البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
HYDROCORTISONE
MEDOMIE PHARMA LTD, ISRAEL
H02AB09
GRANULES IN CAPSULES FOR OPENING
HYDROCORTISONE 5 MG
PER OS
Required
DIURNAL EUROPE B.V., THE NETHERLANDS
HYDROCORTISONE
Alkindi is indicated for replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old)
2020-05-03
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only ALKINDI 0.5 MG ALKINDI 1 MG ALKINDI 2 MG ALKINDI 5 MG GRANULES IN CAPSULE FOR OPENING ACTIVE INGREDIENT: Each capsule for opening contains 0.5 mg, 1 mg, 2 mg or 5 mg of hydrocortisone, respectively. INACTIVE INGREDIENTS AND ALLERGENS IN THE MEDICINAL PRODUCT: See section 2, ‘Important information about some of this medicine’s ingredients’ and section 6, ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult with your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. IMPORTANT! ALKINDI GRANULES ARE MARKETED IN CAPSULES. OPEN THE CAPSULE, EMPTY IT AND USE THE CONTENTS ONLY ACCORDING TO THE INSTRUCTIONS IN THIS LEAFLET. SEE SECTION 3. DISCARD THE EMPTY CAPSULE AND PREVENT ACCESS TO IT BY CHILDREN. SWALLOWING THE CAPSULE MAY CAUSE CHOKING. 1. WHAT IS THIS MEDICINE INTENDED FOR? Alkindi is intended as a replacement hormone therapy in instances of adrenal gland insufficiency in infants, children and adolescents (from birth up to 18 years of age). THERAPEUTIC GROUP – the medicine belongs to the group of corticosteroids for systemic use – glucocorticoids. Alkindi contains a substance called hydrocortisone, an alternative version of cortisol, which is the natural hormone released into the body by the adrenal glands. When these glands are not fully functioning, the amount of cortisol secreted is reduced. Alkindi constitutes a replacement for the natural hormone. 2. BEFORE USING THIS MEDICINE Do not use this medicine: if you/your child are sensitive (allergic) to the active ingredient (hydrocortisone) or to any of the other ingredients of this medicine listed in sectio اقرأ الوثيقة كاملة
1 1. NAME OF THE MEDICINAL PRODUCT Alkindi 0.5 mg Alkindi 1 mg Alkindi 2 mg Alkindi 5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Alkindi 0.5 mg granules in capsules for opening Each capsule contains 0.5 mg hydrocortisone Alkindi 1 mg granules in capsules for opening Each capsule contains 1 mg hydrocortisone Alkindi 2 mg granules in capsules for opening Each capsule contains 2 mg hydrocortisone Alkindi 5 mg granules in capsules for opening Each capsule contains 5 mg hydrocortisone For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules in capsules for opening. The granules are white to off-white and contained in a transparent colourless (size 00el) hard capsule. Alkindi 0.5 mg granules in capsules for opening The capsule is printed with "INF-0.5" in red ink. Alkindi 1 mg granules in capsules for opening The capsule is printed with "INF-1.0" in blue ink. Alkindi 2 mg granules in capsules for opening The capsule is printed with "INF-2.0" in green ink. Alkindi 5 mg granules in capsules for opening The capsule is printed with "INF-5.0" in grey ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alkindi is indicated for replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used. 2 Monitoring of the clinical response is necessary and patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual responsiveness to the medicinal product, and the effect of stress (e.g. surgery, infection, trauma). During stress it may be necessary to increase the dose temporarily. _Replacement therapy in primary and secondary adrenal insufficiency _ Alkindi is given as replacement therapy by oral administration of granules according to clinical practice اقرأ الوثيقة كاملة