Австралія - англійська - 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.

США - англійська - NLM (National Library of Medicine)

nova homeopathic therapeutics, inc. - berberis vulgaris fruit (unii: 6xef22ahc3) (berberis vulgaris fruit - unii:6xef22ahc3), selenicereus grandiflorus flower (unii: ii877k4unr) (selenicereus grandiflorus flower - unii:ii877k4unr), activated charcoal (unii: 2p3vwu3h10) (activated charcoal - unii:2p3vwu3h10), chelidonium majus (unii: 7e889u5rnn) (chelidonium majus - unii:7e889u5rnn), cupric acetate (unii: 39m11xph03) (cupric cation - unii:8cbv67279l), tubocurarine chloride (unii: 900961z8vr) (chloride ion - unii:q32zn48698), solanum dulcam - berberis vulgaris fruit 6 [hp_x] in 1 ml - suggested use for one or more of the following symptoms: allergic bronchial and/or emotional asthma attacks.

США - англійська - NLM (National Library of Medicine)

nova homeopathic therapeutics, inc. - gold (unii: 79y1949pyo) (gold - unii:79y1949pyo), atropa belladonna (unii: wqz3g9pf0h) (atropa belladonna - unii:wqz3g9pf0h), selenicereus grandiflorus stem (unii: 7114sv0myk) (selenicereus grandiflorus stem - unii:7114sv0myk), cinchona pubescens bark (unii: s96n10r972) (cinchona pubescens bark - unii:s96n10r972), conium maculatum flowering top (unii: q28r5gf371) (conium maculatum flowering top - unii:q28r5gf371), tubocurarine chloride (unii: 900961z8vr) (chloride ion - unii:q32zn48698), gelsemium sem - gold 12 [hp_x] in 1 ml - suggested use for one or more of the following symptoms: strained or tired eyes from extensive driving, computer use, reading or television.

США - англійська - NLM (National Library of Medicine)

king bio inc. - matricaria recutita (unii: g0r4ubi2zz) (matricaria recutita - unii:g0r4ubi2zz), clematis vitalba flower (unii: 7scp4n87ci) (clematis vitalba flower - unii:7scp4n87ci), croton tiglium seed (unii: 0hk2gzk66e) (croton tiglium seed - unii:0hk2gzk66e), tubocurarine chloride (unii: 900961z8vr) (tubocurarine - unii:w9yxs298bm), solanum dulcamara top (unii: kps1b1162n) (solanum dulcamara top - unii:kps1b1162n), graphite (unii: 4qqn74lh4o) (graphite - unii:4qqn74lh4o), strychnos ignatii seed (unii: 1nm3m2487k) - uses a natural aid for: - indecisiveness - irresolution - dissatisfaction - aversion to responsibility - avoidance of high pressure situations - fickleness uses a natural aid for: indecisiveness, irresolution, dissatisfaction, aversion to responsibility, avoidance of high pressure situations, fickleness.

США - англійська - NLM (National Library of Medicine)

ohm pharma inc. - barium iodide (unii: wkc4t7680a) (barium cation - unii:v645272hln), selenicereus grandiflorus stem (unii: 7114sv0myk) (selenicereus grandiflorus stem - unii:7114sv0myk), activated charcoal (unii: 2p3vwu3h10) (activated charcoal - unii:2p3vwu3h10), hawthorn leaf with flower (unii: 6om09rpy36) (hawthorn leaf with flower - unii:6om09rpy36), tubocurarine chloride (unii: 900961z8vr) (tubocurarine - unii:w9yxs298bm), potassium carbonate (unii: bqn1b9b9ha) (carbonate ion - unii:7ujq5ope7d), kalmia latifolia - uses: temporarily relieves cardio - circulatory ailments.** **this statement has not been evaluated by the fda. it is based on documented homeopathic materia medica. cardio - circulatory ailments relief

