Селлсепт

General characteristics. Structure:

One capsule contains:
Active agent: the mikofenolata mofetit 250 mg

Excipients: prezhelatinizirovanny starch, croscarmellose sodium, поливидон (K-90), magnesium stearate

One tablet, coated contains:
Active agent: the mikofenolata mofetit 500 mg

Excipients: microcrystallic cellulose, croscarmellose sodium, поливидон (K-90), magnesium stearate.

Pharmacological properties:

Immunosuppressant, inozinmonofosfatdegidrogenaza inhibitor
Mikofenolata mofetit (MMF) represents 2-morfolinoetilovy ether of mikofenolny acid (IFC). IFC - powerful selection noncompetitive and reversible inhibitor of an inozinmonofosfatdegidrogenaza (IMFDG) which suppresses synthesis of guanozinovy nucleotides of de novo. The mechanism by which the IFC suppresses fermental activity of IMFDG, apparently, is connected with the fact that the IFC structurally imitates both a cofactor of a nikotinamiddinukleotidfosfat, and the catalyzing water molecule. It interferes with oxidation of IMF in ksantozo-5-monophosphate - the most important stage of biosynthesis of guanozinovy nucleotides de novo. The IFC has more expressed cytostatic effect on lymphocytes, than on other cells as proliferation of T and V-lymphocytes very strongly depends on synthesis of de novo purines while cells of other types can pass to bypass ways of metabolism.
For prevention of rejection after renal transplantation, heart and a liver, treatment of refractory rejection of the replaced kidney of MMF appoint in a combination with antithymocyte globulin, OKT3 (an orthoclone of mouse monoclones), cyclosporine and corticosteroids.
At transplantation of a kidney MMF combination with corticosteroids and cyclosporine reduces the frequency of inefficiency of therapy in the first 6 months after transplantation and histologically the proved rejection during therapy, in a dose of 2 g/days reduces the cumulative frequency of death of a transplant and lethality in 12 months after transplantation of a kidney, but in a dose of 3 g a day increases the frequency of a premature elimination from a research on any reason.
On frequency histologically of the proved rejection, a lethality and repeated transplantations at heart transplantation of MMF surpasses Azathioprinum.
MMF in a combination with corticosteroids and cyclosporine more effectively, than Azathioprinum, prevents acute rejection and provides similar survival with Azathioprinum at patients with primary liver transplantation.
Therapy of MMF reduced the frequency of death of a transplant or lethal outcomes in 6 months after the beginning of therapy by 45% (р = 0.062) at the patients who transferred renal transplantation with acute, cell-mediated graft rejection, refractory to therapy.

Preclinical data on safety
In doses by 2-3 times exceeding therapeutic at renal transplantation and by 1.3 - 2 times - in comparison with that at patients after heart transplantation, микофенолат mofetit did not possess cancerogenic action, did not influence fertility of males of rats. In the doses rendering sharp cytotoxic effect in two tests (definition of a thymidinekinase in cells of a mouse lymphoma and with mouse microkernels) mofetit a mikofenolat it is potentially capable to cause chromosomal instability.
In researches on animals oral administration of drug in the dose, by 0.5 times exceeding system influence of a dose of 2 g a day after renal transplantation, and approximately by 0.3 times of the clinical dose of 3 g exceeding system influence a day the recommended ambassador of heart transplantation caused malformations (including, an anophthalmia, an agnathia and hydrocephaly) in the first generation of posterity, without toxic action on mother and fertility and reproductibility of succeeding generations.
In teratogenecity researches on the animals receiving drug in a dose on system influence approximately by 0.5 times exceeding a dose of 3 g a day, the resorption of fruits and inborn malformations at rats was noted (including an anophthalmia, an agnathia and hydrocephaly), malformations of cardiovascular system, kidneys, an ectopia of heart and kidneys, phrenic and umbilical hernias, without signs of toxic action on mother were found in posterity of rabbits.
In toxicological researches of a mikofenolat of a mofetil on animals the main defeats were localized in the hemopoietic and lymphoid bodies, and arose at such level of system influence of drug which is equivalent or less clinical influence of the dose of 2 g a day recommended to patients after renal transplantation. Mofetit a profile of not clinical toxicity of a mikofenolat, matches the undesirable phenomena noted in clinical trials at the person which allowed to obtain data on safety, more significant for population of patients.

