Sunitinib Pfizer

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Sunitinib malate 66.8mg equivalent to sunitinib 50mg;  

Tilgjengelig fra:

Pfizer New Zealand Limited

Dosering :

50 mg

Legemiddelform:

Capsule

Sammensetning:

Active: Sunitinib malate 66.8mg equivalent to sunitinib 50mg   Excipient: Croscarmellose sodium Gelatin Ink Iron oxide black Iron oxide red Iron oxide yellow Magnesium stearate Mannitol Povidone Sodium laurilsulfate Titanium dioxide

Resept typen:

Prescription

Indikasjoner:

Treatment of advanced renal cell carcinoma

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, Aluminium/polyvinyl chloride(PVC)/polychlorotriflouroethylene(PCTFE, Aclar) - 28 capsules - 36 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

2020-10-30

Informasjon til brukeren

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

Preparatomtale

Version: pfdsuntc10821
Supersedes: N/A
Page 1 of 32
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SUNITINIB PFIZER (sunitinib 12.5 mg capsules)
SUNITINIB PFIZER (sunitinib 25 mg capsules)
SUNITINIB PFIZER (sunitinib 37.5 mg capsules)
SUNITINIB PFIZER (sunitinib 50 mg capsules)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of SUNITINIB PFIZER is sunitinib malate.
SUNITINIB PFIZER capsules
contain sunitinib malate equivalent to 12.5 mg, 25 mg, 37.5 mg or 50
mg sunitinib.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
SUNITINIB PFIZER is supplied as a hard gelatin capsule for oral
administration.
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.
Not all strengths may be marketed.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SUNITINIB PFIZER is indicated for the treatment of advanced renal cell
carcinoma.
SUNITINIB PFIZER is indicated for the treatment of gastrointestinal
stromal tumour (GIST) after
failure of imatinib mesilate treatment due to resistance or
intolerance.
SUNITINIB PFIZER is indicated for the treatment of unresectable,
well-differentiated pancreatic
neuroendocrine tumours (pancreatic NET).
Version: pfdsuntc10821
Supersedes: N/A
Page 2 of 32
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
For GIST and mRCC,
the recommended dose of SUNITINIB PFIZER is 50 mg taken orally once
daily for 4 consecutive weeks followed by a 2 week rest period
(Schedule 4/2) to comprise a
complete cycle of 6 weeks.
For pancreati