Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

amgen inc - pegfilgrastim (unii: 3a58010674) (pegfilgrastim - unii:3a58010674) - pegfilgrastim 6 mg in 0.6 ml - neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see clinical studies (14.1)] . limitations of use neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. neulasta is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see dosage and administration (2.2) and clinical studies (14.2)] . neulasta is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. reactions have included anaphylaxis [see warnings and precautions (5.3)] . risk summary although available data with neulasta use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outc

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lipegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: acetic acid; polysorbate 20; sorbitol; sodium hydroxide; water for injections - lonquex? is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)

Euroopa Liit - inglise - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Iisrael - inglise - Ministry of Health

kamada ltd, israel - pegfilgrastim - solution for injection - pegfilgrastim 10 mg/ml - pegfilgrastim - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

Iisrael - inglise - Ministry of Health

amgen europe b.v. - pegfilgrastim - solution for injection - pegfilgrastim 10 mg/ml ml - pegfilgrastim - pegfilgrastim - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy. ( with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Iisrael - inglise - Ministry of Health

abic marketing ltd, israel - lipegfilgrastim - solution for injection - lipegfilgrastim 6 mg / 0.6 ml - lipegfilgrastim - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

mylan institutional llc - pegfilgrastim (unii: 3a58010674) (pegfilgrastim - unii:3a58010674) - fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see clinical studies (14.1)] . fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. fulphila is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. reactions have included anaphylaxis [see warnings and precautions (5.3)] . although available data with fulphila or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. these studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). in pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (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 2-4% and 15-20%, respectively. retrospective studies indicate that exposure to pegfilgrastim is without significant adverse effect on fetal outcomes and neutropenia. preterm deliveries have been reported in some patients. pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. at cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. no evidence of fetal loss or structural malformations was observed in any study. cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation). there are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production. other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fulphila and any potential adverse effects on the breastfed child from fulphila or from the underlying maternal condition. the safety and effectiveness of pegfilgrastim have been established in pediatric patients. no overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature. use of pegfilgrastim in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients with sarcoma [see clinical pharmacology (12.3) and clinical studies (14.1)] . of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. no overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

biocon biologics inc. - pegfilgrastim (unii: 3a58010674) (pegfilgrastim - unii:3a58010674) - fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see clinical studies (14.1)] . fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. fulphila is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. reactions have included anaphylaxis [see warnings and precautions (5.3)] . although available data with fulphila or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. these studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). in pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (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 2-4% and 15-20%, respectively. retrospective studies indicate that exposure to pegfilgrastim is without significant adverse effect on fetal outcomes and neutropenia. preterm deliveries have been reported in some patients. pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. at cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. no evidence of fetal loss or structural malformations was observed in any study. cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation). there are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production. other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fulphila and any potential adverse effects on the breastfed child from fulphila or from the underlying maternal condition. the safety and effectiveness of pegfilgrastim have been established in pediatric patients. no overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature. use of pegfilgrastim in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients with sarcoma [see clinical pharmacology (12.3) and clinical studies (14.1)] . of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. no overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

