HYPNOVEL 10MG/2ML SOLUTION FOR INJECTION

Active substance: MIDAZOLAM

View full screen / Print PDF » Download PDF ⇩

Transcript
10145878 GB FY 1303.1073

Patient Product Information

Hypnovel® 10mg/2ml solution for injection
Midazolam (as midazolam hydrochloride)

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
troublesome, or if you notice any side effects not listed
in this leaflet, please tell your doctor or nurse.
In this leaflet:
1. What Hypnovel is and what it is used for
2. Before you are given Hypnovel
3. How Hypnovel is given
4. Possible side effects
5. How to store Hypnovel
6. Further information

1. WHAT HYPNOVEL IS AND WHAT
IT IS USED FOR
Hypnovel (midazolam) belongs to a group of medicines
known as benzodiazepines. It is a short-acting medicine
that is used to induce sedation (a very relaxed state of
calm, drowsiness or sleep) and relieves anxiety and
muscle tension.
This medicine is used for:
● Conscious sedation (an awake but very relaxed state of
calm or drowsiness during a medical test or procedure)
in adults and children.
● Sedation of adults and children, in intensive care units.
● Anaesthesia in adults, used alone or with other
medicines.

● Premedication (medicine used to cause relaxation,
calm and drowsiness before an anaesthetic) in adults
and children.

● You are debilitated (have an illness that makes you feel
very weak, run down and short of energy).
● You have myasthenia gravis (a neuromuscular disease
causing muscle weakness).
● You regularly drink large amounts of alcohol or you
have had problems with alcohol use in the past.
● You regularly take recreational drugs or you have had
problems with drug use in the past.
● You are pregnant or think you may be pregnant (see
‘Pregnancy and breast-feeding’).
If any of the above apply to you, or if you are not sure,
talk to your doctor or nurse before you are given
Hypnovel.

2. BEFORE YOU ARE GIVEN
HYPNOVEL
You must not be given Hypnovel if:

● You are allergic (hypersensitive) to any of the
ingredients of the medicine (see 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 Hypnovel for conscious sedation.
You must not be given Hypnovel if any of the above
apply to you. If you are not sure, talk to your doctor or
nurse before you are given this medicine.

● atorvastatin (used to treat high cholesterol)
● rifampicin (used to treat mycobacterial infections such
as tuberculosis)
● 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
Hypnovel.

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 Hypnovel.

Using other medicines

Drinking alcohol

This is extremely important, as using more than one
medicine at the same time can strengthen or weaken the
effect of the medicines involved.

Pregnancy and breast-feeding

Please tell your doctor or nurse if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription and herbal medicines.

Take special care with Hypnovel
Children and babies

If your child is going to be given this medicine:
● It is particularly important to tell your doctor or nurse
if your child has cardiovascular disease (heart
problems). Your child will be carefully monitored and
the dose will be adjusted specially.
● Children must be carefully monitored. For infants and
babies under 6 months this will include monitoring of
breathing and oxygen levels.

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)
● 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 or
clarithromycin)
● diltiazem (used to treat high blood pressure)
● medicines for HIV called protease inhibitors (such as
saquinavir)

Adults

Before Hypnovel is given, let your doctor or nurse
know if:
● You are over 60 years of age.
● You have a long term illness (such as breathing
problems or kidney, liver or heart problems).
1

Do not drink alcohol if you have been given Hypnovel.
This is because alcohol can increase the sedative effect of
Hypnovel and may cause problems with your breathing.
Talk to your doctor if you are pregnant, or think you are
pregnant. Your doctor will decide if this medicine is
suitable for you.
Do not breast-feed for 24 hours after being given
Hypnovel. This is because Hypnovel may pass into your
breast milk.

Driving and using machines

● Do not drive or use machinery until you are
completely recovered. Your doctor should advise you
when you can start these again.
● Hypnovel may make you sleepy, forgetful
or affect your concentration and co-ordination. This
may affect your performance at skilled tasks such as
driving or using machines.
● You should always be taken home by a responsible
adult after your treatment.
Please turn over

This information is intended for medical or healthcare professionals only:
The tear-off portion above is intended for the patient
INFORMATION FOR HEALTHCARE PROFESSIONALS

Hypnovel® 10mg/2ml solution for injection
Midazolam (as midazolam hydrochloride)

Please refer to the Summary of Product Characteristics for full prescribing information.
Presentation

2 ml glass ampoules containing 10 mg/2 ml midazolam.
The solution is clear and colourless. Excipients are sodium
chloride, hydrochloric acid, sodium hydroxide solution and
water for injections. Hypnovel 10mg/2ml, cartons of
10 ampoules.
Important information about the excipients in Hypnovel.
Hypnovel is essentially ‘sodium free’ as it contains
less than 1 mmol sodium (23 mg) per ampoule.

