HYDREA hydroxycarbamide (hydroxyurea) 500 mg capsule bottle

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

hydroxycarbamide (hydroxyurea), Quantity: 500 mg

可用日期:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

药物剂型:

Capsule, hard

组成:

Excipient Ingredients: indigo carmine; dibasic sodium phosphate heptahydrate; magnesium stearate; titanium dioxide; citric acid; lactose monohydrate; iron oxide yellow; Gelatin; erythrosine; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid

给药途径:

Oral

每包单位数:

100 capsules

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

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

產品總結:

Visual Identification: Opaque green cap and opaque pink body imprinted CHP 500 in black ink.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

授权状态:

Registered

授权日期:

1994-01-18

资料单张

HYDREA
®
_hydroxycarbamide (hi-DROX-eee-Car-bah-myd) (hydroxyurea)
(hi-DROX-eee-U-re-aah)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about HYDREA. 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 HYDREA
against the benefits they expect it
will have for you. This leaflet does
not contain everything about
HYDREA. Your doctor has been
provided with full information and
can answer any questions you may
have. Follow your doctor's advice
even if it differs from what is in this
leaflet.
PLEASE READ THIS LEAFLET CAREFULLY
AND KEEP IT IN A SAFE PLACE SO YOU
MAY REFER TO IT LATER.
WHAT HYDREA IS USED
FOR
HYDREA is used to treat various
types of cancers such as, leukemia
and cancer of the ovary.
HYDREA contains hydroxyurea, an
anti-cancer medicine. It interferes
with the replication of cells and
causes cell death, particularly in
cancer cells.
HYDREA 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
HYDREA for another reason. Ask
your doctor if you have any questions
about why HYDREA was prescribed
for you.
This medicine is available only with
a doctor's prescription.
HYDREA 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 ARE GIVEN
HYDREA
_WHEN YOU MUST NOT TAKE_
_HYDREA_
•
YOU MUST NOT TAKE HYDREA IF
YOU HAVE AN ALLERGY TO
HYDREA, OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
•
DO NOT TAKE HYDREA 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 HYDREA is appropriate
in this situation.
•
DO NOT TAKE HYDREA IF YOU
ARE PREGNANT OR INTEND TO
BECOME PREGNANT.
HYDREA may cause harm to the
unborn baby i

产品特点

AU_PI_HYDREA V13.1
1
AUSTRALIAN PRODUCT INFORMATION – HYDREA
®
(HYDROXYCARBAMIDE (HYDROXYUREA))
1
NAME OF THE MEDICINE
Hydroxycarbamide (hydroxyurea).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
HYDREA hydroxycarbamide (hydroxyurea) is an antineoplastic agent,
available for oral use as
capsules containing 500mg hydroxycarbamide (hydroxyurea).
Excipients with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Capsules containing 500mg hydroxycarbamide (hydroxyurea); opaque
green/opaque pink capsule shell,
marked with “BMS 303”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Significant tumour response to HYDREA has been demonstrated in chronic
myelocytic leukaemia
(pretreatment phase and palliative care) and recurrent, metastatic, or
inoperable carcinoma of the ovary.
4.2
DOSE AND METHOD OF ADMINISTRATION
Because of the rarity in children of chronic myelocytic leukaemia,
carcinoma of the ovary, and
carcinomas of the head and neck, 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 cautioned not to allow the
powder to come in contact with the skin and mucous membranes,
including avoidance of inhaling the
powder when opening the capsules. People who are not taking HYDREA
should not be exposed to it.
To decrease the risk of exposure, wear disposable gloves when handling
HYDREA, or bottles
containing HYDREA. Anyone handling HYDREA should wash their hands
before and after contact
with