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tolmar inc. - leuprolide acetate (unii: 37jns02e7v) (leuprolide - unii:efy6w0m8tg) - leuprolide acetate 7.5 mg in 0.25 ml - eligard® is indicated for the palliative treatment of advanced prostate cancer. hypersensitivity eligard® is contraindicated in patients with hypersensitivity to gnrh, gnrh agonist analogs or any of the components of eligard® .  anaphylactic reactions to synthetic gnrh or gnrh agonist analogs have been reported in the literature. risk summary based on findings in animal studies and mechanism of action, eligard® may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform the drug-associated risk. expected hormonal changes that occur with eligard® treatment increase the risk for pregnancy loss. in animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation in rats. advise pregnant patients and females of reproductive potential of the potential risk to the fetus (see data) . animal data in animal developmental and reproduc

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tai tong ah co pte ltd - menthol 3.5% - menthol   external analgesic for the relief from pain, swelling and itching due to skin irritation, skin infection, minor cuts, fungal infection, abrasions, bruises, minor burns and scalds, insect bites and a range of skin problems.

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amneal pharmaceuticals llc - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate 50 ug - mometasone furoate nasal spray 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older. mometasone furoate  nasal spray 50 mcg is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older. mometasone furoate nasal spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients [see warnings and precautions (5.3), description (11)] . risk summary mometasone is minimally absorbed systemically following nasal use, and maternal use is not expected to result in fetal exposure to the drug. available data from observational studies of mometasone use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies with pregnant mice, rats, or rabbits (subcutaneous, subcutaneous/topical dermal/oral, and topical dermal/oral, respectively), mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (mrhd) on a mcg/m2 or auc basis [see data] . however, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at a dose less than the maximum recommended daily intranasal dose (mrdid) (on a mcg/m2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at approximately 2 times the mrdid (on a mcg/m2 basis with a maternal subcutaneous dose of 180 mcg/kg). no toxicity was observed with a dose that produced an exposure less than the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 20 mcg/kg and above). in an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 10 times the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at a dose approximately 6 times the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 300 mcg/kg and above). in another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation. treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at a dose less than the mrdid (on a mcg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg). there were no findings at a dose less than the mrdid (on a mcg/m2 basis with a maternal subcutaneous dose of 7.5 mcg/kg). embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis. in the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 6 times the mrdid (on a mcg/m2 basis with maternal topical dermal doses of 150 mcg/kg and above). in the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at a dose approximately 30 times of the mrdid (on a mcg/m2 basis with a maternal oral dose of 700 mcg/kg). at approximately 110 times the mrdid (on a mcg/m2 basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed. no effects were observed at a dose approximately 6 times the mrdid (on a mcg/m2 basis with a maternal oral dose of 140 mcg/kg). risk summary there are no available data on the presence of mometasone furoate nasal spray in human milk, the effects on the breastfed child, or the effects on milk production. however, mometasone is minimally absorbed systemically by the mother following nasal use, and breastfeeding is not expected to result in exposure of the infant to mometasone. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mometasone furoate nasal spray and any potential adverse effects on the breastfed infant from mometasone furoate nasal spray or from the underlying maternal condition. the safety and effectiveness of mometasone furoate  nasal spray for prophylaxis of the nasal symptoms of seasonal allergic rhinitis in pediatric patients 12 years of age and older have been established [see adverse reactions (6.1)  and clinical studies (14.1)] . use of mometasone furoate  nasal spray for this indication is supported by evidence from controlled trials in adult and pediatric patients 12 years of age and older [see clinical studies (14.1)] .  the safety and effectiveness of mometasone furoate nasal spray for the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients less than 18 years of age have not been established. effectiveness was not demonstrated in one 4-month trial conducted to evaluate the safety and efficacy of mometasone furoate in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients 6 to 17 years of age. the primary objective of the study was to evaluate safety; efficacy parameters were collected as secondary endpoints. a total of 127 patients with chronic rhinosinusitis with nasal polyps were randomized to placebo or mometasone furoate nasal spray 100 mcg once or twice daily (patients 6 to 11 years of age) or 200 mcg once or twice daily (patients 12 to 17 years of age). the results of this trial did not support the efficacy of mometasone furoate nasal spray in the treatment of chronic rhinosinusitis with nasal polyps in pediatric patients. the adverse reactions reported in this trial were similar to the adverse reactions reported in patients 18 years of age and older with chronic