Australie - anglais - APVMA (Australian Pesticides and Veterinary Medicines Authority)

new australia agricultural development company pty ltd - fipronil - bait - fipronil nitrile active 0.5 g/kg - household insecticide

Australie - anglais - APVMA (Australian Pesticides and Veterinary Medicines Authority)

innovate ag pty limited - clitoria ternatea extract - emulsifiable concentrate - clitoria ternatea extract extract active 400.0 g/l - mixed function pesticide

Australie - anglais - APVMA (Australian Pesticides and Veterinary Medicines Authority)

the hunter river company pty limited - fluazuron; 1-octyl-2-pyrrolidinone; 1-dodecyl-2-pyrrolidinone; 1-methyl-2-pyrrolidinone - topical solution/suspension - fluazuron ungrouped active 25.0 g/l; 1-octyl-2-pyrrolidinone ungrouped other 100.0 g/l; 1-dodecyl-2-pyrrolidinone ungrouped other 100.0 g/l; 1-methyl-2-pyrrolidinone solvent other 415.0 g/l - parasiticides

Australie - anglais - Department of Health (Therapeutic Goods Administration)

sigma company limited - codeine phosphate hemihydrate, quantity: 15 mg; paracetamol, quantity: 500 mg - tablet, uncoated - excipient ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; povidone; ethanol; purified water; potato starch; docusate sodium - for the temporary relief of acute moderate pain in patients over the age of 12 years (see also contraindications and paediatric use).

Australie - anglais - Department of Health (Therapeutic Goods Administration)

sigma company limited - codeine phosphate hemihydrate,doxylamine succinate,paracetamol -

Australie - anglais - Department of Health (Therapeutic Goods Administration)

sigma company limited - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 15 mg - tablet, uncoated - excipient ingredients: potato starch; purified water; povidone; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; docusate sodium; ethanol - for the temporary relief of acute moderate pain in patients over the age of 12 years (see also contraindications and paediatric use).

États-Unis - anglais - NLM (National Library of Medicine)