coherus biosciences inc - pegfilgrastim (unii: 3a58010674) (pegfilgrastim - unii:3a58010674) - udenyca is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see clinical studies (14.1)] . limitations of use udenyca is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. udenyca is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see dosage and administration (2.2) and clinical studies (14.2)] . udenyca is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. reactions have included anaphylaxis [see warnings and precautions (5.3)] . risk summary although available data with udenyca or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. these studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). in pregnant rabbits, increased embryo lethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (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 risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. at cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. no evidence of fetal loss or structural malformations was observed in any study. cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation). risk summary there are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production. other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for udenyca and any potential adverse effects on the breastfed child from udenyca or from the underlying maternal condition. the safety and effectiveness of udenyca have been established in pediatric patients. no overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature. use of udenyca in pediatric patients for chemotherapy-induced neutropenia is based on udenyca's approval as a biosimilar to pegfilgrastim and evidence from adequate and well controlled studies of pegfilgrastim in adults with additional pharmacokinetic and safety data of pegfilgrastim in pediatric patients with sarcoma [see clinical pharmacology (12.3) and clinical studies (14.1)] . the use of udenyca to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on udenyca's approval as a biosimilar to pegfilgrastim and evidence from efficacy studies of pegfilgrastim conducted in animals and clinical data supporting the use of pegfilgrastim in patients with cancer receiving myelosuppressive chemotherapy. efficacy studies of pegfilgrastim products could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. results from population modeling and simulation indicate that two doses of pegfilgrastim (table 1), administered one week apart provide pediatric patients with exposures comparable to that in adults receiving two 6 mg doses one week apart [see dosage and administration (2.3), clinical pharmacology (12.3) and clinical studies (14.2)] . of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. no overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients. - store udenyca prefilled syringes in the refrigerator between 36°f to 46° f (2°c to 8°c). - keep the udenyca prefilled syringe in the original carton to protect from light. - do not freeze udenyca. if udenyca is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting. throw away (dispose of) any udenyca prefilled syringes that have been frozen more than 1 time. - if udenyca is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting. - throw away (dispose of) any udenyca prefilled syringes that have been frozen more than 1 time. - throw away (dispose of) any udenyca prefilled syringes that have been left out at room temperature for more than 48 hours. - keep the udenyca prefilled syringe out of the reach of children. - it is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider. - make sure that the name udenyca appears on the carton and prefilled syringe label. - check the carton and prefilled syringe label to make sure the dose strength is 6 mg/0.6 ml. - you should not inject a dose of udenyca to children weighing less than 45 kg from a udenyca prefilled syringe. a dose less than 0.6 ml (6 mg) cannot be accurately measured using the udenyca prefilled syringe. - do not use a prefilled syringe after the expiration date on the label. - do not shake the prefilled syringe - do not remove the needle cap from the prefilled syringe until you are ready to inject. - do not use the prefilled syringe if the carton is open or damaged. - do not use a prefilled syringe if it has been dropped on a hard surface. the prefilled syringe may be broken even if you cannot see the break. use a new prefilled syringe. - do not attempt to activate the needle safety guard prior to injection - alcohol wipe - cotton ball or gauze - 1 adhesive bandage - sharps disposal container - do not grab the plunger or the plunger head. - do not grab the needle cap. - the medicine appears discolored or cloudy. - the medicine contains lumps, flakes, or particles. - it appears used or damaged. - the needle cap is missing or not securely attached. - the expiration date printed on the label has passed. - abdomen (except for a two-inch area surrounding the navel) - thighs - back of upper arms (only if someone else is giving you the injection) - upper outer area of the buttocks (only if someone else is giving you the injection) - do not remove the needle cap from the prefilled syringe until you are ready to inject. - do not twist or bend the needle cap. - do not hold the prefilled syringe by the plunger rod - do not put the needle cap back onto the syringe. dispose of (throw away) the needle cap in your household trash - do not use the prefilled syringe if it has been dropped with the needle cap removed. - do not touch the plunger or grasp the syringe above the finger grips. - do not touch the plunger head while inserting the needle into the skin. - do not touch the cleaned area of the skin - if you see drops of blood at the injection site, treat by pressing a cotton