Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - zidovudine - solution for infusion - zidovudine 200 mg / 20 ml - zidovudine - zidovudine - retrovir iv for infusion is indicated for the short term management of serious manifestations of human immunodeficiency virus (hiv) infection in patients with acquired immuno deficiency syndrome (aids) or aids who are unable to take retrovir oral formulations.retrovir chemoprophylaxis, is indicated for use in hiv-positive pregnant women (over 14 weeks of gestation) for prevention of maternal-foetal hiv transmission and for primary prophylaxis of hiv infection in newborn infants. retrovir i.v. should only be used when oral treatment is not possible (except during labour and delivery).

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

baxter healthcare pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection, concentrated - excipient ingredients: hydrogenated soy phosphatidylcholine; histidine; hydrochloric acid; ammonium sulfate; cholesterol; water for injections; sodium hydroxide; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; sucrose - indications: for the treatment of: (1) advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. (2) aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/cubic mm) and extensive mucocutaneous or visceral disease. as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and doxorubicin (or other anthracycline). indications as at 29 february 2008: caelyx, as monotherapy, is indicated for the treatment of metastatic breast cancer. caelyx is also indicated for the treatment of: advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/mm3) and extensive mucocutaneous or visceral dise

Malta - English - Medicines Authority

viatris hellas ltd 253-255, mesogion avenue, 154 51 neo psychiko, athens,, greece - solution for injection/infusion - phenytoin sodium 50 mg/ml - antiepileptics

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

sun pharma anz pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection - excipient ingredients: hydrochloric acid; sodium hydroxide; sucrose; histidine; cholesterol; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; hydrogenated soy phosphatidylcholine; ammonium sulfate; ethanol; water for injections - liposomal doxorubicin sun, as monotherapy, is indicated for the treatment of metastatic breast cancer.,liposomal doxorubicin sun is also indicated for the treatment of:,? advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.,? aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.,liposomal doxorubicin sun may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and doxorubicin (or other anthracycline).,liposomal doxorubicin sun is also indicated, in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - zidovudine 10 mg/ml - solution for injection - 200mg/20ml - active: zidovudine 10 mg/ml excipient: hydrochloric acid sodium hydroxide water for injection - retrovir iv for infusion is indicated for the short-term management of serious manifestations of human immunodeficiency virus (hiv) infection in patients with acquired immune deficiency syndrome (aids), who are unable to take retrovir oral formulations.

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

viiv healthcare pty ltd - zidovudine, quantity: 250 mg - capsule, hard - excipient ingredients: gelatin; maize starch; microcrystalline cellulose; sodium starch glycollate; magnesium stearate; indigo carmine; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid; potassium hydroxide - retrovir is indicated for: . treatment of adult patients with severe symptomatic human immunodeficiency virus infection (aids or advanced aids related complex); . treatment of other hiv-positive adult patients with less than 500 cd4 cells/mm3. notes: (1) the limited available data currently support the extended use of retrovir (indication 2 above). (2) the optimal dosage for these indications has not been established. . combination therapy in advanced hiv infection. the addition of hivid (zalcitabine) may be considered for the management of adult patients with advanced hiv infection and cd4 + cell counts less than or equal to 200/mm3, who have received retrovir monotherapy for less than 12 months. retrovir monotherapy is still indicated as initial therapy for adult patients with hiv infection who fulfil the approved indications. new indications approved 7th february 1997: retrovir (zidovudine) is indicated for the treatment of hiv infection, alone and in combination with other antiretroviral therapies. the

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

viiv healthcare pty ltd - zidovudine, quantity: 100 mg - capsule - excipient ingredients: sodium starch glycollate; microcrystalline cellulose; maize starch; magnesium stearate; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid; potassium hydroxide - retrovir is indicated for: . treatment of adult patients with severe symptomatic human immunodeficiency virus infection (aids or advanced aids related complex); . treatment of other hiv-positive adult patients with less than 500 cd4 cells/mm3. notes: (1) the limited available data currently support the extended use of retrovir (indication 2 above). (2) the optimal dosage for these indications has not been established. . combination therapy in advanced hiv infection. the addition of hivid (zalcitabine) may be considered for the management of adult patients with advanced hiv infection and cd4 + cell counts less than or equal to 200/mm3, who have received retrovir monotherapy for less than 12 months. retrovir monotherapy is still indicated as initial therapy for adult patients with hiv infection who fulfil the approved indications. new indications approved 7th february 1997: retrovir (zidovudine) is indicated for the treatment of hiv infection, alone and in combination with other antiretroviral therapies. the

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

janssen products, lp - bedaquiline fumarate (unii: p04qx2c1a5) (bedaquiline - unii:78846i289y) - bedaquiline 100 mg - sirturo is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (mdr-tb). reserve sirturo for use when an effective treatment regimen cannot otherwise be provided. this indication is approved under accelerated approval based on time to sputum culture conversion [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. limitations of use: - do not use sirturo for the treatment of: latent infection due to mycobacterium tuberculosis drug-sensitive tuberculosis extra-pulmonary tuberculosis infections caused by non-tuberculous mycobacteria - latent infection due to mycobacterium tuberculosis - drug-sensitive tuberculosis - extra-pulmonary tuberculosis - infections caused by non-tuberculous myco

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - phenytoin 50mg; phenytoin 50mg; phenytoin 50mg - chewable tablet - 50 mg - active: phenytoin 50mg excipient: magnesium stearate purified talc quinoline yellow saccharin sodium spearmint flavour natural 11584 sucrose sunset yellow fcf wheat starch active: phenytoin 50mg excipient: spearmint flavour natural 11584 magnesium stearate maize starch purified talc quinoline yellow saccharin sodium sucrose sunset yellow fcf active: phenytoin 50mg excipient: confectioner's sugar magnesium stearate purified talc quinoline yellow saccharin sodium spearmint flavour natural 11584 sunset yellow fcf - dilantin is indicated for the control of grand mal and psychomotor seizures. dilantin will prevent or effectively decrease the incidence and severity of convulsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, dilantin frequently improves the mental condition and outlook of epileptic patients and there is also increasing evidence that dilantin is valuable in the prevention of seizures occurring during or after neurosurgery. phenytoin serum level determinations may be necessary for optimal dosage adjustments.

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

viiv healthcare pty ltd - zidovudine, quantity: 10 mg/ml - oral liquid, solution - excipient ingredients: citric acid; glycerol; maltitol solution; purified water; sodium benzoate; saccharin sodium; flavour - (1) treatment of adult patients with severe symptomatic human immunodeficiency virus infection (aids or advanced aids related complex). (2) treatment of other hiv-positive adult patients with less than 500 cd4 cells/mm3. new indications as at 11 may 1994: retrovir is indicated for: . treatment of adult patients with severe symptomatic human immunodeficiency virus infection (aids or advanced aids related complex); . treatment of other hiv-positive adult patients with less than 500 cd4 cells/mm3. notes: (1) the limited available data currently support the extended use of retrovir (indication 2 above). (2) the optimal dosage for these indications has not been established . combination therapy in advanced hiv infection: the addition of hivid (zalcitabine) may be considered for the management of adult patients with advanced hiv infection and cd4 + cell counts less than or equal to 200/mm3, who have received retrovir monotherapy for less than 12 months. retrovir monotherapy is still indicated as initial therapy f