국가: 이스라엘
언어: 영어
출처: Ministry of Health
METYRAPONE
CTS LTD
V04CD01
CAPSULES
METYRAPONE 250 MG
PER OS
Required
HRA PHARMA RARE DISEASES, FRANCE
METYRAPONE
METYRAPONE
Diagnostic test for ACTH insufficiency and in the differential diagnosis of ACTH dependant Cushing’s Syndrome. For the Management of patient with endogenous Cushing’s syndrome.
2020-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only METOPIRONE 250, CAPSULES Each capsule contains: Metyrapone 250 mg Inactive and allergenic ingredients in the preparation - see Section 2 “Important information about some of the ingredients of the medicine” and Section 6 “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Metopirone 250 acts as a diagnostic preparation that is intended to identify whether you suffer from inadequate production of the hormone ACTH (a hormone secreted by the pituitary gland and which is responsible for cortisol secretion), or as a diagnostic preparation that is intended to help diagnose a specific type of Cushing’s syndrome. Cushing’s syndrome is a set of symptoms resulting from elevated levels of the cortisol hormone (a hormone produced by the adrenal gland). Metopirone 250 is also used for treating signs and symptoms of endogenous Cushing’s syndrome by lowering elevated levels of cortisol. THERAPEUTIC GROUP: Metyrapone belongs to the group of endocrine medicines which are also known as diagnostic preparations used to assess pituitary gland function. 2. BEFORE USING THE MEDICINE X DO NOT TAKE THE MEDICINE IF: ! SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TAKING METOPIRONE 250 AS A DIAGNOSTIC PREPARATION, INFORM THE DOCTOR IF: • You have, or think you may have, a condition in which your hormone levels are low (e.g., reduced adrenal gland production of cortisol or severe hypopituitarism). Your doctor will perform a test to make sure the medicine is right for you. • You are sensitive (allergic) to 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metopirone 250 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Metyrapone 250mg Excipients with known effect: Each capsule contains 0.71 mg of sodium ethyl parahydroxybenzoate and 0.35 mg sodium propyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Yellowish-white, oblong, opaque, soft gelatin capsules printed ‘HRA’ on one side in red ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a diagnostic test for ACTH insufficiency and in the differential diagnostic of ACTH dependent Cushing’s syndrome. For the management of patients with endogenous Cushing’s syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY DIAGNOSTIC APPLICATIONS (i) Short single-dose test – diagnosis of ACTH insufficiency This can be performed on an ambulatory basis. In this test, plasma 11- desoxycortisol and/or ACTH levels are determined after a single dose of Metopirone 250. The patient is given 30 mg/kg (maximum 3 g Metopirone 250) at midnight with yoghurt or milk to minimize nausea and vomiting. _Paediatric population_ : The same dose as in adults is recommended in children. The blood sample for the assay is taken early in the morning (7:30– 8:00 hours). The plasma should be frozen as soon as possible. The patient is then given a prophylactic dose of 50 mg cortisone acetate. Evaluation: Normal values will depend on the method used to determine ACTH and 11-desoxycortisol levels. An intact ACTH reserve is generally indicated by an increase in plasma ACTH to at least 44 pmol/L (200 ng/L) or by an increase in 11-desoxycortisol to over 0.2 micromol/L (70 microg/L). Patients with suspected adrenocortical insufficiency should be hospitalised overnight as a precautionary measure. (ii) Multiple-dose test – diagnosis of ACTH insufficiency and differential diagnosis of adrenocortical hyperfunction in Cushing’s syndrome. The patient must be hospitalised. In this test, urinary steroid levels are measured. The first da 전체 문서 읽기