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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 100 mg - capsule, soft - excipient ingredients: gelatin; iron oxide black; ethyl lactate; lecithin; polysorbate 20; glycerol; sorbitan oleate; purified water; tricaprin; peg-40 hydrogenated castor oil; titanium dioxide - ciclosporin is indicated: ? as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. ? for induction and/or maintenance of remission in the nephrotic syndrome. ciclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see section 4.4 special warnings and precautions for use). ? for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. ? in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - sodium valproate 100mg - tablet - 100 mg - active: sodium valproate 100mg excipient: hydrated silica light kaolin magnesium stearate maize starch purified water - epilepsy: primary generalised epilepsy (petit mal absences, various forms of myoclonic epilepsy and tonic-clonic grand mal seizures). partial (focal) epilepsy either alone or as adjuvant therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - estradiol hemihydrate 7.84mg equivalent to estradiol 7.59 mg (100 µg/24h) - transdermal patch - 100 mcg/24h - active: estradiol hemihydrate 7.84mg equivalent to estradiol 7.59 mg (100 µg/24h) excipient: acrylates copolymer ethyl oleate glyceryl monolaurate isopropyl myristate - for short-term treatment of complaints associated with the menopause and post-menopause, including signs and symptoms of oestrogen deficiency, whether naturally or surgically induced. oestrogen replacement therapy in women with an intact uterus should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals. prevention of postmenopausal osteoporosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - topiramate 100mg;   - film coated tablet - 100 mg - active: topiramate 100mg   excipient: colloidal silicon dioxide croscarmellose sodium opadry yellow 85g32313 magnesium stearate mannitol microcrystalline cellulose pregelatinised maize starch - topiramate actavis is indicated in adults and children. topiramate actavis tablet range is not suitable for any children weighing less than 25 kg and is not suitable as monotherapy for children or adolescents weighing less than 50 kg. - as monotherapy in patients with newly diagnosed epilepsy - for conversion to monotherapy in patients with epilepsy - as add-on therapy in partial onset seizures, generalised tonic-clonic seizures or seizures associated with lennox-gastaut syndrome.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - testosterone undecylate 1000mg;   - solution for injection - 1000 mg/4ml - active: testosterone undecylate 1000mg   excipient: benzyl benzoate castor oil - testosterone replacement in primary and secondary male hypogonadism

New Zealand - English - Medsafe (Medicines Safety Authority)

actavis new zealand limited - metformin hydrochloride 1000mg;  ;   - coated tablet - 1000 mg - active: metformin hydrochloride 1000mg     excipient: magnesium stearate opadry clear oy-29020 povidone water - -treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. -metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents. - adjuvant therapy in insulin dependent diabetes especially if overweight.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - amisulpride 100mg;  ;  ; amisulpride 100mg - tablet - 100 mg - active: amisulpride 100mg     excipient: hydrated silica lactose monohydrate magnesium stearate methylcellulose potato starch active: amisulpride 100mg excipient: hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - danazol 100mg - capsule - 100 mg - active: danazol 100mg excipient: colloidal silicon dioxide gelatin   iron oxide black   lactose lactose monohydrate magnesium stearate microcrystalline cellulose povidone sodium laurilsulfate sodium starch glycolate tekprint black sw-9008 titanium dioxide   - endometriosis: danazol is indicated for use in the treatment of endometriosis amenable to hormonal management. menorrhagia: danazol is indicated for the short-term (up to 6 months) management of primary menorrhagia. fibrocystic disease of the breast: danazol is indicated for the treatment of fibrocystic disease of the breast in both pre- and post-menopausal women. hereditary angioedema: danazol is indicated for the prophylaxis of attacks of hereditary angioedema of a severe or life-threatening nature, in male and female patients.

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - doxycycline hydrochloride 114mg (as docyclycine hyclate = doxycycline 100mg);   - tablet - 100 mg - active: doxycycline hydrochloride 114mg (as docyclycine hyclate = doxycycline 100mg)   excipient: colloidal silicon dioxide magnesium stearate maize starch microcrystalline cellulose opadry white y-1r-7000b

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - quetiapine fumarate 115.122mg equivalent to 100 mg quetiapine - film coated tablet - 100 mg - active: quetiapine fumarate 115.122mg equivalent to 100 mg quetiapine excipient: calcium hydrogen phosphate dihydrate colloidal silicon dioxide lactose monohydrate magnesium stearate microcrystalline cellulose opacode black s-1-17823 opadry yellow 03b82923 povidone purified talc sodium starch glycolate - acute and chronic psychoses, including schizophrenia.