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

salix pharmaceuticals, inc. - methylnaltrexone bromide (unii: rfo6il3d3m) (methylnaltrexone - unii:0rk7m7iabe) - methylnaltrexone bromide 150 mg - relistor tablets and relistor injection are indicated for the treatment of opioid-induced constipation (oic) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. relistor injection is indicated for the treatment of oic in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. relistor is contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation [see warnings and precautions ( 5.1)] . risk summary the limited available data with relistor in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriages. there are clinical considerations when relistor is used by pregnant women [see clinical considerations]. in animal reproduction studies, no effects on embryofetal development were observed with the administration of intravenous methylnaltrexone bromide during organogenesis in rats and rabbits at doses up to 20 times and 26 times, respectively, the subcutaneous maximum recommended human dose (mrhd) of 12 mg relistor injection per day. the intravenous doses in rats and rabbits are about 0.5 times and 0.7 times, respectively, the oral mrhd of 450 mg/day [see data]. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and 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 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions the use of relistor during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. data animal data reproduction studies have been performed with methylnaltrexone bromide administered during the period of organogenesis to rats at intravenous doses up to 25 mg/kg/day (about 20 times the subcutaneous mrhd of 12 mg/day based on body surface area), and did not cause any adverse effects on embryofetal development. in rabbits, intravenous doses of methylnaltrexone bromide up to 16 mg/kg/day (about 26 times the subcutaneous mrhd of 12 mg/day) did not show any embryofetal toxicity. the intravenous doses in rats (25 mg/kg/day) and rabbits (16 mg/kg/day) are about 0.5 and 0.7 times, respectively, the oral mrhd of 450 mg/day based on body surface area. a pre- and postnatal development study in rats showed no evidence of any adverse effect on pre- and postnatal development at subcutaneous doses of methylnaltrexone bromide up to 100 mg/kg/day (about 81 times the subcutaneous mrhd of 12 mg/day; about 2.2 times the oral mrhd of 450 mg/day). risk summary there is no information regarding the presence of methylnaltrexone in human milk, the effects on the breastfed infant, or the effects on milk production. methylnaltrexone is present in rat milk [see data]. because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with relistor. data radioactivity appeared in rat milk within 30 minutes of a single subcutaneous administration of radiolabeled methylnaltrexone bromide and was concentrated up to 24-fold at 8 hours after administration relative to plasma concentrations. safety and effectiveness of relistor tablets and injection have not been established in pediatric patients. juvenile animal studies in juvenile rats administered intravenous methylnaltrexone bromide for 13 weeks, adverse clinical signs such as convulsions, tremors and labored breathing were observed, and the juvenile rats were found to be more sensitive to the adverse effects of methylnaltrexone when compared to adult animals. juvenile dogs administered intravenous methylnaltrexone bromide for 13 weeks had a toxicity profile similar to adult dogs [see nonclinical toxicology ( 13.2)] . of the total number of patients in clinical studies of relistor tablets, a total of 136 patients (10%) were aged 65 years and older, while 23 (2%) were aged 75 and older. in clinical studies of relistor tablets, no overall differences in effectiveness were observed. adverse reactions were similar; however, there was a higher incidence of diarrhea in elderly patients. of the total number of patients in clinical studies of relistor injection, a total of 226 (28%) were aged 65 years and older, while 108 (13%) were aged 75 years and older. in clinical studies of relistor injection, no overall differences in safety or effectiveness were observed between elderly patients and younger patients. based on pharmacokinetic data, and safety and efficacy data from controlled clinical trials, no dosage adjustment based on age is recommended. monitor elderly patients for adverse reactions. in a study of subjects with varying degrees of renal impairment receiving relistor injection subcutaneously, there was a significant increase in the exposure to methylnaltrexone in subjects with moderate and severe renal impairment (creatinine clearance less than 60 ml/minute as estimated by cockcroft-gault) compared to healthy subjects [see clinical pharmacology ( 12.3)] . therefore, a dosage reduction of relistor tablets and relistor injection is recommended in patients with moderate and severe renal impairment [see dosage and administration ( 2.4)] . no dosage adjustment of relistor tablets or relistor injection is needed in patients with mild renal impairment (creatinine clearance greater than 60 ml/minute as estimated by cockcroft-gault). tablets in a study of subjects with varying degrees of hepatic impairment