eli lilly and company - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - basaglar® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. limitations of use basaglar is not recommended for the treatment of diabetic ketoacidosis. basaglar is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients with hypersensitivity to insulin glargine or any of the excipients in basaglar [see warnings and precautions (5.5)] . risk summary published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products and adverse developmental outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). in animal reproduction studies, another insulin glargine product was administered to rats before, during and throughout pregnancy at doses up to 7 times the clinical dose of 10 units/day and to rabbits during organogenesis at doses approximately 2 times the clinical dose of 10 units/day. the effects of this other insulin glargine product did not generally differ from those observed with regular human insulin in rats or rabbits (see data). the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data human data published data do not report a clear association with insulin glargine products and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine products are used during pregnancy. however, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some with no comparative group. animal data subcutaneous reproduction and teratology studies have been performed with another insulin glargine product and with regular human insulin in rats and himalayan rabbits. this other insulin glargine product was given to female rats before mating, during mating, and throughout pregnancy at dose up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day) based on mg/m2 . in rabbits, doses of 0.072 mg/kg/day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m2 , were administered during organogenesis. the effects of this other insulin glargine product did not generally differ from those observed with regular human insulin in rats and rabbits. however, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. fertility and early embryonic development appeared normal. risk summary there are no data on the presence of insulin glargine in human milk, the effects on the breastfed infant, or the effects on milk production. endogenous insulin is present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for basaglar and any potential adverse effects on the breastfed child from basaglar or from the underlying maternal condition. the safety and effectiveness of basaglar have been established in pediatric patients (age 6 to 15 years) with type 1 diabetes based on an adequate and well-controlled trial of another insulin glargine product, 100 units/ml, in pediatric patients (age 6 to 15 years) with type 1 diabetes and additional data in adults with type 1 diabetes [see clinical studies (14.2)] . the safety and effectiveness of basaglar in pediatric patients younger than 6 years of age with type 1 diabetes and pediatric patients with type 2 diabetes has not been established. in the pediatric clinical trial, pediatric patients (age 6 to 15 years) with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in trials with type 1 diabetes [see adverse reactions (6.1)] . of the total number of subjects in clinical studies of patients with type 2 diabetes who were treated with basaglar or another insulin glargine product, 100 units/ml, each in combination with oral agents in a controlled clinical trial environment, 28.3% were 65 and over, while 4.5% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, 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. nevertheless, caution should be exercised when basaglar is administered to geriatric patients. in elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. hypoglycemia may be difficult to recognize in the elderly. the effect of renal impairment on the pharmacokinetics of basaglar has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. frequent glucose monitoring and dose adjustment may be necessary for basaglar in patients with renal impairment [see warnings and precautions (5.3)] . the effect of hepatic impairment on the pharmacokinetics of basaglar has not been studied. however, as with all insulin products, more frequent glucose monitoring and dose adjustment may be necessary for basaglar in patients with hepatic impairment [see warnings and precautions (5.3)] . instructions for use basaglar® kwikpen® (insulin glargine) injection, for subcutaneous use 100 units/ml, 3 ml single-patient-use pen read the instructions for use before you start using basaglar and each time you get another basaglar® kwikpen® . there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your basaglar kwikpen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. basaglar kwikpen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units (3ml) of basaglar. one pen contains multiple doses of medicine. - your healthcare provider will tell you how many units to give as your dose and how to inject your prescribed dose of medicine. - you can give a dose of 1 to 80 units in a single injection. - if your prescribed dose is more than 80 units, you will need to give yourself more than 1 injection. - the plunger only moves a little with each injection, and you may not notice that it moves. when the plunger reaches the end of the cartridge, you have used all 300 units in the pen. people who are blind or have vision problems should not use the pen without help from a person trained to use the basaglar prefilled pen. how to recognize your basaglar kwikpen - pen color: light grey - dose knob: light grey with green ring on the end - labels: light grey with green color bars supplies needed to give your injection - basaglar kwikpen - kwikpen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab preparing your pen - wash your hands with soap and water. - check the pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - check the liquid in the pen. basaglar should look clear and colorless. do not use if it is cloudy, colored, or has particles or clumps in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming means removing the air from the needle and cartridge that may collect during normal use. it is important to prime your pen before each injection so that it will work correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units . - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with needle pointing up. push the dose knob in until it stops, and “0” is seen in the dose window. hold the dose knob in and count to 5 slowly . you should see insulin at the tip of the needle. - if you do not see insulin, repeat the priming steps, but not more than 4 times. - if you still do not see insulin, change the needle and repeat the priming steps. small air bubbles are normal and will not affect your dose. selecting your dose - if your dose is more than 80 units, you will need to give more than 1 injection. - talk to your healthcare provider about how to give your dose. - use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks because you may dial the wrong dose. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers are printed on the dial. - the odd numbers, after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you can not inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. do not inject where the skin has pits, is thickened, or has lumps. do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - basaglar is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. note: do not try to inject your insulin by turning the dose knob. you will not receive your insulin by turning the dose knob. - pull the needle out of your skin. - a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window you did not receive your full dose. do not redial. insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat that injection. monitor your blood glucose and call your healthcare provider for further instructions. