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

arrotex pharmaceuticals pty ltd - venlafaxine hydrochloride, quantity: 84.9 mg (equivalent: venlafaxine, qty 75 mg) - capsule, modified release - excipient ingredients: iron oxide black; colloidal anhydrous silica; ethylcellulose; iron oxide red; magnesium stearate; microcrystalline cellulose; povidone; purified talc; titanium dioxide; gelatin; copovidone; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia - blooms the chemist venlafaxine xr is indicated for the treatment of: - major depression, including prevention of relapse and recurrence where appropriate; - generalised anxiety disorder; - social anxiety disorder; panic disorder, including prevention of relapse.

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

arrotex pharmaceuticals pty ltd - venlafaxine hydrochloride, quantity: 169.8 mg (equivalent: venlafaxine, qty 150 mg) - capsule, modified release - excipient ingredients: gelatin; ethylcellulose; sunset yellow fcf; povidone; magnesium stearate; microcrystalline cellulose; brilliant blue fcf; copovidone; allura red ac; purified talc; colloidal anhydrous silica; titanium dioxide; propylene glycol; ethanol; isopropyl alcohol; shellac; tert-butyl alcohol; sodium hydroxide - blooms the chemist venlafaxine xr is indicated for the treatment of: - major depression, including prevention of relapse and recurrence where appropriate; - generalised anxiety disorder; - social anxiety disorder; panic disorder, including prevention of relapse.

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

arrotex pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 41.7 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; allura red ac aluminium lake; indigo carmine aluminium lake; iron oxide red - blooms the chemist rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. prevention of cardiovascular events: blooms the chemist rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). blooms the chemist rosuvastatin is indicated to: reduce the risk of nonfatal myocardial infarction; reduce the risk of nonfatal stroke; reduce the risk of coronary artery revascularisation procedures. in patients with hypercholesterolaemia: blooms the chemist rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with blooms the chemist rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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

arrotex pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 20.8 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; crospovidone; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; allura red ac aluminium lake; indigo carmine aluminium lake; iron oxide red - blooms the chemist rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. prevention of cardiovascular events: blooms the chemist rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). blooms the chemist rosuvastatin is indicated to: reduce the risk of nonfatal myocardial infarction; reduce the risk of nonfatal stroke; reduce the risk of coronary artery revascularisation procedures. in patients with hypercholesterolaemia: blooms the chemist rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with blooms the chemist rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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

arrotex pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 10.4 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; lactose monohydrate; crospovidone; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; allura red ac aluminium lake; indigo carmine aluminium lake; iron oxide red - blooms the chemist rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. prevention of cardiovascular events: blooms the chemist rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). blooms the chemist rosuvastatin is indicated to: reduce the risk of nonfatal myocardial infarction; reduce the risk of nonfatal stroke; reduce the risk of coronary artery revascularisation procedures. in patients with hypercholesterolaemia: blooms the chemist rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with blooms the chemist rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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

arrotex pharmaceuticals pty ltd - rosuvastatin calcium, quantity: 5.2 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; crospovidone; lactose monohydrate; titanium dioxide; hypromellose; sunset yellow fcf aluminium lake; triacetin; quinoline yellow aluminium lake; indigo carmine aluminium lake; iron oxide yellow - blooms the chemist rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate. prevention of cardiovascular events: blooms the chemist rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). blooms the chemist rosuvastatin is indicated to: reduce the risk of nonfatal myocardial infarction; reduce the risk of nonfatal stroke; reduce the risk of coronary artery revascularisation procedures. in patients with hypercholesterolaemia: blooms the chemist rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with blooms the chemist rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

United States - English - NLM (National Library of Medicine)

sandoz inc - desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - desogestrel 0.15 mg - isibloomtm (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and the norplant system depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. in a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. this represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. this rate includes patients who did not take the drug correctly. chancef 85 85 spermicidesg 26 6 40 periodic abstinence 25 63   calendar 9   ovulation method 3   sympto-thermal

United States - English - NLM (National Library of Medicine)

xiromed, llc. - desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - desogestrel 0.15 mg - isibloom (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and the norplant system depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. in a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. this represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. this rate includes patients who did not take the drug correctly. chancef 85 85 spermicidesg 26 6 40 periodic abstinence 25 63   calendar 9   ovulation method 3   sympto-thermalh

