Forsteo

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

teriparatide

Dostupné z:

Eli Lilly Nederland B.V.

ATC kód:

H05AA02

INN (Medzinárodný Name):

teriparatide

Terapeutické skupiny:

Calcium homeostasis

Terapeutické oblasti:

Osteoporosis; Osteoporosis, Postmenopausal

Terapeutické indikácie:

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral 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.

Prehľad produktov:

Revision: 24

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2003-06-10

Príbalový leták

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
FORSTEO 20 MICROGRAMS/80 MICROLITERS SOLUTION FOR INJECTION IN
PRE-FILLED PEN
teriparatide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What FORSTEO is and what it is used for
2.
What you need to know before you use FORSTEO
3.
How to use FORSTEO
4.
Possible side effects
5
How to store FORSTEO
6.
Content of the pack and other information
1.
WHAT FORSTEO IS AND WHAT IT IS USED FOR
FORSTEO contains the active substance teriparatide that is used to
make the bones stronger, and to
reduce the risk of fractures by stimulating bone formation.
FORSTEO 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FORSTEO
DO NOT USE FORSTEO
•
if you are allergic to teriparatide or any of the other ingredients of
this medicine (listed in
section 6).
•
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
(metastasised) 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

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
FORSTEO 20 micrograms/80 microliters solution for injection in
pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 80 microliters 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
FORSTEO 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 FORSTEO is 20 micrograms administered once
daily.
The maximum total duration of treatment with FORSTEO should be 24
months (see section 4.4). The
24-month course of FORSTEO 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 FORSTEO therapy, patients may be continued on
other osteoporosis therapies.
3
Special populations
_Patients with renal impairment _
FORSTEO must not be used in patients with severe renal impairment (see
section 4.3.). In patients
with moderate renal impairment, FORSTEO should be used with caution.
No special caution is
required for patients with mild renal impairment.
_ _
_Patients with hepatic impairment _
No data are available in