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. the plunger only moves a little with each injection, and you may not notice that it moves. if you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. do not rub the area. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section below). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles 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. - 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. - the used pen may be discarded in your household trash after you have removed the needle. storing your basaglar kwikpen unused pens - store unused pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze basaglar. do not use if it has been frozen. - unused pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)] and away from heat and light. - throw away the pen you are using after 28 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the sight and reach of children. - always use a new needle for each injection. - do not share your pen or needles with other people. you may give other people a serious infection or get a serious infection from them. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you can not remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your basaglar kwikpen, contact lilly at 1-800-lillyrx (1-800- 545-5979) or call your healthcare provider for help. for more information on basaglar kwikpen and insulin, go to www.basaglar.com. scan this code to launch www.basaglar.com this instructions for use have been approved by the u.s. food and drug administration. basaglar® and basaglar® kwikpen® are trademarks of eli lilly and company. instructions for use revised: november 2022 manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2015, 2022, eli lilly and company. all rights reserved. baskp-0009-ifu-20221115 instructions for use basaglar® tempo pen™ (insulin glargine) injection, for subcutaneous use 100 units/ml, 3 ml pen, single-patient-use read the instructions for use before you start using basaglar and each time you get another basaglar tempo pen. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your basaglar tempo pen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. basaglar tempo pen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units (3ml) of basaglar. one pen contains multiple doses of medicine. - your healthcare provider will tell you how many units to give as your dose and how to inject your prescribed dose of medicine. - you can give a dose of 1 to 80 units in a single injection. - if your prescribed dose is more than 80 units, you will need to give yourself more than 1 injection. - the plunger only moves a little with each injection, and you may not notice that it moves. when the plunger reaches the end of the cartridge, you have used all 300 units in the pen. people who are blind or have vision problems should not use the pen without help from a person trained to use the basaglar prefilled pen. this basaglar tempo pen contains a component that allows for data connectivity when used with a compatible transmitter. how to recognize your basaglar tempo pen - pen color: light grey - dose knob: light grey - labels: light grey with green color bars supplies needed to give your injection - basaglar tempo pen - tempo pen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab preparing your pen - wash your hands with soap and water. - check the pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - check the liquid in the pen. basaglar should look clear and colorless. do not use if it is cloudy, colored, or has particles or clumps in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming means removing the air from the needle and cartridge that may collect during normal use. it is important to prime your pen before each injection so that it will work correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units . - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with the needle pointing up. push the dose knob in until it stops, and “0 ” is seen in the dose window. hold the dose knob in and count to 5 slowly . you should see insulin at the tip of the needle. - if you do not see insulin, repeat the priming steps 6 to 8, but not more than 4 times. - if you still do not see insulin, change the needle and repeat the priming steps 6 to 8. small air bubbles are normal and will not affect your dose. selecting your dose - you can give a dose of 1 to 80 units in a single injection. - if your dose is more than 80 units, you will need to give more than 1 injection. - talk to your healthcare provider about how to give your dose. - use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks because you may dial the wrong dose. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers are printed on the dial. - the odd numbers, after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. - the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you cannot inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. do not inject where skin has pits, is thickened, or has lumps. do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - basaglar is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. note: do not try to inject your insulin by turning the dose knob. you will not receive your insulin by turning the dose knob. - pull the needle out of your skin. - a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window you did not receive your full dose. do not redial . insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat that injection. monitor your blood sugar (glucose) and call your healthcare provider for further instructions. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. the plunger only moves a little with each injection, and you may not notice that it moves. if you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. do not rub the area. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section below). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles 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. - 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. - the used pen may be thrown away (discarded) in your household trash after you have removed the needle. storing your basaglar tempo pen unopened pens - store unopened pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze basaglar. do not use if it has been frozen. - unopened pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)] and away from heat and light. - throw away the pen you are using after 28 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the sight and reach of children. - always use a new needle for each injection. - do not share your pen or needles with other people. you may give other people a serious infection or get a serious infection from them. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you cannot remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your basaglar tempo pen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on basaglar tempo pen and insulin, go to www.basaglar.com. scan this code to launch www.basaglar.com this instructions for use have been approved by the u.s. food and drug administration. basaglar® is a registered trademark and tempo pentm is a trademark of eli lilly and company. instructions for use revised: november 2022 manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2021, 2022, eli lilly and company. all rights reserved. bastp-0004-ifu-20221115

