United States - English - 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)]

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - norethindrone acetate (unii: 9s44lic7oj) (norethindrone - unii:t18f433x4s), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norethindrone acetate 1 mg - femhrt is indicated in women with an intact uterus for the: - treatment of moderate to severe vasomotor symptoms associated with the menopause. - prevention of postmenopausal osteoporosis. when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis. non-estrogen medications should be carefully considered. the mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin d intake, and when indicated, pharmacologic therapy. postmenopausal women require an average of 1500 mg/day of elemental calcium. therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. vitamin d supplementation of 400-800 iu/day may also be required to ensure adequate daily intake in postmenopausal women. risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previou

Australia - English - Department of Health (Therapeutic Goods Administration)

life healthcare pty ltd - 34203 - uncoated femoral stem prosthesis, modular - made of cocrmo, with sandblasted surface for use with bone cement. have the mutars fit (diam 16 mm h7g6) and serration (72 teeth) which allows an adjustment of the antetorsion angle in 5 degree steps. the stem is curved to suit the femur?s physiological antecurvature. it has a hexagonal cross section for rotation stability and collar at the proximal end to prevent subsidence. from length 160mm the stems have 5mm diameter distal bore holes for additional fixation with cortical screws. a femoral stem used in cases of major bone loss to support a hip, knee or diaphysis replacement prosthesis and provide primary fixation to the bone. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

life healthcare pty ltd - 34190 - uncoated hip femur prosthesis, modular - composed of titanium alloy tial6v4. proximal femur component of the mutars (modular universal tumor and revision system) system in two different lengths of 50 mm and 70 mm with taper (12/14), with retention rings for fixation of the attachment tube and various stems. the treatment can be adjusted with the use of the extension pieces of 20 mm increments. the proximal femur allows the adjustment of the antetorsion angles in 5 degree increments. proximal femoral replacement component indicated for tumours in the area of the proximal femur or other major bone defects including hip joint arthroplasty as hemi prosthesis or total hip replacement. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis.

Australia - English - Department of Health (Therapeutic Goods Administration)

life healthcare pty ltd - 34190 - uncoated hip femur prosthesis, modular - tial6v4 alloy with sand blasted surface. on the lateral surface a porous structure is provided for better bone ingrowth. trochanter major-like curvature for attachment of trochanteric bone and/or soft tissue with various lateral and medial suture holes. connects with other mutars components through a precise female cylindrical connection with serrated teeth (72) to provide rotational stability and allow for intra-operative adjustment of the femoral antetorsion angle in 5 degree increments. a hip joint replacement component of the mutars system that replaces the proximal part of the femur. primary indication for the use of the mutars systems is after bone resection because of a tumour. further indications for the use of the mutars systems are massive bone loss such as in morbus gorham or for the revision arthroplasty and for the prosthetic treatment in case of fractures, pseudarthrosis and arthrosis.

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - estradiol acetate (unii: 5r97f5h93p) (estradiol - unii:4ti98z838e) - estradiol acetate 0.1 mg in 24 [usp'u] - femring therapy is indicated in the: 1. treatment of moderate to severe vasomotor symptoms due to menopause. 2. treatment of moderate to severe vulvar and vaginal atrophy due to menopause. femring should not be used in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of breast cancer. - known or suspected estrogen-dependent neoplasia. - active deep vein thrombosis, pulmonary embolism or history of these conditions. - active arterial thromboembolic disease (for example, stroke and myocardial infarction) or a history of these conditions. - known liver dysfunction or disease. - known or suspected pregnancy.

