Canada - English - Health Canada

leo pharma inc - calcipotriol; betamethasone (betamethasone dipropionate) - ointment - 50mcg; 0.5mg - calcipotriol 50mcg; betamethasone (betamethasone dipropionate) 0.5mg - anti-inflammatory agents

Canada - English - Health Canada

teva canada limited - betamethasone (betamethasone dipropionate); calcipotriol - ointment - 0.5mg; 50mcg - betamethasone (betamethasone dipropionate) 0.5mg; calcipotriol 50mcg - anti-inflammatory agents

Israel - English - Ministry of Health

taro international ltd, israel - benzoyl peroxide as hydrous; clindamycin as phosphate - gel - benzoyl peroxide as hydrous 5 %w/w; clindamycin as phosphate 1 %w/w - clindamycin, combinations - mild to moderate acne vulgaris, particulary inflammatory lesions.

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - eptifibatide - injection - 2 mg/ml - eptifibatide 2 mg/ml

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - eptifibatide - injection - 0.75 mg/ml - eptifibatide 0.75 mg/ml

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - diphtheria toxoid protein; meningococcal (serogroup a) polysaccharide (monovalent conjugate); meningococcal (serogroup c) polysaccharide (monovalent conjugate); meningococcal (serogroup w-135) polysaccharide (monovalent conjugate); meningococcal (serogroup y) polysaccharide (monovalent conjugate) - injection, solution - 48 microgram (diptheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio) - diphtheria toxoid protein 48 mcg/dose (0.5 ml) (diphtheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio); meningococcal (serogroup a) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup c) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup w-135) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup y) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml)

Singapore - English - HSA (Health Sciences Authority)

merck pte. ltd. - interferon beta-1a - injection, solution - 44mcg/0.5ml - interferon beta-1a 44mcg/0.5ml

Malta - English - Medicines Authority

ursapharm arzeneitmittel gmbh industriestrasse, 66129 saarbrucken, germany - antazoline phosphate, tetryzoline hydrochloride - eye drops, solution - antazoline phosphate 0.15 mg/ml tetryzoline hydrochloride 0.5 mg/ml - ophthalmologicals

