HYPNOVEL 10MG/2ML SOLUTION FOR INJECTION

Active substance: MIDAZOLAM

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Patient Product Information

Hypnovel® lOmg/2m1

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:
I.
2.
3.
4.
5.
6.

What Hypnovel is and what it is used for
Before you are given Hypnovel
How Hypnovel is given
Possible side effects
How to store Hypnovel
Further information

1. WHAT HYPNOVEL IS AND WHAT
IT IS USED FOR
Hypnovel (midazolam) belongs to a group of medicines
known as bcnzodiazepiues. 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.

2. BEFORE YOU ARE GIVEN
HYPNOVEL
You must not be given llypnovel if:
• You are allergic (hypersensitive) to any of the
ingredients of the medicine (see section 6, Further
i nfonnation).
• You are allergic to other beuzodiazepine medicines,
such as diazepam or nitrazepam.
• You have severe breathing problems and you arc
going to have Hypnovel for conscious sedation.
You must not be given F]ypnovel 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.

Take special care with Ilypnovel
Children and babies
lfyour 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 specialh
• Children must be carefully monitored.
For infants and babies under 6 months this will
include monitoring of breathing and oxygen levels.

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

Using other medicines

Drinking alcohol
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.

Pregnancy and breast-feeding

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

Talk to your doctor if you are pregnant, or think you are
pregnant. Your doctor will decide if this medicine is
suitable for you.

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

Do not breast-feed for 24 hours after being given
Hypnovcl. This is because Hypnovel may pass into your
breast milk.

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)
• antidepres.sants (medicines for depression)
• narcotic analgesics (very strong pain killers)
• antihistamines (used to treat allergies)
• medicines to treat fungal infections (ketoconazole,
voricouazole, fluconazole, itraconazole. posaconazole)
• macrolide antibiotics (such as ervthromvcin or
clarithromycin)
• diltiazem (used to treat high blood pressure)
• medicines for HIV called protease inhibitors (such as
saquinavir)
• 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.

Driving and using machines

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.

• 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.

Important information about some of the
ingredients of hlypnovel
Hypnovel is essentially ‘sodium free’ as it contains less than
I 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.
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 HEALTI-ICARE PROFESSIONALS

I-lypnovel’ iOmg/2m1 solution for injection
Midazolarn (as inidazolarn hydrochloride)
Please refer to the Summary of Product Characteristics for full prescribing information.

Presentation
2 nil glass ampoules containing 10 mgJ2 nil midazolam.
The solution is clear and colourless. Exeipients are sodium
chloride, hydrochlortc acid, sodium hydroxide solution and
water for injections. Hypnovel 10 mg/2 ml, cartons of
10 ampoules.
Important information about the excipients in l-lypnovel.
Hypnovel is essentially ‘sodium free’ as it contains less
than I inniol sodium (23 mg) per ampoulc.

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.

Indication

Adults 60 /
debilitated or
chronicalla ill

Adults <60)

i.v.
Initial dose:
0.5mg

iv.
Anaesthesia 1-2 mg

Slow

preme-

repeated

dication

uptitration as
in.
0.07-0.1 mg/kg needed i.m.
0.025-0.05 mg/kg

i.v.
Anaesthesia 0.15-0.2 mg/kg
(0.3-0,35 without
induction
premedication)

Children

rectal

>6 months
0.3-0.5 mg’kg
i.m. 1-15 years
0.08-0.2 mg/kg

i.,’.
0.05-0.15 mg/kg
(0.1 5-0.3 without
premedication)

‘‘‘
intermittent
lower doses
.
doses 01
h
t).03-0. I mg/ke
recommended

Sedative
component
in combined or
br
anaesthesia continuous
adults
intusion oF
<60 years
0.03-0.1 mg/kgb
.

.

.

,

-

Additional details are provided in the text following the table.

i.s. in neonates
<32 weeks

Indication

Adults <60

y

Adults 60 v/
debilitated or
chronically ill

gestational age
0.03 mg/kg/li

Children

iv in neonates

.

Lv.

Loadin dose:
0.03-0.3 mg’ke in increments
of 1-2.) ma
,

i.s’.

Lv.

i.s.6 months

Initial dose:
2-2.5 nig
Titration
doses: I mg
Total dose:
3.5-7.5 mg

lniiial dose:
0.5-I mg
Titration doses:
0.5-i mg
Total dose:
<3.5 mg

5 years
Initial dose:
0.05-0.1 mg/kg
Total dose:

Conscious
sedation

“6mg
Lv. 6-I 2 years

Initial dose:
0.025-0.05 mg/kg
Total dose:
<10mg

rectal
>6 months
0.3-0.5 mg/kg
i.m. 1-15 years
0.1)5-0.1 5mg/kg

.

