Midazolam 1 mg/ml solution for injection/infusion in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Midazolam

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N05CD08

INN (International Name):

Midazolam

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion in pre-filled syringe

Therapeutic area:

midazolam

Authorization status:

Marketed

Authorization date:

2020-09-11

Patient Information leaflet

Var
PSUSA-00002057-202209 13 July 2023
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED
SYRINGE
midazolam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Midazolam 1 mg/ml Solution for injection/infusion in pre-filled
syringe is and what it is
used
for
2.
What you need to know before you are given Midazolam 1 mg/ml Solution
for
injection/infusion in pre-filled syringe
3.
How to use Midazolam 1 mg/ml Solution for injection/infusion in
pre-filled syringe
4.
Possible side effects
5.
How to store Midazolam 1 mg/ml Solution for injection/infusion in
pre-filled syringe
6.
Contents of the pack and other information
1.
WHAT MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED
SYRINGE IS AND WHAT
IT IS USED FOR
Midazolam 1 mg/ml Solution for injection/infusion in pre-filled
syringe contains contains Midazolam.
This belongs to a group of medicines called ‘benzodiazepines’.
Midazolam 1 mg/ml Solution for injection/infusion in pre-filled
syringe works quickly to make you
feel sleepy or to put you to sleep. It also makes you calm and relaxes
your muscles.
Midazolam 1 mg/ml Solution for injection/infusion in pre-filled
syringe is used in adults:
•
As a general anaesthetic to put you to sleep or to keep you asleep.
Midazolam 1 mg/ml Solution for injection/infusion in pre-filled
syringe is also used in adults and in
children (≥ 12 years age):
•
To make you feel calm and sleepy if you are in intensive care. This is
called ‘sedation’.
•
Before and during a medical test or procedure where you are going to
stay awake. It makes you
feel calm and sleepy. Th

Summary of Product characteristics

Health Products Regulatory Authority
25 August 2023
CRN00DR4K
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam 1 mg/ml solution for injection/infusion in pre-filled
syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains midazolam hydrochloride corresponding to
1 mg midazolam.
Each 5 ml pre-filled syringe contains midazolam hydrochloride
corresponding to 5 mg midazolam.
Excipient with known effect: Contains 3.53 mg sodium (as sodium
chloride) per ml of solution for injection or infusion.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion in pre-filled syringe (graduation 0.1
ml)
Clear, colorless to pale yellow solution free from foreign particles
with a pH in the range of 2.9 - 3.7 and 270 mOsm/kg to
330 mOsm/kg osmolality.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midazolam 1 mg/ml Solution for injection/infusion in pre-filled
syringe is a short acting sleep-inducing drug that is indicated:
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
Inchildren:
• _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_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED
SYRINGE IS RECOMMENDED TO BE ADMINISTERED IN ADULTS
AND IN CHILDREN AGED 12 YEARS AND ABOVE.
Standard Dosage
Midazolam is a potent sedative agent that requires titration and slow
administration. Titration is strongly recommended to
safely obtain the desired level of sedation according to the clinical
need, physical status, age and concomitant medication. In
adults over 60 yea