Solu-Cortef

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Hydrocortisone sodium succinate equivalent to 250 mg hydrocortisone

제공처:

Pharmacia Limited Company trading as Pharmacia

INN (International Name):

Hydrocortisone sodium succinate (= 250 mg hydrocortisone)

복용량:

250 mg

약제 형태:

Powder for injection

구성:

Active: Hydrocortisone sodium succinate equivalent to 250 mg hydrocortisone Excipient: Benzyl alcohol Dibasic sodium phosphate Monobasic sodium phosphate Sodium hydroxide Water for injection

패키지 단위:

Vial, diluent top vial/powder bottom, 2 mL

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Pharmacia & Upjohn Company LLC

제품 요약:

Package - Contents - Shelf Life: Vial, diluent top vial/powder bottom - 2 mL - 24 months from date of manufacture stored at or below 25°C protect from light 3 days reconstituted stored at or below 25°C protect from light

승인 날짜:

1972-07-14

제품 특성 요약

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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SOLU-CORTEF
®
hydrocortisone sodium succinate 100 mg Act-O-Vial Powder for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Act-O-Vial contains 133.7 mg hydrocortisone sodium succinate
equivalent to 100 mg
hydrocortisone when mixed with 2 mL of sterile Water for Injections.
For the full list of excipients, see section 6.1, List of excipients.
3. PHARMACEUTICAL FORM
SOLU-CORTEF is a white or nearly white odourless, hygroscopic
amorphous solid, available in
Act-O-Vials.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 supplementation 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
•
Hypercalcaemia associated with cancer
•
Nonsuppurative thyroiditis.
RHEUMATIC DISORDERS
As adjunctive therapy for short-term administration (to tide the
patient over an acute episode or
exacerbation) in:
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•
Post-trauma osteoarthritis
•
Epicondylitis
•
Synovitis or osteoarthritis
•
Acute nonspecific tenosynovitis
•
Rheumatoid arthritis, including juvenile rheumatoid arthritis
(selected cases may require low
dose maintenance therapy)
•
Acute and subacute bursitis
•
Acute gouty arthritis
•
Psoriatic arthritis
•
Ankylosing spondylitis.
COLLAGEN DISEASE