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

cipla australia pty ltd - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 8 mg - tablet, uncoated - excipient ingredients: erythrosine aluminium lake; lactose monohydrate; magnesium stearate; potato starch; povidone; docusate sodium; colloidal anhydrous silica - for the temporary relief of acute moderate pain in patients over the age of 12 years

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

cipla australia pty ltd - hydrocortisone sodium succinate, quantity: 133.7 mg (equivalent: hydrocortisone, qty 100 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate - when oral therapy is not feasible, and the strength, form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, [invented name] powder for injection is indicated for intravenous or intramuscular use in the following conditions: 1. endocrine disorders ? primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplements may be necessary, particularly when synthetic analogues are used). ? preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful ? shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected ? congenital adrenal hyperplasia ? nonsuppurative thyroiditis ? hypercalcaemia associated with cancer. 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ? post-traumatic osteoarthritis ? synovitis of osteoarthritis ? rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) ? acute and subacute bursitis ? epicondylitis ? acute nonspecific tenosynovitis ? acute gouty arthritis ? psoriatic arthritis ? ankylosing spondylitis. 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: ? systemic lupus erythematosus ? systemic dermatomyositis (polymyositis) ? acute rheumatic carditis. 4. dermatological diseases ? pemphigus ? severe erythema multiforme (stevens-johnson syndrome) ? exfoliative dermatitis ? bullous dermatitis herpetiformis ? severe seborrhoeic dermatitis ? severe psoriasis ? mycosis fungoides. 5. allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: ? bronchial asthma ? drug hypersensitivity reactions ? contact dermatitis ? urticarial transfusion reactions ? atopic dermatitis ? serum sickness ? acute noninfectious laryngeal oedema (adrenaline is the drug of first choice). 6. ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye, such as: ? herpes zoster ophthalmicus ? iritis, iridocyclitis ? chorioretinitis ? diffuse posterior uveitis and choroiditis ? optic neuritis ? sympathetic ophthalmia ? anterior segment inflammation ? allergic conjunctivitis ? allergic corneal marginal ulcers ? keratitis. 7. gastrointestinal diseases to tide the patient over a critical period of the disease in: ? ulcerative colitis (systemic therapy) ? regional enteritis (systemic therapy). 8. respiratory diseases ? symptomatic sarcoidosis ? loeffler?s syndrome not manageable by other means ? berylliosis ? fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy ? aspiration pneumonitis. 9. haematological disorders ? acquired (autoimmune) haemolytic anaemia ? erythroblastopenia (rbc anaemia) ? idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated) ? secondary thrombocytopenia in adults ? congenital (erythroid) hypoplastic anaemia. 10. neoplastic diseases for palliative management of: ? leukaemias and lymphomas in adults ? acute leukaemia in childhood. 11. oedematous states ? to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus. 12. miscellaneous ? tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurological or myocardial involvement.

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

cipla medpro (pty) ltd - capsules - see ingredients - each capsule contains zidovudine 100,0 mg

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

cipla medpro (pty) ltd - capsules - see ingredients - each capsule contains oseltamivir phosphate equivalent to oseltamivir 75,0 mg

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

cipla medpro (pty) ltd - injection - see ingredients - each vial contains zoledronate trisodium equivalent to zoledronic acid 4,0 mg

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

cipla limited, india - paracetamol - effeverscent granules - 1000

Ireland - English - HPRA (Health Products Regulatory Authority)

cipla (eu) limited - imatinib mesilate - capsules hard - 400 milligram - other cytostatics - antineoplastic agents; protein kinase inhibitor - it is indicated for the treatment of:
paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid; leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;
paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated; phase or blast crisis;
adult patients with ph+ cml in blast crisis;
adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;
adult patients with relapsed or refractory ph+ all as monotherapy;
adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived; growth factor receptor (pdgfr) gene re-arrangements;
adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr
rearrangement

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

cipla australia pty ltd - tadalafil, quantity: 2.5 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; magnesium stearate; microcrystalline cellulose; lactose monohydrate; sodium lauryl sulfate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red - cipla tadalafil is indicated for the treatment of: ? erectile dysfunction (ed) in adult males ? moderate to severe lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph) in adult males

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

cipla australia pty ltd - tadalafil, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; lactose monohydrate; microcrystalline cellulose; hyprolose; titanium dioxide; hypromellose; triacetin; iron oxide yellow - cipla tadalafil is indicated for the treatment of: ? erectile dysfunction (ed) in adult males ? moderate to severe lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph) in adult males

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

cipla australia pty ltd - tadalafil, quantity: 5 mg - tablet - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; hyprolose; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red - cipla tadalafil is indicated for the treatment of: ? erectile dysfunction (ed) in adult males ? moderate to severe lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph) in adult males