Midazolam Rowa 10 mg oromucosal solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Midazolam

Available from:

Rowa Pharmaceuticals Limited

ATC code:

N05CD08

INN (International Name):

Midazolam

Pharmaceutical form:

Oromucosal solution

Therapeutic area:

midazolam

Authorization status:

Not marketed

Authorization date:

2021-01-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIDAZOLAM ROWA 2.5 MG OROMUCOSAL SOLUTION
MIDAZOLAM ROWA 5 MG OROMUCOSAL SOLUTION
MIDAZOLAM ROWA 7.5 MG OROMUCOSAL SOLUTION
MIDAZOLAM ROWA 10 MG OROMUCOSAL SOLUTION
midazolam
READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START GIVING 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 your child. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as those of the child for
whom this medicine has been
prescribed.
•
If you see 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 Rowa
is and what it is used for
2.
What you need to know before you give Midazolam Rowa
3.
How to give Midazolam Rowa
4.
Possible side effects
5.
How to store Midazolam Rowa
6.
Contents of the pack and other information
1.
WHAT MIDAZOLAM ROWA
IS AND WHAT IT IS USED FOR
Midazolam Rowa is an oromucosal solution, containing midazolam.
Midazolam belongs to a group
of medicines known as benzodiazepines. Midazolam Rowa is used to stop
a prolonged, acute
convulsive- seizure in infants, toddlers, children and adolescents
(from 3 months to less than 18 years
of age).
In infants from 3 to 6 months it should only be used in a hospital
setting where monitoring is
possible and resuscitation equipment is available.
This medicine must only be used by parents/carers where the child has
been diagnosed to have
epilepsy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE MIDAZOLAM ROWA
DO NOT GIVE MIDAZOLAM ROWA
IF THE PATIENT HAS:
•
An allergy to midazolam, benzodiazepines (such as diazepam) or any of
the other ingredients of
this medicine (listed in section 6)
•
A disease of the nerves and muscles causing muscle weakness
(myasthenia gravis)
•
Severe difficulty breathing at rest M

Summary of Product characteristics

Health Products Regulatory Authority
21 March 2024
CRN00DZ9V
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Midazolam Rowa 10 mg oromucosal solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Midazolam Rowa 10 mg oromucosal solution
Each pre-filled oral syringe contains midazolam hydrochloride
equivalent to 10 mg midazolam in 2 ml solution
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal solution Clear solution
pH 2.9 to 3.7
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of prolonged, acute, convulsive seizures in infants,
toddlers, children and adolescents (from 3 months to < 18 years).
Midazolam Rowa must only be used by parents/carers where the patient
has been diagnosed to have epilepsy.
For infants between 3-6 months of age treatment should be in a
hospital setting where monitoring is possible and
resuscitation equipment is available. See section 4.2.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Standard doses are indicated below:
AGE RANGE
DOSE
LABEL
COLOUR
3 to 6 months hospital setting
2.5 mg
Yellow
> 6 months to < 1 year
2.5 mg
Yellow
1 year to < 5 years
5 mg
Blue
5 years to < 10 years
7.5 mg
Purple
10 years to < 18 years
10 mg
Orange
Carers should only administer a single dose of midazolam. If the
seizure has not stopped within 10 minutes after administration
of midazolam, emergency medical assistance must be sought and the
empty syringe given to the healthcare professional to
provide information on the dose received by the patient.
A second or repeat dose when seizures re-occur after an initial
response should not be given without prior medical advice (see
section 5.2).
Special populations
_Paediatric population_
Health Products Regulatory Authority
21 March 2024
CRN00DZ9V
Page 2 of 12
The safety and efficacy of midazolam in children aged 0 to 3 months
has not been established. No data are available.
_Renal impairment_
No dose adjustment is required, however, Midazolam Rowa should be used
with caution in patients wit