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Package leaflet: Information for the user

Midazolam 1 mg/ml solution for injection/infusion
Midazolam 5 mg/ml solution for injection/infusion
midazolam
Read all of this leaflet carefully fluconazole, itraconazole,
before you start using this posaconazole),
medicine because it contains - antibiotics (erythromycin,
important information for you. clarithromycin, telithromycin,
- Keep this leaflet. You may need roxithromycin),
to read it again. - blood pressure drugs, calcium
- If you have any further questions, channel blocker like diltiazem,
ask your doctor or nurse. verapamil,
- If you get any side effects, talk to - medicines for HIV (human
your doctor or nurse. This includes immunodeficiency virus)
any possible side effects not listed (efavirenz or saquinavir,
in this leaflet. See section 4. lopinavir and other protease
inhibitors),
What is in this leaflet - medicines for treatment of
1. What Midazolam is and what it is hepatitis C virus (simeprevir,
used for boceprevir and telaprevir),
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2. What you need to know before - medicines for epilepsy
you are given Midazolam (carbamazepine, phenytoin or
3. How Midazolam is given valproic acid),
4. Possible side effects - atorvastatin (used to treat high
5. How to store Midazolam cholesterol),
6. Contents of the pack and other - rifampicin (used to treat
information mycobacterial infections such as
tuberculosis),
- ticagrelor (used to prevent heart
1. What Midazolam is and what it attack),
is used for - aprepitant, netupitant,
casoprepitant (used to stop you
Midazolam belongs to a class of feeling or being sick),
medicines called benzodiazepines - some medicines to treat cancer
(sedatives). It is a short-acting (e.g. imatinib, lapatinib,
medicine that is used to induce idelalisib, vermurafenib),
sedation (a state of calm, drowsiness - everolimus, ciclosporin (used to
or sleep) and relieves anxiety and prevent organ transplant rejection),
muscle tension. This drug is used for: - propiverine (used for urinary
- Conscious sedation (an awake incontinence),
state of calm or drowsiness) in - herbal medicines (e.g. St John’s
adults and children. Wort, Ginkgo biloba or ginseng).
- Sedation of adults and children,
in intensive care units. Concomitant use of midazolam and
- Anaesthesia in adults opioids (strong pain killers,
(premedication before induction, medicines for substitution therapy
induction of anaesthesia, as and some cough medicines)
a sedative component with other increases the risk of drowsiness,
medicines for maintenance of difficulties in breathing (respiratory
anaesthesia). depression), coma and may be
- Premedication before induction life-threatening. Because of this,
of anaesthesia in children. concomitant use should only be
considered when other treatment
options are not possible.
2. What you need to know before However if your doctor does
you are given Midazolam prescribe midazolam together with
opioids the dose and duration of
You should not be given concomitant treatment should be
Midazolam: limited by your doctor.
- if you are allergic to midazolam, Please tell your doctor about all
other benzodiazepines or any of opioid medicines you are taking,
the other ingredients of this and follow your doctor’s dose
medicine (listed in section 6), recommendation closely. It could
- for conscious sedation, if you be helpful to inform friends or
have severe breathing difficulties. relatives to be aware of the signs
and symptoms stated above.
Warnings and precautions Contact your doctor when
Talk to your doctor or nurse before experiencing such symptoms.
you are given Midazolam if you:
- are over 60 years of age, Operations
- have a long-term illness or are If you are going to have an inhaled
debilitated (e.g. chronic respiratory anaesthetic (one that you breathe
problems, kidney, liver or heart in) for an operation or for dental
diseases), treatment, it is important to tell
- have myasthenia gravis your doctor or dentist that you have
(a neuromuscular disease been given Midazolam.
characterized by muscle weakness),
- have a history of alcohol or drug Midazolam with alcohol
abuse, Alcohol may strengthen the
- are using other medicines, sedative (calming) effect of
including those not prescribed by midazolam therefore you should
your attending physician (see avoid any alcohol intake.
section “Other medicines and
Midazolam”), Pregnancy and breast-feeding
- if your breathing sometimes stops If you are pregnant or
while you are sleeping, breast-feeding, think you may be
- are pregnant or if you suspect pregnant or are planning to have
pregnancy. a baby, ask your doctor for advice
before this medicine is given to
Midazolam should be used only you. Your doctor will decide if this
when age- and size-appropriate medicine should be given to you or
resuscitation facilities are available. not.
Administration of midazolam may After you have been given
depress myocardial contractility Midazolam, do not breastfeed for
