Bleomycin Formulation

Bleomycin Formulation Specification

Salt Composition
Bleomycin (as Bleomycin sulfate) 15 IU/vial

Indication
Treatment of squamous cell carcinomas, lymphomas, testicular cancer

Origin
Biotechnological/Fermentation derived

Dosage Form
Lyophilized powder for injection

Ingredients
Bleomycin sulfate, excipients

Application
Used intravenously, intramuscularly or subcutaneously as prescribed

Fermentation Smell
Characteristic mild fermentation odor

Enzymatic Activity
Not an enzyme; acts as a cytotoxic agent

Storage Instructions
Store below 25°C. Protect from light. Reconstituted solution to be used immediately.

Shelf Life
36 months (lyophilized powder)

Manufacturing Standard
Manufactured according to GMP guidelines

Reconstitution
To be reconstituted with sterile water for injection

Sterility
Sterile

Packaging
Glass vial packed individually in a carton with leaflet

Prescription Category
Prescription only medicine (Rx)

Route of Administration
Intravenous, intramuscular, subcutaneous

Solubility
Soluble in water when reconstituted

About Bleomycin Formulation

Bleomycin Formulation

Bleomycin is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug and is classified as an antitumor antibiotic. Bleomycin is used in the treatment of squamous cell cancers, melanoma, sarcoma, testicular cancer, Hodgkin's and non-Hodgkin's lymphoma, and pleural effusion. Bleomycin and Blenoxane - Chemotherapy.

Advanced Biotechnological Production

Bleomycin Formulation is derived through controlled fermentation methods, ensuring product consistency and efficacy for cancer treatment. Each production batch meets international GMP standards, offering pharmaceutical grade quality required for sensitive clinical applications.

Flexible Administration Routes

This formulation provides versatility with options for intravenous, intramuscular, or subcutaneous injection, catering to clinical needs and patient-specific protocols. Reconstitution with sterile water renders the product ready for various oncology treatment regimens as prescribed by healthcare professionals.

Reliable Packaging and Shelf Life

Each glass vial is individually sealed and packed in a carton with an informative leaflet, securing its sterility and prolonging shelf life for up to 36 months as a lyophilized powder. Proper storage (below 25C and protected from light) ensures sustained pharmaceutical integrity until reconstitution.

FAQs of Bleomycin Formulation:

Q: How should Bleomycin Formulation be reconstituted before administration?

A: Reconstitute the lyophilized powder in the vial using sterile water for injection according to the instructions provided in the accompanying leaflet. The solution should be prepared just prior to administration and used immediately.

Q: What are the approved routes of administration for Bleomycin Formulation?

A: Bleomycin Formulation can be administered intravenously, intramuscularly, or subcutaneously. The choice of route depends on clinical judgment and patient condition, as determined by the prescribing healthcare professional.

Q: When should the reconstituted solution be used, and can it be stored?

A: The reconstituted solution should be used immediately after preparation. It should not be stored for future use to ensure sterility and efficacy.

Q: Where should Bleomycin Formulation be stored before and after reconstitution?

A: Keep the unopened lyophilized powder stored below 25C, protected from light. Once reconstituted, the solution must be administered promptly and cannot be stored safely.

Q: What are the key benefits of using this Bleomycin Formulation?

A: This formulation offers reliable sterility, flexible administration options, and proven efficacy for several cancers. It is produced under GMP guidelines using biotechnological methods, ensuring quality and consistent clinical results.

Q: What is the primary medical use of Bleomycin Formulation?

A: Bleomycin Formulation is primarily prescribed for the treatment of squamous cell carcinomas, various types of lymphomas, and testicular cancer as a cytotoxic chemotherapy agent.

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