What Midazolam Sandoz contains
- The active substance is midazolam (as hydrochloride)
- For Midazolam Sandoz 1 mg/ml, oplossing voor injectie of infusie the other ingredients are sodium chloride, hydrochloric acid and water for injections.
- For Midazolam Sandoz 5 mg/ml, oplossing voor injectie of infusie the other ingredients are sodium chloride, hydrochloric acid. sodium hydroxide and water for injections.
What Midazolam Sandoz looks like and contents of the pack
Midazolam Sandoz is a clear, slightly yellow solution contained in a clear glass ampoule.
Midazolam Sandoz 1 mg/ml, oplossing voor injectie of infusie is marketed with pack sizes of 5 ampoules with each 5 ml solution for injection or infusion.
Midazolam Sandoz 5 mg/ml, oplossing voor injectie of infusie is marketed with pack sizes of 5 ampoules with each 1 ml, 3 ml, or 10 ml solution for injection or infusion.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz B.V., Veluwezoom 22, Almere, Nederland
Correspondentie: Postbus 10332, 1301 AH Almere
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
In het register ingeschreven onder:
Midazolam Sandoz 1 mg/ml, RVG 110832
Midazolam Sandoz 5 mg/ml, RVG 110837
This medicinal product is authorised in the Member States of the EEA under the following names:
|The Netherlands ||Midazolam Sandoz 1 mg/ml, oplossing voor injectie
| ||Midazolam Sandoz 5 mg/ml, oplossing voor injectie
|Czech Republic ||Midazolam Sandoz 1 mg/ml
| ||Midazolam Sandoz 5 mg/ml
|Hungary ||Midazolam Sandoz 1 mg/ml oldatos injekció
| ||Midazolam Sandoz 5 mg/ml oldatos injekció
|Poland ||Midazolam Sandoz
|Slovenia ||Midazolam Lek 1 mg/ml raztopina za injiciranje ali infundiranje
| ||Midazolam Lek 5 mg/ml raztopina za injiciranje ali infundiranje
This leaflet was last revised in November 2012
[To be completed nationally]
The following information is intended for healthcare professionals only
Preparation of solution for infusion
Midazolam Sandoz can be diluted with 0.9% sodium chloride solution, glucose 50 mg/ml (5%) or 100 mg/ml (10%) solution, or Ringer or Hartmann solution at a ratio of 15 mg of midazolam to 100-1,000 ml of infusion solution. These solutions remain stable for 24 hours at room temperature, and 3 days at +2 °C to +8 °C. Midazolam Sandoz must not be mixed with any
solution other than those listed above. In particular, Midazolam Sandoz must not be diluted with 6% w/v dextran (with 0.9% sodium chloride) in dextrose or mixed with alkaline injection injections. Midazolam precipitates in sodium bicarbonate.
The ampoule and the solution should be visually inspected prior to use. Only intact ampoules and clear solutions without particles and discoloration should be used.
Shelf life and storage
Midazolam Sandoz ampoules are intended for single use only.
Ampoule before opening
Store in the original package in order to protect from light
Ampoule after dilution
Chemical and physical in-use stability of the dilutions has been demonstrated for 24 hours at room temperature (15 – 25°C) or for 3 days at +2 °C to +8 °C.
From the microbiological point of view, the dilutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are at the responsibility of the user and would normally not be longer than 24 hours at +2 to +8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
In case of continuous intravenous infusion, midazolam injection solution may be diluted in the range of 0.015 to 0.15 mg with one of the solution mentioned above.
Disposal of waste
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.