CYCLOLUX 0.5 MMOLML SOLUTION FOR INJECTION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Gadoteric acid (as meglumine salt)

Available from:

FARMACO HEALTHCARE SDN. BHD.

INN (International Name):

Gadoteric acid (as meglumine salt)

Units in package:

1 x 15 ml Vials; 10 x 10 ml Vials; 1 x 10 ml Vials; 10 x 15 ml Vials; 1 x 20 ml Vials; 10 x 20 ml Vials

Manufactured by:

Sanochemia Pharmazeutika GmbH

Summary of Product characteristics

CYCLOLUX
0.5 MMOL/ML SOLUTION FOR INJECTION
1. NAME OF THE MEDICINAL
PRODUCT
CYCLOLUX
0.5 mmol/ml solution for injection
2. QUALITATIVE AND QUANTI-
TATIVE COMPOSITION
1 ml solution for injection contains
279.32 mg gadoteric acid (as me-
glumine salt) corresponding to Gad-
olinium (III) oxide 90.62mg, DOTA
202.21mg, Meglumine 97.6mg.
For the full list of excipients, see
section 6.1.
3. PHARMACEUTICAL FORM
Gadoteric acid (as meglumine salt) is a clear,
colourless to pale yellowish solution, free
from visible particulates.
Contrast medium
concentration
279.32 mg/ml
0.5 mmol/ml
Osmolality at 37°C
1.35 Osm/kg H
2
O
Viscosity at 37°C
1.8 mPas
pH value
6.5 – 8.0
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use
only.
Cyclolux should be used only when diagnos-
tic information is essential and not available
with unenhanced magnetic resonance imag-
ing (MRI).
Magnetic resonance imaging for:
• Cerebral and spinal disease
• Disease of the vertebral column
• and
other
whole-body
pathologies
(in-
cluding Angiography)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest dose that provides sufficient en-
hancement for diagnostic purposes should
be used. The dose should be calculated based
on the patient’s body weight, and should not
exceed the recommended dose per kilogram
of body weight detailed in this section.
Adults
Cyclolux should always be administered by med-
ically qualified personnel.
The doses are determined by the physician and
are adapted to each individual’s needs.
The recommended dose is 0.2ml/kg (0.1mmol/kg)
in adult, children and infant.
In angiography, depending on the result of ex-
amination being performed, a second injection
may be administered during the same session if
necessary.
In some exceptional cases, as in the confirma-
tion of isolated metastasis or the detection of
leptomeningeal tumours, a second injection of
0.4ml/kg (0.2mmol/kg) can be administered.
SPECIAL POPULATIONS
Impaired renal function
The adult dose applies to patients