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

novartis pharmaceuticals corporation - secukinumab (unii: dlg4eml025) (secukinumab - unii:dlg4eml025) - secukinumab 150 mg in 1 ml - cosentyx® is indicated for the treatment of moderate to severe plaque psoriasis (pso) in patients 6 years and older who are candidates for systemic therapy or phototherapy. cosentyx is indicated for the treatment of active psoriatic arthritis (psa) in patients 2 years of age and older. cosentyx is indicated for the treatment of adult patients with active ankylosing spondylitis (as). cosentyx is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation. cosentyx is indicated for the treatment of active enthesitis-related arthritis (era) in pediatric patients 4 years of age and older. cosentyx is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (hs). cosentyx is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in cosentyx. cases of anaphylaxis have been reported during treatment with cosentyx [see warnings and precautions (5.2)] . risk summary limited available human data with cosentyx use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in an embryo-fetal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose (mrhd) (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data an embryo-fetal development study was performed in cynomolgus monkeys with secukinumab. no malformations or embryo-fetal toxicity were observed in fetuses from pregnant monkeys that were administered secukinumab weekly by the subcutaneous route during the period of organogenesis at doses up to 30 times the mrhd (on a mg/kg basis at a maternal dose of 150 mg/kg). a pre- and post-natal development toxicity study was performed in mice with a murine analog of secukinumab. no treatment-related effects on functional, morphological, or immunological development were observed in fetuses from pregnant mice that were administered the murine analog of secukinumab on gestation days 6, 11, and 17 and on postpartum days 4, 10, and 16 at doses up to 150 mg/kg/dose. risk summary it is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. there are no data on the effects of cosentyx on the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cosentyx and any potential adverse effects on the breastfed child from cosentyx or from the underlying maternal condition. subcutaneous administration pediatric plaque psoriasis the safety and effectiveness of cosentyx have been established for the treatment of moderate to severe pso in pediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy [see adverse reactions (6.1) and clinical studies (14.2)] . safety and effectiveness of cosentyx in pediatric patients with pso below the age of 6 years have not been established. juvenile psoriatic arthritis the safety and effectiveness of cosentyx have been established for the treatment of active jpsa in pediatric patients aged 2 years and older who weigh 15 kg or more [see adverse reactions (6.1) and clinical studies (14.6)] . the safety and effectiveness of cosentyx in pediatric patients less than 2 years of age with jpsa or with a body weight less than 15 kg has not been established. enthesitis-related arthritis the safety and effectiveness of cosentyx for the treatment of active era in pediatric patients aged 4 years and older who weigh 15 kg or more has been established [see adverse reactions (6.1) and clinical studies (14.6)] . the safety and effectiveness of cosentyx in pediatric patients below the age of 4 years old or with body weight less than 15 kg have not been established. hidradenitis suppurativa the safety and effectiveness of cosentyx in pediatric patients with hs have not been established. intravenous administration the safety and effectiveness of intravenous cosentyx in pediatric patients have not been established. of the 3,430 pso subjects exposed to subcutaneous cosentyx in clinical trials, a total of 230 (7%) were 65 years of age or older, and 32 (1%) subjects were 75 years of age or older. although no differences in safety or efficacy were observed between subjects 65 years of age or older and younger adult subjects, the number of subjects 65 years of age and older was not sufficient to determine whether they respond differently from younger adult subjects. of the 1,060 subjects with hs exposed to cosentyx in clinical trials, a total of 14 (1.3%) were 65 years of age and older. clinical trials in hs did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 300 mg/2 ml single-dose prefilled syringe be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the prefilled syringe before you use it for the first time. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx prefilled syringe if either the seal on the outside carton or the seal of the blister are broken. keep the cosentyx prefilled syringe in the sealed carton until you are ready to use it. - do not use the cosentyx prefilled syringe if the syringe has been dropped onto a hard surface or dropped after removing the needle cap. - do not shake the cosentyx prefilled syringe. - the 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 prefilled syringe. - 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 syringe guard to be activated too early. - throw away (dispose of) the used cosentyx prefilled syringe right away after use. do not re-use the cosentyx prefilled syringe . see “how should i dispose of the used cosentyx prefilled syringe?” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx prefilled syringe in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx prefilled syringe in the original carton until ready to use to protect from light. - do not freeze the cosentyx prefilled syringe. - throw away (dispose of) any expired or unused cosentyx prefilled syringes. keep cosentyx and all medicines out of the reach of children. cosentyx prefilled syringe parts (see figure a): - areas of your body that you may use as injection sites include: the front of your thighs (see figure c) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - the front of your thighs (see figure c) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) - the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - choose a different site for each injection of cosentyx. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with 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. t2023-42 instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 150 mg/ml single-dose prefilled syringe be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the prefilled syringe before you use it for the first time. children should not inject cosentyx themselves using the prefilled syringe. an adult caregiver should prepare and inject cosentyx after receiving proper training in subcutaneous injection technique. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx prefilled syringe if either the seal on the outside carton or the seal of the blister are broken. keep the cosentyx prefilled syringe in the sealed carton until you are ready to use it. - do not use the cosentyx prefilled syringe if the syringe has been dropped onto a hard surface or dropped after removing the needle cap. - do not shake the cosentyx prefilled syringe. - the needle caps of the prefilled syringes contain latex. do not handle the prefilled syringes if you are sensitive to latex. - the 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 prefilled syringe. - 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 syringe guard to be activated too early. - throw away (dispose of) the used cosentyx prefilled syringe right away after use. do not re-use the cosentyx prefilled syringe. see “how should i dispose of used cosentyx prefilled syringes?” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx prefilled syringes in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx prefilled syringes in the original carton until ready to use to protect from light. - the cosentyx prefilled syringes may be stored at room temperature, up to 86°f (30°c), for up to 4 days. - write the date the cosentyx prefilled syringes were removed from and returned to the refrigerator in the space provided on the carton. - throw away the cosentyx prefilled syringe if it has been kept outside of the refrigerator over 4 days. - cosentyx prefilled syringe may be returned to the refrigerator only 1 time and must be stored between 36°f to 46°f (2°c to 8°c) until you use it or until it expires. - do not freeze the cosentyx prefilled syringes. - throw away (dispose of) any expired or unused cosentyx prefilled syringes. keep cosentyx and all medicines out of the reach of children. - if your prescribed dose of cosentyx is 150 mg , you must give 1 injection . - if your prescribed dose of cosentyx is 300 mg , you must give 2 injections . - areas of your body that you may use as injection sites include: the front of your thighs (see figure c) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - the front of your thighs (see figure c) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) - the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - choose a different site for each injection of cosentyx. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with 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. t2023-43 instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 75 mg/0.5 ml single-dose prefilled syringe be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the prefilled syringe before you use it for the first time. children should not inject cosentyx themselves using the prefilled syringe. an adult caregiver should prepare and inject cosentyx after receiving proper training in subcutaneous injection technique. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx prefilled syringe if either the seal on the outside carton or the seal of the blister are broken. keep the cosentyx prefilled syringe in the sealed carton until you are ready to use it. - do not use the cosentyx prefilled syringe if the syringe has been dropped onto a hard surface or dropped after removing the needle cap. - do not shake the cosentyx prefilled syringe. - the needle cap of the prefilled syringe contains latex. do not handle the prefilled syringe if you are sensitive to latex. - the 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 prefilled syringe. - 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 syringe guard to be activated too early. - throw away (dispose of) the used cosentyx prefilled syringe right away after use. do not re-use the cosentyx prefilled syringe. see “how should i dispose of the used cosentyx prefilled syringe? ” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx prefilled syringe in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx prefilled syringe in the original carton until ready to use to protect from light. - cosentyx prefilled syringe may be stored at room temperature, up to 86°f (30°c), for up to 4 days. - write the date cosentyx prefilled syringe was removed from and returned to the refrigerator in the space provided on the carton. - throw away cosentyx prefilled syringe if it has been kept outside of the refrigerator over 4 days. - cosentyx prefilled syringe may be returned to the refrigerator only 1 time and must be stored between 36°f to 46°f (2°c to 8°c) until you use it or until it expires. - do not freeze the cosentyx prefilled syringe. - throw away (dispose of) any expired or unused cosentyx prefilled syringe. keep cosentyx and all medicines out of the reach of children. - areas of your body that you may use as injection sites include: the front of your thighs (see figure c) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) the upper outer arms (see figure d) - the front of your thighs (see figure c) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) - the upper outer arms (see figure d) - choose a different site for each injection of cosentyx. