Sunitinib Sandoz

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Sunitinib 50mg

Fáanlegur frá:

Sandoz New Zealand Limited

Skammtar:

50 mg

Lyfjaform:

Capsule

Samsetning:

Active: Sunitinib 50mg Excipient: Croscarmellose sodium Gelatin Printing ink, white Iron oxide black Iron oxide red Iron oxide yellow Magnesium stearate Mannitol Microcrystalline cellulose Povidone Titanium dioxide

Gerð lyfseðils:

Prescription

Ábendingar:

Treatment of advanced renal cell carcinoma

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, Al-OPA/Al/PVC - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle with PP CRC - 30 capsules - 36 months from date of manufacture stored at or below 25°C

Leyfisdagur:

2020-07-15

Upplýsingar fylgiseðill

SUNITINIB SANDOZ
®
1
SUNITINIB SANDOZ ®
_sunitinib _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sunitinib Sandoz.
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 Sunitinib
Sandoz 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 SUNITINIB
SANDOZ IS USED FOR
Sunitinib Sandoz is used in the
treatment of renal cell carcinoma, a
type of kidney cancer.
Sunitinib Sandoz 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.
Sunitinib Sandoz slows down the
growth of these cells.
Sunitinib Sandoz 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 SUNITINIB
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another purpose.
Sunitinib Sandoz is only available
with a doctor's prescription. It is not
addictive.
_USE IN CHILDREN_
_ _
The safety and efficacy of Sunitinib
Sandoz have not been established in
children.
BEFORE YOU TAKE
SUNITINIB SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SUNITINIB SANDOZ IF
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO
•
SUNITINIB (THE ACTIVE INGREDIENT
IN SUNITINIB SANDOZ)
•
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 SUNITINIB SANDOZ AFTER
THE EXPIRY DATE PRINTED ON THE
PACK.
DO NOT USE SUNITINIB SANDOZ IF T

Vara einkenni

220211-sunitinib-sandoz-ds
Page 1 of 30
NEW ZEALAND DATA SHEET
1. SUNITINIB SANDOZ
®
Sunitinib Sandoz
®
12.5 mg capsules
Sunitinib Sandoz
®
25 mg capsules
Sunitinib Sandoz
®
37.5 mg capsules
Sunitinib Sandoz
®
50 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Sunitinib Sandoz
®
12.5 mg capsule contains sunitinib 12.5 mg.
Each Sunitinib Sandoz
®
25 mg capsule contains sunitinib 25 mg.
Each Sunitinib Sandoz
®
37.5 mg capsule contains sunitinib 37.5 mg.
Each Sunitinib Sandoz
®
50 mg capsule contains sunitinib 50 mg.
_Excipient with known effect: _
mannitol.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Capsule.
Sunitinib Sandoz is supplied as a hard gelatin capsule for oral
administration.
Sunitinib Sandoz 12.5 mg capsules are gelatin capsules with orange cap
and orange body,
printed with white ink “12.5 mg” on the body and containing yellow
to orange granules.
Sunitinib Sandoz 25 mg capsules are gelatin capsules with caramel cap
and orange body,
printed with white ink “25 mg” on the body and containing yellow
to orange granules.
Sunitinib Sandoz 37.5 mg capsules are gelatin capsules with yellow cap
and yellow body,
printed with black ink “37.5 mg” on the body and containing yellow
to orange granules.
Sunitinib Sandoz 50 mg capsules are gelatin capsules with caramel cap
and caramel body,
printed with white ink “50 mg” on the body and containing yellow
to orange granules.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Sunitinib Sandoz is indicated for the:
•
treatment of advanced renal cell carcinoma
•
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).
220211-sunitinib-sandoz-ds
Page 2 of 30
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSE
Therapy should be initiated by a physician experienced in the
administration of anti-cancer
agents.
For GIST a