COMPOSITION
Each vial contains
Bleomycin Sulphate U.S.P.
equivalent to Bleomycin 15 units.

PREPARATION OF SOLUTION
Vial should be reconstituted with 5ml sterile water for injection.

STORAGE
Store under refrigeration 2-8° C (36-46° F).
Protect from light.

PRESENTATION
Vial contains 15 units plus diluent.

Action
It inhabits DNA synthesis with some evidence of lesser inhibition of RNA and protein synthesis.

INDICATIONS
Indicated in the following neoplasms either as a single agent or in proven combinations with other approved cheotherapeutic agents.
- Squamous cell Carinoma: head and neck (including mouth, tounge, tonsi, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingiva, epiglottis, larynx), skin, penis, cervix and vulva.
- Lymphomas: Hodgkin's disease, reticulum cell sarcoma, lymphosarcoma.
- Testicular Carcinoma: Embyronal cell, choriocarcinoma and teratocarcinoma.

CONTRAINDICATIONS
Contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.

WARNINGS
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.

PREGNANCY
Safe use of Bleomycin in pregnant women has not been established.

DRUG INTERACTIONS
Serum levels of digoxin and phenytoin may be decreased.

ADVERSE REACTIONS
Pulmonary toxicity, idiosyncratic reactions, integument and mucous membrane toxicity, vascular toxicity, fever, nausea,
vomiting, anorexia, weight loss have been reported.

DOSAGE AND ADMINISTRATION
Squamous cell carcinoma, lymphosarcoma, reticulum cell sarcoma, testicular carcinoma and Hodgkin's Disease: Recommended doses are 0.25 - 0.50 units per kg body weight or 10 to 20 units per m² body surface area, given intravenously, intramuscularly or subcutaneously once or twice weekly.
In Hodgkin's disease after a 50% response, a maintenance dose of one unit daily or five units weekly intravenously or intramuscularly should be given.