Posology and method of administration

Midazolam is a potent sedative agent that requires titration
and slow administration. Titration is strongly recommended
to safely obtain the desired level of sedation according to
the clinical need, physical status, age and concomitant
medication. In adults over 60 years, debilitated or
chronically ill patients and paediatric patients, dose should
be determined with caution and risk factors related to each
patient should be taken into account. Standard dosages are
provided in the table below.
Additional details are provided in the text following the
table.
Indication

Conscious
sedation

Adults
<60 y

Adults ≥60 y /
debilitated or
chronically ill
i.v.
i.v.
Initial dose: Initial dose:
2-2.5 mg
0.5-1 mg
Titration
Titration doses:
doses: 1 mg 0.5-1 mg
Total dose: Total dose:
3.5-7.5 mg <3.5 mg

Children
i.v. 6 months5 years
Initial dose:
0.05-0.1 mg/kg
Total dose:
<6 mg
i.v. 6-12 years
Initial dose:
0.025-0.05 mg/kg
Total dose:
<10 mg
rectal >6 months
0.3-0.5 mg/kg
i.m. 1-15 years
0.05-0.15mg/kg

Indication

Adults
<60 y

Adults ≥60 y /
debilitated or
chronically ill

CONSCIOUS SEDATION DOSAGE

Children

i.v.
Anaesthesia 1-2 mg
premedirepeated
cation
i.m.0.070.1 mg/kg

rectal >6 months
i.v.
0.3-0.5 mg/kg
Initial dose:
i.m. 1-15 years
0.5mg
0.08-0.2 mg/kg
Slow uptitration
as
needed
i.m.0.0250.05 mg/kg

i.v.
0.15Anaesthesia 0.2 mg/kg
induction (0.3-0.35
without
premedication)

i.v.
0.050.15 mg/kg
(0.15-0.3
without
premedication)

i.v.
intermittent
doses of
Sedative
component 0.030.1 mg/kg
in
combined or
anaesthesia continuous
infusion of
0.030.1 mg/kg/h

For conscious sedation prior to diagnostic or surgical
intervention, midazolam is administered i.v. The dose must
be individualised and titrated, and should not be administered
by rapid or single bolus injection. The onset of sedation may
vary individually depending on the physical status of the
patient and the detailed circumstances of dosing (e.g. speed
of administration, amount of dose). If necessary, subsequent
doses may be administered according to the individual need.
The onset of action is about 2 minutes after the injection.
Maximum effect is obtained in about 5 to 10 minutes.

i.v.
lower doses
than
recommended
for
adults <60 years

Sedation
in ICU

i.v.
Loading dose: 0.03-0.3 mg/
kg in increments of
1-2.5 mg
Maintenance dose: 0.03-0.2
mg/kg/h

Adults: the i.v. injection of midazolam should be given
slowly at a rate of approximately 1 mg in 30 seconds.
Adults below the age of 60: the initial dose is 2 to 2.5 mg
given 5 to 10 minutes before the beginning of the
procedure. Further doses of 1 mg may be given as
necessary. Mean total doses have been found to range
from 3.5 to 7.5 mg. A total dose greater than 5 mg is
usually not necessary.
Adults over 60 years of age, debilitated or chronically ill
patients: the initial dose must be reduced to 0.5-1.0 mg
and given 5-10 minutes before the beginning of the
procedure. Further doses of 0.5 to 1 mg may be given as
necessary. Since in these patients the peak effect may be
reached less rapidly, additional midazolam should be
titrated very slowly and carefully. A total dose greater
than 3.5 mg is usually not necessary.

i.v. in neonates
<32 weeks
gestational age
0.03 mg/kg/h
i.v in neonates
>32 weeks and
children up to
6 months
0.06 mg/kg/h
i.v. >6 months
Loading dose:
0.05-0.2 mg/kg
Maintenance dose:
0.06-0.12 mg/kg/h