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

eli lilly and company - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 500 [iu] in 1 ml - humulin r u-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. the safety and efficacy of humulin r u-500 used in combination with other insulins has not been determined. the safety and efficacy of humulin r u-500 delivered by continuous subcutaneous infusion has not been determined. humulin r u-500 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.4)] - in patients who are hypersensitive to humulin r u-500 or any of its excipients [see warnings and precautions (5.5)] risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were not performed. 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 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/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 while available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. all available studies have methodological limitations, including lack of blinding, unclear methods or randomization, and small sample size. risk summary available data from published literature suggests that exogenous human insulin products, including humulin r u-500, are transferred into human milk. there are no adverse reactions reported in breastfed infants in the literature. there are no data on the effects of exogenous human insulin products, including humulin r u-500 on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for humulin r u-500 and any potential adverse effects on the breastfed child from humulin r u-500 or from the underlying maternal condition. the safety and effectiveness of humulin r u-500 in pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day to improve glycemic control have been established. use of humulin r u-500 for this indication is supported by evidence from studies with other insulin human in pediatric patients with type 1 diabetes mellitus and from studies in adults with diabetes mellitus. standard precautions as applied to use of humulin r u-500 in adults are appropriate for use in pediatric patients. the effect of age on the pharmacokinetics and pharmacodynamics of humulin r u-500 has not been studied. caution should be exercised when humulin r u-500 is administered to geriatric patients. in elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia. frequent glucose monitoring and insulin dose reduction may be required in patients with renal impairment. frequent glucose monitoring and insulin dose reduction may be required in patients with hepatic impairment. please read these instructions before use. - for your safety, always inject humulin ®  r u - 500 insulin with a u - 500 syringe. - if you use another kind of syringe, you may get a dangerous overdose. important information - humulin r u-500 is a concentrated insulin. - know your dose. your health care provider will tell you the number of insulin units that you should take. - always inject humulin r u-500 insulin with a u-500 syringe. other syringes will not measure your dose correctly. - if you use the wrong syringe, you can give yourself a severe overdose. this can cause very low blood sugar, which may put your life in danger. for example, using a u-100 syringe can give you a 5 times overdose. - if you do not have a u-500 syringe, you should contact your health care provider or pharmacist. additional safety information - each line on the u-500 syringe measures 5 units of u-500 insulin. - you can give from 5 to 250 units in one injection. - if your dose is more than 250 units, you will need to give more than 1 injection. - make sure you know how to draw up your dose with a u-500 syringe. if you need help, call your health care provider. - do not reuse your u-500 syringe. - do not share your u - 500 syringes with other people. you may give other people a serious infection or get a serious infection from them. - do not mix humulin r u-500 with other insulins in the same syringe. - you can get more instructions by calling lilly at 1-800-lillyrx (1-800-545-5979). - humulin r u-500 multiple-dose vial - u-500 syringe (bd [becton, dickinson and company] syringes recommended) - 2 alcohol swabs - 1 sharps container before you start - check your vial. make sure it says humulin r u-500. - check the expiration date on the vial. do not use it if it is expired. throw away the opened vial after 40 days, even if there is still insulin left in the vial. - see if the insulin in the vial is clear. do not use if it is thick, cloudy, or colored or has solid particles. - make sure you have a new u-500 syringe. check for the green u-500 symbol and green needle shield. - check your supply. make sure you have enough humulin r u-500 insulin and u-500 syringes for several injections. always reorder before you run out. - check with your health care provider if you have any questions. use only a u-500 syringe to inject humulin r u-500 insulin prepare - wash your hands with soap and water. - always use a new syringe for each injection to help prevent infections and blocked needles. inject - inject your insulin exactly 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. - you may see blood after you take the needle out of your skin. this is normal. press the injection site lightly with a piece of gauze or an alcohol swab. do not rub the area. - do not put the needle shield back on the needle, because you may get a needle stick injury. disposal of used syringes - put your used syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) syringes 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. storage and handling - keep away from heat and out of direct light. - do not shake the vial. unopened vials: - store unopened vials in the refrigerator. - do not freeze humulin r u-500. if it has been frozen, do not use it. - if unopened vials have been stored in the refrigerator, you may use them until the expiration date. after the vial has been opened: - store opened vials in the refrigerator or at room temperature (up to 86°f [30°c]) for up to 40 days. - throw away the opened vial after 40 days, even if there is still insulin left in the vial. - always use a u-500 syringe to inject humulin r u-500 insulin. - never use other syringes. the lines and numbers on other syringes will not measure your dose correctly. - you can give yourself the wrong dose if you use any other syringe, such as a u-100, tuberculin or allergy syringe. for example, a u-100 syringe is made to measure u-100 insulin. if you use a u-100 syringe for your u-500 dose, you can give yourself a 5 times overdose. - do not make any changes to your dose or the type of insulin you use unless you are told to do so by your health care provider. - keep your vials and syringes out of the sight and reach of children. frequently asked questions - why do i need to use a u-500 syringe? humulin r u-500 insulin and a u-500 syringe work together to help you inject the correct dose. using any other syringe may result in dosing mistakes. this may put your life in danger. - do i have to convert my humulin r u-500 insulin dose when i use