États-Unis - anglais - NLM (National Library of Medicine)

lannett company, inc. - buprenorphine (unii: 40d3scr4gz) (buprenorphine - unii:40d3scr4gz), naloxone (unii: 36b82amq7n) (naloxone - unii:36b82amq7n) - buprenorphine 2 mg - buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. buprenorphine and naloxone sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [ see warnings and precautions ( 5.9 )] . risk summary the data on use of buprenorphine, one of the active ingredients in buprenorphine and naloxone sublingual tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. there are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see data] . observational studies have reported on congenital malformations among buprenorphine-exposed pregnancies, but were also not designed appropriately to assess the risk of congenital malformations specifically due to buprenorphine exposure [see data] . the extremely limited data on sublingual naloxone exposure in pregnancy are not sufficient to evaluate a drug-associated risk. reproductive and developmental studies in rats and rabbits identified adverse events at clinically relevant and higher doses. embryo-fetal death was observed in both rats and rabbits administered buprenorphine during the period of organogenesis at doses approximately 6 and 0.3 times, respectively, the human sublingual dose of 16 mg/day of buprenorphine. pre- and post-natal development studies in rats demonstrated increased neonatal deaths at 0.3 times and above and dystocia at approximately 3 times the human sublingual dose of 16 mg/day of buprenorphine. no clear teratogenic effects were seen when buprenorphine was administered during organogenesis with a range of doses equivalent to or greater than the human sublingual dose of 16 mg/day of buprenorphine. however, increases in skeletal abnormalities were noted in rats and rabbits administered buprenorphine daily during organogenesis at doses approximately 0.6 times and approximately equal to the human sublingual dose of 16 mg/day of buprenorphine, respectively. in a few studies, some events such as acephalus and omphalocele were also observed but these findings were not clearly treatment-related [see data] . based on animal data, advice pregnant women of the potential risk to a fetus. the estimated background risks of major birth defects miscarriage for the indicated population are 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. clinical considerations disease-associated maternal and embryo-fetal risk untreated opioid addiction in pregnancy is associated with adverse obstetrical outcomes such as low birth weight, preterm birth, and fetal death. in addition, untreated opioid addiction often results in continued or relapsing illicit opioid use. dose adjustment during pregnancy and the postpartum period dosage adjustments of buprenorphine may be required during pregnancy, even if the patient was maintained on a stable dose prior to pregnancy. withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary. fetal/neonatal adverse reactions neonatal opioid withdrawal syndrome may occur in newborn infants of mothers who are receiving treatment with buprenorphine and naloxone sublingual tablets. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight. signs of neonatal withdrawal usually occur in the first days after birth. the duration and severity of neonatal opioid withdrawal syndrome may vary. observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions ( 5.5 )] . labor or delivery opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor. data human data studies have been conducted to evaluate neonatal outcomes in women exposed to buprenorphine during pregnancy. limited data from trials, observational studies, case series, and case reports on buprenorphine use in pregnancy do not indicate an increased risk of major malformations specifically due to buprenorphine. several factors may complicate the interpretation of investigations of the children of women who take buprenorphine during pregnancy, including maternal use of illicit drugs, late presentation for prenatal care, infection, poor compliance, poor nutrition, and psychosocial circumstances. interpretation of data is complicated further by the lack of information on untreated opioid-dependent pregnant women, who would be the most appropriate group for comparison. rather, women on another form of opioid medication-assisted treatment, or women in the general population are generally used as the comparison group. however, women in these comparison groups may be different from women prescribed buprenorphine-containing products with respect to maternal factors that may lead to poor pregnancy outcomes. in a multicenter, double-blind, randomized, controlled trial [maternal opioid treatment: human experimental research (mother)] designed primarily to assess neonatal opioid withdrawal effects, opioid-dependent pregnant women were randomized to buprenorphine (n=86) or methadone (n=89) treatment, with enrollment at an average gestational age of 18.7 weeks in both groups. a total of 28 of the 86 women in the buprenorphine group (33%) and 16 of the 89 women in the methadone group (18%) discontinued treatment before the end of pregnancy. among women who remained in treatment until delivery, there was no difference between buprenorphine-treated and methadone-treated groups in the number of neonates requiring nows treatment or in the peak severity of nows. buprenorphine-exposed neonates required less morphine (mean total dose, 1.1 mg vs. 10.4 mg), had shorter hospital stays (10.0 days vs. 17.5 days), and shorter duration of treatment for nows (4.1 days vs. 9.9 days) compared to the methadone-exposed group. there were no differences between groups in other primary outcomes (neonatal head circumference,) or secondary outcomes (weight and length at birth, preterm birth, gestational age at delivery, and 1-minute and 5-minute apgar scores), or in the rates of maternal or neonatal adverse events. the outcomes among mothers who discontinued treatment before delivery and may have relapsed to illicit opioid use are not known. because of the imbalance in discontinuation rates between the buprenorphine and methadone groups, the study findings are difficult to interpret. animal data the exposure margins listed below are based on body surface area comparisons (mg/m2 ) to the human sublingual dose of 16 mg buprenorphine via buprenorphine and naloxone sublingual tablets. effects on embryo-fetal development were studied in sprague-dawley rats and russian white rabbits following oral (1:1) and intramuscular (im) (3:2) administration of mixtures of buprenorphine and naloxone during the period