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

mayne pharma international pty ltd - doxycycline hyclate, quantity: 116.3 mg (equivalent: doxycycline, qty 100 mg) - capsule, modified release - excipient ingredients: microcrystalline cellulose; purified water; hypromellose phthalate; povidone; diethyl phthalate; magnesium stearate; wheat starch; hypromellose; lactose monohydrate; hyprolose; gelatin; ethanol; shellac; pharmaceutical glaze; carbon black - doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. doxycycline is active against a wide range of gram-positive and gram-negative organisms. note: the 50 mg capsule is not a paediatric formulation. mayne pharma doxycycline capsules are indicated in the treatment of infections caused by the following micro-organisms: mycoplasma pneumoniae: primary atypical pneumonia. rickettsiae: queensland tick typhus, typhus fever and q fever. agents of psittacosis. calymmatobacterium (donovania) granulomitis: granuloma inguinale. agents of lymphogranuloma venereum. borreliae: relapsing fever. chlamydia trachomatis. mayne pharma doxycycline capsules are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline capsules alone, or in combination with topical agents. mayne pharma doxycycline is indicated in the treatment of infections caused by the following gram-negative micro-organisms: vibrio species: cholera. brucella species: brucellosis (in conjunction with streptomycin). yersinia pestis: plague. francisella tularensis: tularemia. bartonella bacilliformis: bartonellosis. bacteroides species. when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: treponema pallidum: syphilis. treponema pertenue: yaws. neisseria gonorrhoea: gonorrhoea (see dosage and administration). mayne pharma doxycycline capsules is not the drug of choice in the treatment of any type of staphylococcal infection or infections caused by streptococcus pneumoniae, haemophilus influenzae, streptococcus pyogenes, streptococcus faecalis, or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxycycline should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory tract infections due to group a beta-haemolytic streptococci (including prophylaxis of rheumatic fever) penicillin is the usual drug of choice. doxycycline is active against both pre-erythroycitic and asexual bloodstages of plasmodium falciparum. the tetracyclines are only partially active against the pre-erythrocytic stages of plasmodium vivax and protection depends on drug suppression of the blood stages. doxycycline has no activity against the relapsing forms (hypnozoites) of plasmodium vivax. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine. in acute intestinal amoebiasis mayne pharma doxycycline capsules may be a useful adjunct to amoebicides. in severe acne mayne pharma doxycycline capsules may be a useful adjunctive therapy.

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

mayne pharma international pty ltd - doxycycline hyclate, quantity: 58.15 mg (equivalent: doxycycline, qty 50 mg) - capsule, modified release - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; hypromellose phthalate; hypromellose; hyprolose; povidone; wheat starch; diethyl phthalate; purified water; gelatin; ethanol; shellac; pharmaceutical glaze; carbon black - doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. doxycycline is active against a wide range of gram-positive and gram-negative organisms. note: the 50 mg capsule is not a paediatric formulation. mayne pharma doxycycline capsules are indicated in the treatment of infections caused by the following micro-organisms: mycoplasma pneumoniae: primary atypical pneumonia. rickettsiae: queensland tick typhus, typhus fever and q fever. agents of psittacosis. calymmatobacterium (donovania) granulomitis: granuloma inguinale. agents of lymphogranuloma venereum. borreliae: relapsing fever. chlamydia trachomatis. mayne pharma doxycycline capsules are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline capsules alone, or in combination with topical agents. mayne pharma doxycycline is indicated in the treatment of infections caused by the following gram-negative micro-organisms: vibrio species: cholera. brucella species: brucellosis (in conjunction with streptomycin). yersinia pestis: plague. francisella tularensis: tularemia. bartonella bacilliformis: bartonellosis. bacteroides species. when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: treponema pallidum: syphilis. treponema pertenue: yaws. neisseria gonorrhoea: gonorrhoea (see dosage and administration). mayne pharma doxycycline capsules is not the drug of choice in the treatment of any type of staphylococcal infection or infections caused by streptococcus pneumoniae, haemophilus influenzae, streptococcus pyogenes, streptococcus faecalis, or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxycycline should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory tract infections due to group a beta-haemolytic streptococci (including prophylaxis of rheumatic fever) penicillin is the usual drug of choice. doxycycline is active against both pre-erythroycitic and asexual bloodstages of plasmodium falciparum. the tetracyclines are only partially active against the pre-erythrocytic stages of plasmodium vivax and protection depends on drug suppression of the blood stages. doxycycline has no activity against the relapsing forms (hypnozoites) of plasmodium vivax. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine. in acute intestinal amoebiasis manye pharma doxycycline capsules may be a useful adjunct to amoebicides. in severe acne mayne pharma doxycycline capsules may be a useful adjunctive therapy

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

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 2.32 mg (equivalent: estradiol, qty 2.25 mg) - drug delivery system, transdermal - excipient ingredients: polyethylene terephthalate; isopropyl palmitate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. lifestyle modifications and the risk-benefit profile of estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing (see section 4.4 special warnings and precautions for use and section 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.

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)

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 3.09 mg (equivalent: estradiol, qty 3 mg) - drug delivery system, transdermal - excipient ingredients: isopropyl palmitate; polyethylene terephthalate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. lifestyle modifications and the risk-benefit profile of estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing( see section 4.4 special warnings and precautions for use and section 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.

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

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 0.77 mg (equivalent: estradiol, qty 0.75 mg) - drug delivery system, transdermal - excipient ingredients: isopropyl palmitate; polyethylene terephthalate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). estraderm mx 25 is not indicated for the prevention of post-menopausal bone mineral density loss. combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer

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

juno pharmaceuticals pty ltd - estradiol hemihydrate, quantity: 1.54 mg (equivalent: estradiol, qty 1.5 mg) - drug delivery system, transdermal - excipient ingredients: isopropyl palmitate; polyethylene terephthalate; ethyl acetate; acrylic acid; 2-ethylhexyl acrylate; methyl acrylate; glycidyl methacrylate; 2,2'-azobisisobutyronitrile; hexane - menopausal symptoms: short-term treatment of signs and symptoms of oestrogen deficiency due to menopause, whether natural or surgically induced. in women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (refer to section 5.1 pharmacodynamic properties - clinical trials and section 4.2 dose and method of administration). prevention of post-menopausal bone mineral density loss: estraderm mx 50, 75 and 100 may be used for prevention of post-menopausal bone mineral density loss in women with an increased risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. when prescribed solely for the prevention of postmenopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of bone mineral density loss. lifestyle modifications and the risk-benefit profile of estraderm mx should be taken into careful consideration and discussed with the patient to allow the patient to make an informed decision prior to prescribing (see section 4.4 special warnings and precautions for use and sectoin 4.2 dose and method of administration). combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase risk of breast cancer.

Israel - English - Ministry of Health

dexcel pharma technologies ltd - chlorhexidine digluconate - chip - chlorhexidine digluconate 2.5 mg - chlorhexidine - chlorhexidine - the perio- chip is indicated for reduction and/or elimination of pathogenic periodontal pocket microbiota, delaying and/or arresting recolonization of the subgingival microflora, reduction and/or elimination of inflammatory lesions in the periodontal pockets, and as an adjunct to mechanical treatment in periodontitis.

Israel - English - Ministry of Health

taro pharmaceutical industries ltd - warfarin sodium - tablets - warfarin sodium 1 mg - warfarin - warfarin - coumadin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. coumadin is indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. coumadin is indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.