Australija - anglų - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - methylphenidate hydrochloride, quantity: 10 mg - capsule, hard - excipient ingredients: strong ammonia solution; shellac; gelatin; purified talc; propylene glycol; iron oxide yellow; ammonio methacrylate copolymer; triethyl citrate; titanium dioxide; povidone; iron oxide red; methacrylic acid copolymer; potassium hydroxide; sucrose; maize starch - rubifen la modified release capsules are indicated for the treatment of attention-deficit hyperactivity disorder (adhd).,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.,rubifen la modified release capsules are 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.,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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - methylphenidate hydrochloride, quantity: 30 mg - capsule, hard - excipient ingredients: iron oxide yellow; gelatin; titanium dioxide; iron oxide red; propylene glycol; strong ammonia solution; triethyl citrate; methacrylic acid copolymer; shellac; ammonio methacrylate copolymer; purified talc; potassium hydroxide; povidone; sucrose; maize starch - rubifen la modified release capsules are indicated for the treatment of attention-deficit hyperactivity disorder (adhd).,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.,rubifen la modified release capsules are 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.,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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - methylphenidate hydrochloride, quantity: 20 mg - capsule, hard - excipient ingredients: potassium hydroxide; iron oxide red; gelatin; povidone; shellac; purified talc; methacrylic acid copolymer; titanium dioxide; propylene glycol; ammonio methacrylate copolymer; strong ammonia solution; triethyl citrate; sucrose; maize starch - rubifen la modified release capsules are indicated for the treatment of attention-deficit hyperactivity disorder (adhd).,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.,rubifen la modified release capsules are 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.,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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - methylphenidate hydrochloride, quantity: 40 mg - capsule, hard - excipient ingredients: gelatin; strong ammonia solution; purified talc; potassium hydroxide; triethyl citrate; ammonio methacrylate copolymer; iron oxide red; propylene glycol; methacrylic acid copolymer; iron oxide yellow; titanium dioxide; povidone; shellac; sucrose; maize starch - rubifen la modified release capsules are indicated for the treatment of attention-deficit hyperactivity disorder (adhd).,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.,rubifen la modified release capsules are 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.,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.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

mayne pharma commercial llc - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 100 mg - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - cardiogenic shock. - sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - known hypersensitivity to the drug or to any of its components, including iodine. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see clinical considerations). in animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryo- fetal toxicity at doses less than the maximum recommended human maintenance dose (see data) . advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. clinical considerations disease-associated maternal and or embryo/fetal risk the incidence of ventricular tachycardia is increased and may be more symptomatic during pregnancy. ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse. most tachycardia episodes are initiated by ectopic beats and the occurrence of arrhythmia episodes may therefore, increase during pregnancy due to the increased propensity to ectopic activity. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions amiodarone and its metabolite have been shown to cross the placenta. adverse fetal effects associated with maternal amiodarone use during pregnancy may include neonatal bradycardia, qt prolongation, and periodic ventricular extrasystoles, neonatal hypothyroidism (with or without goiter) detected antenatally or in the newborn and reported even after a few days of exposure, neonatal hyperthyroxinemia, neurodevelopmental abnormalities independent of thyroid function, including speech delay and difficulties with written language and arithmetic, delayed motor development, and ataxia, jerk nystagmus with synchronous head titubation, fetal growth restriction, and premature birth. monitor the newborn for signs and symptoms of thyroid disorder and cardiac arrhythmias. labor and delivery risk of arrhythmias may increase during labor and delivery. patients treated with amiodarone hydrochloride tablets should be monitored continuously during labor and delivery [see warnings and precautions (5.4)]. data animal data in pregnant rats and rabbits during the period of organogenesis, amiodarone hcl in doses of 25 mg/kg/day (approximately 0.4 and 0.9 times, respectively, the maximum recommended human maintenance dose 1) had no adverse effects on the fetus. in the rabbit, 75 mg/kg/day (approximately 2.7 times the maximum recommended human maintenance dose 1) caused abortions in greater than 90% of the animals. in the rat, doses of 50 mg/kg/day or more were associated with slight displacement of the testes and an increased incidence of incomplete ossification of some skull and digital bones; at 100 mg/kg/day or more, fetal body weights were reduced; at 200 mg/kg/day, there was an increased incidence of fetal resorption. (these doses in the rat are approximately 0.8, 1.6 and 3.2 times the maximum recommended human maintenance dose 1) adverse effects on fetal growth and survival also were noted in one of two strains of mice at a dose of 5 mg/kg/day (approximately 0.04 times the maximum recommended human maintenance dose 1). risk summary amiodarone and one of its major metabolites, dea, are present in breastmilk at between 3.5% and 45% of the maternal weight- adjusted dosage of amiodarone. there are cases of hypothyroidism and bradycardia in breastfed infants, although it is unclear if these effects are due to amiodarone exposure in breastmilk. breastfeeding is not recommended during treatment with amiodarone hydrochloride tablets [see warnings and precautions (5.6, 5.7)] . infertility based on animal fertility studies, amiodarone hydrochloride tablets may reduce female and male fertility. it is not known if this effect is reversible. [see nonclinical toxicology (13.1)] . the safety and effectiveness of amiodarone hydrochloride tablets in pediatric patients have not been established. normal subjects over 65 years of age show lower clearances and increased drug half-life than younger subjects [see clinical pharmacology (12.3)]. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Kanada - anglų - Health Canada

almay toronto inc. - salicylic acid - liquid - .5% - salicylic acid .5% - keratolytic agents

Kanada - anglų - Health Canada

almay toronto inc. - salicylic acid - gel - .5% - salicylic acid .5% - keratolytic agents

Kanada - anglų - Health Canada

almay toronto inc. - salicylic acid - liquid - .5% - salicylic acid .5% - keratolytic agents

Kanada - anglų - Health Canada

almay toronto inc. - sulfur - cream - 5% - sulfur 5% - keratolytic agents

Kanada - anglų - Health Canada

almay toronto inc. - octinoxate; octisalate; oxybenzone; titanium dioxide - lotion - 7.5%; 5%; 4.5%; 2.5% - octinoxate 7.5%; octisalate 5%; oxybenzone 4.5%; titanium dioxide 2.5% - sunscreen agents