Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

bluepoint laboratories - cisplatin (unii: q20q21q62j) (cisplatin - unii:q20q21q62j) - cisplatin 1 mg in 1 ml - cisplatin injection is indicated for the treatment of advanced testicular cancer. cisplatin injection is indicated for the treatment of advanced ovarian cancer. cisplatin injection is indicated for the treatment of advanced bladder cancer. cisplatin injection is contraindicated in patients with severe hypersensitivity to cisplatin [see warnings and precautions ( 5.4)] . risk summary based on human data from published literature, cisplatin injection can cause fetal harm when administered to pregnant women. advise pregnant women and females of reproductive potential of the potential risk to a fetus. data demonstrates transplacental transfer of cisplatin. exposure of pregnant women to cisplatin-containing chemotherapy has been associated with oligohydramnios, intrauterine growth restriction, and preterm birth. cases of neonatal acute respiratory distress syndrome, cytopenias, and hearing loss have been reported. cisplatin injection administration to animals during and after organogenesis resulted in teratogenicity. a published study in mice showed placental transfer of cisplatin increased with placenta maturation. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. risk summary limited data from published literature report the presence of cisplatin in human milk in low amounts. because of the potential for serious adverse reactions from cisplatin injection in a breastfed child and because of the potential for tumorigenicity shown for cisplatin injection, advise lactating women not to breastfeed during treatment with cisplatin injection. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiation of cisplatin injection. contraception females cisplatin injection can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1)] . advise females of reproductive potential to use effective contraception during treatment and for 14 months following the last dose of cisplatin injection. males advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 11 months after the last dose of cisplatin injection. infertility females the use of cisplatin has been associated with cumulative dose-dependent ovarian failure, premature menopause, and reduced fertility. males the use of cisplatin has been associated with a cumulative dose-dependent impairment of spermatogenesis (oligospermia, azoospermia; possibly irreversible) and reduced fertility. ototoxic effects may be more severe and detrimental in pediatric patients receiving cisplatin injection, particularly in patients less than 5 years of age. consider audiometric and vestibular function monitoring in all patients receiving cisplatin injection. the prevalence of hearing loss in pediatric patients is particularly high and is estimated to be 40% to 60%. earlier detection of hearing loss can limit the potential impact of hearing impairment on a pediatric patient’s cognitive and social development [see warnings and precautions ( 5.6)]. for the treatment of metastatic testicular tumors or advanced bladder cancer, clinical studies of cisplatin injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in four clinical trials of combination chemotherapy for advanced ovarian carcinoma, 1,484 patients received cisplatin either in combination with cyclophosphamide or with paclitaxel. of these, 426 (29%) were older than 65 years. in these trials, age was not found to be a prognostic factor for survival. however, in a later secondary analysis for one of these trials, geriatric patients were found to have shorter survival compared with younger patients. in all four trials, geriatric patients experienced more severe neutropenia than did younger patients. higher incidences of severe thrombocytopenia and leukopenia were also seen in geriatric patients compared with younger patients, although not in all cisplatin-containing treatment arms. in the two trials where nonhematologic toxicity was evaluated according to age, geriatric patients had a numerically higher incidence of peripheral neuropathy than did younger patients. other reported clinical experience suggests that geriatric patients may be more susceptible to nephrotoxicity, myelosuppression, and infectious complications than are younger patients [see warnings and precautions ( 5.1, 5.2, 5.4)]. cisplatin is known to be substantially excreted by the kidney. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored. patients with baseline renal impairment may be more susceptible to nephrotoxicity [see warnings and precautions ( 5.1)] . ensure adequate hydration before, during, and after cisplatin injection administration [see dosage and administration ( 2.1)]. measure serum creatinine, blood urea nitrogen, creatinine clearance, and serum electrolytes prior to initiating therapy, and as clinically indicated. consider alternative treatments or reduce the dose of cisplatin injection for patients with baseline renal impairment or who develop significant reductions in creatinine clearance during treatment with cisplatin injection according to clinical treatment guidelines [see dosage and administration ( 2.5)].

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - bevacizumab 25 mg/ml;  ;   - concentrate for infusion - 25 mg/ml - active: bevacizumab 25 mg/ml     excipient: dibasic sodium phosphate monobasic sodium phosphate monohydrate polysorbate 20 trehalose water for injection - metastatic colorectal cancer. avastin in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - cisplatin - concentrate for soln for inf - 1 mg/ml - platinum compounds

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - cisplatin - concentrate for soln for inf - 0.5 mg/ml

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - aflibercept 25 mg/ml;   - concentrate for infusion - 25 mg/ml - active: aflibercept 25 mg/ml   excipient: citric acid dibasic sodium phosphate heptahydrate hydrochloric acid monobasic sodium phosphate monohydrate polysorbate 20 sodium chloride sodium citrate dihydrate sodium hydroxide sucrose water for injection - zaltrap in combination with irinotecan-fluoropyrimidine-based chemotherapy is indicated in adults with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - aflibercept 25 mg/ml;   - concentrate for infusion - 25 mg/ml - active: aflibercept 25 mg/ml   excipient: citric acid dibasic sodium phosphate heptahydrate hydrochloric acid monobasic sodium phosphate monohydrate polysorbate 20 sodium chloride sodium citrate dihydrate sodium hydroxide sucrose water for injection - zaltrap in combination with irinotecan-fluoropyrimidine-based chemotherapy is indicated in adults with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

wg critical care, llc - cisplatin (unii: q20q21q62j) (cisplatin - unii:q20q21q62j) - cisplatin 1 mg in 1 ml - cisplatin injection is indicated as therapy to be employed as follows: in established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. in established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. an established combination consists of cisplatin injection and cyclophosphamide. cisplatin injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received cisplatin injection therapy. cisplatin injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy. cisplatin is contraindicated in patients with preexistin

New Zealand - Tiếng Anh - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - cisplatin 1 mg/ml;   - solution for injection - 1 mg/ml - active: cisplatin 1 mg/ml   excipient: hydrochloric acid sodium chloride sodium hydroxide water for injection - cisplatin accord injection is indicated for the palliative treatment of: · metastatic non-seminomatous germ cell carcinoma; · advanced-stage refractory ovarian carcinoma; · advanced-stage refractory bladder carcinoma; and · refractory squamous cell carcinoma of the head and neck. it may be used as a single agent or in combination with other chemotherapeutic agents. it may be employed, in appropriate circumstances, in addition to other modalities, e.g. radiotherapy or surgery.

Canada - Tiếng Anh - Health Canada

david bull laboratories (pty) ltd. - cisplatin - liquid - .5mg - cisplatin .5mg - antineoplastic agents

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

teva parenteral medicines, inc. - cisplatin (unii: q20q21q62j) (cisplatin - unii:q20q21q62j) - cisplatin 50 mg in 50 ml - cisplatin injection is indicated for the treatment of advanced testicular cancer. cisplatin injection is indicated for the treatment of advanced ovarian cancer. cisplatin injection is indicated for the treatment of advanced bladder cancer. cisplatin injection is contraindicated in patients with severe hypersensitivity to cisplatin [see warnings and precautions (5.4)] . risk summary based on human data from published literature, cisplatin injection can cause fetal harm when administered to pregnant women. advise pregnant women and females of reproductive potential of the potential risk to a fetus. data demonstrates transplacental transfer of cisplatin. exposure of pregnant women to cisplatin-containing chemotherapy has been associated with oligohydramnios, intrauterine growth restriction, and preterm birth. cases of neonatal acute respiratory distress syndrome, cytopenias, and hearing loss have been reported. cisplatin injection administration to animals during and after organogenesis resulted in teratogenicit