Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
hydrocortisone
Diurnal Europe B.V.
H02AB09
hydrocortisone
Corticosteroids for systemic use
Adrenal Insufficiency
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Revision: 8
Authorised
2018-02-09
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER ALKINDI 0.5 MG GRANULES IN CAPSULES FOR OPENING ALKINDI 1 MG GRANULES IN CAPSULES FOR OPENING ALKINDI 2 MG GRANULES IN CAPSULES FOR OPENING ALKINDI 5 MG GRANULES IN CAPSULES FOR OPENING hydrocortisone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as those of the child for whom this medicine has been prescribed. - If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Alkindi is and what it is used for 2. What you need to know before you give Alkindi 3. How to give Alkindi 4. Possible side effects 5. How to store Alkindi 6. Contents of the pack and other information 1. WHAT ALKINDI IS AND WHAT IT IS USED FOR Alkindi contains the active substance hydrocortisone. Hydrocortisone belongs to a group of medicines known as corticosteroids. Hydrocortisone is a synthetic version of the natural hormone cortisol. Cortisol is made by the adrenal glands in the body. Alkindi is for use in children and adolescents aged birth to 18 years when the body is not making enough cortisol, because part of the adrenal gland is not working (adrenal insufficiency, often caused by an inherited condition called congenital adrenal hyperplasia). 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE ALKINDI DO NOT GIVE ALKINDI: - If your child is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6). - If your child has difficulties swallowing food, or is a premature baby who cannot yet be fed by mouth. WARNING Alkindi granules come in a capsule that must be opened before use, dis Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Alkindi 0.5 mg granules in capsules for opening Alkindi 1 mg granules in capsules for opening Alkindi 2 mg granules in capsules for opening Alkindi 5 mg granules in capsules for opening 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. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dose must be individualised according to the response of the individual patient. The lowest possible dose should be used. 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, 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 p Прочетете целия документ