Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Lanreotide acetate 149.4mg equivalent to lanreotide 120 mg
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Lanreotide acetate 149.4 mg (equivalent to lanreotide 120 mg)
120 mg
Solution for injection
Active: Lanreotide acetate 149.4mg equivalent to lanreotide 120 mg Excipient: Glacial acetic acid Water for injection
Prescription
Ipsen Manufacturing Ireland Limited
Treatment of acromegaly when circulating levels of GH and IGF-1 remain abnormal after surgery and/or radiotherapy, or in patients who are dopamine agonist treatment refractory. Treatment of symptoms of carcinoid syndrome associated with carcinoid tumours. The treatment of well or moderately differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease.
Package - Contents - Shelf Life: Syringe, plastic, pre-filled, PP stopper - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. short term excursions up to 40C allowed (no more than three, and no more than 72 h cumulatively).
2016-08-04
SOMATULINE ® AUTOGEL ® 1 SOMATULINE ® AUTOGEL ® 60, 90 AND 120 MG _Lanreotide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully. It provides some information about your medicine. If you have any questions or are not sure about anything after you have read this leaflet, please ask your doctor or pharmacist. The name of your medicine is Somatuline ® Autogel ® . Somatuline Autogel is a solution for injection in a pre-filled syringe, ready to use and fitted with an automatic safety system. It is a white to pale yellow semi-solid formulation. The active substance is lanreotide. The dose of lanreotide you will receive is 60, 90 or 120 mg. There is an extra amount filled into the syringe to ensure that the correct dose can be injected. The other ingredients are sterile water and acetic acid. The product is for single use only. WHAT IS SOMATULINE AUTOGEL? Somatuline Autogel is a prolonged release formulation of lanreotide. Lanreotide is an octapeptide, an analogue of a naturally occurring hormone, somatostatin. Lanreotide lowers the levels of hormones in the body such as GH (growth hormone) and IGF-1 (insulin-like growth factor-1). WHAT IS SOMATULINE AUTOGEL USED FOR? Somatuline Autogel is used for the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy, or in patients who do not respond to therapy with drugs called dopamine agonists. Somatuline Autogel is used for the treatment of symptoms associated with carcinoid syndrome, such as flushing and diarrhoea. Somatuline Autogel is used for the treatment and control of the growth of some advanced tumours of the intestine and pancreas that cannot be removed by surgery (called gastroenteropancreatic neuroendocrine tumours or GEP- NETs). BEFORE YOU ARE GIVEN SOMATULINE AUTOGEL _WHEN YOU MUST NOT BE GIVEN _ _IT _ Do not be given Somatuline Autogel if: • you are breastfeeding • you have a tumour blocking your intestines • you are allergic to lanreot Διαβάστε το πλήρες έγγραφο
Somatuline Autogel Data Sheet v8 Page 1 NEW ZEALAND DATASHEET 1. PRODUCT NAME SOMATULINE AUTOGEL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lanreotide acetate 60, 90 and 120 mg solution for Injection in a pre-filled syringe. 3. PHARMACEUTICAL FORM Lanreotide (presented as lanreotide acetate 60 mg, 90 mg, 120 mg) solution for injection in a pre-filled syringe. White to pale-yellow semi-solid formulation. Somatuline Autogel is formulated as a prolonged-release solution of lanreotide acetate for deep subcutaneous injection. Prolonged release of the peptide is achieved by the physical nature of the supersaturated solution. Each pre-filled syringe contains a supersaturated solution of lanreotide acetate corresponding to 24.6 mg of lanreotide base per 100 mg of solution, which ensures an actual injection dose of 60 mg, 90 mg and 120 mg of lanreotide, respectively. The formulation contains water for injections and glacial acetic acid (for pH adjustment) as excipients. The pH of Somatuline Autogel solution is around 6.1. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Somatuline Autogel is indicated for: • the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory • the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours • the treatment of well or moderately differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease. 4.2 DOSAGE AND METHOD OF ADMINISTRATION POSOLOGY: _ACROMEGALY: _ In patients receiving a somatostatin analogue for the first time, the recommended starting dose is 60 mg of Somatuline Autogel administered every 28 days. Thereafter, in all patients, the dosage strength (60 mg, 90 mg and 120 mg) should be individualised according to the response to treatment (as judged by a reduction in GH and/or IGF-1 levels). If the desired response is not obtained, th Διαβάστε το πλήρες έγγραφο