Pharmacokinetics. Pharmacokinetic characteristics of MMF were studied at the patients who transferred renal transplantation, hearts and a liver. In general, at patients is after renal transplantation and heart the MMF pharmacokinetic profile is identical. In the early post-transplant period at the patients who transferred liver transplantation and receiving MMF in a dose of 1.5 g, concentration of IFC same as at the patients after renal transplantation receiving MMF in a dose of 1 g.

Absorption. After oral administration there is a bystry and full absorption and full presistemny metabolism of a mikofenolat mofetit with formation of an active metabolite - IFC (mikofenolny acid). Bioavailability of a mikofenolat mofetit at oral administration, according to the size AUCMFK (the areas under a curve "concentration - time"), makes, on average, 94% of that at its intravenous administration. After oral administration of concentration of a mikofenolat of a mofetil in plasma are not defined.
In the early post-transplant period (up to 40 days after renal transplantation, heart or a liver) the average sizes AUCMFK were about 30% lower, and the maximum concentration - are about 40% lower, than in the late post-transplant period (3-6 months after change).
Meal does not influence extent of absorption of a mikofenolat of a mofetil (AUCMFK) at its appointment on 1.5 g two times a day as the patient after transplantation of a kidney. However the maximum concentration of IFC at administration of drug during food decreases by 40%.

Distribution. As a rule, approximately in 6-12 hours after administration of drug secondary increase in concentration of IFC in plasma is observed that demonstrates hepatoenteric recirculation of drug. At co-administration of Colestyraminum of AUCMFK decreases approximately by 40% that demonstrates interruption of hepatoenteric circulation.
In clinically significant concentration of IFC for 97% contacts plasma albumine.

Metabolism. The IFC is metabolized, generally under the influence of a glyukuroniltransferaza with formation pharmacological of an inactive phenolic glucuronide of IFC (MFKG). In vivo MFKG turns into free IFC during hepatoenteric recirculation.

Removal. After oral administration it is radioactive marked Mikofenolat the mofetila of 93% of the received dose is allocated with urine, and 6% - with a stake. The most part (about 87%) of the entered dose is removed with urine in the form of MFKG. Insignificant amounts of drug (<1% of a dose) are removed with urine in the form of IFC.
Clinically defined concentration of IFC and MFKG are not removed by a hemodialysis. However at higher concentration of MFKG (> 100 mkg/ml) some of its part can be removed. Sekvestranta of bile acids like Colestyraminum reduce AUCMFK, interrupting hepatoenteric recirculation.

Bioequivalence. At a research of bioequivalence of two peroral forms of release of MMF it was shown that two tablets on 500 mg are equivalent to four capsules on 250 mg.

Pharmacokinetics in special clinical cases. In a research with one-time administration of drug at patients with a heavy chronic renal failure (a glomerular filtration rate <25 ml/min. / 1.73 sq.m) AUCMFK was 28-75% more, than at healthy volunteers and patients with less expressed damage of kidneys. After reception of a single dose of AUCMFKG in 3-6 times more at patients with a heavy renal failure that will be coordinated with the known data on renal removal of MFKG.
Researches on repeated introduction of a mikofenolat of a mofetil at a heavy chronic renal failure were not conducted.
At patients with a delay of function of a renal transplant after change average AUC0-12 value for IFC is comparable with that at patients at whom the transplant began to function after change without delay, and average AUC0-12 value for MFKG in plasma was 2-3 times more.
Patients with damage of a liver. At volunteers with alcoholic cirrhosis after oral administration of MMF changes in pharmacokinetics of IFC and MFKG are not revealed that specifies, on the fact that defeat of a parenchyma of a liver is not a contraindication for purpose of MMF. Influence of hepatic pathology on this process probably depends on a specific disease. In case of a liver disease with dominance of defeat of bilious ways (for example, primary biliary cirrhosis) the effect can be another.
At patients of advanced and senile age (≥ 65 years) the pharmacokinetics was not studied.

Indications to use:

Prevention of acute rejection of body and treatment of rejection of body, refractory to therapy, at patients after allogenic renal transplantation.
Prevention of acute rejection of body and improvement of survival of a transplant and survival of patients after allogenic heart transplantation.
Prevention of acute rejection of body at patients after allogenic liver transplantation.

Селлсепт appoint in the form of a combination therapy with cyclosporine and corticosteroids.

