Spojené státy - angličtina - NLM (National Library of Medicine)

amgen usa inc. - evolocumab (unii: lkc0u3a8nj) (evolocumab - unii:lkc0u3a8nj) - repatha is indicated: - in adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization - as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (ldl-c)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce ldl-c - as an adjunct to diet and other ldl-c-lowering therapies in pediatric patients aged 10 years and older with hefh, to reduce ldl-c - as an adjunct to other ldl-c-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (hofh), to reduce ldl-c repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in repatha. serious hypersensitivity reactions including angioedema have occurred in patients treated with repatha [see warnings and precautions (5.1)]. risk summary available data from clinical trials and postmarketing reports on repatha use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, there were no effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times the exposure at the maximum recommended human dose of 420 mg every month. in a similar study with another drug in the pcsk9 inhibitor antibody class, humoral immune suppression was observed in infant monkeys exposed to that drug in utero at all doses. the exposures where immune suppression occurred in infant monkeys were greater than those expected clinically. no assessment for immune suppression was conducted with evolocumab in infant monkeys. measurable evolocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that evolocumab, like other igg antibodies, crosses the placental barrier. monoclonal antibodies are transported across the placenta in increasing amounts especially near term; therefore, evolocumab has the potential to be transmitted from the mother to the developing fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) 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. there is a pregnancy safety study for repatha. if repatha is administered during pregnancy, healthcare providers should report repatha exposure by contacting amgen at 1-800-77-amgen (1-800-772-6436) or https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting. data animal data in cynomolgus monkeys, no effects on embryo-fetal or postnatal development (up to 6 months of age) were observed when evolocumab was dosed during organogenesis to parturition at 50 mg/kg once every 2 weeks by the subcutaneous route at exposures 30- and 12-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma auc. no test of humoral immunity in infant monkeys was conducted with evolocumab. risk summary there is no information regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production. human igg is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for repatha and any potential adverse effects on the breastfed infant from repatha or from the underlying maternal condition. the safety and effectiveness of repatha in combination with diet and other ldl-c-lowering therapies for the treatment of hofh have been established in pediatric patients aged 10 years and older. use of repatha for this indication is supported by evidence from an adequate and well-controlled trial in adults and pediatric patients aged 13 years and older with hofh (including 7 pediatric patients treated with repatha) and from open-label studies which included an additional 19 pediatric patients aged 11 years and older with hofh not previously treated with repatha [ see adverse reactions (6.1) and clinical studies (14)]. the safety and effectiveness of repatha as an adjunct to diet and other ldl-c-lowering therapies for the treatment of hefh have been established in pediatric patients aged 10 years and older. use of repatha for this indication is based on data from a 24-week, randomized, placebo-controlled, double-blind trial in pediatric patients with hefh. in the trial, 104 patients received repatha 420 mg subcutaneously once monthly and 53 patients received placebo; 39 patients (25%) were 10 to 11 years of age [see adverse reactions (6.1) and clinical studies (14)] . the safety and effectiveness of repatha have not been established in pediatric patients with hefh or hofh who are younger than 10 years old or in pediatric patients with other types of hyperlipidemia. in controlled trials, 7656 (41%) patients treated with repatha were ≥ 65 years old and 1500 (8%) were ≥ 75 years old. no overall differences in safety or effectiveness were observed between these patients and younger patients, 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. no dose adjustment is needed in patients with renal impairment [see clinical pharmacology (12.3)]. no dose adjustment is needed in patients with mild to moderate hepatic impairment (child-pugh a or b). no data are available in patients with severe hepatic impairment [see clinical pharmacology (12.3)] . - it is important that you do not try to give yourself the injection unless you have received training from your healthcare provider. - children who are 10 to 17 years of age should use the on-body infusor and prefilled cartridge under adult supervision, as instructed by the healthcare provider. - keep the on-body infusor and prefilled cartridge in the original carton to protect from light or physical damage. - the on-body infusor and prefilled cartridge must be kept in the refrigerator 36°f to 46°f (2°c to 8°c). - for your injection, take your on-body infusor and prefilled cartridge out of the refrigerator and let them sit at room temperature for at least 45 minutes before you inject. - after you remove the on-body infusor and prefilled cartridge from the