Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Somatropin (rbe)
Pfizer Ltd
H01AC01
Somatropin (rbe)
200microgram
Powder and solvent for solution for injection
Subcutaneous
Schedule 4 (CD Anab)
Valid as a prescribable product
BNF: 06050100; GTIN: 7317964366183
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. - 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. IN THIS LEAFLET : 1. What Genotropin MiniQuick is and what it is used for 2. Before you use Genotropin MiniQuick 3. How to use Genotropin MiniQuick 4. Possible side effects 5 How to store Genotropin MiniQuick 6. Further 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. Your excessive fat will decrease and your reduced muscle mass will improve. • If you were small or too light at birth. Growth hormone c Read the complete document
OBJECT 1 GENOTROPIN 0.2MG MINIQUICK Summary of Product Characteristics Updated 30-Apr-2018 | Pfizer Limited 1. Name of the medicinal product GENOTROPIN MINIQUICK 0.2 mg powder and solvent for solution for injection. 2. Qualitative and quantitative composition GENOTROPIN MINIQUICK 0.2 mg powder and solvent for solution for injection. One cartridge contains 0.2 mg per 0.25 ml of somatropin* after reconstitution corresponding to a concentration of 0.8 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 cong Read the complete document