Zoledronic acid Teva Generics

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

zoledronic acid monohydrate

Available from:

Teva Generics B.V

ATC code:

M05BA08

INN (International Name):

zoledronic acid

Therapeutic group:

Bisphosphonates

Therapeutic area:

Osteoporosis; Osteitis Deformans

Therapeutic indications:

Treatment of osteoporosisin post-menopausal womenin adult menat increased risk of fracture, including those with recent low-trauma hip fracture.Treatment of osteoporosis associated with long-term systemic glucocorticoid therapyin post-menopausal womenin adult menat increased risk of fracture.Treatment of Paget's disease of the bone in adults.

Product summary:

Revision: 2

Authorization status:

Withdrawn

Authorization date:

2014-03-27

Patient Information leaflet

51
B. PACKAGE LEAFLET
Medicinal product no longer authorised
52
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ZOLEDRONIC ACID TEVA GENERICS 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 Generics is and what it is used for
2.
What you need to know before you are given Zoledronic acid Teva
Generics
3.
How Zoledronic acid Teva Generics is given
4.
Possible side effects
5.
How to store Zoledronic acid Teva Generics
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID TEVA GENERICS IS AND WHAT IT IS USED FOR
Zoledronic acid Teva Generics 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 steroids, 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 m

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Zoledronic acid Teva Generics 5 mg solution for infusion in bottles
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle 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. This is especially
important for the elderly and for patients receiving diuretic therapy.
Adequate calcium and vitamin D intake are recommended in association
with zoledronic acid 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 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 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 fracture repair (see section 5.1). In
patients with a recent low-trauma hip fractur