Miprosed 5mg/ml Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MIDAZOLAM

Available from:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

ATC code:

N05CD08

INN (International Name):

MIDAZOLAM 5 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

MIDAZOLAM 5 mg/ml

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-05-15

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MIPROSED 5MG/ML ORAL SOLUTION
midazolam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS GIVEN
THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or
pharmacist.

If you or your child experiences any side effects, talk to your
doctor, nurse or
pharmacist. This includes any possible side effects not listed in this
leaflet. See section
4.
The name of your medicine is Miprosed 5mg/ml Oral Solution but it will
be referred to as
‘Miprosed’ throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Miprosed is and what it is used for
2.
What you need to know before you or your child use Miprosed
3.
How to give Miprosed
4.
Possible side effects
5.
How to store Miprosed
6.
Contents of the pack and other information
1.
WHAT MIPROSED IS AND WHAT IT IS USED FOR
Miprosed contains an active substance midazolam. Midazolam is a member
of a group of
medicines called benzodiazepines which can help to relieve anxiety.
Midazolam is used for
sedation and anxiolysis prior to diagnostic, surgical, therapeutic or
endoscopic procedures and
as a premedication before being induced for general anaesthesia in
children aged between 6
months and 14 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD USE MIPROSED
DO NOT GIVE MIPROSED IF THE PATIENT HAS:

an allergy (hypersensitivity) to midazolam, to any other
benzodiazepines (such as
diazepam) or to any of the other ingredients of this medicine (listed
in section 6)

severe liver disease

a disorder of the nerves or muscles that have severe muscle weakness
(myasthenia
gravis)

severe breathing problems

a condition that temporarily stops breathing during sleep (sleep apnea
syndrome)
Do not use this medicine if any of the above apply to the patient. If
you are not sure, talk to
your doctor or pharmacist before using Miprosed.
WARNINGS AND PRECAUTIONS
Miprosed should be admin

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Miprosed 5mg/ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is midazolam.
Each ml of oral solution contains 5mg midazolam.
Each ml of oral solution contains 1.94mg propylene glycol (E1520) and
630mg glycerol
(E422).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution
Clear colourless to pale yellow coloured oral solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Miprosed is indicated in children aged 6 months to 14 years for:
•
Sedation and anxiolysis prior to diagnostic, surgical, therapeutic or
endoscopic procedures.
•
Premedication before induction of general anaesthesia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Sedation and anxiolysis prior to diagnostic, surgical, therapeutic or
endoscopic procedures: _
Children (6 months to 14 years): 0.25mg/kg to 0.5mg/kg administered
15-30 minutes before
the intervention. Maximum per dose: 20mg.
_Premedication before induction of general anaesthesia: _
Children (6 months to 14 years): 0.25mg/kg to 0.5mg/kg administered
15-30 minutes before
the induction of anaesthesia. Maximum per dose: 20mg.
The dose should be adapted to the patient’s weight and administered
rounded to the nearest
syringe graduation in millilitres. The maximum dose should not exceed
20mg of midazolam
even for children weighing more than 80kg (0.25mg/kg) or 40kg
(0.5mg/kg). In obese
children the dose should be given according to the actual body weight
up to the maximum
limit of 20mg. General fasting guidelines should be respected before
sedation with Miprosed.
Special populations
_Renal impairment_
No dose adjustment is required; however, midazolam should be used with
caution in patients
with chronic renal failure as elimination of midazolam may be delayed
and the effects
prolonged (see section 4.4).
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_Hepatic impairment_
Hepatic impairment reduces the clearance of midazolam with a
subsequent increase in
terminal half-life. Theref