MASH CO. FOR PHARMACEUTICAL INDUSTRIES-EGYPT - search results

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

sirturo- bedaquiline fumarate tablet

janssen products, lp - bedaquiline fumarate (unii: p04qx2c1a5) (bedaquiline - unii:78846i289y) - bedaquiline 100 mg - sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (mdr-tb). reserve sirturo for use when an effective treatment regimen cannot otherwise be provided. this indication is approved under accelerated approval based on time to sputum culture conversion [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. limitations of use: - do not use sirturo for the treatment of: latent infection due to mycobacterium tuberculosis drug-sensitive tuberculosis extra-pulmonary tuberculosis infections caused by non-tuberculous mycobacteria - latent infection due to mycobacterium tuberculosis - drug-sensitive tuberculosis - extra-pulmonary tuberculosis - infections caused by non-tuberculous myco

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

creon micro pancreatic extract 20 g enteric coated granules bottle

viatris pty ltd - pancreatic extract, quantity: 601.2 mg/g (equivalent: protease, qty 2000 ph eur unit; equivalent: amylase, qty 36000 ph eur unit; equivalent: lipase, qty 50000 ph eur unit) - granules, enteric-coated - excipient ingredients: hypromellose phthalate; cetyl alcohol; dimeticone 1000; macrogol 4000; triethyl citrate - creon micro is indicated as pancreatic enzyme replacement in paediatric and adult patients with pancreatic exocrine insufficiency (pei). pancreatic exocrine insufficiency is often associated with, but not limited to: cystic fibrosis, chronic pancreatitis, pancreatic surgery, gastrointestinal bypass surgery (eg. bilroth ii gastroenterostomy), ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm).

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

kuvan sapropterin dihydrochloride 100 mg soluble tablet bottle

biomarin pharmaceutical australia pty ltd - sapropterin dihydrochloride, quantity: 100 mg - tablet, soluble - excipient ingredients: sodium stearylfumarate; calcium hydrogen phosphate; mannitol; crospovidone; ascorbic acid; riboflavin - kuvan is indicated for the treatment of hyperphenylalaninemia (hpa) in sapropterin-responsive adult and paediatric patients with phenylketonuria (pku) or tetrahydrobiopterin (bh4) deficiency (see section 4.2 dose and method of administration for definition of sapropterin responsiveness)