BUCCOLAM Oromucosal solution Ref.[7765] Active ingredients: Midazolam

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Shire Services BVBA, rue Montoyer 47, 1000 Brussels, Belgium

Product name and form

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

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.

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
Water for injections
Hydrochloric acid (for pH adjustment and conversion of midazolam to the hydrochloride salt)
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Amber, pre-filled needle-free oral syringe (polypropylene) with plunger (polypropylene) and end cap (high density polyethylene) packed in a protective, capped plastic tube.

StrengthVolume of solutionSyringe volumeAge rangeLabel colour
2.5 mg0.5 ml1 ml3 months to < 1 yearYellow
5 mg1 ml3 ml1 year to < 5 yearsBlue
7.5 mg1.5 ml3 ml5 years to < 10 yearsPurple
10 mg2 ml 3 ml10 years to < 18 yearsOrange

BUCCOLAM is available in cartons containing 4 pre-filled syringes.

Marketing authorization holder

Shire Services BVBA, rue Montoyer 47, 1000 Brussels, Belgium

Marketing authorization dates and numbers

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

Drugs

Drug Countries
BUCCOLAM Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Poland, Romania, United Kingdom

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