Iomeron

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Iomeprol 816mg;  

Dostupné s:

Regional Health Ltd

INN (Mezinárodní Name):

Iomeprol 816 mg

Dávkování:

400 mg iodine/mL

Léková forma:

Solution for injection

Složení:

Active: Iomeprol 816mg   Excipient: Hydrochloric acid Trometamol Water for injection

Jednotky v balení:

Bottle, 10 x 50mL, 500 mL

Třída:

General sale

Druh předpisu:

General sale

Výrobce:

Spin SpA

Přehled produktů:

Package - Contents - Shelf Life: Bottle, 10 x 50mL - 500 mL - 60 months from date of manufacture stored at or below 30°C protect from light. (Type II glass (Ph Eur)) - Bottle, glass, 10 x 100mL - 1000 mL - 60 months from date of manufacture stored at or below 30°C protect from light. (Type II glass (Ph Eur))

Datum autorizace:

1993-08-16

Charakteristika produktu

NEW ZEALAND DATA SHEET, IOMERON®
New Zealand Data Sheet, IOMERON®
Page 1 of 11
1 PRODUCT NAME
IOMERON® (iomeprol) solution for injection 300 mg iodine per mL
IOMERON® (iomeprol) solution for injection 350 mg iodine per mL
IOMERON® (Iomeprol) solution for injection 400 mg iodine per mL
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Iomeprol 612 mg / mL (equivalent to 300 mg iodine per mL)
Iomeprol 714 mg / mL (equivalent to 350 mg iodine per mL)
Iomeprol 816 mg (equivalent to 400 mg iodine per mL)
Excipients:
Trometamol (tromethamine USP), hydrochloric acid (Ph.Eur.), water for
injection (Ph.Eur.).
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
IOMERON® contains as its active principal iomeprol, a tri-iodinated,
non-ionic contrast agent, and is
for use in X ray examinations:
_Iomeron 300: _
Intravenous urography (in adults and paediatrics), peripheral
phlebography, CT
(brain and body), cavernosography, intravenous DSA, conventional
angiography,
intra-arterial DSA, angiocardiography (in adults and paediatrics),
conventional
selective coronary arteriography, interventional coronary
arteriography, ERCP,
arthrography, hysterosalpingography, fistulography, discography,
galactography,
cholangiography, dacryocystography, sialography, retrograde
urethrography,
retrograde pyelo-ureterograpy, myelography.
_Iomeron 350: _
_Intravenous urography (in adults and paediatrics), CT (body),
intravenous DSA, _
_conventional angiography, intra-arterial DSA, angiocardiography (in
adults and _
_paediatrics), conventional selective coronary arteriography,
interventional coronary _
_arteriography, arthrography, hysterosalpingography, fistulography,
galactography, _
_retrograde cholangiography, dacryocystography, sialography. _
_Iomeron 400: _
_ Intravenous urography (in adults including those with renal
impairment or _
_diabetes), CT (body), conventional angiography, intra-arterial DSA, _
_angiocardiography (in adults and paediatrics), conventional selective
coronary _