Speed Cure Pharma - search results

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

speed stick overtime clear gel- aluminum zirconium tetrachlorohydrex gly stick

colgate-palmolive company - aluminum zirconium tetrachlorohydrex gly (unii: 8o386558je) (aluminum cation - unii:3xhb1d032b, aluminum zirconium tetrachlorohydrex gly - unii:8o386558je) - antiperspirant - reduces underarm wetness - 48 hour protection

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

speed stick power fresh power fresh- aluminum zirconium tetrachlorohydrex gly stick

colgate-palmolive company - aluminum zirconium tetrachlorohydrex gly (unii: 8o386558je) (aluminum zirconium tetrachlorohydrex gly - unii:8o386558je) - antiperspirant - reduces underarm wetness - 24 hour protection

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

speed stick cool clean- aluminum zirconium tetrachlorohydrex gly stick

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

empaveli- pegcetacoplan injection, solution

apellis pharmaceuticals, inc. - pegcetacoplan (unii: to3jyr3bou) (pegcetacoplan - unii:to3jyr3bou) - empaveli® is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (pnh). empaveli is contraindicated: - in patients with hypersensitivity to pegcetacoplan or to any of the excipients [see warnings and precautions (5.3)] . - for initiation in patients with unresolved serious infection caused by encapsulated bacteria including streptococcus pneumoniae , neisseria meningitidis , and haemophilus influenzae type b [see warnings and precautions (5.1)] . risk summary there are insufficient data on empaveli use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with untreated pnh in pregnancy (see clinical considerations) . the use of empaveli may be considered following an assessment of the risks and benefits. treatment of pregnant cynomolgus monkeys with pegcetacoplan at a subcutaneous dose of 28 mg/kg/day (2.9 times human exposure based on auc) from the gestation period through parturition resulted in a statistically significant increase in abortions or stillbirths compared to controls (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or fetal/neonatal risk pnh in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. data animal data animal reproduction studies with pegcetacoplan were conducted in cynomolgus monkeys. pegcetacoplan treatment of pregnant cynomolgus monkeys at a subcutaneous dose of 28 mg/kg/day (2.9 times human exposure based on auc) from the gestation period through parturition resulted in a statistically significant increase in abortions and stillbirths compared to controls. no increase in abortions or stillbirths occurred at a dose of 7 mg/kg/day (1.3 times human exposure based on auc). no maternal toxicity or teratogenic effects were observed in offspring delivered at term. no developmental effects were observed in infants up to 6 months postpartum. systemic exposure to pegcetacoplan of less than 1% of maternal levels was detected in fetuses from monkeys treated with 28 mg/kg/day from the period of organogenesis through the second trimester. risk summary it is not known whether pegcetacoplan is secreted in human milk or whether there is potential for absorption and harm to the infant. there are no data on the effects of pegcetacoplan on milk production. pegcetacoplan is present in milk of lactating monkeys (see animal data) . since many medicinal products are secreted into human milk, and because of the potential for serious adverse reaction in a breastfeeding child, breastfeeding should be discontinued during treatment and for 40 days after the last dose. data animal data pegcetacoplan was detectable in milk of lactating monkeys at less than 1% concentration of serum levels but was not detectable in the serum of nursing infants. contraception females empaveli may cause embryo-fetal harm when administered to pregnant women [see use in specific populations (8.1)] . pregnancy testing is recommended for females of reproductive potential prior to treatment with empaveli. advise female patients of reproductive potential to use effective contraception during treatment with empaveli and for 40 days after the last dose. safety and effectiveness in pediatric patients have not been established. clinical studies of empaveli did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between geriatric and younger patients. instructions for use empaveli® (em-puh-vel-ee) (pegcetacoplan) injection, for subcutaneous use infusion pump important information this instructions for use is for the infusion pump only. if using empaveli injector, follow the instructions for use that comes with the empaveli injector. read this instructions for use before you start using empaveli with an infusion pump and each time you get a refill as there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. your healthcare provider should show you or your caregiver how to infuse empaveli the right way before you use it for the first time. ask your healthcare provider about any instructions you do not understand. how should i store empaveli? - store vials of empaveli in the refrigerator between 36°f to 46°f (2°c to 8°c) in the original carton to protect from light. - do not use empaveli past the expiration date stamped on the carton. keep empaveli and all medicines out of the reach of children. - find a well-lit, flat work surface area, like a table. - remove a single vial carton from the refrigerator. keep the vial in the carton at room temperature and allow it to warm up for about 30 minutes. - do not try to speed up the warming process. - infusion pump and manufacturer's instructions (not shown) - compatible syringe for your infusion pump - transfer needle or - needleless transfer device to draw up the medicine