Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

duopharma (m) sdn. bhd. - naltrexone hydrochloride -

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

arrotex pharmaceuticals pty ltd - naltrexone hydrochloride, quantity: 50 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; crospovidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - arx-naltrexone is indicated for use within a comprehensive treatment program for alcohol dependence. arx-naltrexone is also indicated as adjunctive therapy in the maintenance of formerly opioid-dependent patients who have ceased the use of opioids such as diamorphine (heroin) and morphine.

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

inova pharmaceuticals (australia) pty ltd - naltrexone hydrochloride, quantity: 8 mg; bupropion hydrochloride, quantity: 90 mg - tablet, modified release - excipient ingredients: cysteine hydrochloride monohydrate; hypromellose; microcrystalline cellulose; indigo carmine aluminium lake; lactose monohydrate; disodium edetate; crospovidone; silicon dioxide; lactose; magnesium stearate; hyprolose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - contrave is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (18 years and older) with an initial body mass index (bmi) of:,? greater than or equal to 30 kg/m2 (obese), or,? greater than or equal to 27 kg/m2 to less than 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension).,treatment with contrave should be discontinued after 16 weeks if patients have not lost at least 5 percent of their initial body weight (see clinical trials).

European Union - English - EMA (European Medicines Agency)

orexigen therapeutics ireland limited - bupropion hydrochloride, naltrexone hydrochloride - obesity; overweight - antiobesity preparations, excl. diet products - mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial body mass index (bmi) of≥ 30 kg/m2 (obese), or≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)treatment with mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight.

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

accord healthcare pty ltd - naltrexone hydrochloride, quantity: 50 mg - tablet, film coated - excipient ingredients: lactose monohydrate; crospovidone; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - reviatrexone is indicated for use within a comprehensive treatment program for alcohol dependence. reviatrexone is also indicated as adjunctive therapy in the maintenance of formerly opioid-dependent patients who have ceased the use of opioids such as diamorphine (heroin) and morphine.

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

par pharmaceutical, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 10 mg - oxycodone hcl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - •because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxycodone hcl extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - •oxycodone hcl extended-release tablets are not indicated as an as-needed (prn) analgesic oxycodone hcl extended-release tablets are contraindicated in patients with: - •significant respiratory depression - •acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - •know

Ireland - English - HPRA (Health Products Regulatory Authority)

aop orphan pharmaceuticals gmbh - naltrexone hydrochloride - film-coated tablet - 50 milligram(s) - drugs used in alcohol dependence; naltrexone

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

complete pharmacy and medical solutions - naltrexone (unii: 5s6w795cqm) (naltrexone - unii:5s6w795cqm), triamcinolone (unii: 1zk20vi6ty) (triamcinolone - unii:1zk20vi6ty) - treatment with naltrexone implants should be part of a comprehensive management program that includes psychological and psychosocial support. naltrexone tablets were initially approved by the fda in 1985 for the treatment of abuse and addiction of opioids. naltrexone in oral and extended release injection forms have been approved by the fda for the treatment and abuse of alcohol. naltrexone implants may be useful for the treatment of alcohol or opioid dependence in patients who are able to abstain from opioid or alcohol in an outpatient setting prior to initiation of treatment. patients should not be actively drinking or be on any opioids at the time of initial naltrexone implant administration. naltrexone is contraindicated in: - patients receiving opioid analgesics (see precautions). - patients with current physiologic opioid dependence (see warnings). - patients in acute opiate withdrawal (see warnings). - any individual who has failed the naloxone challenge test or has a positive urine screen for opioids.

Canada - English - Health Canada

bausch health, canada inc. - naltrexone hydrochloride; bupropion hydrochloride - tablet (extended-release) - 8mg; 90mg - naltrexone hydrochloride 8mg; bupropion hydrochloride 90mg - anorexigenic agents, miscellaneous

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

generic health pty ltd - naltrexone hydrochloride -