Združene države Amerike - angleščina - NLM (National Library of Medicine)

naari pte. limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - drospirenone and ethinyl estradiol tablets usp are indicated for use by females of reproductive potential to prevent pregnancy drospirenone and ethinyl estradiol tablet is contraindicated in females who are known to have or develop the following conditions: • renal impairment • adrenal insufficiency • a high risk of arterial or venous thrombotic diseases. examples include women who are known to: ○ smoke, if over age 35 [see boxed warning and warnings and precautions ( 5.1) ] ○ have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions ( 5.1) ] ○ have cerebrovascular disease [see warnings and precautions ( 5.1) ] ○ have coronary artery disease [ see warnings and precautions ( 5.1) ] ○ have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions ( 5.1) ] ○ have inherited or acquired hypercoagulopathies [see warnings and precautions ( 5.1) ] ○ have uncontrolled hypertension [see warnings and precautions ( 5.6) ] ○ have diabetes mellitus with vascular disease [see warnings and precautions ( 5.8) ] ○ have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see warnings and precautions ( 5.9) ] - undiagnosed abnormal uterine bleeding [see warnings and precautions ( 5.10) ] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions ( 5.3) ] - liver tumor (benign or malignant) or liver disease [see warnings and precautions ( 5.4) and use in specific populations ( 8.7) ] - use of hepatitis c drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir due to the potential for alt elevations [see warnings and precautions ( 5.5) and drug interactions ( 7.2) ]. risk summary there is no use for contraception in pregnancy; therefore, drospirenone and ethinyl estradiol tablets should be discontinued during pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to chcs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. data human data a retrospective database study of women in norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight z-scores. post-marketing adverse event data on the use of drospirenone and ethinyl estradiol tablets usp in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. risk summary drsp is present in human milk. after a single oral administration of 3 mg drsp/0.03 mg ee tablets, drsp concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. the estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see data). there is limited information on the effects of drospirenone and ethinyl estradiol tablets on the breast-fed infant. chcs can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding. [see also dosage and administration (2.2)]. the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for drospirenone and ethinyl estradiol tablets and any potential adverse effects on the breast-fed child from drospirenone and ethinyl estradiol tablets or from the underlying maternal condition. data human data an open-label study evaluated the degree of drsp transfer into milk within 72 hours following a single oral administration of 3 mg drsp/0.03 mg ee tablets to 6 healthy lactating women who were 1 week to 3 months postpartum. drsp was present in breast milk with a mean cmax of 13.5 ng/ml, while the mean cmax in serum of lactating women was 30.8 ng/ml. the drsp concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/ml, with a mean ± standard deviation value of 3.7 ± 1.9 ng/ml. based on single dose data, the maximal daily infant dose of drsp was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. safety and efficacy of drospirenone and ethinyl estradiol tablets have been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. drospirenone and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population. drospirenone and ethinyl estradiol tablets are contraindicated in patients with renal impairment [see contraindications (4) and warnings and precautions (5.2) ]. in subjects with creatinine clearance (clcr) of 50 to 79 ml/min, serum drsp concentrations were comparable to those in a control group with clcr ≥ 80 ml/min. in subjects with clcr of   30 to 49 ml/min, serum drsp concentrations were on average 37% higher than those in the control group. in addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs [see clinical pharmacology (12.3) ]. drospirenone and ethinyl estradiol tablets are contraindicated in patients with hepatic disease [see contraindications (4) and warnings and precautions (5.4) ]. the mean exposure to drsp in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. drospirenone and ethinyl estradiol tablets have not been studied in women with severe hepatic impairment. no clinically significant difference was observed between the pharmacokinetics of drsp or ee in japanese versus caucasian women [see clinical pharmacology (12.3) ].

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - ethinylestradiol, quantity: 20 microgram; drospirenone, quantity: 3 mg - tablet, uncoated - excipient ingredients: magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; purified talc; microcrystalline cellulose - yaz is indicated for use as: - an oral contraceptive. - treatment of moderate acne vulgaris in women who seek oral contraception - treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of yaz for pmdd was not assessed beyond 3 cycles. yaz has not been evaluated for treatment of pms (premenstrual syndrome), see clinical trials.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - drospirenone,ethinylestradiol -

Irska - angleščina - HPRA (Health Products Regulatory Authority)

rowex ltd - drospirenone; ethinylestradiol - film-coated tablet - 0.03 mg/3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - drospirenone,ethinylestradiol -

Irska - angleščina - HPRA (Health Products Regulatory Authority)

bayer limited - drospirenone; ethinylestradiol - film-coated tablet - 0.03 mg/3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Velika Britanija - angleščina - MHRA (Medicines & Healthcare Products Regulatory Agency)

consilient health ltd - drospirenone; ethinylestradiol - oral tablet - 3mg ; 20microgram

Izrael - angleščina - Ministry of Health

bayer israel ltd - drospirenone; ethinylestradiol - film coated tablets - drospirenone 3 mg; ethinylestradiol 0.03 mg - drospirenone and estrogen - drospirenone and estrogen - oral contraception.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 20 microgram - tablet, film coated - excipient ingredients: lactose; magnesium stearate; povidone; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - this medicine is indicated for use as: ? an oral contraceptive. ? treatment of moderate acne vulgaris in women who seek oral contraception. ? treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who have chosen oral contraceptives as their method of birth control. the efficacy of drospirenone 3 mg /ethinylestradiol 20 ?g for pmdd was not assessed beyond 3 cycles. drospirenone 3 mg /ethinylestradiol 20 ?g has not been evaluated for treatment of pms (premenstrual syndrome), see section 5.1 pharmacodynamic properties - clinical trials.

Belgija - angleščina - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ceres pharma sa-nv - ethinylestradiol 0,03 mg; drospirenone 3 mg - film-coated tablet - 0,03 mg - 3 mg - drospirenone 3 mg; ethinylestradiol 0.03 mg - drospirenone and ethinylestradiol