Signifor 0.9 mg/1ml Solution for Injection

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Pasireotide diaspartate

Boleh didapati daripada:

FTA Healthcare Sdn. Bhd.

INN (Nama Antarabangsa):

Pasireotide diaspartate

Unit dalam pakej:

6ampoule Ampoules; 30ampoule Ampoules; 60ampoule Ampoules

Dikeluarkan oleh:

NOVARTIS PHARMA STEIN AG

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
SIGNIFOR SOLUTION FOR INJECTION
Pasireotide (0.3mg/1ml, 0.6mg/1ml and 0.9mg/1ml)
1
WHAT IS IN THIS LEAFLET
1.
WHAT SIGNIFOR IS USED FOR
2.
HOW SIGNIFOR WORKS
3.
BEFORE YOU USE SIGNIFOR
4.
HOW TO USE SIGNIFOR
5.
WHILE YOU ARE USING SIGNIFOR
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF SIGNIFOR
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT SIGNIFOR IS USED FOR
Signifor is a medicine that contains the
active substance pasireotide. It is used
to
treat
Cushing’s
disease
in
adult
patients for whom surgery is not an
option or for whom surgery has failed.
HOW SIGNIFOR WORKS
Signifor is able to block the production
of
ACTH,
helping
to
control
the
over-production
of
cortisol
and
improve the symptoms of Cushing’s
disease.
BEFORE YOU USE SIGNIFOR
_Do not use Signifor _
-
if you are allergic to pasireotide or
any of the other ingredients of this
medicine.
-
if you have severe liver problems.
_PREGNANCY, BREAST-FEEDING AND _
_FERTILITY _
Ask
your
doctor
or
pharmacist
for
advice before using any medicine.
-
You should not use Signifor during
pregnancy
unless
clearly
necessary. If you are pregnant or
think
that
you
may
be,
it
is
important to tell your doctor who
will discuss with you whether you
can
use
Signifor
during
your
pregnancy.
-
You should not breast-feed while
using
Signifor.
It
is
not
known
whether Signifor passes into breast
milk.
-
If you are a sexually active woman,
you should use an effective method
of contraception during treatment.
Ask your doctor about the need for
contraception
before
taking
this
medicine.
_Before you start to use it _
Talk
to
your
doctor
before
using
Signifor if you currently have or have
ever had:
-
problems with your blood sugar
levels,
whether
too
high
(as
in
diabetes)
or
too
low
(hypoglycaemia)
-
heart problems such as a recent
heart
attack,
congestive
heart
failure
(a
type
of
heart
disease
where
the
heart
cannot
pump
enough blood around the body) or
sudden and oppressive chest pain
(usu

Ciri produk

Novartis
Malaysia Package Insert
13 Jan 2020
Signifor
®
1
NAME OF THE MEDICINAL PRODUCT
Signifor 0.3mg solution for injection
Signifor 0.6mg solution for injection
Signifor 0.9mg solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Signifor 0.3 mg solution for injection
One ampoule of 1 ml contains 0.3 mg pasireotide (as pasireotide
diaspartate).
Signifor 0.6 mg solution for injection
One ampoule of 1 ml contains 0.6 mg pasireotide (as pasireotide
diaspartate).
Signifor 0.9 mg solution for injection
One ampoule of 1 ml contains 0.9 mg pasireotide (as pasireotide
diaspartate). For the full list
of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection (injection). Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adult patients with Cushing’s disease for whom surgery
is not an option or for
whom surgery has failed.
4.2
POSOLOGY AND
METHOD OF ADMINISTRATION
Posology
The recommended initial dose is 0.6 mg pasireotide by subcutaneous
injection twice a day.
Two months after the start of Signifor therapy, patients should be
evaluated for clinical
benefit. Patients who experience a significant reduction in urinary
free cortisol (UFC) levels
should continue to receive Signifor for as long as benefit is derived.
A dose increase to 0.9
mg may be considered based on the response to the treatment, as long
as the 0.6 mg dose is
RECORDATI RARE DISEASES
Novartis
Malaysia Package Insert
13 Jan 2020
Signifor
®
well tolerated by the patient. Patients who have not responded to
Signifor after two months of
treatment should be considered for discontinuation.
Management of suspected adverse reactions at any time during the
treatment may require
temporary dose reduction of Signifor. Dose reduction by decrements of
0.3 mg twice a day is
suggested.
If a dose of Signifor is missed, the next injection should be
administered at the scheduled
time. Doses should not be doubled to make up for a missed dose.
_Switch from intramuscular to subcutaneous formulation _
The