ball or gauze to the site as needed. - 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 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 - 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 reuse the prefilled syringe. - do not recycle prefilled syringes or sharps disposal container or throw them into household trash. coherus biosciences udenyca® (pegfilgrastim-cbqv) manufactured by: coherus biosciences, inc., redwood city, california 94065-1442 u.s. license no. 2023 © 2019 coherus biosciences inc. all rights reserved. for more information go to www.udenyca.com or call 1-800-4udenyca (1-800-483-3692) pmd-0005, rev. 02   - store udenyca prefilled autoinjector in the refrigerator between 36°f to 46°f (2°c to 8°c). - keep the udenyca prefilled autoinjector in the original carton to protect from light. - do not freeze udenyca. if udenyca is accidentally frozen, allow the prefilled autoinjector to thaw in the refrigerator before injecting. throw away (dispose of) any udenyca prefilled autoinjectors that have been frozen more than 1 time. - if udenyca is accidentally frozen, allow the prefilled autoinjector to thaw in the refrigerator before injecting. - throw away (dispose of) any udenyca prefilled autoinjectors that have been frozen more than 1 time. - throw away (dispose of) any udenyca prefilled autoinjectors that have been left out at room temperature for more than 48 hours. - keep the udenyca prefilled autoinjector out of the reach of children. - it is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider. - only adults can self-inject udenyca with the prefilled autoinjector. - make sure that the name udenyca appears on the carton and prefilled autoinjector label. - check the carton and prefilled autoinjector label to make sure the dose strength is 6 mg/0.6 ml. - you should not inject a dose of udenyca to children weighing less than 45 kg from an udenyca prefilled autoinjector. a dose less than 0.6 ml (6 mg) cannot be accurately measured using the udenyca prefilled autoinjector. - do not use a prefilled autoinjector after the expiration date on the label. - do not shake the prefilled autoinjector. - do not remove the clear cap from the prefilled autoinjector until you are ready to inject. - do not use the prefilled autoinjector if the carton is open or damaged. - do not use a prefilled autoinjector if it has been dropped on a hard surface. the prefilled autoinjector may be broken even if you cannot see the break. use a new prefilled autoinjector. - leave the prefilled autoinjector in the carton at room temperature for 30 minutes before injecting. - do not remove the clear cap while allowing the prefilled autoinjector to reach room temperature. - do not warm the prefilled autoinjector in any other way. for example, do not warm it in a microwave, in hot water, or in direct sunlight. - 1 single-dose udenyca prefilled autoinjector - 1 alcohol wipe (not included) - 1 cotton ball or gauze pad (not included) - 1 sharps disposal container (not included). see "how should i throw away (dispose of) the used udenyca prefilled autoinjector?" in step 10. - - abdomen (except for a two-inch area surrounding the navel) - thighs - back of upper arms - upper outer area of the buttocks - do not inject into moles, scars, birthmarks, or areas where the skin is tender, bruised, red, or hard. - change (rotate) your injection site with each injection. - do not inject through clothing. clean the injection site with an alcohol wipe. let your skin air dry. do not touch this area again before injection. - hold the prefilled autoinjector with the clear cap facing down. - it is normal to see 1 or more air bubbles in the viewing window. - make sure the liquid is clear and colorless. - the medicine appears discolored or cloudy. - the medicine contains lumps, flakes, or particles. - if it has been dropped, crushed or damaged in any way. - it is normal to see a few drops of liquid at the end of the needle. - throw away the clear cap. - do not put the clear cap back on the prefilled autoinjector after it has been removed. - do not touch the gray needle guard. - do not rub the injection site. - slight bleeding at the injection site is normal. - put your used prefilled autoinjector in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) prefilled autoinjectors in the 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 prefilled autoinjectors. 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 reuse the prefilled autoinjector. do not recycle your used sharps disposal container. - the clear cap, alcohol swab, cotton ball or gauze pad, and packaging may be placed in your household trash. - see prescribing information for information on udenyca. - the on-body injector is for adult patients only. - the on-body injector is not recommended for patients with hematopoietic subsyndrome of acute radiation syndrome. - for patients who have had severe skin reactions to acrylic adhesives, consider the benefit-risk profile before administering pegfilgrastim via the on-body injector for udenyca. - the on-body injector should be applied to intact, non-irritated skin on the abdomen or back of the arm. the back of the arm may only be used if there is a caregiver available to monitor the status of the on-body injector. - the on-body injector has a self-adhesive backing to attach it to the skin, do not use additional materials to hold it in place as this could lead to a missed or incomplete dose of udenyca. - do not expose the on-body injector for udenyca to the following environments as the on-body injector may be damaged