Movymia

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

teriparatide

Fáanlegur frá:

STADA Arzneimittel AG

ATC númer:

H05AA02

INN (Alþjóðlegt nafn):

teriparatide

Meðferðarhópur:

Calcium homeostasis

Lækningarsvæði:

Osteoporosis

Ábendingar:

Movymia is indicated in adults.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 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.

Vörulýsing:

Revision: 10

Leyfisstaða:

Authorised

Leyfisdagur:

2017-01-11

Upplýsingar fylgiseðill

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOVYMIA 20 MICROGRAMS/80 MICROLITERS SOLUTION FOR INJECTION
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 Movymia is and what it is used for
2.
What you need to know before you use Movymia
3.
How to use Movymia
4.
Possible side effects
5.
How to store Movymia
6.
Contents of the pack and other information
1.
WHAT MOVYMIA IS AND WHAT IT IS USED FOR
Movymia contains the active substance teriparatide that is used to
make the bones stronger, and to
reduce the risk of fractures by stimulating bone formation.
Movymia 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
medicines called corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MOVYMIA
DO NOT USE MOVYMIA
•
if you are allergic to teriparatide or any of the other ingredients of
this medicine (listed in
section 6).
•
if you have high levels of calcium in your blood (pre-existing
hypercalcaemia).
•
if you suffer from serious kidney problems.
•
if you have ever had bone cancer or if other cancers 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 of bone

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Movymia 20 micrograms/80 microliters solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 80 microliters contains 20 micrograms of teriparatide*.
One cartridge of 2.4 mL of solution 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 (injection).
Colourless, clear solution for injection with a pH of 3.8 – 4.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Movymia 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 Movymia is 20 micrograms administered once
daily.
Patients should receive supplemental calcium and vitamin D supplements
if dietary intake is
inadequate.
The maximum total duration of treatment with teriparatide should be 24
months (see section 4.4). The
24-month course of teriparatide should not be repeated over a
patient’s lifetime.
Following cessation of teriparatide therapy, patients may be continued
on other osteoporosis therapies.
3
_Special populations_
_Renal impairment_
Teriparatide must not be used in patients with severe renal impairment
(see section 4.3). In patients
with moderate renal impairment, teriparatide should be used with
caution. No special caution is
required for patients with mild renal impairment.
_Hepatic impair