Estats Units - anglès - NLM (National Library of Medicine)

eton pharmaceuticals, inc. - hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj) - alkindi sprinkle is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. alkindi sprinkle is contraindicated in patients with hypersensitivity to hydrocortisone or to any of the ingredients in alkindi sprinkle. anaphylactic reactions have occurred in patients receiving corticosteroids [see adverse reactions (6.2)] . risk summary untreated adrenocortical insufficiency in pregnancy can result in a high rate of complications, including maternal mortality. the use of physiologic doses of hydrocortisone is not expected to cause major birth defects, miscarriage and adverse maternal and fetal outcomes. available data from observational studies with hydrocortisone use in pregnancy have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (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 human data available data from observational studies with hydrocortisone use in pregnant women have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. evidence from published epidemiologic studies suggest that there may be a small increased risk of cleft lip with or without cleft palate associated with first trimester systemic corticosteroid use in pregnant patients. however, the data are limited and report inconsistent findings, and studies have important methodological limitations, including non-randomized design, retrospective data collection, lack of dose-response data and the inability to control for confounders, such as underlying maternal disease and use of concomitant medications. in addition, unlike other corticosteroids, hydrocortisone is enzymatically deactivated by the placenta and therefore, limits fetal exposure. animal data corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. animal studies in which corticosteroids have been given to pregnant mice, rats and rabbits without adrenocortical insufficiency have yielded an increased incidence of cleft palate in the offspring. risk summary cortisol is present in human milk. the use of hydrocortisone at a physiologic dose for adrenocortical insufficiency is not expected to adversely affect the breastfed infant or milk production. there are no data on the presence of hydrocortisone in breast milk, the effect on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for alkindi sprinkle and any potential adverse effects on the breastfed infant from alkindi sprinkle or from the underlying maternal condition. the safety and effectiveness of alkindi sprinkle have been established in pediatric patients for replacement therapy of adrenocortical insufficiency and the information on this use is discussed throughout the labeling. use of alkindi sprinkle in pediatric patients is supported by use in pediatric patients for adrenocortical insufficiency with another hydrocortisone product, along with supportive pharmacokinetic and safety data in 24 pediatric patients with adrenocortical insufficiency. no new adverse reactions were identified [see adverse reactions (6) and clinical pharmacology (12.3)] . alkindi sprinkle are oral granules contained within capsules that must be opened and not swallowed whole to administer the granules. additionally, alkindi sprinkle granules should not be administered via nasogastric or gastric tubes as they may cause tube blockage [see dosage and administration (2.2)] . instructions for use alkindi® sprinkle(ælˈkɪndi spr-en-kle) (hydrocortisone) oral granules read this instructions for use before you start using alkindi sprinkle, and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your child's medical condition or treatment. important information you need to know before giving alkindi sprinkle - alkindi sprinkle comes in a capsule that must be opened before use. - do not let your child swallow the capsule. small children may choke. - do not let your child chew or crush the granules in the capsule. - do not let the capsules get wet as this may make some of the granules stick to the capsule. - your healthcare provider will decide the right dose of alkindi sprinkle for your child. follow your healthcare provider's instructions for the dose of alkindi sprinkle to give your child. - ask your healthcare provider or pharmacist if you are not sure how to prepare or give the prescribed dose of alkindi sprinkle to your child. - call your healthcare provider if granules come back up into your child's mouth (regurgitation) or your child has vomiting after swallowing alkindi sprinkle. your child may not have received the full dose of alkindi sprinkle and another dose of alkindi sprinkle may be needed. - your child may sometimes pass the alkindi sprinkle granules in their stools (bowel movement). it does not mean that alkindi sprinkle is not working. do not give your child another dose of alkindi sprinkle. supplies needed to give alkindi sprinkle: - alkindi sprinkle capsule(s) for prescribed dose - 1 spoon - soft food such as yogurt or pureed fruit or sip of fluids such as water, milk, breastmilk or formula preparing and giving alkindi sprinkle: step 1: check the expiration date on the alkindi sprinkle bottle. do not use alkindi sprinkle after the expiration date on the bottle has passed. step 2: remove the prescribed dose of alkindi sprinkle capsules from the bottle. step 6: giving alkindi sprinkle alkindi sprinkle can be given (a) with food onto a spoon, (b) without food onto a spoon, or (c) directly into the child's mouth. do not add the granules to a fluid before giving alkindi sprinkle because it can result in less than the full dose given and it may leave a bitter taste in the mouth. (c) directly onto the child's tongue. pour all granules that make up the prescribed dose directly onto the child's tongue. tap the capsule to make sure all granules are removed. the alkindi sprinkle granules should be given and swallowed within 5 minutes to avoid a bitter taste. step 7: give fluids after giving alkindi sprinkle, give a sip of fluids such as water, milk, breastmilk or formula right away to make sure all granules are swallowed. throwing away (disposal of) alkindi sprinkle: ask your pharmacist how to throw away medicines you no longer use. how should i store alkindi sprinkle? - store alkindi sprinkle at room temperature between 68°f to 77°f (20°c to 25°c). - store in the original bottle to protect from light. - after the bottle has been opened, use the alkindi sprinkle capsules within 60 days. keep alkindi sprinkle and all medicines out of the reach of children. alkindi sprinkle is manufactured for eton pharmaceuticals, inc. by glatt pharmaceutical services gmbh & co. kg werner-glatt-strasse 1, binzen, baden-wuerttemberg, 79589, germany alkindi® is a registered trademark of diurnal limited. alkindi is covered by the following us patents: 9,649,280; 9,675,559; 9,717,740; and other patents in other countries internationally. for more information, go to www.alkindisprinkle.com or call 1-833-343-2500. this instructions for use has been approved by the u.s. food and drug administration. revised: 12/2022

