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

ms health pty ltd - mifepristone, quantity: 200 mg - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; povidone - mifepristone linepharma 200 mg tablet is indicated in females of childbearing age for preparation for the action of registered prostaglandin analogues that are indicated for the termination of pregnancy for medical reasons beyond the first trimester.

Ireland - English - HPRA (Health Products Regulatory Authority)

dechra regulatory b.v. - amoxicillin trihydrate; potassium clavulanate - tablet - 40, 10 mg/tablet - amoxicillin and enzyme inhibitor

Ireland - English - HPRA (Health Products Regulatory Authority)

dechra regulatory b.v. - potassium bromide - tablet - 325 mg/tablet - bromides

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

alphapharm pty ltd - roxithromycin, quantity: 300 mg - tablet, film coated - excipient ingredients: povidone; hyprolose; maize starch; poloxamer; colloidal anhydrous silica; purified talc; magnesium stearate; glucose; titanium dioxide; hypromellose; propylene glycol - adults: roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible micro-organisms: upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. lower respiratory tract infection: acute bronchitis and acute exacerbation of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. non-gonococcal urethritis. children: roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children weighing greater than 40 kg caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis. acute tonsillitis. impetigo. appropriate culture and sensitivity tests should be performed when necessary to determine an organisms susceptibility and thus treatment suitability. therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

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

alphapharm pty ltd - roxithromycin, quantity: 150 mg - tablet, film coated - excipient ingredients: povidone; hyprolose; maize starch; poloxamer; colloidal anhydrous silica; purified talc; magnesium stearate; glucose; titanium dioxide; hypromellose; propylene glycol - adults: roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible micro-organisms: upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. lower respiratory tract infection: acute bronchitis and acute exacerbation of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. non-gonococcal urethritis. children: roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children weighing greater than 40 kg caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis. acute tonsillitis. impetigo. appropriate culture and sensitivity tests should be performed when necessary to determine an organisms susceptibility and thus treatment suitability. therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

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

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 800 mg - tablet - excipient ingredients: colloidal anhydrous silica; brilliant blue fcf; indigo carmine; magnesium stearate; microcrystalline cellulose; croscarmellose sodium - for use in adult patients for: 1. the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients; 2. the treatment of acute attacks of herpes zoster (shingles), when the duration of rash is less than 72 hours; 3. the management of patients with advanced symptomatic hiv disease (cd4+ counts, < 150 x 10exp6/l). genital herpes initial episodes: the duration of viral shedding is reduced very significantly; the duration of pain and time to healing are also reduced. the promptness of initiation of therapy and/or the patient's prior exposure to herpes simples virus may influence the degree of benefit from therapy. intravenous therapy should be considered in patients in whom prostration, central nervous system involvement or inability to tak eoral medication requires hospitalisation and initiationof more aggressive management. aciclovir does not prevent the establishment of latency in primary episodes. recurrent episodes: a) suppression: in patients with frequent recurrences, suppressive therapy prevents or reduces the frequency and/or severity of recurrences in a high proportion of patients. abortive episodes (prodromal symptoms without vesicle formation) and occasional breakthrough episodes may, however, continue to occur during suppressive therapy. suppressive therapy is not considered appropriate for patiens in whom attacks are mild, last for short periods and/or occur infrequently (for example, less frequently than once a month). aciclovir is effective only during the period of intake and has no residual beneficial effect. it does not eradicate the body viral pool. following cessation of therapy the time to onset of recurrences, their frequency, severity and duration remain generally unaffected. some patients may experience increased severity of the first episode following cessation of therapy. the risk of inducing viral resistance and of potential long term adverse effects (see carcinogenicity, mutagenicity, effects on fertility) shoulld be weighed carefully before initiating suppressive therapy. asymptomatic cases of genital herpes are known to shed the virus with a high frequency. however, at present only limited data are available on the extent and frequency of vial shedding in patients receiving suppressive therapy. therefore, if therapy with aciclovir tablets is being used in the prenatal period (see use in pregnancy) it should not be assumed that viral shedding has ceased. pregnancy should be managed according to considerations normally applicable to patients with genital herpes. in view of the complex and variable natural history of genital herpes, suppressive thearpy should be interrupted periodically to ascertain whether the disease has undergone spontaneous change in frequency or severity (see dosage and administration). b) intermittent treatment: for certain patients intermittent short-term treatment of recurrences is effective. although the average patient would derive limited benefits from such treatment, a minority of patients who have experienced severe, prolonged recurrent episodes or recurrences complicated by eczema, burns or immunosuppression may experience more appreciable benefits. in those patients, intermittent treatment may be more appropriate than suppressive therapy when recurrences are infrequent. herpes zoster in controlled trials, aciclovir was shown to reduce acute pain and rash progression in adult patients of all ages with herpes zoster, in whom the duration of rash was less than 72 hours. the same treatment on controlled trials, aciclovir was shown to reduce acute pain and rash progression appeared to be relatively less effective in younger patients, in whom herpes zoster is generally a milder disease. in ophthalmic zoster, oral aciclovir has been shown to reduce the incidence of stromal keratitis and both the incidence and severity of anterior uveitis, but not other ocular complications oracute pain. note: in immune-competent patients with very severe herpes zoster, immune-compromised patients or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. patients with advanced symptomatic hiv disease (cd4+ counts, < 150 x 10exp6/l) studies have shown that oral aciclovir reduced mortality in patients with advanced hiv disease. in addition, oral aciclovir provided effective prophylaxis for herpes virus disease. no significant effect was seen on prophylaxsis of cmv disease of eb v disease.