and the patient could be injured: diagnostic imaging (e.g., ct scan, mri, ultrasound, x-ray) radiation treatment oxygen rich environments such as hyperbaric chambers. - diagnostic imaging (e.g., ct scan, mri, ultrasound, x-ray) - radiation treatment - oxygen rich environments such as hyperbaric chambers. - do not use udenyca onbody to deliver any other drug product. - do not use the on-body injector if its packaging has been previously opened, or the expiration date on the carton or any components has passed. - do not use if the name udenyca does not appear on udenyca onbody carton. - do not modify the on-body injector. - do not fill the udenyca on-body injector on the adhesive side. use the metal medicine port. - do not attempt to reapply the on-body injector. - do not use if either the on-body injector or prefilled syringe is dropped. start again with a new on-body injector or prefilled syringe. - store the onbody in the refrigerator at 36°f to 46°f (2°c to 8°c) until ready for use. if the onbody is stored at room temperature for more than 12 hours, do not use. start again with a new onbody. - keep the prefilled syringe in the carton until use to protect from light. - do not freeze the onbody. - do not separate the components of udenyca onbody until ready for use. - one udenyca prefilled syringe - one on-body injector for udenyca - udenyca patient information - udenyca prescribing information - instructions for use for healthcare provider - instructions for use for patient - if its packaging has been previously opened - if the packaging or trays appear to be damaged or have been dropped - if the expiry date on the syringe tray or on-body injector tray has passed. - you can use the left or right side of the abdomen, except for a two-inch area right around navel. - you can use the back of upper arm only if there is a caregiver available to monitor the status of the on-body injector. - apply the on-body injector to intact, non-irritated skin. - do not apply the on-body injector on areas with scar tissue, moles, or excessive hair. in case of excessive hair, carefully trim hair to get the on-body injector close to the skin. - do not apply the on-body injector on areas where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the on-body injector. - do not apply the on-body injector on surgical sites. - do not apply the on-body injector on areas where the on-body injector will be affected by folds in the skin. - thoroughly clean the site with alcohol to enhance on-body injector‘s adherence to the skin. only use alcohol to clean the skin. - make sure the skin is oil-free prior to applying the on-body injector. - allow the skin to completely dry on its own (e.g. without blowing on or fanning the area) before attaching the on-body injector. - do not touch this area again before attaching the on-body injector. - do not remove the on-body injector from the tray before filling it. - do not remove the green fill guide. - do not grasp the gray needle cap. - do not remove the gray needle cap until ready to fill the on-body injector. - do not grasp the plunger rod. - do not use if the liquid contains particulate matter or discoloration is observed prior to administration. - do not use if any part appears to be damaged, cracked or broken. - do not use if the gray needle cap is missing or not securely attached. - do not use if the expiration date printed on the label has passed. - do not remove the gray needle cap until ready to fill the on-body injector. - do not shake the prefilled syringe. - do not fill the udenyca on-body injector on the adhesive side. use the metal medicine port. - do not touch the plunger until the needle is fully inserted into the metal medicine port. - do not move the needle in the metal medicine port. - do not insert the needle more than once. - do not bend the needle. avoid spilling the medicine. - do not remove the green fill guide before filling the on-body injector. - do not recap the needle. - do not touch or contaminate the automatic needle opening. - do not pull off the adhesive pad or fold it. - do not place adhesive on skin that is damp. - do not touch the adhesive. - grasp the on-body injector’s plastic case with your fingertips and only by sides, keeping fingers off of the adhesive. - do not et the adhesive bend or curl while applying the on-body injector to skin. - the on-body injector will always flash a slow green light to let them know it is working properly. - the patient should keep the on-body injector dry for at least 3 hours after it was placed on their skin. - after approximately 27 hours the on-body injector will start to deliver the dose. - immediately before dose delivery starts the injection needle will be automatically inserted into the skin. - when the dose delivery starts it will take about 5 minutes to complete. during this time, the on-body injector will flash a fast green light. - when dose delivery is complete, the on-body injector will sound a long beep, and the status light will turn solid green. the needle will retract automatically. - do not remove the on-body injector until the status light is solid green. - if the red error light is flashing, or the adhesive is noticeably wet (saturated), or the on-body injector is dislodged, the patient should contact their healthcare provider immediately as they may need a replacement dose. - the patient should remain in a place where they can monitor the on-body injector for the entire dose delivery. the patient should avoid activities and settings that may interfere with wearing and monitoring during