refrigerator, they should be kept at room temperature at 68°f to 77°f (20°c to 25°c) in the original carton and must be used within 30 days. - do not store the on-body infusor and prefilled cartridge in temperatures above 77°f (25°c) such as in your vehicle's glove box or trunk. do not freeze. - do not shake the on-body infusor or prefilled cartridge. - do not remove the on-body infusor and prefilled cartridge from the box or clear tray until you are ready to inject. - do not touch the start button until you place the loaded on-body infusor and prefilled cartridge onto your skin and are ready to inject. - after you insert the cartridge into the on-body infusor, make sure you give your injection within 5 minutes. waiting longer than 5 minutes can dry out the medicine. - you can only press the start button 1 time. if an error occurs, the on-body infusor cannot be used. - do not use the on-body infusor and prefilled cartridge if either has been dropped onto a hard surface. part of the on-body infusor and prefilled cartridge may be broken even if you cannot see the break. use a new on-body infusor and prefilled cartridge. - do not reuse the on-body infusor and prefilled cartridge. the on-body infusor and prefilled cartridge are for single-dose only. - do not let the on-body infusor get wet from water or any other liquids. it contains electronics that should not get wet. - the single-dose on-body infusor for subcutaneous injection is made to only be used with the prefilled cartridge. - moderate physical activities can be done during the injection process, such as walking, reaching and bending. - do not use the on-body infusor and prefilled cartridge after the expiration date on the carton. - the on-body infusor and prefilled cartridge are not made with natural rubber latex. - do not try to warm the prefilled cartridge by using a heat source such as hot water or a microwave. - do not touch the start button until the on-body infusor is on the skin and you are ready to inject. - do not use if the white paper cover is missing or damaged. - clear tray containing the on-body infusor and prefilled cartridge - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container - your thigh - stomach area (abdomen), except for a two -inch area right around your navel - outer area of upper arm (only if someone else is giving the injection) - do not touch this area again before injecting. - do not inject into areas where the skin is tender, bruised, red or hard. avoid injecting into areas with wrinkles, skin folds, scars, stretch marks, moles and excessive hair. - do not use if the medicine is cloudy or discolored or contains flakes or particles. - do not use if any part of the cartridge looks cracked or broken. - do not use if pieces of the cartridge are missing or not securely attached. - do not remove or rotate the cartridge top or bottom. - do not touch the bottom of the cartridge after cleaning with alcohol wipe. - do not touch the start button until you have placed the loaded on-body infusor on your skin. - do not close the door if the cartridge is missing or not fully inserted. - do not touch the start button until you have placed the loaded on-body infusor on your skin. - do not pull the skin adhesive backing off the on-body infusor. - do not touch the skin adhesive. - do not touch the start button until you have placed the loaded on-body infusor on your skin. - do not touch the needle cover area. - do not place the loaded on-body infusor on your body if the red status light flashes continuously. - do not fold the skin adhesive over onto itself. - do not move the loaded on-body infusor after it has been placed onto your skin. - you may hear a pumping sound. - you may feel a pinch. - make sure you see a green, flashing status light. - you may hear beeps that mean your injection has started. - the status light changes to solid green . - you hear several beeps. - the plunger fills medicine window all the way. - the used on-body infusor will beep when removed from your skin. - it is normal to see a few drops of fluid on your skin after you remove the used on-body infusor. - the on-body infusor contains batteries, electronics, and a needle. - put the used on-body infusor in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the on-body infusor in your household trash. - if you do not have a 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 you should throw away used 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. - 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. - do not recycle the on-body infusor or sharps disposal container or throw them into household trash. manufactured by : amgen inc. one amgen center drive thousand oaks, ca 91320-1799 © 2015-2021 amgen inc. all rights reserved. revised: 9/2021 v8 u.s. license number 1080 this instructions for use contains information on how to inject repatha. - it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. - the orange cap on the repatha sureclick autoinjector contains a needle cover (located inside the cap) that contains dry natural rubber, which is made from latex. tell your healthcare provider if you are allergic to latex. - keep the autoinjector and all medicines out of the reach of children. - keep the autoinjector in the original carton to protect from light. - keep the autoinjector in the refrigerator at 36°f to 46°f (2°c to 8°c). - after removing from the refrigerator, the autoinjector may be kept at room temperature between 68°f to 77°f (20°c to 25°c) and must be used within 30 days. - throw away repatha that has been stored at room temperature for more than 30 days. - do