Aclasta solution for infusion

Երկիր: Հայաստան

Լեզու: անգլերեն

Աղբյուրը: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ակտիվ բաղադրիչ:

zoledronic acid (zoledronic acid monohydrate)

Հասանելի է:

Novartis Pharma Stein AG

ATC կոդը:

M05BA08

INN (Միջազգային անվանումը):

zoledronic acid (zoledronic acid monohydrate)

Դոզան:

0,05mg/ml

Դեղագործական ձեւ:

solution for infusion

Միավորները փաթեթում:

100ml plastic vial

Ռեկվիզորի տեսակը:

Prescription

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2018-11-07

Ապրանքի հատկությունները

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.
3
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
fracture, a loading dose of 50 000 to 125 000 IU of vitamin D given
orally or via