Bleomycin (Bleomycin)

Trade Name : Bleomycin

West-Ward Pharmaceuticals Corp

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 15 [USP'U]/1

BLEOMYCIN SULFATE Cytoprotective Agent [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Bleomycin (Bleomycin) which is also known as Bleomycin and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 15 [USP'U]/1 per ml. Read more

Bleomycin (Bleomycin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx ONLY
  • No data
  • Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of . It is freely soluble in water. Bleomycin for injection is provided as a sterile, white to off-white, lyophilized cake or powder in vials for intramuscular, intravenous, or subcutaneous administration. Each 15 unit and 30 unit vial contains sterile bleomycin sulfate equivalent to 15 or 30 units of bleomycin, respectively. The pH range is 4.0 to 6.0 in a solution reconstituted with Sterile Water for Injection. Its chemical name is n -[3-(dimethylsulphonio)propyl]bleomycin-amide (bleomycin A) and n -4-(guanidobutyl)bleomycinamide (bleomycin B).
  • The molecular formula of bleomycin A is CHNOS and a calculated molecular weight of 1414. The molecular formula of bleomycin B is CHNOS and a calculated molecular weight of 1425. The structural formula is shown at right:
  • Note:
  • No data
  • Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the
  • Bleomycin is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.
  • Patients receiving bleomycin must be observed carefully and frequently during and after therapy. It should be used with extreme caution in patients with significant impairment of renal function or compromised pulmonary function.
  • Pulmonary toxicities occur in 10% of treated patients. In approximately 1%, the nonspecific pneumonitis induced by bleomycin progresses to pulmonary fibrosis and death. Although this is age and dose related, the toxicity is unpredictable. Frequent roentgenograms are recommended (see : ).
  • A severe idiosyncratic reaction (similar to anaphylaxis) consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with bleomycin. Since these reactions usually occur after the first or second dose, careful monitoring is essential after these doses (see : ).
  • Renal or hepatic toxicity, beginning as a deterioration in renal or liver function tests, have been reported. These toxicities may occur at any time after initiation of therapy.
  • No data
  • No data
  • Because of the possibility of an anaphylactold reaction, lymphoma patients should be treated with 2 units or less for the first two doses. If no acute reaction occurs, then the regular dosage schedule may be followed.
  • The following dose schedule is recommended:
  • Squamous cell carcinoma, non-Hodgkin's lymphoma, testicular carcinoma
  • Hodgkin's diseaseu2014
  • Pulmonary toxicity of bleomycin appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution.
  • Note: When bleomycin for injection is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.
  • Improvement of Hodgkin's disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted.
  • Malignant Pleural Effusionu2013n- Arrayn- Array
  • Use in Patients with Renal Insufficiency
  • The following dosing reductions are proposed for patients with creatinine clearance (CrCL) values of less than 50 mL/min:
  • CrCL can be estimated from the individual patientu2019s measured serum creatinine (Scr) values using the Cockroft and Gault formula:Malesu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 CrCL = [weight x (140 u2013 Age)]/(72 x Scr)Femalesu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 CrCL = 0.85 x [weight x (140 u2013 Age)]/(72 x Scr)
  • Where CrCL in mL/min/1.73 m, weight in kg, age in years, and Scr in mg/dL.
  • Bleomycin for Injection, USP is available as follows:
  • NDC 0143-9240-01
  • NDC 0143-9241-01
  • The sterile powder is stable under refrigeration 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F) and should not be used after the expiration date is reached.
  • Bleomycin should not be reconstituted or diluted with DW or other dextrose containing diluents. When reconstituted in DW and analyzed by HPLC, bleomycin demonstrates a loss of A and B potency that does not occur when bleomycin is reconstituted in Sodium Chloride for Injection, 0.9%.
  • Bleomycin is stable for 24 hours at room temperature in Sodium Chloride.
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .
  • For Product Inquiry call 1-877-845-0689.
  • 1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
  • 2.OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling occupational exposure to hazardous drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
  • 3.American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. 2006;63:1172-1193.
  • 4.Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.
  • Manufactured by
  • THYMOORGAN PHARMAZIE GmbH,
  • u00a0Schiffgraben 23, 38690 Goslar, Germany
  • u00a0
  • Distributed by
  • West-Ward Pharmaceuticals
  • Eatontown, NJ 07724 USA
  • u00a0Revised January 2017
  • 127.207.022/00
  • NDC 0143-9240-01 Rx onlyn Bleomycinu00a0for Injection, USPEquivalent to
  • Cytotoxic
  • NDC 0143-9241-01 Rx onlyn Bleomycinu00a0for Injection, USPEquivalent to
  • Cytotoxic
  • No data

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