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

cipla australia pty ltd - salmeterol xinafoate, quantity: 36.32 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation); fluticasone propionate, quantity: 125 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include: - patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids. - patients who are symptomatic on current inhaled corticosteroid therapy.,for the symptomatic treatment of patients with severe copd (fev1 less than 50 precent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. fluticasone propionate/salmeterol (125 microgram/25 microgram and 250 microgram/25 microgram) is not indicated for the initiation of bronchodilator therapy in copd.

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

cipla australia pty ltd - methotrexate, quantity: 10 mg - tablet - excipient ingredients: calcium hydrogen phosphate; lactose monohydrate; sodium starch glycollate type a; microcrystalline cellulose; purified talc; magnesium stearate - antineoplastic chemotherapy,treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methotrexate cipla is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides.,psoriasis chemotherapy,(see warnings box and section 4.4 special warnings and precautions for use),because of the high risk attending to its use, methotrexate cipla is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and / or after dermatologic consultations.,rheumatoid arthritis chemotherapy,(see warnings box and section 4.4 special warnings and precautions for use),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 (see sections 4.4 special warnings and precautions for use and 4.5 interactions with other medicines and other forms of interactions).,steroids may be reduced gradually in patients who respond to methotrexate.,combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. rest and physiotherapy as indicated should be continued.

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

cipla australia pty ltd - methotrexate, quantity: 2.5 mg - tablet - excipient ingredients: calcium hydrogen phosphate; lactose monohydrate; sodium starch glycollate type a; microcrystalline cellulose; purified talc; magnesium stearate - antineoplastic chemotherapy,treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methotrexate cipla is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides.,psoriasis chemotherapy,(see warnings box and section 4.4 special warnings and precautions for use),because of the high risk attending to its use, methotrexate cipla is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and / or after dermatologic consultations.,rheumatoid arthritis chemotherapy,(see warnings box and section 4.4 special warnings and precautions for use),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 (see sections 4.4 special warnings and precautions for use and 4.5 interactions with other medicines and other forms of interactions).,steroids may be reduced gradually in patients who respond to methotrexate.,combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. rest and physiotherapy as indicated should be continued.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

cipla medpro (pty) ltd - powder - 2,5 iu - each 1,0 ml dose contains purified rabies antigen (rabies virus pitman-moore strain 3218) =2,5 iu

Malta - English - Medicines Authority

cipla europe n.v. uitbreidingstraat 80, 2600 antwerp, belgium - capecitabine - film-coated tablet - capecitabine 150 mg - antineoplastic agents

Malta - English - Medicines Authority

cipla europe n.v. uitbreidingstraat 80, 2600 antwerp, belgium - capecitabine - film-coated tablet - capecitabine 500 mg - antineoplastic agents

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

cipla australia pty ltd - salbutamol sulfate, quantity: 6 mg (equivalent: salbutamol, qty 5 mg) - inhalation, conventional - excipient ingredients: sulfuric acid; water for injections; sodium chloride - for the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise induced asthma or in other situations known to induce bronchospasm.

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

cipla australia pty ltd - salbutamol sulfate, quantity: 3 mg (equivalent: salbutamol, qty 2.5 mg) - inhalation, conventional - excipient ingredients: water for injections; sulfuric acid; sodium chloride - for the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise induced asthma or in other situations known to induce bronchospasm.

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

cipla australia pty ltd - bosentan monohydrate, quantity: 129.08 mg (equivalent: bosentan, qty 125 mg) - tablet, film coated - excipient ingredients: maize starch; sodium starch glycollate type b; povidone; pregelatinised maize starch; glycerol dibehenate; magnesium stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; purified water; ethylcellulose; cetyl alcohol; hydrogen peroxide; sodium lauryl sulfate; octamethylcyclotetrasiloxane; silica dimethicone silylate; dimeticone 5000; cyclomethicone - bosentan is indicated for the treatment of: - idiopathic pulmonary arterial hypertension - familial pulmonary arterial hypertension - pulmonary arterial hypertension associated with scleroderma or - pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who functional class ii, iii or iv symptoms.

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

cipla australia pty ltd - bosentan monohydrate, quantity: 129.08 mg (equivalent: bosentan, qty 125 mg) - tablet, film coated - excipient ingredients: maize starch; sodium starch glycollate type b; povidone; pregelatinised maize starch; glycerol dibehenate; magnesium stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; purified water; ethylcellulose; cetyl alcohol; hydrogen peroxide; sodium lauryl sulfate; octamethylcyclotetrasiloxane; silica dimethicone silylate; dimeticone 5000; cyclomethicone - bosentan is indicated for the treatment of: - idiopathic pulmonary arterial hypertension - familial pulmonary arterial hypertension - pulmonary arterial hypertension associated with scleroderma or - pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who functional class ii, iii or iv symptoms.