Aclasta solution for infusion

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

zoledronic acid (zoledronic acid monohydrate)

Dostupné s:

Novartis Pharma Stein AG

ATC kód:

M05BA08

INN (Mezinárodní Name):

zoledronic acid (zoledronic acid monohydrate)

Dávkování:

0,05mg/ml

Léková forma:

solution for infusion

Jednotky v balení:

100ml plastic vial

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2018-01-26

Charakteristika produktu

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
3
least two weeks after hip fracture repair (see section 5.1). In
patients with a recent low-trauma hip
fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given
orally or vi