США - англійська - NLM (National Library of Medicine)

king bio inc. - matricaria recutita (unii: g0r4ubi2zz) (matricaria recutita - unii:g0r4ubi2zz), clematis vitalba flower (unii: 7scp4n87ci) (clematis vitalba flower - unii:7scp4n87ci), croton tiglium seed (unii: 0hk2gzk66e) (croton tiglium seed - unii:0hk2gzk66e), tubocurarine chloride (unii: 900961z8vr) (tubocurarine - unii:w9yxs298bm), solanum dulcamara top (unii: kps1b1162n) (solanum dulcamara top - unii:kps1b1162n), graphite (unii: 4qqn74lh4o) (graphite - unii:4qqn74lh4o), strychnos ignatii seed (unii: 1nm3m2487k) - uses a natural aid for: - indecisiveness - irresolution - dissatisfaction - aversion to responsibility - avoidance of high pressure situations - fickleness uses a natural aid for: indecisiveness, irresolution, dissatisfaction, aversion to responsibility, avoidance of high pressure situations, fickleness.

США - англійська - NLM (National Library of Medicine)

bioenergetics, inc. - arsenicum alb 12x, belladonna 12x, cimicifuga 6x, curare 12x, cyclamen 6x, gelsemium 6x, glonoin 9x, iris versicolor 6x, mag phos 12, pulsatilla 6x, rhus tox 6x, sanguinaria 6x, secale corn 6x, spigelia 6x - for temporary relief of various types of headaches including migraine. these uses are based on traditional homeopathic practice. they have not been evauated by the fda.

США - англійська - NLM (National Library of Medicine)

ohm pharma inc. - barium iodide (unii: wkc4t7680a) (barium cation - unii:v645272hln), selenicereus grandiflorus stem (unii: 7114sv0myk) (selenicereus grandiflorus stem - unii:7114sv0myk), activated charcoal (unii: 2p3vwu3h10) (activated charcoal - unii:2p3vwu3h10), hawthorn leaf with flower (unii: 6om09rpy36) (hawthorn leaf with flower - unii:6om09rpy36), tubocurarine chloride (unii: 900961z8vr) (tubocurarine - unii:w9yxs298bm), potassium carbonate (unii: bqn1b9b9ha) (carbonate ion - unii:7ujq5ope7d), kalmia latifolia - contraindicaciones: ninguna reportada

США - англійська - NLM (National Library of Medicine)

physicians total care, inc. - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 10 mg - dicyclomine hydrochloride tablets and capsules are indicated for the treatment of functional bowel/ irritable bowel syndrome. - obstructive uropathy - obstructive disease of the gastrointestinal tract - severe ulcerative colitis (see precautions ) - reflux esophagitis - unstable cardiovascular status in acute hemorrhage - glaucoma - myasthenia gravis - evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations - infants less than 6 months of age (see warnings and precautions: information for patients. ) - nursing mothers (see warnings and precautions: information for patients .) abuse of and/or dependence on dicyclomine for anticholinergic effects have been rarely reported.

США - англійська - NLM (National Library of Medicine)

ncs healthcare of ky, inc dba vangard labs - dicyclomine hydrochloride (unii: cq903kqa31) (dicyclomine - unii:4kv4x8if6v) - dicyclomine hydrochloride 10 mg - dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see use in specific populations (8.4)], n ursing mothers [see use in specific populations (8.3)], and in patients with: • unstable cardiovascular status in acute hemorrhage. • myasthenia gravis [see warnings and precautions (5.4). • glaucoma [see adverse reactions (6.3) and drug interactions (7.1)]. • obstructive uropathy [see warnings and precautions (5.8)] . • obstructive disease of the gastrointestinal tract [see warnings and precautions (5.5) • severe ulcerative colitis [see warnings and  precautions (5.7) • reflux esophagitis pregnancy category b adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. however, epidemiologic studies did not show an increased risk of structural malformations among babies born