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

avallon pharmaceuticals pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.1 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: hyprolose; calcium stearate; triethyl citrate; crospovidone; sodium carbonate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide yellow; quinoline yellow aluminium lake; macrogol 400; brilliant scarlet 4r aluminium lake; 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: duodenal ulcer; gastric ulcer; gastro-oesophageal reflux disease (gord) i. symptomatic gord. the treatment of heartburn and other symptoms associated with gord ii. 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 micro-organism. 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 - englanti - Department of Health (Therapeutic Goods Administration)

avallon pharmaceuticals pty ltd - pantoprazole sodium sesquihydrate, quantity: 22.55 mg (equivalent: pantoprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: hyprolose; crospovidone; triethyl citrate; sodium carbonate; microcrystalline cellulose; colloidal anhydrous silica; calcium stearate; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; hypromellose; iron oxide yellow; quinoline yellow aluminium lake; macrogol 400; brilliant scarlet 4r aluminium lake - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: duodenal ulcer; gastric ulcer; gastro-oesophageal reflux disease (gord) i. symptomatic gord. the treatment of heartburn and other symptoms associated with gord ii. 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 micro-organism. 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 - englanti - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.1 mg (equivalent: pantoprazole, qty 40 mg) - injection, powder for - excipient ingredients: mannitol; tribasic sodium phosphate dodecahydrate - short-term use where oral therapy is not appropriate for: 1.symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: ?duodenal ulcer ?gastric ulcer ?reflux oesophagitis ?gastrointestinal lesions refractory to h2 blockers ?zollinger-ellison syndrome,2.maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.,note. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory drugs, whether on first presentation or recurrence.

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

juno pharmaceuticals pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: nitrogen; mannitol - bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection), in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection), as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection) is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

juno pharmaceuticals pty ltd - bortezomib, quantity: 1 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection), in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection), as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection) is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

juno pharmaceuticals pty ltd - bortezomib, quantity: 2.5 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - bortezomib juno in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib juno as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib juno is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib juno in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

avallon pharmaceuticals pty ltd - lansoprazole, quantity: 30 mg - capsule - excipient ingredients: methacrylic acid - ethyl acrylate copolymer (1:1); hypromellose; indigo carmine; colloidal anhydrous silica; titanium dioxide; maize starch; purified talc; macrogol 300; sucrose; carmoisine; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - adults:. lanzopran capsules are indicated for. - healing and long-term management of reflux oesophagitis. . - healing and long-term management for patients with duodenal ulcer.. - healing of benign gastric ulcer. patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. . - patients with benign peptic lesions that do not respond to h2-receptor antagonists.. - eradication of h. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics. . - relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia. . paediatric and adolescent patients i to 17 years of age:. lanzopran capsules are indicated for. - treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. . - healing of erosive oesophagitis.

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

avallon pharmaceuticals pty ltd - terbinafine hydrochloride, quantity: 281.31 mg (equivalent: terbinafine, qty 250 mg) - tablet, uncoated - excipient ingredients: magnesium stearate; sodium starch glycollate type a; purified talc; microcrystalline cellulose; colloidal anhydrous silica; hypromellose - treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as trichophyton (e.g. t. rubrum, t. mentagrophytes, t. verrucosum, t. violaceum), microsporum canis and epidermophyton floccosum, where oral therapy is considered appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to topical therapy. onychomycosis in adults (fungal infection of the nail) caused by dermatophyte fungi.

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

aft pharmaceuticals pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - analgesia (adults and children over 12 years of age) ? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain (excluding intermittent top up injections) ? field block (minor nerve block and infiltration) ? continuous peripheral nerve block infusion or intermittent injections for post ? operative pain management ? continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0 - 12 years) ? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine-aft for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

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

aft pharmaceuticals pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - analgesia (adults and children over 12 years of age) ? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain (excluding intermittent top up injections) ? field block (minor nerve block and infiltration) ? continuous peripheral nerve block infusion or intermittent injections for post ? operative pain management ? continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0 - 12 years) ? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine-aft for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).