Israel - anglès - Ministry of Health

medomie pharma ltd, israel - hydrocortisone - granules in capsules for opening - hydrocortisone 0.5 mg - hydrocortisone - alkindi is indicated for replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old)

Israel - anglès - Ministry of Health

medomie pharma ltd, israel - hydrocortisone - granules in capsules for opening - hydrocortisone 1 mg - hydrocortisone - alkindi is indicated for replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old)

Israel - anglès - Ministry of Health

medomie pharma ltd, israel - hydrocortisone - granules in capsules for opening - hydrocortisone 2 mg - hydrocortisone - alkindi is indicated for replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old)

Israel - anglès - Ministry of Health

medomie pharma ltd, israel - hydrocortisone - granules in capsules for opening - hydrocortisone 5 mg - hydrocortisone - alkindi is indicated for replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old)

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

south eastern sydney local health district - skin, quantity: 1 u - graft - excipient ingredients: glycerol - skin - repair, replacement and regeneration of lost ordamaged skin

Estats Units - anglès - NLM (National Library of Medicine)

eiger biopharmaceuticals, inc. - lonafarnib (unii: iow153004f) (lonafarnib - unii:iow153004f) - zokinvy is indicated in patients 12 months of age and older with a body surface area (bsa) of 0.39 m2 and above: - to reduce the risk of mortality in hutchinson-gilford progeria syndrome (hgps) - for the treatment of processing-deficient progeroid laminopathies with either: heterozygous lmna mutation with progerin-like protein accumulation homozygous or compound heterozygous zmpste24 mutations - heterozygous lmna mutation with progerin-like protein accumulation - homozygous or compound heterozygous zmpste24 mutations limitations of use zokinvy is not indicated for other progeroid syndromes or processing-proficient progeroid laminopathies. based upon its mechanism of action, zokinvy would not be expected to be effective in these populations. zokinvy is contraindicated in patients taking: - strong cyp3a inhibitors [see drug interactions (7.1)] - strong or moderate cyp3a inducers [see drug interactions (7.1)] - midazolam [see drug interactions (7.2)] - lovastatin, simvastatin, or atorvastatin [see drug interactions (7.2)] risk summary based on findings from animal studies, zokinvy can cause embryofetal harm when administered to a pregnant woman. there are no human data on zokinvy use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. advise pregnant women of the risk to a fetus. in animal reproduction studies, oral administration of lonafarnib to pregnant rats during organogenesis produced embryo-fetal toxicity at exposures that were 1.2-times the human exposure at the recommended dose of 150 mg/m2 twice daily. in pregnant rabbits, oral administration of lonafarnib during organogenesis produced skeletal malformations and variations at exposures lower than the human exposure at 150 mg/m2 twice daily, and maternal toxicity at 26 times the human exposure at 150 mg/m2 twice daily (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. data animal data in an embryo-fetal development study in rats, oral administration of lonafarnib during organogenesis produced an increase in post-implantation loss (resorptions) and decreases in fetal body weight and number of live fetuses at 30 mg/kg/day (1.2 times the auc [area under the plasma concentration-time curve] in humans at the recommended dose of 150 mg/m2 twice daily). no effects on embryo-fetal development in rats were observed at systemic exposures lower than the human auc at 150 mg/m2 twice daily. in rabbits, oral administration of lonafarnib during organogenesis resulted in skeletal malformations and variations at systemic exposures lower than the human auc at the recommended dose of 150 mg/m2 twice daily, and maternal toxicity (body weight loss and abortion) at 120 mg/kg/day (26 times the human auc at 150 mg/m2 twice daily). no effects in offspring were observed in a pre- and postnatal development study in rats with maternal administration of up to 20 mg/kg/day orally (auc lower than the human auc at 150 mg/m2 twice daily) during organogenesis through lactation. risk summary there are no data on the presence of zokinvy in human milk, the effects on the breastfed infant, or the effects on milk production. lonafarnib is excreted in rat milk (see data) . when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zokinvy and any potential adverse effects of the breastfed infant from zokinvy or from the underlying maternal condition. data lonafarnib is excreted in milk following oral administration in lactating rats, with a mean milk to plasma concentration ratio of 1.5 at 12 hours. contraception zokinvy can cause embryo-fetal harm when administered to pregnant women [see use in specific populations (8.1)] . advise females of reproductive potential to use appropriate effective contraception during treatment with zokinvy. infertility based on findings in