Aclasta
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
06-12-2023
Vara einkenni
(SPC)
06-12-2023
Opinber matsskýrsla
(PAR)
28-07-2015
Virkt innihaldsefni:
zoledronic acid
Fáanlegur frá:
Sandoz Pharmaceuticals d.d.
ATC númer:
M05BA08
INN (Alþjóðlegt nafn):
zoledronic acid
Meðferðarhópur:
Drugs for treatment of bone diseases
Lækningarsvæði:
Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Ábendingar:
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 and in men at increased risk of fracture. Treatment of Paget's disease of the bone.,
Vörulýsing:
Revision: 31
Leyfisstaða:
Authorised
Leyfisdagur:
2005-04-15
Upplýsingar fylgiseðill
31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACLASTA 5 MG SOLUTION FOR INFUSION
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 Aclasta is and what it is used for
2.
What you need to know before you are given Aclasta
3.
How Aclasta is given
4.
Possible side effects
5.
How to store Aclasta
6.
Contents of the pack and other information
1.
WHAT ACLASTA IS AND WHAT IT IS USED FOR
Aclasta 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 play a role in the more
gradual bone loss observed in men.
In both women and men, Aclasta strengthens the bone and therefore
makes it less likely to break.
Aclasta is also used in patients who
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aclasta 5 mg solution for infusion
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
Aclasta. 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 Aclasta 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 Aclasta 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
Aclasta 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 Aclasta infusion at
least two weeks after hip fracture repair (see section 5.1). In
patients with a recent low-trauma hip
3
fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given
orally or via
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