the dosing of udenyca administered by the on-body injector or could cause the obi to fall off. for example, avoid traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector (this includes the approximately 5-minute delivery period plus an hour post-delivery). - if the patient has an allergic reaction during the delivery of udenyca, the patient should remove the on-body injector and call his or her healthcare provider or seek emergency care right away. - if placed on the back of the arm, remind the patient that a caregiver must be available to monitor the on-body injector. - the on-body injector has a self-adhesive backing to attach it to the skin. - do not use other materials to hold it in place as this could cover audio/visual indicators or compress the on-body injector against the patient’s skin, as this could lead to a missed or incomplete dose of udenyca. - always dispose of the empty on-body injector in a sharps disposal container as instructed by your healthcare provider or by state or local laws. - keep the on-body injector at least four inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. failure to keep the on-body injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of udenyca. - do not apply the on-body injector to the patient if red error light is on. - do not leave the on-body injector on the patient if red error light is on. electromagnetic compatibility the delivery system is designed to conform to the electromagnetic compatibility (emc) standard iec 60601-1-2:2020 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard under home and hospital use environments. to avoid electromagnetic interference (emi) that may affect the performance of the delivery system [(i) dose accuracy, (ii) treatment duration, (iii) injection depth, (iv) visual and audible feedback], do not use the delivery system near sources of strong electric and magnetic interference (emi), such as mri, ionizing radiation, ct, diathermy, electromagnetic security systems (e.g., metal detectors), and large electric motors. in addition, portable and mobile rf communication equipment, such as rf emitters, cellular telephones, 2- way radios, bluetoothtm devices, and microwave ovens in close proximity to this device may affect the operation of the delivery system. some of these emi sources (mostly rf emitters) may not be visible and the device can potentially be exposed to fields from these emi sources without the user’s awareness. if you identify or suspect that external rf sources or other equipment are influencing delivery system operation (from known or unknown sources), try to (as applicable) increase the delivery system distance from the emi source. electromagnetic emissions the delivery system has been tested and found to comply with the limits for a class b digital device, pursuant to part 15 of the fcc rules. these limits are designed to provide reasonable protection against harmful interference in a residential installation. if this delivery system does cause harmful interference to radio or television reception, which can be determined by turning the radio or television off and on, the user is encouraged to try to correct the interference by one or more of the following measures: reorient or relocate the receiving antenna. increase the separation between the equipment and receiver. connect the radio or television to an outlet on a circuit different from that to which the receiver is connected. consult the dealer or an experienced radio/tv technician. electromagnetic immunity the delivery system has been tested to comply in either a home healthcare environment or professional healthcare environment. proximity fields from rf wireless communications equipment immunity the delivery system is tested per iec 61000-4-3 at frequencies and levels as specified below to ensure enclosure port immunity to rf wireless communications equipment. warning: portable rf communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the delivery system. otherwise, degradation of the performance of this equipment could result. warning: use of this delivery system adjacent to other equipment should be avoided because it could result in improper operation. if such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. symbols glossary - the on-body injector for udenyca is intended for delivery of udenyca. this on-body injector delivers udenyca with an injection under-the-skin (subcutaneous). see the patient information that comes with your on-body injector for important information. - your healthcare provider will use a prefilled syringe with udenyca to fill the on-body injector prior to applying it. the prefilled syringe with udenyca and the on-body injector are provided to your healthcare provider as part of udenyca onbody. the on-body injector is applied directly to your skin using a self- adhesive backing. the on-body injector lets you know its status with sounds and lights. - you should only receive a dose of udenyca on the day your healthcare provider tells you. - you should not receive your dose of udenyca any sooner than 24 hours after you finish receiving your chemotherapy. the on-body injector for udenyca is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector on your skin. - if you have concerns about your medicine, call your healthcare provider right away. serious allergic reactions can happen with udenyca. ask your caregiver to be nearby for the first use. plan to be in a place where you or your caregiver can closely monitor the on-body injector for udenyca for about 5-minutes during udenyca delivery