Sedation
in ICU
.

.

-

Mamtenance dose:
0.03-0. tug/kg/li
.

.,

.

Adults: the i.v. injection of midazolam should be given
slowly at a rate of approximately I mg in 30 seconds.
Adults below the age of60: the initial dose is 2 to 2.5 mg
given 5 to 10 minutes before the beginning of the
procedure. Further doses of I 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 chronicallj’ ill
patients: the initial dose must he reduced to 0.5-1.0mg
and given 5-10 minutes before the beginning of the
procedure. Further doses of 0.5 to I 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’s..

,

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.

>32 ts.ceks and
children up to
6 months

0.06 makh
i.v. >6 months
Loading dos
0.05-0.2 mg/kg
Maintenance
dose:
0.06-0.12 ma/kg/h
.



CONSCIOUS SEDATION DOSAGE
For conscious sedation prior to diagnostic or surgical
intervention, midazolam is administered i.v. The dose
must be individttalised 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.

children i. v. administratio,,: 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.
Children less than 6 months of age: paecliatric patients
less than 6 months of age are particularly vulnerable to
airtvay obstntction and hypoventilation. For this reason,
the use in conscious sedation in children less than 6
months of age is not recommended.
childrei, 6 months to 5 ears of age: initial dose 0.05 to
0.1 mg/kg. A total dose up to 0.6 mg/kg may he necessary
to reach the desired endpoint, but the total close 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
maxiimim 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.mn. 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 I mg’ml are not
recommended. Higher concentrations should be diluted
to 1mg/mI.

ANAESTHESIA DOSAGE-PREM EDICATION
Premedication with midazolam given shortly before a
procedure produces sedation (induction of sleepiness or
drowsiness and relief of apprehension) and preoperative
impainnent of memory. Midazolam can also be
administered in combination with anticholinergics. For
this indication midazolam should be acli’ninistered 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 i’nay occur.

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13:08:42

Normal adult dose
Your doctor will decide on a suitable dose fur 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 I-Iypnovel 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 first
and then be given Hypnovel. The dose will be adjusted
specially for you.
HypnoeI 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 l-lypnovel 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 l-Iypnovel 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 eardiorespiratory
depression (slowed or stopped breathing and heart
beat) and coma.

Stopping I-Lypnovel
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 eflctive 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.

ithdra,’a1
7
LJ sj’mptoms:
Benzodiazcpine 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 woiTied (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).

4. POSSIBLE SIDE EFFECTS
Like all medicines, Hypnovel can cause side effects,
although not everybody will get them.
The following undesirable effects have been reported
(frequency not known).
Stop having l-lypno el 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).

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

Other possible side effects
hnin une .systen: problems:
• general allergic reactions (skin reactions, heart and
blood system reactions, wheezing)

Efftcts on behaviour:
• agitation

• restlessness
• hostility, rage or aggression
• excitement.
Muscle pro ble,ns:
• muscle spasms and muscle tremors (shaking of your
muscles that you cannot control).

Mental amid Nervous system pi’oblemns:
• 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. I-low 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).
Heart and circulation problems:
• low blood pressure
• slow heart rate
• redness of the face and neck (flushing), fainting or
headache.

Each ampoule (small glass bottle) contains 10 mg of
midazolam (in 2 millilitres of liquid).
The other ingredients are sodium chloride, hydrochloric
acid, sodium hydroxide and water for injections.

What Hypnovel looks like and contents of the
pack

Breathing problems:

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.

• shortness of breath
• hiccup.

Hypnovel is supplied in clear glass ampoules in packs of 10.

Stomach, gut and nwuth problems:

Marketing Authorisation Holder and
Manufacturer

• feeling sick or being sick
• constipation

• dry mouth.
Ski,: pro blems:
• rash

• hives (lumpy rash)
• itchiness.

Imijection site problems:
• redness
• swelling of the skin
• blood clots or pain at the injection site.

Injury:
• Patients taking benzodiazepine medicines have a
higher risk of falling and breaking hones.
General:
• tiredness (fatigue).

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 leaflei, please
tell your doctor or nurse.

5. HOW TO STORE HYPNOVEL
Your doctor or pharnacist is responsible for storing
Hypnovel. They are also responsible for disposing of any
unused l-lypnovel 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.

6. FURTHER INFORMATION
What Hypnovel contains
The active substance in Hypnovel 10 mg/2 ml is
mida7olam (as midazolam hydrochloride). Each I ml of
liquid medicine contains 5 mg (milligrams) of midazolam.

