Midazolam 5 mg/ml solution for injection/infusion

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Midazolam

Disponible desde:

Baxter Holding B.V.

Código ATC:

N05CD; N05CD08

Designación común internacional (DCI):

Midazolam

Dosis:

5 milligram(s)/millilitre

formulario farmacéutico:

Solution for injection/infusion

Área terapéutica:

Benzodiazepine derivatives; midazolam

Fecha de autorización:

2019-09-13

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIDAZOLAM 5 MG/ML SOLUTION FOR INJECTION/INFUSION
MIDAZOLAM (AS MIDAZOLAM HYDROCHLORIDE)
The name of your medicine is Midazolam 5 mg/ml solution for
injection/infusion, which will be referred to as Midazolam
throughout this leaflet.
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
pharmacist 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 or nurse. This includes any possible side
effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT MIDAZOLAM IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIDAZOLAM
3.
HOW TO TAKE MIDAZOLAM
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MIDAZOLAM
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MIDAZOLAM IS AND WHAT IT IS USED FOR
Midazolam
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.
Midazolam works quickly to make you feel sleepy or to put you
to sleep. It also makes you calm and relaxes your muscles.
MIDAZOLAM IS USED IN ADULTS:
•
as a general anaesthetic to put them to sleep or to keep
them asleep.
MIDAZOLAM IS ALSO USED IN ADULTS AND CHILDREN:
•
to make them feel calm and sleepy if they are in intensive
care. This is called 'sedation'.
•
before and during a medical test or procedure where they
are going to stay awake. It makes them feel calm and
sleepy. This is called 'conscious sedation'.
•
to make them feel calm and sleepy before they are given
an anaesthetic.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIDAZOLAM
DO NOT TAKE MIDAZOLAM IF:
•
You are allergic

Ficha técnica

Health Products Regulatory Authority
17 September 2019
CRN008LLK
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam 5 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains midazolam (as hydrochloride) 5 mg.
Each 1 ml ampoule contains midazolam (as hydrochloride) 5 mg.
Each 3 ml ampoule contains midazolam (as hydrochloride) 15 mg.
Each 10 ml ampoule contains midazolam (as hydrochloride) 50 mg.
This medicine contains sodium. The sodium content is less than 1 mmol
(23 mg) per ampoule i.e sodium-free.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection/infusion
A clear, colourless to pale yellow solution, practically free from any
visible particles.
pH of the solution is between 2.90 and 3.70 and osmolality of the
solution should be 180 mOsmol/kg to 220 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midazolam 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
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
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 years, debilitated or chronically ill patients and
paediatric patients, dose should be determined with caution and
risk factors related to each patient should be taken into account.
Standard dosage