美国 - 英文 - NLM (National Library of Medicine)

bluepoint laboratories - leucovorin calcium (unii: rpr1r4c0p4) (leucovorin - unii:q573i9dvlp) - leucovorin 10 mg in 1 ml - leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form. leucovorin is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin b12 . a hematologic remission may occur while neurologic manifestations continue to progress.

美国 - 英文 - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - 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. % of women experiencing an accidental pregnancy in the first year of continuous use method lowest expected* typical** (no contraception) (85) (85) oral contraceptives combined 0.1 3*** progestin only 0.5 3*** diaphragm with spermicidal cream or jelly 6 18 spermicides alone (foam, creams, jellies and vaginal suppositories) 3 21 vaginal sponge nulliparous 6 18 multiparous 9 28 iud 0.8-2.0 3# condom without spermicides 2 12 periodic abstinence (all methods) 1-9 20 injectable progestogen 0.3-0.4 0.3-0.4 implants 6 capsules 0.04 0.04 2 rods 0.03 0.03 female sterilization 0.2 0.4 male sterilization 0.1 0.15 reproduced with permission of the population counsil from j. trusell, et. al: contraceptive failure in the united states: an update. studies in family planning, 21(1), january-february 1990. * the authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy. ** this term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy. *** combined typical rate for both combined and progestin only. # combined typical rate for both medicated and nonmedicated iud. briellyn is contraindicated in females who are known to have or develop the following conditions:

美国 - 英文 - NLM (National Library of Medicine)

accord healthcare inc. - mycophenolate sodium (unii: wx877sqi1g) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolic acid 180 mg - mycophenolic acid delayed release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. mycophenolic acid delayed release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. mycophenolic acid delayed release tablet is to be used in combination with cyclosporine and corticosteroids. mycophenolic acid delayed release tablets and mycophenolate mofetil (mmf) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent. mycophenolic acid delayed release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (mpa), mycophenolate mofetil, or to any of its excipients. reactions like rash, pruritus, hypotension, and chest pain have been observed in clinical trials and post marketing reports [see adverse reactions ( 6) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolic acid delayed release treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary following oral or intravenous (iv) administration, mmf is metabolized to mycophenolic acid (mpa), the active ingredient in mycophenolic acid delayed release and the active form of the drug. use of mmf during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see human data]. oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.05 and 1.1 times exposure at the recommended clinical doses in kidney transplant patients for rats and rabbits, respectively) (see animal data). risks and benefits of mycophenolic acid delayed release should be discussed with the patient. when appropriate, consider alternative immunosuppressants with less potential for embryo-fetal toxicity. the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data a spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23% to 27% of live births in mmf exposed pregnancies, based on published data from pregnancy registries. malformations that have been documented include external ear, eye, and other facial abnormalities, including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45% to 49% following mmf exposure. animal data in animal reproductive toxicology studies, congenital malformations and pregnancy loss occurred when pregnant rats and rabbits received mycophenolate at dose multiples equivalent to and less than the recommended human dose. oral administration of mycophenolate sodium to pregnant rats from gestational day 7 to day 16 at a dose as low as 1 mg per kg resulted in malformations including anophthalmia, exencephaly, and umbilical hernia. the systemic exposure at this dose represents 0.05 times the clinical exposure at the human dose of 1,440 mg per day of mycophenolic acid delayed release. oral administration of mycophenolate to pregnant rabbits from gestational day 7 to day 19 resulted in embryofetal lethality and malformations, including ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at doses equal to or greater than 80 mg per kg per day, in the absence of maternal toxicity. this corresponds to about 1.1 times the recommended clinical dose based on bsa. risk summary there are no data on the presence of mycophenolate in human milk, or the effects on milk production. there are limited data in the national transplantation pregnancy registry on the effects of mycophenolate on a breastfed child (see data) . studies in rats treated with mmf have shown mycophenolic acid to be present in milk. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mycophenolic acid delayed release and any potential adverse effects on the breastfed infant from mycophenolic acid delayed release or from the underlying maternal condition. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. data limited information is available from the national transplantation pregnancy registry. of seven infants reported by the national transplantation pregnancy registry to have been breastfed while the mother was taking mycophenolate, all were born at 34 to 40 weeks gestation and breastfed for up to 14 months. no adverse events were reported. females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. pregnancy planning for female patients taking mycophenolic acid delayed release who are considering pregnancy, consider alternative immunosuppressants with less potential for embryo-fetal toxicity. risks and benefits of mycophenolic acid delayed release should be discussed with the patient. pregnancy testing to prevent unplanned exposure during pregnancy, females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 miu/ml immediately before starting mycophenolic acid delayed release. another pregnancy test with the same sensitivity should be done 8 to 10 days later. repeat pregnancy tests should be performed during routine follow-up visits. results of all pregnancy tests should be discussed with the patient. in the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryo-fetal toxicity whenever possible. contraception female patients females of reproductive potential taking mycophenolic acid delayed release must receive contraceptive counseling and use acceptable contraception (see table 5 for acceptable contraception methods). patients must use acceptable birth control during entire mycophenolic acid delayed release therapy, and for 6 weeks after stopping mycophenolic acid delayed release, unless the patient chooses abstinence (she chooses to avoid heterosexual intercourse completely). patients should be aware that mycophenolic acid delayed release reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness [see patient counseling information ( 17), drug interactions ( 7.8) ]. table 5: acceptable contraception methods for females of reproductive potential pick from the following birth control options: or or male patients genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 2.5 times. thus, the risk of genotoxic effects on sperm cells cannot be excluded. based on this potential risk, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with mycophenolic acid delayed release and for at least 90 days after cessation of treatment [see use in specific populations (8.1), nonclinical toxicology (13.1), patient counseling information (17)]. the safety and effectiveness of mycophenolic acid delayed release have been established in pediatric kidney transplant patients 5 to 16 years of age who were initiated on mycophenolic acid delayed release at least 6 months post-transplant. use of mycophenolic acid delayed release in this age group is supported by evidence from adequate and well-controlled studies of mycophenolic acid delayed release in a similar population of adult kidney transplant patients with additional pharmacokinetic data in pediatric kidney transplant patients [see dosage and administration ( 2.2, 2.3), clinical pharmacology (12.3)] . pediatric doses for patients with bsa <1.19 m 2 cannot be accurately administered using currently available formulations of mycophenolic acid delayed release tablets. the safety and effectiveness of mycophenolic acid delayed release in de novo pediatric kidney transplant patients and in pediatric kidney transplant patients below the age of 5 years have not been established. clinical studies of mycophenolic acid delayed release did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. of the 372 patients treated with mycophenolic acid delayed release in the clinical trials, 6% (n=21) were 65 years of age and older and 0.3% (n=1) were 75 years of age and older. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

