Endoxan 500mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyclophosphamide monohydrate, Quantity: 534.5 mg (Equivalent: cyclophosphamide monohydrate, Qty 500 mg)

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

1 vial X 500mg

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Frequently responsive myeloproliferative and lymphoproliferative disorders: Malignant lymphomas including Hodgkins (Stages III and IV, Peter's Staging System*) and non-Hodgkins lymphomas; multiple myeloma; leukaemias; mycosis fungoides (advanced disease). *Modified as the International Staging Classification for Hodgkin's Disease in 'Report of the Committee on the Staging of Hodgkin's Disease'. Cancer Res 26: 1310, 1966. Stage I. Disease limited to one anatomic region (Stage I) or two contiguous anatomic regions (Stage I2) on the same side of the diaphragm. Stage II. Disease in more than two anatomic regions or two contiguous regions on the same side of the diaphragm. Stage III. Disease on both sides of the diaphragm but not extending beyond the involvement of lymph nodes, spleen and/or Waldeyer's ring. Stage IV. Involvement of the bone marrow, lung parenchyma, pleura, liver, bone, skin, kidneys, gastrointestinal tract, or in any tissue or organ in addition to lymph nodes, spleen or Waldeyer's ring. All stages are subclassified as A or B to indicate the absence or presence, respectively, of systemic symptoms. Frequently responsive solid malignancies: Neuroblastoma (patients with disseminated disease); adenocarcinoma of the ovary, retinoblastoma. Infrequently responsive malignancies: Carcinoma of the breast; malignant neoplasms of the lung. Immunosuppressive properties: Cyclophosphamide has also been used in the treatment of autoimmune diseases and immunopathies of unspecified type (i.e. Wegener's granulomatosis) when these diseases have been resistant to conventional first and second line of treatment, and for the prevention of transplant rejection. Cyclophosphamide can be recommended for use in treatment of nonmalignancies only when in the opinion of the physician the benefits to the patient outweigh the risk of treatment with cyclophosphamide.

Product summary:

Visual Identification: White cystalline substance; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2002-06-04

Patient Information leaflet

ENDOXAN (cyclophosphamide)
Consumer Medicine Information
ENDOXAN CMI 030506
Page 1 of 5
Baxter
ENDOXAN
_Cyclophosphamide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
ENDOXAN.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given ENDOXAN against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET IN A SAFE
PLACE.
You may need to read it again.
WHAT ENDOXAN IS USED FOR
ENDOXAN is used in the
treatment of various types of
cancer.
It can also be used in some
diseases of the immune system,
and to prevent rejection of organ
transplants.
ENDOXAN belongs to a group
of medicines called
antineoplastic or cytotoxic
medicines. You may also hear
of these being called
chemotherapy medicines.
In cancer, ENDOXAN works by
stopping cancer cells from
growing and multiplying.
In other conditions, it works by
lowering the immune system.
Your doctor may have
prescribed ENDOXAN for
another reason. ASK YOUR
DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
ENDOXAN HAS BEEN
PRESCRIBED FOR YOU.
ENDOXAN is often used in
combination with other
medicines to treat cancer.
ENDOXAN is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
ENDOXAN
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT HAVE ENDOXAN IF YOU
HAVE AN ALLERGY TO ENDOXAN
(CYCLOPHOSPHAMIDE).
Symptoms of an allergic
reaction may include:

shortness of breath,
wheezing, difficulty
breathing or a tight feeling in
your chest

swelling of the face, lips,
tongue or other parts of the
body

rash, itching, hives or
flushed, red skin

dizziness or lightheadedness
DO NOT HAVE ENDOXAN IF YOU
HAVE ANY OF THE FOLLOWING
MEDICAL CONDITIONS, UNLESS YOU
HAVE FIRST DISCUSSED THIS WITH
YOUR DOCTOR:

condition of the blood with a
reduced n

Summary of Product characteristics

Endoxan (Cyclophosphamide monohydrate) Injection
Version 1.1
1 of 23
AUSTRALIAN PRODUCT INFORMATION – ENDOXAN
(CYCLOPHOSPHAMIDE MONOHYDRATE) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Cyclophosphamide monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cyclophosphamide is chemically 2-Bis (2-chloroethyl) aminoperhydro-1,
3, 2oxazaphosphorine
2-oxide. It exists as the monohydrate. The white crystalline
monohydrate is soluble in water (>
4% w/v). Cyclophosphamide monohydrate liquefies when its water of
crystallisation is lost.
ACTIONS: Cytostatic alkylating agent
There are no excipients in Endoxan powder for injection.
3
PHARMACEUTICAL FORM
Powder for Injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
The proper use of cyclophosphamide requires accurate diagnosis,
careful assessment of the
anatomic extent of the disease, knowledge of the type and effects of
any previous therapy, and
continued evaluation of the patient’s general and haematologic
status. It is essential that
adequate clinical and laboratory facilities be available for proper
monitoring of patients during
treatment with cyclophosphamide.
The clinical course of the disease should be recorded in objective
terms before treatment is begun
and thereafter at regular intervals. Careful management of patients
receiving cyclophosphamide
will help achieve maximum benefit with minimum risk.
_ANTINEOPLASTIC PROPERTIES _
Patients
with
neoplasms
that
might
preferably
be
treated
by
surgical
and/or
irradiation
procedures should ordinarily not be treated by chemotherapy alone.
The following classification is a guide to the various neoplastic
conditions in which benefit may
be derived from chemotherapy with cyclophosphamide:
_Frequently responsive myeloproliferative and lymphoproliferative
disorders:_
Malignant lymphomas including Hodgkins (stages III and IV, Peter’s
Staging System*) and non-
Hodgkins lymphomas; multiple myeloma; leukaemias; mycosis fungoides
(advanced disease).
_Stage I:_ Disease limited to one anatomic region (Stage I) or two
co