IBRANCE

Država: Indonezija

Jezik: indonezijščina

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktivna sestavina:

PALBOCICLIB

Dostopno od:

PFIZER INDONESIA - Indonesia

INN (mednarodno ime):

PALBOCICLIB

Odmerek:

100 MG

Farmacevtska oblika:

KAPSUL

Enote v paketu:

DUS, 1 BLISTER @ 7 KAPSUL

Izdeluje:

PFIZER MANUFACTURING DEUTSCHLAND GMBH - Federal Republic of Germany

Datum dovoljenje:

2019-10-24

Lastnosti izdelka

PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Palbociclib
Trade Name: Ibrance
CDS Effective Date: June 12, 2017
Supersedes: NA
1.
NAME OF THE MEDICINAL PRODUCT
1.1.
PRODUCT NAME
IBRANCE
®
1.2.
STRENGTH
75 mg, 100 mg, and 125 mg
1.3.
PHARMACEUTICAL DOSAGE FORM
Hard capsules
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1.
QUALITATIVE DECLARATION
Each capsule contains 75 mg or 100 mg or 125 mg of palbociclib
freebase.
N
N
N
N
N
N
M
M
E
E
O
O
N
N
H
H
N
N
N
N
H
H
N
N
O
O
M
M
E
E
Palbociclib is a yellow to orange powder with a pKa of 7.4 (the
secondary piperazine
nitrogen) and 3.9 (the pyridine nitrogen).
2.2.
QUANTITATIVE DECLARATION
Excipients: see Section 6.1 (List of excipients) for the full list of
excipients.
3.
PHARMACEUTICAL FORM
Hard gelatin capsules 75 mg, 100 mg, and 125 mg
DISETUJUI OLEH BPOM : 18/9/2019
EREG10024111800010
EREG10024111800011
EREG10024111800012
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
IBRANCE in combination with letrozole is indicated for the treatment
of hormone receptor
(HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative locally advanced
or metastatic breast cancer with proven diagnosis of adenocarcinoma of
the breast with
evidence of loco regionally recurrent or metastatic disease not
amenable to resection or
radiation.
In pre- or perimenopausal women, the endocrine therapy
should be
combined with a
luteinizing hormone-releasing hormone (LHRH) agonist.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of IBRANCE is a 125 mg capsule taken orally once
daily for
21 consecutive days followed by 7 days off treatment (Schedule 3/1) to
comprise a complete
cycle of 28 days.
When coadministered with palbociclib, the recommended dose of
letrozole is 2.5 mg taken
orally
once
daily
continuously
throughout
the
28-day
cycle.
Please
refer
to
the
full
prescribing information of letrozole.
Treatment
of
pre/perimenopausal
women
with
the
combination
of
palbociclib
plus
an
aromatase inhibitor should always be combined with an LHRH agonist
(see S