receiving a 450 mg dose of relistor tablets, there was a significant increase in systemic exposure of methylnaltrexone for subjects with moderate (child-pugh class b) and severe (child-pugh class c) hepatic impairment compared to healthy subjects with normal hepatic function [see clinical pharmacology ( 12.3)] . therefore, a dosage reduction of relistor tablets is recommended in patients with moderate or severe hepatic impairment [see dosage and administration ( 2.5)]. no dosage adjustment of relistor tablets is needed in patients with mild hepatic impairment (child-pugh class a). injection in a study of subjects with mild or moderate hepatic impairment, there was no clinically meaningful change in systemic exposure of methylnaltrexone compared to healthy subjects with normal hepatic function [see clinical pharmacology ( 12.3)] . therefore, no dosage adjustment of relistor injection is needed for patients with mild or moderate hepatic impairment [see clinical pharmacology ( 12.3)]. patients with severe hepatic impairment were not studied. in patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions. if considering dosage adjustment, follow the recommendations in table 3 [see dosage and administration ( 2.5)]. instructions for use relistor ® (rel-i-store) (methylnaltrexone bromide) injection, for subcutaneous use pre-filled syringe read this instructions for use before you start using relistor and each time you get a refill. 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. the following instructions explain how to prepare and give an injection of relistor the right way, when using a pre-filled syringe of relistor. important information: - do not use a relistor pre-filled syringe and attached needle more than 1 time, even if there is medicine left in the syringe. see step 4 “dispose of used pre-filled syringes and needles.” - safely throw away relistor pre-filled syringes and attached needle after use. - to avoid needle-stick injuries, do not recap used needles. - avoid touching the trigger fingers of the relistor pre-filled syringe to keep from activating the needle guard (safety device) too soon. the needle guard is activated by pressure from the plunger on the trigger fingers (see figure a). gather the supplies you will need for your injection (see figure a). these include: - 1 relistor pre-filled syringe with attached needle - 1 alcohol swab - 1 cotton ball or gauze - 1 adhesive bandage - a puncture resistant container, such as an fda-cleared sharps disposal container to dispose of used pre-filled syringes and needles. see step 4: “dispose of used pre-filled syringes and needles.” step 1: choose and prepare the injection site - choose an injection site on your stomach-area (abdomen), thighs, or upper arms. see the shaded areas in figures b and c below. do not inject at the exact same spot each time (rotate injection sites). do not inject into areas where the skin is tender, bruised, red or hard. avoid areas with scars or stretch marks. figure b abdomen or thigh – use these sites when injecting yourself or another person. figure c upper arm – use this site only when injecting another person. - clean the injection site with an alcohol swab and let it air dry. do not touch this area again before giving the injection (see figure d). step 2: prepare the pre-filled syringe - choose a flat, clean, well-lit work surface. - wash your hands with soap and water before preparing for the injection. - look at the pre-filled syringe of relistor (see figure e). make sure that the dose prescribed by your healthcare provider matches the dose on the pre-filled syringe label. look at the plunger rod of the syringe. if the dose prescribed by your healthcare provider is 8 mg, the plunger rod will be yellow; if the prescribed dose is 12 mg, the plunger rod of the syringe will be dark blue (see figure e). - the liquid in the pre-filled syringe should be colorless to pale yellow, and should not have any particles in it. do not use the pre-filled syringe if it looks discolored, cloudy, or has any particles. - use one hand to firmly hold the barrel of the pre-filled syringe. use your other hand to pull the needle cap straight off (see figure f). do not touch the needle or allow it to touch anything. step 3: inject relistor - use one hand to pinch the skin around the injection site (see figure g). - use your other hand to hold the pre-filled syringe. insert the full length of the needle into the skin at a 45-degree angle with a quick “dart‑like” motion (see figure h). - let go of the skin and slowly push the plunger in with your thumb until the pre-filled syringe is empty (see figure i). this will release the needle guard (safety device). - continue to hold pressure on the plunger with your thumb and quickly pull the needle out of the skin. be careful to keep the needle at the same angle as it was inserted. remove your thumb from the plunger to allow the protective sleeve to cover the needle (see figure j). there may be a little bleeding at the injection site. - hold a cotton ball or gauze over the injection site (see figure k). do not rub the injection site. apply an adhesive bandage to the injection site if needed. step 4: dispose of used pre-filled syringes and needles - do not reuse the pre-filled syringe and attached needle. - to avoid needle-stick