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

novartis pharmaceuticals australia pty ltd - methylphenidate hydrochloride, quantity: 30 mg - capsule, modified release - excipient ingredients: purified talc; methacrylic acid copolymer; ammonio methacrylate copolymer; titanium dioxide; triethyl citrate; iron oxide yellow; gelatin; macrogol 6000; maize starch; purified water; sucrose; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; iron oxide red; strong ammonia solution; ethanol absolute; potassium hydroxide - ritalin 10 tablets and ritalin la capsules are indicated for the treatment of adhd. ritalin 10 tablets are also indicated for the treatment of narcolepsy. attention-deficit hyperactivity disorder (adhd) adhd was previously known as attention-deficit disorder. other terms used to describe this behavioural syndrome include: minimal brain dysfunction in children, hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction and psycho-organic syndrome of children. ritalin 10 / ritalin la are indicatedas 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. special diagnostic considerations for adhd in children: the aetiology of this syndrome is unknown and there is no single diagnostic test. adequate diagnosis requires the use, not only of medical, but also of psychological, educational and social resources. characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and an abnormal eeg. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. drug treatment is not indicated for all children with this syndrome. stimulants are not intended for use in children who exhibit symptoms secondary to environmental factors (e.g. child abuse in particular) or primary psychiatric disorders. appropriate educational placement is essential and psychosocial intervention is generally necessary. when remedial measures alone are insufficient, the decision to prescribe stimulant medicine will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. continuation of treatment in adolescent and special diagnostic considerations for adhd in adults: there is limited information to guide clinicians about how long older adolescents should continue to receive treatment with drugs for attention deficit hyperactivity disorder (adhd). the decision should be based on the extent to which symptoms of adhd and social functioning have improved to a point that medication is no longer needed. if older adolescents have been largely symptom-free for a year and are functioning well, a trial without medication is warranted. this should be undertaken at times of low stress such as during holidays or in a period when a school routine is well established. adhd needs to be considered in adults who present with longstanding symptoms suggestive of adhd (inattention, impulsivity, disorganisation) that appear to have started in childhood and are persisting into adult life. further, people with personality disorder and/or problems with drug use accompanied by a significant level of impulsivity and inattention should be referred for evaluation by a psychiatrist with the training and skills required to assess and treat adhd. this expertise is necessary due to the overlap of adhd symptoms with anxiety, mood and personality disorders. narcolepsy the symptoms include daytime sleepiness, inappropriate sleep episodes and rapidly occurring loss of voluntary muscle tone. ritalin 10 is effective for symptoms of sleepiness but not for loss of voluntary muscle tone.

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

novartis pharmaceuticals australia pty ltd - methylphenidate hydrochloride, quantity: 20 mg - capsule, modified release - excipient ingredients: macrogol 6000; titanium dioxide; gelatin; ammonio methacrylate copolymer; purified talc; triethyl citrate; methacrylic acid copolymer; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; iron oxide yellow; shellac; iron oxide red; strong ammonia solution; ethanol absolute; potassium hydroxide; maize starch; sucrose - ritalin 10 tablets and ritalin la capsules are indicated for the treatment of adhd. ritalin 10 tablets are also indicated for the treatment of narcolepsy. attention-deficit hyperactivity disorder (adhd) adhd was previously known as attention-deficit disorder. other terms used to describe this behavioural syndrome include: minimal brain dysfunction in children, hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction and psycho-organic syndrome of children. ritalin 10 / ritalin la are indicatedas 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. special diagnostic considerations for adhd in children: the aetiology of this syndrome is unknown and there is no single diagnostic test. adequate diagnosis requires the use, not only of medical, but also of psychological, educational and social resources. characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and an abnormal eeg. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. drug treatment is not indicated for all children with this syndrome. stimulants are not intended for use in children who exhibit symptoms secondary to environmental factors (e.g. child abuse in particular) or primary psychiatric disorders. appropriate educational placement is essential and psychosocial intervention is generally necessary. when remedial measures alone are insufficient, the decision to prescribe stimulant medicine will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. continuation of treatment in adolescent and special diagnostic considerations for adhd in adults: there is limited information to guide clinicians about how long older adolescents should continue to receive treatment with drugs for attention deficit hyperactivity disorder (adhd). the decision should be based on the extent to which symptoms of adhd and social functioning have improved to a point that medication is no longer needed. if older adolescents have been largely symptom-free for a year and are functioning well, a trial without medication is warranted. this should be undertaken at times of low stress such as during holidays or in a period when a school routine is well established. adhd needs to be considered in adults who present with longstanding symptoms suggestive of adhd (inattention, impulsivity, disorganisation) that appear to have started in childhood and are persisting into adult life. further, people with personality disorder and/or problems with drug use accompanied by a significant level of impulsivity and inattention should be referred for evaluation by a psychiatrist with the training and skills required to assess and treat adhd. this expertise is necessary due to the overlap of adhd symptoms with anxiety, mood and personality disorders. narcolepsy the symptoms include daytime sleepiness, inappropriate sleep episodes and rapidly occurring loss of voluntary muscle tone. ritalin 10 is effective for symptoms of sleepiness but not for loss of voluntary muscle tone.

