Midazolam 2 mg/ml Solution for injection or infusion

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Midazolam

Dostupno od:

Accord Healthcare Ireland Ltd.

ATC koda:

N05CD; N05CD08

INN (International ime):

Midazolam

Doziranje:

2 milligram(s)/millilitre

Farmaceutski oblik:

Solution for injection/infusion

Područje terapije:

Benzodiazepine derivatives; midazolam

Status autorizacije:

Marketed

Datum autorizacije:

2006-09-01

Uputa o lijeku

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. See section 4.
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 (hypersensitive) to midazolam or any of the other
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 b

Svojstava lijeka

Health Products Regulatory Authority
06 November 2023
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam 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
o
Premedication before induction of anaesthesia

SEDATION IN INTENSIVE CARE UNITS
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
Midazolam is a potent sedative that requires dose titration and slow
administration. Dose titration is required to optimise
safety whilst achieving the desired level of sedation according to the
clinical need, physical status, age and concomitant
Health Products Regulatory Authority
06 November 2023
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Page 2 of 17
medication. In adults over 60 years, debilitated or chronically ill
patients and paediatric patients, the dose should be
determined with caution and risk factors related to each patient
should be taken into account. Standard dosages are shown in
the table below; additional details are provided in