Evoloxa powder lyophilized for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

zoledronic acid (zoledronic acid monohydrate)

Available from:

PharmaTech CJSC

ATC code:

M05BA08

INN (International Name):

zoledronic acid (zoledronic acid monohydrate)

Dosage:

4mg

Pharmaceutical form:

powder lyophilized for solution for infusion

Units in package:

(1) glass vial 5ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-11-20

Patient Information leaflet

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOLOXA
®
(ZOLEDRONIC ZCID 4 MG/VIAL) POWDER LYOPHILIZED FOR SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT 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.
˗
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
- 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.
IN THIS LEAFLET:
1. What EVOLOXA
®
is and what it is used for
2. What you need to know before you are given EVOLOXA
®
3. How EVOLOXA
®
is given
4. Possible side effects
5. How to store EVOLOXA
®
6. Contents of the pack and other information
1.
WHAT EVOLOXA
® IS AND WHAT IT IS USED FOR
EVOLOXA
®
4 mg/vial powder lyophilized for solution for infusion 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 estrogen, 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
Pha

Summary of Product characteristics

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