not recommended. Certican has not been evaluated with full dose tacrolimus in controlled clinical trials. OVERDOSAGE In animal studies, everolimus showed a low acute toxic potential. No lethality or severe toxicity was observed after single oral doses of 2000 mg/kg (limit test) in either mice or rats. Reported experience with overdose in humans is very limited. is a single case of an accidental ingestion of 1.5 mg everolimus in a 2-year old child where no adverse events were observed. Single doses up to 25 mg have been administered to transplant patients with acceptable acute tolerability. General supportive measures should be initiated in all cases of overdose. The Poisons Information Centre (telephone 13 11 26) is available for advice. PRESENTATION AND STORAGE CONDITIONS Certican tablets to yellowish, marbled, round, flat with bevelled edge) 0.25mg (engraved with on one side and on the 60’s; 0.50 mg (engraved with “C” “” “CH” on one side and on the other): 60’s; 0.75 mg (engraved with on one side and on the “” “CL” “” other): 60’s; 1.0 mg (engraved with on one side and on the other): 50’s, 60’s, 100’s, “CU” “” 120’s. Certican dispersible tablets (white to yellowish, marbled, round, flat with bevelled edge) 0.10mg (engraved with on one side and on the other): 0.25mg (engraved with on one “I” “” “JO” side and on the other): 50’s, 60’s, 100’s, 120’s “” Not all presentations are marketed in Australia. Store below 30°C in the original packaging. Protect from light and moisture. NAME AND ADDRESS OF THE SPONSOR Novartis Pharmaceuticals Australia Pty Limited ( No: 18 004 244 160) 54 Waterloo Road NORTH RYDE NSW 2113 ® = Registered Trademark POISON SCHEDULE OF THE MEDICINE Prescription Only Medicine (Schedule 4) DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (THE ARTG) 17 March 2005
not recommended. Certican has not been evaluated with full dose tacrolimus in controlled clinical trials. OVERDOSAGE In animal studies, everolimus showed a low acute toxic potential. No lethality or severe toxicity was observed after single oral doses of 2000 mg/kg (limit test) in either mice or rats. Reported experience with overdose in humans is very limited. is a single case of an accidental ingestion of 1.5 mg everolimus in a 2-year old child where no adverse events were observed. Single doses up to 25 mg have been administered to transplant patients with acceptable acute tolerability. General supportive measures should be initiated in all cases of overdose. The Poisons Information Centre (telephone 13 11 26) is available for advice. PRESENTATION AND STORAGE CONDITIONS Certican tablets to yellowish, marbled, round, flat with bevelled edge) 0.25mg (engraved with “C” on one side and “” on the 60’s; 0.50 mg (engraved with “CH” on one side and “” on the other): 60’s; 0.75 mg (engraved with “CL” on one side and “” on the other): 60’s; 1.0 mg (engraved with “CU” on one side and “” on the other): 50’s, 60’s, 100’s, 120’s. Certican dispersible tablets (white to yellowish, marbled, round, flat with bevelled edge) 0.10mg (engraved with “I” on one side and “” on the other): 0.25mg (engraved with “JO” on one side and “” on the other): 50’s, 60’s, 100’s, 120’s Not all presentations are marketed in Australia. Store below 30°C in the original packaging. Protect from light and moisture. NAME AND ADDRESS OF THE SPONSOR Novartis Pharmaceuticals Australia Pty Limited ( No: 18 004 244 160) 54 Waterloo Road NORTH RYDE NSW 2113 ® = Registered Trademark POISON SCHEDULE OF THE MEDICINE Prescription Only Medicine (Schedule 4) DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (THE ARTG) 17 March 2005
auspar-everolimus-130521-pi.docx