not store the autoinjector in extreme heat or cold. for example, avoid storing the autoinjector in your vehicle's glove box or trunk. - do not freeze or use the autoinjector if it has been frozen. - do not use the autoinjector after the expiration date on the label. - do not shake the autoinjector. - do not remove the orange cap from the autoinjector until you are ready to inject. leaving the cap off for more than 5 minutes can dry out the medicine. - do not use the autoinjector if it has been dropped on a hard surface. part of the autoinjector may be broken even if you cannot see the break. use a new autoinjector and call 1-844-repatha (1-844-737-2842). - do not try to warm the autoinjector by using a heat source such as hot water or microwave. - do not leave the autoinjector in direct sunlight. - do not shake the autoinjector. - do not remove the orange cap from the autoinjector yet. - do not use the autoinjector if the medicine is cloudy or discolored or contains flakes or particles. - do not use the autoinjector if any part appears cracked or broken. - do not use the autoinjector if the autoinjector has been dropped. - do not use the autoinjector if the orange cap is missing or not securely attached. - do not use the autoinjector if the expiration date printed on the label has passed. - new autoinjector - alcohol wipes - cotton balls or gauze pads - adhesive bandages - sharps disposal container (see step 4: finish ) - thigh - stomach (abdomen), except for a 2 inch area around your navel (belly button) - outer area of upper arm (only if someone else is giving you the injection) - do not touch this area again before injecting. - choose a different site each time you give yourself an injection. if you want to use the same injection site, make sure it is not the same spot you used for the last injection. - do not inject into areas where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. - avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. - do not twist, bend, or wiggle the orange cap. - do not put the orange cap back onto the autoinjector. - do not put fingers into the yellow safety guard. - do not remove the orange cap from the autoinjector until you are ready to inject. - 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. - do not reuse the autoinjector. - do not recap the autoinjector or put fingers into the yellow safety guard. manufactured by: amgen inc. one amgen center drive thousand oaks, ca 91320-1799 u.s. license no: 1080 © 2015-2022 amgen inc. all rights reserved. revised: 8/2022 v9 this printed material is recyclable. - it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. - the gray needle cap on the repatha prefilled syringe contains dry natural rubber, which is made from latex. tell your healthcare provider if you are allergic to latex. - keep the repatha prefilled syringe in the original carton to protect from light during storage. - keep the repatha prefilled syringe in the refrigerator between 36°f to 46°f (2°c to 8°c). - if removed from the refrigerator, the repatha prefilled syringe should be kept at room temperature at 68°f to 77°f (20°c to 25°c) in the original carton and must be used within 30 days. - do not freeze the repatha prefilled syringe or use a repatha prefilled syringe that has been frozen. - do not use the repatha prefilled syringe if the packaging is open or damaged. - do not remove the gray needle cap from the repatha prefilled syringe until you are ready to inject. - do not use the repatha prefilled syringe if it has been dropped onto a hard surface. part of the repatha prefilled syringe may be broken even if you cannot see the break. use a new repatha prefilled syringe and call 1-844-repatha (1-844-737-2842). - do not use the repatha prefilled syringe after the expiration date. - 1 repatha prefilled syringe in carton - alcohol wipes - cotton ball or gauze pad - adhesive bandage - sharps disposal container (see step 4: finish) check the expiration date on the repatha prefilled syringe carton: do not use if this date has passed. - thigh - stomach (abdomen), except for a two inch area around your belly button - peel paper off of tray. - place the tray on your hand. - turn the tray over and gently press the middle of the tray's back to release the syringe into your palm. - if prefilled syringe does not release from tray, gently press on back of tray do not pick up or pull the prefilled syringe by the plunger rod or gray needle cap. this could damage the syringe. do not remove the gray needle cap from the prefilled syringe until you are ready to inject. always hold the prefilled syringe by the syringe barrel. - the name repatha appears on the prefilled syringe label. - the medicine in the prefilled syringe is clear and colorless to slightly yellow. - the expiration date on the prefilled syringe has not passed. if the expiration date has passed, do not use the prefilled syringe. do not use the prefilled syringe if any part of the prefilled syringe appears cracked or broken. do not use the prefilled syringe if the gray needle cap is missing or not securely attached. do not use the prefilled syringe if the medicine is cloudy or discolored or contains particles. - put the used syringe in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the syringe in your household trash. - if you do not have a 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 you should throw away used 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. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: amgen inc. thousand oaks, ca 91320-1799 © 2015-2016, 2021 amgen inc. all rights reserved. issued: 5/2021 v3

