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

pfizer australia pty ltd - hydrocortisone sodium succinate, quantity: 334.25 mg (equivalent: hydrocortisone, qty 250 mg) - injection, powder for - excipient ingredients: dibasic sodium phosphate; monobasic sodium phosphate; sodium hydroxide - 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, solu-cortef 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.

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

pfizer australia pty ltd - hydrocortisone sodium succinate, quantity: 134 mg (equivalent: hydrocortisone, qty 100 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; sodium hydroxide - 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, solu-cortef 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.

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

compliance management solutions - 61473 - dermatological carbon dioxide laser system - the fractional co2 laser therapy systems is indicated for treatment of skin diseases, including seborrheic keratosis, syringoma, verruca vulgaris, flat wart, eyelid xanthoma, melanocytic nevus.

Israel - English - Ministry of Health

rafa laboratories ltd - fentanyl - patches - fentanyl 100 mcg/hour - fentanyl - management of chronic pain and intractable pain requiring opioid analgesia.fenta should only be used in patients who are already receiving opioid therapy who have demonstrated opioid tolerance.

Israel - English - Ministry of Health

rafa laboratories ltd - fentanyl - patches - fentanyl 12.5 mcg/hour - management of chronic pain and intractable pain requiring opioid analgesia.fenta should only be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance.

Israel - English - Ministry of Health

rafa laboratories ltd - fentanyl - patches - fentanyl 25 mcg/hour - fentanyl - management of chronic pain and intractable pain requiring opioid analgesia.fenta should only be used in patients who are already receiving opioid therapy who have demonstrated opioid tolerance.

Israel - English - Ministry of Health

rafa laboratories ltd - fentanyl - patches - fentanyl 50 mcg/hour - fentanyl - management of chronic pain and intractable pain requiring opioid analgesia.fenta should only be used in patients who are already receiving opioid therapy who have demonstrated opioid tolerance.

Israel - English - Ministry of Health

rafa laboratories ltd - fentanyl - patches - fentanyl 75 mcg/hour - fentanyl - management of chronic pain and intractable pain requiring opioid analgesia.fenta should only be used in patients who are already receiving opioid therapy who have demonstrated opioid tolerance.

European Union - English - EMA (European Medicines Agency)

novartis europharm ltd - aliskiren, amlodipine - hypertension - agents acting on the renin-angiotensin system - rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.

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

teva uk ltd - etoricoxib - oral tablet - 30mg