মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

mirum pharmaceuticals inc. - maralixibat chloride (unii: v78m04f0xc) (maralixibat - unii:uyb6uof69l) - livmarli® is indicated for the treatment of cholestatic pruritus in patients 3 months of age and older with alagille syndrome (algs). livmarli is indicated for the treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis (pfic). limitations of use: livmarli is not recommended in a subgroup of pfic type 2 patients with specific abcb11 variants resulting in non-functional or complete absence of bile salt export pump (bsep) protein [see clinical studies (14.2)] . livmarli is contraindicated in patients with prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) [see warnings and precautions (5.1)] . risk summary maternal use at the recommended clinical dose of livmarli is not expected to result in measurable fetal exposure because systemic absorption following oral administration is low [see clinical pharmacology (12.3)]. maralixibat may inhibit the absorption of fat-soluble vitamins [see warnings and precautions (5.3) and clinical considerations] . in animal reproduction studies, no developmental effects were observed (see data) . the estimated background risk of major birth defects for algs is higher than the general population because algs is an autosomal dominant condition. the background risk of miscarriage for algs is unknown. the background risk of birth defects and miscarriage for pfic is unknown. 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 fetal/neonatal adverse reactions maralixibat may inhibit the absorption of fat-soluble vitamins (fsv). monitor for fsv deficiency and supplement as needed. increased supplementation of fsvs may be needed during pregnancy [see warnings and precautions (5.3)] . data animal data no effects on embryo-fetal development were observed in pregnant rats treated orally with up to 1000 mg/kg/day (approximately 3300 to 12000 times the maximum recommended dose based on auc [area under the plasma concentration-time curve]) or in pregnant rabbits treated orally with up to 250 mg/kg/day (approximately 1200 to 4700 times the maximum recommended dose based on auc) during the period of organogenesis. no effects on postnatal development were observed in a pre- and postnatal development study, in which female rats were treated orally with up to 750 mg/kg/day during organogenesis through lactation. maternal systemic exposure to maralixibat at the maximum dose tested was approximately 2500 to 9400 times the maximum recommended dose based on auc. risk summary livmarli has low absorption following oral administration, and breastfeeding is not expected to result in exposure of the infant to livmarli at the recommended dose [see clinical pharmacology (12.3)] . there are no data on the presence of livmarli in human milk, the effects on the breastfed infant, or the effects on milk production. patients with algs or pfic can have fsv deficiency as part of their disease. maralixibat may reduce absorption of fat-soluble vitamins [see warnings and precautions (5.3)] . monitor fsv levels and supplement fsv intake, if fsv deficiency is observed during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother's need for livmarli and any potential adverse effects on the breastfed child from livmarli or from the underlying maternal condition. algs the safety and effectiveness of livmarli for the treatment of cholestatic pruritus in alagille syndrome have been established in pediatric patients aged 3 months of age and older. use of livmarli in this population is supported by evidence from a study of patients 1 to 15 years of age (n=31) that included 18 weeks of open-label treatment followed by a 4 week placebo-controlled randomized withdrawal period and a subsequent 26-week open-label treatment period. additional safety information was obtained from four studies in patients up to 21 years of age (n=55) [see adverse reactions (6) and clinical studies (14.1)] . use of livmarli in patients 3 to <12 months of age is supported by an open-label, multicenter study of livmarli which showed a similar safety, tolerability and pharmacokinetic profile to patients with algs ≥12 months of age. the safety and effectiveness of livmarli have not been established in patients with algs less than 3 months of age. pfic the safety and effectiveness of livmarli for the treatment of cholestatic pruritus in pfic have been established in pediatric patients aged 5 years of age and older. use of livmarli in this population is supported by evidence from trial 2 in patients 1 to <18 years of age that included 26 weeks of placebo-controlled safety and efficacy data [see adverse reactions (6) and clinical studies (14.2)] . the safety and effectiveness of livmarli have not been established in patients with pfic younger than 12 months of age. the safety and effectiveness of livmarli for the treatment of pruritus in algs or pfic in adult patients, 65 years of age and older, have not been established. clinical studies of livmarli included algs or pfic patients with impaired hepatic function at baseline. the efficacy and safety in algs or pfic patients with clinically significant portal hypertension and in patients with decompensated cirrhosis have not been established. livmarli is contraindicated in patients with prior or active hepatic decompensation events [see dosage and administration (2.5), contraindications (4), warnings and precautions (5.1), and clinical studies (14)] . - before you give livmarli for the first time, talk to your healthcare provider or pharmacist about how to correctly measure your prescribed dose. - you may be given 1 or more dosing dispensers of different sizes as shown in table 1 below. always use the correct dosing dispenser size provided with livmarli based on your current prescribed dose. - your prescribed dose may change over time. use the table above to choose the correct dosing dispenser size for your prescribed dose. - if you do not have the correct dosing dispenser size for your prescribed dose, contact your healthcare provider or pharmacist. - the dosing dispenser may be used for 100 days if cleaned correctly (see section c). after 100 days, replace the dosing dispenser with a new one. a new replacement dosing dispenser may be used within the 100 days if necessary. - do not use a household teaspoon or any other dosing device to measure the dose. - do not open more than 1 bottle at a time. - do not give more than the prescribed dose. - do not use livmarli after 100 days of first opening the bottle or after the throw away (discard) date listed on the pharmacy label (see section d). - when you start a new bottle of livmarli, use a new dosing dispenser. - store unopened livmarli at room temperature, between 68°f and 77°f (20°c and 25°c). - after opening the livmarli bottle, store below 86°f (30°c). - store the dosing dispenser in a clean, dry place when not in use. livmarli (9.5 mg/ml):                                          figure a                                          figure b                                                  figure c figure d figure e - make sure you use the correct dosing dispenser size for your prescribed dose (see table 1). - after 100 days, replace with a new dosing dispenser provided. a new replacement dosing dispenser may be used within the 100 days if necessary. - check the dosing dispenser for any damage to the barrel, plunger or tip (see figure g). if you cannot see the dosage marking or if it becomes hard to move the plunger, replace with a new dosing dispenser. figure f figure g figure h figure i figure j figure k figure l figure m figure n figure o figure p figure q figure r section c: cleaning instructions for the dosing dispenser figure s figure t figure u figure v figure w figure x before you give the next dose, put the dosing dispenser back together by pushing the plunger into the barrel (see figure y). figure y section d: disposal - throw away (dispose of) the bottle of livmarli following the steps below 100 days after first opened or after the throw away (discard) date listed on the pharmacy label, even if there is still medicine in it. mix medicine with a substance such as dirt, cat litter, or used coffee grounds. place the mixture in a container such as a sealed plastic bag. delete all personal information on the prescription label of the empty medicine bottle, then throw away (dispose of) in the household trash or recycle the empty bottle. - mix medicine with a substance such as dirt, cat litter, or used coffee grounds. - place the mixture in a container such as a sealed plastic bag. - delete all personal information on the prescription label of the empty medicine bottle, then throw away (dispose of) in the household trash or recycle the empty bottle. - throw away (dispose of) used dosing dispensers in the household trash.