and for an hour after the delivery. - do not take udenyca if you have had a serious allergic reaction to pegfilgrastim products or to filgrastim products. - tell your healthcare provider if you have had severe skin reactions to acrylic adhesives. - if you have an allergic reaction during the delivery of udenyca, remove the on- body injector by grabbing the edge of the adhesive pad and peeling off the on- body injector. get emergency medical help right away. caution the needle may be exposed. dispose of the on-body injector into a sharps disposal container right away. - call your healthcare provider right away if you have severe pain or skin discomfort around your on-body injector. - call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder area. this pain could mean your spleen is enlarged or ruptured. - call your healthcare provider or get emergency medical help right away if you get any of these symptoms of acute respiratory distress syndrome (ards): fever, shortness of breath, trouble breathing, or a fast rate of breathing. - call your healthcare provider right away if you experience any of these symptoms of kidney injury (glomerulonephritis): puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual. - call your healthcare provider if you have persistent or worsening redness or tenderness at the application site (may be a sign of infection). - the on-body injector is for adult patients only. - this on-body injector delivers udenyca with an under-the-skin (subcutaneous) injection. - the on-body injector is small, for one-time use, lightweight, battery-powered, and waterproof up to 5 feet (1.5 meters) for 1 hour. - the on-body injector can be worn in a shower. after showering, check the on- body injector to make sure it has not become loose (dislodged). - avoid getting body lotions, creams, oils or cleaning agents near the on-body injector as these products may loosen the adhesive. before your next scheduled udenyca dose, avoid use of lotions, creams, or oils on your arms and stomach area (abdomen). - only expose the on-body injector to temperatures between 41°f and 104°f (5°c and 40°c). - do not use bathtubs, hot tubs, whirlpools, or saunas while wearing the on-body injector. this may affect your medicine. - do not expose the on-body injector to direct sunlight. if the on-body injector is exposed to direct sunlight for more than 1 hour, it may affect your medicine. wear the on-body injector under clothing. - do not sleep on the on-body injector or apply pressure during wear, especially during dose delivery. this may affect on-body injector performance. - do not peel off or disturb the on-body injector adhesive before your full dose is complete. this may result in a missed or incomplete dose of udenyca. - do not expose the on-body injector to the following because the on-body injector may be damaged and you could be injured: diagnostic imaging (e.g., ct scan, mri, ultrasound, x-ray) radiation treatment oxygen rich environments, such as hyperbaric chambers. - diagnostic imaging (e.g., ct scan, mri, ultrasound, x-ray) - radiation treatment - oxygen rich environments, such as hyperbaric chambers. - keep the on-body injector at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. failure to keep the on-body injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of udenyca. - avoid activities and places that may interfere with monitoring during the dosing of udenyca administered by the on-body injector. for example, avoid traveling, driving, or operating heavy machinery during hours 26-29 following application of the on-body injector for udenyca (this includes the 5-minute dose delivery period plus an hour post-delivery). - if you must travel by airplane before the approximately 5-minute dose delivery period with the on-body injector, avoid airport x-ray scans. request a manual pat down instead. use care during a manual pat down to help prevent the on-body injector from being accidentally removed. for more information go to: http://www.tsa.gov/travelerinformation/travelers-disabilities-and-medical-conditions - keep the on-body injector and adhesive backing dry for at least 3 hours after it was placed on your skin, and for 3 hours prior to dose delivery. - be careful not to bump the on-body injector, or knock the on-body injector off your body. - the on-body injector has a self-adhesive backing to attach it to the skin. do not add other materials to hold it in place as this could lead to a missed or incomplete dose of udenyca. - if the on-body injector was placed on the back of your arm, a caregiver must be available to monitor the status of the on-body injector. - if the on-body injector comes away from your skin at any time, do not reapply it. call your healthcare provider right away as you may need a replacement dose. caution the needle may be exposed. dispose of the on-body injector into a sharps disposal container right away. - if you hear beeping at any time, check the status light. if it is flashing red, call your healthcare provider right away, as you may need a replacement dose. - right before the injection starts the injection needle will be automatically inserted into the skin. - dose delivery will take around 5-minutes to complete. the on-body injector will flash a fast, green light. - you may hear the pump working. this is okay. - when dose delivery is complete, a long beep will sound and the status light will turn solid green. - if you hear beeping at any time, check the status light. if it is flashing red, call your healthcare provider right away, as you may need a