Israel - Englisch - Ministry of Health

merck sharp & dohme israel ltd - alendronate as sodium - tablets - alendronate as sodium 70 mg - alendronic acid - fosalan is indicated for the treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures). treatment to increase bone mass in men with osteoporosis.

Israel - Englisch - Ministry of Health

merck serono ltd - bisoprolol fumarate - tablets - bisoprolol fumarate 5 mg - bisoprolol - - treatment of stable chronic, moderate to severe heart failure with impaired systolic ventricular function ( ejection fraction < 35 %, determined by echocardiography) in addition to ace inhibitors and diuretics, and optionally cardiac glycosides.- hypertension- coronary heart disease (angina pectoris)

Israel - Englisch - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - pembrolizumab - concentrate for solution for infusion - pembrolizumab 25 mg/ml - pembrolizumab - melanoma• keytruda is indicated for the treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma.•keytruda is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage iib, iic, or iii melanoma following complete resection.non-small cell lung cancer• keytruda, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (nsclc) negative for egfr or alk genomic tumor aberrations.• keytruda, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound , is indicated for the first-line treatment of patients with metastatic squamous nsclc.• keytruda, as a single agent, is indicated for the treatment of patients with metastatic nsclc whose tumors express pd-l1 [tumor proportion score (tps) ≥50%)] as determined by a validated test. patients with egfr or alk genomic tumor aberrations should have disease progression on or after platinum-containing chemotherapy and an approved therapy for these aberrations prior to receiving keytruda .• keytruda, as a single agent, is indicated for the treatment of patients with advanced nsclc whose tumors express pd-l1 as determined by a validated test, with disease progression on or after platinum containing chemotherapy. patients with egfr or alk genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving keytruda .• keytruda , as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage ib (t2a ≥4 cm), ii, or iiia nsclc.head and neck cancer• keytruda, in combination with platinum and fluorouracil (fu), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (hnscc).• keytruda, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent hnscc whose tumors express pd-l1 [combined positive score (cps) ≥1] as determined by a validated test .• keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic hnscc with disease progression on or after platinum-containing chemotherapy..classical hodgkin lymphoma• keytruda is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma (chl).• keytruda is indicated for the treatment of pediatric patients with refractory chl, or chl that has relapsed after 2 or more lines of therapyprimary mediastinal large b-cell lymphoma keytruda is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large b-cell lymphoma (pmbcl), or who have relapsed after 2 or more prior lines of therapy.limitation of use: keytruda is not recommended for treatment of patients with pmbcl who require urgent cytoreductive therapy.urothelial carcinoma• keytruda is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express pd-l1 [combined positive score (cps ≥10) ] as determined by a validated test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of pd-l1 status. • keytruda is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.microsatellite instability-high cancerkeytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (msi h) or mismatch repair deficient (dmmr). • solid tumors that have progressed following prior systemic treatment and who have no satisfactory alternative treatment options,or• colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.limitation of use: the safety and effectiveness of keytruda in pediatric patients with msi h central nervous system cancers have not been established. gastric cancer• keytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction (gej) adenocarcinoma in adults whose tumors express pd-l1 with a cps ≥ 1.• keytruda ,as a single agent, is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gej whose tumors express pd-l1 [combined positive score (cps) ≥1] as determined by a validated test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, her2/neu targeted therapy.cervical cancer• keytruda, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express pd-l1 (cps ≥1) as determined by a validated test. • keytruda, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express pd-l1 (cps ≥1) as determined by a validated test.biliary tract carcinomakeytruda, in combination with chemotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract carcinoma (btc).merkel cell carcinomakeytruda is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic merkel cell carcinoma (mcc).renal cell carcinoma• keytruda, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).• keytruda, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced rcc.• keytruda is indicated for the adjuvant treatment of patients with rcc at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.non-muscle invasive bladder cancer (nmibc)keytruda 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 tumors who are ineligible for or have elected not to undergo cystectomy.esophageal cancer• keytruda is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (gej) (siewert type i) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.• keytruda is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express pd-l1 (cps ≥10) as determined by a validated test, with disease progression after one or more prior lines of systemic therapy.cutaneous squamous cell carcinomakeytruda is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cscc) or locally advanced cscc that is not curable by surgery or radiationmicrosatellite instability-high or mismatch repair deficient colorectal cancer (crc)keytruda is indicated for the first-line treatment of patients with unresectable or metastatic msi-h or dmmr colorectal cancer (crc).tumor mutational burden-high cancerkeytruda is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (tmb-h) [≥10 mutations/megabase (mut/mb)] solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.limitations of use: the safety and effectiveness of keytruda in pediatric patients with tmb-h central nervous system cancers have not been established.triple negative breast cancer• keytruda, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (tnbc) whose tumors express pd-l1 (cps ≥10) as determined by a validated test• keytruda 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 a single agent as adjuvant treatment after surgery.endometrial carcinomakeytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy and who are not candidates for curative surgery or radiation.

Israel - Englisch - Ministry of Health

merck serono ltd - bisoprolol fumarate - film coated tablets - bisoprolol fumarate 1.25 mg - bisoprolol - treatment of stable chronic, moderate to severe heart failure with impaired systolic ventricular function (ejection fraction < 35 %, determined by echocardiography) in addition to ace inhibitors and diuretics, and optionally cardiac glycosides.

