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

aspen pharmacare australia pty ltd - ondansetron hydrochloride dihydrate, quantity: 5 mg (equivalent: ondansetron, qty 4 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; titanium dioxide; iron oxide yellow; hypromellose - ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy

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

sandoz pty ltd - esomeprazole magnesium trihydrate, quantity: 22.264 mg (equivalent: esomeprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: glyceryl monostearate; povidone; purified water; crospovidone; polysorbate 80; silicon dioxide; hypromellose phthalate; microcrystalline cellulose; pregelatinised maize starch; hyprolose; iron oxide red; purified talc; methacrylic acid - ethyl acrylate copolymer (1:1); macrogol 6000; light magnesium oxide; macrogol 400; titanium dioxide; hypromellose; iron oxide yellow; maize starch; sucrose - esomeprazole enteric-coated tablet indicated for:,1] gastro-oesophageal reflux disease (gord),- treatment of erosive reflux oesophagitis,- long-term management of patients with healed oesophagitis to prevent relapse,- symptomatic treatment of gastro-oesophageal reflux disease (gord),2] patients requiring nsaid therapy,- short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy.,- healing of gastric ulcers associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy,- prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug nsaid (non-selective and cox-2 selective) therapy in patients at risk.,3] prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion.,4] pathological hypersecretory conditions including zollinger-ellison syndrome and idiopathic hypers

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

sandoz pty ltd - esomeprazole magnesium trihydrate, quantity: 44.528 mg (equivalent: esomeprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: crospovidone; purified talc; light magnesium oxide; purified water; pregelatinised maize starch; microcrystalline cellulose; silicon dioxide; glyceryl monostearate; polysorbate 80; methacrylic acid - ethyl acrylate copolymer (1:1); povidone; iron oxide red; macrogol 6000; hyprolose; hypromellose phthalate; macrogol 400; maize starch; sucrose; titanium dioxide; hypromellose - esomeprazole enteric-coated tablet indicated for:,1] gastro-oesophageal reflux disease (gord),- treatment of erosive reflux oesophagitis,- long-term management of patients with healed oesophagitis to prevent relapse,- symptomatic treatment of gastro-oesophageal reflux disease (gord),2] patients requiring nsaid therapy,- short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy.,- healing of gastric ulcers associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy,- prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug nsaid (non-selective and cox-2 selective) therapy in patients at risk.,3] prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion.,4] pathological hypersecretory conditions including zollinger-ellison syndrome and idiopathic hypers

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

sandoz pty ltd - voriconazole, quantity: 50 mg - tablet, film coated - excipient ingredients: povidone; croscarmellose sodium; lactose monohydrate; magnesium stearate; pregelatinised maize starch; titanium dioxide; hypromellose; triacetin - voriconazole sandoz 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,- prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.,- this brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. for dosing requirements for populations who require intravenous or oral suspension treatment see dosage and administration.

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

sandoz pty ltd - voriconazole, quantity: 200 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; lactose monohydrate; povidone; croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; triacetin - voriconazole sandoz 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,- prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.,- this brand is only available as tablets and therefore only indicated for adults and children 12 years or older who can tolerate tablets. for dosing requirements for populations who require intravenous or oral suspension treatment see dosage and administration.

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

lupin australia pty limited - esomeprazole magnesium, quantity: 22.264 mg (equivalent: esomeprazole, qty mg) - tablet, enteric coated - excipient ingredients: purified water; purified talc; lactose monohydrate; crospovidone; light magnesium oxide; macrogol 400; hyprolose; macrogol 6000; glyceryl monostearate; methacrylic acid - ethyl acrylate copolymer (1:1); polysorbate 80; silicon dioxide; iron oxide red; pregelatinised maize starch; povidone; microcrystalline cellulose; hypromellose phthalate; titanium dioxide; hypromellose; iron oxide yellow; maize starch; sucrose - esomeprazole enteric-coated tablet indicated for:,1] gastro-oesophageal reflux disease (gord),- treatment of erosive reflux oesophagitis,- long-term management of patients with healed oesophagitis to prevent relapse,- symptomatic treatment of gastro-oesophageal reflux disease (gord),2] patients requiring nsaid therapy,- short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy.,- healing of gastric ulcers associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy,- prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug nsaid (non-selective and cox-2 selective) therapy in patients at risk.,3] prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion.,4] pathological hypersecretory conditions including zollinger-ellison syndrome and idiopathic hypersecretion,in combination with appropriate antibiotics for:,- healing of duodenal ulcer associated with helicobacter pylori,- eradication of helicobacter pylori in patients with active or healed peptic ulcer

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

lupin australia pty limited - esomeprazole magnesium, quantity: 44.528 mg (equivalent: esomeprazole, qty mg) - tablet, enteric coated - excipient ingredients: polysorbate 80; hypromellose phthalate; pregelatinised maize starch; macrogol 6000; light magnesium oxide; purified water; povidone; glyceryl monostearate; silicon dioxide; microcrystalline cellulose; crospovidone; macrogol 400; purified talc; iron oxide red; lactose monohydrate; methacrylic acid - ethyl acrylate copolymer (1:1); hyprolose; titanium dioxide; hypromellose; maize starch; sucrose - esomeprazole enteric-coated tablet indicated for:,1] gastro-oesophageal reflux disease (gord),- treatment of erosive reflux oesophagitis,- long-term management of patients with healed oesophagitis to prevent relapse,- symptomatic treatment of gastro-oesophageal reflux disease (gord),2] patients requiring nsaid therapy,- short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy.,- healing of gastric ulcers associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy,- prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug nsaid (non-selective and cox-2 selective) therapy in patients at risk.,3] prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion.,4] pathological hypersecretory conditions including zollinger-ellison syndrome and idiopathic hypersecretion,in combination with appropriate antibiotics for:,- healing of duodenal ulcer associated with helicobacter pylori,- eradication of helicobacter pylori in patients with active or healed peptic ulcer

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

strides pharma science pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.4 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: colloidal anhydrous silica; hypromellose; macrogol 6000; sodium starch glycollate; mannitol; calcium stearate; sodium carbonate; crospovidone; sodium hydroxide; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin - 1. for 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 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. 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.

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

strides pharma science pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.7 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: sodium starch glycollate; hypromellose; sodium carbonate; crospovidone; colloidal anhydrous silica; mannitol; sodium hydroxide; calcium stearate; macrogol 6000; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate - 1. for 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 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. 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.

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

strides pharma science pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.1 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: triethyl citrate; sodium carbonate; hyprolose; iron oxide yellow; calcium stearate; crospovidone; hypromellose; mannitol; methacrylic acid - ethyl acrylate copolymer (1:1) - 1. for 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 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; i) clarithromycin and amoxicillin, or ii) clarithromycin and metronidazole, or iii) 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. 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.