Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

theratechnologies inc. - tesamorelin acetate (unii: lgw5h38ve3) (tesamorelin - unii:mqg94m5eeo) - tesamorelin 1 mg in 1 ml - egrifta is indicated for the reduction of excess abdominal fat in hiv-infected adult patients with lipodystrophy. limitations of use: - long-term cardiovascular safety of egrifta has not been established. consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. - egrifta is not indicated for weight loss management as it has a weight neutral effect. - there are no data to support improved compliance with anti-retroviral therapies in hiv-positive patients taking egrifta. egrifta is contraindicated in patients with: - disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. - active malignancy. any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy [see warnings and precautions (5.1)] . - known hypersensitivity to tesamorelin or the excipients in egrifta [see warnings and precautions (5.5)]. - pregnant women because mo

Izraēla - angļu - Ministry of Health

promedico ltd - selinexor - tablets - selinexor 20 mg - selinexor - multiple myeloma• xpovio® in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.• xpovio in combination with dexamethasone is indicated for the treatment of adult patients with relapsed refractory multiple myeloma (rrmm) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (pi), at least one immunomodulatory agent (imid), and an anti- cd38 monoclonal antibody (mab).diffuse large b-cell lymphomaxpovio is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl), not otherwise specified, including dlbcl arising from follicular lymphoma, after at least 2 lines of systemic therapy.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

bracco diagnostics inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide 5 ug in 5 ml - kinevac is indicated in adults to: - to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. kinevac is contraindicated in patients with: - a history of hypersensitivity to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)] . - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - inclisiran sodium (unii: upc6btx7py) (inclisiran - unii:uow2c71pg5) - leqvio® is indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce low-density lipoprotein cholesterol (ldl-c). none. risk summary discontinue leqvio when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. inclisiran increases ldl-c uptake and lowers ldl-c levels in the circulation, thus decreasing cholesterol and possibly other biologically active substances derived from cholesterol; therefore, leqvio may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. there are no available data on the use of leqvio in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed in rats and rabbits with subcutaneous administration of inclisiran during organogenesis at doses up to 5 to 10 times the maximum recommended human dose (mrhd) based on body surface area (bsa) comparison (see data ). no adverse developmental outcomes were observed in offspring of rats administered inclisiran from organogenesis through lactation at 5 times the mrhd based on bsa comparison (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is 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. data animal data in embryo-fetal development studies conducted in sprague-dawley rats and new zealand white rabbits, inclisiran was administered by subcutaneous injection at dose levels of 50, 100, and 150 mg/kg once daily during organogenesis (rats: gestation days 6 to 17; rabbits: gestation days 7 to 19). there was no evidence of embryo-fetal toxicity or teratogenicity at doses up to 5 and 10 times, respectively, the mrhd based on bsa comparison/dose. inclisiran crosses the placenta and was detected in rat fetal plasma at concentrations that were 65 to 154 times lower than maternal levels. in a pre- and postnatal development study conducted in sprague-dawley rats, inclisiran was administered once daily by subcutaneous injection at levels of 50, 100, and 150 mg/kg from gestation day 6 through lactation day 20. inclisiran was well-tolerated in maternal rats, with no evidence of maternal toxicity and no effects on maternal performance. there were no effects on the development of the f1 generation, including survival, growth, physical and reflexological development, behavior, and reproductive performance at doses up to 5 times the mrhd, based on bsa comparison/dose. risk summary there is no information on the presence of inclisiran in human milk, the effects on the breastfed infant, or the effects on milk production. inclisiran was present in the milk of lactating rats in all dose groups. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data ). oligonucleotide-based products typically have poor oral bioavailability; therefore, it is considered unlikely that low levels of inclisiran present in milk will adversely impact an infant’s development during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for leqvio and any potential adverse effects on the breastfed infant from leqvio or from the underlying maternal condition. data in lactating rats, inclisiran was detected in milk at mean maternal plasma:milk ratios that ranged between 0.361 and 1.79. however, there is no evidence of systemic absorption in the suckling rat neonates. the safety and effectiveness of leqvio have not been established in pediatric patients. of the 1,833 patients treated with leqvio in clinical studies, 981 (54%) patients were 65 years of age and older, while 239 (13%) patients were 75 years of age and older. no overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients. no dose adjustments are necessary for patients with mild, moderate, or severe renal impairment [see clinical pharmacology (12.3)] . leqvio has not been studied in patients with end stage renal disease [see clinical pharmacology (12.3)] . no dose adjustment is necessary in patients with mild to moderate hepatic impairment. leqvio has not been studied in patients with severe hepatic impairment [see clinical pharmacology (12.3)] .

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

laboratoire aguettant - zinc gluconate trihydrate (unii: f2f0xu34wq) (zinc cation - unii:13s1s8sf37) - zinc cation 1 mg in 1 ml

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

hameln pharma gmbh - pentetate zinc trisodium (unii: nxu65ic8pg) (pentetic acid - unii:7a314hqm0i) - pentetate zinc trisodium 1000 mg in 5 ml - zn-dtpa is indicated for treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination. none. pregnancy category b risk summary there are no adequate and well-controlled studies of zn-dtpa use in pregnant women. chelation treatment of pregnant women should begin and continue with zn-dtpa. reproduction studies have been performed in pregnant mice at doses up to 31 times (11.5 mmol/kg) the recommended daily human dose and have revealed no evidence of impaired fertility or harm to the fetus due to zn-dtpa. there was a slight reduction in the average birth weight. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether zn-dtpa is excreted in human milk. radiocontaminants are known to be excreted in breast milk. women with known or suspected internal contamination with radiocontaminants should not breast feed, whether

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

pharmacy value alliance, llc - zinc gluconate (unii: u6wsn5sq1z) (zinc cation - unii:13s1s8sf37) - if symptoms persist beyond 7 days. as ask health professional before use. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

pharmacy value alliance, llc - zinc gluconate (unii: u6wsn5sq1z) (zinc cation - unii:13s1s8sf37) - if symptoms persist beyond 7 days. ask health professional before use. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - zinc acetate (unii: fm5526k07a) (zinc cation - unii:13s1s8sf37) -

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

taisho pharmaceutical california inc. - zinc oxide (unii: soi2loh54z) (zinc cation - unii:13s1s8sf37) - - helps treat and prevent diaper rash  - protect chafed skin due to diaper rash and helps seal out wetness