Route of administration and doses:

Prevention of graft rejection of a kidney. Reception on 1.0 g two times a day (a daily dose of 2 g) is recommended to patients with renal transplants. Though in clinical trials it was shown that the dose in 1.5 g two times a day (a daily dose of 3 g) also is safe and effective, its advantages in respect of efficiency at patients after renal transplantation are not established. At the patients receiving 2 g of MMF a day, the safety profile, in general, was better, than at receiving a daily dose in 3 g.
Prevention of graft rejection of heart. The recommended dosing mode - on 1.5 g 2 times a day (a daily dose of 3 g).
Prevention of graft rejection of a liver. The recommended dosing mode - on 1.5 g 2 times a day (a daily dose of 3 g).
Treatment of the first or refractory graft rejection of a kidney. The recommended dosing mode - 1.5 g 2 times a day (a daily dose of 3 g).
After renal transplantation, heart or a liver the first dose of Sellsept should be accepted as soon as possible.

Dosing in special cases
At a neutropenia (absolute number of neutrophils <1300 in 1 мкл blood) needs to interrupt treatment of MMF or to reduce its dose and to carefully observe the patient.
At patients with a heavy chronic renal failure (a glomerular filtration rate less than 25 ml/min. / 1.73 the sq.m) out of the next post-transplant period or after therapy concerning acute or refractory rejection should avoid doses higher than 1 g 2 times a day.
Data on the patients with a heavy renal failure who transferred heart transplantation or a liver no.
Dose adjustment by the patient with a delay of function of a renal transplant is not required.
The patient who transferred renal transplantation and having severe defeat of a parenchyma of a liver, dose adjustment is not required. Data on patients with the severe defeat of a parenchyma of a liver which transferred heart transplantation no.
At the patients of advanced and senile age (≥ 65 years) who transferred renal transplantation, the recommended dose equals 1 g 2 times a day, and after heart transplantation or a liver - 1.5 g 2 times a day (see. "Special ukzaniye").
Children: safety and efficiency of drug at patients of children's age is not established. The pharmacokinetic data obtained at the children who transferred transplantation of a kidney are very limited, and at children is after heart transplantation or a liver, - are absent.

Features of use:

As well as against the background of the combined immunosuppression in general, at purpose of MMF as component of the immunosuppressive scheme there is an increased risk of development of lymphoma and other malignant new growths, especially skin (see. "Side effects"). This risk, apparently, is connected not using any drug per se, and with intensity and duration of immunosuppression.
As well as at all patients with the increased risk of a carcinoma cutaneum, it is necessary to limit influence of solar and ultraviolet rays to wearing the corresponding closed clothes and use of sunblock creams with high value of a protective factor.
The patients receiving MMF have to be informed on need at once to report to the doctor about any symptoms of an infection, bleeding, bleedings or other signs of oppression of marrow.
Excessive suppression of immune system can also increase sensitivity to infections, including, opportunistic, to sepsis and other infections with a lethal outcome. During treatment of MMF vaccination can be less effective; it is necessary to avoid use of live attenuated vaccines. It is possible to carry out anti-influenza vaccination according to national recommendations.
As reception of MMF can be followed by side reactions from digestive tract, it is necessary to be careful at purpose of MMF sick with diseases of a digestive tract in an aggravation stage.
As MMF is IMFDG inhibitor, from the theoretical point of view, it is not necessary to appoint it to patients with the rare genetically caused hereditary deficit of a gipoksantinguaninfosforiboziltransferaza (Lesh-Nayena and Kelly-Zigmillera's syndromes).
MMF is not recommended to appoint along with Azathioprinum as both drugs oppress marrow, and their concomitant use was not studied.
It is necessary to be careful at co-administration of MMF with the drugs influencing hepatic intestinal circulation as they can reduce efficiency of MMF (see. "Medicinal interactions").
At patients with a heavy chronic renal failure it is necessary to avoid purpose of doses more than 1 g 2 times a day.
Dose adjustment by the patient with a delay of function of a renal transplant is not required, however they need to be observed carefully. Data on the patients who transferred heart transplantation or a liver and having a heavy renal failure no.
At patients of senile age the risk of the undesirable phenomena can be higher, than at younger patients.
Laboratory control: at treatment of MMF it is necessary to define the developed blood count within the first month - weekly, within the second and third months of treatment - two times a month, and then for the first year - monthly. The neutropenia can be connected both with reception of MMF, and using other medicines, viral infections or a combination of these reasons. At emergence of a neutropenia (the absolute number of neutrophils less than 1300 in 1 мкл) needs to be interrupted treatment of MMF or to reduce a dose, at the same time making careful observation of these patients.
Treatment of drug
As mofetit a mikofenolat in an experiment on rats and rabbits showed teratogenic action, Sellsept's tablets it is not necessary to break and break integrity of capsules of Sellsept. It is necessary to avoid inhalation of the powder which is contained in Sellsept's capsules or his direct hit on skin or mucous membranes. If it occurred, it is necessary to wash out carefully this site water with soap, and eyes - simply water.