কানাডা - ইংরেজি - Health Canada

mirum pharmaceuticals, inc. - maralixibat (maralixibat chloride) - solution - 9.5mg - maralixibat (maralixibat chloride) 9.5mg

ইস্রায়েল - ইংরেজি - Ministry of Health

neopharm (israel) 1996 ltd - maralixibat chloride - solution (oral) - maralixibat chloride 10 mg/ml - maralixibat chloride - livamrli ® is an ileal bile acid transporter (ibat) inhibitor indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 1 year of age and older.

ইউরোপীয় ইউনিয়ন - ইংরেজি - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

hospira, inc. - zinc chloride (unii: 86q357l16b) (zinc cation - unii:13s1s8sf37) - zinc cation 1 mg in 1 ml - zinc 1 mg/ml (zinc chloride injection, usp) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition. administration helps to maintain zinc serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms. none known.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

american regent, inc. - zinc sulfate anhydrous (unii: 0j6z13x3wo) (zinc cation - unii:13s1s8sf37) - zinc cation 1 mg in 1 ml - zinc sulfate injection, usp is indicated for use as a supplement to intravenous solutions given for tpn. administration helps to maintain plasma levels and to prevent depletion of endogenous stores. zinc sulfate injection, usp should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential to increase renal loss of zinc from a bolus injection.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