Spojené státy - angličtina - NLM (National Library of Medicine)

direxctrx - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - 1.1 treatment of active duodenal ulcer omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. 1.2 helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. dual therapy omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin is more likely to be associated with the

Spojené státy - angličtina - NLM (National Library of Medicine)

rugby laboratories - purified water (99.05%) - eyewash washes the eye to help relieve - irritation - discomfort - burning - stinging - itching by removing - loose foreign material - air pollutants (smog or pollen) - chlorinated water

Spojené státy - angličtina - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine transdermal system is indicated in adults for the prevention of: scopolamine transdermal system is contraindicated in patients with: available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine (see data) . in animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. 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,

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - alanine; arginine ; glycine; histidine; isoleucine; leucine ; lysine hydrochloride; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine; sodium acetate trihydrate ; potassium chloride; calcium chloride dihydrate; magnesium sulphate heptahydrate ; sodium glycerophosphate hydrate; zinc sulphate heptahydrate; glucose monohydrate; soya bean oil, refined ph.eur; olive oil, refined; medium chain triglycerides saturated; fish oil, rich in omega-3 acids - emulsion for infusion - 42% +10 % + 20 percent - solutions for parenteral nutrition; amino acids

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - alanine; arginine ; glycine; histidine; isoleucine; leucine ; lysine hydrochloride; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine; sodium acetate trihydrate ; potassium chloride; calcium chloride dihydrate; magnesium sulphate heptahydrate ; sodium glycerophosphate hydrate; zinc sulphate heptahydrate; glucose monohydrate; soya bean oil, refined ph.eur; olive oil, refined; medium chain triglycerides saturated; fish oil, rich in omega-3 acids - emulsion for infusion - 13 %+ 10 % +20 percent - solutions for parenteral nutrition; amino acids

Spojené státy - angličtina - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - brolucizumab (unii: xsz53g39h5) (brolucizumab - unii:xsz53g39h5) - beovu® is indicated for the treatment of: beovu is contraindicated in patients with ocular or periocular infections. beovu is contraindicated in patients with active intraocular inflammation. beovu is contraindicated in patients with known hypersensitivity to brolucizumab or any of the excipients in beovu. hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation. risk summary there are no adequate and well-controlled studies of beovu administration in pregnant women. in an animal reproduction study, intravitreal administration of brolucizumab to pregnant monkeys once every 4 weeks in one eye from organogenesis to birth did not indicate any harmful effects with respect to pre- or postnatal development at 10-fold the maximum recommended human dose (mrhd) on a mg/kg basis (see data ). based on the anti-vegf mechanism of action for brolucizumab [see clinical pharmacology (12.1)] , treatment with beovu may pose a risk to human embryo-fetal development. beovu should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. all pregnancies have a background risk of birth defect, loss, and other adverse outcomes. the 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 is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in an enhanced pre- and postnatal development (eppnd) study in pregnant cynomolgus monkeys, brolucizumab was administered to all animals by intravitreal (ivt) injection to one eye at doses of 3 or 6 mg once every 4 weeks until delivery. there was no impact of ivt administration of brolucizumab on embryo-fetal development, pregnancy or parturition; or on the survival, growth, or postnatal development of offspring at 6 mg/eye (10-fold the mrhd on a mg/kg basis). vegf inhibition has been shown to cause malformations, embryo-fetal resorption, and decreased fetal weight. vegf also has been shown to affect follicular development, corpus luteum function, and fertility. risk summary there is no information regarding the presence of brolucizumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion. because many drugs are transferred in human milk and because of the potential for absorption and adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for at least one month after the last dose when stopping treatment with beovu. contraception females females of reproductive potential should use highly effective contraception (methods that result in less than 1% pregnancy rates) during treatment with beovu and for at least one month after the last dose when stopping treatment with beovu. infertility no studies on the effects of brolucizumab on fertility have been conducted. based on its anti-vegf mechanism of action, treatment with beovu may pose a risk to reproductive capacity. the safety and efficacy of beovu in pediatric patients has not been established. in the two phase 3 clinical studies in amd, approximately 90% (978/1089) of patients randomized to treatment with beovu were ≥ 65 years of age and approximately 60% (648/1089) were ≥ 75 years of age. in the two phase 3 clinical studies in dme, approximately 45% (164/368) of patients randomized to treatment with beovu were ≥ 65 years of age and approximately 10% (37/368) were ≥ 75 years of age. no significant differences in efficacy or safety were seen with increasing age in these studies. no dosage regimen adjustment is required in patients 65 years and above.

