Midazolam Injection 5mg/ml

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

MIDAZOLAM

Tilgjengelig fra:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC-kode:

N05CD08

INN (International Name):

MIDAZOLAM 5 mg/ml

Legemiddelform:

SOLUTION FOR INFUSION OR INJECTION

Sammensetning:

MIDAZOLAM 5 mg/ml

Resept typen:

POM

Terapeutisk område:

PSYCHOLEPTICS

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2006-08-23

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDAZOLAM 5MG/ML SOLUTION FOR INJECTION OR INFUSION
Midazolam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or nurse.

This medicine has been prescribed for you personally and you should
not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
The name of your medicine is Midazolam 5mg/ml Solution for Injection
or Infusion. In the rest of this leaflet it
is called Midazolam Injection.
IN THIS LEAFLET:
1.
What Midazolam Injection is and what it is used for
2.
Before you are given Midazolam Injection
3.
How Midazolam Injection should be given
4.
Possible side effects
5.
How to store Midazolam Injection
6.
Further information
1. WHAT MIDAZOLAM INJECTION IS AND WHAT IT IS USED FOR
The active ingredient in Midazolam Injection is midazolam which
belongs to a group of sedative medicines
called benzodiazepines.
Midazolam injection is used:
•
For sedation before and during minor medical, dental or surgical
procedures
•
For sedation of patients in intensive care
•
For pre-medication before surgery
•
At the start of a general anaesthetic
2. BEFORE YOU ARE GIVEN MIDAZOLAM INJECTION
YOU SHOULD NOT BE GIVEN MIDAZOLAM INJECTION IF YOU:
•
Are ALLERGIC TO MIDAZOLAM OR ANY OF THE OTHER INGREDIENTS CONTAINED IN
MIDAZOLAM INJECTION (see
list under heading ‘What Midazolam Injection contains’ in section
6)
•
Have SEVERE BREATHING PROBLEMS
•
Have SEVERE LIVER PROBLEMS
If any of the above statements apply to you, you should not be given
Midazolam Injection.
SPEAK TO YOUR DOCTOR BEFORE YOU ARE GIVEN MIDAZOLAM INJECTION IF YOU:
•
Are ELDERLY
•
Are VERY RUN DOWN and LACK STRENGTH
•
Have problems with your LIVER, KIDNEYS OR LUNGS
•
Have a condition called MYASTHENIA GRAVIS which causes VERY WEAK
MUSCLES
•
Have a PERSONALITY DISORDER, DEPRESSION, AGGRESSIVE TENDENCIES, or if
you feel SUICIDAL
•
Have

Preparatomtale

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
NAME OF THE MEDICINAL PRODUCT
Midazolam 5mg/ml Solution for Injection or Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Midazolam 5mg/ml
Each 2ml ampoule contains 10mg midazolam
3.
PHARMACEUTICAL FORM
Solution for injection or infusion (injection)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
As intravenous sedative cover before and during minor medical, dental
and
surgical procedures such as gastroscopy, endoscopy, cystoscopy,
bronchoscopy and cardiac catheterisation.
For sedation by intravenous injection (either continuous infusion or
intermittent bolus injection) in critically ill patients in intensive
care.
As an intramuscular premedication for patients with physical status
ASA I-IV
who are to undergo surgical procedures.
As an alternative intravenous agent for the induction of anaesthesia
in high
risk and elderly patients, especially where cardiovascular stability
is of
particular importance. Induction is more reliable when heavy opiate
premedication has been administered or when Midazolam Injection is
given
with a narcotic analgesic such as fentanyl.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage depends on the individual response, age and weight. Midazolam
5mg/ml may be given by intramuscular, intravenous or slow intravenous
injection.
Intravenous sedation
_ _
One or more intravenous injections to be administered over a single
operating
session.
Page 2 of 14
Dosage should be titrated according to an individual's response, age
and
weight. The end-point of this titration is dependent on the procedure.
Full
sedation will be evident by drowsiness and slurred speech, although a
response
to commands will be maintained.
Adults
2mg, (0.4ml of 5mg/ml midazolam injection solution) over a
period of 30 seconds initially
Elderly
1 to 1.5mg (0.2-0.3ml of 5mg/ml midazolam injection solution)
over a period of 30 seconds initially.
If adequate sedation is not achieved after two minutes, incremental
doses of
0.5-1mg, (0.1-0.2ml of 5mg/ml midazol