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MIDAZOLAM 1MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): MIDAZOLAM HYDROCHLORIDE

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doctor (for more information see section ‘Using other medicines’)
- are pregnant or think be pregnant.
PATIENT INFORMATION LEAFLET

Midazolam 1 mg/ml Solution
for Injection or Infusion
Midazolam 5 mg/ml Solution
for Injection or Infusion
Midazolam

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 your pharmacist or nurse.
• 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 or nurse. This
includes any possible side effects not listed in this leaflet. See section 4
What is in this leaflet:
1. What midazolam is and what it is used for
2. What you need to know before you take midazolam
3. How to use midazolam
4. Possible side effects
5. How to store midazolam
6. Contents of the pack and other information

1. What midazolam is and what it is used for
Midazolam 1 mg/ml & 5 mg/ml Solution for Injection or Infusion contains
Midazolam. Midazolam belongs to a group of medicines known as
benzodiazepines (sedatives).
It is a short acting medicine that is used to induce sedation (a state of calm,
drowsiness or sleep) and relieves anxiety, muscle tension. It has anticonvulsant
effects and causes anterograde amnesia. This medicine is used for:
- Conscious sedation (state of calm or drowsiness where you remain
awake) in adults and children
- Sedation in intensive care units in adults and children.
- Anaesthesia in adults (premedication before induction, induction of
anaesthesia, as a sedative component with other medicines in
anaesthesia)
- Premedication before induction of anaesthesia in children.

2. What you need to know before you take midazolam
Do not use midazolam
• If you are allergic (hypersensitive) to midazolam, group of medicines
known as benzodiazepines or any of the midazolam solution for injection
• If you have severe difficulties with your breathing and that you are to
undergo conscious sedation.
Take Special Care with midazolam
Midazolam should be used only when age- and size-appropriate
resuscitation facilities are available. Administration of midazolam may
depress myocardial contractility and cause apnoea (suspension of
breathing). Severe cardio respiratory adverse events have occurred on
rare occasions. These have included respiratory depression, apnea,
respiratory and/or cardiac arrest. To avoid such incidents, the injection
should be given slowly and the dose should be as low as possible.
Special care needs to be taken if midazolam is used in babies or children.
Let your doctor know if your child has a cardiovascular disease. Your
child will be carefully monitored and the dose will be adjusted specially.
Patients under 6 months old in sedation in Intensive Care Unit are more
likely to develop breathing problems, so they will be dosed very gradually
and their breathing and oxygen levels observed.
When midazolam is given as a premedication, you will be checked closely
to how you respond and to ensure you have received the right dose as
the sensitivity varies depending of the patient.
The use of midazolam is not recommended in neonates and children up
to 6 months of age.
Paradoxical reactions and anterograde amnesia (loss of memory for
recent events) have been reported to occur with midazolam (see section
4. Possible Side Effects).
Let your doctor know if you:
- are over 60 years of age
- have a long term illness or are debilitated (for example, chronic
respiratory problems, renal, hepatic or cardiac disorders).
- have a myasthenia gravis (neuromuscular disease characterized by a
muscle weakness).
- have a history of alcohol or drug abuse.
- are taking any other medicines including those not prescribed by your

The following information is intended for medical or healthcare
professionals only
Preparation of solution for infusion
Midazolam injection can be diluted with 0.9% sodium chloride solution, 5% or
10% dextrose solution, or Ringer or Hartmann solution at a ratio of 15 mg of

