Sutent capsules hard

Pajjiż: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

sunitinib (sunitinib malate)

Disponibbli minn:

Pfizer Italia S.r.L.

Kodiċi ATC:

L01XE04

INN (Isem Internazzjonali):

sunitinib (sunitinib malate)

Dożaġġ:

12,5mg

Għamla farmaċewtika:

capsules hard

Unitajiet fil-pakkett:

(30) plastic bottle

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2019-04-12

Karatteristiċi tal-prodott

ST 18_0
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SUTENT
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_EACH 12.5 MG CAPSULE CONTAINS: _
_Active ingredient:_ Sunitinib malate 16.7 mg, equivalent to 12.5 mg
of sunitinib._ _
_ _
_EACH 25 MG CAPSULE CONTAINS: _
_Active ingredient:_ Sunitinib malate 33.4 mg, equivalent to 25 mg of
sunitinib._ _
_ _
_EACH 50 MG CAPSULE CONTAINS: _
_Active ingredient:_ Sunitinib malate 66.8 mg, equivalent to 50 mg of
sunitinib._ _
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
12.5 mg hard gelatine capsule:
Opaque, hard gelatine capsules, size No. 4, orange-red body and cap
with
"Pfizer/STN 12.5 mg" printed in white ink. Capsule content: yellow to
orange granules.
25 mg hard gelatin capsule: Opaque, hard gelatine capsules, size No.
3, orange-red body and opaque caramel-
coloured cap with "Pfizer/STN 25 mg" printed in white ink. Capsule
content: yellow to orange granules.
50 mg hard gelatine capsule: Opaque, hard gelatine capsules, size No.
2, opaque caramel-coloured body and cap
with "Pfizer/STN 50 mg" printed in white ink. Capsule content: yellow
to orange granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

inoperable and/or metastatic gastrointestinal stromal tumours (GIST)
in adults when imatinib mesylate
treatment is ineffective due to resistance or intolerance

advanced or metastatic renal cell carcinoma (mRCC) in adults

inoperable or metastatic, well-differentiated pancreatic
neuroendocrine tumours (pancreatic NET) with
disease progression in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route. For adults.
The drug may be prescribed only by a specialist experienced in
treatment with anti-cancer drugs.
For GST and mRCC, the recommended Sutent dose is 50 mg daily,
administered orally for 4 weeks, followed
by a 2-week interval (4/2 regimen). The full treatment cycle is 6
weeks.
For pancreatic NET, the recommended Sutent dose is 37.5 mg orally once
daily, uninterrupted.
The drug may be administer