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

merck sharp & dohme (australia) pty ltd - pneumococcal purified capsular polysaccharides, quantity: 50 microgram/ml - injection, solution - excipient ingredients: water for injections; phenol; sodium chloride - pneumovax 23 is indicated for immunisation of individuals in the following situations: all individuals over the age of 65 years; individuals with asplenia, either functional or anatomical, including sickle cell disease, in persons more than 2 years of age; where possible the vaccine should be given at least 14 days before splenectomy; immunocompromised patients at increased risk of pneumococcal disease (eg patients with hiv infection before the development of aids, nephrotic syndrome, multiple myeloma, lymphoma, hodgkin's disease and organ transplantation); aboriginal and torres strait islander people over 50 years of age; immunocompetent persons at increased risk of complications from pneumococcal disease because of chronic illness (eg chronic cardiac, renal or pulmonary disease, diabetes mellitus, alcoholism and cirrhosis); patients with cerebrospinal fluid leaks. in australia, the national health and medical research council (nhmrc) currently recommends the vaccination of tobacco smokers with the 23-valent

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

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 651.6 mg (equivalent: raltegravir, qty 600 mg) - tablet, film coated - excipient ingredients: hypromellose; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; carnauba wax; titanium dioxide; lactose monohydrate; triacetin; iron oxide yellow; iron oxide black - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

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

merck sharp & dohme (australia) pty ltd - pembrolizumab, quantity: 100 mg - injection, concentrated - excipient ingredients: histidine; sucrose; water for injections; polysorbate 80; histidine hydrochloride monohydrate - melanoma,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of unresectable or metastatic melanoma in adults.,keytruda? (pembrolizumab) is indicated for the adjuvant treatment of adult and adolescent (12 years and older) patients with stage iib, iic, or iii melanoma who have undergone complete resection.,non-small cell lung cancer (nsclc),,keytruda? (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic non-squamous nsclc, with no egfr or alk genomic tumour aberrations.,keytruda? (pembrolizumab), in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of patients with metastatic squamous nsclc.,keytruda? (pembrolizumab) is indicated as monotherapy for the first-line treatment of patients with nsclc expressing pd-l1 [tumour proportion score (tps) greater than or equal 1%] as determined by a validated test, with no egfr or alk genomic tumour aberrations, and is,,? stage iii where patients are not candidates for surgical resection or definitive chemoradiation, or,,? metastatic.,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with advanced nsclc whose tumours express pd-l1 with a greater than or equal 1% tps as determined by a validated test and who have received platinum-containing chemotherapy. patients with egfr or alk genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving keytruda.,keytruda? (pembrolizumab) is indicated as monotherapy for the adjuvant treatment of patients with stage ib (t2a greater than or equal 4 cm), ii, or iiia nsclc who have undergone complete resection and platinum-based chemotherapy.,head and neck squamous cell cancer (hnscc),,keytruda? (pembrolizumab), as monotherapy or in combination with platinum and 5-fluorouracil (5-fu) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent hnscc, and whose tumours express pd-l1 [combined positive score (cps) greater than or equal 1] as determined by a validated test.,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with metastatic or unresectable recurrent hnscc with disease progression on or after platinum-containing chemotherapy and whose tumours express pd-l1 [combined positive score (cps) greater than or equal 1] as determined by a validated test.,classical hodgkin lymphoma (chl),keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of adult and paediatric patients with relapsed or refractory classical hodgkin lymphoma (chl):,1. following autologous stem cell transplant (asct) or,,2. following at least two prior therapies when asct or multi-agent chemotherapy is not a treatment option.,the approval of this indication in paediatric patients is on the basis of objective response rate from patients aged 11 years and older from single arm trial data and extrapolation from adult data (see section 5.1 pharmacodynamic properties, clinical trials).,primary mediastinal b-cell lymphoma (pmbcl),,keytruda? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with refractory primary mediastinal b-cell lymphoma (pmbcl), or who have relapsed after 2 or more prior lines of therapy. the approval of this indication is on the basis of objective response rate (orr) and duration of response from non-randomised studies. see section 5.1 pharmacodynamic properties, clinical trials.,urothelial carcinoma,,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy. this indication is approved based on overall response rate and duration of response in a single-arm study. improvements in overall survival, progression-free survival, or health-related quality of life have not been established.,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemotherapy.,endometrial carcinoma,,keytruda? (pembrolizumab), in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is not msi-h or dmmr, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.,cervical cancer,keytruda? (pembrolizumab) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express pd-l1 [combined positive score (cps) greater than or equal 1] as determined by a validated test.,renal cell carcinoma (rcc),keytruda? (pembrolizumab), in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (rcc).,keytruda? in combination with lenvima? (lenvatinib) is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,keytruda? (pembrolizumab), as monotherapy, is indicated for the adjuvant treatment of patients with rcc with a clear cell component who are at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (see section 5.1, clinical trials: renal cell carcinoma).,oesophageal cancer,keytruda? (pembrolizumab), in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced or metastatic carcinoma of the oesophagus or her2 negative gastroesophageal junction adenocarcinoma (tumour centre 1 to 5 centimetres above the gastroesophageal junction) that is not amenable to surgical resection or definitive chemoradiation.,triple-negative breast cancer,keytruda? (pembrolizumab) is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (tnbc) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.,keytruda? (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic tnbc whose tumours express pd-l1 (cps greater than or equal 10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease. urothelial carcinoma,keytruda? (pembrolizumab) is indicated for the treatment of patients with bacillus calmette-guerin (bcg)-unresponsive, high-risk, non-muscle invasive bladder cancer (nmibc) with carcinoma in-situ (cis) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.,this indication was approved via the provisional approval pathway based on complete response rate and duration of response. continued approval of this indication depends on verification and description of benefit in confirmatory trials.,cutaneous squamous cell carcinoma,,keytruda? (pembrolizumab) is indicated as monotherapy for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cscc) or locally advanced cscc that is not curable by surgery or radiation.,this indication was approved via the provisional approval pathway based on objective response rate and duration of response from a single-arm study. improvements in overall survival, progression-free survival, or healthrelated quality of life have not been established. full registration for this indication depends on submission of further clinical data to confirm the clinical benefit of the medicine.,tumour mutational burden-high (tmb-h) cancer,keytruda? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (tmb-h) [greater than or equal 10 mutations/megabase (mut/mb)] solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.,this indication was approved via the provisional approval pathway, based on the pooling of data on objective response rate and response duration across multiple different tissue types in a single-arm trial. the assumption that tmb-h status is predictive of the treatment effect of keytruda for every tissue type has not been verified. full registration for this indication depends on verification and description of clinical benefit in confirmatory trials. microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) cancer,keytruda? (pembrolizumab) is indicated for the treatment of adult and paediatric patients with unresectable or metastatic solid tumours that are msi-h or dmmr, as determined by a validated test, that have progressed following prior treatment and when there are no satisfactory alternative treatment options.,microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) colorectal cancer,keytruda? (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic colorectal cancer (crc) that is msi-h or dmmr as determined by a validated test.

