Midazolam 1 mg/ml Solution for Injection or Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Midazolam

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N05CD; N05CD08

INN (International Name):

Midazolam

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Benzodiazepine derivatives; midazolam

Authorization status:

Marketed

Authorization date:

2009-03-06

Patient Information leaflet

NLH107700 var PSUSA July 23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 are 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 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 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 are given midazolam
3.
How midazolam is given
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 which 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MIDAZOLAM
YOU MUST NOT BE GIVEN MIDAZOLAM
•
If you are allergic (hypersensitive) to midazolam or any of the other
ingredients of the medicine (listed in
section 6)
•
You are allergic to other benzodiazepine medicines, such as diazepam
or nitrazepam.
You have severe breathin

Summary of Product characteristics

Health Products Regulatory Authority
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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.

ANAESTHESIA
– 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.

ANAESTHESIA
– Premedication before induction of anaesthesia

SEDATION IN INTENSIVE CARE UNITS
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
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should be determined with caution and risk factors related to each
patient should be taken into account. Standard dosages are
provided in Table 1 and additional details are provided in the