Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
hydrocortisone, Quantity: 2 mg
Chiesi Australia Pty Ltd
Granules
Excipient Ingredients: microcrystalline cellulose; hypromellose; magnesium stearate; ethylcellulose
Oral
50 capsules per bottle
(S4) Prescription Only Medicine
Replacement therapy of adrenal insufficiency
Visual Identification: The granules are white to off-white and contained in a transparent colourless size 00el hard capsule. The capsule is printed with INF-2.0 in green ink.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2020-08-18
ALKINDI CMI v3.0 1 ALKINDI ® _Hydrocortisone (0.5 mg, 1 mg, 2 mg or 5 mg) granules in capsules for opening_ Consumer Medicine Information WARNING ALKINDI granules come in a capsule that must be opened before use, discard the empty capsule after use out of reach of children. Do NOT swallow the capsule – small children may choke. WHAT IS IN THIS LEAFLET This leaflet answers some of the more common questions about ALKINDI. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of your child being given this medicine against the benefits this medicine is expected to have for your child. IF YOU HAVE ANY CONCERNS ABOUT GIVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET, YOU MAY NEED TO READ IT AGAIN. WHAT ALKINDI IS USED FOR ALKINDI contains a medicine called hydrocortisone. Hydrocortisone belongs to a group of medicines known as corticosteroids. Hydrocortisone is a synthetic version of the hormone cortisol. Cortisol is made naturally by the adrenal glands in the body. ALKINDI is used 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). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ALKINDI HAS BEEN PRESCRIBED FOR YOUR CHILD. This medicine is available only with a doctor’s prescription. BEFORE YOU GIVE ALKINDI _WHEN YOU MUST NOT GIVE IT _ DO NOT GIVE ALKINDI: If your child is allergic to hydrocortisone or any of the other ingredients of this medicine. If your child has difficulties swallowing food, or is a premature baby who cannot yet be fed by mouth. _BEFORE YOU GIVE ALKINDI _ TALK TO YOUR DOCTOR OR PHARMACIST BEFORE GIVING ALKINDI IF YOUR CHILD IS: - unwell or has an infection. The endocrinologist may need to increase the dose of ALKINDI temporarily; talk to your endocrinologist if your child is unwell. If y Belgenin tamamını okuyun
ALKINDI Product Information ALKINDI PI v3.3 1 AUSTRALIAN PRODUCT INFORMATION ALKINDI ® (HYDROCORTISONE) – GRANULES (IN CAPSULE) 1. NAME OF THE MEDICINE Hydrocortisone. 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 LIST OF EXCIPIENTS. 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 Replacement therapy of adrenal insufficiency. ALKINDI Product Information ALKINDI PI v3.3 2 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used. Alkindi was developed for use in patients requiring smaller doses. Alternative formulations of hydrocortisone should be considered for patients requiring larger doses. 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 necessa Belgenin tamamını okuyun