from the vial - infusion set (not shown; varies according to device manufacturer's instructions) - infusion tubing - sharps container - alcohol wipes - gauze and tape, or transparent dressing - remove the vial from the carton. carefully look at the liquid in the vial of empaveli. empaveli is a clear, colorless to slightly yellowish liquid. check for particles or color changes (see figure b ). - empaveli is a clear, colorless to slightly yellowish liquid. check for particles or color changes (see figure b ). - the liquid looks cloudy, contains particles, or is dark yellow. - the protective flip cap is missing or damaged. - the expiration date on the label has passed. - remove the protective flip cap from the top of the vial to show the middle part of the gray rubber stopper of the empaveli vial (see figure c ). throw away the protective flip cap. - clean the gray rubber stopper with a new alcohol wipe and allow the gray rubber stopper to dry for at least 30 seconds. do not touch the exposed gray rubber stopper after wiping. - attach a sterile transfer needle to a sterile syringe. - pull back the plunger to the 20-ml mark to fill the syringe with air (see figure d ). - push the air-filled syringe with transfer needle attached down through the center of the vial gray rubber stopper. - the tip of the transfer needle should not be in the solution to avoid creating air bubble(s) (see figure e ). - gently push the air from the syringe into the vial. this will inject the air from the syringe into the vial. - turn the vial upside down and insert the transfer needle in the empaveli solution (see figure f ). - with the transfer needle tip in the empaveli solution, slowly pull the plunger back to fill the syringe with all the empaveli solution (see figure g ). - remove the filled syringe with empaveli and the transfer needle from the vial. - remove the transfer needle by using 1 hand to slide the needle into the needle cap and scoop upwards to cover the needle (see figure h ). - after the needle is covered, push the needle cap down towards the syringe to fully attach it with 1 hand to prevent an accidental stick with the needle (see figure i ). - twist off and remove the transfer needle (see figure j ). - gather the infusion pump supplies and follow the device manufacturer's instructions to prepare the pump and tubing. - select an area on your stomach (abdomen), thighs, hips, or upper arms for the infusion(s) (see figure k ). avoid the following infusion areas: do not infuse into areas where the skin is tender, bruised, red, or hard. avoid infusing into tattoos, scars, or stretch marks. - do not infuse into areas where the skin is tender, bruised, red, or hard. - avoid infusing into tattoos, scars, or stretch marks. - use a different site(s) from the last time you infused empaveli. if there are multiple infusion sites, they should be at least 3 inches apart. change (rotate) infusion sites in between each infusion (see figure l ). - clean the skin at each infusion site(s) with a new alcohol wipe, starting at the center of each infusion site and working outward in a circular motion (see figure m ). - let the skin dry. - pinch the skin between your thumb and forefinger around the infusion site (where you plan to insert the needle). - insert the needle into the skin (see figure n ). - secure the needle(s) using gauze and tape or a transparent dressing placed over the infusion site(s) (see figure o ). - follow the device manufacturer's instructions to start the infusion. - start the infusion right away after drawing empaveli into the syringe. - empaveli infusion takes about 30 minutes (if using 2 infusion sites) or about 60 minutes (if using 1 infusion site) to complete. - follow the device manufacturer's instructions to complete the infusion. - record your treatment as directed by your healthcare provider. - after the infusion is complete, remove the dressing and slowly take out the needle(s). cover the infusion site with a new dressing. - remove the infusion set from the pump and throw it away into the sharps container (see figure p ). - clean and store the infusion pump according to the device manufacturer's instructions. - put the used needles, syringes, and empaveli infusion tubing in an fda-cleared sharps disposal container right away after use (see figure p ). - do not dispose of (throw away) the used needles, syringes, and empaveli infusion tubing 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 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 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 throw away your used sharps disposal container in your household trash unless your community guidelines permit this. - do not recycle your used sharps disposal container. call 1-866-692-7527 to speak with an apellis representative. manufactured for: apellis pharmaceuticals, inc. 100 fifth avenue waltham, ma 02451 copyright © 2021 apellis pharmaceuticals, inc. all rights reserved. empaveli is a registered trademark of apellis pharmaceuticals, inc. this instructions for use has been approved by the u.s. food and drug administration. revised 09/2023 emp-ifu-29sep2023-4.0 instructions for use empaveli® injector (pegcetacoplan) injection, for subcutaneous use single-use on-body injector important information this instructions for use is for the empaveli injector only. read this instructions for use before you start using the injector and each time you get a refill as there may be new information. the empaveli injector is placed on your body to give medicine under the skin. