Australien - engelsk - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - hydromorphone hydrochloride, quantity: 8 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; iron oxide red; macrogol 400; propylene glycol; isopropyl alcohol; purified water - jurnista 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. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 3 mg - lunesta is indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, lunesta administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). none known. lunesta is a schedule iv controlled substance under the controlled substances act. other substances under the same classification are benzodiazepines and the nonbenzodiazepine hypnotics zaleplon and zolpidem. while eszopiclone is a hypnotic agent with a chemical structure unrelated to benzodiazepines, it shares some of the pharmacologic properties of the benzodiazepines. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the dru

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - hydromorphone hydrochloride 16mg (+ 9% overage to account for residual drug retained in capsule shell) - modified release tablet - 16 mg - active: hydromorphone hydrochloride 16mg (+ 9% overage to account for residual drug retained in capsule shell) excipient: butylated hydroxytoluene cellulose acetate hypromellose iron oxide black macrogol 3350 magnesium stearate opacode black ns-78-17821 opadry clear ys-1-19025-a opadry yellow y-30-12863-a polyethylene oxide povidone sodium chloride - jurnista is indicated in the treatment of moderate to severe chronic pain.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - hydromorphone hydrochloride 32mg - modified release tablet - 32 mg - active: hydromorphone hydrochloride 32mg excipient: butylated hydroxytoluene cellulose acetate hypromellose iron oxide black iron oxide yellow macrogol 3350 magnesium stearate opacode black ns-78-17821 opadry clear ys-1-19025-a opadry white y-30-18037 polyethylene oxide povidone sodium chloride - jurnista is indicated in the treatment of moderate to severe chronic pain.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - hydromorphone hydrochloride 4mg (+ 9% system overage) - modified release tablet - 4 mg - active: hydromorphone hydrochloride 4mg (+ 9% system overage) excipient: butylated hydroxytoluene cellulose acetate hypromellose iron oxide black iron oxide yellow macrogol 3350 magnesium stearate opacode black ns-78-17821 opadry clear ys-1-19025-a polyethylene oxide povidone sodium chloride - jurnista is indicated in the treatment of moderate to severe chronic pain.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - hydromorphone hydrochloride 64mg - modified release tablet - 64 mg - active: hydromorphone hydrochloride 64mg excipient: butylated hydroxytoluene cellulose acetate hypromellose iron oxide black macrogol 3350 magnesium stearate opacode black ns-78-17821 opadry blue y-30-10701 opadry clear ys-1-19025-a polyethylene oxide povidone sodium chloride - jurnista is indicated in the treatment of moderate to severe chronic pain.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - hydromorphone hydrochloride 8mg (+ 9% overage to account for residual drug retained in capsule shell) - modified release tablet - 8 mg - active: hydromorphone hydrochloride 8mg (+ 9% overage to account for residual drug retained in capsule shell) excipient: butylated hydroxytoluene cellulose acetate hypromellose iron oxide black macrogol 3350 magnesium stearate opacode black ns-78-17821 opadry clear ys-1-19025-a opadry red y-30-15595-a polyethylene oxide povidone sodium chloride - jurnista is indicated in the treatment of moderate to severe chronic pain.

USA - engelsk - NLM (National Library of Medicine)

waylis therapeutics llc - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - lunesta® (eszopiclone) is indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, lunesta administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). lunesta is contraindicated in patients who have experienced complex sleep behaviors after taking lunesta [see warnings and precautions (5.1)]. lunesta is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . risk summary available pharmacovigilance data with lunesta use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or ad

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

nuvanta sdn. bhd. - commiphora mukul; boswellia serrata; withania somnifera; oroxylum indicum; smilax china; pluchea lanceolata; zingiber officinale -

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - hydromorphone hydrochloride -