Updated instructions

Edit the instructions. Oxaliplatinum, in dosage forms - concentrate for solution for infusions 5 mg / ml and lyophilizate for solution for infusion, 50, 100, 150 mg

January 19, 2016
The need to supplement the instructions for the use of medicinal products with the following information is revealed: 1. In the section "Indications for use", the information should be presented in the following edition: "Adjuvant therapy for colon cancer of the third stage (stage D according to Duke's classification) after radical resection of the primary tumor in combination with fluorouracil / calcium folinate, metastatic colorectal cancer (in combination with fluorouracil / calcium

Edit the instructions.Suxamethonium chloride, in a dosage form, solution for intravenous and intramuscular administration

December 25, 2015
According to current information, suxamethonium chloride, in the form of a solution for intravenous and intramuscular administration, is contraindicated in the following cases: - Hypersensitivity to suxamethonium chloride or to any of the excipients. Patients with a tendency to malignant hyperthermia. - Hyperkalemia and patients at risk of hyperkalemia (severe renal failure): excessive hyperkalemia in patients with such

Edit the instructions. Lidocaine, bupivacaine, ropivacaine, procaine, articaine

December 7, 2015
FGBU "NTSESMP" of the Ministry of Health of Russia informs that during the analysis of information on the clinical use of medicines used for local anesthesia, according to the data of the Automated Information System of Roszdravnadzor, for the period from 01.01.2010 to 23.10.2015 82 reports on 64 lethal undesirable reactions associated with the use of local anesthetics. In the civil turnover of the Russian Federation there are

Edit the instructions. Tacrolimus, in a capsule dosage form

November 19, 2015
The need to supplement the instructions for the use of medicines containing tacrolimus the following information: 1. In the section "Pharmacotherapeutic group", the information should be stated in the following edition: "immunosuppressive agent - calcineurin inhibitor". 2. The "Side effect" section should be supplemented with the following information: - "Heart disorders" subsection - "very rarely: prolongation of the QT interval, violation

Edit the instructions. Fluconazole, in a capsule dosage form

November 19, 2015
The need to supplement the instructions for the use of medicines with the following information was identified. 1. The section "Indications for Use" should be submitted in the following edition: Fluconazole is indicated for the treatment of the following diseases in adults: - Cryptococcal meningitis - Coccidioidomycosis - Invasive candidiasis - Mucous candidiasis, incl. Oropharyngeal candidiasis, esophageal candidiasis, candiduria and chronic cutaneous

Edit the instructions. Filgrastim, in a dosage form solution for intravenous and subcutaneous administration

November 19, 2015
The need to supplement the instructions for the use of medicines containing filgrastim, the following information: 1. In the section "Indications for use", indicate "Adults and children." - Neutropenia, febrile neutropenia in patients receiving intensive myelosuppressive cytotoxic chemotherapy for malignant diseases (with the exception of chronic myelogenous leukemia and myelodysplastic syndrome) - Neutropenia

Edit the instructions. Bortezomib, in the dosage form of lyophilizate

November 9, 2015
The need to supplement the instructions for the use of medicines containing bortezomib the following information: 1. In the section "Indications for use", correct "mantle cell lymphoma in patients who have previously received at least 1 treatment line" for "mantle cell lymphoma". 2. The section "Contraindications" should be supplemented with information on the simultaneous use of CYP3A isoenzymes with strong inducers (rifampicin,

Edit the instructions. Yopromide, in a dosage form, solution for injection

October 6, 2015
Exclude from the sections "Indications for use", "With care", "Method of administration and dose", "Side effect","Overdose", "Interaction with other medicines", "Special instructions" information on the possible intrathecal administration of the drug and indicate this method of administration in the section "Contraindications."

Cancellation of state registration. Zevalin

October 3rd, 2015
The Ministry of Health of the Russian Federation in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "On the circulation of medicinal products" decided to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate LSR-003171 / 09 dated 04.24.2009 issued by Bayer Schering Pharma AG, Germany): Zevalin

Edit the instructions. Zolpidem

September 23, 2015
It is necessary to amend the instructions for the use of registered medicines with INN Zolpidem , regarding the addition of the following information to the sections "Method of administration and dose" and "Influence of medicinal product for medical use on the ability to drive vehicles and mechanisms": 1. The recommended adult dose should not exceed 10 mg per day.Medicinal preparations of zolpidem should be taken

Edit the instructions. Codeine

September 23, 2015
It is necessary to amend the instructions for the use of registered codeine-containing medicines, in the part of supplementing the section "Contraindications" with the following information: 1. Codeine-containing drugs are contraindicated for the treatment of cough and cold in children under 12 years of age, and children and adolescents in age from 12 to 18 years in the presence of pathology of the respiratory system (for example, bronchial asthma and other chronic

Cancellation of state registration. Endothelon

September 23, 2015
The Ministry of Health of the Russian Federation in accordance with Article 32 of the Federal Law of 12.04.2010 No. 61-FZ "On the circulation of medicines" decided to abolish state registration and exclude from the state register of medicinal products for medical use of the drug Endotelin (tablets 150 mg., Reg., P N013271 / 01 dated 01.04.2011, issued by SANOFI-AVENTIS FRANCE, France) on