Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

northwest cosmetic laboratories llc, dba elevation labs, idaho - active ingredients: titanium dioxide 3.3% zinc oxide 14.9%, sunscreen - uses: helps prevent sunburn. if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin ageing caused by the sun. directions: shake well before use. apply liberally and reapply every 80 minutes, especially after swimming or towel drying. sun protection measures spending time in the sun increases your risk of skin cancer and early skin aging. to decrease this risk, regularly use a sunscreen with a broad spectrum spf value of 15 or higher and other sun protection measures including: limit lime in the sun, especially from 10 am-2 pm wear longsleeved shirts, pants, hats, and sunglasses for children under 6 months of age ask a doctor

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

northwest cosmetic laboratories llc, dba elevation labs, idaho - - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) -

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

northstar rx llc - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 0.4 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. oral contraceptives should not be used in women who currently have the following conditions: •thrombophlebitis or thromboembolic disorders •a past history of deep vein thrombophlebitis or thromboembolic disorders •cerebrovascular or coronary artery disease •known or suspected carcinoma of the breast •carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia •undiagnosed abnormal genital bleeding •cholestatic jaundice of pregnancy or jaundice with prior pill use •hepatic adenomas or car

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

northstar rx llc - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - falmina is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. emergency contraceptive pills: the fda has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 lactation amenorrhea method: lam is a highly effective, temporary method of contraception.10 source: trussell j. contraceptive efficacy. in: hatcher ra, trussell j, stewart f, cates w, stewart gk, kowel d, guest f. contraceptive technology: seventeenth revised edition. new york ny: irvington publishers; 1998. 1. among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. the proportion of women who become pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. among such populations, about 89% become pregnant within one year. this estimate was lowered slightly (to 85%) to represent the proportion who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. foams, creams, gels, vaginal suppositories, and vaginal film. 6. cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. with spermicidal cream or jelly. 8. without spermicides. 9. the treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. the fda has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. however, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. in a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. this represents an overall pregnancy rate of 0.84 per 100 woman-years. this rate includes patients who did not take the drug correctly. one or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills. combination oral contraceptives should not be used in women with any of the following conditions: thrombophlebitis or thromboembolic disorders a history of deep-vein thrombophlebitis or thromboembolic disorders cerebrovascular or coronary artery disease (current or past history) valvular heart disease with thrombogenic complications thrombogenic rhythm disorders hereditary or acquired thrombophilias major surgery with prolonged immobilization diabetes with vascular involvement headaches with focal neurological symptoms uncontrolled hypertension current diagnosis of, or history of, breast cancer, which may be hormone-sensitive undiagnosed abnormal genital bleeding cholestatic jaundice of pregnancy or jaundice with prior pill use hepatic adenomas or carcinomas, or active liver disease known or suspected pregnancy hypersensitivity to any of the components of falmina women who are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (alt) elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment ).

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

afaxys pharma, llc - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - jasmiel® is indicated for use by females of reproductive potential to prevent pregnancy. jasmiel is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. the effectiveness of jasmiel for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating and weight gain. in this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. diagnosis is made by healthcare providers according to dsm-iv criteria, with symptomatology assessed prospectively over at least two menstrual cycles. in making the diagnosis, care should be taken to rule out other cyclical mood disorders. jasmiel has not been evaluated for the treatment of premenstrual syndrome (pms). jasmiel is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. jasmiel should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. jasmiel 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) ] - 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 tumors, 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 (7.3) ]. risk summary there is no use for contraception in pregnancy; therefore, jasmiel 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 drsp/ee 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 jasmiel 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 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 jasmiel 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)]. the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for jasmiel and any potential adverse effects on the breast-fed child from jasmiel 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 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 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 jasmiel 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. jasmiel has not been studied in postmenopausal women and is not indicated in this population. jasmiel is 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 levels 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)] . jasmiel 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. jasmiel 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)] .