Children i.v. administration: midazolam should be
titrated slowly to the desired clinical effect. The initial
dose of midazolam should be administered over
2 to 3 minutes. One must wait an additional
2 to 5 minutes to fully evaluate the sedative effect before
initiating a procedure or repeating a dose. If further
sedation is necessary, continue to titrate with small
increments until the appropriate level of sedation is
achieved. Infants and young children less than 5 years of
age may require substantially higher doses (mg/kg) than
older children and adolescents.
1

10145878 318x420mm.indd 1

Children less than 6 months of age: paediatric patients
less than 6 months of age are particularly vulnerable to
airway obstruction and hypoventilation. For this reason,
the use in conscious sedation in children less than
6 months of age is not recommended.
Children 6 months to 5 years of age: initial dose 0.05 to
0.1 mg/kg. A total dose up to 0.6 mg/kg may be necessary
to reach the desired endpoint, but the total dose should not
exceed 6 mg. Prolonged sedation and risk of
hypoventilation may be associated with the higher doses.
Children 6 to 12 years of age: initial dose 0.025 to
0.05 mg/kg. A total dose of up to 0.4 mg/kg to a
maximum of 10 mg may be necessary. Prolonged
sedation and risk of hypoventilation may be associated
with the higher doses.
Children 12 to 16 years of age: should be dosed as adults.
Children rectal administration: the total dose of
midazolam usually ranges from 0.3 to 0.5 mg/kg. Rectal
administration of the ampoule solution is performed by
means of a plastic applicator fixed on the end of the
syringe. If the volume to be administered is too small,
water may be added up to a total volume of 10 ml. Total
dose should be administered at once and repeated rectal
administration avoided.
The use in children less than 6 months of age is not
recommended, as available data in this population
are limited.
Children i.m. administration: the doses used range
between 0.05 and 0.15 mg/kg. A total dose greater than
10.0 mg is usually not necessary. This route should only
be used in exceptional cases. Rectal administration
should be preferred as i.m. injection is painful.
In children less than 15 kg of body weight, midazolam
solutions with concentrations higher than 1mg/ml are not
recommended. Higher concentrations should be diluted
to 1mg/ml.
Please turn over

20.09.2013 16:24:08

Important information about some of the
ingredients of Hypnovel

Hypnovel is essentially ‘sodium free’ as it contains less
than 1 mmol sodium (23 mg) per ampoule (small glass
bottle).

3. HOW HYPNOVEL IS GIVEN
Hypnovel should be given only by experienced
healthcare professionals (doctor or nurse). It should be
given in a place (hospital, clinic or surgery) equipped to
monitor and support the patient’s breathing, heart and
circulation (cardiovascular function) and recognise the
signs of and manage the expected side effects of
anaesthesia.

Normal adult dose

Your doctor will decide on a suitable dose for you. The
dose you are given will depend on why you are being
treated and the type of sedation needed. Your weight,
age, your state of health, how you respond to Hypnovel
and whether other medicines are needed at the same
time will also influence the dose that you are given.
If you need strong painkillers, you will be given these
fi rst and then be given Hypnovel. The dose will be
adjusted specially for you.

Hypnovel may be given to you in one of four
different ways:

● by slow injection into a vein (intravenous injection)
● through a tube into one of your veins (intravenous
infusion)
● by injection into a muscle (intramuscular injection)
● into your back passage (rectum).
You should always be taken home by a responsible adult
after your treatment.

Children and babies

● In infants and babies under 6 months of age
Hypnovel is only recommended for sedation in
intensive care units. The dose will be given
gradually into a vein.
● Children 12 years and under will usually be given
Hypnovel into a vein. When Hypnovel is used for
premedication (to cause relaxation, calm and
drowsiness before an anaesthetic) it may be given
into the back passage (rectum).

If you receive more Hypnovel than you should

Your medicine will be given to you by a doctor or
nurse. If you are accidentally given too much Hypnovel
you may:
● Feel drowsy.
● Lose your co-ordination (ataxia) and reflexes.
● Have problems with your speech (dysarthria).
● Have involuntary eye movements (nystagmus).
● Develop low blood pressure (hypotension).
● Stop breathing (apnoea) and suffer cardiorespiratory
depression (slowed or stopped breathing and heart
beat) and coma.

Stopping Hypnovel

● restlessness
● hostility, rage or aggression
● excitement.

If you receive long term treatment with Hypnovel (are
given the medicine for a long time) you may:
● Become tolerant to Hypnovel. The medicine becomes
less effective and does not work as well for you.
● Become dependent upon this medicine and get
withdrawal symptoms (see below).
Your doctor will reduce your dose gradually to avoid
these effects happening to you.

