ENDOXAN 500 MG INJECTION

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

CYCLOPHOSPHAMIDE

から入手可能:

MEGAPHARM LTD

ATCコード:

L01AA01

医薬品形態:

POWDER FOR SOLUTION FOR INJECTION

構図:

CYCLOPHOSPHAMIDE 500 MG/VIAL

投与経路:

I.V

処方タイプ:

Required

製:

BAXTER ONCOLOGY GmbH, GERMANY

治療群:

CYCLOPHOSPHAMIDE

治療領域:

CYCLOPHOSPHAMIDE

適応症:

Malignant Diseases: Cycophosphamide although effective alone in susceptible melignancies is more frequently used concurrently or sequentially with other antineoplastic drugs. The following malignancies are often susceptible. Cycophosphamide treatment: 1) Malignant lymphomas (Stages III and IV of the Ann Arbor staging system) Hodgkin`s disease lymphocytic lymphoma (nodular or diffuse) mixed-cell type lymphoma histiocytic lymphoma Burkitt`s lymphoma. 2) Multiple myeloma. 3) Leukemias: Chronic lymphocytic leukemia chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis) acute myelogenous and monocytic leukemia acute lymphoblastic (stemcell) leukemia in children. 4) Mycosis fungoides (advenced disease). 5) Neuroblastoma (disseminated disease). 6) Adenocarcinoma of the ovary. 7) Retinoblastoma. 8) Carcinoma of the breast. Nonmallgnant Disease Biopsy proven "Minimal Change" nephrotic syndrome in children whose disease fails to respond adequately to another treatment. Severe cases of systemic lupus Erythematos as which did not respond to other treatment especially with nephritis

承認日:

2015-07-31

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Endoxan 500 mg injection
Endoxan 1 gram injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_ENDOXAN 500 MG_
1 vial contains: 534.5 mg cyclophosphamide 1 H
2
O (equivalent to 500 mg
cyclophosphamide without H
2
O)
_ENDOXAN 1 G_
1 vial contains: 1069.0 mg cyclophosphamide 1 H
2
O (equivalent to 1000.0 mg
cyclophosphamide without H
2
O)
3. PHARMACEUTICAL FORM
Endoxan / 500 mg / 1 g in vials: white powder for solution for
injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MALIGNANT DISEASES:
Cyclophosphamide,
although
effective
alone
in
susceptible
malignancies,
is
more
frequently used concurrently or sequentially with other antineoplastic
drugs. The following
malignancies are often susceptible to cyclophosphamide treatment:
1. Malignant lymphomas (Stages III and IV of the Ann Arbor staging
system), Hodgkin’s
disease,
lymphocytic
lymphoma
(nodular
or
diffuse),
mixed-cell
type
lymphoma,
histiocytic lymphoma, Burkitt’s lymphoma.
2. Multiple myeloma.
3. Leukemias: Chronic lymphocytic leukemia, chronic granulocytic
leukemia (it is usually
ineffective in acute blastic crisis), acute myelogenous and monocytic
leukemia, acute
lymphoblastic (stem-cell) leukemia in children.
4. Mycosis fungoides (advanced disease).
5. Neuroblastoma (disseminated disease).
6. Adenocarcinoma of the ovary.
7. Retinoblastoma.
8. Carcinoma of the breast.
NONMALIGNANT DISEASES:
Biopsy proven Minimal Change nephrotic syndrome in children whose
disease fails to
respond adequately to another treatment.
Severe cases of systemic Lupus Erythematoses which did not respond to
other treatment,
especially with nephritis.
Notes on conditioning prior to allogeneic bone marrow transplantation:
Indication for bone marrow transplantation and thus for preceding
conditioning therapy
with Endoxan depends on a complex constellation of factors and must be
decided on an
individual basis. Significant factors include disease stage, prognosis
(risk group), nature
and success of previous