Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
somatropin
Ipsen Pharma
H01AC01
somatropin
Pituitary and hypothalamic hormones and analogues
Turner Syndrome; Dwarfism, Pituitary
Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion.Long-term treatment of growth failure associated with Turner syndrome.Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation.Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment.
Revision: 20
Authorised
2001-02-15
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER NUTROPINAQ 10 MG/2 ML (30 IU) 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 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NutropinAq is and what it is used for 2. What you need to know before you use NutropinAq 3. How to use NutropinAq 4. Possible side effects 5. How to store NutropinAq 6. Contents of the pack and other information 1. WHAT NUTROPINAQ IS AND WHAT IT IS USED FOR NutropinAq contains somatropin which is a recombinant growth hormone similar to the human’s natural growth hormone made by your body. It is recombinant, meaning it is made outside of the body by a special process. Growth Hormone (GH) is a chemical messenger made by a small gland in your brain called the pituitary. In children it tells the body to grow, help the bones to develop normally and, in later adult life, GH helps to maintain a normal body shape and metabolism. IN CHILDREN, NUTROPINAQ IS USED: • When your body does not make enough growth hormone and for this reason you are not growing properly. • When you have Turner syndrome. Turner syndrome is a genetic abnormality in girls (absence of female sexual chromosome(s)) that prevents growth. • When your kidneys are damaged and they lose their ability to function normally with an impact on growth. In adults NutropinAq is used for: • If your body does not make enough growth hormone as an adult. This can start during adult life or continue from when you were a child. BENEFITS IF USING THIS MEDICINE In childre Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT NutropinAq 10 mg/2 ml (30 IU) solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains 5 mg of somatropin* One cartridge contains 10 mg (30 IU) of somatropin * Somatropin is a human growth hormone produced in _Escherichia coli _ cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Paediatric population _ - Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. - Long-term treatment of girls from 2 years old with growth failure associated with Turner syndrome. - Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. _Adult population _ - Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment. In adults with growth hormone deficiency the diagnosis should be established depending on the etiology: _Adult-onset: _ The patient must have growth hormone deficiency as a result of hypothalamic or pituitary disease, and at least one other hormone deficiency diagnosed (except for prolactin). Test for growth hormone deficiency should not be performed until adequate replacement therapy for other hormone deficiencies have been instituted. _Childhood-onset: _ Patients who have had growth hormone deficiency as a child should be retested to confirm growth hormone deficiency in adulthood before replacement therapy with NutropinAq is started. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indic Прочетете целия документ