País: Suécia
Língua: sueco
Origem: Läkemedelsverket (Medical Products Agency)
amikacinsulfat
Tillomed Pharma GmbH
J01GB06
amikacin sulfate
250 mg/ml
Injektions-/infusionsvätska, lösning
natriummetabisulfit Hjälpämne; amikacinsulfat 333,16 mg Aktiv substans
Receptbelagt
Förpacknings: Injektionsflaska, 5 x 2 ml; Injektionsflaska, 1 x 2 ml; Injektionsflaska, 1 x 4 ml; Injektionsflaska, 5 x 4 ml
Godkänd
2019-05-03
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMIKACIN TILLOMED 250MG/ML SOLUTION FOR INJECTION/INFUSION Amikacin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 your 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 any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. Whatis and what it is used for 2. What you need to know before you use Leia o documento completo3. How to use 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR is an antibiotic used to treat serious infections in adults and children including, infants less than 4 weeks old. Areas of application include infections of the respiratory tract and the lungs, the urinary and genital tract, the gastrointestinal tract, inflammation of the inner lining of the heart (endocarditis), infected burns as well as bacterial infections of the blood associated with one of the infections mentioned. Amikacin may also be used to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DO NOT USE • if you are allergic to amikacin or any of the other ingredients of this medicine (listed in section 6); • if you are allergic to other aminoglycoside antibiotics. • if you have bronchial asthma with a known allergy to sulfites. WARNINGS AND PRECAUTIONS Please talk to your doctor or pharmacist before taking , especially • if you have kidney problems (impaired renal function) • if you
SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amikacin Tillomed 250 mg/ml Solution for Injection/Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 250 mg of amikacin (as sulphate). Each 2 ml vial contains 500 mg of amikacin (as sulphate). Each 4 ml vial contains 1 g of amikacin (as sulphate). Excipients with known effect: Each 2 ml vial contains 6.6 mg of sodium metabisulphite (E223) (equivalent to 4.44 mg SO 2 ) and 13.32 mg of sodium. Each 4 ml vial contains 13.2 mg of sodium metabisulphite (E223) (equivalent to 8.9 mg SO 2 ) and 26.65 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Clear, colourless to light straw-coloured solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Amikacin is indicated in the treatment of following infections in adults and pediatric patients including neonates (see section 5.1) - Hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) - Complicated Urogenital tract infections including pyelonephritis - Complicated Intraabdominal infections - Endocarditis (only in combination with other antibiotics), - Infected burns Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Amikacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose must be adjusted individually, based on body weight and renal function, and the serum concentration must be monitored regularly. Renal function status should be estimated by measuring the serum creatinine concentration or by calculating the endogenous creatinine clearance value. The BUN (blood urea nitrogen) test is much less reliable for this purpose. Evaluation Leia o documento completo