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

merck sharp & dohme (australia) pty ltd - elbasvir,grazoprevir -

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

merck sharp & dohme (australia) pty ltd - pneumococcal purified capsular polysaccharides, quantity: 50 microgram/ml - injection, solution - excipient ingredients: water for injections; phenol; sodium chloride - pneumovax 23 is indicated for immunisation of individuals in the following situations: all individuals over the age of 65 years; individuals with asplenia, either functional or anatomical, including sickle cell disease, in persons more than 2 years of age; where possible the vaccine should be given at least 14 days before splenectomy; immunocompromised patients at increased risk of pneumococcal disease (eg patients with hiv infection before the development of aids, nephrotic syndrome, multiple myeloma, lymphoma, hodgkin's disease and organ transplantation); aboriginal and torres strait islander people over 50 years of age; immunocompetent persons at increased risk of complications from pneumococcal disease because of chronic illness (eg chronic cardiac, renal or pulmonary disease, diabetes mellitus, alcoholism and cirrhosis); patients with cerebrospinal fluid leaks. in australia, the national health and medical research council (nhmrc) currently recommends the vaccination of tobacco smokers with the 23-valent polysaccharide pneumococcal vaccine. pneumovax 23 is indicated for immunisation only against pneumococcal disease caused by those pneumococcal types included in the vaccine. effectiveness of the vaccine in the prevention of pneumococcal pneumonia and pneumococcal bacteremia has been demonstrated. in australia, the national health and medical research council (nhmrc) currently recommeds the vaccination of tabacco smokers with the 23-valent polysaccharide pneumococcal vaccine. pneumovax 23 will not prevent disease caused by capsular types of pneumococcus othar those contained in the vaccine.

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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg); metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; sodium stearylfumarate; povidone; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - velmetia (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].

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 850 mg; sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium stearylfumarate; povidone; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - velmetia (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].

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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg); metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: povidone; microcrystalline cellulose; sodium stearylfumarate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - velmetia (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].

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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 32.13 mg (equivalent: sitagliptin, qty 25 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.

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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate; croscarmellose sodium; sodium stearylfumarate; magnesium stearate; 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.