Ireland - English - HPRA (Health Products Regulatory Authority)

pharma regulatory solutions ltd - voriconazole - pdr for soln for infusion - 200 milligram - triazole derivatives - antimycotics for systemic use, triazole derivatives - voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis. treatment of candidaemia in non-neutropenic patients. treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). treatment of serious fungal infections caused by scedosporium spp. and fusarium spp. voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients.

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

link medical products pty ltd t/a link pharmaceuticals - methotrexate, quantity: 17.5 mg - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; water for injections - psoriasis therapy (see warning box): trexject may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis in adults which is not adequately responsive to other forms of treatment. however, due to the high risk associated with its use, methotrexate should be used after the diagnosis has been definitely established, as by biopsy and/or after dermatologic consultation.,rheumatoid arthritis therapy (see warning box): management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to, or intolerant of, an adequate trial of nsaids and one or more disease modifying drugs. aspirin, nsaids and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of nsaids including salicylate has not been fully explored. steroids may be reduced gradually in patients who respond to methotrexate. combined use of methotrexate with gold or penicillamine, has not been studied and may increase the incidence of adverse effects. rest and physiotherapy as indicated should be continued.

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - methotrexate - solution for injection in pre-filled injector - 17.5 milligram(s) - folic acid analogues; methotrexate

United States - English - NLM (National Library of Medicine)

advagen pharma limited - acyclovir (unii: x4hes1o11f) (acyclovir - unii:x4hes1o11f) - herpes zoster infections acyclovir is indicated for the acute treatment of herpes zoster (shingles). genital herpes acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. chickenpox acyclovir is indicated for the treatment of chickenpox (varicella). acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir. safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than 2 years of age have not been established. of 376 subjects who received acyclovir in a clinical study of herpes zoster treatment in immunocompetent subjects≥50 years of age, 244 were 65 and over while 111 were 75 and over. no overall differences in effectiveness for time to cessation of new lesion formation or time to healing were reported between geriatric subjects and younger adult subjects. the duration of pain after healing was longer in patients 65 and over. nausea, vomiting, and dizziness were reported more frequently in elderly subjects. elderly patients are more likely to have reduced renal function and require dose reduction. elderly patients are also more likely to have renal or cns adverse events. with respect to cns adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients (see clinical pharmacology, adverse reactions: observed during clinical practice, and dosage and administration).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

dermal laboratories ltd - isopropyl myristate; liquid paraffin - cutaneous gel - 150mg/1gram ; 150mg/1gram

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

interpharma pty ltd - dexmedetomidine hydrochloride, quantity: 236.4 microgram (equivalent: dexmedetomidine, qty 200 microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - icu sedation.,for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine ever pharma by continuous infusion in these patients should not exceed 24 hours.,procedural sedation,for sedation of non-intubated patients prior to and/or during surgical and other procedures.

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

mayne pharma international pty ltd - oxycodone hydrochloride, quantity: 5 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium starch glycollate type a; silicon dioxide; lactose monohydrate; maize starch; stearic acid - mayne pharma oxycodone ir is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

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

sandoz pty ltd - quetiapine fumarate, quantity: 345.36 mg (equivalent: quetiapine, qty 300 mg) - tablet, film coated - excipient ingredients: magnesium stearate; calcium hydrogen phosphate dihydrate; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; hypromellose; titanium dioxide; macrogol 400; povidone - bipolar disorder, adults maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes, treatment of depressive episodes associated with bipolar disorder (see dosage and administration), treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate, children/adolescents aged 10 to 17 years, monotherapy treatment of acute mania associated with bipolar i disorder, schizophrenia (adults and adolescents aged 13 to 17 years), treatment of schizophrenia

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

sandoz pty ltd - quetiapine fumarate, quantity: 230.24 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; sodium starch glycollate type a; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; macrogol 400; magnesium stearate; calcium hydrogen phosphate dihydrate - bipolar disorder, adults maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes, treatment of depressive episodes associated with bipolar disorder (see dosage and administration), treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate, children/adolescents aged 10 to 17 years, monotherapy treatment of acute mania associated with bipolar i disorder, schizophrenia (adults and adolescents aged 13 to 17 years), treatment of schizophrenia

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

sandoz pty ltd - quetiapine fumarate, quantity: 115.12 mg (equivalent: quetiapine, qty 100 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; povidone; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - bipolar disorder, adults maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes, treatment of depressive episodes associated with bipolar disorder (see dosage and administration), treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate, children/adolescents aged 10 to 17 years, monotherapy treatment of acute mania associated with bipolar i disorder, schizophrenia (adults and adolescents aged 13 to 17 years), treatment of schizophrenia