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

northstar rx llc - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone 500 ug - dasetta™ 7/7/7 tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and the norplant® system depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. adapted from hatcher et al, 1998, ref. #1. emergency contraceptive pills: treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 lactational amenorrhea method: lam is highly effective, temporary method of contraception.1 0 source: trussell j, contraceptive efficacy. in hatcher ra, trussell j, stewart f, cates w, stewart gk, kowal d, guest f, contraceptive technology: seventeenth revised edition. new york ny: irvington pu

Australia - engleză - APVMA (Australian Pesticides and Veterinary Medicines Authority)

arysta lifescience north america llc - amicarbazone - water dispersible granule - amicarbazone triazole active 700.0 g/kg - herbicide

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - norelgestromin (unii: r0tay3x631) (norelgestromin - unii:r0tay3x631), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (bmi) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. limitations of use : norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with bmi ≥ 30 kg/m2 [see contraindications (4), warnings and precautions (5.1)  and clinical studies (14)] . norelgestromin and ethinyl estradiol transdermal system is contraindicated in females who are known to have or develop the following conditions: - at high risk of arterial or venous thromboembolic events. examples include women who: - 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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see warnings and precautions (5.5)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.7)] - have headaches with focal neurological symptoms or have migraine headaches with aura - women over age 35 with any migraine headaches [see warnings and precautions (5.8)] -   body mass index ≥ 30 kg/m2  [see warnings and precautions (5.1)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.3), use in specific populations (8.6)  and clinical pharmacology (12.3)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.9)] - pregnancy, because there is no reason to use hormonal contraceptives during pregnancy [see warnings and precautions (5.10)  and use in specific populations (8.1)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.12)] - 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 (5.4)] there is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early 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 low dose hormonal contraceptives prior to conception or during early pregnancy. the administration of hormonal contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion. the effects of norelgestromin and ethinyl estradiol in nursing mothers have not been evaluated and are unknown. when possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. estrogen-containing chcs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. small amounts of contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of norelgestromin and ethinyl estradiol have been established in women of reproductive age. efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. norelgestromin and ethinyl estradiol has not been studied in postmenopausal women and is not indicated in this population. no studies with norelgestromin and ethinyl estradiol have been conducted in women with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of combined hormonal contraceptive use until markers of liver function return to normal and combined hormonal contraceptive causation has been excluded [see contraindications (4)  and warnings and precautions (5.3)] . no studies with norelgestromin and ethinyl estradiol have been conducted in women with renal impairment. norelgestromin and ethinyl estradiol transdermal system is contraindicated in women with a bmi ≥ 30 kg/m2 because of the potential increased risk of vte [see contraindications (4)  and warnings and precautions (5.1)] . norelgestromin and ethinyl estradiol may be less effective in preventing pregnancy in women who weigh 198 lbs or more [see clinical studies (14)] . norelgestromin and ethinyl estradiol transdermal system norelgestromin and ethinyl estradiol transdermal system is for skin use only. do not cut, damage, or alter the norelgestromin and ethinyl estradiol transdermal patch in any way. how to start using your norelgestromin and ethinyl estradiol transdermal patch: figure a - if you are not currently using hormonal birth control, you have 2 ways to begin using your norelgestromin and ethinyl estradiol transdermal patch. choose the way that is best for you: - first day start: apply your first norelgestromin and ethinyl estradiol transdermal patch during the first 24 hours of your menstrual period. - sunday start: apply your first norelgestromin and ethinyl estradiol transdermal patch on the first sunday after your menstrual period begins. use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. if your period starts on sunday, apply your first norelgestromin and ethinyl estradiol transdermal patch that day, and no back-up birth control is needed. - if you are changing from oral hormone birth control pills, a vaginal contraceptive ring or another contraceptive transdermal patch to the norelgestromin and ethinyl estradiol transdermal patch: - complete your current oral hormone birth control pill cycle, vaginal ring cycle or contraceptive transdermal patch cycle. apply your first norelgestromin and ethinyl estradiol transdermal patch on the day you would normally start your next oral birth control pill, patch or insert your next vaginal ring. - if you do not get your period within 1 week after taking your last active pill, removing your last vaginal ring or contraceptive transdermal patch, check with your