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Certican山萊恩

Certican

everolimus

Manufacturer:

Novartis

Distributor:

DKSH
/
Four Star
Concise Prescribing Info
Contents
Everolimus
Indications/Uses
Prophylaxis of organ rejection at low to moderate immunological risk receiving renal, hepatic or cardiac transplant. In combination w/ ciclosporin (for microemulsion) & corticosteroids. In combination w/ tacrolimus & corticosteroids in hepatic transplant.
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Dosage/Direction for Use
Adult Renal or cardiac transplant Initially 0.75 mg bd administered after transplantation. Hepatic transplant 1 mg bd w/ initial dose approx 4 wk after transplantation. Adjust dose at 4-5 days intervals based on achieved blood levels, tolerability, response, change in co-medications & clinical situation.
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Overdosage
View Certican overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Take consistently either always w/ or always w/o meals. Swallow whole, do not chew/crush. Avoid grapefruit juice.
Contraindications
Hypersensitivity to everolimus & sirolimus.
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Special Precautions
Management of immunosuppression. Combination w/ thymoglobulin induction. Serious & opportunistic infections. Liver function impairment.  Lymphomas. Monitor for skin neoplasms & minimise exposure to UV light, sunlight & use sunscreen. Hyperlipidemia. Angioedema. Everolimus & calcineurin inhibitor-induced renal dysfunction. Proteinuria. Renal graft thrombosis. Wound-healing combinations. Thrombotic microangiopathy/thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome. Vaccination. Interstital lung disease/non-infectious pneumonitis. New onset DM. Male infertility may occur in prolonged use. Rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. Black patients. Childn & adolescents. Pregnancy & lactation.
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Adverse Reactions
Viral, bacterial & fungal infections, upper & lower resp tract infection, sepsis, UTI, wound infection, leucopenia, hyperlipidaemia, pericardial & pleural effusion, HTN, abdominal pain, peripheral oedema, incisional hernia.
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Drug Interactions
Strong & moderate CYP3A4 inhibitors/inducers. Increased bioavailability w/ ciclosporin. Increased clearance & decreased Cmax & AUC of midazolam. Increased blood levels w/ fluconazole, erythromycin, verapamil, nicardipin, diltiazem, nelfinavir, indinavir, amprenavir. Increased metabolism & decreased blood levels w/ St. John's wort, carbamazepine, phenobarb, phenytoin, efavirenz, nevirapine. Grapefruit juice; live vaccines.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Certican detailed prescribing information
Storage
View Certican storage conditions for details to ensure optimal shelf-life.
Description
View Certican description for details of the chemical structure and excipients (inactive components).
Action
View Certican mechanism of action for pharmacodynamics and pharmacokinetics details.
MIMS Class
Immunosuppressants
ATC Classification
L04AH02 - everolimus ; Belongs to the class of mammalian target of rapamycin (mTOR) kinase inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Certican tab 0.25 mg
Packing/Price
60's
Form
Certican tab 0.5 mg
Packing/Price
60's
Form
Certican tab 0.75 mg
Packing/Price
60's
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