Epistatus 10 mg Munhålelösning

Krajina: Švédsko

Jazyk: švédčina

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktívna zložka:

midazolammaleat

Dostupné z:

SERB S.A.

ATC kód:

N05CD08

INN (Medzinárodný Name):

midazolammaleat

Dávkovanie:

10 mg

Forma lieku:

Munhålelösning

Zloženie:

glycerol Hjälpämne; maltitol, flytande Hjälpämne; etanol, vattenfri Hjälpämne; midazolammaleat 13,6 mg Aktiv substans

Typ predpisu:

Receptbelagt

Prehľad produktov:

Förpacknings: Förfylld oral doseringsspruta, 1 st (1 ml)

Stav Autorizácia:

Godkänd

Dátum Autorizácia:

2019-03-29

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPISTATUS 2.5 MG OROMUCOSAL SOLUTION
EPISTATUS 5 MG OROMUCOSAL SOLUTION
EPISTATUS 7.5 MG OROMUCOSAL SOLUTION
EPISTATUS 10 MG OROMUCOSAL SOLUTION
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 your child or adolescent. Do not
pass it on to others. It may
harm them, even if their signs of illness are the same as those of the
patient for whom this
medicine has been prescribed.
▪
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 is and what it is used for
2.
What you need to know before you use
3.
How to give
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
oromucosal solution contains the medicine midazolam,
which belongs to a group of
medicines known as benzodiazepines.
is used to stop a prolonged, acute convulsive seizure
(‘fit’) in infants, toddlers,
children and adolescents aged from 3 months to less than 18 years.
In infants from 3 months to less than 6 months, this medicine should
only be used in a hospital setting
where monitoring is possible and resuscitation equipment is available
(see “Warnings and
precautions” for more information).
This medicine must only be given by parents or caregivers where the
patient has been diagnosed with
epilepsy. The patient’s doctor should give the parents or caregivers
instructions on how to give
and what to do if the seizure does not stop (see also
“How to give ”).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
DO NOT GIVE

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Epistatus 2.5 mg oromucosal solution
Epistatus 5 mg oromucosal solution
Epistatus 7.5 mg oromucosal solution
Epistatus 10 mg oromucosal solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.5 mg oromucosal solution
Each pre-filled oral syringe (0.25 ml) contains midazolam maleate
corresponding to 2.5 mg
midazolam.
5 mg oromucosal solution
Each pre-filled oral syringe (0.5 ml) contains midazolam maleate
corresponding to 5 mg
midazolam.
7.5 mg oromucosal solution
Each pre-filled oral syringe (0.75 ml) contains midazolam maleate
corresponding to 7.5 mg
midazolam.
10 mg oromucosal solution
Each pre-filled oral syringe (1 ml) contains midazolam maleate
corresponding to 10 mg
midazolam.
Excipients with known effect
2.5 mg oromucosal solution
Ethanol 49 mg/dose.
Maltitol, liquid 169 mg/dose.
5 mg oromucosal solution
Ethanol 99 mg/dose.
Maltitol, liquid 338 mg/dose.
7.5 mg oromucosal solution
Ethanol 148 mg/dose.
Maltitol, liquid 506 mg/dose.
10 mg oromucosal solution
Ethanol 197 mg/dose.
Maltitol, liquid 675 mg/dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal solution.
Clear colourless to pale yellow solution, practically free from
visible particles.
pH 4.8 - 5.6
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is indicated for the treatment of prolonged, acute,
convulsive seizures in
infants, toddlers, children and adolescents aged from 3 months to less
than 18 years.
must only be used by parents / caregivers 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 4.4.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Standard doses are indicated below:
Age range
Dose
Labelled packaging colo