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

hospira australia pty ltd - gabapentin -

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

janssen-cilag pty ltd - etravirine, quantity: 100 mg - tablet - excipient ingredients: hypromellose; croscarmellose sodium; magnesium stearate; lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica - etravirine, in combination with other antiretroviral agents is indicated for the treatment of hiv-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents.,this indication is based on 24-week analyses from 2 randomised, double-blind, placebo controlled trials of etravirine. both studies were conducted in clinically advanced, 3-class antiretroviral (nnrti, n(t)rti, pi) treatment-experienced adults (see section 5.1 pharmacodynamic properties ? clinical trials).,treatment history of patients and genotypic testing should be performed to guide the use of etravirine.

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

janssen-cilag pty ltd - rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg) - tablet, film coated - excipient ingredients: hypromellose; lactose monohydrate; macrogol 3000; croscarmellose sodium; silicon dioxide; magnesium stearate; povidone; polysorbate 20; titanium dioxide; triacetin; microcrystalline cellulose - edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-naive adult patients with viral load less than or equal to 100,000 copies/ml at baseline. this indication is based on week 48 safety and efficacy analyses from 2 randomised double-blind, controlled phase iii trials in treatment-naive adult patients and on week 96 safety and efficacy analyses from the phase iib trial tmc278-c204 in treatment-naive adult patients (see clinical trials section).

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

gilead sciences pty ltd - sofosbuvir, quantity: 400 mg; ledipasvir acetone solvate, quantity: 95.9 mg (equivalent: ledipasvir, qty 90 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; silicon dioxide; magnesium stearate; croscarmellose sodium; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; polyvinyl alcohol; macrogol 3350 - harvoni (ledipasvir/sofosbuvir fixed-dose combination) is indicated for the treatment of chronic hepatitis c (chc) infection in adults. (see precautions and clinical trials sections for information on the available data for hcv patients of each genotype, see dosage and administration section for recommended regimens and treatment durations for different patient subgroups).

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

janssen-cilag pty ltd - abiraterone acetate, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; silicified microcrystalline cellulose; hypromellose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - zytiga is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or ? patients with mcrpc who have received prior chemotherapy containing a taxane.

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

gilead sciences pty ltd - emtricitabine, quantity: 200 mg; tenofovir alafenamide fumarate, quantity: 28.04 mg; rilpivirine hydrochloride, quantity: 27.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; povidone; croscarmellose sodium; polysorbate 20; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - odefsey is indicated as a complete regimen for the treatment of hiv-1 infection in adults and adolescents (12 years and older with body weight at least 35 kg) with plasma hiv-1 rna <= 100,000 copies/ml at the start of therapy. the patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of odefsey.

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

sandoz pty ltd - clarithromycin, quantity: 500 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; croscarmellose sodium; macrogol 4000; hypromellose; titanium dioxide; microcrystalline cellulose; powdered cellulose - clarithromycin sandoz clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: acute streptococcal pharyngitis; community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophilia and streptococcus pneumoniae;uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes;disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare and skin and skin structure infections due to mycobacterium chelonae. clarithromycin should be used in combination with other anti mycobacterial agents.prevention of disseminated mycobacterium avium complex infection in hiv infected adults with cd4 lymphocyte counts <75 cells/mm 3 (see precautions). disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae;combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. clarithromycin sandoz clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro organisms in the conditions listed below:acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes; community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila; skin and skin structure infections (eg impetigo); disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. acute otitis media.note:1. penicillins are the drug of first choice in the treatment of acute otitis media. 2. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. there is insufficient evidence of efficacy to support the use of clarithromycin in acute bronchitis in young children. 4. the data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

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

avallon pharmaceuticals pty ltd - clarithromycin, quantity: 250 mg - tablet, film coated - excipient ingredients: titanium dioxide; powdered cellulose; magnesium stearate; hypromellose; macrogol 4000; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate - noumed clarithromycin clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: acute streptococcal pharyngitis; community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophilia and streptococcus pneumoniae;uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes;disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare and skin and skin structure infections due to mycobacterium chelonae. clarithromycin should be used in combination with other anti mycobacterial agents.prevention of disseminated mycobacterium avium complex infection in hiv infected adults with cd4 lymphocyte counts <75 cells/mm 3 (see precautions). disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae;combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. noumed clarithromycin clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro organisms in the conditions listed below:acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes; community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila; skin and skin structure infections (eg impetigo); disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. acute otitis media.note:1. penicillins are the drug of first choice in the treatment of acute otitis media. 2. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. there is insufficient evidence of efficacy to support the use of clarithromycin in acute bronchitis in young children. 4. the data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

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

sandoz pty ltd - clarithromycin, quantity: 250 mg - tablet, film coated - excipient ingredients: titanium dioxide; powdered cellulose; magnesium stearate; hypromellose; macrogol 4000; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate - clarithromycin sandoz clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: acute streptococcal pharyngitis; community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophilia and streptococcus pneumoniae;uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes;disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare and skin and skin structure infections due to mycobacterium chelonae. clarithromycin should be used in combination with other anti mycobacterial agents.prevention of disseminated mycobacterium avium complex infection in hiv infected adults with cd4 lymphocyte counts <75 cells/mm 3 (see precautions). disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae;combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. clarithromycin sandoz clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro organisms in the conditions listed below:acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes; community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila; skin and skin structure infections (eg impetigo); disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. acute otitis media.note:1. penicillins are the drug of first choice in the treatment of acute otitis media. 2. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. there is insufficient evidence of efficacy to support the use of clarithromycin in acute bronchitis in young children. 4. the data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

axichem pty ltd - triclopyr present as the butoxyethyl ester - emulsifiable concentrate - triclopyr present as the butoxyethyl ester pyridine-pyridinoxy active 600.0 g/l - herbicide - agricultural non-crop areas | commercial/industrial land | fallow land | fenceline weed control | fire trail | firebreak weed co - acacia genus | african boxthorn | angophora - regrowth | australian or native blackthorn | banksia - regrowth | bitter bark or quinine tree | black or brisbane black wattle | blackberry | blackberry in assoc with other weed (see | brigalow | broadleaf hopbush | brooms | brown salwood or hickory wattle | budda or false sandalwood | camel or afghan melon | camphor laurel | capeweed | castor oil bush | chilean cestrum | chinee apple | common prickly pear | dawson gum | english broom | english ivy | eucalyptus | eucalyptus - see label for exceptions | eucalyptus - seedling | fennel | furze or gorse | groundsel bush | horehound | lantana - lantana camara | narrow leaf hop bush | needlewood | olive - olea europaea | paddy melon | paperbark | prickly acacia | privet | rubber vine | saffron thistle | silver wattle | smooth tree or drooping prickly pear | sweet briar or wild rose | tiger pear | tree-of-heaven | turpentine bush | yellow wood | afghan melon | bitter melon | black wattle | blackberry with dock | blackber