LEUKERAN chlorambucil 2mg tablet bottle

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

chlorambucil, Quantity: 2 mg

Verfügbar ab:

Aspen Pharmacare Australia Pty Ltd

Darreichungsform:

Tablet, film coated

Zusammensetzung:

Excipient Ingredients: lactose; microcrystalline cellulose; stearic acid; colloidal anhydrous silica; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 400

Verabreichungsweg:

Oral

Einheiten im Paket:

50 tablets, 25 tablets

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Treatment of Hodgkin's disease, certain forms of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, Waldenstrom's macroglobulinaemia, advanced ovarian adenocarcinoma. Leukeran has a significant effect in a proportion of patients with breast cancer

Produktbesonderheiten:

Visual Identification: Brown, film-coated, round, biconvex tablets, engraved 'GX EG3' on one side and 'L' on the other.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2000-12-12

Gebrauchsinformation

LEUKERAN
®
_chlorambucil 2 mg tablets_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Leukeran. It does not
contain all the available information.
It does not take the place of talking to
your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Leukeran
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LEUKERAN IS
USED FOR
Leukeran contains chlorambucil as
the active ingredient.
Leukeran belongs to a group of
medicines called cytotoxics and is
used to treat some types of cancer
and certain blood disorders.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LEUKERAN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LEUKERAN IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO:
•
chlorambucil
•
any of the tablet ingredients listed
at the end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty in breathing;
swelling of the face, lips, tongue or
any other parts of the body; rash,
itching or hives on the skin.
DO NOT TAKE LEUKERAN IF YOU ARE
PLANNING TO BECOME PREGNANT OR
LIKELY TO FATHER A CHILD.
Leukeran may harm the eggs and
sperm so reliable contraceptive
methods must be taken to avoid
pregnancy whilst you or your partner
is taking this medicine.
DO NOT TAKE LEUKERAN IF YOU ARE
PREGNANT OR BREAST FEEDING UNLESS
YOU AND YOUR DOCTOR HAVE
DISCUSSED THE RISKS AND BENEFITS
INVOLVED.
DO NOT TAKE LEUKERAN AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
BOTTLE LABEL.
DO NOT TAKE IT IF THE BOTTLE SHOWS
SIGNS OF HAVING BEEN TAMPERED
WITH.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE TAKING LEUKERAN, TALK TO
YOUR DOCTOR.
_BEFO

Fachinformation

LEUKERAN_Product Information (PI)
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION (PI)
CHLORAMBUCIL (LEUKERAN)
TABLETS
1.
NAME OF THE MEDICINE
LEUKERAN chlorambucil 2mg tablet
2.
QUALITATIVE AND QUANITATIVE COMPOSITION
LEUKERAN tablets contain 2 mg chlorambucil
Chlorambucil is a white or off-white crystalline or granular powder.
It is practically
insoluble in water, freely soluble in acetone and in alcohol.
3.
PHARMACEUTICAL FORM
Tablets, film-coated
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Treatment of Hodgkin's disease, certain forms of non-Hodgkin's
lymphoma, chronic
lymphocytic
leukaemia,
Waldenstrom's
macroglobulinaemia,
advanced
ovarian
adenocarcinoma.
LEUKERAN has a significant effect in a proportion of patients with
breast cancer.
4.2 DOSE AND METHOD OF ADMINISTRATION
THE LITERATURE SHOULD BE CONSULTED FOR FULL DETAILS OF THE TREATMENT
SCHEDULES
USED.
LEUKERAN IS AN ACTIVE CYTOTOXIC AGENT FOR USE ONLY UNDER THE DIRECTION
OF
PHYSICIANS EXPERIENCED IN THE ADMINISTRATION OF SUCH AGENTS.
LEUKERAN is administered orally and should be taken daily on an empty
stomach (at
least one hour before meal or three hours after meal).
HODGKIN'S DISEASE: Used as a single agent a typical dosage is 0.2
mg/kg/day for four
to eight weeks. LEUKERAN is usually included in combination therapy
and a number
of regimens have been used. LEUKERAN may also be used as an
alternative to
nitrogen mustard with a reduction in toxicity but similar therapeutic
results.
NON-HODGKIN'S LYMPHOMA: Used as a single agent the usual dosage is 0.1
to
0.2 mg/kg/day for four to eight weeks initially; maintenance therapy
is then given either
by a reduced daily dosage or intermittent courses of treatment.
LEUKERAN
is
useful
in
the
management
of
patients
with
advanced
diffuse
lymphocytic lymphoma and those who have relapsed after radiotherapy.
LEUKERAN_Product Information (PI)
Page 2 of 9
There
is
no
significant
difference
in
the
overall
response
rate
obtained
with
chlorambucil
as
a
single
agent
and
combination
chemotherapy
in
patients
with
advanced n