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. your healthcare provider should show you or your caregiver how to inject empaveli the right way before you use it for the first time. it is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. ask your healthcare provider about any instructions you do not understand. if you have questions, concerns, or need of help, please call apellisassist® at 1-866-my-apl-assist (1-866-692-7527). how should i store empaveli? - store vials of empaveli in the refrigerator between 36°f to 46°f (2°c to 8°c) in the original carton to protect from light. - do not use empaveli past the expiration date stamped on the carton. keep empaveli, empaveli injector, and all medicines out of the reach of children. - find a well-lit, flat work surface area, like a table. - remove a single vial carton of empaveli from the refrigerator. keep the vial in the carton at room temperature and allow it to warm up for about 30 minutes . do not try to speed up the warming process. do not try to speed up the warming process. - wash your hands well with soap and water. - dry your hands. - remove the vial from the carton. carefully look at the liquid in the vial of empaveli. - empaveli is a clear, colorless to slightly yellowish liquid. check for particles or color changes. do not use and call apellisassist if: - flip up to remove the protective flip cap from the top of the vial to show the exposed middle part of the gray rubber stopper of the empaveli vial. - throw away the protective flip cap. - clean the gray rubber stopper on the top of the empaveli vial with a new alcohol wipe. - allow the gray rubber stopper to dry for at least 30 seconds. do not touch the exposed gray rubber stopper after wiping. do not remove the needleless transfer device from the blister package. do not touch the spike or the inside of the needleless transfer device. do not use the needleless transfer device if it comes out or is dropped out of the package. do not use the needleless transfer device if the package is opened. - remove the cover of the needleless transfer device package. - place the vial on a clean, flat surface and hold the vial by the base with one hand. - using the outside of the blister package to firmly hold the needleless transfer device, push needleless transfer device straight down onto the vial top until it snaps securely into place. - remove the blister package from the needleless transfer device and throw the blister package away. do not touch the connector at the top of the transfer device. - remove the syringe from its packaging. do not touch the tip of the syringe. - attach the syringe to the needleless transfer device by twisting the tip of the syringe to the right (clockwise) onto the top of the needleless transfer device. - turn the empaveli vial upside down. - slowly pull the syringe plunger down to fill the syringe with empaveli. - withdraw all empaveli from the vial into the syringe. - make sure there is 20 ml of empaveli in the syringe. - remove air from syringe by gently pushing on the plunger. - while holding the empaveli vial and syringe, turn the empaveli vial and filled syringe upright and place the bottom of the empaveli vial on a flat surface. - remove the filled syringe from the needleless transfer device with one hand while holding the empaveli vial with the other hand and twisting the filled syringe to the left (counterclockwise). - place the syringe on a clean, flat surface while you prepare the empaveli injector. the syringe will not leak when set down. do not touch the tip of the filled syringe. do not remove the needleless transfer device from the vial. - throw away the vial with the needleless transfer device attached into the household trash. important information for administration with empaveli injector - do not use empaveli injector if tamper-proof label has been broken. - do not use empaveli injector if you have a skin condition on your stomach (injection site). - do not use if you dropped empaveli injector. - do not use if the sealed plastic tray is open or damaged. - do not use if the expiration date on the box has passed. - do not use if you have an acrylic allergy. tell your healthcare provider if you are allergic to acrylic. - do not reuse empaveli injector. - do not store the filled empaveli injector. - wear loose clothes so that they do not get in the way of the empaveli injector. - do not store the empaveli injector in direct sunlight. if the empaveli injector is stored in direct sunlight, do not use it and call apellisassist at 1-866-my-apl-assist (1-866-692-7527). - do not apply empaveli injector along the belt line or on areas where the injector will be affected by folds in the skin. - do not touch the white adhesive on the bottom of empaveli injector before attaching to stomach. - do not let your clothes touch the clean site. - do not remove the red safety tab until empaveli injector is attached to body. - do not remove empaveli injector from the skin until the button pops out. - do not throw away (dispose of) the empaveli injector into household trash. see the section "remove and dispose of empaveli injector" for information on how to dispose of the empaveli injector. - choose an injection site at least 1 inch from the edge of your belly button and the edge of the empaveli injector, and 1 inch from last injection site. - use the empaveli injector on stomach only. - do not remove empaveli injector from the skin during injection. - do not bathe, shower, exercise, use hot tubs, whirlpools, or saunas. avoid getting your stomach wet. the empaveli injector is not waterproof. water or sweat may loosen empaveli injector from skin. - do not sleep or bathe during injection. - avoid intense physical activity. - do not bump or knock the empaveli injector. - do not bump the empaveli injector button. - do not use anything to hold the empaveli injector in place. - pick up the syringe filled with empaveli. - twist the filled syringe