Long term treatment
If you receive long-term midazolam, you may become tolerant (midazolam
becomes less effective) or you may be become dependent upon this medicine.
After treatment for a long time (such as in an intensive care unit) the
following withdrawal symptoms may occur: headaches, muscle pain,
anxiety, tension, restlessness, confusion, irritability, inability to sleep,
mood changes, hallucinations and convulsions. Your doctor will reduce
your dose gradually to avoid these effects happening to you.
Using other medicines:
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
This is extremely important, as using more than one medicine at the same
time can strengthen or weaken the effect of the medicines involved.
In particular, tell your doctor or nurse if you are taking any of the following
medicines:
• tranquilisers (for anxiety or to help you sleep)
• hypnotics (medicines to make you sleep)
• sedatives (to make you feel calm or sleepy)
• nefazodone and other antidepressants (medicines for depression)
• narcotic analgesics (very strong pain killers)
• antihistamines (used to treat allergies)
• medicines to treat fungal infections (ketoconazole, voriconazole,
fluconazole, itraconazole, posaconazole)
• macrolide antibiotics (such as erythromycin, clarithromycin or roxithromycin)
• diltiazem, verapamil (used to treat high blood pressure)
• medicines for HIV called protease inhibitors (such as saquinavir)
• atorvastatin (used to treat high cholesterol)
• aprepitant (medicine for prevention of chemotherapy-induced nausea
and vomiting)
• rifampicin (used to treat mycobacterial infections such as tuberculosis)
• carbamezapine or phenytoin (used to treat epileptic seizures and nerve pain)
• efavirenz (used to treat Human immunodeficiency virus)
• the herbal medicine St. John’s Wort.
If any of the above apply to you, or if you are not sure, talk to your doctor
or nurse before you are given Midazolam.
Operations
If you are going to have an inhaled anaesthetic (one that you breathe in)
for an operation or for dental treatment, it is important to tell your doctor or
dentist that you have been given Midazolam.
Using midazolam with food and drink
While you are using midazolam you must not drink any alcohol, since
alcohol can markedly increase the sedative effect of midazolam.
Pregnancy and breast-feeding and fertility:
• 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. If your doctor decides that you should be given this
medicine during late pregnancy, labour or caesarean section, you might
have an inhalation risk and your baby might have an irregular heart beat,
hypotonia (state of low muscle tone), feeding difficulties, a low body
temperature and respiratory depression.
• If you have passed through prolonged treatment during last phase of
pregnancy with this medicine, your baby may develop physical
dependence and risk of withdrawal symptoms after birth.
• Midazolam may pass into breast milk, therefore, if you are breast
feeding you should not do so for 24 hours after receiving this medicine.
Driving and using machines:
This medicine may make you sleepy, forgetful, dizzy or affect your
concentration and co-ordination.
• Do not drive while taking this medicine until you know how it affects you.
This may affect your performance at skilled tasks, e.g. driving or operating
machinery.
• After midazolam administration you should not drive a vehicle or operate a
machine until completely recovered. Your doctor should advise you when
you can start these again.
• You should always be accompanied to home by a responsible adult after
your treatment.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in
the information provided with the medicine and
- It was not affecting your ability to drive safely

Important information about some of the ingredients of midazolam
solution for injection
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose i.e. essentially ‘sodium free’.

