HOLOXAN 1g powder for injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

ifosfamide, Quantity: 1 g

Tilgjengelig fra:

Baxter Healthcare Pty Ltd

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients:

Administreringsrute:

Intravenous

Enheter i pakken:

1 x 1g vial

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Use in the treatment of tumours sensitive to ifosfamide either as a single agent or in combination with other chemotherapeutic agents. Tumour types that have been demonstrated to respond to ifosfamide single agent or in combination are germ cell tumours, sarcomas, lymphomas. Anti-tumour activity has been shown in ovarian and cervical cancers. Some activity has also been seen in lung and breast cancer.

Produkt oppsummering:

Visual Identification: A white to almost white crystalline substance.; Container Type: Vial; Container Material: Glass; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1993-10-21

Informasjon til brukeren

HOLOXAN (ifosfamide)
Consumer Medicine Information
HOLOXAN CMI 070919
Page 1 of 5
Baxter
HOLOXAN
_Ifosfamide _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
HOLOXAN.
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 HOLOXAN 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 HOLOXAN IS USED FOR
HOLOXAN is used to treat
various types of cancer. These
include:

lymphoma, a cancer of the
lymph glands (one type of
lymphoma is also called
Hodgkin’s Disease)

a type of cancer called
sarcoma

cancer of the testes

breast cancer

ovarian cancer

cervical cancer

lung cancer
HOLOXAN belongs to a group
of medicines called
antineoplastic or cytotoxic
medicines. You may also hear
of these being called
chemotherapy medicines.
HOLOXAN works by stopping
cancer cells from growing and
multiplying.
Your doctor may have
prescribed HOLOXAN for
another reason. ASK YOUR
DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
HOLOXAN HAS BEEN
PRESCRIBED FOR YOU.
HOLOXAN is often used in
combination with other
medicines to treat cancer.
HOLOXAN is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
HOLOXAN
_WHEN YOU MUST NOT BE GIVEN IT _
DO NOT HAVE HOLOXAN IF YOU
HAVE AN ALLERGY TO HOLOXAN
(IFOSFAMIDE).
Symptoms of an allergic
reaction to HOLOXAN 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 HOLOXAN IF YOU
HAVE, OR HAVE HAD, ANY OF THE
FOLLOWING MEDICAL CONDITIONS,
UNLESS YOU HAVE FIRST DISCUSSED
THIS WITH YOUR DOCTOR:

s

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION
HOLOXAN (IFOSFAMIDE)
1. NAME OF THE MEDICINE
Ifosfamide Injection 500mg, 1g and 2g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500mg, 1g and 2g of ifosfamide.
3. PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion. Ifosfamide is a
chemotherapeutic agent related
chemically to the nitrogen mustards and is a synthetic analogue of
cyclophosphamide.
Ifosfamide is
a white crystalline powder that is soluble in water.
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS _
Indications for the use of ifosfamide are tumours sensitive to
ifosfamide either as a single agent or in
combination with other chemotherapeutic agents. Tumour types that have
been demonstrated to
respond to ifosfamide single agent or in combination are germ cell
tumours, sarcomas, lymphomas.
Anti-tumour activity has been shown in ovarian and cervical cancers.
Some activity has also been
seen in lung and breast cancer.
_4.2 DOSE AND METHOD OF ADMINISTRATION _
Ifosfamide should be administered only by physicians experienced with
this drug. Dosage must be
individualized. Doses and duration of treatment and/or treatment
intervals depend on the therapeutic
indication, the scheme of a combination therapy, the patient’s
general state of health and organ
function, and the results of laboratory monitoring. In combination
with other agents of similar toxicity,
a dose reduction or extension of the therapy-free intervals may be
necessary.
Where
indicated,
use
of
hematopoiesis-stimulating
agents
(colony-stimulating
factors
and
erythropoiesis-stimulating
agents)
may
be
considered
to reduce the risk
of
myelosuppressive
complications and/or help facilitate the delivery of the intended
dosing.
During or immediately after administration, adequate amounts of fluid
should be ingested or infused to
force diuresis in order to reduce the risk of urothelial toxicity.
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to
administration. Before parenteral adm