The results of pre-clinical research and studies in humans have shown that the drug can cross the placenta. Since the safety of testosterone suspension gains in pregnant women has not been established to a sufficient degree, should not be given this drug to pregnant women, except in cases when the resulting benefits of the treatment justifies the potential risk to the fetus.
Results of pre-clinical research and studies in humans show that tacrolimus is excreted in breast milk. Since we can not exclude adverse effect on newborn babies, women taking should not breastfeed.
Many of NLC declared below are reversible and / or reduced at lower dosage. When administered orally the incidence of ADRs are lower than by intravenous administration.
Not often: deviations ECG parameters, heart attack, heart failure, shock, myocardial hypertrophy, cardiac arrest. gastrointestinal diseases and liver Very common: diarrhea, nausea and / or vomiting frequently: dysfunction of the gastrointestinal tract (eg, dyspepsia), deviations in the levels of liver enzymes, abdominal pain, constipation, changes in weight or appetite, inflammation and ulcers in the gastrointestinal tract, jaundice, biliary tract and gallbladder. not often: ascites, intestinal obstruction (ileus), liver damage tissue, pancreatitis. rare: hepatic failure Blood and lymphatic system Common: anemia , leukopenia, thrombocytopenia, hemorrhage, leukocytosis, coagulation disorder. not often: failure of the hematopoietic system, including pancytopenia, thrombotic microangiopathy. The kidneys are very common: renal dysfunction (eg, increased creatinine level in blood serum) Common: loss of kidney tissue, renal failure not often:. proteinuria Metabolism and electrolytes Very often, hyperglycemia, hyperkalemia, diabetes mellitus Common: hypomagnesaemia, hyperlipidemia, hypophosphatemia, hypokalemia, hyperuricemia, hypocalcemia, acidosis, hyponatremia, hypovolemia, other electrolyte disturbances, dehydration. Uncommon: gipoproteinuriya, testosterone suspension gains hyperphosphatemia, increased amylase, hypoglycemia. musculoskeletal system Common: convulsions not often: myasthenia gravis, joint diseases Nervous system / system senses Very common: tremor, headache, insomnia Common: sensory disturbances (eg paraesthesia), blurred vision, confusion consciousness, depression, dizziness, agitation, neuropathy, seizures, raskoordinirovannost, psychosis, anxiety, nervousness, sleep disturbances, impaired consciousness, emotional lability, hallucinations, hearing loss, impaired thinking, encephalopathy. not often: hypertension, eye diseases, amnesia, cataract , speech disorders, paralysis, coma, deafness.
Very rare: blindness, respiratory system often: a violation of the respiratory function (eg, shortness of breath), pleural effusion not often: atelectasis, bronchospasm. Skin Common: pruritus, alopecia, rash, sweating, acne, photosensitivity not often: hirsutism rare: Layella syndrome Very rare: Stevens-Johnson syndrome Mixed symptoms Very common: localized pain (such as arthralgia) often: fever, peripheral edema, fatigue, impaired urination not often: swelling and other disorders of the genitals in women .Neoplasms Patients receiving immunosuppressive therapy are at increased risk of developing malignancies. When applying tacrolimus noted development of both benign and malignant tumors, including the development of Epstein-Barr virus -. Associate (EBV) lymphoproliferative disorders and skin cancer hypersensitivity reactions in patients receiving tacrolimus were marked allergic and anaphylactic reactions.Infections Patients receiving tacrolimus as treatment with other immunosuppressive drugs, increased risk of infections (viral, bacterial, fungal, protozoal). It may get worse for the previously diagnosed infectious disease. In rare cases, there was the development of ventricular hypertrophy or hypertrophy of the interventricular septum of the heart, reported as cardiomyopathies. In most cases these symptoms are reversible, developing, mostly in children who have a minimum concentration of tacrolimus in the blood is much higher than the recommended maximum levels. Other factors that increase the risk of developing clinical conditions were: pre-existing heart disease, corticosteroids, hypertension, renal dysfunction or liver infection, excess fluid in the body and swelling. As with other potential immunosuppressive agents, patients receiving testosterone suspension gains, noted the development of EBV lymphoproliferative disorders. In patients who were switched to therapy , this may be caused by excessive immunosuppression prior to the use of our product. Patients who were switched to therapy prohibited concomitant use antilymphocytic therapy. A very small EBV-ceponegativnyh children (aged up to 2 years), marked by an increased risk of developing lymphoproliferative disorders (in these patients before applying necessary serological identification of virus EBV-virus).