Kenja - Ingliż - Pharmacy and Poisons Board

ccl pharmaceuticals (pvt.) ltd. 65-industrial estate, kot lakhpat, lahore-54770, - dapagliflozin (propanediol monohydrate) &… - tablet - dapagliflozin (propanediol monohydrate) 5mg& … - metformin and dapagliflozin

Kenja - Ingliż - Pharmacy and Poisons Board

ccl pharmaceuticals (pvt.) ltd. 65-industrial estate, kot lakhpat, lahore-54770, - dapagliflozin (propanediol monohydrate) &… - tablet - dapagliflozin (propanediol monohydrate) 5mg &… - metformin and dapagliflozin

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - dapagliflozin 10mg - film coated tablet - 10 mg - active: dapagliflozin 10mg excipient: colloidal silicon dioxide crospovidone lactose microcrystalline cellulose opadry yellow 85f32782 sodium laurilsulfate sodium stearyl fumarate - type 2 diabetes mellitus glycaemic control indicated in adults with type 2 diabetes mellitus: · as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated. · as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy. · in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 clinical efficacy and safety, and 4.4 special warnings and precautions for use for available data on different add-on combination therapies). prevention of hospitalisation for heart failure indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart failure (see section 5.1 pharmacodynamic properties – clinical efficacy and safety). prevention of new or worsening nephropathy indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease for the prevention of new or worsening nephropathy (see section 5.1 pharmacodynamic properties – clinical efficacy and safety).

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

a-s medication solutions - dapagliflozin propanediol (unii: 887k2391vh) (dapagliflozin - unii:1ull0qj8uc) - farxiga (dapagliflozin) is indicated: limitations of use based on animal data showing adverse renal effects, farxiga is not recommended during the second and third trimesters of pregnancy. limited data with farxiga in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure in pregnancy (see clinical considerations) . in animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when dapagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 mg clinical dose (see data). the estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a hba1c greater than 7% and has been reported to be as high as 20 to 25% in women with hba1c greater than 10%. the estimated background risk of 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 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryofetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data animal data dapagliflozin dosed directly to juvenile rats from postnatal day (pnd) 21 until pnd 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. exposure at the lowest dose tested was 15-times the 10 mg clinical dose (based on auc). the renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. in a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. increased incidence or severity of renal pelvic dilatation was observed in 21-day-old pups offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on auc). dose-related reductions in pup body weights were observed at greater or equal to 29-times the 10 mg clinical dose (based on auc). no adverse effects on developmental endpoints were noted at 1 mg/kg/day (19-times the 10 mg clinical dose, based on auc). these outcomes occurred with drug exposure during periods of renal development in rats that corresponds to the late second and third trimester of human development. in embryofetal development studies in rats and rabbits, dapagliflozin was administered throughout organogenesis, corresponding to the first trimester of human pregnancy. in rats, dapagliflozin was neither embryolethal nor teratogenic at doses up to 75 mg/kg/day (1441-times the 10 mg clinical dose, based on auc). dose-related effects on the rat fetus (structural abnormalities and reduced body weight) occurred only at higher dosages, equal to or greater than 150 mg/kg (more than 2344-times the 10 mg clinical dose, based on auc), which were associated with maternal toxicity. no developmental toxicities were observed in rabbits at doses up to 180 mg/kg/day (1191-times the 10 mg clinical dose, based on auc). risk summary there is no information regarding the presence of dapagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. dapagliflozin is present in the milk of lactating rats (see data) . however, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear. since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. because of the potential for serious adverse reactions in breastfed infants, advise women that use of farxiga is not recommended while breastfeeding. data dapagliflozin was present in rat milk at a milk/plasma ratio of 0.49, indicating that dapagliflozin and its metabolites are transferred into milk at a concentration that is approximately 50% of that in maternal plasma. juvenile rats directly exposed to dapagliflozin showed risk to the developing kidney (renal pelvic and tubular dilatations) during maturation. safety and effectiveness of farxiga in pediatric patients under 18 years of age have not been established. no farxiga dosage change is recommended based on age. a total of 1424 (24%) of the 5936 farxiga-treated patients were 65 years and older and 207 (3.5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical studies assessing the efficacy of farxiga in improving glycemic control in type 2 diabetes mellitus. after controlling for level of renal function (egfr), efficacy was similar for patients under age 65 years and those 65 years and older. in patients ≥65 years of age, a higher proportion of patients treated with farxiga for glycemic control had adverse reactions of hypotension [see warnings and precautions (5.2) and adverse reactions (6.1)] . in the dapa-ckd, dapa-hf and deliver studies, safety and efficacy were similar for patients age 65 years and younger and those older than 65. in the dapa-hf study, 2714 (57%) out of 4744 patients with hfref were older than 65 years. in the deliver study, 4759 (76%) out of 6263 patients with heart failure (lvef >40%) were older than 65 years. in the dapa-ckd study, 1818 (42%) out of 4304 patients with ckd were older than 65 years. farxiga was evaluated in 4304 patients with chronic kidney disease (egfr 25 to 75 ml/min/1.73 m2 ) in the dapa-ckd study. farxiga was also evaluated in 1926 patients with an egfr of 30 to 60 ml/min/1.73 m2 in the dapa-hf study. the safety profile of farxiga across egfr subgroups in these studies was consistent with the known safety profile [see adverse reactions (6.1) and clinical studies (14.3 and 14.4)]. farxiga was evaluated in two glycemic control studies that included patients with type 2 diabetes mellitus with moderate renal impairment (an egfr of 45 to less than 60 ml/min/1.73 m2 [see clinical studies (14.1)] , and an egfr of 30 to less than 60 ml/min/1.73 m2 , respectively). patients with diabetes and renal impairment using farxiga may be more likely to experience hypotension and may be at higher risk for acute kidney injury secondary to volume depletion. in the study of patients with an egfr 30 to less than 60 ml/min/1.73 m2 , 13 patients receiving farxiga experienced bone fractures compared to none receiving placebo. use of farxiga for glycemic control in patients without established cv disease or cv risk factors is not recommended when egfr is less than 45 ml/min/1.73 m2 [see dosage and administration (2.2)] . efficacy and safety studies with farxiga did not enroll patients with an egfr less than 25 ml/min/1.73 m2 or on dialysis. no dose adjustment is recommended for patients with mild, moderate, or severe hepatic impairment. however, the benefit-risk for the use of dapagliflozin in patients with severe hepatic impairment should be individually assessed since the safety and efficacy of dapagliflozin have not been specifically studied in this population [see clinical pharmacology (12.3)] .