Malta - angličtina - Malta Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - glucose, amino acids - emulsion for infusion - glucose 50 % amino acids 5.9 % - blood substitutes and perfusion solutions

Spojené státy - angličtina - NLM (National Library of Medicine)

proficient rx lp - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole tablets are indicated for the treatment of: additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole tablets are contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including arip

Spojené státy - angličtina - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - ofatumumab (unii: m95kg522r0) (ofatumumab - unii:m95kg522r0) - kesimpta is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. kesimpta is contraindicated in patients with: - active hbv infection [see warnings and precautions (5.1)] . - history of hypersensitivity to ofatumumab or life-threatening injection-related reaction to kesimpta. hypersensitivity reactions have included anaphylaxis and angioedema [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to kesimpta during pregnancy. healthcare providers are encouraged to enroll pregnant patients, or pregnant women may register themselves in the mothertobaby pregnancy study in multiple sclerosis by calling 1-877-311-8972, by sending an email to mothertobaby@health.ucsd.edu, or by going to www.mothertobaby.org/join-study. risk summary there are no adequate data on the developmental risk associated with the use of kesimpta in pregnant women. ofatumumab may cross the placenta and cause fetal b-cell depletion based on findings from animal studies (see data ). transient peripheral b-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-cd20 antibodies during pregnancy. b-cell levels in infants following maternal exposure to kesimpta have not been studied in clinical trials. the potential duration of b-cell depletion in infants exposed to ofatumumab in utero , and the impact of b-cell depletion on the safety and effectiveness of vaccines, are unknown. avoid administering live vaccines to neonates and infants exposed to kesimpta in utero until b-cell recovery occurs [see warnings and precautions (5.2) and clinical pharmacology (12.2)] . following administration of ofatumumab to pregnant monkeys, increased mortality, depletion of b-cell populations, and impaired immune function were observed in the offspring, in the absence of maternal toxicity, at plasma levels substantially higher than that in humans (see data ). 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data intravenous administration of ofatumumab (weekly doses of 0, 20, or 100 mg/kg) to pregnant monkeys during the period of organogenesis (gestations days 20 to 50) resulted in no adverse effects on embryofetal development; however, b-cell depletion was observed in fetuses at both doses when assessed on gestation day 100. plasma exposure (cave ) at the no-effect dose (100 mg/kg) for adverse effects on embryofetal development was greater than 5000 times that in humans at the recommended human maintenance dose of 20 mg. a no-effect dose for effects on b-cells was not identified; plasma exposure (cave ) at the low-effect dose (20 mg/kg) was approximately 780 times that in humans at the recommended human maintenance dose (rhmd) of 20 mg/month. intravenous administration of ofatumumab (5 weekly doses of 0, 10, and 100 mg/kg, followed by biweekly doses of 0, 3, and 20 mg/kg) to pregnant monkeys throughout pregnancy resulted in no adverse effects on the development of the offspring. however, postnatal death, b-cell depletion, and impaired immune function were observed in the offspring at the high dose. the deaths at the high dose were considered secondary to b-cell depletion. plasma exposure (cave ) in dams at the no-effect dose (100/20 mg/kg) for adverse developmental effects was approximately 500 times that in humans at rhmd. a no-effect level for mortality and immune effects in offspring was not established because of the limited number of evaluable offspring at the low dose. risk summary there are no data on the presence of ofatumumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. human igg is excreted in human milk, and the potential for absorption of ofatumumab to lead to b-cell depletion in the infant is unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kesimpta and any potential adverse effects on the breastfed infant from kesimpta or from the underlying maternal condition. contraception females of childbearing potential should use effective contraception while receiving kesimpta and for 6 months after the last treatment of kesimpta [see warnings and precautions (5.4) and clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients have not been established. clinical studies of kesimpta did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger subjects. - do not use the kesimpta sensoready pen if either the seal on the outer carton or the seal on the kesimpta sensoready pen is broken. keep the kesimpta sensoready pen in the sealed outer carton until you are ready to use it. - do not shake the kesimpta sensoready pen. - if you drop your kesimpta sensoready pen, do not use it if it looks damaged, or if you dropped it with the cap removed. - store your carton of kesimpta sensoready pen in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep kesimpta