Страна: Израел
Език: английски
Източник: Ministry of Health
LANREOTIDE ACETATE
MEDISON PHARMA LTD
H01CB03
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
LANREOTIDE ACETATE 0.03 G/VIAL
I.M
Required
IPSEN PHARMA, FRANCE
LANREOTIDE
LANREOTIDE
Treatment of acromegaly (when the treatment of growth hormone is not normalized after surgery and/or radiotherapy). Treatment of the clinical symptoms of carcinoid tumors (after a test injection). Treatment of primary thyrotropic adenomas responsible for hypethyroidism as a preparation for / or as a complement to surgery and/or radiotherapy or where these therapies are unsuitable.
2015-02-28
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור ךיראת : 61 02. 62 0 22 תילגנאב רישכת םש םושירה רפסמו : 00 22911 3 9 17 1 OMATULINE PR 30 MG S םושירה לעב םש : מ"עב המראפ ןוסידמ ה טורפל דעוימ הז ספוט דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט סקט שדח ט 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ▪ Lanreotide may reduce gallbladder motility and lead to gallstone formation. Therefore patients may need to be monitored periodically. It is advised, during prolonged treatment, to perform before treatment and every 6 months, an echography of the gallbladder ▪ Pharmacological studies in animals and humans show that lanreotide, like somatostatin and other somatostatin analogues, inhibits secretion of insulin and glucagon. Hence, patients treated with lanreotide may experience hypoglycaemia or hyperglycaemia. Blood glucose levels should be monitored when lanreotide treatment is initiated, or when the dose is altered. Any antidiabetic treatment should be adjusted accordingly. In insulin-treated diabetic patients, the insulin doses will initially be reduced by 25%, then adapted to the blood glucose level, which must be carefully controlled in these patients as soon as treatment begins. ▪ Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients, though clinical hypothyroidism is rare. Thyroid function tests are recommended where clinically indicated. ▪ In acromegalic patients and patients presenting with primitive thyrotropic 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ▪ Lanreotide may reduce gallbladder motility and lead to gallstone formation. Therefore patients may need to be monitored periodically. It is advised, du Прочетете целия документ
PHYSICIAN'S PRESCRIBING INFORMATION 1 TRADE NAME OF THE MEDICINAL PRODUCT SOMATULINE P.R. 30 MG 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lanreotide acetate, expressed as lanreotide ....................................... 0.03000 g * For one vial * Taking into account the characteristics of the pharmaceutical form, each vial contains a quantity of lanreotide acetate corresponding to 0.04 g of lanreotide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for prolonged release suspension for injection (I. M.). The powder is made of lyophilised microspheres. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acromegaly (when the treatment of growth hormone is not normalized after surgery and/or radiotherapy). Treatment of clinical symptoms of carcinoid tumours (after a test injection). Treatment of primary thyrotropic adenomas responsible for hyperthyroidism as a preparation for /or as a complement to surgery and/or radiotherapy, or where these therapies are unsuitable. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should be adjusted to each patient in a specialised unit. POSOLOGY Taking into account the variability of the sensitivity of the tumours to somatostatin analogues, it is recommended to start treatment with a test injection, in order to assess the quality of the response (GH secretion, symptoms related to the carcinoid tumour, tumoral secretions...). If no response to the first test injection is seen, the treatment should be reviewed. In acromegaly The frequency of administration of the prolonged release form can initially be set to one intramuscular injection every 14 days. In case of an insufficient response, judged by the levels of growth hormone and IGF-1 (measured prior to the next injection), the frequency of injection may be increased to 1 every 10 days. In carcinoid tumours The frequency of administration of the prolonged release form can initially be set to one intramuscular injection every 14 days. In case of an insufficient respons Прочетете целия документ