Prolia
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
22-09-2023
Fachinformation
(SPC)
22-09-2023
Öffentlichen Beurteilungsberichts
(PAR)
12-09-2018
Wirkstoff:
denosumab
Verfügbar ab:
Amgen Europe B.V.
ATC-Code:
M05BX04
INN (Internationale Bezeichnung):
denosumab
Therapiegruppe:
Drugs for treatment of bone diseases
Therapiebereich:
Bone Resorption; Osteoporosis, Postmenopausal
Anwendungsgebiete:
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
Produktbesonderheiten:
Revision: 27
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2010-05-26
Gebrauchsinformation
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROLIA 60 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
denosumab
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.
-
Your doctor will give you a patient reminder card, which contains
important safety information
you need to be aware of before and during your treatment with Prolia.
WHAT IS IN THIS LEAFLET
1.
What Prolia is and what it is used for
2.
What you need to know before you use Prolia
3.
How to use Prolia
4.
Possible side effects
5.
How to store Prolia
6.
Contents of the pack and other information
1.
WHAT PROLIA IS AND WHAT IT IS USED FOR
WHAT PROLIA IS AND HOW IT WORKS
Prolia contains denosumab, a protein (monoclonal antibody) that
interferes with the action of another
protein, in order to treat bone loss and osteoporosis. Treatment with
Prolia makes bone stronger and
less likely to break.
Bone is a living tissue and is renewed all the time. Oestrogen helps
keep bones healthy. After the
menopause, oestrogen level drops which may cause bones to become thin
and fragile. This can
eventually lead to a condition called osteoporosis. Osteoporosis can
also occur in men due to a number
of causes including ageing and/or a low level of the male hormone,
testosterone. It can also occur in
patients receiving glucocorticoids. Many patients with osteoporosis
have no symptoms, but they are
still at risk of breaking bones, especially in the spine, hips and
wrists.
Surgery or medicines that stop the production of oestrogen or
testosterone used to treat patients with
bre
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Prolia 60 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 60 mg of denosumab in 1 mL of
solution (60 mg/mL).
Denosumab is a human monoclonal IgG2 antibody produced in a mammalian
cell line (Chinese
hamster ovary cells) by recombinant DNA technology.
Excipient with known effect
This medicine contains 47 mg sorbitol in each mL of solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women and in men at
increased risk of fractures. In
postmenopausal women Prolia significantly reduces the risk of
vertebral, non-vertebral and hip
fractures.
Treatment of bone loss associated with hormone ablation in men with
prostate cancer at increased risk
of fractures (see section 5.1). In men with prostate cancer receiving
hormone ablation, Prolia
significantly reduces the risk of vertebral fractures.
Treatment of bone loss associated with long-term systemic
glucocorticoid therapy in adult patients at
increased risk of fracture (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 60 mg denosumab administered as a single
subcutaneous injection once
every 6 months into the thigh, abdomen or upper arm.
Patients must be adequately supplemented with calcium and vitamin D
(see section 4.4).
Patients treated with Prolia should be given the package leaflet and
the patient reminder card.
The optimal total duration of antiresorptive treatment for
osteoporosis (including both denosumab and
bisphosphonates) has not been established. The need for continued
treatment should be re-evaluated
periodically based on the benefits and potential risks of denosumab on
an individual patient basis,
particularly after 5 or more years of use (see section 4.4).
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