USA - engelsk - NLM (National Library of Medicine)

sandoz inc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets (sr) are indicated as an aid to smoking cessation treatment. pregnancy category c risk summary data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately 2 times the maximum recommended human dose (mrhd) and greater and decreased fetal weights were seen at doses three times the mrhd and greater. bupropion hydrochloride extended-release tablets (sr) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clinical consideratio

Australien - engelsk - 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.

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

mundipharma pty ltd - naloxone hydrochloride dihydrate, quantity: 10.9 mg (equivalent: naloxone hydrochloride?, qty 10 mg); oxycodone hydrochloride, quantity: 20 mg - tablet, modified release - excipient ingredients: magnesium stearate; povidone; macrogol 3350; stearyl alcohol; titanium dioxide; lactose monohydrate; purified talc; polyvinyl alcohol; iron oxide red; ethylcellulose - 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.

Australien - engelsk - 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.

Australien - engelsk - 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.

USA - engelsk - NLM (National Library of Medicine)

st marys medical park pharmacy - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets, usp (sr) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical pharmacology). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentrati

USA - engelsk - NLM (National Library of Medicine)

ncs healthcare of ky, inc dba vangard labs - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride extended-release tablets, usp (sr) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical pharmacology). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentrati

USA - engelsk - NLM (National Library of Medicine)

ncs healthcare of ky, inc dba vangard labs - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. a physician considering bupropion hydrochloride tablets for the management of a patient’s first episode of depression should be aware that the drug may cause generalized seizures in a dose-dependent manner with an approximate incidence of 0.4% (4/1,000). this incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. this relative risk is only an approximate estimate because no direct comparative studies have been conducted (see warnings ). the efficacy of bupropion hydrochloride tablets has been established in 3 placebo-controlled trials, including 2 of approximately 3 weeks’ duration in depressed inpatients and one of approximately 6 weeks’ duration in depressed outpatients. the depressive disorder of the patients studied corresponds most closely to the major depression category of the apa diagnostic and statistical manual iii. major depression implies a prominent and relatively p

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - dopamine hydrochloride 40 mg/ml;   - solution for injection - 200 mg/5ml - active: dopamine hydrochloride 40 mg/ml   excipient: sodium metabisulfite water for injection - latest regulatory activity

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

max health limited - dopamine hydrochloride 40 mg/ml - solution for injection - 200 mg/5ml - active: dopamine hydrochloride 40 mg/ml excipient: hydrochloric acid nitrogen sodium hydroxide sodium metabisulfite water for injection - for the correction of haemodynamic imbalance present in: acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure. as an adjunct after open heart surgery, where there is persistent hypotension after correction of hypovolaemia. in chronic cardiac decompensation as in congestive failure.