the u-500 syringe? no, you do not have to convert your dose. your health care provider should tell you how much humulin r u-500 insulin to take in units and when to take it. your health care provider should show you how to draw up your dose using the u-500 syringe. - what should i do if i run out of u-500 syringes? if you run out of u-500 syringes, do not use any other syringe to inject humulin r u-500 insulin. call your health care provider or pharmacist for help. you may also call lilly at 1-800-lilly-rx (1-800-545-5979). where to get more information and help - if you have any questions about humulin r u-500 insulin or u-500 syringes, contact lilly at 1-800-lilly-rx (1-800-545-5979). - you can also call your health care provider or pharmacist. - for more information on humulin r u-500 insulin, go to www.humulin.com scan this code to launch the humulin.com website these instructions for use have been approved by the u.s. food and drug administration. humulin® is a trademark of eli lilly and company. manufactured by: eli lilly and company, indianapolis, in 46285, usa us license number 1891 copyright © 1996, 2022, eli lilly and company. all rights reserved. literature revised: june 2022 linr500vl-0004-ifu-20220627 instructions for use humulin® r u-500 kwikpen® (insulin human) injection, for subcutaneous use 3 ml single-patient-use pen (500 units/ml, u-500) - know your dose of humulin r u-500 insulin. the pen delivers your dose in insulin units . insulin units may not be the same as syringe markings. ask your health care provider what your dose should be for your pen. - your humulin®  r u-500 kwikpen® (pen) works differently from other pens. it dials 5 insulin units with each click. do not count clicks of the dose knob to select your dose. you may get too much insulin or you may not get enough insulin. - humulin r u-500 is a concentrated insulin. do not transfer humulin r u-500 insulin from your pen into a syringe. a severe overdose can happen, causing very low blood sugar, which may put your life in danger. read the instructions for use before you start taking humulin r u-500 and each time you get another 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 humulin r u-500 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. humulin r u-500 kwikpen (“pen”) is a disposable single-patient-use prefilled pen containing 1500 units of humulin r. you can give yourself more than 1 dose from the pen. each turn (click) of the dose knob dials 5 units of insulin. you can give from 5 to 300 units in a single injection. the plunger only moves a little with each injection, and you may not notice that it moves. the plunger will only reach the end of the cartridge when you have used all 1500 units in the pen. inject humulin r u-500 only with your pen. do not transfer insulin from your pen to a syringe. people who are blind or have vision problems should not use the pen without help from a person trained to use the pen. how to recognize your humulin r u-500 kwikpen - pen color: aqua - dose knob: aqua with raised ridges on the end - label: humulin r u-500 and 500 units/ml in a green box supplies needed to give your injection - humulin r u-500 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 kwikpen label. - wipe the rubber seal with an alcohol swab. humulin r u-500 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 your pen means removing the air from the needle and cartridge that may collect during normal use and ensures that the pen is working 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 5 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 priming steps 5 to 7, no more than 8 times. – if you still do not see insulin, change the needle and repeat priming steps 5 to 7. selecting your dose this pen has been made to deliver the dose in insulin units that is shown in the dose window. ask your healthcare provider what your dose should be for this pen. - you can give from 5 to 300 units in a single injection. - if your dose is more than 300 units, you will need to give more than 1 injection. – if you need help with dividing up your dose the right way, ask your healthcare provider. – you must 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 dose knob clicks as you turn it. each click of the dose knob dials 5 insulin units at a time. – do not dial your dose by counting the clicks. you may dial the wrong dose. this may lead to you getting too much insulin or not enough insulin. – 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 (for example, 80) are printed on the dial. – the odd numbers (for example, 125) are shown as lines between the even numbers. - always check the number in the dose window to make sure you have dialed the correct dose. example: 80 units shown in dose window example: 125 units shown in dose window - the pen will not let you dial more than the number of units left in the pen. - if your dose is 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 your full dose. - it is normal to see a small amount of insulin left in the pen that you cannot inject. do not transfer this to a syringe. severe overdose can happen. 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. - choose your injection site. humulin is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe your skin with an alcohol swab, and let your skin 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. - 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, 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 your injection . monitor your blood glucose as instructed by your healthcare provider. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section). - 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 pen unused pens - store unused pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze humulin r u-500. 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). keep away from heat and light. - throw away the pen you are using after 28 days, even if it still has insulin left in it. what you should know if you are switching to humulin r u-500 kwikpen ask your healthcare provider what your dose should be for your pen in insulin units . always follow your healthcare provider's instructions for dosing. general information about the safe and effective use of your pen - keep your pen and needles out of the sight and reach of children. - 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 it is hard to push the dose knob: – 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 humulin r u-500 kwikpen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on humulin r u-500 kwikpen and insulin, go to www.humulin.com. scan this code to launch www.humulin.com these instructions for use have been approved by the u.s. food and drug administration. humulin® and humulin®  kwikpen® are trademarks of eli lilly and company. manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2015, 2022, eli lilly and company. all rights reserved. humulin r u-500 kwikpen meets the current dose accuracy and functional requirements of iso 11608-1. document revision date: june 2022 linr500kp-0005-ifu-20220627