Midazolam 1mg/ml Solution for Injection or Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MIDAZOLAM HYDROCHLORIDE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

N05CD08

INN (International Name):

MIDAZOLAM HYDROCHLORIDE 1 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

MIDAZOLAM HYDROCHLORIDE 1 mg/ml

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2009-01-22

Patient Information leaflet

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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 taking 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 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 very
relaxed state of calm, drowsiness
or sleep) and relieves anxiety and muscle tension.
-
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. 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 other ingridients in the midazolam solution for injection
•
If you have severe difficulties with your breathing and that you are
to undergo conscious
sedation.

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Midazolam 1 mg/ml Solution for Injection or Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection or infusion contains 1 mg of
midazolam (as midazolam
hydrochloride)
Presentations
5 ml
Amount of midazolam
5 mg
Excipient: Contains 3.53 mg sodium (as sodium chloride) per ml of
solution for injection or
infusion.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for Injection or Infusion.
Clear, colorless to pale yellow solution with a pH in the range of 2.9
- 3.7 and 270 mOsm/kg to 330
mOsm/kg osmolality.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midazolam is a short acting sleep-inducing active substance that is
indicated:
IN ADULTS:
•
_Conscious sedation _
before and during diagnostic or therapeutic procedures with or without
local anaesthesia.
•
_Anaesthsia_
–
Premedication before induction of anaesthesia
–
Induction of anaesthesia
–
As a sedative components in combined anaesthesia
•
_Sedation in intensive care units_
_ _
IN CHILDREN:
•
_Conscious sedation _
before and during diagnostic or therapeutic procedures with or without
local anaesthesia.
•
_Anaesthsia_
–
Premedication before induction of anaesthesia
•
_Sedation in intensive care units_
_ _
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
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
ADULTS < 60 Y
ADULTS ≥ 60Y /
DEBILITATED OR
CHRONICALLY ILL
CHIL