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

janssen-cilag pty ltd - selexipag, quantity: 800 microgram - tablet, film coated - excipient ingredients: hyprolose; iron oxide black; carnauba wax; titanium dioxide; maize starch; hypromellose; mannitol; propylene glycol; magnesium stearate; iron oxide yellow - uptravi is indicated for the treatment of:,- idiopathic pulmonary arterial hypertension;,- heritable pulmonary arterial hypertension;,- pulmonary arterial hypertension associated with connective tissue disease;,-pulmonary arterial hypertension associated with congenital heart disease with repaired shunts;,-pulmonary arterial hypertension associated with drugs and toxins;,in patients with who functional class ii, iii or iv symptoms

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

janssen-cilag pty ltd - darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - prezcobix, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus- 1 (hiv-1) infection in:,- antiretroviral treatment-naive patients,- antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma hiv-1 rna <100,000 copies/ml,- antiretroviral treatment-experienced but hiv protease inhibitor-naive patients for whom hiv-1 genotype testing is unavailable (see section 4.2 dose and method of administration)

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

juno pharmaceuticals pty ltd - darunavir, quantity: 800 mg - tablet, film coated - excipient ingredients: silicified microcrystalline cellulose; macrogol 4000; sodium chloride; iron oxide red; purified talc; titanium dioxide; hyprolose; crospovidone; polacrilin potassium; magnesium stearate; colloidal anhydrous silica; polyvinyl alcohol - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - sevelamer carbonate 800mg; sevelamer carbonate 800mg - film coated tablet - 800 mg - active: sevelamer carbonate 800mg excipient: isopropyl alcohol microcrystalline cellulose opacode opadry clear propylene glycol sodium chloride zinc stearate active: sevelamer carbonate 800mg excipient: acetylated monoglycerides hypromellose e-15 hypromellose e-5 isopropyl alcohol microcrystalline cellulose opacode propylene glycol sodium chloride zinc stearate - renvela is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

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

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 800 mg - tablet - excipient ingredients: magnesium stearate; croscarmellose sodium; indigo carmine; microcrystalline cellulose; colloidal anhydrous silica; brilliant blue fcf - 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). for use in accordance with details specified in the "indications" and the "dosage and adminsitration" sections of the approved product information document. a copy is provided as attachment 1.

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)

alphapharm pty ltd - sulfamethoxazole, quantity: 800 mg; trimethoprim, quantity: 160 mg - tablet, uncoated - excipient ingredients: povidone; docusate sodium; magnesium stearate; sodium starch glycollate - indications as at 13 november 2004 : upper and lower respiratory tract infections; renal and urinary tract infections; skin and wound infections; septicaemias and other infections caused by sensitive organisms.

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - aciclovir 800mg;   - dispersible tablet - 800 mg - active: aciclovir 800mg   excipient: colloidal silicon dioxide magnesium stearate microcrystalline cellulose pregelatinised maize starch purified water sodium starch glycolate - · treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes. · suppression (prevention of recurrences) of recurrent herpes simplex infections in immune-competent patients. · prophylaxis of herpes simplex infections in immune-competent patients. · treatment of acute herpes zoster (shingles) infections, for the reduction of the duration and severity of acute symptoms and rash, for the reduction of all zoster associated pain and for the reduction of the incidence and duration of postherpetic neuralgia. · management of patients with severe aids who have a cd4 count of less than 50/µl. studies have shown that oral aciclovir given in conjunction with antiretroviral therapy reduced mortality in patients with advanced hiv disease. · patients undergoing allogenic bone marrow transplantation who are at risk of developing cmv infection while immunosuppressed (preceded by one month's treatment with intravenous aciclovir). studies have shown that oral aciclovir reduced mortality in allogenic bone marrow transplant recipients. in addition oral aciclovir provided effective prophylaxis for herpes virus disease.

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - anhydrous sevelamer carbonate - tablet, film coated - 800 mg - anhydrous sevelamer carbonate 800 mg

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

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 800 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - arx-aciclovir tablets are indicated 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 advaned symptomatic hiv disease cd4 + counts < 150 x 10(6)/l). in accordance with details specified in the "indications" and the "dosage and administration" sections of the approved product information provided as attachment 1.