Buccolam 2.5mg0.5ml oromucosal solution pre-filled oral syringes

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Midazolam hydrochloride

Saatavilla:

Shire Pharmaceuticals Ltd

INN (Kansainvälinen yleisnimi):

Midazolam hydrochloride

Annos:

5mg/1ml

Lääkemuoto:

Oromucosal solution

Antoreitti:

Buccal

luokka:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04080200; GTIN: 5060147020052

Pakkausseloste

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 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 (listed in section 6).

A diseas

Valmisteyhteenveto

OBJECT 1
BUCCOLAM 2.5MG OROMUCOSAL SOLUTION
Summary of Product Characteristics Updated 04-Oct-2016 | Shire
Pharmaceuticals Limited
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.
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 secon