healthcare provider to make sure you are not pregnant. you may still go ahead and start norelgestromin and ethinyl estradiol transdermal patch for contraception. - if you apply your norelgestromin and ethinyl estradiol transdermal patch more than 1 week after taking your last active oral hormone birth control pill, removing your last vaginal ring or contraceptive transdermal patch, use a non-hormonal contraceptive method, such as a condom and spermicide or diaphragm and spermicide, with the norelgestromin and ethinyl estradiol transdermal patch for the first 7 days of patch use. - if you are starting norelgestromin and ethinyl estradiol transdermal system after childbirth: - if you are not breastfeeding, wait 4 weeks before using norelgestromin and ethinyl estradiol transdermal system and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. if you have had sex since your baby was born, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting norelgestromin and ethinyl estradiol transdermal system. - if you are starting norelgestromin and ethinyl estradiol transdermal system after a miscarriage or abortion: - you may start norelgestromin and ethinyl estradiol transdermal system immediately after a miscarriage or abortion that occurs in the first 12 weeks (first trimester) of pregnancy. you do not need to use another contraceptive method. - if you do not start norelgestromin and ethinyl estradiol transdermal system within 5 days after a first trimester miscarriage or abortion, use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, while you wait for your period to start. you have 2 ways to begin using your norelgestromin and ethinyl estradiol transdermal patch. choose the way that is best for you: - first day start: apply your first norelgestromin and ethinyl estradiol transdermal patch during the first 24 hours of your menstrual period. - sunday start: apply your first norelgestromin and ethinyl estradiol transdermal patch on the first sunday after your menstrual period begins. use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. if your period starts on sunday, apply your first norelgestromin and ethinyl estradiol transdermal patch that day, and no back-up birth control is needed. - if you are starting norelgestromin and ethinyl estradiol transdermal system after a miscarriage or abortion that occurs after the first 12 weeks of pregnancy (second trimester), wait 4 weeks before using norelgestromin and ethinyl estradiol transdermal system and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. if you have had sex since your miscarriage or abortion, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting norelgestromin and ethinyl estradiol transdermal system. figure b is a picture of the norelgestromin and ethinyl estradiol transdermal patch. figure b step 1. choose a place on your body for your norelgestromin and ethinyl estradiol transdermal patch - the norelgestromin and ethinyl estradiol transdermal patch may be placed on your upper outer arm, abdomen, buttock or back in a place where it will not be rubbed by tight clothing. avoid the waistline because clothing and belts may cause your patch to be rubbed off. - do not apply the patch to your breasts. - apply the norelgestromin and ethinyl estradiol transdermal patch only to skin that is clean, dry, and free of any powder, make-up, cream, oil, or lotion. - do not apply the norelgestromin and ethinyl estradiol transdermal patch to cut or irritated skin, or in the same location as the previous norelgestromin and ethinyl estradiol transdermal patch. step 2: apply your norelgestromin and ethinyl estradiol transdermal patch - tear open the pouch at the top edge. peel open the foil pouch that contains the norelgestromin and ethinyl estradiol transdermal patch and its clear plastic cover. gently remove the norelgestromin and ethinyl estradiol transdermal patch and its plastic cover together from the pouch, being careful not to separate the patch from the clear plastic cover.  - using a fingernail, peel away half of the clear plastic. avoid touching the sticky surface with your fingers.  - apply the sticky side of the norelgestromin and ethinyl estradiol transdermal patch to clean, dry skin. remove the other half of the clear plastic and apply the entire patch to your skin.  - press firmly on the norelgestromin and ethinyl estradiol transdermal patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. - run your fingers over the entire surface area to smooth out any “wrinkles” around the outer edges of the norelgestromin and ethinyl estradiol transdermal patch. - check your norelgestromin and ethinyl estradiol transdermal patch every day to make sure all edges are sticking correctly.  step 3: throwing away your norelgestromin and ethinyl estradiol transdermal patch - to throw away the norelgestromin and ethinyl estradiol transdermal patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place the container in the trash. - used norelgestromin and ethinyl estradiol transdermal patches should not be flushed in the toilet. important notes: - your norelgestromin and ethinyl estradiol transdermal patch must stick securely to your skin to work properly. - do not try to reapply a norelgestromin and ethinyl estradiol transdermal patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it. do not tape or wrap the patch to your skin or reapply a patch that is partially adhered to clothing. - if your norelgestromin and ethinyl estradiol transdermal patch edge lifts up: - press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. run your fingers over the entire surface area to smooth out any “wrinkles” around the edges of the norelgestromin and ethinyl estradiol transdermal patch. - if your norelgestromin and ethinyl estradiol transdermal patch does not stick completely, remove it and apply a replacement norelgestromin and ethinyl estradiol transdermal