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In experimental models, mycophenolate mofetil was not tumourigenic. In 12 healthy volunteers, the mean absolute bioavailability of oral mycophenolate mofetil relative to i.

Gastro-intestinal CellCept has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.

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If you would like to make a comment or send us feedback on this material, click here. CellCept should be administered with caution in patients with active serious digestive system disease.

Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in mycophenolate mofetil capsules. Action And Clinical Pharmacology: Reporting suspected adverse reactions after authorisation of the medicinal product is important. How to Take It Caregivers administering mycophenolate should wear gloves when handling it due to concern with pregnancy risks and effects on the immune system.

CellCept tablets microcrystalline cellulose polyvidone K croscarmellose sodium magnesium stearate Tablet coating hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide E polyethylene glycol indigo carmine aluminium lake E red iron oxide E The principal adverse reactions associated with the administration of CellCept in combination with ciclosporin and corticosteroids include diarrhoea, leucopenia, sepsis and vomiting, and there is evidence of a higher frequency of certain types of infections see section 4.

Ganciclovir Based on the results of a single dose administration study of recommended doses of oral mycophenolate and IV ganciclovir and the known effects of renal impairment on the pharmacokinetics of CellCept see section 4. MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.

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Marketing authorisation holder 8. When comparing rates of transplant rejection or rates of graft loss between CellCept patients taking PPIs vs. These are insufficient to make dosage recommendations and therefore use in this age group is not recommended. There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving CellCept in combination with other immunosuppressants. Please check that this is the correct company before contacting them.

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This dose represents 0. Use in special populations. Multiple dosing of mycophenolate mofetil in patients with severe chronic renal impairment has not been studied. The educational materials will reinforce the warnings about the teratogenicity of mycophenolate, provide advice on contraception before therapy is started and guidance on the need for pregnancy testing.

Reporting of suspected adverse reactions.

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Safety and efficacy in children have not been established. As some adverse reactions occur with greater frequency in this age group see section 4.

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Caution should be used with medicinal products that interfere with enterohepatic circulation because of their potential to reduce the efficacy of CellCept. No pharmacokinetic data are available during hepatic transplant rejection.