Category C drug.
At purpose of drug in the period of an organogenesis it were noted to pregnant females of rats and rabbits adverse influence on a fruit (including, malformations); these effects developed when using the doses which were not possessing toxic action on mother and are lower than doses recommended for a clinical use after renal transplantation, heart or a liver. The adequate and well controlled researches at pregnant women were not conducted. However as drug has teratogenic effect at animals, it can adversely affect also a fruit of the person. MMF can appoint pregnant only when the potential advantage for mother exceeds possible risk for a fruit.
Therapy of MMF should not be begun until the negative take of inspection on pregnancy when using a method of the analysis of serum or urine with sensitivity not less than 50 MME/ml is received. Prior to therapy of MMF, during treatment and within 6 weeks after its termination use of effective methods of contraception is obligatory even if in the anamnesis the woman has an infertility (except for the postponed hysterectomy). If abstention from sex life is impossible, it is necessary to use two reliable methods of contraception at the same time. At emergence of pregnancy during therapy it is necessary to discuss desirability of its preservation with the doctor.
At rats of a mikofenolat mofetit it is allocated with milk. Whether MMF with women's milk is allocated, it is unknown. As with women's milk many drugs are excreted, and also in connection with a possibility of serious side reactions on a mikofenolat mofetit at babies, a breast or administration of drug do the choice between feeding continuation taking into account importance of treatment for mother.

Side effects:

It is often difficult to establish a profile of the side effects connected using immunodepressants because of existence of a basic disease and simultaneous use of many other medicines.
Data of clinical trials
The main side reactions connected using MMF in a combination with cyclosporine and corticosteroids for prevention of rejection of a renal, cordial or hepatic transplant are diarrhea, a leukopenia, sepsis and vomiting; there are frequencies of opportunistic infections which are also given about increase.
The profile of safety of MMF at treatment of refractory rejection of a kidney is similar to that at prevention of rejection of a kidney when using drug in a dose of 3 g a day. Diarrhea and a leukopenia, then anemia, nausea, vomiting, abdominal pains, sepsis were the prevailing side reactions which were found at patients on MMF more often than at the patients who were intravenously receiving corticosteroids.
Malignant new growths. At the patients who transferred renal transplantation, hearts or a liver and observed not less than 1 year, limfoproliferativny diseases or lymphoma developed at 0.4 - 1% of the patients receiving MMF (in doses of 2 or 3 g a day) in combinations with other immunodepressants. The skin carcinoma (excepting a melanoma) was noted at 1.6 - 4.2% of patients, malignant new growths of other types - at 0.7 - 2.1% of patients. Three-year data on safety at patients after renal transplantation or heart did not reveal any unexpected changes in the frequency of malignant new growths, in comparison with year indicators. After liver transplantation of patients observed not less than 1 year, but it is less than 3 years.
At treatment of refractory rejection of a kidney the frequency of lymphoma at the average period of observation up to 42 months made 3.9%.
Opportunistic infections. The risk of opportunistic infections is increased at all post-transplant patients and increases with increase in degree of immunosuppression. At purpose of MMF (2 or 3 g a day) in a combination with other immunodepressants the patients observed during 1 year after renal transplantation (on a dose of 2 g a day), heart and a liver, the most frequent infections had a candidiasis of skin and mucous membranes, TsMV viremiya/TsMV a syndrome (13.5%) and the infection caused by a herpes simplex virus. At patients of advanced and senile age (≥ 65 years) at treatment of MMF within the combined immunosuppressive therapy the risk of some infections (including fabric invasive forms of a manifest Cytomegaloviral infection), and also, perhaps, gastrointestinal bleedings and a fluid lungs is higher, than at patients of younger age.

