Buccolam

midazolam

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This is a summary of the European public assessment report (EPAR) for Buccolam. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Buccolam.

What is Buccolam?

Buccolam is a medicine that contains the active substance midazolam. It is available as ‘oromucosal solution’ (a solution given in the side of the mouth, into the space between the gum and the cheek) in prefilled syringes. Each syringe contains 2.5 mg, 5 mg, 7.5 mg or 10 mg of midazolam.

What is Buccolam used for?

Buccolam is used to stop prolonged, acute (sudden) convulsive seizures in children and adolescents (from three months to less than 18 years of age).

The medicine can only be obtained with a prescription.

How is Buccolam used?

Buccolam is given in the side of the child’s mouth. The recommended dose ranges from 2.5 mg to 10 mg, depending on the child’s age.

The full amount of the appropriate prefilled syringe should be given slowly into the space between the gum and the cheek. If necessary, the dose can be divided between both sides of the mouth.

When given by carers or parents, Buccolam should only be used when the child has already been diagnosed with epilepsy.

Carers should only administer one dose. If the seizure has not stopped within 10 minutes of giving Buccolam, they should seek medical help immediately.

In infants from three months to less than six months, Buccolam should only be used within a hospital and where equipment is available for resuscitation and monitoring of the patient due to an increased risk respiratory depression (inhibition of breathing).

How does Buccolam work?

The active substance in Buccolam is midazolam, a benzodiazepine, which acts as an anticonvulsant medicine. Convulsions are caused by excessive electrical activity in the brain. Buccolam attaches to the receptors for the neurotransmitter gamma-amino butyric acid (GABA) in the brain and activates them. Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other. In the brain, GABA is involved in reducing the electrical activity. By activating its receptors, Buccolam increases GABA’s effects, which will stop a convulsion.

How has Buccolam been studied?

The company presented results of five key studies from the published literature. These studies looked at children with acute convulsions and compared the effects of oromucosal midazolam with those of diazepam (another benzodiazepine) when given intravenously (into a vein) or rectally (into the rectum). In four of these studies, oromucosal midazolam was compared with rectal diazepam and the measure of effectiveness was the treatment’s ability to stop the seizure within 10 minutes. The fifth study compared buccal midazolam with intravenous diazepam, where the measure of effectiveness was the treatment’s ability to stop the seizure within five minutes.

What benefit has Buccolam shown during the studies?

Reports from the published literature confirmed that oromucosal midazolam is effective in stopping seizures in children. In the four studies, oromucosal midazolam was effective in stopping a seizure within 10 minutes in 65 to 78% of children compared with 41 to 85% of children who received rectal diazepam. When comparing buccal midazolam with intravenous diazepam, the results were also very similar.

What is the risk associated with Buccolam?

The most common side effects with Buccolam (seen in more than 1 patient in 10) are sedation, somnolence (sleepiness), depressed levels of consciousness, respiratory depression and nausea (feeling sick) and vomiting. For the full list of all side effects reported with Buccolam, see the package leaflet.

Buccolam must not be used in people who may be hypersensitive (allergic) to midazolam, benzodiazepines or any of the other ingredients. It must not be used in patients with myasthenia gravis (a disease causing muscle weakness), severe respiratory insufficiency (lung conditions that cause difficulty breathing), sleep apnoea syndrome (frequent interruption of breathing during sleep) or severe liver problems.

Why has Buccolam been approved?

Based on the results of the studies presented, the CHMP concluded that Buccolam is at least as effective as existing treatments for stopping acute prolonged, convulsive seizures in children. Although intravenous medicines may take less time to start working once injected, it takes time to gain access to the veins, especially in children. Buccolam has the advantage of being quicker and easier to administer than rectal or intravenous medicines. With regard to side effects, the medicine may cause respiratory depression, as is the case with other comparable medicines, but is generally well tolerated. The Committee therefore decided that Buccolam’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Buccolam

The European Commission granted a marketing authorisation valid throughout the European Union for Buccolam on 5 September 2011.

For more information about treatment with Buccolam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Buccolam : EPAR - Summary for the public BG = bălgarski 19/09/2011  
Buccolam : EPAR - Summary for the public ES = español 19/09/2011  
Buccolam : EPAR - Summary for the public CS = čeština 19/09/2011  
Buccolam : EPAR - Summary for the public DA = dansk 19/09/2011  
Buccolam : EPAR - Summary for the public DE = Deutsch 19/09/2011  
Buccolam : EPAR - Summary for the public ET = eesti keel 19/09/2011  
Buccolam : EPAR - Summary for the public EL = elliniká 19/09/2011  
Buccolam : EPAR - Summary for the public EN = English 19/09/2011  
Buccolam : EPAR - Summary for the public FR = français 19/09/2011  
Buccolam : EPAR - Summary for the public IT = italiano 19/09/2011  
Buccolam : EPAR - Summary for the public LV = latviešu valoda 19/09/2011  
Buccolam : EPAR - Summary for the public LT = lietuvių kalba 19/09/2011  
Buccolam : EPAR - Summary for the public HU = magyar 19/09/2011  
Buccolam : EPAR - Summary for the public MT = Malti 19/09/2011  
Buccolam : EPAR - Summary for the public NL = Nederlands 19/09/2011  
Buccolam : EPAR - Summary for the public PL = polski 19/09/2011  
Buccolam : EPAR - Summary for the public PT = português 19/09/2011  
Buccolam : EPAR - Summary for the public RO = română 19/09/2011  
Buccolam : EPAR - Summary for the public SK = slovenčina 19/09/2011  
Buccolam : EPAR - Summary for the public SL = slovenščina 19/09/2011  
Buccolam : EPAR - Summary for the public FI = suomi 19/09/2011  
Buccolam : EPAR - Summary for the public SV = svenska 19/09/2011  

This EPAR was last updated on 27/03/2014 .

Authorisation details

Product details

Product details for Buccolam
NameBuccolam
Agency product numberEMEA/H/C/002267
Active substance

midazolam

International non-proprietary name (INN) or common name

midazolam

Therapeutic area Epilepsy
Anatomical therapeutic chemical (ATC) code N05CD08

Publication details

Publication details for Buccolam
Marketing-authorisation holder

ViroPharma SPRL

Revision4
Date of issue of marketing authorisation valid throughout the European Union05/09/2011

Contact address:

ViroPharma SPRL
Rue Montoyer 47
B-1000 Brussels
Belgium

Product information

Product information

20/03/2014  Buccolam -EMEA/H/C/002267 -IB/0019

Name Language First published Last updated
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014
Buccolam : EPAR - Product Information SV = svenska 19/09/2011 27/03/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  
Buccolam : EPAR - All Authorised presentations SV = svenska 19/09/2011  

Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Buccolam : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 09/08/2012 27/03/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Buccolam : EPAR - Public assessment report SV = svenska 19/09/2011  
CHMP summary of positive opinion for Buccolam SV = svenska 24/06/2011  

Authorised

This medicine is approved for use in the European Union

Shortages