País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
SOMATROPIN
Merck Serono Limited
H01AC01
SOMATROPIN
8 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Somatropin and somatropin agonists
Authorised
2011-02-25
PAGE 1 Placeholder for barcode Placeholder for barcode Placeholder for barcode Placeholder for barcode PACKAGE LEAFLET: INFORMATION FOR THE USER 5.83 MG/ML 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 symptoms 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 Saizen is and what it is used for 2. What you need to know before you use Saizen 3. How to use Saizen 4. Possible side effects 5. How to store Saizen 6. Contents of the pack and other information 1. WHAT SAIZEN IS AND WHAT IT IS USED FOR Saizen is a growth hormone. Saizen's main action is to increase growth in children and adolescents and to treat adults with growth hormone deficiency. The growth hormone (somatropin) contained in Saizen is almost the same as human’s natural growth hormone except that it is made outside the body by a process called “recombinant DNA technology” (genetic engineering). SAIZEN IS USED: In children and adolescents: • in the treatment of children with short stature who have failed to grow because their body produces no growth hormone or insufficient levels of growth hormone • in the treatment of girls who have failed to grow due to gonadal dysgenesis (also referred to as Turner Syndrome), confirmed by a test on the chromosomes • in the treatment of pre-pubertal children who have failed to grow due to chronic renal failure, a condition in which kidneys are damaged • in the treatment of growth problems in children who were born small and who have not reached normal height by the age of 4 years or later. In adults: • in th Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Saizen 8 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each cartridge contains 1.50 ml solution (12 mg somatroprin*) or 2.50 ml solution (20 mg somatropin*). * recombinant human growth hormone, produced by recombinant DNA technology in mammalian cells For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear to slightly opalescent solution with pH of 5.6-6.6 and osmolality 250-450 mOsm/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Saizen is indicated in the treatment of: Children and adolescents: Growth failure in children caused by decreased or absent secretion of endogenous growth hormone. Growth failure in girls with gonadal dysgenesis (Turner syndrome), confirmed by chromosomal analysis. Growth failure in prepubertal children due to chronic renal failure (CRF). Growth disturbance (current height 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 (HV SDS <0 during the last year) by 4 years of age or later. Adults: Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency. Patients must also fulfil the following criteria: Childhood onset: Patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with Saizen is started. Adult onset: Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Saizen 8 mg/ml is intended for multiple dose use in an individual patient. Posology It is recommended that Saizen Leia o documento completo