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.25 mg - femynor tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14) ]. do not prescribe femynor to women who are known to have the following conditions: - 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 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 (5.3) ] have diabetes mellitus with vascular disease [see warnings and precautions (5.5) ] have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.6) ] women over age 35 with any migraine headaches [see warnings and precautions (5.6) ] - 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 (5.3) ] - have diabetes mellitus with vascular disease [see warnings and precautions (5.5) ] - have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.6) ] women over age 35 with any migraine headaches [see warnings and precautions (5.6) ] - women over age 35 with any migraine headaches [see warnings and precautions (5.6) ] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2) ] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.7) ] - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.8) and use in specific populations (8.1) ] - breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see warnings and precautions (5.10) ] there is little or no increased risk of birth defects in women who inadvertently use cocs 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 cocs prior to conception or during early pregnancy. do not administer cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. cocs 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 oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of femynor tablets has 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. femynor has not been studied in postmenopausal women and are not indicated in this population. the pharmacokinetics of femynor has not been studied in subjects with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with hepatic impairment. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal and coc causation has been excluded. [see contraindications (4)  and warnings and precautions (5.2) .] the pharmacokinetics of femynor has not been studied in women with renal impairment. femynor™ (feh’ mi nore) (norgestimate and ethinyl estradiol tablets, usp) important information about taking femynor - take 1 pill every day at the same time. take the pills in the order directed on your blister pack. - do not skip your pills, even if you do not have sex often. if you miss pills (including starting the pack late) you could get pregnant . the more pills you miss, the more likely you are to get pregnant. - if you have trouble remembering to take femynor, talk to your healthcare provider. when you first start taking femynor, spotting or light bleeding in between your periods may occur. contact your healthcare provider if this does not go away after a few months. - you may feel sick to your stomach (nauseous), especially during the first few months of taking femynor. if you feel sick to your stomach, do not stop taking the pill. the problem will usually go away. if your nausea does not go away, call your healthcare provider. - missing pills can also cause spotting or light bleeding, even when you take the missed pills later. on the days you take 2 pills to make up for missed pills (see what should i do if i miss any femynor pills? below), you could also feel a little sick to your stomach. - it is not uncommon to miss a period. however, if you miss a period and have not taken femynor according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. if you have a positive pregnancy test, you should stop taking femynor. - if you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister pack. if you do not have an extra blister pack, take the next pill in your blister pack. continue taking all your remaining pills in order. start the first pill of your next blister pack the day after finishing your current blister pack. this will be 1 day earlier than originally scheduled. continue on your new schedule. - if you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. use an additional birth control method, like condoms and a spermicide, until you check with your healthcare provider. - stop taking femynor at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. be sure to use other forms of contraception (like condoms and spermicide) during this time period. before you start taking femynor : - decide what time of day you want to take your pill. it is important to take it at the same time every day and in the order as directed on your blister pack. - have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed. when should i start taking femynor ? if you start taking femynor and you have not used a hormonal birth control method before: - there are 2 ways to start taking your birth control pills. you can either start on a sunday (sunday start) or on the first day (day 1) of your natural menstrual period (day 1 start). your healthcare provider should tell you when to start taking your birth control pill. - if you use the sunday start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take femynor. you do not need back-up contraception if you use the day 1 start. if you start taking femynor and you are switching from another birth control pill: - start your new femynor pack on the same day that you would start the next pack of your previous birth control method. - do not continue taking the pills from your previous birth control pack. if you start taking femynor and previously used a vaginal ring or transdermal patch: - start using femynor on the day you would have reapplied the next ring or patch. if you start taking femyno r and you are switching from a progestin-only method such as an implant or injection: - start taking femynor on the day of removal of your implant or on the day when you would have had your next injection. if you start taking femynor and you are switching from an intrauterine device or system (iud or ius): - start taking femynor on the day of removal of your iud or ius. - you do not need back-up contraception if your iud or ius is removed on the first day (day 1) of your period. if your iud or ius is removed on any other day, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take femynor. keep a calendar to track your period: if this is the first time you are taking birth control pills, read, "when should i start taking femynor ?" above. follow these instructions for either a sunday start or a day 1 start . sunday start: you will use