Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
tedizolid phosphate
Merck Sharp & Dohme B.V.
J01XX11
tedizolid phosphate
Antibacterials for systemic use, , Other antibacterials
Soft Tissue Infections; Skin Diseases, Bacterial
Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older.
Revision: 21
Authorised
2015-03-23
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SIVEXTRO 200 MG FILM- COATED TABLETS tedizolid phosphate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask yo ur doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes an y possible side effec ts not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sivextro is and what it is used for 2. What you need to know before you take Sivextro 3. How to take Sivextro 4. Possible side effects 5. How to store Sivextro 6. Contents of the pack and other information 1. WHAT SIVEXTRO IS AND WHAT IT IS USED FOR Sivextro is an antibiotic that contains the active substance tedizolid phosphate . It belongs to a group of medicines called “ oxazolidinones ” . It is used to treat adults and adolescents 12 years of age and older with infections of the skin and tissues below the skin. It works by stopping the growth of certain bacteria which can cause serious infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIVEXTRO DO NOT TAKE SIVEXTRO • if you are allergic to tedizolid phosphate or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Your doctor will have decided if Sivextro is suitable to treat your infection. Talk to your doctor or nurse before taking Sivextro if any of the following apply to you : - are suffering from diarrhoea, or have suffered from diarrhoea whilst (or up to 2 months after) taking antibiotics in the past. - are allergic to other medicines belonging to the group “ oxazolidinones ” (e.g., linezolid, cycloserine). - have a history of bleeding or easy bruising (which may be a sign of low numbers of platelets, the sma Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sivextro 200 mg film- coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film- coated tablet contains 200 mg tedizolid phosphate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film- coated tablet (tablet). Oval (13.8 mm long by 7.4 mm wide) yellow film - coated tablet debossed with “TZD” on the obverse side and “200” on the reverse side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections ( ABSSSI) in adults and adolescents 12 years of age and older (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Tedizolid phosphate film- coated tablets or powder for concentrate for solution for infusion may be used as initial therapy. Patients who commence treatment on the parenteral formulation may be switched to the oral presentation when clinically indicated. Recommended dose and duration The recommended dosage for adults and adolescents 12 years of age and older is 200 mg once daily for 6 days. The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have not been established (see section 4.4). Missed dose If a dose is missed, it should be taken as soon as possible anytime up to 8 hours prior to the next scheduled dose. If less than 8 hours remains before the next dose, then the patient should wait until the next scheduled dose. Patients should not take a double dose to compensate for a missed dose. Elderly ( ≥65 years) No dosage adjustment is required (see section 5.2). The clinical experience in patients ≥75 years is limited. H epatic impairment No dosage adjustment is required (see section 5.2). 3 Renal impairment No dosage adjustment is required (see section 5.2). Paediatric population The safety and efficacy of tedizolid phosphate i Прочетете целия документ