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

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 200 mg - tablet - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; lactose monohydrate; indigo carmine; croscarmellose sodium; magnesium stearate - for use in adult patients for: 1. the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients; 2. the treatment of acute attacks of herpes zoster (shingles), when the duration of rash is less than 72 hours; 3. the management of patients with advanced symptomatic hiv disease (cd4+counts, <150 x 10exp6/l). genital herpes initial episodes: the duration of viral shedding is reduced very significantly; the duration of pain and time to healing are also reduced. the promptness of initiation of therapy and/or the patient's prior exposure to herpes simples virus may influence the degree of benefit from therapy. intravenous therapy should be considered in patients in whom prostation, central nervous system involvement or inability to take oral medication requires hospitalisation and initiation of more aggressive management. aciclovir does not prevent the establishment of latency in primary episodes. recurrent episodes: a) suppression: in patients with frequent recurrences, suppressive therapy prevents or reduces the frequency and/or severity of recurrences in a high proportion of patients. abortive episodes (prodromal symptoms without vesicle formation) and occasional breakthrough episodes may, however, continue to occur during suppressive therapy. suppressive therapy is not considered appropriate for patients in whom attacks are mild, last for short periods and/or occur infrequently (for example, less frequently than once a month). aciclovir is effective only during the period of intake and has no residula beneficial effect. it does not eradicate the body viral pool. following cessation of therapy of the time to onset of recurrences, their frequency, severity and duration remain generally unaffected. some patients may experience increased severity of the first episode following cessation of therapy. the risk of inducing viral resistance and of potential long term adverse effects (see carcinogenicity, mutagenicity, effects on fertility) should be weighed carefully before initiating suppressive therapy. asymptomatic cases of genital herpes are known to shed the virus with a high frequency. however, at present only limited data are available on the extent and frequency of viral shedding in patients receiving suppressive therapy. therefore, if therapy with aciclovir tablets is being used in prenatal period (see use in pregnancy) it should not be assumed that viral shedding has ceased. pregnancy should be managed according to considerations normally applicable to patients with genital herpes. in view of the complex and variable natural history of genital herpes, suppressive therapy should be interrupted periodically to ascertain whether the disease has undergone spontaneous change in frequency or severity (see dosage and administration). b) intermittent treatment: for certain patients intermittent short-term treatment of recurrences is effective. although the average patient would derive limited benefits from such treatment, a minority of patients who have experienced severe, prolonged recurrent episodes or recurrences complicated by eczema, burns or immunosuppression may experience more appreciable benefits. in those patients, intermittent treatment may be more appropriate than suppressive therapy when recurrences are infrequent. herpes zoster in controlled trials, aciclovir was shown to reduce acute pain and rash progression in adult patients of all ages with herpes zoster, in whom the duration of rash was less than 72 hours. the same treatment on controlled trials, aciclovir was shown to reduce acute pain and rash progression appeared to be relatively less effective in younger patients, in whom herpes zoster is generally a milder disease. in ophthalmic zoster, oral aciclovir has been shown to reduce the incidence of stromal keratitis and both the incidence and severity of anterior uveitis, but not other ocular complicationsor acute pain. note: in im mune-competent patients with very severe herpes zoster, immune-compromised patients or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. patients with advanced symptomatic hiv disease (cd4+ counts, <150 x 10exp6/l). studies have shown that oral aciclovir reduced mortality in patients with advanced hiv disease. in addition, oral aciclovir provided effective prophylaxis for herpes virus disease. no significant effective was seen on prophylaxsis of cmv disease of ebv disease.

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

aspen pharmacare australia pty ltd - naratriptan hydrochloride, quantity: 2.78 mg (equivalent: naratriptan, qty 2.5 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; lactose; titanium dioxide; hypromellose; indigo carmine; triacetin; iron oxide yellow - naramig tablets are indicated for the acute treatment of migraine attacks with or without aura.

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

aspen pharmacare australia pty ltd - sumatriptan succinate, quantity: 70 mg (equivalent: sumatriptan, qty 50 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; lactose; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red - imigran tablets are indicated for the acute relief of migraine attacks with or without aura. there is no information available on the use of imigran tablets in the treatment of basilar or hemiplegic migraines.

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

aspen pharmacare australia pty ltd - sumatriptan succinate, quantity: 140 mg (equivalent: sumatriptan, qty 100 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose - sumatriptan (imigran) tablets and injection are indicated for the acute relief of migraine attacks with or without aura. there is no information available on the use of imigran in the treatment of basilar or hemiplegic migraine.