Roche Products Limited
6 Falcon Way
Shire Park
Weiwyn Garden City, AL? ITW
United Kingdom

This leaflet was last revised in December 2012.

Adults: For preoperative sedation and to impair memory
of preoperative events, the recommended dose for adults
ofASA Physical Status I & II and below 60 years is
1-2 mg iv. repeated as needed, or 0.07 to 0.1 mg/kg
administered i.m. The dose must be reduced and
individualised when ni idazolam is administered to adults
over 60 years of age. debilitated or chronically ill patients.
The recommended initial iv. 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 ease of concomitant
administration of narcotics the mida7olam dose should he
reduced. The usual dose is 2 to 3 mg.

Preniedicated adults helo,i’ the age of 60 years:
an iv. dose of 0.15 to 0.2 mg/kg will usually suffice.
.Von-premedicated adult.s belo,v the age of 60:
the dose may be higher (0.3 to 0.35 mg/kg iv.).
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 close
of up to 0.6 mg/kg may be used for induction, but such
larger doses may prolong recovery.

.eonalc’s and children up to 6 months of age:

Preunedicated adults o,’er 60 j’ears of age, debilitated or
chronically ill patients: the dose should significantly be

The use in children less than 6 months of age is not
recommended as available data arc limited.

reduced, e.g., down to 0.05- 0.15 ma/kg administered i.v.
over 20-30 seconds and allowing 2 minutes for effect.

Children over 6 mouths of age, rectal adnu,ustratio,,:
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.

Non-premedicated adults om’er 60 j’ears of age: usually
require more nudazolam 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 umionths of age, i.in. 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 mida7olam administered i.m. has been shown to be
effective and safe. In children between ages I 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 I mg/mI are not
recommended. 1-ligher concentrations should be diluted to
I mg/mI.

ANAESTHESIA DOSAGE-INDUCTION
Adults: If midazolam is used for induction of anaesthesia
before other anaesthetic agents have been administered,
the individual response is variable. The dose should he
titrated to the desired effect according to the patient’s age
and clinical status. When mida7olam 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°/o
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.

SEDATIVE COMPONENT IN COMBINED
ANAESTHESIA
Adults: Midazolam can he given as a sedative component
in combined anaesthesia by either further intermittent
small i.v. doses (range bebveen 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.

SEDATION IN INTENSIVE CARE UNITS
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.
Adults: Lv. loading dose: 0.03 to 0.3 mg/kg should he
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 hypothermie 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.
I. 1< maintenance dose: doses can range from 0.03 to
0.2 mg/kg/h. In hypovolacmic, vasoconstrieted, 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.

There is no specific data in patients with severe renal
impairment (creatinine clearance below 30 mI/mm)
receiving midazolam for induction of anaesthesia.

Aeonates and children up to 6 uuionths of age:
Midazolam should be given as a continuous iv. infusion,
starting at 0.03 mg/kg/h (0.5 ig!kgmin) in neonates with
a gestational age <32 weeks, or 0.06 mg/kg/h (I j.ig/kg/
mm) 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
tip 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.

Ilepatic Impairment: Hepatic impairment reduces the
clearance of iv. midazolam with a subsequent increase in
terminal half-life. Therefore the clinical effects may he
stronger and prolonged. The required dose of niidazolam
may be reduced and proper monitoring of vital signs
should be established.

children om’er 6 muionths of age: In intubated and
ventilated paediatric patients., a loading dose of 0.05 to
0.2 mg/kg i.v. should he 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
(I to 2 fig/kg/mm). The rate of infusion can be increased
or decreased (generally by 25% of the initial or
subsequent infusion rate) as required. or supplemental iv.
doses of niiclazolam can be administered to increase or
maintain the desired effect.

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 tip to 24 hours at room temperature when
mixed with 500m1 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
December 2012.

When initiating an infusion with midazolam in
haemodynamically compromised patients. the usual
loading dose should be titrated in small increments and
the patient monitored for hacmodynamic instability, e.g.,
hypotension. These patients are also vulnerable to the
respiratory depressant effects of miclazolam and require
careful monitoring of respiratory rate and oxygen
saturation.
In premature infants, neonates and children less than
15 kg of body weight. midazolam solutions with
concentrations higher than I nig/mI are not recommended.
Higher concentrations should he diluted to 1mg/mI.

USE IN SPECIAL POPULATIONS
Renal Impairnient: In patients with renal impairment
(creatinine clearance < 10 mI/mm) 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 a-hydroxymidazolam
glucuronide.
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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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