Bendamustine Mylan

Bendamustine Mylan Caution For Usage

bendamustine

Manufacturer:

Mylan

Distributor:

DKSH

Marketer:

Viatris
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Caution For Usage
Preparation and Administration Precautions: Reconstitution/Preparation for Intravenous Administration: Bendamustine Hydrochloride for Injection is indicated for intravenous administration.
After reconstitution of the solution according to the instructions, Bendamustine Hydrochloride for Injection is administered as a short intravenous infusion over 30 - 60 minutes.
To prepare the ready-to-use solution, the contents of a vial of Bendamustine Hydrochloride for Injection are dissolved in water for Injections as follows: First dissolve the vial of Bendamustine Hydrochloride for Injection containing 25 mg of Bendamustine hydrochloride in 10 mL by shaking.
First dissolve the vial of Bendamustine hydrochloride for Injection containing 100 mg of Bendamustine hydrochloride in 40 mL by shaking.
As soon as clear solution forms (within 5 minutes) the total Bendamustine Hydrochloride for Injection dose is immediately diluted to a final volume of approximately 500 mL with 0.9% sodium chloride solution. If particulate matter is observed, the reconstituted product should not be used.
Apart from isotonic saline solution, Bendamustine Hydrochloride for Injection must not be diluted with other base infusion solutions or other injection solutions.
Admixture Stability: Unopened vial: Do not store above 30°C. Protect from light.
Keep the vial in the outer carton in order to protect from light.
Reconstituted concentration in the vial: The concentrate should be further processed immediately.
Diluted solution for infusion: The chemical and physical stability of the preparation after reconstitution to form the solution for infusion (water for injections and 0.9% Sodium Chloride solution) was confirmed for 3.5 hours at 25°C and 48 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately.
Incompatibilities: This medicinal product must not be mixed with other medicinal products.
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