or pharmacist is responsible for storing
Midazolam. They are also responsible for disposing of
any unused Midazolam correctly.
• Keep out of the reach and sight of children.
• Do not use Midazolam after the expiry date (EXP)
printed on the pack. The expiry date refers to the last
day of that month.
• Do not use Midazolam if the small glass bottle
(ampoule/vial) or packaging is damaged.
• Keep the ampoules/vials in the outer carton in order to
protect from light.
• Do not store above 25°C. Do not freeze.

6. Further information
What Midazolam contains
• The active substance is midazolam (as midazolam
hydrochloride).
In Midazolam 1 mg/ml, each 1 ml of liquid contains
1 mg of midazolam (as midazolam hydrochloride).
In Midazolam 2 mg/ml, each 1 ml of liquid contains
2 mg of midazolam (as midazolam hydrochloride).
In Midazolam 5 mg/ml, each 1 ml of liquid contains
5 mg of midazolam (as midazolam hydrochloride).
• The other ingredients are sodium chloride, hydrochloric
acid and water for injections.
What Midazolam looks like and contents of the pack
Midazolam comes in a colourless glass ampoule/vial
(small bottle). It is a clear, colourless, liquid (solution for
injection/infusion or rectal solution).
The following pack sizes are available for Midazolam
1 mg/ml Injection:
• 2 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 5 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 10 ml glass ampoules: packs of 5, 10, 25, 50 or 100
The following pack sizes are available for Midazolam
2 mg/ml Injection:
• 5 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 25 ml glass ampoules: packs of 5, 10, 10x5, 5x10
• 50 ml glass vial: packs of 1, 5 or 10

Life-threatening side effects are more likely in adults over
60 years, and in people who already have breathing or
heart problems. These side effects are also more likely if
the injection is given too fast or at a high dose.

The following pack sizes are available for Midazolam
5 mg/ml Injection:
• 1 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 2 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 3 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 5 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 10 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 18 ml glass ampoules: packs of 5, 10, 25, 50 or 100

Other possible side effects
Nervous system and mental problems
• Being less alert
• Feeling confused
• Feeling very happy or excited (euphoria).
• Feeling tired or sleepy or being sedated for a long
time.
• Seeing or possibly hearing things that are not really
there (hallucinations).
• disturbance of consciousness (delirium)
• Headache
• Feeling dizzy
• Difficulty co-ordinating muscles
• Fits (convulsions) in premature and new-born babies.
• Temporary memory loss. How long this lasts depends
on how much Midazolam you were given. Occasionally
this has lasted for a long time.
• Feeling agitated, restless, angry or aggressive. You
may also have muscle spasms or shaking of your
muscles that you cannot control (tremors). These
effects are more likely if you have been given a high
dose of Midazolam or if it has been given too quickly. It
is also more likely in children and elderly people.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
UK

Breathing
• Hiccups
• Being short of breath
Mouth, stomach and gut
• Dry mouth
• Constipation
• Feeling sick (nausea) or being sick (vomiting)

Midazolam-hameln 1 mg/ml, 2 mg/ml, 5 mg/ml
Injektions-/Infusionslösung oder Rektallösung

DK

Midazolam
injektions-,
opløsning

FI

Midazolam Hameln 1 mg/ml, 5 mg/ml, injektio/infuusioneste, liuos tai peräruiskeliuos

NL

Midazolam 1 mg/ml, 2 mg/ml, 5 mg/ml, Hameln,
oplossing voor injectie/infusie of rectale
oplossing

SE

Heart and circulation
• Fainting
• Slow heart rate
• Redness of the face and neck (flushing)
• Low blood pressure. This may make you feel dizzy or
light-headed.

Midazolam 1 mg/ml, 2 mg/ml, 5 mg/ml Injection

DE

Midazolam Hameln 1 mg/ml, 5 mg/ml, injektions/infusionsvätska, lösning eller rektallösning

„Hameln“, 1 mg/ml, 5 mg/ml,
infusionseller
rektalvæske,

This leaflet was last approved 04/2009



Skin
• Feeling itchy
• Rash, including a lumpy rash (hives)
• Redness, pain, blood clots or swelling of the skin where
the injection was given.
General
• Allergic reactions including skin rash and wheezing.
• Withdrawal symptoms (see ‘Stopping Midazolam’ in
Section 3 above)
Elderly people
• Older people taking benzodiazepine medicines, like
Midazolam, have a higher risk of falling and breaking
bones.
• Life-threatening side effects are also more likely to
happen in adults over 60 years.
If any of the side effects become serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or nurse.

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-------------------------------------------------------------------------------------------------------------------Chemical and physical in-use stability of the dilutions has
been demonstrated for 3 days at room temperature.
From the microbiological point of view, the dilutions
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.

3. INCOMTABILITIES
Compatibility must be checked before administration, if
intended to be mixed with other drugs.
Midazolam precipitates in solutions containing
bicarbonate. Theoretically, the midazolam injection
solution is likely to be unstable in solutions of neutral
or alkaline pH. If midazolam is mixed with albumin,
amoxicillin sodium, ampicillin sodium, bumetanide,
dexamethasone sodium phosphate, dimenhydrinate,
floxacillin sodium, furosemide, hydrocortisone sodium
succinate,
pentobarbital
sodium,
perphenazine,
prochlorperazine edisylate, ranitidine or thiopental
sodium or trimethoprim-sulfamethoxazole, a white
precipitate forms immediately.

xxxxx_42_10_PB_Midazolam 1_2 & 52 2

A haze is formed immediately followed by a white
precipitate with nafcillin sodium. With ceftazidime a haze
is formed.
With methotrexate sodium a yellow precipitate forms.
With clonidine hydrochloride an orange discoloration
forms. With omeprazole sodium a brown discoloration
forms, followed by a brown precipitate. With foscarnet
sodium a gas is produced.
Midazolam should not be mixed with aciclovir, albumin,
alteplase, acetazolam disodium, diazepam, enoximone,
flecainide acetate, fluorouracil, imipenem, mezlocillin
sodium, phenobarbital sodium, phenytoin sodium,
potassium canrenoate, sulbactam sodium, theophylline,
trometamol, urokinase.

xxxxx/42/10

19.10.2010 10:56:44

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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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