of organogenesis. following oral administration to rats no teratogenic effects were observed at buprenorphine doses up to 250 mg/kg/day (estimated exposure approximately 150 times the human sublingual dose of 16 mg) in the presence of maternal toxicity (mortality). following oral administration to rabbits, no teratogenic effects were observed at buprenorphine doses up to 40 mg/kg/day (estimated exposure approximately 50 times, the human sublingual dose of 16 mg) in the absence of clear maternal toxicity. no definitive drug-related teratogenic effects were observed in rats and rabbits at im doses up to 30 mg/kg/day (estimated exposure approximately 20 times and 35 times, respectively, the human sublingual dose of 16 mg). maternal toxicity resulting in mortality was noted in these studies in both rats and rabbits. acephalus was observed in one rabbit fetus from the low-dose group and omphalocele was observed in two rabbit fetuses from the same litter in the mid-dose group; no findings were observed in fetuses from the high-dose group. maternal toxicity was seen in the high-dose group but not at the lower doses where the findings were observed. following oral administration of buprenorphine to rats, dose-related post-implantation losses, evidenced by increases in the numbers of early resorptions with consequent reductions in the numbers of fetuses, were observed at doses of 10 mg/kg/day or greater (estimated exposure approximately 6 times the human sublingual dose of 16 mg). in the rabbit, increased post-implantation losses occurred at an oral dose of 40 mg/kg/day. following im administration in the rat and the rabbit, post-implantation losses, as evidenced by decreases in live fetuses and increases in resorptions, occurred at 30 mg/kg/day. buprenorphine was not teratogenic in rats or rabbits after im or subcutaneous (sc) doses up to 5 mg/kg/day (estimated exposure was approximately 3 and 6 times, respectively, the human sublingual dose of 16 mg), after iv doses up to 0.8 mg/kg/day (estimated exposure was approximately 0.5 times and equal to, respectively, the human sublingual dose of 16 mg), or after oral doses up to 160 mg/kg/day in rats (estimated exposure was approximately 95 times the human sublingual dose of 16 mg) and 25 mg/kg/day in rabbits (estimated exposure was approximately 30 times the human sublingual dose of 16 mg). significant increases in skeletal abnormalities (e.g., extra thoracic vertebra or thoraco-lumbar ribs) were noted in rats after sc administration of 1 mg/kg/day and up (estimated exposure was approximately 0.6 times the human sublingual dose of 16 mg), but were not observed at oral doses up to 160 mg/kg/day. increases in skeletal abnormalities in rabbits after im administration of 5 mg/kg/day (estimated exposure was approximately 6 times the human sublingual dose of 16 mg) in the absence of maternal toxicity or oral administration of 1 mg/kg/day or greater (estimated exposure was approximately equal to the human sublingual dose of 16 mg) were not statistically significant. in rabbits, buprenorphine produced statistically significant pre-implantation losses at oral doses of 1 mg/kg/day or greater and post-implantation losses that were statistically significant at iv doses of 0.2 mg/kg/day or greater (estimated exposure approximately 0.3 times the human sublingual dose of 16 mg). no maternal toxicity was noted at doses causing post-implantation loss in this study. dystocia was noted in pregnant rats treated intramuscularly with buprenorphine from gestation day 14 through lactation day 21 at 5 mg/kg/day (approximately 3 times the human sublingual dose of 16 mg). fertility, and pre- and postnatal development studies with buprenorphine in rats indicated increases in neonatal mortality after oral doses of 0.8 mg/kg/day and up (approximately 0.5 times the human sublingual dose of 16 mg), after im doses of 0.5 mg/kg/day and up (approximately 0.3 times the human sublingual dose of 16 mg), and after sc doses of 0.1 mg/kg/day and up (approximately 0.06 times the human sublingual dose of 16 mg). an apparent lack of milk production during these studies likely contributed to the decreased pup viability and lactation indices. delays in the occurrence of righting reflex and startle response were noted in rat pups at an oral dose of 80 mg/kg/day (approximately 50 times the human sublingual dose of 16  mg). risk summary based on two studies in 13 lactating women maintained on buprenorphine treatment,  buprenorphine and its metabolite norbuprenorphine were present in low levels in human milk and available data have not shown adverse reactions in breastfed infants. there are no data on the combination product buprenorphine/naloxone in breastfeeding, however oral absorption of naloxone is limited. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for buprenorphine and naloxone sublingual tablets and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. clinical considerations advise breastfeeding women taking buprenorphine products to monitor the infant for increased drowsiness and breathing difficulties. data data were consistent from two studies (n=13) of breastfeeding infants whose mothers were maintained on sublingual doses of buprenorphine ranging from 2.4 to 24 mg/day, showing that the infants were exposed to less than 1% of the maternal daily dose. in a study of six lactating women who were taking a median sublingual buprenorphine dose of 0.29 mg/kg/day 5 to 8 days after delivery, breast milk provided a median infant dose of 0.42 mcg/kg/day of buprenorphine and 0.33 mcg/kg/day of norbuprenorphine, equal to 0.2% and 0.12%, respectively, of the maternal weight-adjusted dose (relative dose/kg (%) of norbuprenorphine was calculated from the assumption that buprenorphine and norbuprenorphine are equipotent). data from a study of seven lactating women who were taking a median sublingual buprenorphine dose of 7 mg/day an average of 1.12 months after delivery indicated that the mean milk concentrations (cavg ) of buprenorphine and norbuprenorphine were 3.65 mcg/l and 1.94 mcg/l respectively. based on the study data, and assuming milk consumption of 150 ml/kg/day, an exclusively breastfed infant would receive an estimated mean absolute infant dose (aid) of 0.55 mcg/kg/day of buprenorphine and 0.29 mcg/kg/day of norbuprenorphine, or a mean relative infant dose (rid) of 0.38% and 0.18%, respectively, of the maternal weight-adjusted dose. infertility chronic use of opioids may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6.2), clinical pharmacology (12.2) , nonclinical toxicology (13.1)]. the safety and effectiveness of buprenorphine and naloxone sublingual tablets have not