and cause apnoea (pauses in 24 hours. This is because midazolam
breathing). In rare cases severe may pass into your breast milk.
cardiorespiratory complications
have occurred, including respiratory Driving and using machines
depression, apnoea, respiratory Midazolam has a major influence
and/or cardiac arrest. To avoid such on the ability to drive and use
complications the medicine should be machines.
injected slowly and the administered This medicine may cause sleepiness
dose must be as low as possible. and forgetfulness, and affect your
concentration and co-ordination.
Special caution is required when This may affect your performance
using midazolam in infants or at skilled tasks such as driving or
children. Let your doctor know if using machines. After midazolam
your child has a cardiovascular administration you should not drive
disease or breathing problems. or operate machines until completely
Your child will be monitored and recovered. The doctor will tell you
the dose will be specially adjusted. when you can recommence these
Patients under 6 months of age activities. You should always be
undergoing sedation in an intensive taken home by a responsible adult
care unit are more likely to develop after your treatment.
breathing problems, so their dosing If insufficient sleep occurs or
will be increased very slowly and alcohol is consumed, the likelihood
their breathing and oxygen levels of impaired alertness may be
will be observed. increased.
When midazolam is used for Midazolam contains sodium
premedication, your response to the Midazolam 1 mg/ml
drug will be checked and the correct In daily dose up to 6.5 ml this
dosage for you will be ascertained, medicine contains less than 1 mmol
as sensitivity varies between sodium (23 mg), that is to say
patients. Midazolam is not essentially ‘sodium-free’. If daily
recommended for new-borns or dose 6.6 ml or more is administered
children under 6 months of age. (equivalent to more than 1 mmol
sodium) the following should be
Paradoxical reactions and taken into account: This medicine
anterograde amnesia (loss of contains 3.5 mg sodium (main
memory for recent events) have component of cooking/table salt) in
been reported to occur with each ml of solution. This is
midazolam (see section 4). equivalent to 0.18 % of the
recommended maximum daily
Long-term treatment dietary intake of sodium for an adult.
If you receive midazolam for
a longer period, you may become Midazolam 5 mg/ml
tolerant (midazolam becomes less In daily dose up to 7.3 ml this
effective) or dependent upon this medicine contains less than 1 mmol
medicine. sodium (23 mg), that is to say
After long-term treatment (e.g. in essentially ‘sodium-free’. If daily
intensive care unit) the following dose 7.4 ml or more is administered
withdrawal symptoms may occur: (equivalent to more than 1 mmol
headaches, diarrhoea, muscle pain, sodium) the following should be
anxiety, tension, restlessness, taken into account: This medicine
confusion, irritability, sleep contains 3.15 mg sodium (main
disturbances, mood changes, component of cooking/table salt) in
hallucinations and convulsions. In each ml of solution. This is
severe cases, depersonalisation, equivalent to 0.16 % of the
numbness and tingling of the recommended maximum daily
extremities, hypersensitivity to dietary intake of sodium for an adult.
light, noise and physical contact
may occur. In order to avoid getting
such adverse reactions your doctor 3. How Midazolam is given
will reduce the dosage gradually.
This medicine should be
Other medicines and Midazolam administered only by experienced
Tell your doctor or nurse if you are physicians in a place that has the
taking, have recently taken or might equipment needed to monitor and
take any other medicines. support the respiratory and
This is extremely important, as cardiovascular function, or by
using more than one medicine at persons specifically trained in the
the same time can strengthen or recognition and management of
weaken the effect of the medicines adverse reactions.
involved.
Dosage and route of administration
In particular, tell your doctor or Your doctor will decide on a suitable
nurse if you are using any of the dose for you. The dosages vary
following medicines: depending on the treatment planned
- tranquilisers (for anxiety or to and the required sedation. The dose
help you sleep), you will receive depends on your
- sedatives (to make you feel calm weight, age, general condition of
or sleepy), health, concomitant medication,
- hypnotics (sleep medicines), response to the drug and whether
- antidepressants (medicines for other medicines are required at the
depression, e.g. nefazodone), same time.
- narcotic analgesics (very strong If you need strong pain killers, you
pain killers, e.g. fentanyl), will receive these first and then have
- anaesthetics (e.g. propofol), your Midazolam dose adjusted
- some antihistamines (allergy specially for you.
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drugs), This medicine will be injected

