Zolestad 5 mg/100 ml, oplossing voor infusie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ZOLEDRONINEZUUR 1-WATER SAMENSTELLING overeenkomend met ; ZOLEDRONINEZUUR 0-WATER

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

M05BA08

INN (Algemene Internationale Benaming):

Zoledronic acid 1-WATER COMPOSITION corresponding to ; zoledronic acid 0-WATER

farmaceutische vorm:

Oplossing voor infusie

Samenstelling:

MANNITOL (D-) (E 421) ; STIKSTOF (HEAD SPACE) (E 941) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE,

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Zoledronic Acid

Product samenvatting:

Hulpstoffen: MANNITOL (D-) (E 421); STIKSTOF (HEAD SPACE) (E 941); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE;

Autorisatie datum:

2017-03-29

Bijsluiter


PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLESTAD 5 MG/100 ML, OPLOSSING VOOR INFUSIE
Zoledronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE,
BECAUSE IT CONTAINS
INPORTANT 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 Zolestad is and what it is used for
2.
What you need to know before you are given Zolestad
3.
How Zolestad is given
4.
Possible side effects
5.
How to store Zolestad
6.
Contents of the pack and other information
1.
WHAT ZOLESTAD IS AND WHAT IT IS USED FOR
Zolestad 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, Zolestad strengthens the bone and therefore makes it
less likely to break.
Zolestad is also used in patients who ha

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zolestad 5 mg/100 ml, oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial 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).
Excipient(s) with known effect
This medicinal product contains less than 1 mmol sodium (23 mg) per
100 ml of Zolestad, i.e.
essentially ‘sodium free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless, sterile solution.
pH: 5.50-7.00
Osmolality (Osmol / kg): 0.23-0.33
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
Zolestad. 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 Zolestad
administration.
2
_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 Zolestad 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 Zolestad 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