tip to the right (clockwise) into the fill port until it is tight. - firmly push the syringe plunger down. - the syringe plunger may be hard to push. - watch the fill gauge move as empaveli is pushed into the injector. - make sure the syringe is empty. if needed, press firmly down on the syringe plunger again. do not remove syringe from filling base. after the empaveli injector is filled, continue with the preparation and injection. do not store filled empaveli injector. - select an area on your stomach to place the empaveli injector. use the empaveli injector on your stomach only. - choose an injection site at least: 1 inch from the edge of your belly button and the edge of the empaveli injector. and 1 inch from your last injection site. - 1 inch from the edge of your belly button and the edge of the empaveli injector. and - 1 inch from your last injection site. avoid an injection site that is tender, bruised, red, hard, irritated, scarred, tattooed, or has stretch marks. do not apply the empaveli injector along the belt line or on areas where the empaveli injector will be affected by folds in the skin. wear loose clothes so that they do not get in the way of the empaveli injector. - clean the injection site with an alcohol wipe. - allow the injection site to dry for at least 30 seconds. do not let your clothes touch the clean injection site. - hold the gray pull tab and pull. allow both the gray and clear pull tabs to fall to the side. - both tabs may fall to the side or come off completely. do not remove the red safety tab until the empaveli injector is attached to the body. - hold the sides of the empaveli injector and pull it straight up to remove it from the filling base. do not touch the adhesive on the bottom of the empaveli injector or fold the adhesive onto itself. - the white adhesive will stay attached to the empaveli injector and the clear liner will stay attached to the filling base. do not remove the red safety tab until the empaveli injector is attached to your body. ensure the injection site has been cleaned before attaching empaveli injector. - position the empaveli injector so that the fill window is pointed up toward your face. - press firmly on the clear portion of the empaveli injector to attach to stomach. do not use anything to hold the empaveli injector in place. - hold the empaveli injector with 1 hand. use the other hand to pull the red safety tab off. - the empaveli injection will not start until the red safety tab is removed. - right away, press the button in firmly until it stays in place to start the empaveli injection. pushing the button in will insert the needle into your skin. you may feel the needle go into your skin. - light daily activities can be done during the empaveli injection. be careful not to bump or knock the empaveli injector or button during the empaveli injection. keep your stomach dry. avoid intense physical activity. do not sleep or bathe during your empaveli injection. - your empaveli injection will continue as long as the button is pushed in. it may take approximately 30 to 60 minutes to complete. - to track progress, watch the fill gauge move across fill window toward empty. it may take some time to move and may move slowly. do not remove the empaveli injector until the button pops out. if the button does not pop out after 2 hours (120 minutes), refer to questions and answers. if the empaveli injector falls off of your body, refer to questions and answers. caution: holding down the button will stop the flow of medicine. injection will begin again when the button is released. if you have an allergic reaction to the adhesive, call your healthcare provider right away. - when the button pops out, the empaveli injection is done. the needle will be pulled out of the skin and back into the empaveli injector. the button popping out is the only way to know if the empaveli injection is complete. do not remove the empaveli injector until the button pops out. - use your thumb to lift the adhesive tab. hold the adhesive tab against the empaveli injector. - slowly peel the empaveli injector away from your skin. - put your used empaveli injector in an fda-cleared sharps disposal container right away after use. do not throw away the empaveli injector in the household trash. the filling base with the syringe attached, alcohol wipe, and packaging may be placed 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 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 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 throw away (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. - keep the used empaveli injector and sharps disposal container out of the reach of children. - keep the empaveli injector in unopened tray inside the original box. - do not open the tray until ready for empaveli injection. - store the empaveli injector unit in clean, dry area away from heat and sunlight, at a temperature between 36°f to 86°f (2°c to 30°c). - use the empaveli injector where the temperature is between 41°f to 104°f (5°c to 40°c). do not touch the bottom of the empaveli injector as the needle will be exposed. set the empaveli injector aside and call apellisassist at 1-866-my-apl-assist (1-866-692-7527). manufactured for: apellis pharmaceuticals, inc. 100 fifth avenue waltham, ma 02451 manufactured by: enable injections, inc. 2863 e. sharon road cincinnati, oh 45421, usa 10130600 rev 04 patent: enableinjections.com/patent copyright © 2023 apellis pharmaceuticals, inc. all rights reserved. apellis, apellisassist, empaveli, and their respective logos are registered trademarks of apellis pharmaceuticals, inc. this instructions for use has been approved by the u.s. food and drug administration. issued: 09/2023 emp inj-ifu-29sep2023-1.0