- antifungal medicines directly into your vein
(ketoconazole, voriconazole, (intravenously), administered by

The following information is Midazolam solution for

intended for healthcare injection/infusion must not be
professionals only: diluted with Macrodex 6 % solution
in glucose.
Instructions for use Midazolam solution for
Midazolam is compatible with the injection/infusion must not be
following solutions for infusion: mixed with alkaline solutions for
- sodium chloride 0.9 % solution injection. Midazolam precipitates in
- glucose 5 % solution solutions containing hydrogen
- glucose 10 % solution carbonate.
- Ringer's solution To avoid potential incompatibility,
- Hartmann's solution Midazolam solution for
injection/infusion must not be
For intravenous infusion, the content mixed with other solutions except
of Midazolam ampoules may be those mentioned above.
diluted with one of the solution
mentioned above in a ratio of 15 mg Midazolam solution for
midazolam per 100 to 1000 ml of injection/infusion is intended for
infusion solution. single use.

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infusion, injected into the muscle Reporting of side effects

(intramuscularly) or administered If you get any side effects, talk to
rectally. your anaesthetist or other doctor. This
includes any possible side effects not
Children and neonates listed in this leaflet. You can also
In neonates and infants under report side effects directly via:
6 months of age midazolam is only Yellow Card Scheme. Website:
recommended for sedation in www.mhra.gov.uk/yellowcard or
intensive care units. The dose will search for MHRA Yellow Card in the
be given gradually into a vein. Google Play or Apple App Store.
Children 12 years and under will By reporting side effects you can help
usually be given midazolam into provide more information on the
a vein. When this medicine is used safety of this medicine.
for premedication (to cause
relaxation, calm and drowsiness
before an anaesthetic) it may be 5. How to store Midazolam
given into the back passage (rectum).
This medicine does not require any
If you are given more Midazolam special temperature storage
than you should conditions. Keep the ampoules in
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The medicine is administered by the the outer carton in order to protect
doctor or nurse. from light.
If you are accidentally given too much
midazolam, this could lead to Keep this medicine out of the sight
drowsiness, ataxia (coordination and reach of children.
disorders of voluntary muscular
action), dysarthria (speech disorder) After opening the ampoule the
and nystagmus (involuntary eye product should be used immediately.
movements), loss of reflexes, apnoea
(suspension of breathing), hypotension Chemical and physical in-use
(low blood pressure), cardiac and stability has been demonstrated
respiratory depression, and coma. In 24 hours at 25 °C and 3 days at
case of overdose careful monitoring of 2 - 8 °C temperature with following
vital signs, symptomatic treatment of infusion solutions: sodium chloride
cardiorespiratory effects and use of 0.9 %, glucose 5 % and 10 %,
benzodiazepine antagonist may be Ringer`s solution and Hartmann`s
required. solution. From a microbiological
point of view, the dilutions should
If you stop using Midazolam be used immediately. If not used
Sudden discontinuation of treatment immediately, in-use storage times and
can be accompanied by withdrawal conditions prior to use are the
symptoms such as headache, responsibility of the user and would
muscular pain, anxiety, tension, normally not be longer than
restlessness, confusion, mood swings, 24 hours at 2 °C to 8 °C, unless