rhinosinusitis with nasal polyps. effect on growth controlled clinical studies have shown nasal corticosteroids may cause a reduction in growth velocity in pediatric patients. this effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (hpa) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. the potential for “catch up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. the growth of pediatric patients receiving nasal corticosteroids, including mometasone furoate nasal spray, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. to minimize the systemic effects of nasal corticosteroids, including mometasone furoate nasal spray, each patient should be titrated to his/her lowest effective dose. a clinical study to assess the effect of mometasone furoate nasal spray (100 mcg total daily dose) on growth velocity has been conducted in pediatric patients 3 to 9 years of age with allergic rhinitis. no statistically significant effect on growth velocity was observed for mometasone furoate  nasal spray compared to placebo following one year of treatment. no evidence of clinically relevant hpa axis suppression was observed following a 30-minute cosyntropin infusion. the potential of mometasone furoate nasal spray to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out. a total of 280 patients above 64 years of age with allergic rhinitis or chronic rhinosinusitis with nasal polyps (age range 64 to 86 years) have been treated with mometasone furoate nasal spray for up to 3 or 4 months, respectively. no observed differences in safety and/or effectiveness in geriatric patients compared to younger adult patients. concentrations of mometasone furoate appear to increase with severity of hepatic impairment [see clinical pharmacology (12.3)] . mometasone furoate (moe met’ a sone fure’ oh ate) nasal spray, 50 mcg for use in your nose only. read the patient instructions for use carefully before you start to use your mometasone furoate nasal spray. if you have any questions, ask your healthcare provider. shake the bottle well before each use. - remove the plastic cap (see figure 1). - before you use mometasone furoate for the first time, prime the pump by pressing downward on the shoulders of the white nasal applicator using your index finger and middle finger while holding the base of the bottle with your thumb (see figure 2). do not pierce the nasal applicator. press down and release the pump 10 times or until a fine spray appears. do not spray into eyes. the pump is now ready to use. the pump may be stored unused for up to 1 week without repriming. if unused for more than 1 week, reprime by spraying 2 times or until a fine spray appears. - gently blow your nose to clear the nostrils. close 1 nostril. tilt your head forward slightly, keep the bottle upright, carefully insert the nasal applicator into the other nostril (see figure 3). do not spray directly onto the nasal septum (the wall between the two nostrils). - for each spray, hold the spray bottle upright and press firmly downward 1 time on the shoulders of the white nasal applicator using your index and middle fingers while supporting the base of the bottle with your thumb. breathe gently inward through the nostril (see figure 4). note: it is important to keep the mometasone furoate unit in an upright orientation (as seen in figure 4). failure to do so may result in an incomplete or non-existent spray. note: it is important to keep the mometasone furoate unit in an upright orientation (as seen in figure 4). failure to do so may result in an incomplete or non-existent spray. - then breathe out through the mouth. - repeat in the other nostril. - wipe the nasal applicator with a clean tissue and replace the plastic cap. each bottle of mometasone furoate nasal spray contains enough medicine for you to spray medicine from the bottle 120 times. do not use the bottle of mometasone furoate nasal spray after 120 sprays. additional sprays after the 120 sprays may not contain the right amount of medicine, you should keep track of the number of sprays used from each bottle of mometasone furoate nasal spray, and throw away the bottle even if it has medicine still left in. do not count any sprays used for priming the device. talk with your healthcare provider before your supply runs out to see if you should get a refill of your medicine. pediatric use: administration to children should be supervised by an adult. steps 1 through 7 from the patient instructions for use  should be followed. cleaning: do not try to unblock the nasal applicator with a sharp object. please see patient instructions for cleaning applicator. patient instructions for cleaning applicator - to clean the nasal applicator, remove the plastic cap (see figure 5).                   figure 5                   figure 5 - pull gently upward on the white nasal applicator to remove (see figure 6).                      figure 6                      figure 6 - soak the nasal applicator in cold tap water and rinse both ends of the nasal applicator under cold tap water and dry (see figure 7). do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine. figure 7 4. rinse the plastic cap under cold water and dry (see figure 8). figure 8   5. put the nasal applicator back together making sure the pump stem is reinserted into the applicator’s center hole (see figure 9). figure 9 6. reprime the pump by pressing downward on the shoulders of the white nasal applicator using your index and middle fingers while holding the base of the bottle with your thumb. press down and release the pump 2 times or until a fine spray appears. do not spray into eyes. the pump is now ready to use. the pump may be stored unused for up to 1 week without repriming. if unused for more than 1 week, reprime by spraying 2 times or until a fine spray appears (see figure 10). figure 10 7. replace the plastic cap (see figure 11). figure 11 this patient information and instructions for use has been approved by the u.s. food and drug administration. distributed by: amneal pharmaceuticals llc bridgewater, nj  08807 rev. 08-2022-03

