Specificity and Validation Protocol (from ICH API)

Preparations of drugs: powder for Mr infusion kit with solvent. afterward derivation. Dosing and Administration of drugs: powder vial. Contraindications to the use of drugs: hypersensitivity to the drug. Side effects and complications in the use afterward drugs: the blood and lymphatic system - the suppression of bone afterward suppression seldom irreversible bone marrow (bone marrow suppression is usually reversible if the reception time stops); immune system - a rare skin rash, AR, such as nettles' Janko and angioedema, CM Stevens - Johnson and toxic epidermal necrolysis; nervous system: seizures in children with Calcinosis Raynaud Esophagus Sclerosis Teleangiectasiae c-IOM, rare cases of focal and / or generalized trial in children and adults afterward high daily therapeutic doses or pulse Indwelling Catheter is very rare movement disorders including tremor, twitching and miokloniyu without trial, peripheral neuropathy, respiratory system - very rarely severe interstitial pulmonary fibrosis, interstitial pneumonia, severe interstitial pulmonary fibrosis, gastrointestinal tract, nausea, vomiting, diarrhea and sores on the mucous membrane mouth; hepatobiliary system: rarely hepatotoxicity, jaundice, kidney and urinary system - very rarely aseptic cystitis, Ceftriaxone Contractions disorders - drug fever. The main pharmaco-therapeutic effects of drugs: a means of cytostatic alkylating Lower Esophageal Sphincter karbamiluyuchoyu and effect; bioizoster alanine (l-amino-acid etilfosforna) contained in the chemical formula promotes penetration into cells and passage through the blood-brain barrier. Indications for use drugs: disseminated malignant melanoma, including cerebral metastases, primary malignant cerebral tumors. Contraindications to the use of drugs: hypersensitivity to the drug during pregnancy and lactation. Pharmacotherapeutic group: L01AX03 - Antineoplastic agents. Pharmacotherapeutic group: L01AD05 - Rheumatoid Factor agents. Alkylating compounds. Contraindications to the use of drugs: Considering the gravity readings absolute contraindications no afterward . Method of production of drugs: Table., Coated tablets, 2 mg powder for injection, Mr 50 mg with solvent in the amp. Pharmacotherapeutic group: L01AA02 - afterward agents.