البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
Somatropin, Quantity: 8 mg/mL
Merck Healthcare Pty Ltd
Somatropin
Injection, solution
Excipient Ingredients: sucrose; poloxamer; sodium hydroxide; water for injections; citric acid; phenol
Subcutaneous
5 cartridges, 1 cartridge
(S4) Prescription Only Medicine
SAIZEN is indicated for:,1. Treatment of growth failure in children due to human growth hormone deficiency.,2. Treatment of growth failure in girls with gonadal dysgenesis (Turner syndrome), confirmed by chromosomal analysis.,3. Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak GH concentrations of less than 2.5 nanogram/ml. Adults must also fulfill 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. Treatment of growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (CRI).
Visual Identification: practically free from visible particles; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2011-08-22
SAIZEN ® _Somatropin (rmc), recombinant human growth hormone_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SAIZEN. It does not contain all of the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of using SAIZEN against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS INFORMATION WITH THE MEDICINE. You may need to read it again later. WHAT SAIZEN IS USED FOR SAIZEN is used to treat: • Growth failure in children who have a deficiency of natural human growth hormone. • Growth failure in girls who have a genetic condition called gonadal dysgenesis, often referred to as Turner Syndrome, which may cause short stature. • Growth hormone deficiency in adults. • Growth disturbance (growth retardation) in pre-pubertal children with chronic renal insufficiency (CRI). SAIZEN contains somatropin, which is the same as natural human growth hormone, but is made in a laboratory. IF YOU ARE UNSURE AS TO WHY YOU HAVE BEEN PRESCRIBED SAIZEN, ASK YOUR DOCTOR. Your doctor may have prescribed it for another reason. SAIZEN is available only on a doctor's prescription. BEFORE YOU USE SAIZEN _WHEN YOU MUST NOT USE IT_ DO NOT USE SAIZEN IF YOU HAVE AN ALLERGY TO: • somatropin • any of the other ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT USE SAIZEN IF: • You currently have any type of active cancer. All cancer treatments must be finished before starting treatment with SAIZEN. • You have an active brain lesion, e.g. brain injury, abscess or tumour. • You have diabetic retinopathy, an eye disease caused by complications of اقرأ الوثيقة كاملة
Version: A013-1019 Page 1 of 18 Supersedes: A012-0818 AUSTRALIAN PRODUCT INFORMATION SAIZEN (SOMATROPIN) 1. NAME OF THE MEDICINE Somatropin (rmc), recombinant human growth hormone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SAIZEN SOLUTION FOR INJECTION Somatropin (rmc) 6 mg/1.03 mL (5.83 mg/mL), 12 mg/1.5 mL (8.00 mg/mL) or 20 mg/2.5 mL (8.00 mg/mL). SAIZEN solution for injection also contains sucrose, poloxamer, phenol and Water for Injection. Sodium hydroxide and citric acid are used for pH adjustment. 3. PHARMACEUTICAL FORM SAIZEN SOLUTION FOR INJECTION SAIZEN solution for injection is presented as a sterile liquid (opalescent white to off-white solution, practically free from visible particles) in glass cartridges for multidose use. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS I. Growth failure in children due to human growth hormone deficiency II. Growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis III. Growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (CRI) IV. SAIZEN is indicated for replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defined by peak GH concentrations of less than 2.5 nanogram/mL. Adults 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. Version: A013-1019 Page 2 of 18 Supersedes: A012-0818 4.2. DOSE AND METHOD OF ADMINISTRATION DOSAGE Treatment should be discontinued when a satisfactory adult height has been reac اقرأ الوثيقة كاملة