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eagle pharmaceuticals, inc. - docetaxel (unii: 15h5577cqd) (docetaxel anhydrous - unii:699121phca) - docetaxel anhydrous 20 mg in 1 ml

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wal-mart stores inc - psyllium husk 3.4g - bulk-forming laxative - for relief of occasional constipation and restoring regularity - natural bulk producing fiber encourages normal elimination without chemical stimulants

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washington homeopathic products - arsenicum album, cuprum arsenicum, veratrum album - relieves the symptoms of diarrhea that come on suddenly with vomiting, purging, spasmodic pains in the bowels.  indications:  arsenicum alb 6c –small, offensive stool* cuprum ars 6c –watery stool* veratrum alb 6c –large stool* ■ cramps* ■ vomiting* ■ spasmodic pains* *these statements have not been reviewed by the food and drug administration. if symptoms persist or recur, discontinue use. if pregnant or nursing a baby, consult a licensed practitioner before using this product.

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teva pharmaceuticals usa, inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronic acid 5 mg

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hospira, inc. - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride anhydrous 2.5 mg in 1 ml - marcaine / marcaine with epinephrine is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. specific concentrations and presentations of marcaine / marcaine with epinephrine are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see dosage and administration (2.2)]. limitations of use not all blocks are indicated for use with marcaine / marcaine with epinephrine given clinically significant risks associated with use [see dosage and administration (2.2), contraindications (4), warnings and precautions (5.1, 5.4, 5.5, 5.7, 5.9)] . marcaine / marcaine with epinephrine is contraindicated in: risk summary marcaine / marcaine with epinephrine is contraindicated for obstetrical paracervical block anesthesia. its use in this technique has resulted in fetal bradycardia and death [see contraindications (4), warnings and precautions (5.1)] . there are no available data on use of marcaine / marcaine with epinephrine in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis at clinically relevant doses. decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning) at a dose level comparable to the daily maximum recommended human dose (mrhd) on a body surface area (bsa) basis. based on animal data, advise pregnant women of the potential risks to a fetus (see data). local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity [see clinical pharmacology (12.3)]. the incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. adverse reactions in the parturient, fetus, and neonate involve alterations of the cns, peripheral vascular tone, and cardiac function. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. clinical considerations maternal adverse reactions maternal hypotension has resulted from regional anesthesia. local anesthetics produce vasodilation by blocking sympathetic nerves. the supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. elevating the patient's legs will also help prevent decreases in blood pressure. the fetal heart rate also should be monitored continuously and electronic fetal monitoring is highly advisable. labor or delivery epidural, caudal, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts. epidural anesthesia has been reported to prolong the second stage of labor by removing the parturient's reflex urge to bear down or by interfering with motor function. the use of obstetrical anesthesia may increase the need for forceps assistance. the use of some local anesthetic drug products during labor and delivery may be followed by diminished muscle strength and tone for the first day or two of life. this has not been reported with bupivacaine. it is extremely important to avoid aortocaval compression by the gravid uterus during administration of regional block to parturients. to do this, the patient must be maintained in the left lateral decubitus position or a blanket roll or sandbag may be placed beneath the right hip and gravid uterus displaced to the left. data animal data bupivacaine hydrochloride produced developmental toxicity when administered subcutaneously to pregnant rats and rabbits at clinically relevant doses. bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.4, 13.3, & 40 mg/kg and to rabbits at doses of 1.3, 5.8, & 22.2 mg/kg during the period of organogenesis (implantation to closure of the hard palate). the high doses are comparable to the daily mrhd of 400 mg/day on a mg/m2 bsa basis. no embryo-fetal effects were observed in rats at the high dose which caused increased maternal lethality. an increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity with the fetal no observed adverse effect level representing approximately 0.3 times the mrhd on a bsa basis. in a rat pre- and post-natal developmental study (dosing from implantation through weaning) conducted at subcutaneous doses of 4.4, 13.3, & 40 mg/kg, decreased pup survival was observed at the high dose. the high dose is comparable to the daily mrhd of 400 mg/day on a bsa basis. risk summary lactation studies have not been conducted with bupivacaine. bupivacaine has been reported to be excreted in human milk suggesting that the nursing infant could be theoretically exposed to a dose of the drug. marcaine / marcaine with epinephrine should be administered to lactating women only if clearly indicated. studies assessing the effects of marcaine / marcaine with epinephrine in breastfed children have not been performed. studies to assess the effect of marcaine / marcaine with epinephrine on milk production or excretion have not been performed. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bupivacaine and any potential adverse effects on the breastfed child from bupivacaine or from the underlying maternal condition. marcaine / marcaine with epinephrine is approved for use in adults. administration of marcaine / marcaine with epinephrine in pediatric patients younger than 12 years is not recommended. continuous infusions of bupivacaine in pediatric patients have been reported to result in high systemic levels of bupivacaine and seizures; high plasma levels may also be associated with cardiovascular abnormalities. patients 65 years and over, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing anesthesia with marcaine / marcaine with epinephrine. in clinical studies of bupivacaine, elderly patients reached the maximal spread of analgesia and maximal motor blockade more rapidly than younger adult patients. differences in various pharmacokinetic parameters have been observed between elderly and younger adult patients [see clinical pharmacology (12.3)] . this product is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. elderly patients may require lower doses of marcaine / marcaine with epinephrine. amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. patients with severe hepatic impairment, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. therefore, consider reduced dosing and increased monitoring for local anesthetic systemic toxicity in patients with moderate to severe hepatic impairment treated with marcaine / marcaine with epinephrine, especially with repeat doses [see warnings and precautions (5.10)] . bupivacaine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. this should be considered when selecting the marcaine / marcaine with epinephrine dosage [see use in specific populations (8.5)] .

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glenmark pharmaceuticals inc., usa - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. drospirenone and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: risk summary there is no use for contraception in pregnancy; therefore, drospirenone and ethinyl estradiol tablets should be discontinued during pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to chcs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. data human data a retrospective database study of women in norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol

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johnson & johnson consumer inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen 650 mg - pain reliever/fever reducer - temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache - minor pain of arthritis - muscular aches - backache - premenstrual and menstrual cramps - the common cold - headache - toothache - temporarily reduces fever