HYDROXYCARBAMIDE MEDSURGE hydroxycarbamide (hydroxyurea) 500 mg capsule blister

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

hydroxycarbamide (hydroxyurea), Quantity: 500 mg

Tilgjengelig fra:

Medsurge Pharma Pty Ltd

Legemiddelform:

Capsule, hard

Sammensetning:

Excipient Ingredients: erythrosine; titanium dioxide; lactose monohydrate; Gelatin; citric acid; quinoline yellow; magnesium stearate; indigo carmine; dibasic sodium phosphate; sodium lauryl sulfate

Administreringsrute:

Oral

Enheter i pakken:

100, 30

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Significant tumour response to hydroxycarbamide (hydroxyurea) has been demonstrated in chronic myelocytic leukaemia (pretreatment phase and palliative care) and recurrent, metastatic, or inoperable carcinoma of the ovary.

Produkt oppsummering:

Visual Identification: Size 0 hard gelatin capsules with an opaque pink body and an opaque light green cap containing a white to off-white homogeneous powder.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2020-06-03

Informasjon til brukeren

CMI EDITION 1.1 JUNE 2020
1
HYDROXYCARBAMIDE
_(SYNONYM: HYDROXYUREA) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Hydroxycarbamide
Medsurge. 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
taking
hydroxycarbamide
(hydroxyurea) 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
HYDROXYCARBAMIDE
(HYDROXYUREA) IS USED
FOR
Hydroxycarbamide
(hydroxyurea)
is
used to treat various types of cancers
such
as
melanoma,
leukemia
and
cancer of the ovary.
Hydroxycarbamide Medsurge contains
hydroxycarbamide
(hydroxyurea),
an
anti-cancer medicine. It interferes with
the replication of cells and causes cell
death, particularly in cancer cells.
Hydroxycarbamide (hydroxyurea) may
be used alone or in combination with
other
treatments
for
cancer.
Your
doctor
will
inform
you
if
this
is
necessary.
Your
doctor
may
have
prescribed
hydroxycarbamide
(hydroxyurea)
for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
HYDROXYCARBAMIDE (HYDROXYUREA)
WAS PRESCRIBED FOR YOU.
This medicine is available only with a
doctor's prescription.
Hydroxycarbamide
(hydroxyurea)
is
not recommended for use in children as
its safety and effectiveness in patients
under 18 years of age has not been
established.
BEFORE YOU TAKE
HYDROXYCARBAMIDE
(HYDROXYUREA)
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE HYDROXYCARBAMIDE
(HYDROXYUREA) IF YOU HAVE AN ALLERGY
TO:
•
hydroxycarbamide (hydroxyurea)
•
any of the ingredients listed at the
end of this leaflet.
DO
NOT
TAKE
HYDROXYCARBAMIDE
(HYDROXYUREA) IF YOU HAVE MARKED
DEPRESSION OF WHITE BLOOD CELLS (BONE
MARROW
DEPRESSION)
OR
RED
BLOOD
CELLS (SEVERE ANAEMIA).
Your
doctor will
be
able to
advise
whether
hydroxycarbamide
(hydroxyurea)
is
a

Preparatomtale

HYDROXYCARBAMIDE (HYDROXYUREA) CAPSULE
_ _
PRODUCT INFORMATION
Edition 1.1 – October 2021
Page
1
AUSTRALIAN PRODUCT INFORMATION –
HYDROXYCARBAMIDE MEDSURGE (HYDROXYCARBAMIDE
(HYDROXYUREA)) CAPSULE
1
NAME OF THE MEDICINE
Hydroxycarbamide (Hydroxyurea)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroxycarbamide (Hydroxyurea) is an antineoplastic agent, available
for oral use as capsules
containing 500mg per capsule.
Excipients with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Hard capsules containing 500 mg hydroxycarbamide (hydroxyurea); size 0
hard gelatin
capsules with an opaque pink body and an opaque light green cap
containing a white to off-
white homogeneous powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Significant tumour response to hydroxycarbamide (hydroxyurea) has been
demonstrated in
chronic myelocytic leukaemia (pretreatment phase and palliative care)
and recurrent,
metastatic, or inoperable carcinoma of the ovary.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Because of the rarity of melanoma, resistant chronic myelocytic
leukaemia, carcinoma of the
ovary, and carcinomas of the head and neck in children, dosage
regimens have not been
established.
All dosage should be based on the patient's actual or ideal weight,
whichever is less.
NOTE: If the patient prefers, or is unable to swallow capsules, the
contents of the capsules may
be emptied into a glass of water and taken immediately. Some inert
material used as a vehicle in
the capsule may not dissolve, and may float to the surface.
Elderly patients may require a lower dose regimen.
Patients who take the drug by emptying the contents of the capsule
into water should be
reminded that this is a potent medication that must be handled with
care. Patients must be
HYDROXYCARBAMIDE (HYDROXYUREA) CAPSULE
_ _
PRODUCT INFORMATION
Edition 1.1 – October 2021
Page
2
cautioned not to allow the powder to come in contact with the skin and
mucous membranes,
including avoidance o