Evoloxa powder lyophilized for solution for infusion

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

zoledronic acid (zoledronic acid monohydrate)

Mevcut itibaren:

PharmaTech CJSC

ATC kodu:

M05BA08

INN (International Adı):

zoledronic acid (zoledronic acid monohydrate)

Doz:

4mg

Farmasötik formu:

powder lyophilized for solution for infusion

Paketteki üniteler:

(1) glass vial 5ml and(1) glass vial with solvent

Reçete türü:

Prescription

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2021-04-16

Ürün özellikleri

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
1
SUMMARY OF PRODUCT CHARACTERISTICS
EVOLOXA
®
(ZOLEDRONIC ACID 4 MG /VIAL )
POWDER LYOPHILIZED FOR SOLUTION FOR INFUSION
_1. NAME _
_1.1 NAME OF THE MEDICINAL PRODUCT _
_ _
EVOLOXA
®
_1.2 INTERNATIONAL NON-PROPRIETARY NAME (INN): _
Zoledronic acid
_2. QUALITATIVE AND QUANTITATIVE COMPOSITION: _
Each vial contains:
Zoledronic acid …4,0 mg
as zoledronic acid monohydrate…4,26 mg
For the full list of excipients, see section 6.1
_3._
_ _
_PHARMACEUTICAL FORM _
Powder lyophilized for solution for infusion
Off white colored lyophilised powder
_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.
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
2
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _
Posology
Patients must be appropriately hydrated prior to administration of
EVOLOXA
®
. 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
EVOLOXA
®
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 EVOLOXA
®
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
EVOLOXA
®
on an individu