injuries, do not recap used needles. - put your used pre-filled syringes and attached needles in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles 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. - if you have any questions, talk to your healthcare provider or pharmacist. - how should i store relistor? - store pre-filled syringes at room temperature between 68° to 77°f (20° to 25°c). - do not freeze relistor. - keep relistor away from light until you are ready to use it. - keep relistor and all medicines, needles and syringes out of the reach of children. for more information, go to www.relistor.com or call 1-800-321-4576. this instructions for use has been approved by the u.s. food and drug administration. distributed by: salix pharmaceuticals, a division of bausch health us, llc bridgewater, nj 08807 usa under license from: progenics pharmaceuticals, inc. tarrytown, ny 10591 usa for injection: u.s. patent numbers: 8,247,425; 8,420,663; 8,552,025; 8,822,490; 9,180,125; 9,492,445; 9,669,096 and 10,376,584 for tablets: u.s. patent numbers: 8,420,663; 8,524,276; 8,956,651; 9,180,125; 9,314,461; 9,492,445; 9,724,343; 10,307,417 and 10,376,505 relistor is a trademark of salix pharmaceuticals, inc. or its affiliates. any other product/brand names are trademarks of the respective owners. © 2020 salix pharmaceuticals, inc. or its affiliates revised: 04/2020 9502505 70014843 instructions for use relistor ® (rel-i-store) (methylnaltrexone bromide) injection, for subcutaneous use vial and syringe with retractable needle in tray read this instructions for use before you start using relistor and each time you get a refill. 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. the following instructions explain how to prepare and give an injection of relistor the right way, when using a relistor tray containing a syringe with a retractable needle. a retractable needle is one that is pulled back so that it is covered after use, to prevent needle-stick injury. important information: - do not use a relistor vial more than 1 time, even if there is medicine left in the vial. - if relistor has been drawn into a syringe and you are unable to use the medicine right away, carefully recap the needle and keep the syringe at room temperature for up to 24 hours. for more information about how to store relistor, see the section called “ how should i store relistor? ” at the end of this instructions for use. - safely throw away relistor vials after use. - do not reuse syringes and needles. see step 5: “dispose of used syringes and needles” for information about how to safely throw away used needles and syringes. - to avoid needle-stick injuries, do not recap used needles. your tray should include (see figure a): - 1 relistor vial - 1 1 ml syringe with retractable needle (vanishpoint) - 2 alcohol swabs - you will also need: - 1 cotton ball or gauze - 1 adhesive bandage - a puncture resistant container, such as an fda-cleared sharps disposal container to dispose of your used syringes and needles. see step 5: “dispose of used syringes and needles.” step 1: choose and prepare the injection site - choose an injection site on your stomach-area (abdomen), thighs, or upper arms. see the shaded areas in figures b and c below. do not inject at the exact same spot each time (rotate injection sites). do not inject into areas where the skin is tender, bruised, red, or hard. avoid areas with scars or stretch marks. - figure b abdomen or thigh – use these sites when injecting yourself or another person. figure c upper arm – use this site only when injecting another person. - clean the injection site with an alcohol swab and let it air dry. do not touch this area again before giving the injection (see figure d). step 2: prepare the injection - choose a flat, clean, well-lit work surface. - wash your hands with soap and water before preparing for the injection. - look at the vial of relistor (see figure e). the liquid in the vial should be colorless to pale yellow, and should not have any particles in it. do not use the vial if it looks discolored, cloudy, or has any particles. step 3: prepare the syringe - remove the cap from the vial containing relistor (see figure f). - wipe the rubber stopper with an alcohol swab (see figure g). - firmly hold the barrel of the syringe with one hand. with your other hand, pull the needle cap straight off (see figure h). do not touch the needle or allow it to touch anything. - carefully pull back on the plunger to the line that matches the dose prescribed by your healthcare provider (see figures i and j). for most people, this will be the 0.4 ml mark which is an 8 mg dose or the 0.6 ml mark which is a 12 mg dose. - use one hand to hold the vial steady. use your other hand to insert the needle straight down into the rubber top of the relistor vial (see figure k). do not insert it at an angle. this may cause the needle to bend or break. you will feel some resistance as the needle passes through the rubber top. - gently push down on the plunger until you feel resistance, and most of the air has gone from the syringe into the vial (see figure l). stop pushing down on the plunger when you feel resistance. if you continue to push down on the plunger when you feel resistance, the needle will pull back (retract) into the syringe