Israel - Englisch - Ministry of Health

merck serono ltd - bisoprolol fumarate - film coated tablets - bisoprolol fumarate 2.5 mg - bisoprolol - treatment of stable chronic, moderate to severe heart failure with impaired systolic ventricular function (ejection fraction < 35 %, determined by echocardiography) in addition to ace inhibitors and diuretics, and optionally cardiac glycosides.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

merck sharp & dohme llc - belzutifan (unii: 7k28nb895l) (belzutifan - unii:7k28nb895l) - welireg is indicated for treatment of adult patients with von hippel-lindau (vhl) disease who require therapy for associated renal cell carcinoma (rcc), central nervous system (cns) hemangioblastomas, or pancreatic neuroendocrine tumors (pnet), not requiring immediate surgery. welireg is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) following a programmed death receptor-1 (pd-1) or programmed death-ligand 1 (pd-l1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (vegf-tki). none. risk summary based on findings in animal studies, welireg can cause fetal harm when administered to a pregnant woman. there are no available data on the use of welireg in pregnant women to inform the drug-associated risk. in an animal reproduction study, oral administration of belzutifan to pregnant rats during the period of organogenesis caused embryo-fetal lethality, reduced fetal body weight, and fetal skeletal malformations at maternal exposures ≥0.2 times the human exposure (auc) at the recommended dose of 120 mg daily (see data ). advise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data in a pilot embryo-fetal development study, pregnant rats received oral doses of 6, 60, or 200 mg/kg/day of belzutifan during the period of organogenesis. belzutifan caused embryo-fetal lethality at doses ≥60 mg/kg/day (approximately 1 time the human exposure at the recommended dose based on auc). reduced fetal body weights, fetal rib malformations, and reduced skeletal ossification occurred at doses of 6 and 60 mg/kg/day (approximately ≥0.2 times the human exposure at the recommended dose based on auc). risk summary there are no data on the presence of belzutifan or its metabolites in human milk or their effects on the breastfed child or on milk production. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with welireg and for 1 week after the last dose. welireg can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating treatment with welireg. contraception females advise females of reproductive potential to use effective non-hormonal contraception during treatment with welireg and for 1 week after the last dose. welireg can render some hormonal contraceptives ineffective [see drug interactions (7.2)] . males advise males with female partners of reproductive potential to use effective contraception during treatment with welireg and for 1 week after the last dose. infertility based on findings in animals, welireg may impair fertility in males and females of reproductive potential [see nonclinical toxicology (13.1) ] . the reversibility of the effect on fertility is unknown. safety and effectiveness of welireg have not been established in pediatric patients. of the patients who received welireg in litespark-004, 3.3% were ≥65 years old [see clinical studies (14.1)] clinical trials of welireg in patients with vhl did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. of the 372 patients who received welireg for advanced rcc in litespark-005, 62% of patients younger than 65 years, 28% of patients were 65 to 74 years, and 10% were 75 years and over. no overall difference in efficacy was reported between patients who were ≥65 years of age and younger patients. dose interruptions occurred in 48% of patients ≥65 years of age and in 34% of younger patients. dose reductions occurred in 18% of patients ≥65 years of age and in 10% of younger patients. no dosage modification of welireg is recommended in patients with mild (egfr 60-89 ml/min/1.73 m2 estimated by mdrd) and moderate (egfr 30-59 ml/min/1.73 m2 ) renal impairment [see clinical pharmacology (12.3)]. welireg has not been studied in patients with severe (egfr 15-29 ml/min/1.73 m2 ) renal impairment. no dosage modification of welireg is recommended in patients with mild [total bilirubin ≤ upper limit of normal (uln) and aspartate aminotransferase (ast) > uln or total bilirubin >1 to 1.5 x uln and any ast] hepatic impairment. welireg has not been studied in patients with moderate or severe hepatic impairment (total bilirubin >1.5 x uln and any ast) [see clinical pharmacology (12.3)] . patients who are dual ugt2b17 and cyp2c19 poor metabolizers have higher belzutifan exposures, which may increase the incidence and severity of adverse reactions of welireg. closely monitor for adverse reactions in patients who are dual ugt2b17 and cyp2c19 poor metabolizers [see warnings and precautions (5), adverse reactions (6), clinical pharmacology (12.5)] .

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - imipenem, quantity: 500 mg; cilastatin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium bicarbonate - primaxin is indicated for the treatment of serious infections caused by susceptible strains of micro-organisms in the diseases listed below: 1. lower respiratory tract infections. 2 intra-abdominal infections. 3. gynaecological infections. 4. bacterial septicaemia. 5. bone and joint infections. 6. skin and skin structure infections. 7. endocarditis. 8. polymicrobial infections. primaxin is indicated for polymicrobial infections including those in which s. pneumoniae (pneumonia, septicaemia), group a beta-haemolytic streptococcus (skin and skin structure), or non-penicillinase-producing s. aureus is one of the causative organisms. however monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin g. efficacy against polymicrobial infection in the immunocompromised host has not yet been established. although clinical improvement has been observed in patients with cystic fibrosis, chronic pulmonary disease, and lower respiratory tract infections cau

Singapur - Englisch - HSA (Health Sciences Authority)

merck pte. ltd. - metformin hydrochloride - tablet, extended release - 500 mg - metformin hydrochloride 500 mg

Singapur - Englisch - HSA (Health Sciences Authority)

merck pte. ltd. - choriogonadotropin alfa - injection, solution - 250 mcg - choriogonadotropin alfa 250 mcg

Singapur - Englisch - HSA (Health Sciences Authority)

merck pte. ltd. - metformin hydrochloride (eqv 780mg metformin base) - tablet, extended release - 1000 mg - metformin hydrochloride (eqv 780mg metformin base) 1000 mg