Iomeron

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Iomeprol 306mg;  ;  

제공처:

Regional Health Ltd

INN (국제 이름):

Iomeprol 306 mg

복용량:

150 mg iodine/mL

약제 형태:

Solution for injection

구성:

Active: Iomeprol 306mg     Excipient: Hydrochloric acid Trometamol Water for injection

패키지 단위:

Bottle, glass, 10 x 50 mL (not marketed), 500 mL

수업:

General sale

처방전 유형:

General sale

Manufactured by:

Spin SpA

제품 요약:

Package - Contents - Shelf Life: Bottle, glass, 10 x 50 mL - 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 200 mL - 2000 mL - 60 months from date of manufacture stored at or below 30°C protect from light. (Type II glass (Ph Eur))

승인 날짜:

1993-08-16

제품 특성 요약

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 _