ipsen biopharmaceuticals, inc. - mecasermin (unii: 7gr9i2683o) (mecasermin - unii:7gr9i2683o) - mecasermin 40 mg in 4 ml - severe primary igf-1 deficiency (primary igfd) increlex is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with: - severe primary igf-1 deficiency or - growth hormone (gh) gene deletion who have developed neutralizing antibodies to gh. severe primary igf-1 deficiency (igfd) is defined by: - height standard deviation score ≤ –3.0 and - basal igf-1 standard deviation score ≤ –3.0 and - normal or elevated growth hormone (gh). limitations of use: increlex is not a substitute to gh for approved gh indications. increlex is not indicated for use in patients with secondary forms of igf-1 deficiency, such as gh deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory corticosteroids. - known hypersensitivity increlex should not be used by patients who are allergic to mecasermin (rhigf-1) or any of the inactive ingredients in increlex, or who have experienced a severe hypersensitivity to increlex [see warnings and precautions (5.2) and adverse reactions (6.3)]. - closed epiphyses increlex should not be used for growth promotion in patients with closed epiphyses. - malignant neoplasia increlex is contraindicated in pediatric patients with malignant neoplasia or a history of malignancy [see warnings and precautions (5.7) and adverse reactions (6.3)]. risk summary there are no available data on increlex use in pregnant women. exposure to increlex during pregnancy is unlikely because the drug is not indicated for use after epiphyseal closure. in animal reproduction studies, there were no observed embryo-fetal development abnormalities with intravenous administration of increlex to pregnant rats and rabbits during fetal organogenesis given at exposures up to 11 and 3 times the maximum recommended human dose (mrhd) of 0.24 mg/kg/day based on body surface area (bsa), respectively (see data) . the estimated background risk of 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 studies to assess embryo-fetal toxicity evaluated the effects of increlex during organogenesis in sprague dawley rats given 1, 4, and 16 mg/kg/day and in new zealand white rabbits given 0.125, 0.5, and 2 mg/kg/day, administered intravenously. there were no observed embryo-fetal developmental abnormalities in rats given up to 16 mg/kg/day (11 times the mrhd based on bsa comparison). in the rabbit study, the noael for fetal toxicity was 0.5 mg/kg/day (approximately equivalent to the mrhd based on bsa) due to an increase in fetal death at 2 mg/kg. increlex displayed no teratogenicity or maternal toxicity in rabbits given up to 2 mg/kg (3 times the mrhd based on bsa). risk summary there is no information available on the presence of mecasermin in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for increlex and any potential adverse effects on the breast-fed child from increlex or from the underlying maternal condition. toxicity (gasping syndrome) with benzyl alcohol serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 mg/kg/day to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 mmol/l to 1.378 mmol/l). increlex contains 9 mg/ml benzyl alcohol as a preservative. additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. use of increlex in infants is not recommended [see warnings and precautions (5.8)] . safety and effectiveness in pediatric patients below the age of 2 years of age have not been established. the safety and effectiveness of increlex in patients aged 65 and over has not been established. instructions for use increlex® (eenk-ruh-lex) (mecasermin) injection for subcutaneous use read this instructions for use before you start using increlex and each time you get a refill. there may be new information. this information does not take the place of talking to your child's doctor about your child's medical condition or treatment. do not share your child's needles and syringes with another person. your child may give another person an infection or your child could get an infection from them. important : - inject increlex exactly as your child's doctor or nurse has shown you. - follow your doctor's instructions for the type of syringe and needle to use to prepare and inject your child's dose of increlex . - always use a new, unopened needle and syringe for each injection. - only use single-use, disposable needles and syringes. never reuse disposable needles and syringes. - throw away used needles and syringes in a puncture-resistant, disposable sharps container as soon as you finish giving the injection. see step 5 "how should i throw away (dispose of) used needles and syringes? " at the end of these instructions. supplies needed to give the injection: - 1 vial of increlex - 1 alcohol swab - 1 gauze or cotton ball - alcohol (to clean the skin at the injection site) - 1 sharps container for throwing away (disposing of) used needles and syringes. see step 5 "how should i throw away (dispose of) used needles and syringes? " at the end of these instructions. preparing the dose: - wash your hands before getting increlex ready for your child's injection. - check the liquid to make sure it is clear and colorless. do not use if it is cloudy or if you see particles. - check the expiration date printed on the label of the vial. do not use increlex if the expiration date has passed. - if you are using a new vial, remove the protective cap. do not remove the rubber top (see figure 1). figure 1: remove the protective cap - wipe the rubber top on the vial with an alcohol swab (see figure 2). figure 2: wipe rubber top with alcohol swab - before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the increlex dose. put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see figure 3). figure 3: inject air into vial - leave the syringe in the vial and turn both upside down. hold the syringe and vial firmly (see figure 4). figure 4: prepare to withdraw liquid - make sure the tip of the needle is in the liquid (see figure 5). pull the plunger to withdraw the correct dose into the syringe (see figure 6). figure 5: tip in liquidfigure 6: withdraw correct dose - before you take the needle out of the vial, check the syringe for air bubbles. if bubbles are in the syringe, hold the vial and syringe with needle straight up and tap the side of the syringe until the bubbles float to the top. push the bubbles out with the plunger and draw liquid back in until you have the correct dose (see figure 7). figure 7: remove air bubbles and refill syringe - remove the needle from the vial. do not let the needle touch anything. you are now ready to inject (see figure 8). figure 8: ready to inject injecting the dose: inject increlex exactly as your child's doctor or nurse has shown you. do not give the increlex injection if your child is unable to eat within 20 minutes before or after the injection . - put used needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - do not try to touch the needle. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how to throw away needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - for the safety and health of you and others, needles and used syringes must never be re-used. - the used alcohol swabs, cotton balls, and gauze may be placed in your household trash. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - always keep the sharps disposal container out of the reach of children. how should i store increlex? - before opening : store new, unopened vials of increlex in the refrigerator between 36°f to 46°f (2°c to 8°c). - after opening : store opened vials of increlex in the refrigerator between 36°f to 46°f (2°c to 8°c) for 30 days after you start using the vial. throw away any unused increlex after 30 days. - do not freeze increlex. if a vial freezes, throw it away. - keep increlex out of direct light. - do not use increlex after the expiration date printed on the label. keep increlex and all medicines out of reach of children. this instructions for use has been approved by the u.s. food and drug administration. for additional information, call 855-463-5127. manufactured by: ipsen biopharmaceuticals, inc. cambridge, ma 02142 usa u.s. license no. 2194 www.ipsenus.com revised: october 2023