3. How to use midazolam
Midazolam should be administered only by experienced physicians in a
setting fully equipped for the monitoring and support of respiratory and
cardiovascular function and by persons specifically trained in the
recognition and management of expected adverse events.
Instructions for proper use
Midazolam is compatible with the following infusion solutions:
- sodium chloride 9 mg/ml (0.9 %) solution
- 5 % dextrose solution
- 10 % dextrose solution
- Fructose 50 mg/ml (5 %) solution
- Ringer solution
- Hartmann’s solution
Do not dilute midazolam solutions with 6% w/v dextran (with 0.9% sodium
chloride) in dextrose.
Do not mix midazolam ampoule solutions in alkaline injections.
Midazolam precipitates in sodium bicarbonate.
To avoid potential incompatibility with other solutions, midazolam
ampoule solution must not be mixed with other solutions except those
mentioned above.
Dosage and route of administration
Your doctor will decide on a suitable dose for you. Doses vary
considerably and will depend on the planned treatment and the sedation
required. Your weight, age, general condition of health, concomitant
medication, response to the drug and whether other medicines are
required at the same time will also influence the dose that you receive.
If you are to receive strong painkillers, you will receive these first and then
have your midazolam dose adjusted specially for you.
Midazolam is given slowly, by injection into a vein (intravenously), by a
drip (infusion), injection into a muscle (intramuscular) or via rectal
administration.
Midazolam ampoules are for single use only. Discard any unused
solution.
The solution should be visually inspected prior to use. Only clear solutions
without particles should be used.
If you use more midazolam than you should
Your medicine will be given by a doctor.
If you accidentally got an overdose, this could lead to sleepiness, ataxia
(in coordination of voluntary muscular action), dysarthria (speech
disorder) and nystagmus (involuntary eye movements), loss of reflexes,
apnoea (suspension of breathing), hypotension (low blood pressure),
cardio respiratory depression and coma. Overdose may require intense
vital sign monitoring and symptomatic treatment of cardio respiratory
effects and use of benzodiazepine antagonist.
If you stop using midazolam
Sudden discontinuation of treatment will therefore be accompanied by
withdrawal symptoms such as headache, muscular pain, anxiety, tension,
restlessness, confusion, mood swings, hallucinations & convulsions,
rebound insomnia, irritability and convulsions. Since the risk of withdrawal
symptoms occurring is greater if treatment is discontinued abruptly, dose
should be reduced gradually when treatment is being discontinued.
For further information on preparation of the medicinal product before use
please refers the end of the PIL ‘The following information is intended for
medical or healthcare professionals only’.
4.

Possible side effects

Like all medicines midazolam can cause side effects, although not
everybody gets them.
Not known (Frequency cannot be estimated):
Immune System Disorders:
General allergic reactions
• skin reactions
• heart and blood system reactions
• wheezing
• anaphylactic shock (a life-threatening allergic reaction)

Talk to your doctor or pharmacist if you are not sure whether it is safe for you
to drive while taking this medicine.

midazolam to 100-1,000 ml of infusion solution. These solutions remain stable
for 24 hours at room temperature, and 3 days at 5°C. Midazolam injection
must not be mixed with any solution other than those listed above. In
particular, midazolam injection must not be diluted with 6% w/v dextran (with
0.9% sodium chloride) in dextrose or mixed with alkaline injection injections.
Midazolam precipitates in sodium bicarbonate.

The solution for injection should be examined visually before administration.
Only solutions without visible particles should be used.
Shelf Life and storage
Midazolam Injection ampoules are intended for single use only.

Psychiatric disorders:
• confusion
• euphoria
• hallucinations
• mood change
• Paradoxical reactions (the opposite to those expected) were observed in
the case of children and elderly people. These took the form of following:
- agitation
- aggressiveness
- hyperactivity
- hostility
- violence
- involuntary movements (including regular and jerky muscle
spasms and muscular tremor)
- paroxysmal excitement
- rage reactions
• These have been observed more when a high dose has been given, or
administered too quickly. Children and the elderly are more susceptible
to these reactions.
• Dependence: Patients can become dependant on midazolam, even in
therapeutic doses. After prolonged use, doses of midazolam will reduce
gradually to avoid withdrawal symptoms including convulsions (see
section 2 ‘BEFORE YOU USE midazolam - Long term treatment’).
Nervous system disorders:
• fatigue
• headache
• difficulty co-ordinating muscles
• dizziness
• reduced alertness
• somnolence
• prolong sedation
• Temporary memory loss has been reported. How long this lasts will
depend on how much midazolam solution for injection you were given
and you may experience this after your treatment. In isolated cases this
has been prolonged.
• Convulsions have been reported in premature infants and new-born babies.
Cardiac disorders:
• severe events have occurred and include heart attack (cardiac arrest)
• low blood pressure
• slow heart rate
• vasodilating effects (for example flushing, fainting and headache)
Respiratory, thoracic and mediastinal disorders:
• breathing complications (sometimes causing the breathing to stop)
• shortness of breath
• sudden blockage of the airway (laryngospasm)
• hiccoughs
• Life-threatening incidents are more likely to occur in adults over 60
years of age and those already experiencing breathing difficulties or
heart problems, particularly when the injection is given too rapidly or at a
high dose (see section “Take special care”)
Gastrointestinal disorders:
• nausea
• vomiting
• constipation
• dry mouth.
Skin and subcutaneous tissue disorders:
• redness of the skin (rash)
• itching weals (urticaria)
• itching skin with a compulsion to scratch (pruritus)
General disorders and administration site conditions:
• fatigue
• redness and pain at injection site (erythema – redness of skin)
• swelling of skin
• blood clots (thrombosis) and inflammation due to blood clot (thrombophebitis)
• An increased risk for falls and fractures has been recorded in elderly
users of benzodiazepines (medicines that induce a state of calm,
drowsiness or sleep).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