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with 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. t2023-44 - do not use the cosentyx unoready pen if the seal on the outer carton is broken. keep the cosentyx unoready pen in the sealed outer carton until you are ready to use it. - do not shake the cosentyx unoready pen. - if you drop your cosentyx unoready pen, do not use it if it looks damaged, or if you dropped it with the cap removed. - the needle is covered by the needle guard and the needle will not be seen. do not touch or push the needle guard because you could get a needle stick. - throw away (dispose of) the used cosentyx unoready pen right away after use. - do not re-use the cosentyx unoready pen. see “step 9. disposing of the used cosentyx unoready pen ” at the end of this instructions for use. - store your carton of cosentyx unoready pen in a refrigerator between 36°f and 46°f (2°c and 8°c). - keep the cosentyx unoready pen in the original carton until ready to use to protect from light. - do not freeze the cosentyx unoready pen. - throw away (dispose of) any expired or unused cosentyx unoready pen. - a new cosentyx unoready pen each cosentyx unoready pen contains 300 mg of cosentyx. check to make sure that you have the correct medicine and dose. - 1 alcohol wipe - 1 cotton ball or gauze - sharps disposal container. see “step 9. disposing of the used cosentyx unoready pen ” at the end of this instructions for use. - look at the expiration date (exp) on your cosentyx unoready pen. do not use the cosentyx unoready pen if the expiration date has passed. - look through the viewing window. the liquid should be clear. its color may vary from colorless to slightly yellow. - do not use if the liquid contains visible particles, is cloudy or is discolored. you may see air bubbles, which is normal. - the recommended site is the front of the thighs. you may also use the lower abdomen, but not the area 2 inches around the navel (belly button) (see figure f) . - choose a different site each time you give an injection. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard or in an area of skin that is affected by psoriasis. avoid areas with 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 g) . - wash your hands well with soap and water. - using a circular motion, clean the injection site with the alcohol wipe (see figure h) . leave it to dry before injecting. - do not touch the cleaned area again before injecting. - only remove the cap when you are ready to use the cosentyx unoready pen. - pull the cap straight off (see figure i) . do not twist the cap. - throw away the cap. do not try to re-attach the cap. - use the cosentyx unoready pen within 5 minutes of removing the cap. - this means the medicine has been delivered. contact your healthcare provider or pharmacist if the green indicator is not visible or does not fill the window. - 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 a few seconds. do not rub the injection site. you may cover the injection site with a small adhesive bandage, if needed. - put your used cosentyx unoready pen in an fda-cleared sharps disposal container right away after use (see figure m) . do not throw away (dispose of) the cosentyx unoready pen in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles, syringes, and cosentyx unoready pens. t2023-45 instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 150 mg/ml single-dose sensoready® pen be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the sensoready pen before you use it for the first time. children should not inject cosentyx themselves using the sensoready pen. an adult caregiver should prepare and inject cosentyx after receiving proper training in subcutaneous injection technique. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx sensoready pen if either the seal on the outer carton or the seal on the pen is broken. keep the cosentyx sensoready pen in the sealed outer carton until you are ready to use it. - do not shake the cosentyx sensoready pen. - the caps of the sensoready pens contain latex. do not handle the sensoready pens if you are sensitive to latex. - if you drop your cosentyx sensoready pen, do not use it if the sensoready pen looks damaged, or if you dropped it with the cap removed. - throw away (dispose of) the used cosentyx sensoready pen right away after use. do not re-use the cosentyx sensoready pen. see “how should i dispose of used cosentyx sensoready pens? ” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx sensoready pens in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx sensoready pens in the original carton until ready to use to protect from light. - the cosentyx sensoready pens may be stored at room temperature, up to 86°f (30°c), for up to 4 days. - write the date the cosentyx sensoready pens were removed from and returned to the refrigerator in the space provided on the carton. - throw away the cosentyx sensoready pen if it has been kept outside of the refrigerator over 4 days. - cosentyx sensoready pen may be returned to the refrigerator only 1 time and must be stored between 36°f to 46°f (2°c to 8°c) until you use it or until it expires. - do not freeze the cosentyx sensoready pens. - throw away (dispose of) any expired or unused cosentyx sensoready pens. keep cosentyx and all medicines out of the reach of children. - if your prescribed dose of cosentyx is 150 mg, you must give 1 injection. - if your prescribed dose of cosentyx is 300 mg, you must give 2 injections. - 1 alcohol wipe - 1 cotton ball or gauze - sharps disposal container. - look through the viewing window. the liquid should be clear. its color may vary from colorless to slightly yellow. do not use if the liquid contains visible particles, is cloudy or is discolored. you may see a small air bubble, which is normal. - look at the expiration date (exp) on your sensoready pen. do not use your cosentyx sensoready pen if the expiration date has passed. - the recommended site is the front of the thighs. you may also use the lower abdomen, but not the area 2 inches around the navel (belly button) (see figure e). - choose a different site each time you give an injection. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with 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 well 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 cosentyx 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 cosentyx sensoready pen within 5 minutes of removing the cap. - hold the cosentyx sensoready pen at 90 degrees to the cleaned injection site (see figure i) . - the 1st click indicates that the injection has started. - several seconds later a 2nd click will indicate that the injection is almost finished. - press the cosentyx sensoready pen firmly against the skin to start the injection (see figure j) . - the 1st click indicates the injection has started. - keep holding the cosentyx sensoready pen firmly against the skin. - the green indicator shows the progress of the injection. - listen for the 2nd click. this indicates the injection is almost complete. - check the green indicator fills the window and has stopped moving (see figure k) . - the cosentyx sensoready pen can now be removed. - this means the medicine has 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. t2023-46

