Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

prime pharmaceutical sdn. bhd. - thiamine mononitrate; pyridoxine hydrochloride (vit.b6); cyanocobalamine 1% -

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

pharmaco australia ltd - clonazepam, quantity: 0.5 mg - tablet, uncoated - excipient ingredients: iron oxide red; magnesium stearate; pregelatinised potato starch; purified talc; maize starch; iron oxide yellow; lactose monohydrate - tablets: most types epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic-clonic fits, whether due to primary generalised epilepsy, or to secondary generalisation of partial epilepsy. in adults all varieties of generalised epilepsy (including myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial epilepsy (including psychomotor seizures).

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

novartis pharmaceuticals australia pty ltd - vildagliptin, quantity: 50 mg - tablet, uncoated - excipient ingredients: sodium starch glycollate; magnesium stearate; lactose; microcrystalline cellulose - treatment of diabetes mellitus type 2 in persons 18 years of age and older, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes: - as monotherapy, in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. - in dual combination with one of metformin, a sulfonylurea or pioglitazone when diet, exercise and the single agent do not result in adequate glycaemic control. - in triple combination with a sulfonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. - in combination with insulin (with or without metformin) when diet, exercise and a stable dose of insulin do not result in adequate glycaemic control.

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

abbvie pty ltd - ritonavir, quantity: 100 mg - tablet, film coated - excipient ingredients: macrogol 3350; macrogol 400; sodium stearylfumarate; titanium dioxide; calcium hydrogen phosphate; sorbitan monolaurate; copovidone; hyprolose; purified talc; polysorbate 80; hypromellose; colloidal anhydrous silica - norvir (ritonavir) is indicated for use in combination with appropriate antiretriviral agents or as monotherapy if combination therapy is inappropriate, for the treatment of hiv-1 infection in adults and children aged 12 years and older. for persons with advanced hiv disease, the indication for ritonavir is based on the results for one study that showed a reduction in both mortality and aids defining clinical events for patients who received ritonavir. median duration of follow-up in this study was 6 months. the clinical benefit from ritonavir for longer periods of treatment is unknown. for persons with less advanced disease, the indication is based on changes in surrogate markers in controlled trials of up to 16 weeks in duration ( see clinical trials).

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

alphapharm pty ltd - erythromycin ethyl succinate, quantity: 482.04 mg (equivalent: erythromycin, qty 400 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate; povidone; maize starch; sorbic acid; calcium hydrogen phosphate; purified talc; magnesium stearate; titanium dioxide; iron oxide red; xanthan gum; polyvinyl alcohol; lecithin - streptococcus pyogenes (group a beta-haemolytic streptococcus). upper and lower respiratory tract, skin and skin structure infections of mild to moderate severity. when oral medication is given, patient must comply with the prescribed regimen. therapeutic dose should be administered for at least 10 days. alpha haemolytic streptococci (viridans group). no controlled clinical efficacy trials have been conducted, however oral erythromycin has been suggested by the american heart association and the american dental association for use in bacterial endocarditis prophylaxis prior to dental/surgical procedures of the upper respiratory tract in penicillin-hypersensitive patients with a history of rheumatic, congenital or other acquired valvular heart disease. erythromycin is unsuitable prior to genitourinary or gastrointestinal tract surgery. staphylococcus aureus. acute infections of skin and skin structure of mild to moderate severity. bacterial resistance may emerge during treatment, hence cultures and sensitivity tests should be performed. streptococcus pneumoniae (diplococcus pneumoniae). upper (e.g. otitis media, pharyngitis) and lower respiratory tract infections (e.g. pneumonia) of mild to moderate degree. mycoplasma pneumoniae (eaton agent, pplo). for respiratory infections due to this organism. haemophilus influenzae. for upper respiratory tract infections of mild to moderate severity. not all strains are susceptible at the erythromycin concentrations normally achieved. chlamydia trachomatis and ureaplasma urealyticum. these organisms are sensitive to erythromycin; clinical studies have demonstrated erythromycin's efficacy in nongonococcal urethritis due to these organisms. a minimum of 10 days therapy is required. chlamydia trachomatis infection (excluding nongonococcal urethritis). erythromycin has shown to be effective in treating trachoma or inclusion body conjunctivitis, acute inclusion conjunctivitis of the newborn (inclusion blennorrhoea) and pneumonia in infants caused by chlamydia trachomatis. treponema pallidum. erythromycin is an alternative drug in treating primary syphilis in patients allergic to penicillins. spinal fluid examinations should be done before treatment and as part of follow-up post therapy. neisseria gonorrhoeae. erythromycin lactobionate for injection in conjunction with oral erythromycin ethylsuccinate, as an alternative treatment for acute uncomplicated gonorrhoea in female patients with penicillin hypersensitivity. before treatment, patients who are suspected of also having syphilis should be evaluated including a microscopic examination for t. pallidum (by immunofluorescence or darkfield) before receiving erythromycin, and monthly serologic tests should be performed for a minimum of 4 months. corynebacterium diphtheriae, c. minutissimum and c. (propionibacterium) acnes. as an adjunct to diphtheria antitoxin, to prevent establishment of carriers, and to eradicate the organism in carriers; in the treatment of erythrasma; adjunctive therapy of moderate to severe acne. bordetella pertussis. for early elimination of the causative organism from the nasopharynx. therapeutic doses should be continued for at least 10 days. the clinical course of the disease is not altered. clostridium tetani. in vitro, clostridium tetani is sensitive to erythromycin. erythromycin may be used prophylatically in penicillin-hypersensitive persons for 5 days. as the value of antibiotic prophylaxis in tetanus is not unequivocally established, wounds should be regularly examined. legionnaires' disease. although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires' disease. campylobacter fetus (subspecies) jejuni, listeria monocytogenes. infections due to this organism when antibiotic therapy is indicated.

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - febantel; pyrantel embonate ; praziquantel - tablet - 150, 144, 50 mg/tablet - febantel, combinations - dogs - endoparasiticide

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - febantel; pyrantel embonate ; praziquantel - tablet - 525, 504, 175 mg/tablet - febantel, combinations - dogs - endoparasiticide

Ireland - English - HPRA (Health Products Regulatory Authority)

chanelle pharmaceuticals manufacturing limited - praziquantel; pyrantel embonate ; febantel - tablet - 50,50,150 mg/tablet - praziquantel, combinations - dogs - endoparasiticide

Ireland - English - HPRA (Health Products Regulatory Authority)

chanelle pharmaceuticals manufacturing limited - praziquantel; pyrantel embonate ; febantel - tablet - 175,504,525 mg/tablet - praziquantel, combinations - dogs - endoparasiticide