Hydrocortisone-AFT hydrocortisone (as sodium succinate) 100 mg powder for injection vial

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 製品の特徴 (SPC)
10-07-2023
ダウンロード 公開評価報告書 (PAR)
10-07-2023

有効成分:

hydrocortisone sodium succinate, Quantity: 133.7 mg

から入手可能:

AFT Pharmaceuticals Pty Ltd

医薬品形態:

Injection, powder for

構図:

Excipient Ingredients:

投与経路:

Intramuscular, Intravenous

パッケージ内のユニット:

1 vial, 10 vials

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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,,Hydrocortisone-AFT 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

製品概要:

Visual Identification: white or almost white powder; Container Type: Vial; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Registered

承認日:

2023-07-10

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製品の特徴

                                Product and Consumer Medicine Information Licence
-------------------------
ACCESS TERMS FOR PRODUCT INFORMATION AND CONSUMER MEDICINE INFORMATION
DOCUMENTS ("LICENCE")
PARTIES
YOU or YOUR means any legal person or entity who accesses or downloads
a PI Document or CMI Document from Our website
and
US, WE or OUR means the COMMONWEALTH OF AUSTRALIA as represented by
the THERAPEUTIC GOODS ADMINISTRATION ABN 40 939 406 804 of 136
Narrabundah Lane, Symonston ACT 2609, Australia.
OPERATIVE PROVISIONS	*
NATURE OF AGREEMENT	*
1.1  This Licence specifies the terms and conditions of Your access
and use of PI Documents and CMI Documents made available to the
general public by Us via Our website.	*
1.2  You acknowledge and agree that accessing PI Documents or CMI
Documents in accordance with this Licence is beneficial to You because
it provides You with product information about therapeutic goods and
is beneficial to Us because it assists Us in our portfolio
responsibilities.	*
TERMS OF ACCESS	*
2.1  We grant to You a perpetual, non-exclusive, royalty-free,
world-wide, irrevocable and non-transferable licence to download,
store in cache, display, print and copy a single copy or part of a
single copy of a PI Document or CMI Document made available via Our
website.	*
2.2  If You wish to use any PI Document or CMI Document for purposes
other than those specified in clause 2.1 of this Licence, You must
seek the permission of the Sponsor.	*
2.3  We may remove a PI Document or CMI Document from Our website at
any time in Our sole discretion.	*
EXCLUSION OF LIABILITY	*
3.1  You acknowledge and agree that You are responsible for making
Your own enquiries to determine whether any PI Document or CMI
Document is accurate, up to date and fit for Your purposes.	*
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purpose of disseminating health information free of charge for the
benefit of the public.  This Licence and any PI Document or CMI
Document made available to You via Our website is not a substitute fo
                                
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