BLEOMYCIN PFI

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

BLEOMYCIN SULFATE

Dostupno od:

MEGAPHARM LTD

ATC koda:

L01DC01

Farmaceutski oblik:

POWDER FOR SOLUTION FOR INJECTION

Sastav:

BLEOMYCIN SULFATE 15000 IU/VIAL

Administracija rute:

INTRAPLEURAL, INTRA-ARTERIAL, I.V, S.C, I.M, INTRA-TUMORAL, INTRA-CAVITARY

Tip recepta:

Required

Proizveden od:

BAXTER ONCOLOGY GmbH, GERMANY

Terapijska grupa:

BLEOMYCIN

Područje terapije:

BLEOMYCIN

Terapijske indikacije:

Bleomycin is useful in the management of the following neoplasms: Squamous cell carcinoma affecting the mouth, nasopharynx and paranasal sinuses, larynx, oesaphagus, cervix, vagina, penis and skin. Well differentiated tumors usually respond better than anaplastic ones.Hodgkin's disease and other malignant lymphomas, including mycosis fungoides. Testicular carcinoma (seminoma and no seminoma) .Malignant effusions of serous cavities (intrapleural and intraperitoneal).Secondary indications in which bleomycin has been shown to be of some value include metastatic malignant melanoma, carcinoma of the thyroid lung and bladder. Local treatment of refractory warts. Bleomycin can be used as a single agent, but is generally used in combination with other cytotoxics and/or with radiation therapy.

Datum autorizacije:

2020-09-30

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Bleomycin PFI
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains Bleomycin sulphate, equivalent to bleomycin 15 units
(USP) or 15 000 I.U.
One unit (USP) equivalent to 1 000 I.U. is equivalent to the
biological activity of 1 mg.
Note: 1 mg active substance is determined by bioassay and is not
identical to 1 mg dry substance.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White to yellowish white powder for solution for infusion, injection
or instillation.
Warning:
It is recommended that BLEOMYCIN be administered under the supervision
of a qualified
physician experienced in the use of cancer chemotherapeutic agents.
Appropriate management of therapy and complications is possible only
when adequate
diagnostic and treatment facilities are readily available. Pulmonary
fibrosis is the most
severe toxicity associated with BLEOMYCIN. The most frequent
presentation is pneumonitis
occasionally progressing to pulmonary fibrosis. Its occurrence is
higher in elderly patients
and those receiving greater than 400 units total dose, but pulmonary
toxicity has been
observed in young patients and those treated with low doses.
A severe idiosyncratic reaction consisting of hypotension, mental
confusion, fever, chills
and wheezing has been reported in approximately 1% of lymphoma
patients treated with
BLEOMYCIN.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BLEOMYCIN is useful in the management of the following neoplasms:
1)
Squamous cell carcinoma affecting the mouth, nasopharynx and paranasal
sinuses,
larynx, esophagus, cervix, vagina, penis and skin. Well-differentiated
tumors usually
respond better than anaplastic ones.
2)
Hodgkin's disease and other malignant lymphomas, including mycosis
fungoides.
3)
Testicular carcinoma (seminoma and non-seminoma).
4)
Malignant effusions of serous cavities (intrapleural and
intraperitoneal)
5)
Additional indications in which BLEOMYCIN has been shown to be of some
value include
metasta