BUCCOLAM® - Neuraxpharm UK

This information is intended for use by healthcare professionals.

BUCCOLAM®

Midazolam

Therapeutic indications: Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years).

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ADVERSE EVENTS SHOULD BE REPORTED

Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/.

Adverse events should also be reported to Neuraxpharm UK Ltd by:

  • Email: pv-uk@neuraxpharm.com
  • Phone number: +44 330 128 0919

Technical information

Pharmaceutical form

Oromucosal solution. Clear colourless solution pH 2.9 to 3.7

Excipients / Ingredients

2,5 mg Each pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution. 5 mg Each pre-filled oral syringe contains 5 mg midazolam (as hydrochloride) in 1 ml solution. 7,5 mg Each pre-filled oral syringe contains 7.5 mg midazolam (as hydrochloride) in 1.5 ml solution. 10 mg Each pre-filled oral syringe contains 10 mg midazolam (as hydrochloride) in 2 ml solution.

Active substance

Midazolam

Strengths, Pack size and Information


Strength
Pack size
Pharmaceutical form
PIP Code
SmPC
PiL
2.5 mg
4 oral syringes
367-1260
5 mg
4 oral syringes
367-1278
7.5 mg
4 oral syringes
367-1286
10 mg
4 oral syringes
367-1294

PROFESSIONAL ACCESS

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Item code no. NXUK032218, Date of prep. March 2022

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