Muscle problems:

● muscle spasms and muscle tremors (shaking of your
muscles that you cannot control).

Mental and Nervous system problems:

● confusion
● euphoria (an excessive feeling of happiness or
excitement)
● hallucinations (seeing and possibly hearing things that
are not really there)
● drowsiness and prolonged sedation
● reduced alertness
● headache
● dizziness
● difficulty co-ordinating muscles
● fits (convulsions) in premature infants and new-born
babies
● temporary memory loss. How long this lasts depends
on how much Hypnovel you were given. You may
experience this after your treatment. In isolated cases
this has been prolonged (lasted for a long time).

Withdrawal symptoms:

Benzodiazepine medicines, like Hypnovel, may make you
dependent if used for a long time (for instance in intensive
care). This means that if you stop treatment suddenly, or
lower the dose too quickly, you may get withdrawal
symptoms. The symptoms can include:
● headache
● muscle pain
● feeling very worried (anxious), tense, restless,
confused or bad-tempered (irritable)
● problems with sleeping (insomnia)
● mood changes
● hallucinations (seeing and possibly hearing things that
are not there)
● fits (convulsions).

Elderly patients:

● Life-threatening side effects are more likely to occur in
adults over 60 years of age and those who already have
breathing difficulties or heart problems, particularly
when the injection is given too quickly or at a high
dose.
If any of the side effects become serious or troublesome, or
if you notice any side effects not listed in this leaflet, please
tell your doctor or nurse.

5. HOW TO STORE HYPNOVEL
Your doctor or pharmacist is responsible for storing
Hypnovel. They are also responsible for disposing of any
unused Hypnovel correctly.
Keep out of the reach and sight of children.
Keep the ampoules (small glass bottle) in the outer carton
in order to protect from light.
Do not use after the expiry date (EXP) printed on the
pack. The expiry date refers to the last day of that month.

Heart and circulation problems:

4. POSSIBLE SIDE EFFECTS

● low blood pressure
● slow heart rate
● redness of the face and neck (flushing), fainting or
headache.

Like all medicines, Hypnovel can cause side effects,
although not everybody will get them. The following
undesirable effects have been reported (frequency not
known).

6. FURTHER INFORMATION
What Hypnovel contains

Breathing problems:

The active substance in Hypnovel is midazolam (as
midazolam hydrochloride). Each 1 ml of liquid medicine
contains 5 mg (milligrams) of midazolam. Each ampoule
(small glass bottle) contains 10 mg of midazolam (in
2 millilitres of liquid).

Stomach, gut and mouth problems:

The other ingredients are sodium chloride, hydrochloric
acid, sodium hydroxide and water for injections.

● shortness of breath
● hiccup.

Stop having Hypnovel 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:
● Anaphylactic shock (a life-threatening allergic
reaction). 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). Signs may include chest
pain which may spread to your neck and shoulders and
down your left arm.
● Breathing problems or complications (sometimes
causing the breathing to stop).
● Choking and sudden blockage of the airway
(laryngospasm).

● feeling sick or being sick
● constipation
● dry mouth.

Skin problems:

● rash
● hives (lumpy rash)
● itchiness.

Injection site problems:

● redness
● swelling of the skin
● blood clots or pain at the injection site.

Life-threatening side effects are more likely to occur in
adults over 60 years of age and those who already have
breathing difficulties or heart problems, particularly if the
injection is given too fast or at a high dose

Injury:

● Patients taking benzodiazepine medicines are at risk of
falling and breaking bones. This risk is increased in the
elderly and those taking other sedatives (including
alcohol).

Other possible side effects
Immune system problems:

● general allergic reactions (skin reactions,
heart and blood system reactions, wheezing)

What Hypnovel looks like and contents
of the pack

Hypnovel is a clear colourless liquid (‘solution for
injection’). This liquid may be further diluted to make it
weaker before it is given to you.
Hypnovel is supplied in clear glass ampoules in packs of 10.

Marketing Authorisation Holder
and Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom

This leaflet was last revised in August 2013.

General:

● tiredness (fatigue).

