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)

rpk pharmaceuticals, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - tri-vylibra tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . tri-vylibra 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-vylibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see clinical studies (14)] . tri-vylibra is contraindicated in females who are known to have or develop 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 cerebrovascular disease [see warnings and precautions (5.1)]

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-vylibra lo (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . tri-vylibra lo (norgestimate and ethinyl estradiol tablets) is contraindicated in females who are known to have or develop 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 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

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

proficient rx lp - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - tri-lo-mili (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . tri-lo-mili (norgestimate and ethinyl estradiol tablets) is contraindicated in females who are known to have or develop 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 o

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

india pesticides limited - tri-allate - unknown - tri-allate carbamate-thiocarbamate active 0.0 - active constituent

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

merck sharp & dohme llc - doravirine (unii: 913p6lk81m) (doravirine - unii:913p6lk81m), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - delstrigo® is indicated as a complete regimen for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 35 kg: - with no prior antiretroviral treatment history, or - to replace the current antiretroviral regimen in those who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of delstrigo [see clinical studies (14)] . - delstrigo is contraindicated when co-administered with drugs that are strong cytochrome p450 (cyp)3a enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of delstrigo [see warnings and precautions (5.3), drug interactions (7.2), and clinical pharmacology (12.3)] . these drugs include, but are not limited to, the following: - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the androgen receptor inhibitor enzalutamide - the antimycobacterials rifampin, rifapentine - the cytotoxic agent mitotane - st. john's wort (hypericum perforatum) - delstrigo is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to delstrigo during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary there is insufficient prospective pregnancy data from the apr to adequately assess the risk of birth defects and miscarriage. doravirine use in individuals during pregnancy has not been evaluated; however, lamivudine and tdf use during pregnancy has been evaluated in a limited number of individuals reported to the apr. available data from the apr show no difference in the overall risk of major birth defects for lamivudine and tdf compared with the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data ). the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in the clinically recognized pregnancies in the u.s. general population is 15-20%. methodological limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates individuals and infants from the limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation. in animal reproduction studies, oral administration of lamivudine to pregnant rabbits during organogenesis resulted in embryolethality at systemic exposure (auc) similar to the recommended clinical dose; however, no adverse development effects were observed with oral administration of lamivudine to pregnant rats during organogenesis at plasma concentrations (cmax ) 35 times the recommended clinical dose. no adverse developmental effects were observed when doravirine and tdf were administered separately at doses/exposures ≥8 (doravirine) and ≥14 (tdf) times those of the recommended human dose (rhd) of delstrigo (see data ). data human data lamivudine : the apr has received a total of over 13,000 prospective reports with follow-up data of possible exposure to lamivudine-containing regimens; over 5,900 reports in the first trimester; over 5,600 reports in the second trimester; and over 1,800 reports in the third trimester. birth defects occurred in 170 of 5,472 (3.1%, 95% ci: 2.7% to 3.6%) live births for lamivudine-containing regimens (first trimester exposure); and 218 of 7,513 (2.9%, 95% ci: 2.5% to 3.3%) live births for lamivudine-containing regimens (second/third trimester exposure). among pregnant mothers in the u.s. reference population, the background rate of birth defects is 2.7%. there was no association between lamivudine and overall birth defects observed in the apr. tdf : the apr has received a total of over 7,000 prospective reports with follow-up data of possible exposure to tenofovir disoproxil-containing regimens; over 5,100 reports in the first trimester; over 1,300 reports in the second trimester; and over 600 reports in the third trimester. birth defects occurred in 113 of 4,576 (2.5%, 95% ci: 2.0% to 3.0%) live births for tdf-containing regimens (first trimester exposure); and 51 of 1,965 (2.6%, 95% ci: 1.9% to 3.4%) live births for tdf-containing regimens (second/third trimester exposure). among pregnant mothers in the u.s. reference population, the background rate of birth defects is 2.7%. there was no association between tenofovir and overall birth defects observed in the apr. animal data doravirine : doravirine was administered orally to pregnant rabbits (up to 300 mg/kg/day on gestation days (gd) 7 to 20) and rats (up to 450 mg/kg/day on gd 6 to 20 and separately from gd 6 to lactation/postpartum day 20). no significant toxicological effects on embryo-fetal (rats and rabbits) or pre/post-natal (rats) development were observed at exposures (auc) approximately 9 times (rats) and 8 times (rabbits) the exposure in humans at the rhd. doravirine was transferred to the fetus through the placenta in embryo-fetal studies, with fetal plasma concentrations of up to 40% (rabbits) and 52% (rats) that of maternal concentrations observed on gd 20. lamivudine : lamivudine was administered orally to pregnant rats (at 90, 600, and 4,000 mg per kg per day) and rabbits (at 90, 300, and 1,000 mg per kg per day and at 15, 40, and 90 mg per kg per day) during organogenesis (on gd 7 through 16 [rat] and 8 through 20 [rabbit]). no evidence of fetal malformations due to lamivudine was observed in rats and rabbits at doses producing plasma concentrations (cmax ) approximately 35 times higher than human exposure at the recommended daily dose. evidence of early embryolethality was seen in the rabbit at system exposures (auc) similar to those observed in humans, but there was no indication of this effect in the rat at plasma concentrations (cmax ) 35 times higher than human exposure at the recommended daily dose. studies in pregnant rats showed that lamivudine is transferred to the fetus through the placenta. in the fertility/pre- and postnatal development study in rats, lamivudine was administered orally at doses of 180, 900, and 4,000 mg per kg per day (from prior to mating through postnatal day 20). in the study, development of the offspring, including fertility and reproductive performance, was not affected by maternal administration of lamivudine. tdf : reproduction studies have been performed in rats and rabbits at doses up to 14 and 19 times the human dose based on body surface area comparisons and revealed no evidence of harm to the fetus. risk summary the centers for disease control and prevention recommend that hiv-1-infected mothers in the united states not breastfeed their infants to avoid risking potential transmission of hiv-1 infection. based on limited published data, both lamivudine and tenofovir are present in human milk. it is unknown whether doravirine is present in human milk, but doravirine is present in the milk of lactating rats (see data ). it is not known whether delstrigo or the components of delstrigo affects human milk production, or has effects on the breastfed infant. because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving delstrigo. data doravirine : doravirine was excreted into the milk of lactating rats following oral administration (450 mg/kg/day) from gd 6 to lactation day 14, with milk concentrations approximately 1.5 times that of maternal plasma concentrations observed 2 hours post dose on lactation day 14. the safety and efficacy of delstrigo for the treatment of hiv-1 infection have been established in pediatric patients weighing at least 35 kg [see indications and usage (1) and dosage and administration (2.2)] . use of delstrigo in this group is supported by evidence from adequate and well-controlled trials in adults with additional pharmacokinetic, safety, and efficacy data from an open-label trial in virologically-suppressed or treatment-naïve pediatric subjects 12 to less than 18 years of age. the safety and efficacy of delstrigo in these pediatric subjects were similar to that in adults, and there was no clinically significant difference in exposure for the components of delstrigo. [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.3).] safety and efficacy of delstrigo in pediatric patients weighing less than 35 kg have not been established. clinical trials of doravirine, lamivudine, or tdf did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. in general, caution should be exercised in the administration of delstrigo in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology (12.3)]. because delstrigo is a fixed-dose combination tablet and the dosage of lamivudine and tdf, both components of delstrigo, cannot be altered, delstrigo is not recommended in patients with estimated creatinine clearance less than 50 ml/min [see warnings and precautions (5.2) and clinical pharmacology (12.3)] . no dosage adjustment of delstrigo is required in patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. delstrigo has not been studied in patients with severe hepatic impairment (child-pugh class c) [see clinical pharmacology (12.3)] .

