Spojené státy - angličtina - NLM (National Library of Medicine)

vertex pharmaceuticals incorporated - ivacaftor (unii: 1y740ill1z) (ivacaftor - unii:1y740ill1z) - ivacaftor 150 mg - kalydeco is indicated for the treatment of cystic fibrosis (cf) in patients age 1 month and older who have at least one mutation in the cftr gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data [see clinical pharmacology (12.1) and clinical studies (14)] . if the patient's genotype is unknown, an fda-cleared cf mutation test should be used to detect the presence of a cftr mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use. none. risk summary there are limited and incomplete human data from clinical trials and postmarketing reports on use of kalydeco in pregnant women. in animal reproduction studies, oral administration of ivacaftor to pregnant rats and rabbits during organogenesis demonstrated no teratogenicity or adverse effects on fetal development at doses that produced maternal exposures up to approximately 5 (rats) and 11 (rabbits) times the exposure at the maximum recommended human dose

Spojené státy - angličtina - NLM (National Library of Medicine)

vertex pharmaceuticals incorporated - lumacaftor (unii: egp8l81apk) (lumacaftor - unii:egp8l81apk), ivacaftor (unii: 1y740ill1z) (ivacaftor - unii:1y740ill1z) - lumacaftor 200 mg - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 1 year and older who are homozygous for the f508del mutation in the cftr gene. if the patient's genotype is unknown, an fda-cleared cf mutation test should be used to detect the presence of the f508del mutation on both alleles of the cftr gene. limitations of use the efficacy and safety of orkambi have not been established in patients with cf other than those homozygous for the f508del mutation. none. risk summary there are limited and incomplete human data from clinical trials and postmarketing reports on use of orkambi or its individual components, lumacaftor or ivacaftor, in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral administration of lumacaftor to pregnant rats and rabbits during organogenesis demonstrated no teratogenicity or adverse effects on fetal development at doses that produced maternal exposures up to approximately 8 (rats) and 5 (rabbits) times the exposure at the maxim

Velká Británie - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

organon pharma (uk) ltd - finasteride - oral tablet - 1mg

Spojené státy - angličtina - NLM (National Library of Medicine)

vertex pharmaceuticals incorporated - tezacaftor (unii: 8rw88y506k) (tezacaftor - unii:8rw88y506k), ivacaftor (unii: 1y740ill1z) (ivacaftor - unii:1y740ill1z) - tezacaftor 100 mg - symdeko is indicated for the treatment of cystic fibrosis (cf) in patients age 6 years and older who are homozygous for the f508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (cftr ) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence [see clinical pharmacology (12.1) and clinical studies (14)] . if the patient's genotype is unknown, an fda-cleared cf mutation test should be used to detect the presence of a cftr mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use. none. risk summary there are limited and incomplete human data from clinical trials and postmarketing reports on the use of symdeko or its individual components, tezacaftor and ivacaftor, in pregnant women to inform a drug-associated risk. although there are no animal reproduction studies with the concomitant administration of tezacaftor and ivacaftor, separate reproductive

Kanada - angličtina - Health Canada

vertex pharmaceuticals (canada) incorporated - tezacaftor; ivacaftor; ivacaftor - tablet - 100mg; 150mg; 150mg - tezacaftor 100mg; ivacaftor 150mg; ivacaftor 150mg - cystic fibrosis transmembrane conductance regulator correctors

Evropská unie - angličtina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cystic fibrosis - other respiratory system products - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Kanada - angličtina - Health Canada

vertex pharmaceuticals (canada) incorporated - lumacaftor; ivacaftor - granules - 100mg; 125mg - lumacaftor 100mg; ivacaftor 125mg - cystic fibrosis transmembrane conductance regulator correctors

Kanada - angličtina - Health Canada

vertex pharmaceuticals (canada) incorporated - lumacaftor; ivacaftor - granules - 150mg; 188mg - lumacaftor 150mg; ivacaftor 188mg - cystic fibrosis transmembrane conductance regulator correctors

Spojené státy - angličtina - NLM (National Library of Medicine)

vertex pharmaceuticals incorporated - elexacaftor (unii: rrn67gmb0v) (elexacaftor - unii:rrn67gmb0v), tezacaftor (unii: 8rw88y506k) (tezacaftor - unii:8rw88y506k), ivacaftor (unii: 1y740ill1z) (ivacaftor - unii:1y740ill1z) - trikafta is indicated for the treatment of cystic fibrosis (cf) in patients aged 2 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene or a mutation in the cftr gene that is responsive based on in vitro data [see clinical pharmacology (12.1)] . if the patient's genotype is unknown, an fda-cleared cf mutation test should be used to confirm the presence of at least one f508del mutation or a mutation that is responsive based on in vitro data. none. risk summary there are limited and incomplete human data from clinical trials on the use of trikafta or its individual components, elexacaftor, tezacaftor and ivacaftor, in pregnant women to inform a drug-associated risk. although there are no animal reproduction studies with the concomitant administration of elexacaftor, tezacaftor and ivacaftor, separate reproductive and developmental studies were conducted with each active component of trikafta in pregnant rats and rabbits. in animal em

Singapur - angličtina - HSA (Health Sciences Authority)

medtronic international, ltd. - orthopaedics - when intended as an adjuct to fusion in skeletally mature patients using allograft and/or autograft of the occipitocervical spine, cervical spine, and the thoracic spine, (occiput-t3), the vertex® reconstruction system is indicated for the following: ddd (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.