מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
SOMATROPIN
FERRING PHARMACEUTICALS LTD
H01AC01
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
SOMATROPIN 10 MG
S.C
Required
FERRING GmbH ,GERMANY
SOMATROPIN
SOMATROPIN
Children :Short stature due to inadequate or failed secretion of pituitary growth hormone or Turner's syndrome. Short stature in children with renal insufficiency.
2015-08-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The dispensing of this medicine requires a doctor’s prescription ZOMACTON ® 10 MG Powder and solvent for reconstituting a solution for subcutaneous injection. COMPOSITION: Each vial of powder contains somatropin 10 mg. After adding the solvent, the vial contains a somatropin solution with a concentration of 10 mg/ml. INACTIVE INGREDIENTS: See section 6 ‘Additional Information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have further questions, refer to your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? CHILDREN: short stature due to non-secretion or inadequate secretion of pituitary growth hormone or Turner’s syndrome. short stature due to renal insufficiency. THERAPEUTIC GROUP: Somatropin is a recombinant growth hormone. 2. BEFORE USING THIS MEDICINE DO NOT USE THE MEDICINE: If you are sensitive )allergic( to the active ingredient or to any of the other ingredients that this medicine contains (see section 6). Do not use Zomacton 10 mg and tell your doctor if you have an active malignant tumor. Malignant tumors must be inactive before beginning treatment. You must complete anti-cancer treatment before beginning treatment with Zomacton 10 mg. In children where bone growth is completed (with closed epiphyses). If you have a severe illness following complications of an open heart or abdominal surgery, multiple injuries from an accident or respiratory failure. In children with chronic kidney disease at the time of kidney transplantation. SPECIAL WARNINGS ABOUT USING THIS MEDICINE: BEFORE TREATMENT WITH THE MEDICINE, CONSULT YOUR DOCTOR Treatment with Zomacton 10 mg must be conducted under supervision of a doctor who is specialized in treating patients wit קרא את המסמך השלם
1. NAME OF THE MEDICINAL PRODUCT ZOMACTON 10 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ZOMACTON 10 mg: Somatropin* …..……………………………………………………………..10 mg (10 mg/ml after reconstitution for one vial) * Produced in E _scherichia coli _ cells using recombinant DNA technology For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Zomacton is a white to off-white lyophilised powder. The solvent is clear and colourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Children: Short stature due to inadequate or failed secretion of pituitary growth hormone or Turner's syndrome. Short stature in children with renal insufficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zomacton therapy should be used only under the supervision of a qualified physician experienced in the management of patients with growth hormone deficiency. The dosage of administration of Zomacton should be individualised for each patient. The duration of treatment, usually a period of several years will depend on maximum achievable therapeutic benefit. The subcutaneous administration of growth hormone may lead to loss or increase of adipose tissue at the injection site. Therefore, injection sites should be alternated. _Growth Hormone Deficiency _ Generally a dose of 0.17 – 0.23 mg/kg bodyweight (approximating to 4.9 mg/m 2 – 6.9 mg/m 2 body surface area) per week divided into 6 - 7 S.C. injections is recommended (corresponding to a daily injection of 0.02 – 0.03 mg/kg bodyweight or 0.7 – 1.0 mg/m 2 body surface area). The total weekly dose of 0.27 mg/kg or 8 mg/m 2 body surface area should not be exceeded (corresponding to daily injections of up to about 0.04 mg/kg). _Turner’s Syndrome _ Generally a dose of 0.33 mg/kg/bodyweight (approximating to 9.86 mg/m 2 /body surface area) per week divided into 6 - 7 S.C.. injections are recommended (corresponding to daily injection of 0.05 mg/kg/bodyweight or 1.40-1.63 mg/m 2 /body surface a קרא את המסמך השלם