Sellsept

Roman name

Cellcept

The composition and the form of

1 tablet coated liner contains mofetila mikofenolata 500 mg; blistere in 10 pcs. , in a package of 5 or 15 blisterov.1 capsule contains mofetila mikofenolata 250 mg, in blistere 10 pcs. , in a package of 10 or 30 blisters.

Pharmacokinetics

Quickly and completely absorbed with the formation of the active metabolita. Bioavailability-94% (with a dose). Getting food is not affected by the degree of suction. Once administered six hours a secondary increase its concentration in plasma by enterogepaticescoy circulation; 97% contact albuminom plasma. Metabolized by the action глюкуронилтрансфераз ы with the formation of inactive glukuronida phenol. When administered orally 93% return rate with urine, and 6% from faeces; Most (about 87%) presented with urine in the form of phenol glukuronida.

Farmakodinamika

Suppress guanozinovykh synthesis of nucleotides. More markedly operates on T compared to other cells.

Indications

Prevention and treatment refrakternogo tissue rejection in patients after allogeneic transplant kidneys (in combination with ziklosporinom and korticosteroidami).

Pregnancy and lactation

Appointed where the potential benefits for a mother than the potential risk to the fetus. The choice between breast-feeding or receiving drugs do, in view of the importance of treatment for the mother.

Contraindications

Гиперчувствительност ь (incl. to mikofenolna acid), child.

Side-Effects

Vomiting, diarrhoea, lakopenia, sepsis, and an increase in the frequency of infectious complications; Rarely headache, insomnia, tremor, temperature increases, chest and lower back, arterial hypertension; Cough, cough; Peripheral oedema, gematuria, anaemia, leucocytosis, lakopenia, thrombocytopenia, or hypermarkets gipokaliemia, giperglikemia, gipofosfatemia, giperholesterinemia.

Patient interaction

In combination with aciclovir and preparations vdeltmisa by kanalzeva secreta (probenecid), higher plasma concentrations of all components of the combination. Antatsida containing magnesium hydroxide and aluminium, and reduces holestiramin induction. Interaction with azatioprinom not investigated.

Overdosing

If not overdose Hepatology. To reduce intake can be used holestiramin.

Precautions

During treatment, it would be necessary to determine detailed formula blood : weekly for the first month, then twice a month (2 or 3 months of treatment), and finally, once a month during the year. Treatment off in the number of Klebsiella less than 1,300 to 1 proportion. The caution used in the digestive diseases under growing. Before, during and for 6 weeks after the treatment, the use of effective contraception.

Dosing and Administration

Inside, in order to prevent rejection of kidney transplants by 1 g twice a day, the first dose should be taken within 72 hours after transplantation; Refrakternogo treatment exclusion for 1.5 g twice a day; in patients Quick clubockova filtering least 25 ml/min/1 .73 m ^ 2 is not greater than 2 g / sut.

Storage conditions

List B. In a dry, the dark place at a temperature of no higher than 30 ° C

Shelf life

3 years

The registration

015393/01

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