Qutavina

Šalis: Europos Sąjunga

kalba: anglų

Šaltinis: EMA (European Medicines Agency)

Veiklioji medžiaga:

teriparatide

Prieinama:

EuroGenerics Holdings B.V.

ATC kodas:

H05AA02

INN (Tarptautinis Pavadinimas):

teriparatide

Farmakoterapinė grupė:

Calcium homeostasis

Gydymo sritis:

Osteoporosis

Terapinės indikacijos:

Qutavina 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 have been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Autorizacija statusas:

Withdrawn

Leidimo data:

2020-08-27

Pakuotės lapelis

21
B. PACKAGE LEAFLET
Medicinal product no longer authorised
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUTAVINA 20 MICROGRAMS/80 MICROLITERS SOLUTION FOR INJECTION IN
PRE-FILLED PEN
teriparatide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Qutavina is and what it is used for
2.
What you need to know before you use Qutavina
3.
How to use Qutavina
4.
Possible side effects
5.
How to store Qutavina
6.
Contents of the pack and other information
1.
WHAT QUTAVINA IS AND WHAT IT IS USED FOR
Qutavina contains the active substance teriparatide that is used to
make the bones stronger, and to
reduce the risk of fractures by stimulating bone formation.
Qutavina 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 QUTAVINA
DO NOT USE QUTAVINA

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 ca

Prekės savybės

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Qutavina 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*.
Each pre-filled pen of 2.7 mL contains 675 micrograms of teriparatide
(corresponding to
250 micrograms per mL).
*Teriparatide, rhPTH(1-34), produced in_ P. fluorescens_, 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
Qutavina 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 Qutavina is 20 micrograms administered once
daily.
The maximum total duration of treatment with Qutavina should be 24
months (see section 4.4).
The 24-month course of Qutavina
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 Qutavina therapy, patients may be continued on
other osteoporosis therapies.
Medicinal product no longer authorised
3
_Special p