Ampoule before opening
Store in the original package in order to protect from light
Ampoule after dilution
Chemical and physical in-use stability of the dilutions has been demonstrated
for 24 hours at room temperature (15 – 25°C) or for 3 days at 5°C.

5. How to store midazolam
• Keep this medicine out of the sight and reach of children.
• Do not use midazolam after the expiry date (EXP) which is stated on the
carton and ampoule. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from light.
Shelf life after dilution
Chemical and physical in-use stability of the dilutions has been
demonstrated for 24 hours at room temperature (15 – 25°C) or for 3 days
at +2 to +8 °C.
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 at 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.
• The product is for single used and any remaining solution should be
discarded. (The injection solution contains no preservatives).
• Do not use midazolam solution for injection or infusion if container is
found leaking, solution is not clear with visible particles or any
discoloration of the solution.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Contents of the pack and other information
What midazolam contains:
The active ingredient is midazolam (as hydrochloride).
For 1 mg/ml
Each ml of solution for injection contains 1 mg of midazolam (as
midazolam hydrochloride)
Presentations
5 ml
Amount of midazolam
5 mg
For 5 mg/ml
Each ml of solution for injection contains 5 mg of midazolam (as
midazolam hydrochloride)
Presentations
1 ml
3 ml
10 ml
Amount of midazolam
5 mg
15 mg 50 mg
The other ingredients include water for injections, sodium chloride,
sodium hydroxide (for pH adjustment) and concentrated hydrochloric acid
(for pH adjustment).
What midazolam solution for injection looks like and contents of the
pack:
Midazolam solution for injection is a clear colourless to pale yellow
solution filled in a clear glass ampoule.
Midazolam solution for injection is available in pack of 10 X 5 ml
ampoules for 1 mg/ml formulation.
Midazolam solution for injection is available in pack of 10 X 1ml, 10 X 3
ml, 10 X 10 ml and 1 X 10 ml ampoules for 5 mg/ml formulation.
The ampoule are available in blister/ tray pack.
Not all pack sizes may be marketed.
Manufacturing authorisation holder and manufacturer:
Accord Healthcare Limited
Sage House,
319 Pinner Road,
North Harrow,
Middlesex, HA1 4HF, UK

