BI ELIGARD CP (Eligard 1 month 7.5mg and MPL-Bicalutamide 50mg, 28 pack)

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

leuprorelin acetate, Quantity: 7.5 mg

זמין מ:

Mundipharma Pty Ltd

INN (שם בינלאומי):

Bicalutamide,leuprorelin acetate

טופס פרצבטיות:

Injection, modified release

הרכב:

Excipient Ingredients: N-methyl-2-pyrrolidone; polyglactin

מסלול נתינה (של תרופות):

Subcutaneous

יחידות באריזה:

Single eligard injection with bicalutamide 50 mg (28 tablets)

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Bicalutamide,Treatment of advanced prostate cancer in combination with LHRH agonist therapy.,Leuprorelin,Eligard? is indicated for the palliative treatment of advanced prostate cancer.

leaflet_short:

Visual Identification: Two-syringe system sterile 20-gauge 5/8-inch needle and silica gel desiccant.; Container Type: Multiple containers; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Licence status A

תאריך אישור:

2016-05-25

עלון מידע

BI ELIGARD
® CP
_bicalutamide & leuprorelin acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Bi ELIGARD cp. 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 Bi ELIGARD
cp 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 BI ELIGARD CP
IS USED FOR
Bi ELIGARD cp combination
therapy is the brand name for packs
containing ELIGARD (leuprorelin
acetate) 7.5 mg or 22.5 mg
subcutaneous injection plus MPL-
BICALUTAMIDE 50 mg tablets.
Bi ELIGARD cp is used to reduce
the symptoms of advanced cancer of
the prostate gland.
Bicalutamide tablets can also be used
to treat disease flare associated with
previous leuprorelin therapy.
Bi ELIGARD cp is a combination
pack consisting of an anti-androgen
(MPL-BICALUTAMIDE) medicine
and a Luteinising Hormone
Releasing Hormone (LHRH) agonist
(ELIGARD).
Androgens such as testosterone are
natural male sex hormones. In some
types of prostate cancer, androgens
may help the cancer cells to grow.
LHRH agonists reduce the level of
testosterone in men.
Bi ELIGARD cp interferes with
some of the actions of these
hormones.
Bi ELIGARD cp should only be
taken by men.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
BI ELIGARD CP
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN BI
ELIGARD CP IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
bicalutamide or leuprorelin
•
any of the ingredients listed at the
end of this leaflet
•
any other anti-androgen
medicines
•
any other LHRH agonists.
Some of t

מאפייני מוצר

BI ELIGARD
®
CP COMBINATION THERAPY
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
BI ELIGARD
® CP (BICALUTAMIDE / LEUPRORELIN ACETATE)
COMPOSITE PACK
1
NAME OF THE MEDICINE
Bicalutamide
Leuprorelin acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BICALUTAMIDE
MPL-BICALUTAMIDE tablets are white film-coated tablets containing 50
mg bicalutamide. Each
tablet contains the following excipients: lactose monohydrate, sodium
starch glycollate type A,
povidone, magnesium stearate, hypromellose, macrogol 400 and titanium
dioxide.
Excipient with known effect: lactose monohydrate.
LEUPRORELIN
ELIGARD is a sterile polymeric matrix formulation of leuprorelin
acetate for subcutaneous
injection. It is designed to deliver leuprorelin acetate at a
controlled rate over a therapeutic
period.
Leuprorelin acetate is a synthetic nonapeptide analogue of naturally
occurring gonadotropin
releasing hormone (GnRH or LH-RH) that, when given continuously,
inhibits pituitary
gonadotropin secretion and suppresses testicular steroidogenesis. The
analogue possesses
greater potency than the natural hormone.
ELIGARD 1 month contains 10.6 mg of lyophilised leuprorelin acetate.
ELIGARD 1 month
delivers 7.5 mg of leuprorelin acetate (equivalent to approximately
7.0 mg leuprorelin free
base) dissolved in 160 mg N-methyl-2-pyrrolidone and 82.5 mg
polyglactin. The approximate
weight of the administered formulation is 250 mg. It is designed to
deliver 7.5 mg of
leuprorelin acetate at a controlled rate over a 1 month therapeutic
period.
ELIGARD 3 month contains 29.2 mg lyophilised leuprorelin acetate.
ELIGARD 3 month delivers
22.5 mg of leuprorelin acetate (equivalent to approximately 21 mg
leuprorelin free base)
dissolved in 193.9 mg N-methyl-2-pyrrolidone and 158.6 mg polyglactin.
The approximate
weight of the administered formulation is 375 mg. It is designed to
deliver 22.5 mg of
leuprorelin acetate at a controlled rate over a 3 month therapeutic
period.
The Atrigel
®
Delivery System is a polymeric (non-gelatin containing) delivery
system
consisting