Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 128.5 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; sodium stearylfumarate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - xelevia (sitagliptin phosphate monohydrate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin,(see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - posaconazole, quantity: 300 mg - injection, concentrated - excipient ingredients: sulfobutyl betadex sodium; disodium edetate; hydrochloric acid; sodium hydroxide; water for injections - noxafil (posaconazole) concentrated injection is indicated for use in the treatment of the following invasive fungal infections in adults: invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. noxafil is also indicated for the: prophylaxis of invasive fungal infections among adults, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - posaconazole, quantity: 100 mg - tablet, modified release - excipient ingredients: hypromellose acetate succinate; microcrystalline cellulose; hyprolose; silicon dioxide; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - noxafil (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older; invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy; fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. noxafil is also indicated for the: treatment of oropharyngeal candidiasis in immunocompromised adults, including patients with disease that is refractory to itraconazole and fluconazole. prophylaxis of invasive fungal infections, among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - suvorexant, quantity: 20 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; copovidone; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; triacetin - belsomra is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. following initiation of treatment, continuation should be re-evaluated after 3 months [see pharmacodynamic properties, clinical trials and adverse effects (undesirable effects) for clinical trial durations].

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - suvorexant, quantity: 15 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; copovidone; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; triacetin - belsomra is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance.,following initiation of treatment, continuation should be re-evaluated after 3 months [see pharmacodynamic properties, clinical trials and adverse effects (undesirable effects) for clinical trial durations].

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 1000 mg; sitagliptin phosphate monohydrate, quantity: 128.5 mg (equivalent: sitagliptin, qty 100 mg) - tablet, modified release - excipient ingredients: povidone; hypromellose; colloidal anhydrous silica; sodium stearylfumarate; propyl gallate; macrogol 3350; kaolin; carnauba wax; titanium dioxide; hyprolose; indigo carmine aluminium lake - janumet xr (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 1000 mg; sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet, modified release - excipient ingredients: povidone; hypromellose; colloidal anhydrous silica; sodium stearylfumarate; propyl gallate; macrogol 3350; kaolin; carnauba wax; titanium dioxide; hyprolose; iron oxide yellow; indigo carmine aluminium lake - janumet xr (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - rubella virus, quantity: 1000 tcid50; measles virus, quantity: 1000 tcid50; mumps virus, quantity: 12500 tcid50 - injection, powder for - excipient ingredients: hydrolysed gelatin; sorbitol; neomycin; phenolsulfonphthalein; monobasic potassium phosphate; sodium bicarbonate; monosodium glutamate monohydrate; dibasic potassium phosphate; sucrose; monobasic sodium phosphate; dibasic sodium phosphate; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; water for injections; ascorbic acid; polysorbate 80; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; histidine hydrochloride; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; menadione; nicotinic acid; aminobenzoic acid; pyridoxal hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - m-m-r ii is indicated for simultaneous immunisation against measles, mumps and rubella.,refer to the nhmrc australian immunisation handbook (aih) for vaccination recommendations and schedule.,there is some evidence to suggest that infants immunised against measles at less than 12 months of age, or who are born to mothers who had wild-type measles and who are vaccinated at less than one year of age may not develop sustained antibody levels when later revaccinated. the advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunisation.,infants who are less than 12 months of age may fail to respond to one or more components of the vaccine due to presence in the circulation of residual antibodies of maternal origin, the younger the infant, the lower the likelihood of seroconversion. in geographically isolated or other relatively inaccessible populations for whom immunisation programmes are logistically difficult, and in population groups in which wild-type measles infections may occur in a significant proportion of infants before 15 months of age, it may be desirable to give the vaccine to infants at an earlier age. infants vaccinated under these conditions at less than 12 months of age should be revaccinated after reaching 12 to 15 months of age.,previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine to reduce the risk of exposure of the pregnant woman.,non-pregnant adolescent and adult females: immunisation of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see 4.4 special warnings and precautions for use and 4.6 fertility, pregnancy and lactation). vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the foetus and consequent congenital rubella injury. congenital malformations do occur in up to seven percent of all live births, and their chance appearance after vaccination should be borne in mind.,women of childbearing age should be advised not to become pregnant for one month after vaccination against rubella (which is included in m-m-r ii) and should be informed of the reasons for this precaution (see 4.6 fertility, pregnancy and lactation, use in pregnancy).,the australian immunisation handbook recommends that effort should be made to identify and immunise non-pregnant seronegative women of child-bearing age.,women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. however, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing. please refer to aih for recommendations for further information regarding serological testing for immunity to rubella.,postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination against rubella (see 4.8 adverse effects (undesirable effects)).,post-partum women it has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period using an appropriate rubella-containing vaccine. (see 4.6 fertility, pregnancy and lactation, use in lactation).,revaccination children vaccinated when younger than 12 months of age should be revaccinated at 12 to 15 months of age. persons who were vaccinated originally when 12 months of age or older should be revaccinated with a mmr-containing vaccine, as per the recommended vaccination schedule. revaccination is intended to seroconvert those who did not respond to the first dose. however, data on long term persistence of antibodies are limited and continued surveillance will be required to allow firm recommendations to be made on revaccination. however, persons should be revaccinated if there is evidence to suggest that initial immunisation was ineffective.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - fosaprepitant dimeglumine, quantity: 257.6 mg (equivalent: fosaprepitant, qty 150 mg) - injection, powder for - excipient ingredients: disodium edetate; sodium hydroxide; hydrochloric acid; polysorbate 80; lactose - emend iv, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of: - highly emetogenic cancer chemotherapy (see dosage and administration); - moderately emetogenic cancer chemotherapy (see dosage and administration).

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 250 mg - capsule, hard - excipient ingredients: sodium lauryl sulfate; lactose; stearic acid; gelatin; titanium dioxide; sodium starch glycollate; tartaric acid; colloidal anhydrous silica; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - temodal capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.