rats, zokinvy may reduce fertility in females and males of reproductive potential [see warnings and precautions (5.6), nonclinical toxicology (13.1)] . the safety and effectiveness of zokinvy for the treatment of hgps and processing-deficient progeroid laminopathies (with either heterozygous lmna mutation with progerin-like protein accumulation or homozygous or compound heterozygous zmpste24 mutations) have been established in pediatric patients 12 months of age and older. use of zokinvy for these indications is supported by adequate and well-controlled studies in pediatric patients 2 years of age and older [see clinical studies (14)] . the safety and effectiveness of zokinvy in pediatric patients less than 12 months of age have not been established. the safety and effectiveness of zokinvy for the treatment of hgps and processing-deficient progeroid laminopathies (with either heterozygous lmna mutation with progerin-like protein accumulation or homozygous or compound heterozygous zmpste24 mutations) have been established in adults. use of zokinvy in adults for these indications is based on adequate and well-controlled studies in pediatric patients 2 years of age and older [see clinical studies (14)] . instructions for use zokinvy™ (zo-kinvy) (lonafarnib) capsules, for oral use this instructions for use contains information on how to mix and give or take a dose of zokinvy if the capsules cannot be swallowed whole. read this instructions for use before you start giving or taking zokinvy and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about you or your child’s medical condition or treatment supplies needed to prepare and give or take a dose of zokinvy   before mixing a dose of zokinvy, gather the following supplies: - the prescribed number of zokinvy capsules for you or your child’s dose. place the capsule or capsules on a clean flat surface. - either ora-blend sf, ora-plus, orange juice or applesauce for mixing. do not mix with juice that contains grapefruit or seville oranges. seville oranges may also be called bitter or sour oranges. - if mixing with ora-blend sf, ora-plus or orange juice: a clean medicine cup with 5 milliliter (ml) and 10 ml measurement levels, or if mixing with applesauce: a clean teaspoon. - clean cup(s) for each zokinvy capsule to be mixed. - a clean spoon for stirring the mixture. how to open zokinvy capsules and mix the capsule contents step 1: if mixing with ora-blend sf, ora-plus or orange juice: use a clean medicine cup to measure either 5 ml or 10 ml of ora-blend sf, ora-plus or orange juice. if mixing with applesauce: measure either 1 or 2 teaspoonfuls of applesauce. you can choose to use 5 ml or 10 ml of liquid or 1 or 2 teaspoonfuls of applesauce (see figure a). step 2: place the ora-blend sf, ora-plus, orange juice or applesauce measured in step 1 into a clean cup (see figure b). step 3: hold a zokinvy capsule above the clean cup containing the liquid or applesauce. hold the zokinvy capsule on both sides between your thumb and forefinger. gently twist and pull apart the capsule (see figure c). empty the contents of the capsule directly into the clean cup (see figure d). step 4: using a clean spoon, mix the zokinvy capsule contents well (see figure e) . if only 1 capsule is to be taken, skip to step 6 . if 2 capsules are to be taken, go to step 5 . step 5: if 2 capsules will be taken, repeat steps 1 through 4 for the second capsule. after completing the mixing process for the second capsule, the 2 servings can either be placed together in a single cup or remain in 2 serving cups for you or your child to take the full dose of zokinvy. after you finish, go to step 6 . step 6: give or take all of the zokinvy mixture with morning and evening meals within about 10 minutes of preparing. how should i store zokinvy? - store at room temperature between 68°f to 77°f (20°c to 25°c) keep zokinvy and all medicines out of reach of children. this instructions for use has been approved by the u.s. food and drug administration. manufactured for: eiger biopharmaceuticals, inc., 2155 park boulevard palo alto, ca 94306 ©2020 eiger biopharmaceuticals issued: 11/2020

Unió Europea - anglès - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastic agents - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy.brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Israel - anglès - Ministry of Health

megapharm ltd - aldesleukin - powder for solution for infusion - aldesleukin 18 miu - aldesleukin - proleukin (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic rcc). proleukin is indicated for the treatment of adults with metastatic melanoma.careful patient selection is mandatory prior to the administration of proleukin.

Unió Europea - anglès - EMA (European Medicines Agency)

eigerbio europe limited - lonafarnib - progeria; laminopathies - other alimentary tract and metabolism products, - zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of hutchinson-gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous lmna mutation with progerin-like protein accumulation or a homozygous or compound heterozygous zmpste24 mutation.