Австралия - английский - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - drospirenone, quantity: 3 mg; ethinylestradiol, quantity: 0.03 mg - tablet - excipient ingredients: lactose monohydrate; magnesium stearate; polacrilin potassium - drospirenone/ethinyloestradiol-alphapharm 3/30 is indicated for use as an oral contraceptive.

Израиль - английский - Ministry of Health

bayer israel ltd - drospirenone; estradiol as hemihydrate - film coated tablets - drospirenone 2 mg; estradiol as hemihydrate 1 mg - estradiol - estradiol - angeliq is indicated for hormone replacement therapy (hrt) for estrogen deficiency symptoms in postmenopausal women more than 1 year post menopause. prevention of postmenopausal osteoporosis in women with an increased risk of future osteoporosis fractures.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - ethinylestradiol, quantity: 30 microgram; drospirenone, quantity: 3 mg - tablet - excipient ingredients: maize starch; magnesium stearate; pregelatinised maize starch; lactose monohydrate; titanium dioxide; hypromellose; macrogol 400 - for use as an oral contraceptive

Ирландия - английский - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone; ethinylestradiol - film-coated tablet - 0.03 / 3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Ирландия - английский - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone; ethinylestradiol - film-coated tablet - 0.02 mg/ 3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Ирландия - английский - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone; ethinylestradiol - film-coated tablet - 0.02 mg/3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Ирландия - английский - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - drospirenone; ethinylestradiol - film-coated tablet - 0.03 mg/3 milligram(s) - progestogens and estrogens, fixed combinations; drospirenone and ethinylestradiol

Соединенные Штаты - английский - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. drospirenone and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: 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

Соединенные Штаты - английский - NLM (National Library of Medicine)

sandoz inc - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone 3 mg - drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is indicated for use by females of reproductive potential to prevent pregnancy. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in females who are known to have or develop the following conditions: there is no use for contraception in pregnancy; therefore, drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium 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. 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/ethinyl estradiol/levomefolate calcium and levomefolate calcium in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. 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/ethinyl estradiol/levomefolate calcium and levomefolate calcium 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 breast-feeding [see also dosage and administration (2.2)]. increase in folate concentration in milk is not expected (see data). the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for safyral and any potential adverse effects on the breast-fed child from drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium or from the underlying maternal condition. 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 post-partum. 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. a study in approximately 60 lactating women demonstrated no significant differences in folate concentrations in milk between women who received 416 mcg/day [6s]-5-methyltetrahydrofolate or 400 mcg/day folic acid and women who received placebo over a 16-week period. studies to date indicate there is no adverse effect of folate on nursing infants. safety and efficacy of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium has 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/ethinyl estradiol/levomefolate calcium and levomefolate calcium has not been studied in postmenopausal women and is not indicated in this population. drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is contraindicated in patients with renal impairment [see contraindications (4) and warnings and precautions (5.2)] . in subjects with creatinine clearance (clcr) of 50–79 ml/min, serum drsp concentrations were comparable to those in a control group with clcr ≥ 80 ml/min. in subjects with clcr of 30–49 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/ethinyl estradiol/levomefolate calcium and levomefolate calcium is 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/ethinyl estradiol/levomefolate calcium and levomefolate calcium has 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)] .

Соединенные Штаты - английский - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets, 3 mg/0.03 mg are indicated for use by females of reproductive potential to prevent pregnancy. drosperinone and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: 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. 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 fir