Kauliv

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

teriparatide

זמין מ:

Strides Pharma (Cyprus) Limited

קוד ATC:

H05AA02

INN (שם בינלאומי):

teriparatide

קבוצה תרפויטית:

Calcium homeostasis

איזור תרפויטי:

Osteoporosis; Osteoporosis, Postmenopausal

סממני תרפויטית:

Kauliv 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).,

leaflet_short:

Revision: 1

מצב אישור:

Authorised

תאריך אישור:

2023-01-12

עלון מידע

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
KAULIV 20 MICROGRAMS/80 MICROLITERS SOLUTION FOR INJECTION
teriparatide
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side affects 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 Kauliv is and what it is used for
2.
What you need to know before you use Kauliv?
3.
How to use Kauliv
4.
Possible side effects
5.
How to store Kauliv?
6.
Contents of the pack and other information
1.
WHAT KAULIV IS AND WHAT IT IS USED FOR
Kauliv contains the active substance teriparatide that is used to make
the bones stronger, and to reduce
the risk of fractures by stimulating bone formation.
Kauliv 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 KAULIV
DO NOT USE KAULIV
•
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 bone

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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
Kauliv 20 micrograms/80 microliters solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 80 microliters contains 20 micrograms of teriparatide*.
Each cartridge of 3 mL of solution contains 750 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 for injection.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Kauliv 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 Kauliv 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 _
_ _
3
_Elderly _
Dose adjustment based on age is not required (see