Effects on behaviour:
● agitation

2

ANAESTHESIA DOSAGE-PREMEDICATION
Premedication with midazolam given shortly before a
procedure produces sedation (induction of sleepiness or
drowsiness and relief of apprehension) and preoperative
impairment of memory. Midazolam can also be
administered in combination with anticholinergics. For
this indication midazolam should be administered i.v. or
i.m., deep into a large muscle mass 20 to 60 minutes
before induction of anaesthesia, or preferably via the
rectal route in children (see below). Close and
continuous monitoring of the patients after
administration of premedication is mandatory as
inter-individual sensitivity varies and symptoms of
overdose may occur.

Adults: For preoperative sedation and to impair memory
of preoperative events, the recommended dose for adults
of ASA Physical Status I & II and below 60 years is
1-2 mg i.v. repeated as needed, or 0.07 to 0.1 mg/kg
administered i.m. The dose must be reduced and
individualised when midazolam is administered to
adults over 60 years of age, debilitated or chronically ill
patients. The recommended initial i.v. dose is 0.5 mg
and should be slowly up titrated as needed. A dose of
0.025 to 0.05 mg/kg administered i.m. is recommended.
In case of concomitant administration of narcotics the
midazolam dose should be reduced. The usual dose is
2 to 3 mg.
Neonates and children up to 6 months of age:
The use in children less than 6 months of age is not
recommended as available data are limited.
Children over 6 months of age, rectal administration:
The total dose of midazolam, usually ranging from
0.3 to 0.5 mg/kg should be administered 15 to
30 minutes before induction of anaesthesia. Rectal
administration of the ampoule solution is performed by
means of a plastic applicator fixed on the end of the
syringe. If the volume to be administered is too small,
water may be added up to a total volume of 10 ml.
Children over 6 months of age, i.m.
administration: As i.m. injection is painful, this route
should only be used in exceptional cases. Rectal
administration should be preferred. However, a dose
range from 0.08 to 0.2 mg/kg of midazolam
administered i.m. has been shown to be effective and
safe. In children between ages 1 and 15 years,
proportionally higher doses are required than in adults
in relation to body-weight.
In children less than 15 kg of body weight, midazolam
solutions with concentrations higher than 1 mg/ml are
not recommended. Higher concentrations should be
diluted to 1 mg/ml.

ANAESTHESIA DOSAGE-INDUCTION

SEDATION IN INTENSIVE CARE UNITS

In premature infants, neonates and children less than
15 kg of body weight, midazolam solutions with
concentrations higher than 1mg/ml are not recommended.
Higher concentrations should be diluted to 1mg/ml.

The desired level of sedation is reached by stepwise
titration of midazolam followed by either continuous
infusion or intermittent bolus, according to the
clinical need, physical status, age and concomitant
medication.

Premedicated adults below the age of 60 years:
an i.v. dose of 0.15 to 0.2 mg/kg will usually suffice.
Non-premedicated adults below the age of 60:
the dose may be higher (0.3 to 0.35 mg/kg i.v.). If
needed to complete induction, increments of
approximately 25% of the patient’s initial dose may be
used. Induction may instead be completed with
inhalational anaesthetics. In resistant cases, a total
dose of up to 0.6 mg/kg may be used for induction, but
such larger doses may prolong recovery.

I.V. maintenance dose: doses can range from
0.03 to 0.2 mg/kg/h. In hypovolaemic, vasoconstricted,
or hypothermic patients the maintenance dose should be
reduced. The level of sedation should be assessed
regularly. With long-term sedation, tolerance may develop
and the dose may have to be increased.
Neonates and children up to 6 months of age:
Midazolam should be given as a continuous i.v. infusion,
starting at 0.03 mg/kg/h (0.5 μg/kg/min) in neonates with
a gestational age <32 weeks, or 0.06 mg/kg/h
(1 μg/kg/min) in neonates with a gestational age
>32 weeks and children up to 6 months. Intravenous
loading doses is not recommended in premature infants,
neonates and children up to 6 months, rather the infusion
may be run more rapidly for the first several hours to
establish therapeutic plasma levels. The rate of infusion
should be carefully and frequently reassessed, particularly
after the first 24 hours so as to administer the lowest
possible effective dose and reduce the potential for drug
accumulation. Careful monitoring of respiratory rate and
oxygen saturation is required.

Premedicated adults over 60 years of age, debilitated
or chronically ill patients: the dose should
significantly be reduced, e.g., down to 0.05- 0.15 mg/
kg administered i.v. over 20-30 seconds and allowing
2 minutes for effect.
Non-premedicated adults over 60 years of age:
usually require more midazolam for induction; an
initial dose of 0.15 to 0.3 mg/kg is recommended.
Non-premedicated patients with severe systemic
disease or other debilitation usually require less
midazolam for induction. An initial dose of 0.15 to
0.25 mg/kg will usually suffice.

