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

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 800 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - arx-aciclovir tablets are indicated for use in adult patients for: (1) the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. (2) the treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. (3) the management of patients with advaned symptomatic hiv disease cd4 + counts < 150 x 10(6)/l). in accordance with details specified in the "indications" and the "dosage and administration" sections of the approved product information provided as attachment 1.

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

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 200 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - arx-aciclovir tablets are indicated for use in adult patients for: (1) the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. (2) the treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. (3) the management of patients with advanced symptomatic hiv disease (cd4 + counts < 150 x 10(6)/l). in accordance with details specified in the "indications" and the "dosage and adminsitration" sections of the approved product information provided as attachment 1.

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

dr reddys laboratories australia pty ltd - sevelamer carbonate, quantity: 800 mg - tablet, film coated - excipient ingredients: hyprolose; crospovidone; silicon dioxide; mannitol; zinc stearate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; purified talc; xanthan gum; polyvinyl alcohol; lecithin - arx-sevelamer is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - alendronate sodium trihydrate 13.05mg equivalent to 10 mg alendronic acid - tablet - 10 mg - active: alendronate sodium trihydrate 13.05mg equivalent to 10 mg alendronic acid excipient: croscarmellose sodium lactose magnesium stearate microcrystalline cellulose

Israel - English - Ministry of Health

j-c health care ltd - topiramate - film coated tablets - topiramate 25 mg - topiramate - topiramate - in adjunctive therapy of adults and children (from 2 years) with partial seizures and generalized tonic-clonic seizures. in adjunctive therapy of seizures with lennox-gastaut syndrome in adults and children. topamax is indicated as monotherapy in patients with newly diagnosed epilepsy in children aged 7 years and above or for conversion to monotherapy in patients with epilepsy. topamax is indicated in adults for the prevention of migraines. the use of topamax in the acute treatment of migraine has not been studied.

Israel - English - Ministry of Health

j-c health care ltd - topiramate - film coated tablets - topiramate 50 mg - topiramate - topiramate - in adjunctive therapy of adults and children (from 2 years) with partial seizures and generalized tonic-clonic seizures. in adjunctive therapy of seizures with lennox-gastaut syndrome in adults and children. topamax is indicated as monotherapy in patients with newly diagnosed epilepsy in children aged 7 years and above or for conversion to monotherapy in patients with epilepsy. topamax is indicated in adults for the prevention of migraines. the use of topamax in the acute treatment of migraine has not been studied.

Israel - English - Ministry of Health

j-c health care ltd - topiramate - film coated tablets - topiramate 100 mg - topiramate - topiramate - in adjunctive therapy of adults and children (from 2 years) with partial seizures and generalized tonic-clonic seizures. in adjunctive therapy of seizures with lennox-gastaut syndrome in adults and children. topamax is indicated as monotherapy in patients with newly diagnosed epilepsy in children aged 7 years and above or for conversion to monotherapy in patients with epilepsy. topamax is indicated in adults for the prevention of migraines. the use of topamax in the acute treatment of migraine has not been studied.

Israel - English - Ministry of Health

j-c health care ltd - topiramate - film coated tablets - topiramate 200 mg - topiramate - topiramate - in adjunctive therapy of adults and children (from 2 years) with partial seizures and generalized tonic-clonic seizures. in adjunctive therapy of seizures with lennox-gastaut syndrome in adults and children. topamax is indicated as monotherapy in patients with newly diagnosed epilepsy in children aged 7 years and above or for conversion to monotherapy in patients with epilepsy. topamax is indicated in adults for the prevention of migraines. the use of topamax in the acute treatment of migraine has not been studied.

Namibia - English - Namibia Medicines Regulatory Council

msd pty ltd - alendronate sodium - tablets - each tablet contains alendronate sodium equiv. to alendronic acid 10,0 mg

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

teva pharma australia pty ltd - methylphenidate hydrochloride, quantity: 36 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; magnesium stearate; hypromellose; triethyl citrate; purified talc; fumaric acid; methacrylic acid copolymer; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; polyvinyl alcohol; macrogol 3350 - methylphenidate xr arx is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme methylphenidate xr arx is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use methylphenidate xr arx for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.