a sunday start if your healthcare provider told you to take your first pill on a sunday. - take pill 1 on the sunday after your period starts . - if your period starts on a sunday, take pill "1 " that day and refer to day 1 start instructions below. - take 1 pill every day in the order on the blister pack at the same time each day for 28 days. - after taking the last pill on day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack (sunday). take the first pill in the new pack whether or not you are having your period. - use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days of the first cycle that you take femynor. day 1 start: you will use a day 1 start if your doctor told you to take your first pill (day 1) on the first day of your period . - take 1 pill every day in the order of the pill blister pack, at the same time each day, for 28 days. - after taking the last pill on day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack. take the first pill in the new pack whether or not you are having your period. femynor comes in a blister pack. read the instructions below for using your blister pack. instructions for using your blister pack: each blister pack contains 28 pills: - 21 red pills with hormones, for days 1 to 21 . - 7 white pills (without hormones), for days 22 to 28 . step 1. set the day - sunday start: take the first pill of the first blister pack on the sunday after your period starts, even if you are still bleeding. if your period begins on sunday, start the blister pack that same day. - day 1 start: take the first pill of the first blister pack during the first 24 hours of your period.   step 2. remove the first pill of the blister pack (sun or day 1) by pressing the pill through the back of the blister foil. step 3. swallow the pill. you will take 1 pill every day, at the same time each day. step 4. wait 24 hours to take your next pill. continue to take one pill each day until all pills have been taken. step 5. take your pill at the same time every day. it is important to take the correct pill each day and not miss any pills. to help you remember, take your pill at the same time as another daily activity, like turning off your alarm clock or brushing your teeth. what should i do if i miss any femynor pills? if you miss 1 red “active” pill in weeks 1, 2, or 3, follow these steps: - take it as soon as you remember. take the next pill at your regular time. this means you may take 2 pills in 1 day. - then continue taking 1 pill every day until you finish the pack. - you do not need to use a back-up birth control method if you have sex. if you miss 2 red “active” pills in week 1 or week 2 of your pack, follow these steps: - take the 2 missed pills as soon as possible and the next 2 pills the next day. then continue to take 1 pill every day until you finish the pack. - then continue to take 1 pill every day until you finish the pack. - use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after missing your pills. if you miss 2 red “active” pills in a row in week 3, or you miss 3 or more red “active” pills in a row during weeks 1, 2, or 3 of the pack, follow these steps: - if you are a day 1 starter : throw out the rest of the pill pack and start a new pack that same day. you may not have your period this month but this is expected. however, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. you could become pregnant if you have sex during the first 7 days after you restart your pills. you must use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. - throw out the rest of the pill pack and start a new pack that same day. - you may not have your period this month but this is expected. however, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant. - you could become pregnant if you have sex during the first 7 days after you restart your pills. you must use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. - if you are a sunday starter: keep taking 1 pill every day until sunday. on sunday, throw out the rest of the pack and start a new pack of pills that same day. use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. - keep taking 1 pill every day until sunday. on sunday, throw out the rest of the pack and start a new pack of pills that same day. - use a non-hormonal birth control method (such as a condom and spermicide) as a back-up if you have sex during the first 7 days after you restart your pills. if you have any questions or are unsure about the information in this leaflet, call your healthcare provider. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 this patient information and instructions for use have been approved by the u.s. food and drug administration. rev. 05-2016-00

United States - English - NLM (National Library of Medicine)

par pharmaceutical - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.25 mg - previfem® (norgestimate/ethinyl estradiol tablets) and tri-previfem® (norgestimate/ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . tri-previfem® (norgestimate/ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. previfem® (norgestimate/ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see clinical studies (14)] . do not prescribe previfem® or tri-previfem® to women who are known to have the following conditions: - 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 [s

United States - English - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - previfem® (norgestimate/ethinyl estradiol tablets) and tri-previfem® (norgestimate/ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . tri-previfem® (norgestimate/ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. previfem® (norgestimate/ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see clinical studies (14)] . do not prescribe previfem® or tri-previfem® to women who are known to have the following conditions: - 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 [s

Israel - English - Ministry of Health

novo nordisk ltd., israel - estradiol as hemihydrate - film coated tablets - estradiol as hemihydrate 2 mg - estradiol - estradiol - hormone replacement therapy (hrt) for estrogen deficiency symptoms in postmenopausal women. prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are tolerant of , or contraindicated for other medicinal products approved for the prevention of osteoporosis. estrofem is particularly for women who have been hysterectomized and therefore do not require combined estrogen/progestagen therapy.the experience treating women older than 65 years is limited.