Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Somatropin; Somatropin
Pfizer Healthcare Ireland
H01AC; H01AC01
Somatropin; Somatropin
1.8 milligram(s)
Powder and solvent for solution for injection
Product subject to prescription which may not be renewed (A)
Somatropin and somatropin agonists; somatropin
Marketed
1998-12-10
Page 1 of 10 PfLEET 2023-0087122 PACKAGE LEAFLET: INFORMATION FOR THE USER GENOTROPIN MINIQUICK 0.2MG, 0.4MG, 0.6MG, 0.8MG, 1.0MG, 1.2MG, 1.4MG, 1.6MG, 1.8MG, 2.0MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION somatropin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET : 1. What Genotropin MiniQuick is and what it is used for 2. What you need to know before you use Genotropin MiniQuick 3. How to use Genotropin MiniQuick 4. Possible side effects 5. How to store Genotropin MiniQuick 6. Contents of the pack and other information 1. WHAT GENOTROPIN MINIQUICK IS AND WHAT IT IS USED FOR Genotropin MiniQuick is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone which is needed for bones and muscles to grow. It also helps your fat and muscle tissues to develop in the right amounts. It is recombinant meaning it is not made from human or animal tissue. In children, Genotropin MiniQuick is used to treat growth disturbances: • If you are not growing properly and you do not have enough of your own growth hormone. • If you have Turner syndrome. Turner syndrome is a chromosomal error in girls that can affect growth - your doctor will have told you if you have this. • If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function normally, this can affect growth. • If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you grow taller if you are still growing, and will also improve your body composition. Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 10 August 2022 CRN00CNM8 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT GENOTROPIN MINIQUICK 2 QUALITATIVE AND QUANTITATIVE COMPOSITION GENOTROPIN MINIQUICK 1.8 mg powder and solvent for solution for injection. One cartridge contains 1.8 mg per 0.25 ml of somatropin* after reconstitution corresponding to a concentration of 7.2 mg/ml. * produced in Escherichia coli cells by recombinant DNA technology. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. A two chamber cartridge with a white powder in the front compartment and a clear solution in the rear compartment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Children Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD) and growth disturbance associated with Turner syndrome or chronic renal insufficiency. Growth disturbance [current height standard deviation score (SDS) < - 2.5 and parental adjusted height SDS < - 1] in short children born small for gestational age (SGA), with a birth weight and/or length below - 2 SD, who failed to show catch-up growth [height velocity (HV) SDS < 0 during the last year] by 4 years of age or later. Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing. Adults Replacement therapy in adults with pronounced growth hormone deficiency. _Adult Onset:_ Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency. _Childhood Onset:_ Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients Կարդացեք ամբողջական փաստաթուղթը