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

par pharmaceutical, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - tri-previfem® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . tri-previfem® 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. tri-previfem® 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 norgestimate and ethinyl estradiol 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 cerebrovascu

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) - tri-previfem® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . tri-previfem® 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. tri-previfem® 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 norgestimate and ethinyl estradiol 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 cerebrovascu

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

bryant ranch prepack - 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)] - 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 zafemy 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 zafemy 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. zafemy has not been studied in postmenopausal women and is not indicated in this population. no studies with zafemy 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 zafemy have been conducted in women with renal impairment. zafemy 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)] . zafemy may be less effective in preventing pregnancy in women who weigh 198 lbs or more [see clinical studies (14)] . zafemy®  (za fe ʹ my) (n orelgestromin and ethinyl estradiol transdermal system) zafemy is for skin use only. do not cut, damage, or alter the zafemy patch in any way. how to start using your zafemy patch: figure a - if you are not currently using hormonal birth control, you have 2 ways to begin using your zafemy patch. choose the way that is best for you: - first day start: apply your first zafemy patch during the first 24 hours of your menstrual period. - sunday start: apply your first zafemy 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 zafemy 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 zafemy patch: - complete your current oral hormone birth control pill cycle, vaginal ring cycle or contraceptive transdermal patch cycle. apply your first zafemy 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 zafemy patch for contraception. - if you apply your zafemy 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 zafemy patch for the first 7 days of patch use. - if you are starting zafemy after childbirth: - if you are not breastfeeding, wait 4 weeks before using zafemy 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 zafemy. - if you are starting zafemy after a miscarriage or abortion: - you may start zafemy 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 zafemy 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 zafemy patch. choose the way that is best for you: - first day start: apply your first zafemy patch during the first 24 hours of your menstrual period. - sunday start: apply your first zafemy 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 zafemy patch that day, and no back-up birth control is needed. - if you are starting zafemy after a miscarriage or abortion that occurs after the first 12 weeks of pregnancy (second trimester), wait 4 weeks before using zafemy 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 zafemy. figure b is a picture of the zafemy patch. figure b step 1. choose a place on your body for your zafemy patch - the zafemy 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 zafemy patch only to skin that is clean, dry, and free of any powder, make-up, cream, oil, or lotion. - do not apply the zafemy patch to cut or irritated skin, or in the same location as the previous zafemy patch. step 2: apply your zafemy patch - tear open the pouch at the top edge. peel open the foil pouch that contains the zafemy patch and its clear plastic cover. gently remove the zafemy 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 zafemy 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 zafemy 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 zafemy patch. - check your zafemy patch every day to make sure all edges are sticking correctly.  step 3: throwing away your zafemy patch - to throw away the zafemy 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 zafemy patches should not be flushed in the toilet. important notes: - your zafemy patch must stick securely to your skin to work properly. - do not try to reapply a zafemy 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 zafemy 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 zafemy patch. - if your zafemy patch does not stick completely, remove it and apply a replacement zafemy patch. - do not tape or wrap the zafemy patch to your skin or reapply a zafemy patch that is partially stuck to clothing. - if your zafemy patch has been off or partially off: - for less than 1 day, try to reapply it. if the zafemy patch does not stick completely, apply a new zafemy 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 zafemy 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 zafemy cycle. - talk to your healthcare provider about a replacement zafemy patch prescription so you will always have an extra zafemy 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 zafemy 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 zafemy patch becomes uncomfortable or your application site is red, painful or swollen, change your zafemy patch. remove your zafemy patch and apply a new patch to a new location until your next "patch change day." - if you forget to change or remove your zafemy 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 zafemy 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 zafemy patch for 1 or 2 days, apply a new zafemy 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 zafemy 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 zafemy 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 zafemy 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 zafemy patch at the start of your next patch cycle, you could become pregnant. apply the first zafemy 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 zafemy cycle. - if you have trouble remembering to change your zafemy 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 zafemy 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 zafemy 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. 04-2022-04

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

green circle pty ltd - evening primrose oil, quantity: 600 mg (equivalent: gamma-linolenic acid, qty 60 mg) - capsule, soft - excipient ingredients: d-alpha-tocopherol; soya oil; gelatin; glycerol; purified water

