Midazolam Medical Valley 5 mg Munhålelösning

Страна: Швеция

Език: шведски

Източник: Läkemedelsverket (Medical Products Agency)

Активна съставка:

midazolam

Предлага се от:

Medical Valley Invest AB

АТС код:

N05CD08

INN (Международно Name):

midazolam

дозиране:

5 mg

Лекарствена форма:

Munhålelösning

Композиция:

midazolam 5 mg Aktiv substans

Вид предписание :

Receptbelagt

Каталог на резюме:

Förpacknings: Förfylld oral doseringsspruta, 2 st (1 ml); Förfylld oral doseringsspruta, 4 st (1 ml)

Статус Оторизация:

Godkänd

Дата Оторизация:

2020-12-16

Данни за продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Midazolam Medical Valley 2.5 mg oromucosal solution
Midazolam Medical Valley 5 mg oromucosal solution
Midazolam Medical Valley 7.5 mg oromucosal solution
Midazolam Medical Valley 10 mg oromucosal solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.5 mg oromucosal solution
Each pre-filled oral syringe contains midazolam hydrochloride
equivalent to 2.5 mg midazolam in 0.5 ml
solution
5 mg oromucosal solution
Each pre-filled oral syringe contains midazolam hydrochloride
equivalent to 5 mg midazolam in 1 ml
solution
7.5 mg oromucosal solution
Each pre-filled oral syringe contains midazolam hydrochloride
equivalent to 7.5 mg midazolam in 1.5 ml
solution
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).
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.
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 professi