Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

siga technologies, inc. - tecovirimat (unii: f925rr824r) (tecovirimat - unii:f925rr824r) - tpoxx® is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 3 kg. the effectiveness of tpoxx for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical [see clinical studies (14)] . tpoxx efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models. tpoxx capsules: none. tpoxx injection: the excipient hydroxypropyl-β-cyclodextrin is eliminated through glomerular filtration. therefore, tpoxx injection is contraindicated in patients with severe renal impairment (defined as creatinine clearance below 30 ml/min) [see warnings and precautions (5.2) and use in specific populations (8.6)] . risk summary there are no available data on the use of tecovirimat in pregnant individuals to evaluate for a

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

innovata plc - icodextrin sodium chloride ph.eur. s(+) sodium lactate 960%w/w solution calcium chloride dihydrate magnesium chloride hexahydrate - solvent for parenteral use - 40 mg/ml

Malaezia - engleză - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

baxter healthcare (malaysia) sdn. bhd. - icodextrin; calcium chloride ph eur; magnesium chloride ph eur; sodium lactate usp; sodium chloride ph eur -

Noua Zeelandă - engleză - Ministry for Primary Industries

agrihealth nz limited - sodium bicarbonate; potassium chloride; sodium chloride; malto-dextrine; potassium phosphate monobasic; dextrose; dextrin; glycine; potassium citrate - sodium bicarbonate 65.71 g/kg; potassium chloride 10 g/kg; sodium chloride 88.57 g/kg; malto-dextrine 35.72 g/kg; potassium phosphate monobasic 28.43 g/kg; dextrose 571.4 g/kg; dextrin 107.18 g/kg; glycine 91.53 g/kg; potassium citrate 1.44 g/kg - oral nutrient/electrolyte

Canada - engleză - Health Canada

baxter corporation - sodium chloride; sodium lactate; calcium chloride; magnesium chloride; icodextrin - solution - 5.35g; 4.48g; 257mg; 51mg; 75g - sodium chloride 5.35g; sodium lactate 4.48g; calcium chloride 257mg; magnesium chloride 51mg; icodextrin 75g - hemodialysis solution

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

max health limited - voriconazole 200mg - powder for infusion - 200 mg - active: voriconazole 200mg excipient: hydrochloric acid hydroxypropyl-beta-cyclodextrin sodium chloride - voriconazole is indicated for treatment of the following fungal infections: · invasive aspergillosis. · serious candida infections (including c. krusei), including oesophageal and systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). · serious fungal infections caused by scedosporium spp. and fusarium spp. · other serious fungal infections, in patients intolerant of, or refractory to, other therapy.

Uniunea Europeană - engleză - EMA (European Medicines Agency)

hikma farmaceutica (portugal) s.a. - voriconazole - bacterial infections and mycoses; aspergillosis; candidiasis - antimycotics for systemic use - voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:treatment of invasive aspergillosis;treatment of candidaemia in non-neutropenic patients;treatment of fluconazole-resistant serious invasive candida infections (including c. krusei);treatment of serious fungal infections caused by scedosporium spp. and fusarium spp.voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections.prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct)recipients.