EFMODY 10 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

HYDROCORTISONE

Dostupné z:

MEDOMIE PHARMA LTD, ISRAEL

ATC kód:

H02AB09

Forma lieku:

MODIFIED RELEASE CAPSULES HARD

Zloženie:

HYDROCORTISONE 10 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

DIURNAL EUROPE B.V., THE NETHERLANDS

Terapeutické oblasti:

HYDROCORTISONE

Terapeutické indikácie:

Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults

Dátum Autorizácia:

2023-06-15

Súhrn charakteristických

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