BUCCOLAM 5 MG

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

MIDAZOLAM AS HYDROCHLORIDE

Disponível em:

NEOPHARM CURE (2005) LTD

Código ATC:

N05CD08

Forma farmacêutica:

OROMUCOSAL SOLUTION

Composição:

MIDAZOLAM AS HYDROCHLORIDE 5 MG

Via de administração:

BUCCAL

Tipo de prescrição:

Required

Fabricado por:

SHIRE SERVICES BVBA, BELGIUM

Área terapêutica:

MIDAZOLAM

Indicações terapêuticas:

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.

Data de autorização:

2018-04-30

Folheto informativo - Bula

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) -
1986
The dispensing of this medicine requires a physician’s prescription
only
BUCCOLAM 2.5 MG
BUCCOLAM 5 MG
BUCCOLAM 7.5 MG
BUCCOLAM 10 MG
OROMUCOSAL SOLUTION
COMPOSITION:
Each pre-filled syringe contains:
Active ingredient:
Midazolam (as hydrochloride): 5 mg/ml
For the list of excipients - see section 6 "Further Information".
READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. This insert contains
concise information about the medicine. In case you have any
additional questions, please refer to
the physician or the pharmacist.
This medicine has been prescribed for the treatment of your
child/patient. Do not pass it on to others.
It may harm them, even though it may seem to you that they have a
similar medical state.
This medicine is intended for use in children and adolescents aged 3
months and older, but younger
than 18 years of age.
IF THE SEIZURE DOES NOT STOP WITHIN 10 MINUTES OF GIVING BUCCOLAM:
-
YOU MUST TELEPHONE FOR AN AMBULANCE IMMEDIATELY.
-
YOU MUST KEEP THE EMPTY ORAL SYRINGE AND GIVE IT TO THE AMBULANCE
STAFF SO THAT THEY
KNOW HOW MUCH BUCCOLAM HAS BEEN GIVEN TO THE PATIENT.
-
DO NOT GIVE THE PATIENT ANOTHER DOSE OF BUCCOLAM!
Taking this medicine with other opioids or other medications which
suppress the central nervous
system (including narcotics) or alcohol, may result in profound
sedation, breathing difficulties
(respiratory depression), coma and death.
1. WHAT IS THIS MEDICINE USED FOR?
This medicine is used for the treatment of prolonged, acute,
convulsive, epileptic seizures in infants,
toddlers, children and adolescents (from 3 months to less than 18
years of age).
This medicine must only be used by parents/carers where the
child/patient has been diagnosed to
have epilepsy.
IN INFANTS FROM 3 MONTHS TO LESS THAN 6 MONTHS IT SHOULD ONLY BE USED
IN A HOSPITAL SETTING WHERE
MONITORING OF THE INFANT’S CONDITION IS POSSIBLE AND RESUSCITATION
EQUIPMENT IS AVAILABLE.
THERAPEUTIC G

Características técnicas

1
THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH
AND
ITS CONTENT WAS CHECKED AND APPROVED
SUMMARY OF PRODUCT CHARACTERISTICS
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.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
•
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death [see section 4.5].
•
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative treatment
options are inadequate.
•
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Standard doses are indicated below:
AGE RANGE
DOSE
LABEL COLOUR
3
_ _
to 6 months
hospita