Medirax 2.5 mg nasal spray, solution in single-dose container

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Midazolam hydrochloride

Verfügbar ab:

Medir B.V.

ATC-Code:

N05CD08

INN (Internationale Bezeichnung):

Midazolam hydrochloride

Darreichungsform:

Nasal spray, solution in single-dose container

Therapiebereich:

midazolam

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2023-01-20

Gebrauchsinformation

Medirax 2.5 mg
CTD - Module 1.31
Medirax 3.75 mg
Medirax 5 mg
Package leaflet
1/11
version 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDIRAX 2.5 MG
nasal spray, solution in single-dose container
MEDIRAX 3.75 MG
nasal spray, solution in single-dose container
MEDIRAX 5 MG
nasal spray, solution in single-dose container
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 pharmacist.
•
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 Medirax is and what it is used for
2. What you need to know before you use Medirax
3. How to use Medirax
4. Possible side effects
5. How to store Medirax
6. Contents of the pack and other information
1. WHAT MEDIRAX IS AND WHAT IT IS USED FOR
Medirax
contains midazolam as active ingredient, which belongs to the group of
medicines
known as benzodiazepines.
Medirax
is used for:
•
Conscious sedation, an awake but relaxed state of calm or drowsiness
during a medical test
or procedure
•
Premedication to cause relaxation, calm and drowsiness before an
anaesthetic
This medicine must only be given by healthcare professionals for
conscious sedation or
premedication.
•
Stopping sudden prolonged, convulsive seizures
This medicine must only be given by parents or caregivers where the
patient has been
diagnosed with epilepsy.
Medirax 2.5 mg
CTD - Module 1.31
Medirax 3.75 mg
Medirax 5 mg
Package leaflet
2/11
version 9
Medirax
is for adults and children of 12 kg and more and of 2 years and older.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEDIRAX
DO NOT USE MEDIRAX IF THE PATIENT HAS:
•
An allergy to midazolam, to any benzodia

Fachinformation

Health Products Regulatory Authority
20 January 2023
CRN009L7V
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medirax 2.5 mg nasal spray, solution in single-dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains midazolam as hydrochloride equivalent to
50 mg midazolam.
Each single-dose container holds one dose (50 microliters) of 2.5 mg
midazolam (as hydrochloride).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, solution in single-dose container
Clear, slightly yellow solution.
pH 3.3 - 3.8
Osmolarity 2400-2800 mmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Medirax is a short-acting sleep-inducing and anticonvulsive drug that
is indicated in:

Conscious sedation before and during diagnostic or therapeutic
procedures with or without local anaesthesia

Premedication before induction of anaesthesia
Medirax must only be used by healthcare professionals for conscious
sedation or premedication

Treatment of prolonged, acute, convulsive seizures.
Medirax must only be used by parents/care givers where the patient has
been diagnosed to have epilepsy.
Medirax is indicated in adults and children > 12 kg and aged 2 years
and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Standard dosages are provided in the table 1 below. Additional details
are provided in the text following the table.
Health Products Regulatory Authority
20 January 2023
CRN009L7V
Page 2 of 13
Table 1
AGE/BODY WEIGHT RANGE
FIRST DOSE
SECOND DOSE
At least 10 min after
first dose
CONSCIOUS SEDATION AND PREMEDICATION
12 kg to 43 kg
2.5 mg
2.5 mg
> 44 kg and < 60 years
5 mg
2.5 mg or 5 mg*
>60 years
2.5 mg
2.5 mg
TREATMENT OF PROLONGED, ACUTE, CONVULSIVE EPILEPTIC
SEIZURES
12 kg to 18 kg
2.5 mg
2.5 mg
19 kg to 39 kg
3.75 mg
3.75 mg
> 40 kg or
> 12 years to < 60 years
5 mg
5 mg
> 60years
3.75 mg
3.75 mg
* depending on desired level and duration of sedation
CONSCIOUS SEDATION AND PREMEDICATION DOSAGE

Medirax must only be used by