SUTENT sunitinib (as malate) 37.5 mg capsul blister pack.

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

sunitinib malate, Quantity: 50.1 mg (Equivalent: sunitinib, Qty 37.5 mg)

Tilgængelig fra:

Pfizer Australia Pty Ltd

INN (International Name):

sunitinib malate

Lægemiddelform:

Capsule

Sammensætning:

Excipient Ingredients: propylene glycol; iron oxide black; isopropyl alcohol; butan-1-ol; ammonia; ethanol absolute; titanium dioxide; povidone; purified water; potassium hydroxide; mannitol; Shellac; croscarmellose sodium; iron oxide yellow; magnesium stearate; sodium lauryl sulfate; Gelatin

Indgivelsesvej:

Oral

Enheder i pakken:

28 capsules

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

SUTENT is indicated for: ? treatment of advanced renal cell carcinoma (RCC) ? treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance ? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET).

Produkt oversigt:

Visual Identification: Two piece opaque yellow capsule printed with black ink "Pfizer" on the cap and "STN 37.5mg" on the body and containing yellow to orange granules; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Licence status A

Autorisation dato:

2010-02-10

Indlægsseddel

SUTENT
®
_Sunitinib malate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SUTENT.
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 SUTENT
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SUTENT IS USED
FOR
SUTENT is used in the treatment of
renal cell carcinoma, a type of kidney
cancer.
SUTENT is used to treat
gastrointestinal stromal tumour
(GIST). GIST is a cancer of the
stomach and bowels. It is caused by
the uncontrolled growth of cells in
the wall of the stomach or bowel.
SUTENT slows down the growth of
these cells.
SUTENT is also used to treat
pancreatic neuroendocrine tumours.
This is a rare cancer in the cells of
the pancreas that release hormones.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SUTENT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
SUTENT is only available with a
doctor's prescription. It is not
addictive.
_USE IN CHILDREN_
The safety and efficacy of SUTENT
have not been established in children.
BEFORE YOU TAKE
SUTENT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SUTENT IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO
SUNITINIB (THE ACTIVE INGREDIENT IN
SUTENT) OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
other parts of the body; rash, itching
or hives on the skin.
DO NOT USE SUTENT AFTER THE
EXPIRY DATE PRINTED ON THE PACK.
DO NOT USE SUTENT IF THE
PACKAGING SHOWS SIGNS OF
TAMPERING.
_BEFORE YOU START TO TAKE IT_
YOU MUST TELL YOUR DOCTOR IF:
•
YOU HAVE HIGH BLOOD PRESSURE
•
YOU HAVE OR HAVE HAD AN
ANEURYSM (ABNORMAL BALLOON-
LIKE SWELLING

Produktets egenskaber

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Supersedes: pfpsutec10219
Page 1 of 35
AUSTRALIAN
PRODUCT
INFORMATION
–
SUTENT
® (SUNITINIB MALATE)
1.
NAME OF THE MEDICINE
Sunitinib malate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SUTENT capsule contains sunitinib malate equivalent to sunitinib
12.5 mg, 25 mg,
37.5 mg or 50 mg. Sunitinib malate is a yellow to orange powder with a
pKa of 8.95. The
solubility of sunitinib malate in aqueous media over the range pH 1.2
to pH 6.8 is in excess of
25 mg/mL.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Capsule.
SUTENT is supplied as a hard gelatin capsule for oral administration.
The capsules are
differentiated by size, colour and printing. The hard gelatin capsules
consist of Swedish Orange
cap and body (12.5 mg), Swedish Orange body and caramel cap (25 mg),
yellow cap and body
(37.5 mg) and caramel cap and body (50 mg) and are printed with white
printing ink (12.5 mg,
25 mg and 50 mg) or black printing ink (37.5 mg).
12.5 mg strength: Hard gelatin capsule with Swedish Orange cap and
Swedish Orange body,
printed with white ink “Pfizer” on the cap, “STN 12.5mg” on
the body.
25 mg strength: Hard gelatin capsule with caramel cap and Swedish
Orange body, printed with
white ink “Pfizer” on the cap, “STN 25mg” on the body.
37.5 mg strength: Hard gelatin capsule with yellow cap and yellow
body, printed with black ink
“Pfizer” on the cap, “STN 37.5mg” on the body.
50 mg strength: Hard gelatin capsule with caramel cap and caramel
body, printed with white
ink “Pfizer” on the cap, “STN 50mg” on the body.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SUTENT is indicated for:
•
treatment of advanced renal cell carcinoma (RCC)
•
treatment of gastrointestinal stromal tumour (GIST) after failure of
imatinib mesilate
treatment due to resistance or intolerance
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Supersedes: pfpsutec10219
Page 2 of 35
•
treatment
of
unresectable,
well-differentiated
pancreatic
neuroendocrine
tumours
(pancreat