barrel. - with the needle still in the vial, turn the vial and syringe upside down. hold the syringe at eye level. make sure the tip of the needle is in the fluid. slowly pull back on the plunger (see figure m) until the top of the plunger lines up with the mark that matches your prescribed dose. for most people, this will be the 0.4 ml mark which is an 8 mg dose or the 0.6 ml mark which is a 12 mg dose. - you may see some fluid or bubbles inside the vial when the syringe is filled. this is normal. - with the needle still in the vial, gently tap the syringe to make any air bubbles rise to the top (see figure n). - gently push the plunger up until all air bubbles are out of the syringe (see figure o). a small air bubble may stay in the syringe. this is okay and it will not affect the dose of medicine in the syringe. - make sure the tip of the needle is in the fluid. slowly pull back the plunger to draw the right amount of liquid back into the syringe (see figure p). - check to be sure that you have the right dose of relistor in the syringe. - slowly withdraw the needle from the vial. do not touch the needle or allow it to touch anything. safely throw away the vial with any unused medicine. step 4: inject relistor - use one hand to pinch the skin around the injection site (see figure q). - use your other hand to hold the syringe. insert the full length of the needle into the skin at a 45-degree angle with a quick “dart-like” motion (see figure r). - let go of the skin and slowly push in on the plunger past the resistance point, until the syringe is empty and you hear a click (see figure s). - the click sound means that the needle (see figure t) has been pulled back (retracted) into the syringe barrel (see figure u). you can now remove the syringe from your skin. - hold a cotton ball or gauze over the injection site (see figure v). do not rub the injection site. apply an adhesive bandage to the injection site if needed. step 5: dispose of used syringes and needles - do not re-use syringes or needles. - to avoid needle-stick injuries, do not recap used needles. - put your used needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles 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. - if you have any questions, talk to your healthcare provider or pharmacist. how should i store relistor? - store relistor vials at room temperature between 68° to 77°f (20° to 25°c). - do not freeze relistor. - keep relistor away from light until you are ready to use it. - if relistor has been drawn into a syringe and you are unable to use the medicine right away, keep the syringe at room temperature for up to 24 hours. keep relistor and all medicines, needles and syringes out of the reach of children. for more information, go to www.relistor.com or call 1-800-321-4576. this instructions for use has been approved by the u.s. food and drug administration. distributed by: salix pharmaceuticals, a division of bausch health us, llc bridgewater, nj 08807 usa under license from: progenics pharmaceuticals, inc. tarrytown, ny 10591 usa for injection: u.s. patent numbers: 8,247,425; 8,420,663; 8,552,025; 8,822,490; 9,180,125; 9,492,445; 9,669,096 and 10,376,584 for tablets: u.s. patent numbers: 8,420,663; 8,524,276; 8,956,651; 9,180,125; 9,314,461; 9,492,445; 9,724,343; 10,307,417 and 10,376,505 relistor is a trademark of salix pharmaceuticals, inc. or its affiliates. any other product/brand names are trademarks of the respective owners. © 2020 salix pharmaceuticals, inc. or its affiliates revised: 04/2020 9502505 70014843 instructions for use relistor ® (rel-i-store) (methylnaltrexone bromide) injection, for subcutaneous use vial read this instructions for use before you start using relistor and each time you get a refill. 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. the following instructions explain how to prepare and give an injection of relistor the right way, when using a vial of relistor. important information: - use the syringes and needles prescribed by your healthcare provider. - do not use a relistor vial more than 1 time, even if there is medicine left in the vial. - if relistor has been drawn into a syringe and you are unable to use the medicine right away, carefully recap the needle and keep the syringe at room temperature for up to 24 hours. for more information about how to store relistor, see the section “how should i store relistor ?” at the end of this instructions for use. - safely throw away relistor vials after use. - do not re-use syringes or needles. see step 5 “dispose of used syringes and needles” for information about how to safely throw away used needles and syringes. - to avoid needle-stick injuries, do not recap used needles. gather the supplies you will need for your injection (see figure a.). these include: - 1 relistor vial - 1 1 ml syringe with a 27-gauge, ½ inch needle for subcutaneous use - 2 alcohol swabs - 1 cotton ball or gauze - 1 adhesive bandage - a puncture resistant container, such as an fda-cleared sharps disposal container to dispose of used syringes and needles. see step 5: “dispose of used syringes and needles.” step 1: choose and prepare the injection site - choose an injection site on your stomach-area (abdomen), thighs, or upper arms. see the shaded areas in figures b and c below. do not inject at the exact