patch. - do not tape or wrap the norelgestromin and ethinyl estradiol transdermal patch to your skin or reapply a norelgestromin and ethinyl estradiol transdermal patch that is partially stuck to clothing. - if your norelgestromin and ethinyl estradiol transdermal patch has been off or partially off: - for less than 1 day, try to reapply it. if the norelgestromin and ethinyl estradiol transdermal patch does not stick completely, apply a new norelgestromin and ethinyl estradiol transdermal patch immediately. no back-up contraception is needed and your "patch change day" will stay the same. - for more than 1 day or if you are not sure for how long, you could become pregnant. to reduce this chance, apply a new norelgestromin and ethinyl estradiol transdermal patch and start a new 4 week cycle. you will now have a new "patch change day." use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first week of your new 4 week norelgestromin and ethinyl estradiol transdermal system cycle. - talk to your healthcare provider about a replacement norelgestromin and ethinyl estradiol transdermal patch prescription so you will always have an extra norelgestromin and ethinyl estradiol transdermal patch available if needed. - if you want to move your "patch change day" to a different day of the week, finish your current cycle. remove your third norelgestromin and ethinyl estradiol transdermal patch on the correct day. - during week 4, the "patch free week" (day 22 through day 28), you may choose an earlier "patch change day" by applying a new patch on the day you prefer. you now have a new day 1 and a new "patch change day." - if your norelgestromin and ethinyl estradiol transdermal patch becomes uncomfortable or your application site is red, painful or swollen, change your norelgestromin and ethinyl estradiol transdermal patch. remove your norelgestromin and ethinyl estradiol transdermal patch and apply a new patch to a new location until your next "patch change day." - if you forget to change or remove your norelgestromin and ethinyl estradiol transdermal patch: - at the start of any patch cycle (week 1, day 1): - you could become pregnant. you must use a back-up contraception method for 7 days. apply the first norelgestromin and ethinyl estradiol transdermal patch of your new cycle as soon as you remember. you now have a new "patch change day" and a new day 1. - in the middle of your patch cycle (week 2 or week 3): - if you forget to change your norelgestromin and ethinyl estradiol transdermal patch for 1 or 2 days, apply a new norelgestromin and ethinyl estradiol transdermal patch as soon as you remember. apply your next patch on your normal "patch change day." no back-up contraception method is needed. - if you forget to change your norelgestromin and ethinyl estradiol transdermal patch for more than 2 days, you could become pregnant. start a new 4 week cycle as soon as you remember by putting on a new norelgestromin and ethinyl estradiol transdermal patch. you now have a different "patch change day" and a new day 1. you must use a back-up contraception method for the first 7 days of your new cycle. - at the end of your patch cycle (week 4): - if you forget to remove your norelgestromin and ethinyl estradiol transdermal patch, take it off as soon as you remember. start your next cycle on your normal "patch change day," the day after day 28. no back-up contraception method is needed. - if you forget to apply your norelgestromin and ethinyl estradiol transdermal patch at the start of your next patch cycle, you could become pregnant. apply the first norelgestromin and ethinyl estradiol transdermal patch of your new cycle as soon as you remember. you now have a new "patch change day" and a new day 1. use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first 7 days of your new 4 week norelgestromin and ethinyl estradiol transdermal system cycle. - if you have trouble remembering to change your norelgestromin and ethinyl estradiol transdermal patch, talk to your healthcare provider about how to make patch changing easier or about using another method of contraception. - if you are not sure how to use your norelgestromin and ethinyl estradiol transdermal patch: - use a back-up contraception method such as a condom and spermicide or diaphragm and spermicide anytime you have sex. make sure to have 1 of these non-hormonal contraception methods ready at all times. - talk to your healthcare provider for instructions on using your norelgestromin and ethinyl estradiol transdermal patch. this patient information and instructions for use have been approved by the u.s. food and drug administration. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 rev. 03-2022-02

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

sunday riley modern skincare, llc - octisalate 5% octocrylene 3.5% zinc oxide 16.32%  - sunscreen • helps prevent sunburn • if used as directed with other sun protection measures (see directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

amneal pharmaceuticals llc - norelgestromin (unii: r0tay3x631) (norelgestromin - unii:r0tay3x631), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - zafemy® is indicated for the prevention of pregnancy in women with a body mass index (bmi) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. limitations of use: zafemy may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. zafemy is contraindicated for use in women with bmi ≥ 30 kg/m2  [see contraindications (4), warnings and precautions (5.1) and clinical studies (14)]. zafemy is contraindicated in females who are known to have or develop the following conditions: - at high risk of arterial or venous thromboembolic events. examples include women who: - 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 inherited or acquired hypercoagulopathies [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)]