Midazolam Injection 2 mg/ml Solution for injection or infusion

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Midazolam

Boleh didapati daripada:

Accord Healthcare Limited

Kod ATC:

N05CD; N05CD08

INN (Nama Antarabangsa):

Midazolam

Dos:

2 milligram(s)/millilitre

Borang farmaseutikal:

Solution for injection/infusion

Jenis preskripsi:

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

Kawasan terapeutik:

Benzodiazepine derivatives; midazolam

Status kebenaran:

Marketed

Tarikh kebenaran:

2006-09-01

Risalah maklumat

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

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam Injection 2 mg/ml Solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution for injection contains 2 mg midazolam as the
hydrochloride.
Each 5 ml of solution for injection contains 10 mg midazolam as the
hydrochloride.
Excipient with known effect:
The 5ml product contains 17.70mg (0.770mmol) 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 2 mg/ml solution for injection or 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
- Premedication before induction of anaesthesia
- Induction of anaesthesia
- As a sedative component 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
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4.2 POSOLOGY AND METH