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - isibloomtm (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and the norplant system depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. in a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. this represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. this rate includes patients who did not take the drug correctly. chancef 85 85 spermicidesg 26 6 40 periodic abstinence 25 63   calendar 9   ovulation method 3   sympto-thermalh 2   post-ovulation 1 withdrawal 19 4 capi   parous women 40 26 42   nulliparous women 20 9 56 sponge   parous women 40 20 42   nulliparous women 20 9 56 diaphragmi 20 6 56 condomj   female (reality® ) 21 5 56   male 14 3 61 pill 5 71   progestin only 0.5   combined 0.1 iud   progesterone t 2 1.5 81   copper t380a 0.8 0.6 78   lng 20 0.1 0.1 81 depo-provera 0.3 0.3 70 norplant® and norplant-2® 0.05 0.05 88 female sterilization 0.5 0.5 100 male sterilization 0.15 0.10 100 emergency contraceptive pills: treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.d lactation amenorrhea method: lam is a highly effective, temporary method of contraception.e source: trussel j. contraceptive efficacy. in hatcher ra, trussell j, stewart f, cates w, stewart gk, kowel d, guest f, contraceptive technology: seventeenth revised edition. new york, ny; irvington publishers, 1998. a among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. c among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. d the treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. the fda has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: ovral® (1 dose is 2 white pills), alesse® (1 dose is 5 pink pills), nordette® or levlen® (1 dose is 4 yellow pills). e however, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. f the percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. among such populations, about 89% become pregnant within one year. this estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. g foams, creams, gels, vaginal suppositories, and vaginal film. h cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. i with spermicidal cream or jelly. j without spermicides. desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception. isibloom is contraindicated in females who are known to have or develop the following conditions:

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - isibloom tm (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and the norplant system depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. in a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. this represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. this rate includes patients who did not take the drug correctly. chance f 85 85 spermicides g 26 6 40 periodic abstinence 25 63   calendar 9   ovulation method 3   sympto-thermal h 2   post-ovulation 1 withdrawal 19 4 cap i   parous women 40 26 42   nulliparous women 20 9 56 sponge   parous women 40 20 42   nulliparous women 20 9 56 diaphragm i 20 6 56 condom j   female (reality ® ) 21 5 56   male 14 3 61 pill 5 71   progestin only 0.5   combined 0.1 iud   progesterone t 2 1.5 81   copper t380a 0.8 0.6 78   lng 20 0.1 0.1 81 depo-provera 0.3 0.3 70 norplant ® and norplant-2 ® 0.05 0.05 88 female sterilization 0.5 0.5 100 male sterilization 0.15 0.10 100 emergency contraceptive pills: treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. d lactation amenorrhea method: lam is a highly effective, temporary method of contraception. e source: trussel j. contraceptive efficacy. in hatcher ra, trussell j, stewart f, cates w, stewart gk, kowel d, guest f, contraceptive technology: seventeenth revised edition. new york, ny; irvington publishers, 1998. a among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. c among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. d the treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. the fda has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: ovral® (1 dose is 2 white pills), alesse® (1 dose is 5 pink pills), nordette® or levlen® (1 dose is 4 yellow pills). e however, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. f the percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. among such populations, about 89% become pregnant within one year. this estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. g foams, creams, gels, vaginal suppositories, and vaginal film. h cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. i with spermicidal cream or jelly. j without spermicides. desogestrel and ethinyl estradiol tablets have not been studied for and are not indicated for use in emergency contraception. isibloom is contraindicated in females who are known to have or develop the following conditions: - thrombophlebitis or thromboembolic disorders - a past history of deep vein thrombophlebitis or thromboembolic disorders - known thrombophilic conditions - cerebral vascular or coronary artery disease (current or history) - valvular heart disease with complications - persistent blood pressure values of ≥ 160 mm hg systolic or ≥ 100 mg hg diastolic 102 - diabetes with vascular involvement - headaches with focal neurological symptoms - major surgery with prolonged immobilization - current diagnosis of, or history of, breast cancer, which may be hormone sensitive  - carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - undiagnosed abnormal genital bleeding - cholestatic jaundice of pregnancy or jaundice with prior pill use - acute or chronic hepatocellular disease with abnormal liver function - hepatic adenomas or carcinomas - known or suspected pregnancy - hypersensitivity to any component of this product - are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment).