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Rx
Osmitrol
40 mg, Proszek do inhalacji w kapsułkach twardych
INN: Mannitolum
Data updated: 2026-04-13
Available in:
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Form
Proszek do inhalacji w kapsułkach twardych
Dosage
40 mg
Route
wziewna
Storage
—
About This Product
User Reviews
Reviews reflect personal experiences and are not medical advice. Always consult your doctor.
Manufacturer
Pharmaxis Europe Limited (Niemcy)
Composition
Mannitolum 40 mg
ATC Code
R05CB16
Source
URPL
11 DESCRIPTION OSMITROL is a sterile, nonpyrogenic solution of Mannitol, USP in a single-dose flexible container for intravenous administration as an osmotic diuretic. It contains no antimicrobial agents. Mannitol is a six carbon sugar alcohol prepared commercially by the reduction of dextrose. The pH is adjusted with sodium hydroxide or hydrochloric acid. Composition, osmolarity, and pH are shown in Table 1 . Table 1 Size Composition Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity pH (mL) Mannitol, USP (g/L) (mOsmol/L) (calc) 10% OSMITROL 500 100 549 5.0 (4.5 TO 7.0) 20% OSMITROL 250 200 1098 5.0 (4.5 TO 7.0) 500 The plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Osmitrol Injection Structural Formula
⚠️ Warnings
General precautions
Bortezomib is a cytotoxic agent. Therefore, caution should be used during handling and preparation of Bortezomib. Use of gloves, eye protection and other protective clothing to prevent skin contact is recommended.
Pregnant personnel should not handle this medicine.
Aseptic technique
must be strictly observed throughout the handling of Bortezomib, since it contains no preservative.
There have been fatal cases of inadvertent intrathecal administration of bortezomib. Bortezomib 1 mg powder for solution for injection is for intravenous use only, while Bortezomib 2.5mg and 3.5 mg powder for solution for injection are for intravenous or subcutaneous use. Bortezomib should not be administered intrathecally.
Instructions for reconstitution
Bortezomib must be reconstituted by a healthcare professional.
Each 6 ml vial of Bortezomib must be reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. Dissolution of the lyophilised powder is completed in less than 2 minutes. After reconstitution, each ml solution contains 1 mg bortezomib. The reconstituted solution is clear and colourless, with a final pH of 4 to 7. The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration. If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Disposal
Bortezomib is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.