देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
HYDROCORTISONE
MEDOMIE PHARMA LTD, ISRAEL
H02AB09
MODIFIED RELEASE CAPSULES HARD
HYDROCORTISONE 10 MG
PER OS
Required
DIURNAL EUROPE B.V., THE NETHERLANDS
HYDROCORTISONE
Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults
2023-06-15
1 Efmody-5_10 mg-SPC Efmody-S P C-0923 PHYSICIAN’S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Efmody 5 mg modified-release hard capsules Efmody 10 mg modified-release hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Efmody 5 mg modified-release hard capsules. Each modified-release hard capsule contains 5 mg hydrocortisone. Efmody 10 mg modified-release hard capsules. Each modified-release hard capsule contains 10 mg hydrocortisone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release hard capsules. Efmody 5 mg modified-release hard capsules. A capsule (approx.19 mm long) with an opaque blue cap and opaque white body printed with “CHC 5 mg” containing white to off white granules. Efmody 10 mg modified-release hard capsules. A capsule (approx.19 mm long) with an opaque green cap and opaque white body printed with “CHC 10 mg” containing white to off white granules. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. 4.2 Posology and method of administration Posology Treatment should be initiated by physicians experienced in the management of CAH. As maintenance therapy the dose must be individualised according to the response of the individual patient. The lowest possible dose should be used. 2 Efmody-5_10 mg-SPC Efmody-S P C-0923 Monitoring of the clinical response is necessary and patients should be observed closely for signs that might require dose adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, changes in electrolytes particularly hypokalaemia, individual responsiveness to the medicinal product, and the effect of stress (e.g. surgery, infection, trauma). As the treatment has a modified-release profile, blood tests are used to monitor clinical response, assessment of the evening dose should be done with a morning blood test and assessment of the morning dose should be done with an early पूरा दस्तावेज़ पढ़ें