Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
macimorelin acetate
Atnahs Pharma Netherlands B.V.
V04CD06
macimorelin
macimorelin
Diagnostic Techniques, Endocrine
This medicinal product is for diagnostic use only. GHRYVELIN is indicated for the diagnosis of growth hormone deficiency (GHD) in adults.
Revision: 3
Authorised
2019-01-11
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT/USER GHRYVELIN ® 60 MG GRANULES FOR ORAL SUSPENSION IN SACHET macimorelin This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE 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 nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What GHRYVELIN is and what it is used for 2. What you need to know before GHRYVELIN is given 3. How GHRYVELIN is given 4. Possible side effects 5. How GHRYVELIN is stored 6. Contents of the pack and other information 1. WHAT GHRYVELIN IS AND WHAT IT IS USED FOR The medicine contains an active substance called macimorelin. Macimorelin acts like a natural hormone and causes the pituitary gland to release growth hormone into the blood stream. GHRYVE LIN is used in adults to test the body´s ability to produce growth hormone. It is used when your doctor thinks that you may not have enough growth hormone (adult growth hormone deficiency). This is not a treatment for patients who do not have enough growth hormone. It is a test that helps your doctor to diagnose this condition. 2. WHAT YOU NEED TO KNOW BEFORE GHRYVELIN IS GIVEN YOU MUST NOT BE GIVEN GHRYVELIN • if you are allergic to macimorelin or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or nurse before you are given GHRYVELIN. WARNINGS AND PRECAUTIONS To ensure that the test results Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT GHRYVELIN 60 mg granules for oral suspension in sachet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 60 mg macimorelin (as acetate). 1 mL of the reconstituted suspension contains 500 micrograms macimorelin. Excipient(s) with known effect Contains lactose monohydrate 1,691.8 mg per sachet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules for oral suspension in sachet. White to off-white granules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. GHRYVELIN is indicated for the diagnosis of growth hormone deficiency (GHD) in adults (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The use of GHRYVELIN must be supervised by a physician or healthcare professional experienced in diagnosing growth hormone deficiency. Posology _Adult population _ The dose is calculated based on the patient´s body weight. The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight. The growth hormone release is to be evaluated with three blood samples collected at 45, 60 and 90 minutes after the administration of the medicinal product. _Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin _ Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving macimorelin. These substances could lead to unreliable GH stimulation resul Aqra d-dokument sħiħ