Unione Europea - inglese - EMA (European Medicines Agency)

janssen-cilag international n.v. - telaprevir - hepatitis c, chronic - antivirals for systemic use - incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis c in adult patients with compensated liver disease (including cirrhosis):who are treatment naïve;who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.

Israele - inglese - Ministry of Health

amgen europe b.v. - blinatumomab - powder for concentrate for solution for infusion - blinatumomab 35 mcg / 1 vial - blinatumomab - • blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b- precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options.• blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b-cell precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b precursor all as part of the consolidation therapy.limitations of use: after failure of two previous treatments and with no cns involvement.

Stati Uniti - inglese - NLM (National Library of Medicine)

fresenius kabi usa, llc - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults to: - to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. sincalide for injection is contraindicated in patients with: - a history of hypersensitivity to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)] . - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous abortion [see warnings and precautions (5.4)]. available data with sincalide for injection are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal embryo-fetal development studies in which sincalide was administered to hamsters and rats during the period of organogenesis, no effects were seen at doses comparable to the maximum recommended clinical dose on a mg/kg basis. however, in a prenatal development study in which rats were administered sincalide during organogenesis through parturition, decreased weight gain and developmental delays were observed at a dose 122 times higher than the maximum recommended human dose based on body surface area. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data there were no effects on embryo-fetal development in hamsters when sincalide was administered subcutaneously at 250 or 750 ng/kg during organogenesis (gestation days 7 to 13) at doses up to 0.8 times the maximum recommended dose of 120 ng/kg on a body surface area basis. no effects on embryo-fetal development were observed in sprague-dawley rats at subcutaneous doses of 250, 450, or 750 ng/kg from gestation days 6 to16, representing 1.0 time the maximum recommended human dose on a body surface area basis. in a separate study at a higher dose of 90 mcg/kg administered subcutaneously to cfy rats from gestation day 10 through parturition (representing 122 times the maximum recommended human dose on a body surface area basis), offspring showed decreased growth, behavioral changes, and developmental delays. risk summary there are no data regarding the presence of sincalide in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sincalide for injection and any potential adverse effect on the breastfed infant from sincalide for injection or from the underlying condition. the safety and effectiveness in pediatric patients have not been established. clinical studies of sincalide for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Malta - inglese - Medicines Authority

om pharma s.a. r. da industria, 2, 2610-088 amadora, lisboa, portugal - lyophilized bacterial, lysates - capsule - lyophilized bacterial lysates 7 mg - other respiratory system products

Malta - inglese - Medicines Authority

om pharma s.a. r. da industria, 2, 2610-088 amadora, lisboa, portugal - lyophilized bacterial, lysates - capsule - lyophilized bacterial lysates 3.5 mg - other respiratory system products

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

pharma regulatory solutions ltd - voriconazole - pdr for soln for infusion - 200 milligram - triazole derivatives - antimycotics for systemic use, triazole derivatives - voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis. treatment of candidaemia in non-neutropenic patients. treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). treatment of serious fungal infections caused by scedosporium spp. and fusarium spp. voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients.

Filippine - inglese - FDA (Food And Drug Administration)

pnsv asia corporation - ascorbic acid / zinc gluconate - syrup - 100mg / 35mg (equi. to 5mg elemntal zinc) per 5ml

Stati Uniti - inglese - NLM (National Library of Medicine)

merck sharp & dohme llc - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen (unii: luy6p8763w) (haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen - unii:luy6p8763w) - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen 7.5 ug in 0.5 ml - liquid pedvaxhib is indicated for routine vaccination against invasive disease caused by haemophilus influenzae type b in infants and children 2 to 71 months of age. liquid pedvaxhib will not protect against disease caused by haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis. as with any vaccine, vaccination with liquid pedvaxhib may not result in a protective antibody response in all individuals given the vaccine. because of the potential for immune tolerance, liquid pedvaxhib is not recommended for use in infants younger than 6 weeks of age. (see precautions.) infants completing the primary two-dose regimen before 12 months of age should receive a booster dose (see dosage and administration). hypersensitivity to any component of the vaccine or the diluent. persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.

Stati Uniti - inglese - NLM (National Library of Medicine)

azurity pharmaceuticals, inc. (formerly arbor pharmaceuticals) - gabapentin enacarbil (unii: 75ocl1spbq) (gabapentin - unii:6cw7f3g59x) - gabapentin enacarbil 300 mg - horizant® is indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls) in adults. horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night. horizant is indicated for the management of postherpetic neuralgia (phn) in adults. none. risk summary there are no adequate data on the developmental risk associated with the use of horizant in pregnant women. in nonclinical studies in rats and rabbits, administration of gabapentin enacarbil was developmentally toxic when administered to pregnant animals at doses and gabapentin exposures greater than those used clinically [see data] . in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data when pregnant rats were administered gabapentin enacarbil (oral d

Stati Uniti - inglese - NLM (National Library of Medicine)

merck sharp & dohme corp. - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen (unii: luy6p8763w) (haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen - unii:luy6p8763w) - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen 1 g in 1 g