Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ioversol
DKSH MALAYSIA SDN BHD
Ioversol
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
Liebel-Flarsheim Canada Inc.
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. Olvassa el a teljes dokumentumot