Teriparatide Sun

国: 欧州連合

言語: 英語

ソース: EMA (European Medicines Agency)

有効成分:

teriparatide

から入手可能:

Sun Pharmaceutical Industries Europe B.V.

ATCコード:

H05AA02

INN（国際名）:

teriparatide

治療群:

Calcium homeostasis

治療領域:

Osteoporosis; Osteoporosis, Postmenopausal

適応症:

Teriparatide SUN 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).

製品概要:

Revision: 1

認証ステータス:

Authorised

承認日:

2022-11-18

情報リーフレット

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
TERIPARATIDE SUN 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 Teriparatide SUN is and what it is used for
2.
What you need to know before you use Teriparatide SUN
3.
How to use Teriparatide SUN
4.
Possible side effects
5.
How to store Teriparatide SUN
6.
Content of the pack and other information
1.
WHAT TERIPARATIDE SUN IS AND WHAT IT IS USED FOR
Teriparatide SUN contains the active substance teriparatide that is
used to make the bones stronger,
and to reduce the risk of fractures by stimulating bone formation.
Teriparatide SUN 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 TERIPARATIDE SUN
DO NOT USE TERIPARATIDE SUN
-
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

製品の特徴

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Teriparatide SUN 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 2.4 ml contains 600 micrograms of teriparatide
(corresponding to
250 micrograms per ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution free from visible particles.
The pH is between 3.8 and 4.5. The osmolality is between 250 to 350
mOsmol.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Teriparatide SUN 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
teriparatide is 20 micrograms administered once daily.
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.
Patients should receive supplemental calcium and vitamin D supplements
if dietary intake is
inadequate.
Following cessation of teriparatide therapy, patients may be continued
on other osteoporosis therapies.
Special populations
_ _
_Elderly patients _
Dose adjustment based on age is not required (see section 5.2).
3
_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 impairment _