오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ustekinumab, quantity: 45 mg - injection, solution - excipient ingredients: histidine; polysorbate 80; histidine hydrochloride monohydrate; water for injections; sucrose - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - amiodarone hydrochloride, quantity: 150 mg - injection, solution - excipient ingredients: polysorbate 80; water for injections; benzyl alcohol; hydrochloric acid; sodium hydroxide - severe cases of tachyarrhythmias (eg. wolff-parkinson-white syndrome, supraventricular, nodal and ventricular tachyardias, atrial flutter and fibrillation, ventricular fibrillation) not responding to other therapy. treatment should be initiated in hospital. it is recommended that the patient should be regularly monitored for possible toxicity (eg. thyroid function, chest x-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation.,amiodarone hhh injection may be used for treatment initiated in a hospital for severe cases of tachyarrhythmias (atrial, junctional and ventricular) not responding to other therapy and when a rapid response is required. amiodarone hhh injection should only be used where facilities exist for cardiac monitoring and defibrillation should the need arise.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - baclofen, quantity: 10 mg - injection, solution - excipient ingredients: sodium chloride; water for injections - baclofen solution for intrathecal injection is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - baclofen, quantity: 10 mg - injection, solution - excipient ingredients: water for injections; sodium chloride - baclofen solution for intrathecal injection is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - baclofen, quantity: 0.05 mg - injection, solution - excipient ingredients: sodium chloride; water for injections - baclofen solution for intrathecal injection is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

미국 - 영어 - NLM (National Library of Medicine)

organon usa inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - remeronsoltab (mirtazapine) orally disintegrating tablets are indicated for the treatment of major depressive disorder. the efficacy of remeron (mirtazapine) tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest 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 concentration, a suicide attempt, or suicidal ideation. the ef

뉴질랜드 - 영어 - Medsafe (Medicines Safety Authority)

max health limited - sodium valproate 100 mg/ml - solution for injection - 100 mg/ml - active: sodium valproate 100 mg/ml excipient: dibasic sodium phosphate dodecahydrate monobasic sodium phosphate dihydrate phosphoric acid sodium hydroxide water for injection - the treatment of patients with epilepsy or bipolar disorder, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

ucb australia pty ltd t/a ucb pharma division of ucb australia - levetiracetam, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: acesulfame potassium; purified water; maltitol solution; methyl hydroxybenzoate; ammonium glycyrrhizinate; citric acid monohydrate; propyl hydroxybenzoate; sodium citrate dihydrate; glycerol; flavour - keppra (film coated tablets and oral solution) is indicated for - use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation, - monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. - add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme), and - add on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige). keppra concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - plerixafor, quantity: 24 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - plerixafor arx is indicated in combination with granulocyte-colony stimulating factor (g-csf) to mobilise haematopoietic stem cells (hscs) to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma (mm).

이스라엘 - 영어 - Ministry of Health

dexcel ltd, israel - tobramycin - solution for inhalation - tobramycin 300 mg / 5 ml - tobramycin - tobramycin - tobi is indicated for the management of pulmonary pseudomonas aeruginosa infection in cystic fibrosis (cf) patients age 6 years or older.