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

organon pharma pty ltd - etoricoxib, quantity: 120 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; carnauba wax; calcium hydrogen phosphate; croscarmellose sodium; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; indigo carmine; triacetin; iron oxide yellow - arcoxia is indicated for: - symptomatic treatment of the signs and symptoms of osteoarthritis (oa). - treatment of acute gouty arthritis. - treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures. the decision to prescribe a selective cox-2 inhibitor should be based on an assessment of the individual patient's overall risks.

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

organon pharma pty ltd - etoricoxib, quantity: 60 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; carnauba wax; calcium hydrogen phosphate; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; indigo carmine; triacetin; iron oxide yellow - arcoxia is indicated for: - symptomatic treatment of the signs and symptoms of osteoarthritis (oa). - treatment of acute gouty arthritis. - treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures. the decision to prescribe a selective cox-2 inhibitor should be based on an assessment of the individual patient's overall risks.

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)

viatris pty ltd - dydrogesterone, quantity: 10 mg; estradiol, quantity: 2 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; colloidal anhydrous silica; lactose monohydrate; maize starch; titanium dioxide; purified talc; iron oxide yellow; macrogol 400 - hormone replacement therapy (hrt) in oestrogen deficiency associated with natural or artificial menopause in women with an intact uterus. prevention of postmenopausal bone mineral density loss in women. for initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used with the goal being short term use (see dosage and administration and clinical trials). when prescribed solely for the prevention of postmenopausal bone mineral density loss in women, 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 osteoporosis. life style modifications and the risk benefit profile of femoston should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing( see precautions and dosage and administration).

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

bayer australia ltd - estradiol, quantity: 5.69 mg - drug delivery system, transdermal - excipient ingredients: ethyl oleate; isopropyl myristate; glyceryl laurate; acrylates/acrylamide copolymer - other conditions: do not remove from primary pack except for immediate use. for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. oestradiol prevents the accelerated loss of bone density due to oestrogen deficiency and may be used for the prevention of post-menopausal bone mineral density loss. in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.,for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. for the prevention of post menopausal bone mineral density loss. when prescribed solely for the prevention of post menopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who, are intolerant of, or contraindicated for non-oestrogen products approved for prevention of osteoporosis. lifestyle modifications and the risk benefit profile of climara should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing (see precautions and dosage and administration sections). in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.

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

bayer australia ltd - estradiol, quantity: 1.97 mg - drug delivery system, transdermal - excipient ingredients: glyceryl laurate; ethyl oleate; isopropyl myristate; acrylates/acrylamide copolymer - other condition: do not remove from primary pack except for immediate use. for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. oestradiol prevents the accelerated loss of bone density due to oestrogen deficiency and may be used for the prevention of post-menopausal bone mineral density loss. in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.,for short term treatment of signs and symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. for the prevention of post menopausal bone mineral density loss. when prescribed solely for the prevention of post menopausal bone mineral density loss, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who, are intolerant of, or contraindicated for non-oestrogen products approved for prevention of osteoporosis. lifestyle modifications and the risk benefit profile of climara should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing (see precautions and dosage and administration sections). in women with an intact uterus, oestrogen should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals.

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

douglas pharmaceuticals australia pty ltd -

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

douglas pharmaceuticals australia pty ltd -