The undesirable phenomena noted at ≥ 10% and at 3 - 10% of the patients receiving MMF in a combination with cyclosporine and corticosteroids after renal transplantation, heart and a liver.
Organism in general ≥ 10%: an adynamy, fever, a headache, infections, pains (in a stomach, a waist, a thorax), peripheral hypostases, sepsis, ascites, abdominal distention, hernias, peritonitis, a hiccups.
3 - 10%: cysts (including, the limfotsel and the gidrotsel), face edemas, a grippopodobny syndrome, bleedings, hernias, an indisposition, pains in the field of a basin, cellulitis, neck pains, pallor of integuments.
System of blood and lymphatic system ≥ 10%: anemia (including, hypochromia), leukocytosis, leukopenia, thrombocytopenia, ecchymomas.
3 - 10%: ecchymomas, polycythemia, petechias, increase in prothrombin and tromboplastinovy time, pancytopenia.
Urinogenital path ≥ 10%: hamaturia, necrosis of renal tubules, infections of urinary tract, renal failure, oliguria.
3 - 10%: albuminuria, dysuria, hydronephrosis, impotence, pyelonephritis, frequent urination, hamaturia, nocturia, renal failure, incontience and ischuria; acute renal failure, hydroscheocele.
Cardiovascular system ≥ 10%: arterial hypertension, arrhythmia, bradycardia, heart failure, hypotension, pericardiac exudate.
3 - 10%: stenocardia, hypotonia, including orthostatic, tachycardia, bradycardia, thrombosis, faints, vazodilatation; arrhythmias (supraventricular and ventricular extrasystoles, blinking and atrial flutter, supraventricular and ventricular tachycardias), cardiac standstill, congestive heart failure, pulmonary hypertensia, vasospasm, increase in venous pressure.
Metabolism ≥ 10%: acidosis (metabolic or respiratory), increase in body weight, hypervolemia; disturbance of healing of wounds.
3 - 10% after renal transplantation: acidosis (metabolic or respiratory), increase in body weight, dehydration, hypervolemia, gout, hypovolemia, hypoxia, thirst, weight loss, alkalosis.
Laboratory indicators ≥ 10%: hyperglycemia, hyperpotassemia, hypopotassemia, hypophosphatemia; a hyperbilirubinemia, increase in residual nitrogen, increase in creatinine, increase in activity of enzymes (LDG, nuclear heating plant, ALT) in blood serum, a hypercholesterolemia, a lipidemia, a hyperuricemia, a hypomagnesiemia, a hyponatremia; hypocalcemia, hypoproteinemia.
3 - 10%: increase in activity of an alkaline phosphatase, gamma глютамилтранс - peptidases, LDG, nuclear heating plant and ALT in blood serum, increase in creatinine of blood serum, a hypercalcemia, a lipidemia, a hypocalcemia, a hypoglycemia, a hypoproteinemia, a hyperuricemia, a hypochloraemia, a hypophosphatemia; hyponatremia.
Digestive tract:> 10%: dyspepsia, vomiting, lock, diarrhea, oral cavity candidiasis, cholangitis, cholestatic jaundice, hepatitis, anorexia.
3 - 10%: dysphagy, ulitis, hyperplasia of gums, stomatitis, esophagitis, gastritis, gastroenteritis, gastrointestinal bleeding, stomach ulcer, intestinal bleeding, intestinal impassability, melena, damage of a rectum, digestive tract candidiasis.
Respiratory organs ≥ 10%: strengthening of cough, short wind, pharyngitis, pneumonia, bronchitis; bronchial asthma, pleural exudate, rhinitis, sinusitis; atelectasis.
3 - 10%: asthma, pleural exudate, fluid lungs, rhinitis, sinusitis, apnoea, atelectasis, bronchitis, nasal bleeding, pneumorrhagia, new growths, pheumothorax, fluid lungs, strengthening of department of a phlegm, change of a voice, hyperventilation, candidiasis of respiratory tracts, rhinitis.
Skin and its appendages ≥ 10%: an acne, a herpes simplex, shingles, rash, an itch, the increased perspiration.
3 - 10%: a hair loss, high-quality new growths of skin, fungal dermatitis, a herpes simplex, shingles, a hirsutism, an itch, a carcinoma cutaneum, a skin hypertrophy, the increased perspiration, skin ulcers, rash, the increased perspiration, an acne, hemorrhage, shingles, a hirsutism, high-quality new growths of skin, skin ulcers, vezikulo-violent rash.
Nervous system ≥ 10%: dizziness, sleeplessness, tremor; psychomotor arousing, alarm, confusion of consciousness, depression, hyper tone, paresthesias, drowsiness, tremor.
3 - 10%: psychomotor excitement, depression, hyper tone of skeletal muscles, paresthesia, drowsiness; spasms, emotional lability, hallucinations, neuropathy, mnestichesky decrease, dizziness; a delirium, dryness in a mouth, neuropathy, psychosis, disturbance of thinking.
Musculoskeletal system ≥ 10%: spasms in legs, muscle pains, muscular weakness.
3 - 10%: joint pains, spasms in legs, muscle pains, muscular weakness, osteoporosis.
Sense bodys ≥ 10%: amblyopia.
3 - 10%: amblyopia, cataract, conjunctivitis; vision disorders, deafness, ear pain, hematopsias, vestibular dizziness.
Endocrine system 3 - 10%: diabetes mellitus, disease of epithelial bodies; Cushing's syndrome, hypothyroidism.

