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

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 13.9 mg; hydrochlorothiazide, quantity: 25 mg; olmesartan medoxomil, quantity: 40 mg - tablet, film coated - excipient ingredients: isopropyl alcohol; silicified microcrystalline cellulose; povidone; lactose monohydrate; pregelatinised maize starch; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - apo-olmesartan/amlodipine/hctz 40/10/25 mg is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. this fixed dose combination is not indicated for initial therapy.

Singapore - English - HSA (Health Sciences Authority)

charles wembley (s.e.a.) co pte ltd - ophthalmology - a diagnostic ophthalmic instrument for determining/measuring the extent of the peripheral visual field: small luminous points (spots) are automatically displayed in various random positions and patient response is recorded.

Singapore - English - HSA (Health Sciences Authority)

charles wembley (s.e.a.) co pte ltd - ophthalmology - the most routine clinical application of the hrt is the detection of glaucoma damage of the optic nerve head (onh) and the follow-up of glaucoma progression with the glaucoma module. the instrument enables the quantitative description of the onh topography and time-related changes to it. a optional application is the location and quantification of retinal edema. the retina module automatically locates and quantifies retinal edema, and offers a quick and noninvasive method to assess diabetic macular edema, central serous retinopathy, cystoid macular edema, occlusive diseases and macular holes. an optional application is the rcm which provides in vivo imaging of cornea, limbus and conjunctiva. in addition, endothelial cell counting and intra-corneal pachmetry can be performed.

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

accord healthcare pty ltd - irinotecan hydrochloride trihydrate, quantity: 300 mg - injection, concentrated - excipient ingredients: sodium hydroxide; lactic acid; hydrochloric acid; sorbitol; water for injections - irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

accord healthcare pty ltd - irinotecan hydrochloride trihydrate, quantity: 500 mg - injection, concentrated - excipient ingredients: hydrochloric acid; water for injections; lactic acid; sodium hydroxide; sorbitol - irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

accord healthcare pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age),complicated skin and skin structure infections,daptomycin accord is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin accord is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin accord therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin accord is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin accord is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

accord healthcare pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age),complicated skin and skin structure infections,daptomycin accord is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin accord is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin accord therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin accord is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin accord is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

accord healthcare pty ltd - aciclovir, quantity: 25 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium hydroxide - aciclovir intravenous infusion is indicated for the purpose of:,1. promoting resolution of acute clinical manifestations of mucocutaneous herpes simplex virus infections in immunocompromised patients.,2. treatment of severe first episode primary or non-primary genital herpes in immune competent patients.,3. treatment of acute manifestations of varicella zoster virus infection in immunocompromised patients.,4. treatment of shingles (varicella zoster virus infection) in immune competent patients who show very severe acute local or systemic manifestations of the disease. benefits can be expected in patients with rash duration shorter than 72 hours. the use of the intravenous infusion may be warranted in only a small subgroup of immune competent patients with shingles.,5. treatment of herpes simplex encephalitis.

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

accord healthcare pty ltd - lidocaine hydrochloride, quantity: 40 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - lidocaine accord solutions are indicated for the production of local or regional anaesthesia by the following techniques: ? infiltration ? intravenous regional anaesthesia ? peripheral nerve block ? epidural block ? subarachnoid block

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

accord healthcare pty ltd - lidocaine hydrochloride, quantity: 50 mg - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium chloride; sodium hydroxide - lidocaine accord solutions are indicated for the production of local or regional anaesthesia by the following techniques: ? infiltration ? intravenous regional anaesthesia ? peripheral nerve block ? epidural block ? subarachnoid block