Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

a-s medication solutions - naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - naloxone hcl nasal spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. naloxone hcl nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. naloxone hcl nasal spray is not a substitute for emergency medical care. naloxone hcl nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients. risk summary the limited available data on naloxone use in pregnant women are not sufficient to inform a drug-associated risk. however, there are clinical considerations [see clinical considerations] . in animal reproduction studies, no embryotoxic or teratogenic effects were observed in mice and rats treated with naloxone hydrochloride during the period of organogenesis at doses equivalent to 6-times and 12-times, respectively, a human dose of 8 mg/day (two naloxone hcl nasal sprays) based on body surface area comparison [see data] . 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 naloxone hydrochloride crosses the placenta, and may precipitate withdrawal in the fetus, as well as in the opioid-dependent mother [see warnings and precautions (5.3)] . the fetus should be evaluated for signs of distress after naloxone hcl nasal spray is used. careful monitoring is needed until the fetus and mother are stabilized. data animal data naloxone hydrochloride was administered during organogenesis to mice and rats at subcutaneous doses up to 10 mg/kg/day (equivalent to 6-times and 12-times, respectively, a human dose of 8 mg (two naloxone hcl nasal sprays)) (based on body surface area comparison). these studies demonstrated no embryotoxic or teratogenic effects due to naloxone hydrochloride. pregnant female rats were administered 2 or 10 mg/kg naloxone subcutaneously from gestation day 15 to postnatal day 21. there were no adverse effects on the offspring (up to 12-times a human dose of 8 mg/day (two naloxone hcl nasal sprays) based on body surface area comparison). risk summary there is no information regarding the presence of naloxone in human milk, or the effects of naloxone on the breastfed infant or on milk production. studies in nursing mothers have shown that naloxone does not affect prolactin or oxytocin hormone levels. naloxone is minimally orally bioavailable. the safety and effectiveness of naloxone hcl nasal spray have been established in pediatric patients of all ages for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. use of naloxone hydrochloride in all pediatric patients is supported by adult bioequivalence studies coupled with evidence from the safe and effective use of other naloxone hydrochloride drug products. no pediatric studies were conducted for naloxone hcl nasal spray. absorption of naloxone hydrochloride following intranasal administration in pediatric patients may be erratic or delayed. even when the opiate-intoxicated pediatric patient responds appropriately to naloxone hydrochloride, he/she must be carefully monitored for at least 24 hours, as a relapse may occur as naloxone hydrochloride is metabolized. in opioid-dependent pediatric patients, (including neonates), administration of naloxone hydrochloride may result in an abrupt and complete reversal of opioid effects, precipitating an acute opioid withdrawal syndrome. neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening, if not recognized, and should be treated according to protocols developed by neonatology experts [see warnings and precautions (5.3)] . in settings such as in neonates with known or suspected exposure to maternal opioid use, where it may be preferable to avoid the abrupt precipitation of opioid withdrawal symptoms, consider use of an alternate naloxone-containing product that can be dosed according to weight and titrated to effect. also, in situations where the primary concern is for infants at risk for opioid overdose, consider whether the availability of alternate naloxone-containing products may be better suited than naloxone hcl nasal spray. geriatric patients have a greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. therefore, the systemic exposure of naloxone hydrochloride can be higher in these patients. clinical studies of naloxone hydrochloride 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 the elderly and younger patients. you and your family members or caregivers should read the instructions for use that comes with naloxone hcl nasal spray before using it. talk to your healthcare provider if you and your family members or caregivers have any questions about the use of naloxone hcl nasal spray. use naloxone hcl nasal spray for known or suspected opioid overdose in adults and children. important: for use in the nose only. how to use naloxone hcl nasal spray: step 1. lay the person on their back to receive a dose of naloxone hcl nasal spray. step 2. remove naloxone hcl nasal spray from the box. peel back the tab with the circle to open the naloxone hcl nasal spray. note: naloxone hcl nasal spray freezes at temperatures below 5°f (-15°c). if this happens, the device will not spray. get emergency medical help right away if this happens. do not wait for naloxone hcl nasal spray to thaw. naloxone hcl nasal spray may still be used if it has been thawed after being previously frozen. step 3. hold the naloxone hcl nasal spray with your thumb on the bottom of the red plunger and your first and middle fingers on either side of the nozzle. step 4. tilt the person's head back and provide support under the neck with your hand. gently insert the tip of the nozzle into one nostril until your fingers on either side of the nozzle are against the bottom of the person's nose. step 5. press the red plunger firmly to give the dose of naloxone hcl nasal spray. step 6. remove the naloxone hcl nasal spray from the nostril after giving the dose. what to do after naloxone hcl nasal spray has been used: step 7. get emergency medical help right away. step 8. put the used naloxone hcl nasal spray back into its box. step 9. throw away (dispose of) the used naloxone hcl nasal spray in a place that is away from children. how should i store naloxone hcl nasal spray? keep naloxone hcl nasal spray and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. distributed by sandoz inc., princeton, nj 08540. for more information, call 1-888-511-0081. issued: 02/2021

