Midazolam 5 mg/ml solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Midazolam

Available from:

AS Kalceks

ATC code:

N05CD08

INN (International Name):

Midazolam

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

midazolam

Authorization date:

2020-05-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION/INFUSION
MIDAZOLAM 5 MG/ML SOLUTION FOR INJECTION/INFUSION
midazolam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
-
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 belongs to a class of medicines called benzodiazepines
(sedatives). It is a short-acting
medicine that is used to induce sedation (a state of calm, drowsiness
or sleep) and relieves anxiety and
muscle tension. This drug is used for:
-
Conscious sedation (an awake state of calm or drowsiness) in adults
and children.
-
Sedation of adults and children, in intensive care units.
-
Anaesthesia in adults (premedication before induction, induction of
anaesthesia, as a sedative
component with other medicines for maintenance of anaesthesia).
-
Premedication before induction of anaesthesia in children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MIDAZOLAM
YOU SHOULD NOT BE GIVEN MIDAZOLAM:
-
if you are allergic to midazolam, other benzodiazepines or any of the
other ingredients of this
medicine (listed in section 6),
-
for conscious sedation, if you have severe breathing difficulties.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given Midazolam if you:
-
are over 60 years of age,
-
have a long-term illness or are debilitated (e.g. chronic respiratory
problems, kidney, liver or
heart diseases),
-
have
_myasthenia gravis _
(a neuromuscular disease characterized by muscle weakness

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam 5 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 5 mg of midazolam (as hydrochloride).
One ampoule with 1 ml of solution contains 5 mg of midazolam.
One ampoule with 3 ml of solution contains 15 mg of midazolam.
One ampoule with 10 ml of solution contains 50 mg of midazolam.
Excipient with known effect
Each ml of solution contains 3.15 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution.
pH 2.9 ‑ 3.7
Osmolality 275 ‑ 305 mOsmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midazolam is a short-acting hypnotic with the following indications
for use:
ADULTS

CONSCIOUS SEDATION with or without local anaesthesia before or during
diagnostic or therapeutic procedures

ANAESTHESIA
o
Premedication before the induction of anaesthesia
o
Induction of anaesthesia
o
As a sedative component in maintenance of anaesthesia

SEDATION IN THE INTENSIVE CARE UNIT CHILDREN

CONSCIOUS SEDATION with or without local anaesthesia before or during
diagnostic or therapeutic procedures

ANAESTHESIA
o
Premedication before the induction of anaesthesia

SEDATION IN THE INTENSIVE CARE UNIT
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
STANDARD DOSAGES
Midazolam is a potent sedative agent that requires slow administration
and titration. Titration is strongly recommended to
safely obtain the desired level of sedation according to clinical
needs, physical status, age, and concomitant medication. For
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patients over 60 years of age, debilitated patients or chronically ill
patients and children the medicine should be administered
with care and the risk factors related to each patient should be
evaluated on an individual basis. Standard dosages a