hallucinations and convulsions, dilution has taken place in
rebound insomnia, irritability. Since controlled and validated aseptic
the risk of withdrawal symptoms conditions.
occurring is greater if treatment is
discontinued abruptly, dose should be Do not use this medicine after the
reduced gradually when treatment is expiry date which is stated on the
being discontinued. carton after EXP. The expiry date
refers to the last day of that month.
If you have any further questions on
the use of this medicine, ask your Do not throw away any medicines
doctor, pharmacist or nurse. via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
4. Possible side effects These measures will help protect
the environment.
Like all medicines, this medicine
can cause side effects, although not
everybody gets them. 6. Contents of the pack and other
information
Tell a doctor straight away if you
notice any of the following side What Midazolam contains
effects. They can be life-threatening - The active substance is midazolam.
and you may need urgent medical
treatment: Midazolam 1 mg/ml
- Anaphylactic shock 1 ml of solution contains 1 mg of
(a life-threatening allergic midazolam.
reaction). Signs may include One ampoule with 5 ml of solution
a sudden rash, itching or lumpy contains 5 mg of midazolam.
rash (hives) and swelling of the
face, lips, tongue or other parts of Midazolam 5 mg/ml
the body. You may also have 1 ml of solution contains 5 mg of
shortness of breath, wheezing or midazolam.
trouble breathing, or a pale skin, One ampoule with 1 ml of solution
a weak and rapid pulse, or feeling contains 5 mg of midazolam.
of loss of consciousness. One ampoule with 3 ml of solution
Additionally, you may experience contains 15 mg of midazolam.
chest pain, which can be a sign of One ampoule with 10 ml of solution
a potentially serious allergic contains 50 mg of midazolam.
reaction called Kounis syndrome.
- Heart attack (cardiac arrest). Signs - The excipients are: hydrochloric
may include chest pain which may acid concentrated, sodium chloride,
spread to your neck and shoulders sodium hydroxide (for pH
and down your left arm. adjustment), water for injections.
- Breathing problems or
complications (sometimes What Midazolam looks like and
causing the breathing to stop). contents of the pack
- Choking and sudden blockage of Clear, colourless solution for
the airway (laryngospasm). injection/infusion of 1 ml, 3 ml or
10 ml (for 5 mg/ml) and 5 ml
Life-threatening side effects are solution (for 1 mg/ml) filled in
more likely to occur in adults over Type I colourless glass ampoules
60 years of age and those who with one point cut.
already have breathing difficulties Pack size: 5 or 10 ampoules.
or heart problems, particularly if Not all pack sizes may be marketed.
the injection is given too fast or at
a high dose. Marketing Authorisation Holder
and Manufacturer
Other possible side effects: AS KALCEKS
The following side effects have Krustpils iela 71E, Rīga, LV-1057,
been reported but their frequency is Latvia
not known and cannot be estimated
from the available data: This medicine is authorised in the
Member States of the European
Immune system disorders: general Economic Area and in the United
allergic reactions (skin reactions, Kingdom (Northern Ireland) under
heart and vascular system reactions, the following names:
wheezing). Estonia, Czech Republic, Poland, Italy,
Sweden Midazolam Kalceks
Psychiatric disorders: confusion, Austria Midazolam Kalceks
disorientation, emotional and mood 1 mg/ml, 5 mg/ml
disturbances, changes in libido. Injektions-/
Paradoxical reactions such as Infusionslösung
restlessness, agitation, irritability, Belgium Midazolam Kalceks