美国 - 英文 - NLM (National Library of Medicine)

sandoz inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 2.5 mg in 3 ml - albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm. albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components.

美国 - 英文 - NLM (National Library of Medicine)

otn generics inc. - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - injection, solution - 2 mg in 1 ml - epirubicin injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. patients should not be treated with epirubicin injection if they have any of the following conditions: baseline neutrophil count < 1500 cells/mm3 ; severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias; previous treatment with anthracyclines up to the maximum cumulative dose; hypersensitivity to epirubicin, other anthracyclines, or anthracenediones; or severe hepatic dysfunction (see warnings and dosage and administration).

美国 - 英文 - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.18 mg - norgestimate and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)]. do not prescribe norgestimate and ethinyl estradiol tablets to women who are known to have the following conditions: 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

美国 - 英文 - NLM (National Library of Medicine)

nostrum laboratories, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 100 mg in 5 ml - morphine sulfate oral solution (10 mg per 5 ml and 20 mg per 5 ml) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients

美国 - 英文 - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol 50 mg - cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. cilostazol is contraindicated in patients with: hypersensitivity to cilostazol or any components of cilostazol (e.g., anaphylaxis, angioedema). teratogenic effects: pregnancy category c . cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human mrhd on a body surface area basis. there are no adequate and well-controlled studies in pregnant women. in a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14th rib, and retarded ossification). at this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about 5 times the exposure in humans given the mrhd. increased inciden

美国 - 英文 - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s) - norethindrone 0.35 mg - progestin-only oral contraceptives are indicated for the prevention of pregnancy. if used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. however, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. the following table lists the pregnancy rates for users of all major methods of contraception. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year‡ method (1) typical use§ (2) perfect use¶ (3) (4) chance# 85 85 spermicidesÞ 26 6 40 periodic abstinence 25 63 calendar 9 ovulation method 3 sympto-thermalß 2 post-ovulation 1 capà parous women 40 26 42 nulliparous women 20 9 56 sponge parous women 40 20 42 nulliparous women 20 9 56 diaphragmà 20 6 56 withdrawal 19 4 condomè female (reality) 21 5 56 male 14 3 61 pill 5 71 progestin only 0.5 combined 0.1 iuds progesterone t 2.0 1.5 81 copper t 380a 0.8 0.6 78 lng 20 0.1 0.1 81 depo-provera® 0.3 0.3 70 levonorgestrel implants (norplant® ) 0.05 0.05 88 female sterilization 0.5 0.5 100 male sterilization 0.15 0.10 100 progestin-only oral contraceptives (pops) should not be used by women who currently have the following conditions:

美国 - 英文 - NLM (National Library of Medicine)

hospira, inc. - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - dextrose monohydrate 70 g in 100 ml - dextrose injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. the use of dextrose injection is contraindicated in patients: risk summary there are no data with dextrose injection in pregnant women. in addition, animal reproduction studies have not been conducted with dextrose. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk consider parenteral nutrition in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, including preterm delivery, low birth weight, intrauterine growth