SONDELBAY (Teriparatide) 20 micrograms 80 microliters solution for injection in pre-filled pen

Country: Malaysia

Language: English

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

Active ingredient:

TERIPARATIDE

Available from:

ACCORD HEALTHCARE SDN.BHD.

INN (International Name):

TERIPARATIDE

Units in package:

3 Units; 1 Units

Manufactured by:

Intas Pharmaceuticals Limited Biopharma Division

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SONDELBAY SOLUTION FOR INJ IN PRE-FILLED PEN
_Teriparatide 20 micrograms in 80 microliters _
1
WHAT IS IN THIS LEAFLET
1.
What Sondelbay is used for
2.
How Sondelbay works
3.
Before you use Sondelbay
4.
How to use Sondelbay
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
Sondelbay
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT SONDELBAY IS USED FOR
Sondelbay contains the active
substance teriparatide that is used
to make the bones stronger, and to
reduce the risk of fractures by
stimulating bone formation.
Sondelbay 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
patients receiving corticosteroids.
Sondelbay is a biosimilar
medicinal product of Forteo
HOW SONDELBAY WORKS
Teriparatide injection contains a
synthetic form of natural human
hormone called parathyroid
hormone (PTH). It works
by causing the body to build new
bone and by increasing bone
strength and density (thickness).
BEFORE YOU USE SONDELBAY
_When you must not use it _
•
You must not use Sondelbay
if you:
•
if you are allergic to
teriparatide or any of the
other ingredients of this
medicine.
•
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.
•
if you are pregnant or breast-
feeding.
_ _

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Sondelbay 20 micrograms/80 microliters solution for injection in
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains 20 micrograms of teriparatide* in 80 microliters.
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
_Escherichia 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 (injection)
Colourless, clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sondelbay 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 have 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 Sondelbay is 20 micrograms administered once
daily.
The maximum total duration of treatment with Sondelbay should be 24
months (see section 4.4). The
24-month course of Sondelbay 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 Sondelbay therapy, patients may be continued on
other osteoporosis therapies.
2
Special populations
_Elderly _
Dosage adjustment based on age is not required (see section 5.2).
_Renal impairment _
Sondelbay must not be used in patients with severe renal impairment
(see section 4.3.). In patients
with moderate renal impairment, Sondelbay should be used with caution.
No special caution is
required for patients with mild renal impairment.
_Hepatic i