United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - fidaxomicin (unii: z5n076g8yq) (fidaxomicin - unii:z5n076g8yq) - fidaxomicin 200 mg - dificid® is indicated in adult and pediatric patients aged 6 months and older for the treatment of c. difficile -associated diarrhea (cdad). to reduce the development of drug-resistant bacteria and maintain the effectiveness of dificid and other antibacterial drugs, dificid should be used only to treat infections that are proven or strongly suspected to be caused by c. difficile . when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. dificid is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in dificid [see warnings and precautions (5.1)] . risk summary the limited available data on use of dificid in pregnant women are insufficient to inform any drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. embryo-fetal

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - fidaxomicin, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; hyprolose; butylated hydroxytoluene; sodium starch glycollate; magnesium stearate; pregelatinised maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; lecithin - dificid (fidaxomicin) is indicated for the treatment of confirmed clostridium difficile infection (cdi) in adults.

United States - English - NLM (National Library of Medicine)

avera mckennan hospital - fidaxomicin (unii: z5n076g8yq) (fidaxomicin - unii:z5n076g8yq) - fidaxomicin 200 mg

Israel - English - Ministry of Health

tradis gat ltd - fidaxomicin - film coated tablets - fidaxomicin 200 mg - fidaxomicin - dificlir is indicated for the treatment of clostridium difficile infections (cdi) also known as c. difficile associated diarrhoea (cdad) in adult and paediatric patients aged 6 years and older.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - fidaxomicin -

European Union - English - EMA (European Medicines Agency)

tillotts pharma gmbh - fidaxomicin - clostridium infections - antidiarrheals, intestinal antiinflammatory / antiinfective agents - dificlir film-coated tablets is indicated for the treatment of clostridioides difficile infections (cdi) also known as c. difficile-associated diarrhoea (cdad) in adult and paediatric patients with a body weight of at least 12.5 kg.consideration should be given to official guidelines on the appropriate use of antibacterial agents.dificlir granules for oral suspension is indicated for the treatment of clostridioides  difficile infections (cdi) also known as c. difficile-associated diarrhoea (cdad) in adults and paediatric patients from birth to < 18 years of age.consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Canada - English - Health Canada

merck canada inc - fidaxomicin - tablet - 200mg - fidaxomicin 200mg - other macrolides

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

astellas pharma ltd - fidaxomicin - tablet - 200mg

Australia - English - Department of Health (Therapeutic Goods Administration)

specialised therapeutics australia pty ltd - fidaxomicin -

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

astellas pharma europe b.v. - fidaxomicin - tablets film-coated - 200mg