ENDOXAN TABLET 50 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CYCLOPHOSPHAMIDE

Available from:

BAXTER HEALTHCARE (ASIA) PTE LTD

ATC code:

L01AA01

Dosage:

50 mg

Pharmaceutical form:

TABLET, SUGAR COATED

Composition:

CYCLOPHOSPHAMIDE 50 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Prasfarma S. L.

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 hypersensitivity to

Summary of Product characteristics

EPE C543
HA-30-02-280
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 transplantations
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