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

brineura cerliponase alfa (rch) 150 mg/5 ml solution for injection vial with flushing solution vial

biomarin pharmaceutical australia pty ltd - cerliponase alfa, quantity: 30 mg/ml - injection, solution - excipient ingredients: dibasic sodium phosphate heptahydrate; sodium chloride; potassium chloride; magnesium chloride hexahydrate; calcium chloride dihydrate; water for injections; monobasic sodium phosphate monohydrate - brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (cln2) disease, also known as tripeptidyl peptidase 1 (tpp1) deficiency.

Canada - English - Health Canada

pharma-ramipril capsule

pharmascience inc - ramipril - capsule - 1.25mg - ramipril 1.25mg - angiotensin-converting enzyme inhibitors

Canada - English - Health Canada

pharma-ramipril capsule

pharmascience inc - ramipril - capsule - 2.5mg - ramipril 2.5mg - angiotensin-converting enzyme inhibitors

Canada - English - Health Canada

pharma-ramipril capsule

pharmascience inc - ramipril - capsule - 5mg - ramipril 5mg - angiotensin-converting enzyme inhibitors

Canada - English - Health Canada

pharma-ramipril capsule

pharmascience inc - ramipril - capsule - 10mg - ramipril 10mg - angiotensin-converting enzyme inhibitors

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

speedmax industrial herbicide