replacement dose. - if the adhesive is noticeably wet or dripping with medicine, call your healthcare provider right away, as you may need a replacement dose. - do not grasp the on-body injector itself to try to pull it off of your body. - if medicine has leaked or the adhesive is noticeably wet or dripping, call your healthcare provider right away, as you may not have received your full dose and you may need a replacement dose. - remove any extra adhesive using soap and water. - check your status light. watch for at least 10 seconds. if the status light is solid green or it has switched off, it is okay. - you should see a black line next to the empty indicator. if the on-body injector is not empty, call your healthcare provider right away, as you may need a replacement dose. - if you hear beeping, or when you check the status light and it is flashing red, call your healthcare provider right away. - if the needle is exposed, call your healthcare provider right away. - after on-body injector removal, place the on-body injector in a sharps disposal container whether the needle is exposed or not. - the on-body injector contains batteries, electronics, and a needle. put the on-body injector in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the on-body injector 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. - 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. - for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to fda's website at: http://www.fda.gov/safesharpsdisposal. - keep the used on-body injector and sharps disposal container away from children. - the status light should be solid green. - if the status light is flashing green, the dose delivery is not complete. wait until you hear a long beep and the status light turns solid green before removing your on-body injector. - the status light turns off 1 hour after delivery completion. - the fill indicator should have a black line next to empty. - if the status light is flashing red, you may not have received your full dose and may need a replacement dose. call your healthcare provider right away. electromagnetic compatibility the delivery system is designed to conform to the electromagnetic compatibility (emc) standard iec 60601-1-2:2020 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard under home and hospital use environments. to avoid electromagnetic interference (emi) that may affect the performance of the delivery system [(i) dose accuracy, (ii) treatment duration, (iii) injection depth, (iv) visual and audible feedback], do not use the delivery system near sources of strong electric and magnetic interference (emi), such as mri, ionizing radiation, ct, diathermy, electromagnetic security systems (e.g., metal detectors), and large electric motors. in addition, portable and mobile rf communication equipment, such as rf emitters, cellular telephones, 2- way radios, bluetoothtm devices, and microwave ovens in close proximity to this device may affect the operation of the delivery system. some of these emi sources (mostly rf emitters) may not be visible and the device can potentially be exposed to fields from these emi sources without the user’s awareness. if you identify or suspect that external rf sources or other equipment are influencing delivery system operation (from known or unknown sources), try to (as applicable) increase the delivery system distance from the emi source. electromagnetic emissions the delivery system has been tested and found to comply with the limits for a class b digital device, pursuant to part 15 of the fcc rules. these limits are designed to provide reasonable protection against harmful interference in a residential installation. if this delivery system does cause harmful interference to radio or television reception, which can be determined by turning the radio or television off and on, the user is encouraged to try to correct the interference by one or more of the following measures: reorient or relocate the receiving antenna. increase the separation between the equipment and receiver. connect the radio or television to an outlet on a circuit different from that to which the receiver is connected. consult the dealer or an experienced radio/tv technician. electromagnetic immunity the delivery system has been tested to comply in either a home healthcare environment or professional healthcare environment. proximity fields from rf wireless communications equipment immunity the delivery system is tested per iec 61000-4-3 at frequencies and levels as specified below to ensure enclosure port immunity to rf wireless communications equipment. warning: portable rf communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the delivery system. otherwise, degradation of the performance of this equipment could result. warning: use of this delivery system adjacent to other equipment should be avoided because it could result in improper operation. if such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. symbols glossary

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - pegfilgrastim (unii: 3a58010674) (pegfilgrastim - unii:3a58010674) - nyvepria is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see clinical studies (14)] . limitations of use nyvepria is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. nyvepria is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. reactions have included anaphylaxis [see warnings and precautions (5.3)] . risk summary although available data with nyvepria or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. these studies have not establishe