nervousness, muscle spasms and 1 mg/ml, 5 mg/ml
tremors, hostility, delusion, anger, solution
aggressiveness, anxiety, nightmares, injectable/pour
abnormal dreams, hallucinations, perfusion Midazolam
psychoses, inappropriate behaviour Kalceks 1 mg/ml,
and other adverse behavioural 5 mg/ml oplossing
effects, excitement and assault have voor injectie/infusie
been reported. These have mostly Midazolam Kalceks
been observed if the injection is 1 mg/ml, 5 mg/ml
given too fast or at a high dose. The Injektions-/
risk of the appearance of these Infusionslösung
symptoms is greater in children and Bulgaria Midazolam Kalceks
elderly patients. 1 mg/ml, 5 mg/ml
инжекционен/
Dependence: midazolam may cause инфузионен разтвор
development of physical dependence, Croatia Midazolam Kalceks
even if used in therapeutic doses. The 1 mg/ml, 5 mg/ml
withdrawal symptoms, including otopina za
seizures, which may occur after injekciju/infuziju
prolonged administration of France MIDAZOLAM
midazolam, can be avoided with KALCEKS 1 mg/mL,
gradual reduction in dosage (see 5 mg/mL, solution
section 2). injectable/pour
perfusion
Nervous system disorders: Germany Midazolam Kalceks
drowsiness and prolonged sedation, 1 mg/ml Injektions-/
decreased alertness, somnolence, Infusionslösung
headache, dizziness, muscular Midazolam
coordination disorders. Temporary Ethypharm Kalceks
memory loss has been reported. Its 5 mg/ml Injektions-/
duration depends on dosage Infusionslösung
administered and it may also occur Hungary Midazolam Kalceks
after the treatment. In isolated cases 1 mg/ml, 5 mg/ml
the memory loss has been prolonged. oldatos injekció vagy
Convulsions have been reported in infúzió
preterm infants and new-born babies. Ireland Midazolam 1 mg/ml,
5 mg/ml solution for
Cardiac disorders: severe adverse injection/infusion
reactions have occurred, such as Latvia Midazolam Kalceks
low blood pressure, slow heart rate, 1 mg/ml, 5 mg/ml
dilation of blood vessels (e.g. šķīdums
flushing, fainting and headache). injekcijām/infūzijām
Lithuania Midazolam Kalceks
Gastrointestinal disorders: nausea, 1 mg/ml, 5 mg/ml
vomiting, constipation, dry mouth. injekcinis ar infuzinis
tirpalas
Skin disorders: skin rash, allergic The Netherlands Midazolam Kalceks
reaction, itching. 1 mg/ml, 5 mg/ml
oplossing voor
General disorders and injectie/infusie
administration site conditions: Slovakia Midazolam Kalceks
tiredness, redness, swelling of the 1 mg/ml, 5 mg/ml
skin, blood clots and pain at the injekčný/infúzny
injection site (erythema, roztok
thrombophlebitis and thrombosis). United Kingdom (Northern Ireland)
Patients taking benzodiazepines are Midazolam 1 mg/ml,
at a higher risk of falling and 5 mg/ml solution for
breaking bones, especially the injection/infusion
elderly and those taking other
sedatives (including alcoholic This leaflet was last revised in
beverages). 05/2024
Patients with severe kidney disease
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are more likely to experience side

effects. 05.06.2024. MUK/I/0/1

The solution should be examined

visually before administration.
Only clear solution without visible
particles may be used.
Instruction of ampoule opening:
1) Turn the ampoule with coloured
point up. If there is any solution
in the upper part of the ampoule,
gently tap with your finger to get
all the solution to the lower part
of the ampoule.
2) Use both hands to open; while
holding the lower part of the
ampoule in one hand, use the other
hand to break off the upper part of
the ampoule in the direction away
from the coloured point (see the
pictures below).

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