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

jsb4, llc - zinc oxide (unii: soi2loh54z) (zinc cation - unii:13s1s8sf37) - - helps prevent sunburn - if used as directed with other sun protection measures ( ​see directions ​), decreases the risk of skin cancer and early skin agin caused by the sun.

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

zhejiang ayan biotech co.,ltd. - avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox), homosalate (unii: v06sv4m95s) (homosalate - unii:v06sv4m95s), octocrylene (unii: 5a68wgf6wm) (octocrylene - unii:5a68wgf6wm), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w) - • helps prevent sunburn. • helps prevent sunburn.

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

the fresh market - avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox), octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), oxybenzone (unii: 95oos7ve0y) (oxybenzone - unii:95oos7ve0y) - sunscreen - lip moisturizer - sunscreen

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

the procter & gamble manufacturing company - avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox), homosalate (unii: v06sv4m95s) (homosalate - unii:v06sv4m95s), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w), octocrylene (unii: 5a68wgf6wm) (octocrylene - unii:5a68wgf6wm) - - helps prevent sunburn - if used as directed with other sun protection measures (see directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius kabi sa-nv - glycine 18,5 mg/ml; valine 5,5 mg/ml; arginine 20 mg/ml; leucine 8,9 mg/ml; serine 9,6 mg/ml; proline 17 mg/ml; alanine 25 mg/ml; lysine acetate 15,66 mg/ml - eq. lysine 11,1 mg/ml; histidine 7,3 mg/ml; threonine 8,6 mg/ml; tryptophan 1,6 mg/ml; taurine 2 mg/ml; tyrosine 0,4 mg/ml; isoleucine 5,2 mg/ml; methionine 3,8 mg/ml; phenylalanine 5,5 mg/ml - solution for infusion - 15 % - histidine 7.3 mg/ml; glycine 18.5 mg/ml; methionine 3.8 mg/ml; leucine 8.9 mg/ml; isoleucine 5.2 mg/ml; lysine acetate 15.66 mg/ml; proline 17 mg/ml; phenylalanine 5.5 mg/ml; tryptophan 1.6 mg/ml; tyrosine 0.4 mg/ml; threonine 8.6 mg/ml; taurine 2 mg/ml; serine 9.6 mg/ml; arginine 20 mg/ml; alanine 25 mg/ml; valine 5.5 mg/ml - amino acids

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ferring sa-nv - desmopressin acetate 15 µg/ml - eq. desmopressin 13,4 µg/ml - solution for injection - 15 µg/ml - desmopressin acetate 15 µg/ml - desmopressin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

boehringer ingelheim animal health belgium sa-nv - ivermectin 15,5 mg/g; praziquantel 77,5 mg/g - oral paste - 15,5 mg/g - 77,5 mg/g - ivermectin 15.5 mg/g; praziquantel 77.5 mg/g - ivermectin, combinations - horse

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

santen oy - timolol maleate 6,84 mg/ml - eq. timolol 5 mg/ml; tafluprost 15 µg/ml - eye drops, solution - 15 µg/ml - 5 mg/ml - timolol maleate 6.84 mg/ml; tafluprost 15 µg/ml - timolol, combinations

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع أدوية العمد - al-amad drug store - nicotine 15.8 mg - 15.8 mg

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

avpak - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 15 years of age and older.   tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients  of age and older. because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with   reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients  15 years of age and older. because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with  allergic rhinitis [see warnings and precautions (5.1)],  reserve use for patients who have an inadequate response or intolerance to alternative therapies. • hypersensitivity to any component of this product. risk summary available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see data]. in animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (mrhdod) based on aucs [see data]. 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 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 poorly or moderately controlled asthma in pregnancy increases the maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age. data human data published data from prospective and retrospective cohort studies have not identified an association with montelukast sodium use during pregnancy and major birth defects. available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups. animal data in embryo-fetal development studies, montelukast administered to pregnant rats and rabbits during organogenesis (gestation days 6 to 17 in rats and 6 to 18 in rabbits) did not cause any adverse developmental effects at maternal oral doses up to 400 and 300 mg/kg/day in rats and rabbits, respectively (approximately 100 and 110 times the auc in humans at the mrhdod, respectively). risk summary a published clinical lactation study reports the presence of montelukast in human milk. data available on the effects of the drug on infants, either directly [see use in specific populations (8.4)]  or through breast milk, do not suggest a significant risk of adverse events from exposure to montelukast sodium. the effects of the drug on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for montelukast sodium and any potential adverse effects on the breastfed infant from montelukast sodium or from the underlying maternal condition. the safety and effectiveness in pediatric patients below the age of 12 months with asthma, 6 months with perennial allergic rhinitis, and 6 years with exercise-induced bronchoconstriction have not been established. of the total number of subjects in clinical studies of montelukast, 3.5% were 65 years of age and over, and 0.4% were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetic profile and the oral bioavailability of a single 10 mg oral dose of montelukast are similar in elderly and younger adults. the plasma half-life of montelukast is slightly longer in the elderly. no dosage adjustment in the elderly is required. no dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency [see clinical pharmacology ( 12.3)]. no dosage adjustment is recommended in patients with renal insufficiency [see clinical pharmacology (12.3)].