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

american regent, inc. - zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [see warnings and precautions (5.6)] risk summary administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with intravenous zinc sulfate.  the estimated background risk of major birth defects and miscarriage for the indicated populations 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 deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. pregnant women have an increased metabolic demand for trace elements, including zinc.  parenteral nutrition with zinc should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary zinc is present in human milk. administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause harm to a breastfed infant. there is no information on the effects of zinc sulfate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zinc sulfate injection and any potential adverse effects on the breastfed infant from zinc sulfate injection or from the underlying maternal condition. zinc sulfate injection is approved for use in the pediatric population, including neonates, as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients [see dosage and administration (2.2)] . because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with zinc sulfate injection may be at higher risk of aluminum toxicity [see warnings and precautions (5.3)] . reported clinical experience with intravenous zinc sulfate has not identified a difference in zinc requirements between elderly and younger patients.  in general, dose selection should be individualized based on the patient’s clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

piramal critical care inc. - zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [ see warnings and precautions ( 5.6) ]. risk summary administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with intravenous zinc sulfate. the estimated background risk of major birth defects and miscarriage for the indicated populations 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 deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. pregnant women have an increased metabolic demand for trace elements, including zinc. parenteral nutrition with zinc should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary zinc is present in human milk. administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause harm to a breastfed infant. there is no information on the effects of zinc sulfate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zinc sulfate injection and any potential adverse effects on the breastfed infant from zinc sulfate injection or from the underlying maternal condition. zinc sulfate injection is approved for use in the pediatric population, including neonates, as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients [see dosage and administration ( 2.2)] . because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with zinc sulfate injection may be at higher risk of aluminum toxicity [see warnings and precautions ( 5.3)] . reported clinical experience with intravenous zinc sulfate has not identified a difference in zinc requirements between elderly and younger patients. in general, dose selection should be individualized based on the patient’s clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - zinc acetate (unii: fm5526k07a) (zinc cation - unii:13s1s8sf37) - zinc cation 25 mg - zinc acetate therapy is indicated for maintenance treatment of patients with wilson’s disease who have been initially treated with a chelating agent (see precautions: monitoring patients). zinc acetate capsules are contraindicated in patients with known hypersensitivity to any of the components of the formulation.