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

nutrition care pharmaceuticals pty ltd - ascorbic acid,colecalciferol,calcium citrate,calcium pantothenate,cyanocobalamin,d-alpha-tocopheryl acid succinate,ferrous gluconate,folic acid,fucus vesiculosus,glutamine,magnesium phosphate pentahydrate,manganese amino acid chelate,nicotinamide,pyridoxine hydrochloride,paeonia lactiflora,panax ginseng,retinol palmitate,riboflavine,thiamine hydrochloride,viburnum opulus,vitex agnus-castus,zinc amino acid chelate -

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

nutrition care pharmaceuticals pty ltd - curcumin,echinacea angustifolia,magnesium amino acid chelate,manganese amino acid chelate,olea europaea,pyridoxine hydrochloride,retinol palmitate,zinc amino acid chelate -

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

nutrition care pharmaceuticals pty ltd - humulus lupulus,matricaria chamomilla,melissa officinalis,passiflora incarnata,rosmarinus officinalis,withania somnifera,ziziphus jujuba -

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

nutrition care pharmaceuticals pty ltd - ascorbic acid,biotin,calcium hydrogen phosphate dihydrate,chromic chloride hexahydrate,colecalciferol,calcium pantothenate,copper gluconate,cyanocobalamin,d-alpha-tocopheryl acid succinate,dunaliella salina,ferrous fumarate,folic acid,heavy magnesium oxide,manganese amino acid chelate,nicotinamide,pyridoxine hydrochloride,potassium gluconate,riboflavine,thiamine nitrate,zinc amino acid chelate -