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

janssen-cilag pty ltd - methylphenidate hydrochloride, quantity: 27 mg - tablet, modified release - excipient ingredients: cellulose acetate; polyethylene oxide; butylated hydroxytoluene; stearic acid; succinic acid; iron oxide red; poloxamer; carnauba wax; hypromellose; sodium chloride; phosphoric acid; povidone; iron oxide yellow; iron oxide black; titanium dioxide; lactose monohydrate; triacetin; macrogol 400; propylene glycol; isopropyl alcohol; purified water - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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

janssen-cilag pty ltd - methylphenidate hydrochloride, quantity: 54 mg - tablet, modified release - excipient ingredients: sodium chloride; phosphoric acid; stearic acid; iron oxide yellow; carnauba wax; povidone; polyethylene oxide; cellulose acetate; hypromellose; iron oxide black; succinic acid; butylated hydroxytoluene; poloxamer; iron oxide red; titanium dioxide; lactose monohydrate; triacetin; propylene glycol; isopropyl alcohol; purified water; macrogol 400 - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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

janssen-cilag pty ltd - methylphenidate hydrochloride, quantity: 36 mg - tablet, modified release - excipient ingredients: stearic acid; poloxamer; polyethylene oxide; butylated hydroxytoluene; iron oxide black; iron oxide yellow; phosphoric acid; cellulose acetate; hypromellose; succinic acid; carnauba wax; sodium chloride; povidone; titanium dioxide; lactose monohydrate; triacetin; macrogol 400; propylene glycol; isopropyl alcohol; purified water - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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

janssen-cilag pty ltd - methylphenidate hydrochloride, quantity: 18 mg - tablet, modified release - excipient ingredients: iron oxide yellow; sodium chloride; povidone; butylated hydroxytoluene; iron oxide black; stearic acid; polyethylene oxide; cellulose acetate; succinic acid; phosphoric acid; hypromellose; carnauba wax; poloxamer; macrogol 400; titanium dioxide; lactose monohydrate; triacetin; propylene glycol; isopropyl alcohol; purified water - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Singapore - English - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - estradiol valerate (in brown tablet); estradiol valerate (in white tablet); norgestrel (in brown tablet) - tablet, sugar coated - 2 mg - estradiol valerate (in brown tablet) 2 mg; estradiol valerate (in white tablet) 2 mg; norgestrel (in brown tablet) 0.5 mg

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

arrotex pharmaceuticals pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism; moderately severe/severe androgen dependent loss of scalp hair (moderately severe/severe androgenic alopecia); moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. apo-cyproterone acetate 50mg inhibits the influence of male sex hormones which are also produced by the female. it is thus possible to treat diseases in women caused by either increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if apo-cyproterone acetate 50mg is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. therefore, in women of child bearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation. men: reduction of drive in sexual deviations. apo-cyproterone acetate 50mg reduces the force of the sexual urge in men with sexual deviations. whilst under treatment the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. apo-cyproterone acetate 50mg should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of reduced drive for personal and social reorientation. inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

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

strides pharma science pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism; moderately severe/severe androgen dependent loss of scalp hair (moderately severe/severe androgenic alopecia); moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. cyrotone inhibits the influence of male sex hormones which are also produced by the female. it is thus possible to treat diseases in women caused by either increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if cyrotone is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male fetus. therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation. men: reduction of drive in sexual deviations. cyrotone reduces the force of the sexual urge in men with sexual deviations. whilst under treatment the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. cyrotone should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to reduced drive for personal and social reorientation. inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

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

sandoz pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism; moderately severe/severe androgen dependent loss of scalp hair (moderately severe/severe androgenic alopecia); moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. cyproterone sandoz 50mg inhibits the influence of male sex hormones which are also produced by the female. it is thus possible to treat diseases in women caused by either increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if cyproterone sandoz 50mg is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation. men: reduction to drive in sexual deviations. cyproterone sandoz 50mg reduces the force of the sexual urge in men with sexual deviations. whilst under treatment the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. cyproterone sandoz 50mg should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to reduced drive for personal and social reorientation. inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

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

amneal pharma australia pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism; moderately severe/severe androgen dependent loss of scalp hair (moderately severe/severe androgenic alopecia); moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. cyproterone an inhibits the influence of male sex hormones which are also produced by the female. it is thus possible to treat diseases in women caused by either increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if cyproterone an is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male fetus. therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation. men: reduction of drive in sexual deviations. cyproterone an reduces the force of the sexual urge in men with sexual deviations. whilst under treatment the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. cyproterone an should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to reduced drive for personal and social reorientation. inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

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

teva pharma australia pty ltd - methylphenidate hydrochloride, quantity: 36 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; magnesium stearate; hypromellose; triethyl citrate; purified talc; fumaric acid; methacrylic acid copolymer; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; polyvinyl alcohol; macrogol 3350 - methylphenidate xr arx is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme methylphenidate xr arx is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use methylphenidate xr arx for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.