been established in pediatric patients. this product is not appropriate for the treatment of neonatal abstinence syndrome in neonates, because it contains naloxone, an opioid antagonist. clinical studies of buprenorphine and naloxone sublingual tablets or buprenorphine sublingual tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. due to possible decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in geriatric patients, the decision to prescribe buprenorphine and naloxone sublingual tablets should be made cautiously in individuals 65 years of age or older and these patients should be monitored for signs and symptoms of toxicity or overdose. the effect of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone has been evaluated in a pharmacokinetic study. both drugs are extensively metabolized in the liver. while no clinically significant changes have been observed in subjects with mild hepatic impairment; the plasma levels have been shown to be higher and half-life values have been shown to be longer for both buprenorphine and naloxone in subjects with moderate and severe hepatic impairment. the magnitude of the effects on naloxone are greater than that on buprenorphine in both moderately and severely impaired subjects. the difference in magnitude of the effects on naloxone and buprenorphine are greater in subjects with severe hepatic impairment than in subjects with moderate hepatic impairment, and therefore the clinical impact of these effects is likely to be greater in patients with severe hepatic impairment than in patients with moderate hepatic impairment. buprenorphine/naloxone products should be avoided in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment [see warnings and precautions (5.12), and clinical pharmacology (12.3 )]. no differences in buprenorphine pharmacokinetics were observed between 9 dialysis-dependent and 6 normal patients following iv administration of 0.3 mg buprenorphine. the effects of renal failure on naloxone pharmacokinetics are unknown. buprenorphine and naloxone sublingual tablets contain buprenorphine, a schedule iii substance under the controlled substances act. buprenorphine, like morphine and other opioids, has the potential for being abused and is subject to criminal diversion. this should be considered when prescribing or dispensing buprenorphine in situations when the clinician is concerned about an increased risk of misuse, abuse, or diversion. healthcare professionals should contact their state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided with, or referred to, more intensive and structured treatment. abuse of buprenorphine poses a risk of overdose and death. this risk is increased with the abuse of buprenorphine and alcohol and other substances, especially benzodiazepines. the healthcare provider may be able to more easily detect misuse or diversion by maintaining records of medication prescribed including date, dose, quantity, frequency of refills, and renewal requests of medication prescribed. proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper handling and storage of the medication are appropriate measures that help to limit abuse of opioid drugs. buprenorphine is a partial agonist at the mu-opioid receptor and chronic administration produces physical dependence of the opioid-type, characterized by moderate withdrawal signs and symptoms upon abrupt discontinuation or rapid taper. the withdrawal syndrome is typically milder than seen with full agonists and may be delayed in onset [see warnings and precautions (5.7)]. neonatal opioid withdrawal syndrome (nows) is an expected and treatable outcome of prolonged use of opioids during pregnancy [see warnings and precautions (5.5)] . buprenorphine (bue'' pre nor' feen) and naloxone (nal ox' one) sublingual tablets, usp (ciii) this “instructions for use” contains information on how to correctly take buprenorphine and naloxone sublingual tablets. important information you need to know before taking buprenorphine and naloxone sublingual tablets: - your healthcare provider should show you how to take buprenorphine and naloxone sublingual tablets the right way. preparing to take buprenorphine and naloxone sublingual tablets: - put the tablets under your tongue. let them dissolve completely. - while buprenorphine and naloxone sublingual tablet is dissolving, do not chew or swallow the tablet because the medicine will not work as well. - talking while the tablet is dissolving can affect how well the medicine in buprenorphine and naloxone sublingual tablet is absorbed. - after buprenorphine and naloxone sublingual tablet is completely dissolved, rinse your mouth with water and swallow. wait for at least one hour before brushing teeth. - if you miss a dose of buprenorphine and naloxone sublingual tablets, take your medicine when you remember. if it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. do not take 2 doses at the same time unless your healthcare provider tells you to. if you are not sure about your dosing, call your healthcare provider. - do not stop taking buprenorphine and naloxone sublingual tablets suddenly. you could become sick and have withdrawal symptoms because your body has become used to the medicine. physical dependence is not the same as drug addiction. your healthcare provider can tell you more about the differences between physical dependence and drug addiction. to have fewer withdrawal symptoms, ask your healthcare provider how to stop using buprenorphine and naloxone sublingual tablets the right way. if you take too much buprenorphine and naloxone sublingual tablets or overdose, call poison control or get emergency medical help right away.   storing buprenorphine and naloxone sublingual tablets: - store buprenorphine and naloxone sublingual tablets at room temperature between 68°f to 77°f (20°c to 25°c). - keep buprenorphine and naloxone sublingual tablets in a safe place, out of the sight and reach of children. disposing of buprenorphine and naloxone sublingual tablets: - dispose of unused buprenorphine and naloxone sublingual tablets as soon as you no longer need them. - dispose of expired, unwanted or unused buprenorphine and naloxone sublingual tablets by promptly flushing down the toilet (if a drug take‐back option is not readily available). visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. if you need help with disposal of buprenorphine and naloxone sublingual tablets, call 1-844-834-0530. distributed by: lannett company, inc. philadelphia, pa 19136 all brand names are the trademarks of their respective owners. this “instructions for use” has been approved by the u.s. food and drug administration. cib72082g rev. 03/2024

