FORTEO 250 UG SOLUTION FOR INJECTION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TERIPARATIDE

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

TERIPARATIDE

Unit dalam pakej:

2.4ml mL

Dikeluarkan oleh:

LILLY FRANCE S.A.S.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FORTEO
® INJECTION
Teriparatide (20 mcg/80 microlitres)
1
WHAT IS IN THIS LEAFLET
1.
What Forteo is used for
2.
How Forteo works
3.
Before your use Forteo
4.
How to use Forteo
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Forteo
8.
Product Description
9.
Manufacture
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT FORTEO IS USED FOR
FORTEO is used to treat osteoporosis
in adults. Osteoporosis is a disease that
causes your bones to become thin and
fragile.
This
disease
is
especially
common
in
women
after
the
menopause, but it can also occur in men.
Osteoporosis is also common in people
receiving corticosteroids.
HOW FORTEO WORKS
FORTEO contains the active substance
teriparatide that is used to make the
bones stronger, and to reduce the risk
of
fractures
by
stimulating
bone
formation.
BEFORE YOU USE FORTEO
_- When you must not use it _
DO NOT USE FORTEO
•
if you are allergic to teriparatide or
any of the other ingredients of this
medicine
(see
section
PRODUCT
DESCRIPTION
)
•
if you suffer from high calcium
levels
(pre-existing
hypercalcaemia).
•
if you suffer from serious kidney
problems.
•
if you have ever been diagnosed
with bone cancer or other cancers
that have spread (metastasized) to
your bones.
•
if you have certain bone diseases.
if you have a bone disease, tell
your doctor.
•
if
you
have
unexplained
high
levels of alkaline phosphatase in
your
blood,
which
means
you
might have Paget’s disease of bone
(disease
with
abnormal
bone
changes). If you are not sure, ask
your doctor.
•
if you have had radiation therapy
involving your bones.
_ _
_Pregnancy and lactation _
Do not use Forteo if you are pregnant
or breast-feeding. If you are a woman
of child-bearing potential, you should
use effective methods of contraception
during use of Forteo. If you become
pregnant,
Forteo
should
be
discontinued.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
-
_Before you start to use it _
Fort

Ciri produk

Forteo_PI_EUSPC 14 Oct 2020_30 Oct 2020 1
FORTEO
®
SOLUTION FOR INJECTION IN PRE-FILLED PEN
1.
NAME OF THE MEDICINAL PRODUCT
FORTEO
®
20 micrograms/80 microliters solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 80 microlitres contains 20 micrograms of teriparatide*.
One pre-filled pen of 2.4 ml contains 600 micrograms of teriparatide
(corresponding to 250 micrograms
per ml).
*Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA
technology, is identical to the
34 N-terminal amino acid sequence of endogenous human parathyroid
hormone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Colourless
, clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FORTEO is indicated in adults.
Treatment of osteoporosis in postmenopausal women and in men at
increased risk of fracture (see section
5.1). In postmenopausal women, a significant reduction in the
incidence of vertebral and non- vertebral
fractures but not hip fractures has been demonstrated.
Treatment of osteoporosis associated with sustained systemic
glucocorticoid therapy in women and men
at increased risk for fracture (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of FORTEO is 20 micrograms administered once
daily.
The maximum total duration of treatment with FORTEO should be 24
months (see section 4.4). The 24-
month course of Forteo should not be repeated over a patient’s
lifetime.
Patients should receive supplemental calcium and vitamin D supplements
if dietary intake is inadequate.
Following cessation of FORTEO therapy, patients may be continued on
other osteoporosis therapies.
Forteo_PI_EUSPC 14 Oct 2020_30 Oct 2020 2
Special populations
_Patients with renal impairment _
FORTEO must not be used in patients with severe renal impairment (see
section 4.3.). In patients with
moderate renal impairment, FORTEO should be used with caution. No
special caution is required for
patients with mild re