Terrosa

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

teriparatide

Available from:

Gedeon Richter Plc.

ATC code:

H05AA02

INN (International Name):

teriparatide

Therapeutic group:

Calcium homeostasis

Therapeutic area:

Osteoporosis

Therapeutic indications:

Terrosa 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.

Product summary:

Revision: 6

Authorization status:

Authorised

Authorization date:

2017-01-04

Patient Information leaflet

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
TERROSA 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 Terrosa is and what it is used for
2.
What you need to know before you use Terrosa
3.
How to use Terrosa
4.
Possible side effects
5
How to store Terrosa
6.
Contents of the pack and other information
1.
WHAT TERROSA IS AND WHAT IT IS USED FOR
Terrosa contains the active substance teriparatide that is used to
make the bones stronger, and to
reduce the risk of fractures by stimulating bone formation.
Terrosa 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 TERROSA
DO NOT USE TERROSA
•
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 (

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Terrosa 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
Terrosa 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 Terrosa 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.
_Special populations _
_Renal impairment_
3
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