Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Shire Services BVBA, rue Montoyer 47, 1000 Brussels, Belgium
BUCCOLAM 2.5 mg oromucosal solution.
BUCCOLAM 5 mg oromucosal solution.
BUCCOLAM 7.5 mg oromucosal solution.
BUCCOLAM 10 mg oromucosal solution.
| Pharmaceutical Form |
|---|
|
Oromucosal solution. Clear colourless solution. pH 2.9 to 3.7 |
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.
| Active Ingredient | Description | |
|---|---|---|
| Midazolam |
Midazolam is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance with low solubility in water. The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables the active ingredient of midazolam to form water-soluble salts with acids. |
| List of Excipients |
|---|
|
Sodium chloride |
Amber, pre-filled needle-free oral syringe (polypropylene) with plunger (polypropylene) and end cap (high density polyethylene) packed in a protective, capped plastic tube.
| Strength | Volume of solution | Syringe volume | Age range | Label colour |
|---|---|---|---|---|
| 2.5 mg | 0.5 ml | 1 ml | 3 months to < 1 year | Yellow |
| 5 mg | 1 ml | 3 ml | 1 year to < 5 years | Blue |
| 7.5 mg | 1.5 ml | 3 ml | 5 years to < 10 years | Purple |
| 10 mg | 2 ml | 3 ml | 10 years to < 18 years | Orange |
BUCCOLAM is available in cartons containing 4 pre-filled syringes.
Shire Services BVBA, rue Montoyer 47, 1000 Brussels, Belgium
BUCCOLAM 2.5 mg oromucosal solution: EU/1/11/709/001
BUCCOLAM 5 mg oromucosal solution: EU/1/11/709/002
BUCCOLAM 7.5 mg oromucosal solution: EU/1/11/709/003
BUCCOLAM 10 mg oromucosal solution: EU/1/11/709/004
Date of first authorisation: 05 September 2011
Date of latest renewal: 26 May 2016
| Drug | Countries | |
|---|---|---|
| BUCCOLAM | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Poland, Romania, United Kingdom |
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