Product Description
Since last manyyears Saintroy Lifescience is leading manufacture, export and supplierofBendamustine injectionfrom Surat, Gujarat, India. Bendamustine Injection used in the treatment of chronic lymphocytic leukemia (CLL).
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ISO/GMP/cGMP/WHOGMP/NAFDAC approved, PPB Kenya approved/USFDA approved/EUGMP approved/MOH Iran approved manufacturing facility inGujarat, India.
Registration: Saintroy Lifescience is interested inregistration of own brand or customer brands in ministry of health of clientscountry and we also provide the products samples, COA, COPP, ACTorCTD dossier, DMF, Manufacturing license, Free sales certificate and other required documents.
Export Country :Saintroy Lifescience Bendamustine injection exportto USA, Canada, Germany, Europe, France, Ghana, Nigeria, Kenya, Senegal,Sudan,UAE, Kuwait, Dubai, Cameroon, Lebanon, Peru, Chile, Somalia, Philippines,Myanmar, Maldives, Thailand, Singapore, Malaysia, Hong Kong, China, Zimbabwe,Togo, Burkina Faso, Niger,Guinea Bissau, Congo, Democratic of republic, IvoryCosta, Oman, Guatemala, Nicaragua, Salvador, Qatar, Costa Rica, Panama, Cuba,Colombia, Bolivia, Argentine, Algeria, Guyana, Morocco, Jordan, Bahrain, Iran,Egypt, Kyrgyzstan, Uzbekistan, Kazakhstan.
Precise Formulation for Oncology NeedsBendamustine injection is meticulously formulated as a lyophilized powder to ensure stability and efficacy in hospital settings. Each vial, available in 25 mg and 100 mg strengths, contains Bendamustine Hydrochloride as the active ingredient alongside pharmaceutical excipients such as mannitol to ensure optimal reconstitution and administration.
Easy and Safe PreparationDesigned for straightforward reconstitution, Bendamustine injection dissolves in 5-10 minutes with sterile water for injection. The neutral pH after reconstitution (approximately 6.5-7.5) supports patient safety and drug compatibility during infusion. This preparation process ensures the medication is ready for immediate administration by oncologists within 30 minutes.
Strict Handling & Storage GuidelinesAs a cytotoxic agent, Bendamustine injection requires rigorous safety procedures, including personal protective equipment during preparation and administration. Any unused solution or waste must be disposed of following specialized cytotoxic waste protocols. Store the product in a cool, dry environment to maintain a stable shelf life of up to 2 years.
FAQ's of Bendamustine injection:
Q: How should Bendamustine injection be prepared before administration?
A: Bendamustine injection is supplied as a lyophilized powder and must be reconstituted with sterile water for injection. Dissolution typically takes about 5 to 10 minutes. The reconstituted solution should be used within 30 minutes to ensure stability and efficacy.
Q: What medical conditions is Bendamustine injection indicated for?
A: Bendamustine injection is indicated for the treatment of Chronic Lymphocytic Leukemia (CLL) and Indolent Non-Hodgkin's Lymphoma (NHL). Its administration helps manage these hematologic malignancies under the supervision of healthcare professionals.
Q: When should the prepared Bendamustine solution be administered?
A: The reconstituted Bendamustine solution should be administered as an intravenous infusion within 30 minutes of preparation. Delayed administration may compromise the effectiveness and safety of the drug.
Q: Where is Bendamustine injection typically handled and administered?
A: Bendamustine injection should only be handled and administered in hospital settings by qualified medical personnel, such as oncologists and trained nurses, due to its cytotoxic nature and preparation requirements.
Q: What personal protective measures are necessary during the preparation and administration of Bendamustine injection?
A: It is essential to wear personal protective equipment, such as gloves and gowns, when handling Bendamustine injection to minimize exposure to this cytotoxic drug and ensure safety during both preparation and administration.
Q: How should unused Bendamustine material or waste be disposed of?
A: Any unused material or waste from Bendamustine injection should be disposed of following established cytotoxic waste disposal procedures to protect healthcare staff and the environment from hazardous exposure.
Q: What are the storage requirements and shelf life for Bendamustine injection?
A: Bendamustine injection should be stored in a cool and dry place in its original packaging to maintain its stability. When properly stored, its shelf life extends up to two years.