OCTREOTIDE BENDALIS 0.5 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OCTREOTIDE AS ACETATE

Available from:

DAVID MARGALIT & CO.LTD

ATC code:

H01CB02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

OCTREOTIDE AS ACETATE 0.5 MG/ML

Administration route:

S.C, I.V

Prescription type:

Required

Manufactured by:

BENDALIS GMBH, GERMANY

Therapeutic area:

OCTREOTIDE

Therapeutic indications:

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.

Authorization date:

2020-03-31

Summary of Product characteristics

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