Czech Republic Midazolam Accord 1 mg/ml, injekční roztok nebo infuzi
Midazolam Accord 5 mg/ml, injekční roztok nebo infuzi
Germany
Midazolam Accord 1 mg/ml Injektionslösung oder
Infusionslösung
Midazolam Accord 5 mg/ml Injektionslösung oder
Infusionslösung
Denmark
Midazolam Accord 1 mg/ml, injektions og
infusionsvæske, opløsning
Midazolam Accord 5 mg/ml, injektions og
infusionsvæske, opløsning
Estonia
Midazolam Accord 1 mg/ml, injekcinis ar infuzinis tirpalas
Midazolam Accord 5 mg/ml, injekcinis ar infuzinis tirpalas
Greece
Midazolam Accord 1 mg/ml, ενέσιμο διάλυμα ή
διάλυμα για έγχυση
Midazolam Accord 5 mg/ml, ενέσιμο διάλυμα ή
διάλυμα για έγχυση
Spain
Midazolam Accord 1 mg/ml, para inyección o infusión
Midazolam Accord 5 mg/ml, para inyección o infusión
Finland
Midazolam Accord 1 mg/ml, injektio- tai
infuusioneste/ Lösning för injektion och infusion
Midazolam Accord 5 mg/ml, injektio- tai
infuusioneste/ Lösning för injektion och infusion
Hungary
Midazolam Accord 1 mg/ml, oldatos injekció/ infúzió
Midazolam Accord 5 mg/ml, oldatos injekció/ infúzió
Ireland
Midazolam 1 mg/ml, Solution for Injection or Infusion
Midazolam 5 mg/ml, Solution for Injection or Infusion
Italy
Midazolam Accord 1 mg/ml, Soluzione per
Iniezione o Infusione
Midazolam Accord 5 mg/ml, Soluzione per
Iniezione o Infusione
Latvia
Midazolam Accord 1 mg/ml, šķīdums injekcijām
vai infūzijām
Midazolam Accord 5 mg/ml, šķīdums injekcijām
vai infūzijām
Malta
Midazolam 1 mg/ml, Solution for Injection or Infusion
Midazolam 5 mg/ml, Solution for Injection or Infusion
The Netherlands Midazolam Accord 1 mg/ml, oplossing voor
injectie of infusie
Midazolam Accord 5 mg/ml, oplossing voor
injectie of infusie
Norway
Midazolam Accord 1 mg/ml, oppløsning til
injeksjon og infusjon
Midazolam Accord 5 mg/ml, oppløsning til
injeksjon og infusjon
Poland
Midazolam Accord
Portugal
Midazolam Accord
Sweden
Midazolam Accord 1 mg/ml, Lösning för injektion
och infusion
Midazolam Accord 5 mg/ml, Lösning för injektion
och infusion
Slovenia
Midazolam Accord 1 mg/ml, raztopina za
injiciranje ali infundiranje
Midazolam Accord 5 mg/ml, raztopina za
injiciranje ali infundiranje
Slovak Republic Midazolam Accord 1 mg/ml, injekčný alebo
infúzny roztok
Midazolam Accord 5 mg/ml, injekčný alebo
infúzny roztok
United Kingdom Midazolam 1 mg/ml, Solution for Injection or Infusion
Midazolam 5 mg/ml, Solution for Injection or Infusion
This leaflet was last revised in 12/2014.

This medicinal product is authorized in the Member States of the
EEA under the following names:
Name of the
member state
Austria

Belgium

Cyprus

Name of the medicinal product
Midazolam Accord 1 mg/ml, Injektionslösung
oder Infusionslösung
Midazolam Accord 5 mg/ml, Injektionslösung
oder Infusionslösung
Midazolam Accord Healthcare 1 mg/ml, solution
pour injection ou perfusion/ oplossing voor
injectie of infusie/ Lösung zur Injektion oder Infusion
Midazolam Accord Healthcare 5 mg/ml, solution
pour injection ou perfusion/ oplossing voor
injectie of infusie/ Lösung zur Injektion oder Infusion
Midazolam Accord 1 mg/ml, ενέσιμο διάλυμα ή
διάλυμα για έγχυση
Midazolam Accord 5 mg/ml, ενέσιμο διάλυμα ή
διάλυμα για έγχυση

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
at 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.

In case of continuous intravenous infusion, midazolam injection solution may be
diluted in the range of 0.015 to 0.15 mg with one of the solution mentioned above.
Disposal of waste
Any unused product or waste material should be disposed of in accordance
with local requirements.

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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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