Children over 6 months of age: In intubated and
ventilated paediatric patients, a loading dose of 0.05 to
0.2 mg/kg i.v. should be administered slowly over at least
2 to 3 minutes to establish the desired clinical effect.
Midazolam should not be administered as a rapid
intravenous dose. The loading dose is followed by a
continuous i.v. infusion at 0.06 to 0.12 mg/kg/h
(1 to 2 μg/kg/min). The rate of infusion can be increased
or decreased (generally by 25% of the initial or
subsequent infusion rate) as required, or supplemental i.v.
doses of midazolam can be administered to increase or
maintain the desired effect.

SEDATIVE COMPONENT IN COMBINED
ANAESTHESIA

Adults: Midazolam can be given as a sedative
component in combined anaesthesia by either further
intermittent small i.v. doses (range between 0.03 and
0.1 mg/kg) or continuous infusion of i.v. midazolam
(range between 0.03 and 0.1 mg/kg/h) typically in
combination with analgesics. The dose and the
intervals between doses vary according to the patient’s
individual reaction.
Adults over 60 years of age, debilitated or chronically
ill patients: lower maintenance doses will be required.

USE IN SPECIAL POPULATIONS

Renal Impairment: In patients with renal impairment
(creatinine clearance < 10 ml/min) the pharmacokinetics
of unbound midazolam following a single i.v. dose is
similar to that reported in healthy volunteers. However,
after prolonged infusion in intensive care unit (ICU)
patients, the mean duration of the sedative effect in the
renal failure population was considerably increased most
likely due to accumulation of α-hydroxymidazolam
glucuronide.
There is no specific data in patients with severe renal
impairment (creatinine clearance below 30 ml/min)
receiving midazolam for induction of anaesthesia.
Hepatic Impairment: Hepatic impairment reduces the
clearance of i.v. midazolam with a subsequent increase in
terminal half-life. Therefore the clinical effects may be
stronger and prolonged. The required dose of midazolam
may be reduced and proper monitoring of vital signs
should be established.

Incompatibilities

Admixture with Hartmann’s solution is not recommended
as the potency of midazolam decreases.

Shelf life

Unopened: 5 years.
Hypnovel solution is stable, both physically and
chemically, for up to 24 hours at room temperature when
mixed with 500ml infusion fluids containing Dextrose 4%
with Sodium Chloride 0.18%, Dextrose 5% or Sodium
Chloride 0.9%.

Special precautions for storage

Keep Hypnovel ampoules in the outer carton.
This healthcare professional leaflet was last revised in
August 2013.

When initiating an infusion with midazolam in
haemodynamically compromised patients, the usual
2

10145878 318x420mm.indd 2

loading dose should be titrated in small increments and
the patient monitored for haemodynamic instability, e.g.,
hypotension. These patients are also vulnerable to the
respiratory depressant effects of midazolam and require
careful monitoring of respiratory rate and oxygen
saturation.

Adults: i.v. loading dose: 0.03 to 0.3 mg/kg should be
given slowly in increments. Each increment of 1 to
2.5 mg should be injected over 20 to 30 seconds allowing
2 minutes between successive increments. In
hypovolaemic, vasoconstricted, or hypothermic patients
the loading dose should be reduced or omitted. When
midazolam is given with potent analgesics, the latter
should be administered first so that the sedative effects of
midazolam can be safely titrated on top of any sedation
caused by the analgesic.

Adults: If midazolam is used for induction of
anaesthesia before other anaesthetic agents have been
administered, the individual response is variable. The
dose should be titrated to the desired effect according
to the patient’s age and clinical status. When
midazolam is used before or in combination with other
i.v. or inhalation agents for induction of anaesthesia,
the initial dose of each agent should be significantly
reduced, at times to as low as 25% of the usual initial
dose of the individual agents. The desired level of
anaesthesia is reached by stepwise titration. The i.v.
induction dose of midazolam should be given slowly
in increments. Each increment of not more than 5 mg
should be injected over 20 to 30 seconds allowing 2
minutes between successive increments.

10145878 GB FY 1303.1073

20.09.2013 16:24:09

Expand view ⇕

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.

Hide
(web2)