Irland - Englisch - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Irland - Englisch - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Irland - Englisch - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Irland - Englisch - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

Irland - Englisch - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dabigatran etexilate mesilate - capsule, hard - dabigatran etexilate

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

glaxosmithkline llc - albiglutide (unii: 5e7u48495e) (albiglutide - unii:5e7u48495e) - albiglutide 30 mg in 0.5 ml - tanzeum is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14)]. limitations of use: tanzeum is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2) [see warnings and precautions (5.1)] . tanzeum is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components. serious hypersensitivity reactions including angioedema have been reported with tanzeum [see warnings and precautions (5.4)]. pregnancy category c there are no adequate and well-controlled studies of tanzeum in pregnant women. nonclinical studies have shown reproductive toxicity, but not teratogenicity, in mice treated with albiglutide at up to 39 times human exposure resulting from the maximum recommended dose of 50 mg/week, based on auc [see nonclinical toxicology (13.1, 13.3)]. tan

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

rebel distributors corp - dabigatran etexilate mesylate (unii: sc7nuw5iit) (dabigatran etexilate - unii:2e18wx195x) - dabigatran etexilate 150 mg - pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. pradaxa is contraindicated in patients with: - active pathological bleeding [see warnings and precautions (5.1) and adverse reactions (6.1)] . - history of a serious hypersensitivity reaction to pradaxa (e.g., anaphylactic reaction or anaphylactic shock) [see adverse reactions (6.1)] .   there are no adequate and well-controlled studies in pregnant women. dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3.0 times the human exposure at maximum recommended human dose [mrhd] of 300 mg/day based on area under the curve [auc] comparisons) prior to mating and up to implantation (gestation day 6). treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition. although dabigatran incr

Israel - Englisch - Ministry of Health

teva israel ltd - dabigatran etexilate as mesylate - capsules - dabigatran etexilate as mesylate 150 mg - dabigatran etexilate - prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults.

Israel - Englisch - Ministry of Health

teva israel ltd - dabigatran etexilate as mesylate - capsules - dabigatran etexilate as mesylate 110 mg - dabigatran etexilate - primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults

Israel - Englisch - Ministry of Health

teva israel ltd - dabigatran etexilate as mesylate - capsules - dabigatran etexilate as mesylate 75 mg - dabigatran etexilate - primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery