ENDOXAN FOR INJECTION 200 mgvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CYCLOPHOSPHAMIDE MONOHYDRATE EQV CYCLOPHOSPHAMIDE ANHYDROUS

Available from:

BAXTER HEALTHCARE (ASIA) PTE LTD

ATC code:

L01AA01

Dosage:

200 mg/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

CYCLOPHOSPHAMIDE MONOHYDRATE EQV CYCLOPHOSPHAMIDE ANHYDROUS 200 mg/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

BAXTER ONCOLOGY GMBH

Authorization status:

ACTIVE

Authorization date:

1988-05-09

Patient Information leaflet

PATIENT INFORMATION LEAFLET
PLEASE READ CAREFULLY! 
ENDOXAN
®
COMPOSITION
Endoxan
®
200 mg
1 injection vial of Endoxan 200 mg contains:
213.8 mg cyclophosphamide monohydrate (equivalent to 200 mg anhydrous
cyclophosphamide) as the active ingredient
Endoxan
®
500 mg
1 injection vial of Endoxan 500 mg contains:
534.5 mg cyclophosphamide monohydrate (equivalent to 500 mg anhydrous
cyclophosphamide) as the active ingredient
Endoxan
®
1 g
1 injection vial of Endoxan 1 g contains:
1.069 g cyclophosphamide monohydrate (equivalent to 1 g anhydrous
cyclophosphamide) as the active ingredient
Endoxan
®
1 Endoxan sugar-coated tablet contains:
53.5 mg cyclophosphamide monohydrate (equivalent to 50 mg anhydrous
cyclophosphamide) as the active ingredient
_List of excipients_
Calcium carbonate, calcium monohydrogen phosphate, carmellose sodium,
gelatine, glycerol, lactose, maize starch,
magnesium stearate, macrogol, montan glycol wax, polysorbate,
polyvidone, saccharose, silicone dioxide, talcum,
titanium dioxide.
PHARMACEUTICAL FORM
Endoxan
®
200 mg/500 mg/1 g, injection vials:
Powder for solution for i.v. injection
Endoxan
®
:
Sugar-coated tablet for oral use
INDICATIONS
Endoxan is used within a combination chemotherapy regimen or as
monotherapy in 
Leukaemias:
acute or chronic lymphocytic and myelogenous leukaemias
Malignant lymphomas:
Hodgkin's disease, non-Hodgkin's lymphomas, plasmacytoma
Metastasizing and non-metastasizing malignant solid tumours: 
ovarian cancer, testicular cancer, breast cancer, small cell lung
cancer, neuroblastoma, Ewing's sarcoma
Progressive "autoimmune diseases":
e.g. rheumatoid arthritis, psoriatic arthropathy, systemic lupus
 erythematosus, scleroderma, systemic vasculitides (e.g.
with nephrotic syndrome), certain types of glomerulonephritis (e.g.
with nephrotic syndrome), myasthenia gravis,
autoimmune haemolytic anaemia, cold agglutinin diseases. 
Immunosuppressive treatment in organ transplantations
CONTRAINDICATIONS
Endoxan should not be used in patients with
● known hypersensiti

Summary of Product characteristics

HA-30-02-279
MAL/SGP C52
Patient Information Leaflet -
Please read carefully!
ENDOXAN
Composition
ENDOXAN 200 mg
1 injection vial of ENDOXAN 200 mg contains:
213.8 mg cyclophosphamide monohydrate (equivalent to 200 mg anhydrous
cyclophosphamide) as the active ingredient
ENDOXAN 500 mg
1 injection vial of ENDOXAN 500 mg contains:
534.5 mg cyclophosphamide monohydrate (equivalent to 500 mg anhydrous
cyclophosphamide) as the active ingredient
ENDOXAN 1 g
1 injection vial of ENDOXAN 1 g contains:
1.069 g cyclophosphamide monohydrate (equivalent to 1 g anhydrous
cyclophosphamide) as the active ingredient
ENDOXAN
1 ENDOXAN sugar-coated tablet contains:
53.5 mg cyclophosphamide monohydrate (equivalent to 50 mg anhydrous
cyclophosphamide) as the active ingredient
_List of excipients _
Calcium carbonate, calcium monohydrogen phosphate, carmellose sodium,
gelatine, glycerol, lactose, maize starch, magnesium stearate,
macrogol, montan glycol wax,
polysorbate, polyvidone, saccharose, silicone dioxide, talcum,
titanium dioxide.
Pharmaceutical form
ENDOXAN 200 mg/500 mg/1 g, injection vials:
Powder for solution for i.v. injection. A white crystalline powder
contained in clear glass injection vials.
ENDOXAN:
Sugar-coated tablet for oral use.
Therapeutic Indications
ENDOXAN is used within a combination chemotherapy regimen or as
monotherapy in
Leukaemias:
acute or chronic lymphocytic and myelogenous leukaemias
Malignant lymphomas:
Hodgkin’s disease, non-Hodgkin’s lymphomas, plasmacytoma
Metastasizing and non-metastasizing malignant solid tumours:
ovarian cancer, testicular cancer, breast cancer, small cell lung
cancer, neuroblastoma, Ewing’s sarcoma
Progressive “autoimmune diseases”:
e.g. rheumatoid arthritis, psoriatic arthropathy, systemic lupus
erythematosus, scleroderma, systemic vasculitides
(e.g. with nephrotic syndrome), certain types of glomerulonephritis
(e.g. with nephrotic syndrome), myasthenia gravis, autoimmune
haemolytic anaemia, cold agglutinin
diseases.
Immunosuppressive treatment in organ transplantati