Spain - English - HMA (Heads of Medicines Agencies)

laboratorios calier - tiamulin 2 % w/w - premix for medicated feed - pigs food, rabbit food - tiamulin

Portugal - English - HMA (Heads of Medicines Agencies)

laboratorios calier - tiamulin 2 % w/w - premix for medicated feed - pigs food, rabbit food - tiamulin

Spain - English - HMA (Heads of Medicines Agencies)

laboratorios calier - tiamulin 10 % w/w - premix for medicated feed - pigs food - tiamulin

Portugal - English - HMA (Heads of Medicines Agencies)

laboratorios calier - tiamulin 10 % w/w - premix for medicated feed - pigs food - tiamulin

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

octapharma australia pty ltd - immunoglobulin - normal -

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

crop culture pty ltd - trinexapac-ethyl - emulsifiable concentrate - trinexapac-ethyl cyclohexanediones active 250.0 g/l - herbicide - poppy | ryegrass seed crop | sugar cane | inter-row spraying | ratoon sugar cane | sugarcane - increase commercial cane sugar (ccs) | increase seed yield | modify alkaloid ratio | commercial cane sugar percenta | improved seed set | improving the percentage of th

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma limited - factor viii (antihaemophilic factor), von willebrand factor human - pdr+solv for soln for inj - 1000/1000 international unit - blood coagulation factors

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma limited - factor viii (antihaemophilic factor), von willebrand factor human - pdr+solv for soln for inj - 500/500 international unit - blood coagulation factors

European Union - English - EMA (European Medicines Agency)

bayer ag - octocog alfa - hemophilia a - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).iblias can be used for all age groups.