Buccolam
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
08-02-2024
Valmisteyhteenveto
(SPC)
08-02-2024
Julkisesta arviointikertomuksesta
(PAR)
19-09-2011
Aktiivinen ainesosa:
midazolam
Saatavilla:
Neuraxpharm Pharmaceuticals S.L.
ATC-koodi:
N05CD08
INN (Kansainvälinen yleisnimi):
midazolam
Terapeuttinen ryhmä:
Psycholeptics
Terapeuttinen alue:
Epilepsy
Käyttöaiheet:
Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from three months to less than 18 years).Buccolam must only be used by parents / carers where the patient has been diagnosed to have epilepsy.For infants between three and six months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.
Tuoteyhteenveto:
Revision: 18
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2011-09-04
Pakkausseloste
52
B. PACKAGE LEAFLET
53
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUCCOLAM 2.5 MG OROMUCOSAL SOLUTION
FOR CHILDREN AGED 3 MONTHS TO LESS THAN 1 YEAR
BUCCOLAM 5 MG OROMUCOSAL SOLUTION
FOR CHILDREN AGED 1 YEAR TO LESS THAN 5 YEARS
BUCCOLAM 7.5 MG OROMUCOSAL SOLUTION
FOR CHILDREN AGED 5 YEARS TO LESS THAN 10 YEARS
BUCCOLAM 10 MG OROMUCOSAL SOLUTION
FOR CHILDREN AGED 10 YEARS TO LESS THAN 18 YEARS
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 BUCCOLAM is and what it is used for
2.
What you need to know before you give BUCCOLAM
3.
How to give BUCCOLAM
4.
Possible side effects
5.
How to store BUCCOLAM
6.
Contents of the pack and other information
1.
WHAT BUCCOLAM IS AND WHAT IT IS USED FOR
BUCCOLAM contains a medicine called midazolam. Midazolam belongs to a
group of medicines
known as benzodiazepines. BUCCOLAM is used to stop a sudden,
prolonged, convulsive, seizure in
infants, toddlers, children and adolescents (from 3 months to less
than 18 years of age).
In infants from 3 months to less than 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 BUCCOLAM
DO NOT GIVE BUCCOLAM IF THE PATIENT HAS:
•
An allergy to midazolam, benzodiazepines (such as diazepam) or any of
the other ingredients of
this medicine (l
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
BUCCOLAM 2.5 mg oromucosal solution
BUCCOLAM 5 mg oromucosal solution
BUCCOLAM 7.5 mg oromucosal solution
BUCCOLAM 10 mg oromucosal solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BUCCOLAM 2.5 mg oromucosal solution
Each pre-filled oral syringe contains 2.5 mg midazolam (as
hydrochloride) in 0.5 ml solution
BUCCOLAM 5 mg oromucosal solution
Each pre-filled oral syringe contains 5 mg midazolam (as
hydrochloride) in 1 ml solution
BUCCOLAM 7.5 mg oromucosal solution
Each pre-filled oral syringe contains 7.5 mg midazolam (as
hydrochloride) in 1.5 ml solution
BUCCOLAM 10 mg oromucosal solution
Each pre-filled oral syringe contains 10 mg midazolam (as
hydrochloride) in 2 ml solution
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal solution
Clear colourless 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).
BUCCOLAM 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.
3
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 b
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