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

newton laboratories, inc. - amanita muscaria var. muscaria fruiting body (unii: dif093i037) (amanita muscaria var. muscaria fruiting body - unii:dif093i037), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av), gold (unii: 79y1949pyo) (gold - unii:79y1949pyo), mahonia aquifolium root bark (unii: vzj9f3c3sb) (mahonia aquifolium root bark - unii:vzj9f3c3sb), dieffenbachia seguine (unii: 01800c6e6b) (dieffenbachia seguine - unii:01800c6e6b), candida albicans (unii: 4d7g21hdbc) (candida albicans - unii:4d7g21 - amanita muscaria var. muscaria fruiting body 20 [hp_x] in 1 ml - vaginitis - feminine care    formulated for symptoms associated with vaginitis and leucorrhea such as itching, burning, dryness, swelling, snoreness and discharge.  formulated for symptoms associated with vaginitis and leucorrhea such as itching, burning, dryness, swelling, snoreness and discharge.

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

newton laboratories, inc. - amanita muscaria var. muscaria fruiting body (unii: dif093i037) (amanita muscaria var. muscaria fruiting body - unii:dif093i037), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av), gold (unii: 79y1949pyo) (gold - unii:79y1949pyo), mahonia aquifolium root bark (unii: vzj9f3c3sb) (mahonia aquifolium root bark - unii:vzj9f3c3sb), dieffenbachia seguine (unii: 01800c6e6b) (dieffenbachia seguine - unii:01800c6e6b), candida albicans (unii: 4d7g21hdbc) (candida albicans - unii:4d7g21 - amanita muscaria var. muscaria fruiting body 20 [hp_x] in 1 g - vaginitis - feminine care    formulated for symptoms associated with vaginitis and leucorrhea such as itching, burning, dryness, swelling, snoreness and discharge.  formulated for symptoms associated with vaginitis and leucorrhea such as itching, burning, dryness, swelling, snoreness and discharge.

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

rite aid corporation - miconazole nitrate 1200 mg (in vaginal insert), miconazole nitrate 2% (external cream) - vaginal antifungal

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

life healthcare pty ltd - 33187 - fixation device, internal, nail, intramedullary, femur - a rod made of metal or other material which, when inserted into the femoral bone intramedullary canal, acts as an immobilization device to hold ends of a fractured bone in position. the device may also be used to support the bone in the presence of a pathological condition. the device may be a locked or unlocked model possessing a number of components to assist fixation of more proximal and distal conditions.

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

life healthcare pty ltd - 33175 - metallic femoral head prosthesis - constructed from tial6v4 alloy. the ic - ball heads are spherical modular femoral heads for the connection with the hip stems of the implantcast company. the heads are only allowed to articulate with polyethylen-inserts or polyethylene-acetabular cups. the head sizes with the longest neck length provide a collar. the ic-heads articulate with either with a monoblock acetabular cup, a liner of a modular acetabular cup, a bipolar head or a dual mobility head. the ic-heads are spherical modular femoral heads for the connection with the hip stems of the implantcast company and used in hip joint arthroplasty. the ic-heads articulate with either with a monoblock acetabular cup, a liner of a modular acetabular cup, a bipolar head or a dual mobility head. hip joint arthroplasty is indicated, if - severe joint destruction with significant impairment where other therapeutic measures are not more promising, - severe joint pain due to degenerative or rheumatoid arthritis, joint fractures or bone necrosis, - post-operative conditions after previous surgery with or without the use of implants. indications for the application of ic - ball heads: - primary total hip arthroplasty of the hip joint affected by arthrosis, - revision hip arthroplasty.

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

life healthcare pty ltd - 33175 - metallic femoral head prosthesis - constructed from cocrmo alloy. the ic - ball heads are spherical modular femoral heads for the connection with the hip stems of the implantcast company. the heads are only allowed to articulate with polyethylen-inserts or polyethylene-acetabular cups. the head sizes with the longest neck length provide a collar. the ic-heads articulate with either with a monoblock acetabular cup, a liner of a modular acetabular cup, a bipolar head or a dual mobility head. the ic-heads are spherical modular femoral heads for the connection with the hip stems of the implantcast company and used in hip joint arthroplasty. the ic-heads articulate with either with a monoblock acetabular cup, a liner of a modular acetabular cup, a bipolar head or a dual mobility head. hip joint arthroplasty is indicated, if - severe joint destruction with significant impairment where other therapeutic measures are not more promising, - severe joint pain due to degenerative or rheumatoid arthritis, joint fractures or bone necrosis, - post-operative conditions after previous surgery with or without the use of implants. indications for the application of ic - ball heads: - primary total hip arthroplasty of the hip joint affected by arthrosis, - revision hip arthroplasty.