האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

takeda pharma a/s - darvadstrocel - rectal fistula - immunosuppressants - alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. alofisel should be used after conditioning of fistula.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.57 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: hypromellose; methacrylic acid copolymer; sodium lauryl sulfate; propylene glycol; povidone; sodium carbonate; calcium stearate; polysorbate 80; crospovidone; titanium dioxide; iron oxide yellow; triethyl citrate; purified water; mannitol; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - adults: 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) duodenal ulcer; ii) gastric ulcer, iii) gastro-oesophageal reflux disease (gord): - symptomatic gord. the treatment of heartburn and other symptoms associated with gord; - reflux oesophagitis; iv) gastrointestinal lesions refractory to h2 blockers; v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: - clarithromycin and amoxicillin or - clarithromycin and metronidazole, or - amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism (see dosage & administration). 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment. children aged from 5 to 17 years: gastro-oesophageal reflux disease (gord) - symptomatic gord. the treatment of heartburn and other symptoms associated with gord. - reflux oesophagitis. the treatment duration should not exceed 8 weeks.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.57 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: triethyl citrate; povidone; sodium lauryl sulfate; purified water; crospovidone; methacrylic acid copolymer; mannitol; polysorbate 80; propylene glycol; calcium stearate; iron oxide yellow; sodium carbonate; titanium dioxide; hypromellose; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - adults: 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) duodenal ulcer; ii) gastric ulcer, iii) gastro-oesophageal reflux disease (gord): - symptomatic gord. the treatment of heartburn and other symptoms associated with gord; - reflux oesophagitis; iv) gastrointestinal lesions refractory to h2 blockers; v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: - clarithromycin and amoxicillin or - clarithromycin and metronidazole, or - amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism (see dosage & administration). 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment. children aged from 5 to 17 years: gastro-oesophageal reflux disease (gord) - symptomatic gord. the treatment of heartburn and other symptoms associated with gord. - reflux oesophagitis. the treatment duration should not exceed 8 weeks.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.1 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: sodium carbonate; iron oxide yellow; titanium dioxide; polysorbate 80; sodium lauryl sulfate; mannitol; methacrylic acid copolymer; povidone; hypromellose; triethyl citrate; propylene glycol; calcium stearate; crospovidone; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - adults: 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) duodenal ulcer; ii) gastric ulcer, iii) gastro-oesophageal reflux disease (gord): - symptomatic gord. the treatment of heartburn and other symptoms associated with gord; - reflux oesophagitis; iv) gastrointestinal lesions refractory to h2 blockers; v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: - clarithromycin and amoxicillin or - clarithromycin and metronidazole, or - amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism (see dosage & administration). 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment. children aged from 5 to 17 years: gastro-oesophageal reflux disease (gord) - symptomatic gord. the treatment of heartburn and other symptoms associated with gord. - reflux oesophagitis. the treatment duration should not exceed 8 weeks.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.1 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: methacrylic acid copolymer; hypromellose; sodium lauryl sulfate; povidone; mannitol; iron oxide yellow; crospovidone; propylene glycol; titanium dioxide; sodium carbonate; triethyl citrate; polysorbate 80; calcium stearate; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - adults: 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) duodenal ulcer; ii) gastric ulcer, iii) gastro-oesophageal reflux disease (gord): - symptomatic gord. the treatment of heartburn and other symptoms associated with gord; - reflux oesophagitis; iv) gastrointestinal lesions refractory to h2 blockers; v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: - clarithromycin and amoxicillin or - clarithromycin and metronidazole, or - amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism (see dosage & administration). 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment. children aged from 5 to 17 years: gastro-oesophageal reflux disease (gord) - symptomatic gord. the treatment of heartburn and other symptoms associated with gord. - reflux oesophagitis. the treatment duration should not exceed 8 weeks.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - brigatinib, quantity: 90 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; magnesium stearate; hydrophobic colloidal silica anhydrous; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - brigatinib, quantity: 180 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; hydrophobic colloidal silica anhydrous; sodium starch glycollate type a; lactose monohydrate; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - brigatinib, quantity: 30 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium starch glycollate type a; hydrophobic colloidal silica anhydrous; microcrystalline cellulose; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - brigatinib, quantity: 180 mg - tablet, film coated - excipient ingredients: hydrophobic colloidal silica anhydrous; sodium starch glycollate type a; magnesium stearate; microcrystalline cellulose; lactose monohydrate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - lisdexamfetamine dimesilate, quantity: 60 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; magnesium stearate; brilliant blue fcf; titanium dioxide; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - attention deficit hyperactivity disorder (adhd): vyvanse is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist. a diagnosis of attention deficit hyperactivity disorder (adhd) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before 12 years of age.,need for comprehensive treatment programme: vyvanse is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use: the physician who elects to use vyvanse for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.,binge eating disorder (bed): vyvanse is indicated for the treatment of moderate to severe bed in adults when nonpharmacological treatment is unsuccessful or unavailable. treatment should be commenced and managed by a psychiatrist.,need for comprehensive treatment programme: vyvanse is indicated as part of a total treatment program for bed that optimally includes other measures (nutritional, psychological, and medical) for patients with this disorder. when remedial measures including psychotherapy are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,limitation of use: vyvanse is not indicated or recommended for weight loss. use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. the safety and effectiveness of vyvanse for the treatment of obesity have not been established. prescribers should consider that serious cardiovascular events have been reported with this class of sympathomimetic drugs. the bed clinical trials were not designed to assess cardiovascular safety. while there is an accumulation of safety data with vyvanse use in the adhd population, this is of limited relevance regarding cardiovascular risk in the bed population. given the higher cardiovascular risk associated with obesity, the bed population may be at a higher risk. see sections 4.4 special warnings and precautions for use, cardiovascular disease and 4.2 dose and method of administration.,long term use: for bed the initial treatment period is 12 weeks. patients should then be observed to assess whether further treatment with vyvanse is required. periodic re-evaluation of the usefulness of vyvanse for the individual patient should be undertaken. see section 5.1 pharmacodynamic properties, clinical trials.