Aclasta 5mg100ml Solution for Infusion

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

zoledronic acid

Dostupné z:

SANDOZ SINGAPORE PTE. LTD.

ATC kód:

M05BA08

Dávkovanie:

5mg

Forma lieku:

INFUSION, SOLUTION

Zloženie:

zoledronic acid 5mg

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

Prescription Only

Výrobca:

Fresenius Kabi Austria GmbH

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2006-03-30

Príbalový leták

 1 
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
anhydrous, corresponding to 
5.330 mg zoledronic acid monohydrate. 

One ml solution contains 0.05 mg zoledronic acid anhydrous,
corresponding to 0.0533 mg zoledronic 
acid monohydrate. 

For a full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Solution for infusion 

The solution is sterile, clear and colorless. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Treatment of osteoporosis 


in post-menopausal women 


in men 
at increased risk of fracture, including those with a
recent low-trauma hip fracture. 

To prevent glucocorticoid-induced bone mineral density loss and
to increase bone mineral density in 
post-menopausal women and men on long-term glucocorticoid use, who
are at increased risk of 
fracture 
Prevention of osteoporosis in post-menopausal women with increased
risk of osteoporosis. 

Treatment of Paget’s disease of the bone. 

The optimal duration of use of bisphosphates for the
treatment of osteoporosis has not been 
determined. All patients on bisphosphonate therapy should have the
need for continued therapy re-
evaluated on a periodic basis.  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

For the treatment of post-menopausal osteoporosis, osteoporosis in
men and the prevention and 
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. 

In patients with a recent low-trauma hip fracture, it is recommended
to give the Aclasta infusion two 
or more weeks after hip fracture repair (see section 5.1). 

Novartis 
  Page 2 
Country Specific�

Súhrn charakteristických

Page 1 of 14
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
anhydrous, corresponding to
5.330 mg zoledronic acid monohydrate.
One ml solution contains 0.05 mg zoledronic acid anhydrous,
corresponding to 0.0533 mg zoledronic
acid monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
The solution is sterile, clear and colorless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis
•
in post-menopausal women
•
in men
at increased risk of fracture, including those with a recent
low-trauma hip fracture.
To prevent glucocorticoid-induced bone mineral density loss and to
increase bone mineral density in
post-menopausal women and men on long-term glucocorticoid use, who are
at increased risk of
fracture.
Prevention of osteoporosis in post-menopausal women with increased
risk of osteoporosis.
Treatment of Paget’s disease of the bone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For the treatment of post-menopausal osteoporosis, osteoporosis in men
and the prevention and
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.
In patients with a recent low-trauma hip fracture, it is recommended
to give the Aclasta infusion two
or more weeks after hip fracture repair (see section 5.1).
For the prevention of postmenopausal osteoporosis, the recommended
regimen is a single intravenous
infusion of 5 mg Aclasta. An annual assessment of the patient's risk
of fracture and clinical response to
treatment should guide the decision of when re-treatment should occur.
For
the
prevention
of
postmenopausal
osteoporosis
it
is
important
that
patients
be
adequately
supplemented with calcium and vitamin D if dietary intake is
inadequate (see section 4.4).
Page
2
of
14
For the treatment of Paget’s disease, Aclas