At prevention of rejection of a renal transplant the profile of safety of MMF in a daily dose of 2 g was slightly better, than in a daily dose of 3 g.

Post-registration use of drug
Digestive organs: colitis (sometimes Cytomegaloviral etiology), pancreatitis, separate cases of an atrophy intestinal ворсин.
Immune system: separate cases of heavy, life-threatening infections (meningitis, an infectious endocarditis), increase in frequency of some infections like tuberculosis and atypical mikobakterialny infections.

Interaction with other medicines:

Acyclovir. At simultaneous use of a mikofenolat of a mofetil and acyclovir concentration of both drugs in plasma at a renal failure increases, it is possible as a result of the competition concerning canalicular secretion that can lead to further increase in concentration of both medicines.
The antacids containing a hydroxide of magnesium and aluminum reduce absorption of a mikofenolat of a mofetil.
Colestyraminum: after purpose of a single dose of a mikofenolat mofetit 1.5 g to the healthy volunteers who were previously accepting 4 g of Colestyraminum 3 times a day for 4 days reduction of AUCMFK by 40% was observed. It is necessary to be careful at co-administration of MMF and drugs influencing hepatoenteric recirculation.
Cyclosporine: mofetit a mikofenolat does not influence cyclosporine pharmacokinetics.
Gantsiklovir: by results of a research with one-time oral administration of the recommended doses of a mikofenolat of a mofetil and intravenous administration of a gantsiklovir, essential change of pharmacokinetics of IFC it is not expected therefore it is not necessary to adjust a dose of a mikofenolat of a mofetil. If mofetit a mikofenolat and ганцикловир appoint the patient with a renal failure, it is necessary to observe patients carefully.
Oral contraceptives: MMF does not influence pharmacokinetics of oral contraceptives, suppression of an ovulation under the influence of oral contraceptives.
Trimethoprimum/sulfamethoxazole: do not influence bioavailability of IFC.
Takrolimus: AUCMFK increases by 30%, and AUCMFKG decreases approximately by 20%. The maximum concentration of IFC did not change, and MFKG - decreased by 20%. Partially it can be caused by strengthening of biliary secretion of MFKG in combination with strengthening of hepatoenteric recirculation of IFC as increase in concentration of IFC after purpose of a takrolimus was more expressed closer to the end of a curve "concentration time" (in 4-12 hours after reception). At the patients accepting такролимус the dose of MMF should not exceed 1 g 2 times a day. Patients it is necessary to observe carefully Data on pharmacokinetics of IFC at patients after liver transplantation at simultaneous therapy of MMF and takrolimusy are limited. On pharmacokinetics of a takrolimus at patients with a stable hepatic transplant of AUC the takrolimusa after multiple dose of MMF in a dose of 1.5 g 2 times a day increased in a research of effect of MMF approximately for 20%.
Other interactions: Blockers of canalicular secretion (пробеницид) increase concentration of MFKG.
Live vaccines: should not be entered to patients in a condition of an immunosuppression. Antibodyformation in response to other vaccines can be reduced.

Contraindications:

The increased individual sensitivity to Sellsept, mikofenolny acid and other components of drug. With care - gastrointestinal diseases (in an aggravation phase).

Overdose:

The person has no data on overdose of a mikofenolat of a mofetil.
The IFC cannot remove from an organism with a hemodialysis method. However at high concentration of MFKG in plasma (> 100 mkg/ml) its small amounts after all are removed. The drugs connecting bile acids, for example, Colestyraminum can promote elimination of IFC from an organism, increasing its excretion.

Storage conditions:

To store at a temperature up to 30 °C, in the place protected from light and moisture.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Capsules of 250 mg - 100, 300 pieces.
Tablets of 500 mg - 4, 50, 100, 150, 500 pieces.