Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - onasemnogene abeparvovec, quantity: 1 u - injection, intravenous infusion - excipient ingredients: magnesium chloride hexahydrate; water for injections; sodium chloride; poloxamer; hydrochloric acid; trometamol - zolgensma (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (smn1) gene and 1 to 3 copies of the smn2 gene.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - onasemnogene abeparvovec, quantity: 1 u - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections; hydrochloric acid; trometamol; magnesium chloride hexahydrate; poloxamer - zolgensma (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (smn1) gene and 1 to 3 copies of the smn2 gene.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - onasemnogene abeparvovec, quantity: 1 u - injection, intravenous infusion - excipient ingredients: sodium chloride; poloxamer; magnesium chloride hexahydrate; water for injections; hydrochloric acid; trometamol - zolgensma (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (smn1) gene and 1 to 3 copies of the smn2 gene.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.25 mg - sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies  (14)]. sprintec is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and pr

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

amag pharmaceuticals, inc. - prasterone (unii: 459ag36t1b) (prasterone - unii:459ag36t1b) - prasterone 6.5 mg - intrarosa® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. undiagnosed abnormal genital bleeding: any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with intrarosa. risk summary intrarosa is indicated only in postmenopausal women. there are no data with intrarosa use in pregnant women regarding any drug-associated risks. animal reproduction studies have not been conducted with prasterone. risk summary intrarosa is indicated only in postmenopausal women. there is no information on the presence of prasterone in human milk, the effects on the breastfed infant, or the effects on milk production. safety and effectiveness have not been established in pediatric patients. of the 1522 prasterone-treated postmenopausal women enrolled in the four placebo-controlled 12-week and one open-label 52-week clinical t

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)]. sprintec is contraindicated in females who are known to have or develop the following conditions: there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. do not administer cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. cocs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; howev

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

rebel distributors corp - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.25 mg - sprintec 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 i lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. method typical use† perfect use‡ (4) adapted from hatcher et al., 1998 ref. #1. in clinical trials with norgestimate and ethinyl estradiol, 1,651 subjects completed 24,272 cycles and a total of 18 pregnancies were reported. this represents an overall use-efficacy (typical user efficacy) pregnancy rate of 0.96 per 100 women-years. this rate includes patients who did not take the drug correctly. oral contraceptives should not be used in women who currently have the following conditions: - thrombophlebitis or th

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - doxycycline hydrochloride -

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - erythromycin -

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - itraconazole, quantity: 50 mg - capsule - excipient ingredients: silicon dioxide; magnesium stearate; sodium starch glycollate type a; hypromellose phthalate; gelatin; brilliant blue fcf; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - superficial mycoses: lozanoc is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and pityriasis versicolor. systemic mycoses: lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see pharmacology).