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

novartis pharmaceuticals australia pty ltd - methylphenidate hydrochloride, quantity: 10 mg - capsule, modified release - excipient ingredients: iron oxide yellow; iron oxide red; methacrylic acid copolymer; triethyl citrate; macrogol 6000; iron oxide black; purified talc; gelatin; ammonio methacrylate copolymer; titanium dioxide; maize starch; purified water; sucrose; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; 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)

pfizer australia pty ltd - tobramycin, quantity: 80 mg - injection, solution - excipient ingredients: sodium hydroxide; sodium metabisulfite; phenol; water for injections; sulfuric acid; disodium edetate - for the treatment of serious infections of the following type where they are caused by susceptible organisms: skin and skin structure infections including burns, bone infections; gastrointestinal infections including peritonitis; central nervous system infections including meningitis, septicaemia and neonatal sepsis; lower respiratory tract infections including pneumonia, bronchopneumonia, and acute bronchitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis.,aminoglycosides, including tobramycin, should not be used in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to other less toxic antibiotics.,tobramycin can be used in serious staphylococcal infections for which penicillin or other less toxic drugs are contraindicated and where susceptibility testing and clinical judgement indicate its use. if susceptibility tests show a resistance to tobramycin in the causative organisms other appropriate therapy should be instituted.,note that bacterial cultures should bo obtained before and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. if the organisms are resistant, other appropriate therapy should be instituted. in patients in whom gram-negative septicaemia, neonatal sepsis or meningitis is suspected, including those in whom concurrent therapy with a penicillin or cefalosporin and an aminoglycoside may be indicated, tobramycin therapy may be initiated before results of susceptibility studies are obtained. the decision to continue tobramycin therapy should be based upon the results of susceptibility studies, the severity of infection and the important additional concepts discussed in the product information leaflet.

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

inova pharmaceuticals (australia) pty ltd - metronidazole, quantity: 7.5 mg/g - gel - excipient ingredients: carbomer 974p; propylene glycol; sodium hydroxide; disodium edetate; propyl hydroxybenzoate; methyl hydroxybenzoate; purified water - zidoval vaginal gel 0.75% is indicated in the treatment of symptomatic bacterial vaginosis (formerly referred to as haemophilus vaginalis vaginitis, gardnerella vaginalis vaginitis, non-specific vaginitis, corynebacterium vaginale vaginitis or anaerobic vaginosis). note: for purpose of this indicated, a clincial diagnosis of bacterial vaginosis is usually defined by the presence of at least three of the following four criteria: a) vaginal discharge ph of greater than 4.5, b) a vaginal discharge emitting a "fishy" amine odour when mixed with a 10% koh solution, c) a vaginal discharge containing clue cells on wet mount microscopy examination, d) a gram stain consistent with a diagnosis of bacterial vaginosis (lactobacillus morphotype absent of markedly decreased, gardnerella morphotype predominant flora, white blood cells absent or few, mobiluncus morphotype may or may not be present). a diagnosis of bacterial vaginosis requires that other pathogens which may be associated with genital infection, such as trichomonas vaginalis, candida albicans, chlamydia trachomatis and neisseria gonorrhoeae, should be ruled out be appropriate laboratory means.

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

novartis pharmaceuticals australia pty ltd - methylphenidate hydrochloride, quantity: 40 mg - capsule, modified release - excipient ingredients: iron oxide yellow; methacrylic acid copolymer; iron oxide red; gelatin; titanium dioxide; purified talc; macrogol 6000; iron oxide black; ammonio methacrylate copolymer; triethyl citrate; maize starch; purified water; sucrose; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; 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: 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)

pfizer australia pty ltd - tobramycin, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections; sulfuric acid; sodium metabisulfite; disodium edetate - tobramycin is indicated in the treatment of the following serious infections caused by susceptible micro-organisms: central nervous system infections, including meningitis; septicaemia and neonatal sepsis; gastro-intestinal infections, including peritonitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis; lower respiratory tract infections, including pneumonia, bronchopneumonia and acute bronchitis; bone, skin and skin structure infections, including burns.,tobramycin may be considered in serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use. aminoglycosides, including tobramycin, are not indicated in uncomplicated initial episodes or urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.,bacterial cultures should be obtained prior to and during treatment to isolate and identify aetiologic organisms and to test their susceptibility to tobramycin. if susceptibility tests show that the causative organism is resistant to tobramycin, other appropriate therapy should be instituted. in patients in whom gram negative septicaemia, neonatal sepsis, or meningitis is suspected, including those in whom concurrent therapy with a penicillin or cefalosporin and an aminoglycoside may be indicated, tobramycin therapy may be initiated before results of susceptibility studies are obtained. the decision to continue tobramycin therapy should be based upon the results of susceptibility studies, severity of the infection, and the important additional concepts discussed in the product information document.

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

pfizer australia pty ltd - vancomycin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide; hydrochloric acid - indications as at 31 october 2003: vancomycin hydrochloride for intravenous infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. vancomycin is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg strep. faecalis), vancomycin is effective only in combination with an aminoglycoside. vancomycin is effective for the treatment of diphtheroid endocarditis. vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral administration the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

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

pfizer australia pty ltd - vancomycin, quantity: 1000 mg - injection, powder for - excipient ingredients: hydrochloric acid; sodium hydroxide - potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. severe staphylococcal (including methicillin resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg strep. faecalis), effective only in combination with an aminoglycoside. diphtheroid endocarditis. in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia, and soft itssue infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin injections. should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c difficile). parenteral administration alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral adminsitration, the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudo-membranous colitis.

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

aft pharmaceuticals pty ltd - methylphenidate hydrochloride, quantity: 60 mg - capsule, hard - excipient ingredients: povidone; purified talc; titanium dioxide; iron oxide yellow; methacrylic acid copolymer; gelatin; potassium hydroxide; shellac; triethyl citrate; propylene glycol; iron oxide red; ammonio methacrylate copolymer; strong ammonia solution; 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.