Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - naloxone hydrochloride injection, usp 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, butorphanol, and cyclazocine. naloxone hydrochloride injection, usp is also indicated for diagnosis of suspected or known acute opioid overdosage. naloxone hydrochloride injection, usp 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 naloxone hydrochloride or to any of the other ingredients in naloxone hydrochloride injection. naloxone hydrochloride injection is an opioid antagonist. physical dependence associated with the use of naloxone hydrochloride injection has not been reported. tolerance to the opioid antagonist effect of naloxone is not known to occur.

Estados Unidos - inglês - NLM (National Library of Medicine)

kaleo, inc. - naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - naloxone hydrochloride injection is indicated for use by military personnel and chemical incident responders for: - emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected. - temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues. naloxone hydrochloride injection is contraindicated in individuals known to be hypersensitive to naloxone hcl or to any of the other ingredients. risk summary life-sustaining therapy for opioid overdose should not be withheld (see clinical considerations) . there is an absence of data on naloxone hcl administered for known or suspected opioid overdose in pregnant patients. available data from retrospective cohort studies on oral naloxone use in pregnant women for opioid use disorder have not identified a drug-associated risk of m

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - 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, butorphanol, and cyclazocine. naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. naloxone 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 naloxone hydrochloride or to any of the other ingredients contained in the formulation. naloxone hydrochloride injection is an opioid antagonist. physical dependence associated with the use of naloxone hydrochloride injection has not been reported. tolerance to the opioid antagonist effect of naloxone is not known to occur. caution: certain glass syringes may malfunction, break or clog when connected to some needleless luer access devices (nlads) and needles. this syringe has a larger internal syringe tip and an external collar (luer collar). the external collar must remain attached to the syringe. data show that the syringe achieves acceptable connections with the bd eclipse™ needle and the terumo surguard3™ safety needle and with the following non-center post nlads: bd smartsite™ and bd-q syte™. the data also show acceptable connections are achieved to the center post icu medical clave™. however, spontaneous disconnection of this glass syringe from needles and nlads with leakage of drug product may occur. assure that the needle or nlad is securely attached before beginning the injection. visually inspect the glass syringe-needle or glass syringe-nlad connection before and during drug administration. figure 1 1. inspect the outer packaging (plastic tube) by verifying: - plastic tube integrity - drug name - drug strength - dose volume - route of administration - expiration date to be sure that the drug has not expired - sterile field applicability do not use if package has been damaged. 2. remove the plastic tube cap of the outer packaging to access the syringe. 3. remove the syringe from the plastic tube. 4. perform visual inspection on the syringe by verifying: - absence of syringe damage - absence of external particles - absence of internal particles - proper drug color - expiration date to be sure that the drug has not expired - drug name - drug strength - dose volume - route of administration - sterile field applicability 5. push plunger rod slightly to break the stopper loose while tip cap is still on. 6. remove tip cap by twisting it off. (see figure 2) figure 2         7. discard the tip cap. 8. expel air bubble. 9. adjust dose by expelling extra volume (where applicable) from the syringe into sterile material prior to administration. 10. connect the syringe to appropriate injection connection depending on route of administration. before injection, ensure that the syringe is securely attached to the needle or needleless luer access device (nlad). 11. depress plunger rod to deliver medication. ensure that pressure is maintained on the plunger rod during the entire administration. 12. remove syringe from nlad (if applicable) and discard into appropriate receptacle. to prevent needle-stick injuries, needles should not be recapped. notes: - all steps must be done sequentially - do not autoclave syringe - do not use this product on a sterile field - do not introduce any other fluid into the syringe at any time - this product is for single dose only; discard unused portion. manufactured by: hikma pharmaceuticals usa inc. berkeley heights, nj 07922 462-892-01 revised may 2023

Estados Unidos - inglês - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - 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. limitations of use: restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. 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 s

Estados Unidos - inglês - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - 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, butorphanol, and cyclazocine. naloxone hydrochloride injection is also indicated for 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 naloxone hydrochloride or to any of the other ingredients contained in the formulation. 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.

Estados Unidos - inglês - NLM (National Library of Medicine)

quality care products, llc - 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 bo

Estados Unidos - inglês - NLM (National Library of Medicine)

proficient rx lp - 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. limitations of use: restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. 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

Estados Unidos - inglês - NLM (National Library of Medicine)

mylan institutional llc - 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, butorphanol, and cyclazocine. naloxone hydrochloride injection is also indicated for 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 naloxone hydrochloride 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 naloxone hydrochloride is not known to

Estados Unidos - inglês - NLM (National Library of Medicine)

baxter healthcare corporation - 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, butorphanol, and cyclazocine. naloxone hydrochloride injection is also indicated for 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 naloxone hydrochloride or to any of the other ingredients contained in the formulation. 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.

Estados Unidos - inglês - NLM (National Library of Medicine)

quality care products, llc - 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. limitations of use: restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. 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