Country: Israel
Language: English
Source: Ministry of Health
OCTREOTIDE AS ACETATE
DAVID MARGALIT & CO.LTD
H01CB02
SOLUTION FOR INJECTION
OCTREOTIDE AS ACETATE 0.2 MG/ML
S.C, I.V
Required
BENDALIS GMBH, GERMANY
OCTREOTIDE
Prevention of complications following pancreatic surgery. Symptomatic control and reduction of GH and IGF-1plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy.Octreotide Bendalis treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery or in the interim period until radiotherapy becomes fully effective. Relief of symptoms associated with functional gastroenteropancreatic endocrine tumours: - Carcinoid tumours with features of the carcinoid syndrome. - VIPomas . - Glucagonomas . - Gastrinomas / zollinger-Ellison syndrome usually in conjunction with proton pump inhibitors or H2- antagonist therapy . - Insulinomas for pre-operative control of hypoglycaemia and for maintenance therapy . - GRFomas. - Octreotide Bendalis is not an antitumour therapy and is not curative in these patients.Emergency management of bleeding gastro-oesophageal varices secondary to cirrhosis in combination with specific therapy such as endoscopic sclerotherapy.
2020-03-31
SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE MEDICINAL PRODUCT Octreotide Bendalis 0.05 mg/ml Octreotide Bendalis 0.1 mg/ml Octreotide Bendalis 0.5 mg/ml Octreotide Bendalis 0.2 mg/ml Solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION O c t r e o t i d e B e n d a l i s _0 . 0 5 _ _m g / m l_ : 1 a m p o u l e w i t h 1 m l c o n t a i n s 5 0 µ g O c t r e o t i d e ( a s O c t r e o t i d e acetate). O c t r e o t i d e B e n d a l i s _0 . 1 _ _m g / m l_ : 1 a m p o u l e w i t h 1 m l c o n t a i n s 1 0 0 µ g O c t r e o t i d e ( a s O c t r e o t i d e acetate). O c t r e o t i d e B e n d a l i s 0_ . 5 _ _m g / m l_ : 1 a m p o u l e w i t h 1 m l c o n t a i n s 5 0 0 µ g O c t r e o t i d e ( a s O c t r e o t i d e acetate). O c t r e o t i d e B e n d a l i s _0 . 2 _ _m g / m l_ : 1 v i a l w i t h 5 m l c o n t a i n s 1 0 0 0 µ g O c t r e o t i d e ( 2 0 0 µ g / m l ) ( a s O c t r e o t i d e acetate). F o r t h e f u l l l i s t o f e x c i p i e n t s , s e e s e c t i o n 6 . 1 . 3. PHARMACEUTICAL FORM Solution for injection/infusion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly inadequately controlled by surgery or radiotherapy. Octreotide Bendalis is also indicated for acromegalic patients unable or unwilling to undergo surgery, or in the initial stage until radiotherapy becomes fully effective. Treatment of symptoms associated with functional gastro- enteropancreatic (GEP) endocrine tumours, e.g. carcinoid tumours with features of a carcinoid syndrome (see section 5.1). Octreotide Bendalis is not an anti-tumour therapy and is not curative in such patients. Prevention of complications following pancreatic surgery. Emergency management to stop bleeding and to prevent re-bleeding from gastro-oesophageal varices in patients with cirrhosis. In such cases, Octreotide Bendalis is to be used in conjunction with specific treatment such as end Read the complete document