États-Unis - anglais - NLM (National Library of Medicine)

becton dickinson and company - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - sodium chloride 9 mg in 1 ml - intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. none known. check flexible container solution composition, lot number, and expiry date. do not remove solution container from its overwrap until immediately before use. use sterile equipment and aseptic technique. to open - turn solution container over so that the text is face down. using the pre-cut corner tabs, peel open the overwrap and remove solution container. - check the solution container for leaks by squeezing firmly. if leaks are found, or if the seal is not intact, discard the solution. - do not use if the solution is cloudy or a precipitate is present. to add medication - identify white additive port with arrow pointing toward container. - immediately before injecting additives, break off white additive port cap with the arrow pointing toward container. - hold base of white additive port horizontally. - insert needle horizontally through the center of white additive port's septum and inject additives. - mix container contents thoroughly. preparation for administration - immediately before inserting the infusion set, break off blue infusion port cap with the arrow pointing away from container. - use a non-vented infusion set or close the air-inlet on a vented set. - close the roller clamp of the infusion set. - hold the base of blue infusion port. - insert spike through blue infusion port by rotating wrist slightly until the spike is inserted. note: see full directions accompanying administration set. warning: do not use flexible container in series connections.

États-Unis - anglais - NLM (National Library of Medicine)

h.j. harkins company, inc. - diclofenac epolamine (unii: x5f8ekl9zg) (diclofenac - unii:144o8ql0l1) - diclofenac epolamine 180 mg - - flector patch is contraindicated in patients with a known hypersensitivity to diclofenac. - flector patch is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.13)]. - flector patch is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)]. - flector patch is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds. teratogenic effects pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation. starting at 30 weeks gestation, avoid use of flector patch, and other nsaids, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur, flector pat