Zometa concentrate for solution for infusion

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

zoledronic acid (zoledronic acid monohydrate)

Доступна с:

Novartis Pharma Stein AG

код АТС:

M05BA08

ИНН (Международная Имя):

zoledronic acid (zoledronic acid monohydrate)

дозировка:

0.8mg/ml

Фармацевтическая форма:

concentrate for solution for infusion

Штук в упаковке:

(1) glass vial 5ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2017-03-15

Характеристики продукта

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zometa 4 mg/5 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial with 5 ml concentrate contains 4 mg zoledronic acid,
corresponding to 4.264 mg zoledronic
acid monohydrate.
One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Prevention of skeletal related events (pathological fractures, spinal
compression, radiation or
surgery to bone, or tumour-induced hypercalcaemia) in adult patients
with advanced
malignancies involving bone.
-
Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zometa must only be prescribed and administered to patients by
healthcare professionals experienced
in the administration of intravenous bisphosphonates. Patients treated
with Zometa should be given the
package leaflet and the patient reminder card.
Posology
_Prevention of skeletal related events in patients with advanced
malignancies involving bone _
_Adults and older people _
The recommended dose in the prevention of skeletal related events in
patients with advanced
malignancies involving bone is 4 mg zoledronic acid every 3 to 4
weeks.
Patients should also be administered an oral calcium supplement of 500
mg and 400 IU vitamin D
daily.
The decision to treat patients with bone metastases for the prevention
of skeletal related events should
consider that the onset of treatment effect is 2-3 months.
_Treatment of TIH _
_Adults and older people _
The recommended dose in hypercalcaemia (albumin-corrected serum
calcium

12.0 mg/dl or
3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
3
_Renal impairment _
_TIH: _
Zometa treatment in TIH patients who also have severe renal impairment
should be considered only
after evaluating the risks and benef