Midazolam Injection 5 mg/ml Solution for injection or infusion

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Midazolam

Tilgjengelig fra:

Accord Healthcare Limited

ATC-kode:

N05CD; N05CD08

INN (International Name):

Midazolam

Dosering :

5 milligram(s)/millilitre

Legemiddelform:

Solution for injection/infusion

Resept typen:

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

Terapeutisk område:

Benzodiazepine derivatives; midazolam

Autorisasjon status:

Marketed

Autorisasjon dato:

2006-09-01

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDAZOLAM 2 MG/ML SOLUTION FOR INJECTION OR INFUSION
MIDAZOLAM 5 MG/ML SOLUTION FOR INJECTION OR INFUSION
Midazolam (as Midazolam hydrochloride)
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.
-
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. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Midazolam Injection is and what it is used for
2.
What you need to know before you use Midazolam Injection
3.
How to use Midazolam Injection
4.
Possible side effects
5.
How to store Midazolam Injection
6.
Contents of the pack and other information
1.
WHAT MIDAZOLAM INJECTION IS AND WHAT IT IS USED FOR
Midazolam Injection 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 USE MIDAZOLAM INJECTION
YOU MUST NOT BE GIVEN MIDAZOLAM INJECTION:

if you are allergic to any of the ingredients of the medicine (listed
in section 6).

if you are allergic to other benzodiazepine medicines, such as
diazepam or nitrazepam.

if you have severe breathing problems and you are going to have
Midazol

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam Injection 5 mg/ml Solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution for injection contains 5mg midazolam (as the
hydrochloride).
Each 2 ml of solution for injection contains 10mg midazolam (as the
hydrochloride).
Each 5 ml of solution for injection contains 25mg midazolam (as the
hydrochloride).
Excipient with known effect:
The 1 ml product contains 1.97mg (0.086 mmol) of sodium per dose.
The 2 ml product contains 3.93mg (0.171 mmol) of sodium per dose.
The 5 ml product contains 9.83mg (0.428 mmol) of sodium per dose.
For a full list of Excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless or slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midazolam 5 mg/ml solution for injection for infusion is a
short-acting sedative and sleep-inducing drug. The
indications are as follows:
IN ADULTS
• CONSCIOUS SEDATION before and during diagnostic or therapeutic
procedures with or without local anaesthesia
• ANAESTHESIA
• SEDATION IN INTENSIVE CARE UNITS
IN CHILDREN
- Premedication before induction of anaesthesia
- Induction of anaesthesia
- As a sedative component in combined anaesthesia
• 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
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