LUMICEF SUBCUTANEOUS INJECTION 210 MG SYRINGE

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

BRODALUMAB

Διαθέσιμο από:

Kyowa Kirin Malaysia Sdn. Bhd.

INN (Διεθνής Όνομα):

BRODALUMAB

Μονάδες σε πακέτο:

1 Pre-Filled Syringes

Κατασκευάζεται από:

Kyowa Kirin Co., Ltd., Takasaki Plant

Φύλλο οδηγιών χρήσης

_ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
LUMICEF
® SUBCUTANEOUS INJECTION 210 MG
SYRINGE
Brodalumab (210 mg)
Page 1
WHAT IS IN THIS LEAFLET
1.
WHAT LUMICEF
® IS USED FOR
2.
HOW LUMICEF
® WORKS
3.
BEFORE YOU USE LUMICEF
®
4.
HOW TO USE LUMICEF
®
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
LUMICEF
®
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
WHAT IS LUMICEF
® USED FOR
LUMICEF
®
is
used
to
treat
a
skin
condition called “plaque psoriasis”, which
causes
inflammation
and
scaly
plaque
formation on the skin. LUMICEF
®
is used
in adults with moderate to severe plaque
psoriasis affecting large areas of the body.
Using LUMICEF
®
will benefit you by
leading to improvements of skin clearance
and reducing psoriasis signs and
symptoms, such as itch, redness, scaling,
burning, stinging, cracking, flaking and
pain.
HOW LUMICEF
® WORKS
LUMICEF
®
is a medicine that contains the
active substance brodalumab. Brodalumab
is a monoclonal antibody, a specialised
type of protein that recognizes and attaches
to certain proteins in the body.
Brodalumab
belongs
to
a
group
of
medicines
called
interkeukin
(IL)
inhibitors.
This
medicine
works
by
blocking the activity of IL-17 proteins,
which are present at increased levels in
diseases such as psoriasis.
BEFORE YOU USE LUMICEF
®
-
_When you must not use it _
DO NOT USE
LUMICEF
®
:
•
If you are allergic to brodalumab or any
of other ingredients of this medicine
(listed in Product Description). If you
think you may be allergic, ask your
doctor
for
advice
before
using
LUMICEF
®
.
•
If you have active Crohn’s disease
•
If you have an infection which your
doctor
thinks
is
important
(for
example, active tuberculosis (TB))
•
Do not use this medicine after the
expiry date which is stated on the
outer carton and label of the pre-filled
syringe after EXP. The expiry date
refers to the last day of that month.
•
Do not use this medicine if you notice
the solution is cl

Αρχείο Π.Χ.Π.

1
LUMICEF
® SUBCUTANEOUS INJECTION 210 MG SYRINGE
Brodalumab (genetical recombination) drug product
1.
NAME OF THE MEDICINAL PRODUCT
LUMICEF
®
subcutaneous injection 210 mg syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution.
1 ml solution contains 140 mg
brodalumab.
Brodalumab is a recombinant human monoclonal antibody produced in
Chinese Hamster Ovary (CHO)
cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
The liquid is clear to slightly opalescent, colourless to slightly
yellow and free from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LUMICEF
®
is indicated for the treatment of moderate to severe plaque psoriasis
in adult patients who are
candidates for systemic therapy or phototherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
LUMICEF
®
is intended for use under the guidance and supervision of a physician
experienced in the
diagnosis and treatment of psoriasis.
Posology
The recommended dose is 210 mg administered by subcutaneous injection
at weeks 0, 1, and 2 followed
by 210 mg every 2 weeks.
Consideration should be given to discontinuing treatment in patients
who have shown no response after 12-
16 weeks of treatment. Continued treatment beyond 16 weeks in patients
who have not achieved an
adequate response is not likely to result in greater success.
_Special populations _
_ _
_Elderly (aged 65 years and over) _
No dose adjustment is recommended in elderly patients (see section
5.2).
_Renal and hepatic impairment _
LUMICEF
®
has not been studied in these patient populations. No dose
recommendations can be made.
_ _
_Paediatric population _
The safety and efficacy of LUMICEF
®
in children and adolescents below the age of 18 years have not yet
XXXXXX
2
been established. No data are available.
Method of administration
LUMICEF
®
is administered by subcutaneous injection. Each pre-filled syringe is
for single use only.
LUMICEF
®
should not be injected in