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

emcure pharmaceuticals pty ltd - carmustine, quantity: 100 mg - injection, powder for - excipient ingredients: - indications as at 16 december 1985: carmustine is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1. malignant glioma. 2. multiple myeloma: in combination with prednisone. 3. hodgkin's disease: as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4. non-hodgkins lymphomas: as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

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

emcure pharmaceuticals pty ltd - teriflunomide, quantity: 14 mg - tablet, film coated - excipient ingredients: hyprolose; maize starch; microcrystalline cellulose; sodium starch glycollate type a; silicon dioxide; lactose monohydrate; magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc; indigo carmine aluminium lake - teriflunomide is indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

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

emcure pharmaceuticals pty ltd - pemetrexed disodium hemipentahydrate, quantity: 604.1 mg (equivalent: pemetrexed, qty 500 mg) - injection, powder for - excipient ingredients: mannitol; sodium hydroxide; hydrochloric acid; nitrogen - malignant pleural mesothelioma pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,non-small cell lung cancer pemetrexed in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,pemetrexed as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

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

emcure pharmaceuticals pty ltd - nitrofurantoin, quantity: 50 mg - capsule, hard - excipient ingredients: lactose monohydrate; pregelatinised maize starch; purified talc; titanium dioxide; purified water; quinoline yellow; iron oxide yellow; gelatin; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens. nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis.

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

emcure pharmaceuticals pty ltd - nitrofurantoin, quantity: 100 mg - capsule, hard - excipient ingredients: lactose monohydrate; pregelatinised maize starch; purified talc; titanium dioxide; purified water; quinoline yellow; iron oxide yellow; gelatin; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens. nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis.

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

emcure pharmaceuticals pty ltd - cidofovir, quantity: 75 mg/ml - injection, concentrated - excipient ingredients: water for injections; nitrogen; hydrochloric acid; sodium hydroxide - empovir is indicated in adults for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids).

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

emcure pharmaceuticals pty ltd - melphalan hydrochloride, quantity: 55.97 mg (equivalent: melphalan, qty 50 mg) - injection, diluent for - excipient ingredients: sodium citrate dihydrate; ethanol; water for injections; propylene glycol - for?the?treatment?of?patients?with?multiple?myeloma?for?whom?oral therapy?is?not?appropriate

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

emcure pharmaceuticals pty ltd - amikacin sulfate, quantity: 667.5 mg (equivalent: amikacin, qty 500 mg) - injection - excipient ingredients: sodium citrate dihydrate; sulfuric acid; water for injections; sodium metabisulfite - amikacin injection is indicated in the short-term treatment of serious infections caused by susceptible strains of gram-negative bacteria.,staphylococcus aureus, including methicillin-resistant strains is the principal gram-positive organism sensitive to amikacin.,the use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy, and should be confined to patients suffering from severe infections caused by susceptible strains of stapylococcus who have failed to respond or are allergic to other available antibiotics.,amikacin injection is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used.,in certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated because of the possibility of infections due to gram-positive organisms such as streptococci or pneumococci. if concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately because in-vitro mixing of the two drugs causes inactivation of amikacin.,clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures (including those resulting from burns), intra-abdominal organs, post-operative infections and complicated and recurrent urinary tract infections, when caused by susceptible organisms.

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

emcure pharmaceuticals pty ltd - flecainide acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate - flec-em is indicated for:,1. supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. wolff-parkinson-white and lown-ganong-levine syndromes b) due to dual av nodal pathways in patients with debilitating symptoms c) paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms,although flec-em may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. in these patients, particularly in the presence of impaired left ventricular function, flec-em should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,use of flec-em in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. life threatening ventricular arrhythmias not controlled by other drugs. flec-em tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.

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

emcure pharmaceuticals pty ltd - flecainide acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate - flec-em is indicated for:,1. supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. wolff-parkinson-white and lown-ganong-levine syndromes b) due to dual av nodal pathways in patients with debilitating symptoms c) paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms,although flec-em may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. in these patients, particularly in the presence of impaired left ventricular function, flec-em should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,use of flec-em in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. life threatening ventricular arrhythmias not controlled by other drugs. flec-em tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.