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

a-s medication solutions - naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including, propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine and butorphanol and cyclazocine. naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock. (see clinical pharmacology; adjunctive use in septic shock ). naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to it or to any of the other ingredients in naloxone hydrochloride. naloxone hydrochloride is an opioid antagonist. physical dependence associated with the use of naloxone hydrochloride has not been reported. tolerance to the opioid antagonist effect of naloxone hydrochloride is not known to occur.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 80 mg; naloxone hydrochloride dihydrate, quantity: 43.6 mg (equivalent: naloxone hydrochloride?, qty 40 mg) - tablet, modified release - excipient ingredients: ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; povidone; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - targin modified release tablet is indicated for the management of severe pain where:,- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and,- the pain is opioid-responsive; and,- requires daily, continuous, long term treatment.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is not indicated as an as-needed (prn) analgesia,the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 60 mg; naloxone hydrochloride dihydrate, quantity: 32.7 mg (equivalent: naloxone hydrochloride?, qty 30 mg) - tablet, modified release - excipient ingredients: ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; povidone; titanium dioxide; iron oxide red; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - targin modified release tablet is indicated for the management of severe pain where:,- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and,- the pain is opioid-responsive; and,- requires daily, continuous, long term treatment.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is not indicated as an as-needed (prn) analgesia,the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 30 mg; naloxone hydrochloride dihydrate, quantity: 16.48 mg (equivalent: naloxone hydrochloride?, qty 15 mg) - tablet, modified release - excipient ingredients: povidone; ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - targin modified release tablet is indicated for the management of severe pain where:,- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and,- the pain is opioid-responsive; and,- requires daily, continuous, long term treatment.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is not indicated as an as-needed (prn) analgesia,the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 15 mg; naloxone hydrochloride dihydrate, quantity: 8.24 mg (equivalent: naloxone hydrochloride?, qty 7.5 mg) - tablet, modified release - excipient ingredients: hyprolose; ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - targin modified release tablet is indicated for the management of severe pain where:,- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and,- the pain is opioid-responsive; and,- requires daily, continuous, long term treatment.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is not indicated as an as-needed (prn) analgesia,the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

Canada - engleză - Health Canada

hikma canada limited - naloxone hydrochloride (naloxone hydrochloride dihydrate) - solution - 0.4mg - naloxone hydrochloride (naloxone hydrochloride dihydrate) 0.4mg - opiate antagonists

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 40 mg; naloxone hydrochloride dihydrate, quantity: 21.8 mg (equivalent: naloxone hydrochloride?, qty 20 mg) - tablet, modified release - excipient ingredients: lactose monohydrate; iron oxide yellow; ethylcellulose; magnesium stearate; polyvinyl alcohol; povidone; titanium dioxide; purified talc; macrogol 3350; stearyl alcohol - targin modified release tablet is indicated for the management of severe pain where:,- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and,- the pain is opioid-responsive; and,- requires daily, continuous, long term treatment.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is not indicated as an as-needed (prn) analgesia,the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 10 mg; naloxone hydrochloride dihydrate, quantity: 5.45 mg (equivalent: naloxone hydrochloride?, qty 5 mg) - tablet, modified release - excipient ingredients: titanium dioxide; lactose monohydrate; stearyl alcohol; macrogol 3350; ethylcellulose; polyvinyl alcohol; purified talc; magnesium stearate; povidone - targin modified release tablet is indicated for the management of severe pain where:,- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and,- the pain is opioid-responsive; and,- requires daily, continuous, long term treatment.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is not indicated as an as-needed (prn) analgesia,the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

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

mundipharma pty ltd - oxycodone hydrochloride, quantity: 5 mg; naloxone hydrochloride dihydrate, quantity: 2.73 mg (equivalent: naloxone hydrochloride?, qty 2.5 mg) - tablet, modified release - excipient ingredients: ethylcellulose; macrogol 3350; brilliant blue fcf aluminium lake; stearyl alcohol; polyvinyl alcohol; titanium dioxide; magnesium stearate; lactose monohydrate; purified talc; hyprolose - targin modified release tablet is indicated for the management of severe pain where:,- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and,- the pain is opioid-responsive; and,- requires daily, continuous, long term treatment.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is not indicated as an as-needed (prn) analgesia,the naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.