SANDOSTATIN 0.2 MGML

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

OCTREOTIDE

Fáanlegur frá:

NOVARTIS ISRAEL LTD

ATC númer:

H01CB02

Lyfjaform:

SOLUTION FOR INJECTION / INFUSION

Samsetning:

OCTREOTIDE 0.2 MG/ML

Stjórnsýsluleið:

S.C, I.V

Gerð lyfseðils:

Required

Framleitt af:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Meðferðarhópur:

OCTREOTIDE

Lækningarsvæði:

OCTREOTIDE

Ábendingar:

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. Sandostatin 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. Sandostatin 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 sclerothera

Leyfisdagur:

2010-03-31

Upplýsingar fylgiseðill

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה
ןכדועמ(
05.2013
) :ךיראת
6.11.2014
.
:םושירה רפסמו תילגנאב רישכת םש
SANDOSTATIN 0.05 MG 047-03-25697-00
SANDOSTAIN 0.1MG 047-01-25698-00
SANDOSTAIN 0.2MG 047-02-25699-00
SANDOSTATIN 0.5MG 107-13-27200-00 :םושירה לעב םש
NOVARTIS PHARMA SERVICES AG
.
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
תושקובמה תורמחהה
6
Warnings and
precautions
…
CARDIOVASCULAR RELATED EVENTS
Uncommon cases of bradycardia have
been reported.
…
…
CARDIOVASCULAR RELATED EVENTS
Uncommon cCases of bradycardia have
been reported (frequency: common).
…
6
Warnings and
precautions
…
GLUCOSE METABOLISM
…
…
GLUCOSE METABOLISM
… Hypoglycemia has also been reported.
7
Adverse
drug
reactions
…
TABLE 1 ADVERSE DRUG REACTIONS REPORTED
IN CLINICAL STUDIES
….
GENERAL DISORDERS AND ADMINISTRATION
SITE DISORDERS:
Very common:
Injection site
localized pain
….
…
TABLE 7.1 ADVERSE DRUG REACTIONS
REPORTED IN CLINICAL STUDIES
…
GENERAL DISORDERS AND ADMINISTRATION
SITE CONDITIONS
Very common:
Injection
site
localized
pain
reaction.
Common:
Asthenia
…
8 Interactions
…
…
Dose adjustment of medicinal products
such as beta blockers, calcium channel
blockers, or agents to control fluid and
electrolyte balance may be necessary
when Sandostatin LAR is administered
concomitantly (see section 6 Warnings
and precautions).
Dose
adjustments
of
insulin
and
antidiabetic medicinal products may be
required
when
Sandostatin
LAR
is
administered concomitantly (see section
6 Warnings and precautions).
…
צמ
"
ןולעה ב ,
תונמוסמ ובש תושקובמה תורמחהה
בוהצ עקר לע
.
ונמוס תורמחה רדגב םניאש םייוניש
)ןולעב(
םייוניש אלו יתוהמ ןכות קר ןמסל שי .הנוש
עבצב
.טסקטה םוקימב ךיראתב ינורטקלא ראוד�

Vara einkenni

SAS API DEC21 V4
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sandostatin

0.05mg/ml
Sandostatin

0.1 mg/ ml
Sandostatin

0.5 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 1 ml contains 0.05, 0.1 or 0.5 mg octreotide (as
octreotide acetate)
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection /infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic Indications
Prevention of complications following pancreatic surgery.
Symptomatic control and reduction of growth hormone (GH) and IGF-1
plasma levels in patients with
acromegaly who are inadequately controlled by surgery or radiotherapy.
Sandostatin 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 gastro-entero-pancreatic
(GEP) endocrine tumors:
•
Carcinoid tumors 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 hypoglycemia and for
maintenance therapy.
•
GRFomas.
Sandostatin is not an anti-tumors therapy and is not curative in these
patients.
Emergency management of bleeding gastro-esophageal varices secondary
to cirrhosis in combination
with specific therapy such as endoscopic sclerotherapy.
4.2.
Posology and method of administration
SAS API DEC21 V4
2
_ _
Posology
General target population
_Acromegaly _
Initially 0.05 to 0.1 mg by subcutaneous (s.c.) injection every 8 or
12 hours. Dosage
adjustment should be based on monthly assessment of GH and IGF-1
levels (target: GH
<2.5 ng/mL; IGF-1 within normal range) and clinical symptoms, and on
tolerability. In most
patients, the optimal daily dose will be 0.3 mg. A maximum dose of 1.5
mg per day should
not be exceeded. For patients on a stable dose of Sandost