Australia - inglés - 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.

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

generic health pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.4 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: mannitol; sodium carbonate; sodium starch glycollate; crospovidone; colloidal anhydrous silica; calcium stearate; hypromellose; macrogol 6000; sodium hydroxide; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin - adults 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: ? duodenal ulcer ? gastric ulcer ? gastro-oesophageal reflux disease (gord): - symptomatic gord. the treatment of heartburn and other symptoms associated with gord - reflux oesophagitis ? gastrointestinal lesions refractory to h2 blockers ? 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 section 4.2 dose and method of 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.

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

generic health pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.7 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: mannitol; sodium carbonate; sodium starch glycollate; crospovidone; colloidal anhydrous silica; calcium stearate; hypromellose; macrogol 6000; sodium hydroxide; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin - adults 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: ? duodenal ulcer ? gastric ulcer ? gastro-oesophageal reflux disease (gord): - symptomatic gord. the treatment of heartburn and other symptoms associated with gord - reflux oesophagitis ? gastrointestinal lesions refractory to h2 blockers ? 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 section 4.2 dose and method of 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.

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

janssen-cilag pty ltd - abiraterone acetate, quantity: 250 mg - tablet - excipient ingredients: colloidal anhydrous silica; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; povidone - zytiga is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or ? patients with mcrpc who have received prior chemotherapy containing a taxane.

Reino Unido - inglés - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord-uk ltd - betamethasone valerate - cutaneous ointment - 1mg/1gram

Canadá - inglés - Health Canada

c.p. industries ltd - benzalkonium chloride; alkyl dimethyl ethylbenzyl ammonium chloride - solution - 4.5%; 4.5% - benzalkonium chloride 4.5%; alkyl dimethyl ethylbenzyl ammonium chloride 4.5% - disinfectants (for agents used on object)

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

pfizer australia pty ltd - water for injections, quantity: 1 ml - diluent, not applicable - excipient ingredients: - enbrel is indicated for the treatment of: adults rheumatoid arthritis active, adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (dmards). enbrel can be used in combination with methotrexate. severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease. psoriatic arthritis the signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. enbrel has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function. plaque psoriasis adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy. ankylosing spondylitis the signs and symptoms of active ankylosing spondylitis in adults. non-radiographic axial spondyloarthritis treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri change who have had an inadequate response to nsaids . * active disease is defined as a bath ankylosing spondylitis disease activity index (basdai) score of greater than or equal to 4.,children and adolescents juvenile idiopathic arthritis active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more dmards. active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy. active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate. enbrel has not been studied in children aged less than 2 years. paediatric plaque psoriasis chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant pasi response is not achieved.

Australia - inglés - 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.

Australia - inglés - 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.

Australia - inglés - 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.