Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Somatropin 8.8mg ((includes 0.8 mg overfill))
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Somatropin 8.8 mg ((includes 0.8 mg overfill))
8 mg
Injection with diluent
Active: Somatropin 8.8mg ((includes 0.8 mg overfill)) Excipient: Phosphoric acid Sodium hydroxide Sucrose Metacresol Water for injection
Cartridge, glass, solvent, 1.37mL, 1 dose unit
Prescription
Prescription
Merck SL
SAIZEN is indicated for: 1. Growth failure in children due to human growth hormone deficiency. 2. Growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis. 3.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. 4. Growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (CRI).
Package - Contents - Shelf Life: Cartridge, glass, solvent, 1.37mL - 1 dose units - - Combination pack, powder + solvent - 1 dose units - 3 years unopened stored at or below 25°C 28 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, powder + solvent - 5 dose units - 3 years unopened stored at or below 25°C 28 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, somatropin powder 8mg - 1 dose units - 3 years from date of manufacture stored at or below 25°C
2003-03-14
SAIZEN ® 1 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 co Đọc toàn bộ tài liệu
A008-0618 -1- Supersedes: A007-0218 NEW ZEALAND DATA SHEET 1. PRODUCT NAME SAIZEN ® solution for injection cartridge Somatropin (rmc*), recombinant human growth hormone 6 mg/1.03 mL (5.83 mg/mL) 12 mg/1.5 mL (8.00 mg/mL) 20 mg/2.5 mL (8.00 mg/mL) *recombinant mouse cell 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SAIZEN is a recombinant human growth hormone (somatropin), which is prepared from genetically engineered mammalian cells (recombinant mouse cells – C127) transformed with a bovine papilloma virus vector containing the human growth hormone coding sequence. According to the European Pharmacopoeia, somatropin (rmc) 3 IU equals 1 mg somatropin (rmc) by weight. The dose in mg, set out below, is based on this equivalence. Each cartridge contains 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). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM SAIZEN solution for injection is a clear solution, free from visible particles. The solution should not be administered if it contains particles or is not clear. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SAIZEN is indicated for: Children and adolescents (≤ 18 years old): 1. Growth failure in children due to human growth hormone deficiency. 2. Growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis. A008-0618 -2- Supersedes: A007-0218 3. Growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (CRI). Adults (> 18 years old): 4. SAIZEN is indicated for replacement therapy in adults (over 18 years old) 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 th Đọc toàn bộ tài liệu