CORTICIP hydrocortisone (as sodium succinate) 100 mg powder for injection vial

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

hydrocortisone sodium succinate, Quantity: 133.7 mg (Equivalent: hydrocortisone, Qty 100 mg)

Доступно од:

Cipla Australia Pty Ltd

Фармацеутски облик:

Injection, powder for

Састав:

Excipient Ingredients: monobasic sodium phosphate; dibasic sodium phosphate

Пут администрације:

Intramuscular, Intravenous

Јединице у пакету:

5 x 100 mg powder for injection in glass vials

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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.

Резиме производа:

Visual Identification: White to off-white, lyophilized cake/powder in clear tubular glass vial with lyo rubber stopper and yellow coloured flip-off aluminum seal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус ауторизације:

Registered

Датум одобрења:

2022-06-08