Iżrael - Ingliż - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol - film coated tablets - dapagliflozin propanediol 12.30 mg/dose - dapagliflozin - type 2 diabetes mellitusforxiga is indicated in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise• as monotherapy when metformin is considered inappropriate due to intolerance.• in addition to other medicinal products for the treatment of type 2 diabetes.heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failurechronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease

Iżrael - Ingliż - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol - film coated tablets - dapagliflozin propanediol 6.150 mg/dose - dapagliflozin - type 2 diabetes mellitusforxiga is indicated in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise• as monotherapy when metformin is considered inappropriate due to intolerance.• in addition to other medicinal products for the treatment of type 2 diabetes.heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failurechronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; copovidone; silicon dioxide; magnesium stearate; lactose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - type 2 diabetes mellitus glycaemic control,cipla dapagliflozin is indicated in adults with type 2 diabetes mellitus:,?as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwiseindicated but was not tolerated. ?as initial combination therapy with metformin, as an adjunct to diet and exercise, to improveglycaemic control when diet and exercise have failed to provide adequate glycaemic control andthere are poor prospects for response to metformin monotherapy (for example, high initialhaemoglobin a1c [hba1c] levels). ?in combination with other anti-hyperglycaemic agents to improve glycaemic control, when thesetogether with diet and exercise, do not provide adequate glycaemic control (see section 5.1pharmacodynamic properties ? clinical trials and section 4.4 special warnings and precautions foruse for available data on different add-on combination therapies).,prevention of hospitalisation for heart failure dapaglicip is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 pharmacodynamic properties ? clinical trials).,heart failure,dapaglicip is indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties).,chronic kidney disease,dapaglicip is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (ckd stage 2, 3 or 4 and urine acr greater than or equal 30 mg/g)

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; copovidone; silicon dioxide; magnesium stearate; lactose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - type 2 diabetes mellitus glycaemic control,cipla dapagliflozin is indicated in adults with type 2 diabetes mellitus:,?as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwiseindicated but was not tolerated. ?as initial combination therapy with metformin, as an adjunct to diet and exercise, to improveglycaemic control when diet and exercise have failed to provide adequate glycaemic control andthere are poor prospects for response to metformin monotherapy (for example, high initialhaemoglobin a1c [hba1c] levels). ?in combination with other anti-hyperglycaemic agents to improve glycaemic control, when thesetogether with diet and exercise, do not provide adequate glycaemic control (see section 5.1pharmacodynamic properties ? clinical trials and section 4.4 special warnings and precautions foruse for available data on different add-on combination therapies).,prevention of hospitalisation for heart failure dapaglicip is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 pharmacodynamic properties ? clinical trials).,heart failure,dapaglicip is indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties).,chronic kidney disease,dapaglicip is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (ckd stage 2, 3 or 4 and urine acr greater than or equal 30 mg/g)

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; copovidone; silicon dioxide; magnesium stearate; lactose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - type 2 diabetes mellitus glycaemic control,cipla dapagliflozin is indicated in adults with type 2 diabetes mellitus:,?as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwiseindicated but was not tolerated. ?as initial combination therapy with metformin, as an adjunct to diet and exercise, to improveglycaemic control when diet and exercise have failed to provide adequate glycaemic control andthere are poor prospects for response to metformin monotherapy (for example, high initialhaemoglobin a1c [hba1c] levels). ?in combination with other anti-hyperglycaemic agents to improve glycaemic control, when thesetogether with diet and exercise, do not provide adequate glycaemic control (see section 5.1pharmacodynamic properties ? clinical trials and section 4.4 special warnings and precautions foruse for available data on different add-on combination therapies).,prevention of hospitalisation for heart failure dapaglicip is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 pharmacodynamic properties ? clinical trials).,heart failure,dapaglicip is indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy (see section 5.1 pharmacodynamic properties).,chronic kidney disease,dapaglicip is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (ckd stage 2, 3 or 4 and urine acr greater than or equal 30 mg/g)

Kenja - Ingliż - Pharmacy and Poisons Board

dawa limited plot no 7879/8,baba dogo road,ruaraka-p.o box - dapagliflozin propanediol monohydrate - film-coated tablet - each film coated tablet contains: dapagliflozin… - dapagliflozin