Magnevist

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

gadopentetic acid (gadopentetate dimeglumine)

Доступна с:

Bayer Schering Pharma AG

ИНН (Международная Имя):

gadopentetic acid (gadopentetate dimeglumine)

дозировка:

469mg/ml

Фармацевтическая форма:

solution for injection

Тип рецепта:

Prescription

Характеристики продукта

spcde-magnevist-de24.1-jun2011
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PROFESSIONAL USER'S INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Magnevist
®
0.5 mmol/ml, solution for injection
2.
Qualitative and Quantitative Composition
Active substance: dimeglumine gadopentetate
1 ml aqueous injection solution contains 469 mg of gadopentetate
dimeglumine (corresponding
to 0.5 mmol of gadopentetate dimeglumine, corresponding to 78.63 mg of
gadolinium).
For the complete listing of excipients, see Section 6.1.
Concentration of gadopentetate dimeglumine
(mg/ml)
469
(mmol/ml)
0.5
Content of dimeglumine gadopentetate in (g)
5-ml vial
2.3
Vial/ready-to-use syringe
with
10 ml
4.7
Vial/ready-to-use syringe
with
15 ml
7.0
Vial/ready-to-use syringe
with
20 ml
9.4
Vial
with
30 ml
14.1
Bottle
with
100 ml
46.9
3.
DOSAGE FORM
Injection solution.
Clear, particle-free.
Physicochemical and/or physical properties:
pH
7.0-7.9
Viscosity (mPa·s or cP)
at 20°C
4.9
at 37°C
2.9
Osmolality
(mOsm/kg H
2
O)
1960
Specific gravity (g/ml)
at 20°C
1.210
at 37°C
1.195
4.
CLINICAL PARTICULARS:
4.1
THERAPEUTIC INDICATIONS
This drug is a diagnostic agent for intravenous application.
Intravenous injection of Magnevist provides more conclusive diagnostic
information compared
with a scan obtained without contrast medium (plain scan). With
Magnevist, high-contrast
images can be obtained of areas of the brain in which the blood-brain
barrier is impaired or
absent or of body regions with an altered blood supply (perfusion) or
altered extracellular
spaces.
_Cranial and spinal magnetic resonance tomography (MRT)_
_ _
In particular for tumour detection and for other differential
diagnostics clarification when there
is suspicion of
spcde-magnevist-de24.1-jun2011
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-
meningioma,
-
(acoustic) neurinoma,
-
tumours with infiltrative growth (e.g. glioma) and metastases.
•
For verification of small and/or isointensive tumours,
•
where there is suspicion of recurrence following operations or
radiation therapy,
•
for
differentiated
presentation
of
rare
neoplasias
such
as
hemang