Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ethambutol hydrochloride
Imported (Germany)
J04AK02
Ethambutol hydrochloride
100mg/1ml
Solution for infusion
No Controlled Drug Status
Valid as a prescribable product
SW Pharma GmbH
treatment of tuberculosis
BNF:
PACKAGE LEAFLET: INFORMATION FOR THE USER EMB-FATOL ® 1.0 G , CONCENTRATE FOR THE PREPARATION OF A SOLUTION FOR INFUSION For use in adults, adolescents and children Active substance: Ethambutol dihydrochloride WHAT IS IN THIS LEAFLET 1. What EMB-Fatol ® 1.0 g is and what it is used for 2. What you need to know before you take EMB-Fatol ® 1.0 g 3. How to take EMB-Fatol ® 1.0 g 4. Possible side effects 5. How to store EMB-Fatol ® 1.0 g 6. Contents of the pack and other information 1. WHAT EMB-FATOL ® 1.0 G IS AND WHAT IT IS USED FOR EMB-Fatol ® 1.0 g is a medicine for the treatment of tuberculosis. EMB-Fatol ® 1.0 g is used in adults, adolescents and children, where oral use is impossible or where a resorption disorder is known, - for the treatment of all forms and stages of pulmonary tuberculosis and tuberculosis of other organs with a pathogen sensitivity against ethambutol, always in combination with other antimycobacterially active drugs. - for empirical therapy in the initial phase of standard tuberculosis treatment in initially unclear resistance situations or in cases requiring retreatment. - for use in the scope of modified tuberculosis therapy regimes in the case of proven resistance against one or several of the standard combination partners. The quickest possible readjustment to an oral therapy is to be aimed for. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMB-FATOL ® 1.0 G DO NOT TAKE EMB-FATOL ® 1.0 G 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. - if you are allergic to ethambutol or any of the othe Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT EMB-FATOL 1.0 G, concentrate for preparation of a solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Ethambutol dihydrochloride One 10 ml bottle contains 1.0 g Ethambutol dihydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for preparation of a solution for infusion Clear, colourless concentrate for preparation of a solution for infusion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EMB-Fatol 1.0 g concentrate for preparation of a solution for infusion is used for the treatment of tuberculosis in patients where oral use is impossible or where a resorption disorder is known. EMB-Fatol is used in adults, adolescents and children. - for the treatment of all forms and stages of pulmonary tuberculosis and extrapulmonary tu- berculosis with a pathogen sensitivity against ethambutol, always in combination with other antimycobacterially active drugs. - for empirical therapy in the initial phase of standard tuberculosis treatment in initially unclear resistance situations or in cases requiring retreatment. - for use in the scope of modified tuberculosis therapy regimes in the case of proven re- sistance against one or several of the standard combination partners. The quickest possible readjustment to an oral therapy is to be aimed for. The generally accepted guidelines on the appropriate use of antimicrobial active substances in the administration of EMB-Fatol 1.0 g concentrate for preparation of a solution for infusion must be observed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ethambutol is one of the standard tuberculosis therapeutics and is always applied in the context of a combination therapy. The choice of tuberculosis therapy regime and the applied combination partners is based on the local resistance situation, on the results of the resistance tests of the patient isolate in question as well as the patient's reliability and willingness for cooperation (complia Read the complete document