Zoledronic acid Teva Pharma
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
12-12-2018
Produktets egenskaber
(SPC)
12-12-2018
Offentlige vurderingsrapport
(PAR)
12-12-2018
Aktiv bestanddel:
zoledronic acid
Tilgængelig fra:
Teva B.V.
ATC-kode:
M05BA08
INN (International Name):
zoledronic acid
Terapeutisk gruppe:
Drugs for treatment of bone diseases
Terapeutisk område:
Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Terapeutiske indikationer:
Treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. Treatment of Paget’s disease of the bone in adults.,
Produkt oversigt:
Revision: 11
Autorisation status:
Withdrawn
Autorisation dato:
2012-08-15
Indlægsseddel
53
B. PACKAGE LEAFLET
Medicinal product no longer authorised
54
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ZOLEDRONIC ACID TEVA PHARMA 5 MG SOLUTION FOR INFUSION IN BOTTLES
zoledronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.
-
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zoledronic acid Teva Pharma is and what it is used for
2.
What you need to know before you are given Zoledronic acid Teva Pharma
3.
How Zoledronic acid Teva Pharma is given
4.
Possible side effects
5.
How to store Zoledronic acid Teva Pharma
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID TEVA PHARMA IS AND WHAT IT IS USED FOR
Zoledronic acid Teva Pharma contains the active substance zoledronic
acid. It belongs to a group of
medicines called bisphosphonates and is used to treat post-menopausal
women and adult men with
osteoporosis or osteoporosis caused by treatment with corticosteroids
used to treat inflammation, and
Paget’s disease of the bone in adults.
OSTEOPOROSIS
Osteoporosis is a disease that involves the thinning and weakening of
the bones and is common in
women after the menopause, but can also occur in men. At the
menopause, a woman’s ovaries stop
producing the female hormone oestrogen, which helps keep bones
healthy. Following the menopause
bone loss occurs, bones become weaker and break more easily.
Osteoporosis could also occur in men
and women because of the long term use of steroids, which can affect
the strength of bones. Many
patients with osteoporosis have no symptoms but they are still at risk
of breaking bones because
osteoporosis has made their bones weaker. Decreased circulating levels
of sex hormones, mainly
oestrogens converted from androgens, also
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as
monohydrate).
Each ml of the solution contains 0.05 mg zoledronic acid (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis
•
in post-menopausal women
•
in adult men
at increased risk of fracture, including those with a recent
low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic
glucocorticoid therapy
•
in post-menopausal women
•
in adult men
at increased risk of fracture.
Treatment of Paget’s disease of the bone in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients must be appropriately hydrated prior to administration of
Zoledronic acid Teva Pharma. This
is especially important for the elderly (≥ 65 years) and for
patients receiving diuretic therapy.
Adequate calcium and vitamin D intake are recommended in association
with Zoledronic acid Teva
Pharma administration.
_Osteoporosis_
For the treatment of post-menopausal osteoporosis, osteoporosis in men
and the treatment of
osteoporosis associated with long-term systemic glucocorticoid
therapy, the recommended dose is a
single intravenous infusion of 5 mg Zoledronic acid Teva Pharma
administered once a year.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need
for continued treatment should be re-evaluated periodically based on
the benefits and potential risks of
Zoledronic acid Teva Pharma on an individual patient basis,
particularly after 5 or more years of use.
In patients with a recent low-trauma hip fracture, it is recommended
to give the zoledronic acid
infusion at least two weeks after hip
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