Manufacturer
NOVARTIS PHARMA STEIN AG
Contents
Everolimus
Indication
In combination w/ ciclosporin for microemulsion & corticosteroids for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. In combination w/ tacrolimus & corticosteroids for the prophylaxis of organ rejection in patients receiving hepatic transplant.
Instruction
Administration in a 10 mL oral syringe: Place the Certican dispersible tablets into a syringe. The maximum amount of Certican that can be dispersed in a 10 mL syringe is 1.25 mg. Add water to the 5 mL mark. Wait 90 sec while shaking gently. After dispersion deliver directly into the mouth. Rinse the syringe with 5 mL water and administer into the mouth. Further drink 10 to 100 mL of water, or diluted syrup.
Administration with a plastic cup: Place the Certican dispersible tablets in approximately 25 mL of water in a plastic cup. The maximal amount of Certican that can be dispersed in 25 mL of water is 1.5 mg. The cup is left for approx. 2 minutes to allow the tablets to dissolve and gently agitated before drinking. Immediately rinse the cup with an additional 25 mL of water and drink completely.
Administration via nasogastric tube: Place the Certican dispersible tablets in a small plastic medicine beaker, which contain 10 mL water, wait 90 sec while swirling gently. Put the dispersion into a syringe and inject slowly (within 40 sec) into the nasogastric tube. Rinse the beaker (and the syringe) 3 times with 5 mL water and inject into the tube. Finally flush the tube with 10 mL water. The nasogastric tube should be clamped for a minimum of 30 minutes after Certican administration.
Drug interaction
CYP3A4 & CYP2D6 substrates w/ narrow therapeutic index. Rifampicin, rifabutin or ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin or ritonavir, midazolam, St. John's wort, erythromycin, fluconazole, phenytoin, carbamazepine, phenobarb, Ca-channel blockers, PIs, anti-HIV drugs. Grapefruit & grapefruit juice; live vaccines.
Malaysia
