United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glenmark pharmaceuticals europe ltd - atovaquone; proguanil hydrochloride - oral tablet - 250mg ; 100mg

European Union - English - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemophilia a - antihemorrhagics - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype.hemlibra can be used in all age groups.

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

arrotex pharmaceuticals pty ltd - lamotrigine, quantity: 200 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; povidone; saccharin sodium; purified talc; magnesium stearate; mannitol; flavour - seaze is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. there is extensive experience with lamotrigine used initially as add-on therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. initial monotherapy therapy in newly diagnosed paediatric patients is not recommended.( see pharmacology, clinical trials.)

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

arrotex pharmaceuticals pty ltd - lamotrigine, quantity: 100 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; povidone; saccharin sodium; purified talc; magnesium stearate; mannitol; flavour - seaze is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. there is extensive experience with lamotrigine used initially as add-on therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. initial monotherapy therapy in newly diagnosed paediatric patients is not recommended.( see pharmacology, clinical trials.)

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

arrotex pharmaceuticals pty ltd - lamotrigine, quantity: 50 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; povidone; saccharin sodium; purified talc; magnesium stearate; mannitol; flavour - seaze is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. there is extensive experience with lamotrigine used initially as add-on therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. initial monotherapy therapy in newly diagnosed paediatric patients is not recommended.( see pharmacology, clinical trials.)

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

arrotex pharmaceuticals pty ltd - lamotrigine, quantity: 25 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; povidone; saccharin sodium; purified talc; magnesium stearate; mannitol; flavour - seaze is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. there is extensive experience with lamotrigine used initially as add-on therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs. initial monotherapy therapy in newly diagnosed paediatric patients is not recommended.( see pharmacology, clinical trials.)

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

juno pharmaceuticals pty ltd - amoxicillin, quantity: 1 g - injection, powder for - excipient ingredients: - ibiamox is intended for use where the patient?s condition precludes the administration of the oral form of amoxicillin. it is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms.,note: therapy should be guided by bacteriological studies, including sensitivity tests, and clinical response. however, in emergency cases where the causative organism has not been identified, therapy with amoxicillin sodium may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.,septicaemia: (bacterial) h. influenzae; e. coli (see section 5.1 pharmacodynamic properties - microbiology); p. mirabilis; streptococcus; strep. pneumoniae; strep. faecalis and salmonella typhi.,skin and skin structure: staphylococcus (non-penicillinase-producing), streptococcus; e. coli (see section 5.1 pharmacodynamic properties - microbiology).,respiratory, acute and chronic: h. influenzae; streptococcus; strep. pneumoniae; staphylococcus (non-penicillinase producing); e. coli (see section 5.1 pharmacodynamic properties - microbiology).,genitourinary tract (complicated and uncomplicated), acute and chronic: e. coli (see section 5.1 pharmacodynamic properties - microbiology); p. mirabilis and strep. faecalis.,gonorrhoea: n. gonorrhoeae (nonpenicillinase producing),prophylaxis of endocarditis: amoxicillin sodium may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with prosthetic heart valves or those who have previously had endocarditis.

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

medis pharma pty ltd - gemfibrozil, quantity: 600 mg - tablet, film coated - excipient ingredients: hyprolose; colloidal anhydrous silica; pregelatinised maize starch; calcium stearate; microcrystalline cellulose; polysorbate 80; titanium dioxide; hypromellose; indigo carmine; macrogol 4000 - gemfibrozil is indicated as an adjunct to diet and other therapeutic measures for the following: * severe hypertriglyceridaemia (types iv and v) in persons who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. * dyslipidaemia associated with diabetes. * reduction of risk of coronary heart disease in patients with type iia and iib hypercholesterolaemia. * because of potential toxicity such as malignancy, gall bladder disease, abdominal pain leading to appendicectomy and other abdominal surgeries, an increased incidence in noncoronary mortality, and the 29% increase in all-cause mortality seen with the chemically and pharmacologically related drug clofibrate, the potential benefits of gemfibrozil in treating type iia patients with elevations of ldl choleserol only is not likely to outweigh the risks. in a subgroup analysis of patients in the helsinki heart study with above median hdl cholesterol values at baseline (greater than 1.2mmol/l), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups. note: gemfibrozil is indicated when exercise, weight loss and specific dietary or other non-drug measures such as limiting alcohol intake have failed. other medical disorders such as hypothyroidism and diabetes should be controlled as much as possible. periodic determinations of serum lipids should be obtained during treatment with gemfibrozil. the drug should be withdrawn or additionals therapy instituted if the lipid response is deemed inadequate after three months.

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

arrotex pharmaceuticals pty ltd - gemfibrozil, quantity: 600 mg - tablet, film coated - excipient ingredients: polysorbate 80; sodium lauryl sulfate; crospovidone; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; croscarmellose sodium; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 8000; triacetin; polydextrose - ausgem is indicated as an adjunct to diet and other therapeutic measures for the following conditions: -severe hypertiglyceridamia (types iv and v) in those who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. -dyslipidaemia associated with diabetes. -reduction of risk of coronary heart disease in patients with type iia and iib hypercholesterolaemia. beacause of potential toxicity such as malignancy, gallbladder disease, abnormal pain leading to appendectomy and other abdominal surgeries, an increased incidence in non-coronary mortality and the 29% increase in all-cause mortality seen with the chemically and pharmacologically related drug, clofibrate, the potential benefits of gemfibrozil in treating type iia patients with elevation of ldl-cholesterol only are not likely to outweigh the risks. in a subgroup analysis of patients in the helsinki heart study with above-median hdl-cholesterol values at baseline (>1.2mmol/l), both gemfibrozil and placebo subgroups had similar incidences of serious coronary events. note: ausgem is indicated when exercise, weight loss and specific dietary or other non-drug measures, for example, limiting alcohol intake have failed. other medical disorders such as hypothyroidism and diabetes should be controlled as much as possible. periodic determinations of serum lipids should be obtained during treatment with ausgem. the drug should be withdrawn or additional therapy instituted if the lipid response is deemed inadequate after 3 months.

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

novo nordisk pharmaceuticals pty ltd - glucagon, quantity: 1 mg (equivalent: glucagon, qty 1 iu) - diluent, not applicable - excipient ingredients: water for injections - therapeutic: treatment of severe hypoglycaemic reactions which may occur in the management of diabetic patients receiving insulin or oral hypoglycaemic agents. to prevent the occurrence of secondary hypoglycaemia, oral carbohydrate should be given to restore the hepatic glycogen when the patient has responded to the treatment. the mechanism and hence treatment of sulfonylurea-induced hypoglycaemia differs from that of severe insulin-induced hypoglycaemia in some important ways. consciousness should preferably be restored by the administration of intravenous glucose. if glucagon is used due to the unavailability of intravenous glucose (e.g. before reaching a hospital) care should be taken to protect against secondary hypoglycaemia with constant monitoring of the patient's blood sugar level by medical personnel. subsequent administration of intravenous glucose may be required.,diagnostic: motility inhibitor in examinations of the gastrointestinal tract in adults, e.g. double contrast radiography and endoscop