sensoready pen in the original carton until ready to use to protect from light. - if needed, kesimpta sensoready pen may be stored for up to 7 days at room temperature, up to 86°f (30°c). - write the date taken out of the refrigerator in the space provided on the carton. - if stored below 86°f (30°c), unused kesimpta may be returned to the refrigerator and must be used within the next 7 days. if this kesimpta is not used within those 7 days, then discard the medicine. - do not freeze kesimpta sensoready pen. - 1 alcohol wipe - 1 cotton ball or gauze - sharps disposal container - look through the viewing window. the liquid should be clear to slightly cloudy. - look at the expiration date (exp) on your kesimpta sensoready pen. do not use your pen if the expiration date has passed. - the recommended site is the front of the thighs. you may also use the lower stomach area (lower abdomen), but not the area 2 inches around the navel (belly button) (see figure e ). - do not inject into areas where the skin is tender, bruised, red, scaly, or hard. avoid areas with moles, scars or stretch marks. - if a caregiver or healthcare provider is giving you your injection, they may also inject into your outer upper arm (see figure f ). - wash your hands with soap and water. - using a circular motion, clean the injection site with the alcohol wipe. leave it to dry before injecting (see figure g ). - do not touch the cleaned area again before injecting. - only remove the cap when you are ready to use the kesimpta sensoready pen. - twist off the cap in the direction of the arrow (see figure h ). - throw away the cap. do not try to re-attach the cap. - use the kesimpta sensoready pen within 5 minutes of removing the cap. - hold the kesimpta sensoready pen at 90 degrees to the cleaned injection site (see figure i ). - the 1st click indicates that the injection has started - a 2nd click will indicate that the injection is almost complete - press the kesimpta sensoready pen firmly against the skin to start the injection (see figure j ). - the 1st click indicates the injection has started. - keep holding the kesimpta sensoready pen firmly against your skin. - the green indicator shows the progress of the injection. - listen for the 2nd click. this indicates that the injection is almost complete. - check to see if the green indicator fills the window and has stopped moving (see figure k ). - the kesimpta sensoready pen can now be removed (see figure l ). - in case the green indicator does not fill the window, it means the medicine has not been delivered. contact your healthcare provider if the green indicator is not visible. - there may be a small amount of blood at the injection site. you can press a cotton ball or gauze over the injection site and hold it for 10 seconds. do not rub the injection site. you may cover the injection site with a small adhesive bandage, if needed. - 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. t2022-54 - do not use the kesimpta prefilled syringe if either the seal on the outer carton or the seal of the blister is broken. keep the kesimpta prefilled syringe in the sealed carton until you are ready to use it. - do not shake the kesimpta prefilled syringe. - the kesimpta prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. the needle guard will help to prevent needle stick injuries to anyone who handles the kesimpta prefilled syringe after injection. - do not remove the needle cap until just before you give the injection. - avoid touching the syringe guard wings before use. touching them may cause the needle guard to be activated too early. - do not use if the prefilled syringe has been dropped onto a hard surface or dropped after removing the needle cap. - throw away (dispose of) the used kesimpta prefilled syringe right away after use. do not re-use a kesimpta prefilled syringe. see "how should i dispose of used kesimpta prefilled syringes?” at the end of these instructions for use. - store your carton of the kesimpta prefilled syringe in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the kesimpta prefilled syringe in the original carton until ready to use to protect from light. - if needed, kesimpta prefilled syringe may be stored for up to 7 days at room temperature, up to 86°f (30°c). - write the date taken out of the refrigerator in the space provided on the carton. - if stored below 86°f (30°c), unused kesimpta may be returned to the refrigerator and must be used within the next 7 days. if this kesimpta is not used within those 7 days, then discard the medicine. - do not freeze the kesimpta prefilled syringe. - 1 alcohol wipe - 1 cotton ball or gauze - sharps disposal container - areas of your body that you may use as injection sites include: the front of your thighs (see figure d ) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure d ) your outer upper arms, if a healthcare provider or caregiver is giving you the injection (see figure e ) - the front of your thighs (see figure d ) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure d ) - your outer upper arms, if a healthcare provider or caregiver is giving you the injection (see figure e ) - do not inject into areas where the skin is tender, bruised, red, scaly, or hard. avoid areas with moles, scars, or stretch marks. - 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. t2024-33