Midazolam 2mg/ml Solution for Injection/Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Midazolam

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

N05CD; N05CD08

INN (International Name):

Midazolam

Dosage:

2 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:

Not marketed

Authorization date:

1998-10-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIDAZOLAM 2MG/ML SOLUTION FOR INJECTION/INFUSION
MIDAZOLAM 5MG/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.
- This medicine has been prescribed for you. 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.
The name of your medicine is Midazolam 2mg/ml Solution for
Injection/Infusion, Midazolam 5mg/ml
Solution for Injection/Infusion; it will be called Midazolam Injection
for ease here after
WHAT IS IN THIS LEAFLET
1. What Midazolam Injection is and what it is used for
2. What you need to know before you are given Midazolam Injection
3. How you will be given 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 2 mg/ml & 5 mg/ml Solution for injection or infusion
contains Midazolam. Midazolam
belongs to a group of medicines called benzodiazepines. It can cause
you to fall asleep
and it can also relieve anxiety .
Midazolam is used to:
• sedate patients before and during minor medical, dental and
surgical procedures (such as passing
a tube into the stomach, intestine, bladder, lungs or heart)
• provide sedation for patients in intensive care
• bring about anaesthesia in high risk and elderly patients,
especially where it is important to keep the
heart and blood vessels in a stable state. This works best when heavy
opiate (narcotic)
premedication has been given, or when midazolam is given with a
narcotic pain relieving drug such
as fentanyl.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MIDAZOLAM INJECTION
You

Summary of Product characteristics

Health Products Regulatory Authority
14 February 2020
CRN008JX8
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam 2mg/ml Solution for Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml solution contains 2mg midazolam.
Each 5ml Ampoule contains 10mg of midazolam
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sterile solution for injection or infusion.
Clear, colourless or slightly yellow sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 continuous infusion in patients in intensive care.
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 is given with a narcotic
analgesic such as fentanyl.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
INTRAVENOUS SEDATION: One or more intravenous administrations over a
single operating session.
_ _
_ADULTS:_An assessment should be made of the degree of sedation
necessary for the planned procedure.
The dose should be titrated against the response of the patient. The
desired titration end point will depend upon the
procedure. Full sedation will be evident by drowsiness, slurred speech
but response to commands will be maintained.
As a guide, it is recommended that 1ml of Midazolam 2mg/ml solution
(equivalent to 2mg midazolam) be administered
intravenously over 30 seconds. If after 2 minutes, sedation is not
adequate, incremental doses of 0.25ml to 0.5ml of midazolam
2mg/ml solution (0.5 to 1mg midazolam) should be given.
Usual dose range 2.5mg - 7.5mg total dose (equivalent to around
0.07mg/kg body weight).
Dosages greater than 5.0mg are not usually necessary.
_ _
_ELD