same spot each time (rotate injection sites). do not inject into areas where the skin is tender, bruised, red or hard. avoid areas with scars or stretch marks. - figure b abdomen or thigh – use these sites when injecting yourself or another person. - figure c upper arm – use this site only when injecting another person. - clean the injection site with an alcohol swab and let it air dry. do not touch this area again before giving the injection (see figure d). step 2: prepare the injection - choose a flat, clean, well-lit work surface. - wash your hands with soap and water before preparing for the injection. - look at the vial of relistor (see figure e). the liquid in the vial should be colorless to pale yellow, and should not have any particles in it. do not use the vial if it looks discolored, cloudy, or has any particles. step 3: prepare the syringe - remove the cap from the relistor vial (see figure f). - wipe the rubber stopper with an alcohol swab (see figure g). - firmly hold the barrel of the syringe with one hand. with your other hand, pull the needle cap straight off (see figure h). do not touch the needle or allow it to touch anything. - carefully pull back on the plunger to the line that matches the dose prescribed by your healthcare provider (see figures i and j). for most people, this will be the 0.4 ml mark which is an 8 mg dose or the 0.6 ml mark which is a 12 mg dose. - use one hand to hold the vial steady. use your other hand to insert the needle straight down into the rubber top of the vial (see figure k). do not insert it at an angle. this may cause the needle to bend or break. you will feel some resistance as the needle passes through the rubber top. - gently push down the plunger until all of the air has gone from the syringe into the vial (see figure l). - with the needle still in the vial, turn the vial and syringe upside down. hold the syringe at eye level. make sure the tip of the needle is in the fluid. slowly pull back on the plunger (see figure m) until the top of the plunger lines up with the mark that matches your prescribed dose. for most people, this will be the 0.4 ml mark which is an 8 mg dose or the 0.6 ml mark which is a 12 mg dose. - you may see some fluid or bubbles inside the vial when the syringe is filled. this is normal. - with the needle still in the vial, gently tap the side of the syringe to make any air bubbles rise to the top (see figure n). - slowly push the plunger up until all air bubbles are out of the syringe (see figure o). a small air bubble may stay in the syringe. this is okay and it will not affect the dose of medicine in the syringe. - make sure the tip of the needle is in the fluid. slowly pull back the plunger to draw the right amount of liquid back into the syringe (see figure p). - check to be sure that you have the right dose of relistor in the syringe. - slowly withdraw the needle from the vial. do not touch the needle or allow it to touch anything. safely throw away the vial with any unused medicine. step 4: inject relistor - use one hand to pinch the skin around the injection site (see figure q). - use your other hand to hold the syringe. insert the full length of the needle into the skin at a 45-degree angle with a quick “dart‑like” motion (see figure r). - let go of the skin and slowly push in on the plunger until the syringe is empty (figure s). - when the syringe is empty, quickly pull the needle out of the skin, being careful to keep it at the same angle as it was inserted. there may be a little bleeding at the injection site. - hold a cotton ball or gauze over the injection site (figure t). do not rub the injection site. apply an adhesive bandage to the injection site if needed. step 5: dispose of used syringes and needles - do not re-use a syringe or needle. - to avoid needle-stick injuries, do not recap a used needle. - put your used needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles 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. - if you have any questions, talk to your healthcare provider or pharmacist. how should i store relistor? - store relistor vials at room temperature between 68° to 77°f (20° to 25°c). - do not freeze relistor. - keep relistor away from light until you are ready to use it. - if relistor has been drawn into a syringe and you are unable to use the medicine right away, keep the syringe at room temperature for up to 24 hours. keep relistor and all medicines, needles and syringes out of the reach of children. for more information, go to www.relistor.com or call 1-800-321-4576. this instructions for use has been approved by the u.s. food and drug administration. distributed by: salix pharmaceuticals, a division of bausch health us, llc bridgewater, nj 08807 usa under license from: progenics pharmaceuticals, inc. tarrytown, ny 10591 usa for injection: u.s. patent numbers: 8,247,425; 8,420,663; 8,552,025; 8,822,490; 9,180,125; 9,492,445; 9,669,096 and 10,376,584 for tablets: u.s. patent numbers: 8,420,663; 8,524,276; 8,956,651; 9,180,125; 9,314,461; 9,492,445; 9,724,343; 10,307,417 and 10,376,505 relistor is a trademark of salix pharmaceuticals, inc. or its affiliates. any other product/brand names are trademarks of the respective owners. © 2020 salix pharmaceuticals, inc. or its affiliates revised: 04/2020 9502505 70014843

