Singapore - English - HSA (Health Sciences Authority)

pharmline marketing pte. ltd. - azelastine hydrochloride; fluticasone propionate - spray, metered - azelastine hydrochloride 0.1 %w/w; fluticasone propionate 0.0365 %w/w

Singapore - English - HSA (Health Sciences Authority)

pharmline marketing pte. ltd. - azelastine hydrochloride; fluticasone propionate - spray, metered - azelastine hydrochloride 0.1 %w/w; fluticasone propionate 0.0365 %w/w

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sandoz ltd - budesonide - spray - 64microgram/1dose

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

hikma pharmaceuticals usa inc. - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol tartrate 10 mg in 1 ml - butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see warnings] reserve butorphanol tartrate nasal spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): butorphanol tartrate nasal spray should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. butorphanol tartrate nasal spray is contraindicated in: butorphanol tartrate nasal spray contains butorphanol, a schedule iv controlled substance. butorphanol tartrate nasal spray contains butorphanol, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings] . misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of butorphanol tartrate nasal spray increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of butorphanol tartrate nasal spray with alcohol and other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of butorphanol tartrate nasal spray abuse include those with a history of prolonged use of any opioid, including products containing butorphanol, those with a history of drug or alcohol abuse, or those who use butorphanol tartrate nasal spray in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. butorphanol tartrate nasal spray, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of butorphanol tartrate nasal spray abuse of butorphanol tartrate nasal spray poses a risk of overdose and death. the risk is increased with concurrent use of butorphanol tartrate nasal spray with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue butorphanol tartrate nasal spray in a patient physically dependent on opioids. rapid tapering of butorphanol tartrate nasal spray in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing butorphanol tartrate nasal spray, gradually taper the dosage using a patient-specific plan that considers the following: the dose of butorphanol tartrate nasal spray the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration, and warnings] . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see pregnancy] .

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

mylan pharmaceuticals inc. - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol tartrate 10 mg in 1 ml - butorphanol tartrate nasal spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see warnings), reserve butorphanol tartrate nasal spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) butorphanol tartrate nasal spray is contraindicated in: butorphanol tartrate nasal spray contains butorphanol, a schedule iv controlled substance. butorphanol tartrate nasal spray contains butorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. butorphanol tartrate nasal spray can be abused and is subject to misuse, addiction, and criminal diversion (see warnings). all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - budesonide 2 mg/ml ((100 micrograms/spray));   - nasal spray suspension - 100 mcg/dose - active: budesonide 2 mg/ml ((100 micrograms/spray))   excipient: disodium edetate dispersible cellulose glucose hydrochloric acid polysorbate 80 potassium sorbate purified water - for the prevention and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis. for the symptomatic relief of nasal polyposis.

Israel - English - Ministry of Health

medison pharma ltd - fentanyl as citrate - nasal spray, solution - fentanyl as citrate 1 mg / 1 ml - fentanyl - pecfent is indicated for the management of breakthrough pain (btp) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Israel - English - Ministry of Health

medison pharma ltd - fentanyl as citrate - nasal spray, solution - fentanyl as citrate 4 mg / 1 ml - fentanyl - pecfent is indicated for the management of breakthrough pain (btp) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

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

akorn - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older. none. risk summary published data from postmarketing experience with antihistamines, with similar mechanism of action to olopatadine hydrochloride nasal spray, have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are no published human data specific to olopatadine hydrochloride nasal spray. in animal reproductive studies, oral administration of olopatadine hydrochloride to pregnant rats and rabbits caused a decrease in the number of live fetuses at maternal doses approximately 110 and 1,460 times the maximum recommended human daily intranasal dose (mrhdid) on a mg/m2 basis, respectively (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 birth defect,

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

archimedes pharma us inc. - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl 100 ug - lazanda (fentanyl) nasal spray is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer. patients must remain on around-the-clock opioids when taking lazanda. lazanda is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could occur in patients not taking chronic opioids. for this reason, lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, or dental pain. [4] lazanda is intended to be prescribed only by healthcare professionals who are knowledgeable of and