Cardiolek-320 Injection 320 mg

Země: Tanzanie

Jazyk: angličtina

Zdroj: Tanzania Medicinces & Medical Devices Authority

Aktivní složka:

Iodixanol

Dostupné s:

Unique Pharmaceutical Laboratories (A division of J.B. Chemicals & Pharmaceuticals Ltd), INDIA

ATC kód:

X-raycontrastmedium, iodinated

INN (Mezinárodní Name):

Iodixanol

Dávkování:

320 mg

Léková forma:

Injection

Výrobce:

Unique Pharmaceutical Laboratories (A Div. Of. J. B. Chemicals & Pharmaceutical Ltd), INDIA

Přehled produktů:

Physical description: Clear, colourless slightly viscous liquid, free from foreign matter; Local technical representative: JILICHEM (T) Limited (5053)

Stav Autorizace:

Registered/Compliant

Datum autorizace:

2021-06-03

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CARDIOLEK-320
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains;
Iodixanol USP--------------652 mg equivalent to 320 mg of Iodine
3
PHARMACEUTICAL FORM
Physical description/appearance of the product: Clear, colorless
slightly
viscous liquid. Free from foreign matter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
X-ray
contrast
medium
for
use
in
adults
for
cardioangiography,
cerebral
angiography
(conventional
and
i.a.DSA),
peripheral
arteriography
(conventional
and
i.a.DSA),
abdominal
angiography
(i.a.DSA), urography, venography, CT-enhancement.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
To be administered Intravenous & Intra-arterial
4.3
CONTRAINDICATIONS
Hypersensitivity to Iodixanol or any components of its formulation.
Manifested thyrotoxicosis. Decompensated cardiac insufficiency.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE WARNINGS:
The risk of serious reactions in connection with use of CARDIOLEK is
regarded as very minor. However, iodinated contrast media may provoke
serious or fatal reactions, anaphylactoid reactions or other
manifestations
of hypersensitivity. A course of action should therefore be planned in
advance with necessary drugs and equipment available for immediate
treatment, should a serious reaction occur.
A property of non-ionic contrast media is the low interference with
normal
physiological
functions.
As
a
consequence
of
this,
non-ionic
contrast
media have less anticoagulant activity in vitro than ionic media. When
performing vascular catheterization procedures one should be aware of
this and pay meticulous attention to the angiographic technique and
flush
the catheter frequently with physiological saline (if necessary with
the
addition
of
heparin)
so
as
to
minimize
the
risk
of
procedure-related
thrombosis and embolism.
Iodinated contrast media may give rise to transient renal dysfunction
or
failure. Patients with preexisting renal dysfunction, diabet