OPTIRAY 320

Country: Malaysia

Language: English

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

Active ingredient:

Ioversol

Available from:

DKSH MALAYSIA SDN BHD

INN (International Name):

Ioversol

Units in package:

50 ml 10 Units mL; 50 ml 10 Units mL; 125 ml 10 Units mL; 100 ml 10 Units mL; 200 ml 10 Units mL

Manufactured by:

Liebel-Flarsheim Canada Inc.

Summary of Product characteristics

OPTIRAY 320
(ioversol injection 68%, 320 mgI/mL)
OPTIRAY 350
(ioversol injection 74%, 350 mgI/mL)
THERAPEUTIC OR PHARMA COLOGICAL CLASSIFICATION
No n-ion ic, l ow os molality, water sol uble radio paq ue
Contrast m ed ium for intra vascul ar use
A. GENERAL
ACT IONS AND CLIN ICAL PH ARM AC OLOGY
The pharmacoki netics of Optiray (iov ersol) in normal sub jec ts conform to an op en two com partment
model with first order eli mination (a rap id alpha ph ase of 6.8 minutes for drug distr ibution and a
slower beta phase of 92 minutes, for drug eliminati on.) Based on the blood cl earance curv es for 12
healthy vol un teers (6 rece iving 50 mL an d 6 receiving 150 mL of Optiray 32 0), the bio log ical half -life
was 1.5 hours for both do se leve ls and there was no evide nce of any dose rel ated differ ence in the
rate of elimi nation. The mean half -life for urin ary excretion fol low ing a 50 mL d ose w as 118 minutes
(10 5-156) an d followi ng a 150 mL d ose was 105 mi nutes.
Optiray is ex creted mai nly through the kidne ys followi ng intravascul ar administration, Fecal
elimination is 3-9%. Approximately 50% of the injected dose is excret ed at 1.5 hours and 86% at
48 hours: about 1.5% is retained, mos tly by the thyroid and liver. In patien ts with im pair ed renal
function and in infants with immature ki dneys, the elimination hal f-life is pro lon ged. In patients with
severe r enal dis ease, excretion do es n ot occ ur.
Optiray like all other contr ast me dia, may induce cha nges in thyroid function in some
patie nts, a nd ele vation of t hyroxine and/or TSH m ay be obser ved.