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

accord healthcare pty ltd - busulfan, quantity: 60 mg - injection, concentrated - excipient ingredients: macrogol 400; dimethylacetamide - busulfan accord is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - posaconazole - mycoses - antimycotics for systemic use - posaconazole accord is indicated for use in the treatment of the following fungal infections in adults:invasive aspergillosis;fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.posaconazole accord is also indicated for prophylaxis of invasive fungal infections in the following patients: patients receiving remission-induction chemotherapy for acute myelogenous leukemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

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

accord healthcare pty ltd - lidocaine hydrochloride, quantity: 20 mg - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; sodium chloride; water for injections - lidocaine accord solutions are indicated for the production of local or regional anaesthesia by the following techniques: ? infiltration ? intravenous regional anaesthesia ? peripheral nerve block ? epidural block ? subarachnoid block

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

accord healthcare pty ltd - lidocaine hydrochloride, quantity: 40 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - lidocaine accord solutions are indicated for the production of local or regional anaesthesia by the following techniques: ? infiltration ? intravenous regional anaesthesia ? peripheral nerve block ? epidural block ? subarachnoid block

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

accord healthcare pty ltd - lidocaine hydrochloride, quantity: 100 mg - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; water for injections; sodium chloride - lidocaine accord solutions are indicated for the production of local or regional anaesthesia by the following techniques: ? infiltration ? intravenous regional anaesthesia ? peripheral nerve block ? epidural block ? subarachnoid block

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

accord healthcare pty ltd - lidocaine hydrochloride, quantity: 50 mg - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium chloride; sodium hydroxide - lidocaine accord solutions are indicated for the production of local or regional anaesthesia by the following techniques: ? infiltration ? intravenous regional anaesthesia ? peripheral nerve block ? epidural block ? subarachnoid block

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

accord healthcare pty ltd - lidocaine hydrochloride, quantity: 200 mg - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid; sodium chloride - lidocaine accord solutions are indicated for the production of local or regional anaesthesia by the following techniques: ? infiltration ? intravenous regional anaesthesia ? peripheral nerve block ? epidural block ? subarachnoid block

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

accord healthcare pty ltd - lidocaine hydrochloride, quantity: 400 mg - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid - lidocaine accord solutions are indicated for the production of local or regional anaesthesia by the following techniques: ? infiltration ? intravenous regional anaesthesia ? peripheral nerve block ? epidural block ? subarachnoid block

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

accord healthcare pty ltd - lidocaine hydrochloride, quantity: 100 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections - lidocaine accord solutions are indicated for the production of local or regional anaesthesia by the following techniques: ? infiltration ? intravenous regional anaesthesia ? peripheral nerve block ? epidural block ? subarachnoid block

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

american regent, inc. - zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [see warnings and precautions (5.6)] risk summary administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with intravenous zinc sulfate.  the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.  all pregnancies have a background risk of birth defect, loss, or other adverse outcomes.  in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. pregnant women have an increased metabolic demand for trace elements, including zinc.  parenteral nutrition with zinc should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary zinc is present in human milk. administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause harm to a breastfed infant. there is no information on the effects of zinc sulfate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zinc sulfate injection and any potential adverse effects on the breastfed infant from zinc sulfate injection or from the underlying maternal condition. zinc sulfate injection is approved for use in the pediatric population, including neonates, as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients [see dosage and administration (2.2)] . because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with zinc sulfate injection may be at higher risk of aluminum toxicity [see warnings and precautions (5.3)] . reported clinical experience with intravenous zinc sulfate has not identified a difference in zinc requirements between elderly and younger patients.  in general, dose selection should be individualized based on the patient’s clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.