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

mebrom pty ltd - methyl bromide - pressurised gas - methyl bromide gas active 1000.0 g/kg - mixed function pesticide - buildings & similar structures qps & cue | cane products qps & approved cue | cereal grain qps & approved cue | compost well-rot - damping off fungi | insect | nematode - soil borne plant parasitic | nutgrass | rodent, rat or mouse | stored product insect pests | weed seed | black rat/mouse | brown rat/mouse | fat hen | fusarium spp. | mouse | prince of wales feather | pythium spp. | rat | rhizoctonia spp. | rodent | roof rat | victorian nutgrass | weed seeds | winter grass

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

trical australia pty ltd - methyl bromide - pressurised gas - methyl bromide gas active 1000.0 g/kg - mixed function pesticide - bed - plant - qps and cue treatment | buildings & similar structures qps & cue | cane products qps & approved cue | cereal grain - damping off fungi | insect | nematode - soil borne plant parasitic | nutgrass | rodent, rat or mouse | stored product insect pests | weed seed | black rat/mouse | brown rat/mouse | fat hen | fusarium spp. | mouse | prince of wales feather | pythium spp. | rat | rhizoctonia spp. | rodent | roof rat | victorian nutgrass | weed seeds | winter grass

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

trical australia pty ltd - methyl bromide - liquid - methyl bromide gas active 1000.0 g/kg - mixed function pesticide - bed - plant - qps and cue treatment | buildings & similar structures qps & cue | cane products qps & approved cue | cereal grain - damping off - pythium ultimum | damping off - rhizoctonia spp. | damping off fungi | fusarium spp. | insect | nematode - soil borne plant parasitic | nutgrass | rodent, rat or mouse | stored product insect pests | weed seed | black rat/mouse | brown rat/mouse | fat hen | fusarium patch | fusarium spp. | mouse | prince of wales feather | pythium spp. | rat | rhizoctonia spp. | rodent | roof rat | soil fungi | victorian nutgrass | weed seeds | winter grass

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

link medical products pty ltd t/a link pharmaceuticals - methylnaltrexone bromide, quantity: 12 mg - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; sodium calcium edetate; glycine hydrochloride; water for injections; sodium chloride - relistor is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care when response to laxative therapy has not been sufficient.

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

alphapharm pty ltd - methylprednisolone sodium succinate -

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

alphapharm pty ltd - methylprednisolone sodium succinate -

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

mebrom pty ltd - chloropicrin; methyl bromide - pressurised spray - chloropicrin gas active 20.0 g/kg; methyl bromide gas active 980.0 g/kg - mixed function pesticide - bed - plant - qps and cue treatment | buildings & similar structures qps & cue | cane products qps & approved cue | cereal grain - damping off - pythium ultimum | damping off - rhizoctonia spp. | damping off fungi | fusarium spp. | insect | nematode - soil borne plant parasitic | nutgrass | rodent, rat or mouse | stored product insect pests | weed seed | black rat/mouse | brown rat/mouse | fat hen | fusarium patch | fusarium spp. | mouse | prince of wales feather | pythium spp. | rat | rhizoctonia spp. | rodent | roof rat | soil fungi | victorian nutgrass | weed seeds | winter grass

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

trical australia pty ltd - chloropicrin; methyl bromide - gas (soil fumigant) - chloropicrin gas active 20.0 g/kg; methyl bromide gas active 980.0 g/kg - mixed function pesticide - bed - plant - qps and cue treatment | buildings & similar structures qps & cue | cane products qps & approved cue | cereal grain - damping off | damping off - pythium ultimum | damping off - rhizoctonia spp. | fusarium spp. | insect | nematode - soil borne plant parasitic | nutgrass | rodent, rat or mouse | stored product insect pests | weed seed | black rat/mouse | brown rat/mouse | fat hen | fusarium patch | fusarium spp. | mouse | prince of wales feather | rat | rodent | roof rat | sclerotinia spp. | soil fungi | victorian nutgrass | weed seeds | winter grass

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

rentokil - methyl bromide(1000g/kg) - pressurised gas - group 8a insecticide - bed - plant - qps and cue treatment | buildings & similar structures qps & cue | cane products qps & approved cue | cereal grain - damping off - pythium ultimum | damping off - rhizoctonia spp. | damping off fungi | fusarium spp. | insect | nematode - soil borne plant parasitic | nutgrass | rodent, rat or mouse | stored product insect pests | weed seed | black rat/mouse | brown rat/mouse | fat hen | fusarium patch | fusarium spp. | mouse | prince of wales feather | pythium spp. | rat | rhizoctonia spp. | rodent | roof rat | soil fungi | victorian nutgrass | weed seeds | winter grass