SANDOSTATIN AMPOULES 0.05 MG1 ML

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

OCTREOTIDE

제공처:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

OCTREOTIDE

패키지 단위:

5Units Units

Manufactured by:

DELPHARM DIJON

환자 정보 전단

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SANDOSTATIN
® SOLUTION FOR INJECTION/
INFUSION
Octreotide Acetate (0.05mg/1ml, 0.1 mg/1ml)
1
WHAT IS IN THIS LEAFLET
1.
What Sandostatin is used for
2.
How Sandostatin works
3.
Before you use Sandostatin
4.
How to use Sandostatin
5.
While you are using Sandostatin
6.
Side effects
7.
Storage and Disposal of
Sandostatin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT SANDOSTATIN IS USED FOR
Sandostatin is used
•
to treat acromegaly, a condition
where the body produces too
much growth hormone. Normally,
growth hormone controls growth
of tissues, organs, and bones. Too
much growth hormone leads to an
increase in the size of bones and
tissues, especially in the hands
and feet. By decreasing the
growth hormone levels,
Sandostatin markedly reduces the
symptoms of acromegaly, which
include headache, excessive
perspiration, numbness of the
hands and feet, tiredness, and joint
pain.
•
to relieve symptoms associated
with some tumours of the
gastrointestinal tract (e.g.
carcinoid tumors, VIPomas,
glucagonomas, gastrinomas,
insulinomas, GRFomas). In these
conditions, there is
overproduction of some specific
hormones and other related
substances by the stomach,
bowels, or pancreas. This
overproduction upsets the natural
hormonal balance of the body, and
results in a variety of symptoms,
such as flushing, diarrhoea, low
blood pressure, rash, and weight
loss. Treatment with
Sandostatin
helps to control these symptoms.
•
to prevent complications
following surgery of the pancreas
gland. Treatment with Sandostatin
helps to lower the chance of
complications (e.g. abscess in the
abdomen, inflammation of the
pancreas gland) after the surgery.
•
to stop bleeding and to protect
from re-bleeding from ruptured
gastro-oesophageal varices in
individual suffering from cirrhosis
(chronic liver disease). Treatment
with Sandostatin helps to control
bleeding and reduce transfusion
requirements.
HOW SANDOSTATIN WORKS
Sandostatin is a synth

제품 특성 요약

Novartis
Page 2
Malaysian Package Leaflet
14-Feb-2023
Sandostatin
SANDOSTATIN
®
Antigrowth hormone.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Solution for injection (s.c) or concentrate for solution for infusion
(i.v.infusion).
The solution is clear and colourless.
ACTIVE SUBSTANCE(S)
The active substance is octreotide acetate.
1 mL ampoules containing 0.05, 0.1 or 0.5 mg octreotide (as free
peptide).
Certain dosage strengths and dosage forms may not be available in all
countries.
EXCIPIENTS
Lactic acid, mannitol, sodium hydrogen carbonate, water for
injections.
INDICATIONS
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 H
2
-antagonist therapy.
•
Insulinomas, for pre-operative control of hypoglycemia and for
maintenance therapy.
•
GRFomas.
Sandostatin is not an anti-tumor therapy and is not curative in these
patients.
Prevention of complications following pancreatic surgery.
Emergency management to stop bleeding and to protect from re-bleeding
owing to gastro-
esophageal varices in patients with cirrhosis. Sandostatin is to be
used in association with
specific treatment such as endoscopic sclerotherapy.
Novartis
Page 3
Malaysian Package Leaflet
14-Feb-2023
Sandostatin
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
GENERAL TARGET POPULATION
ACROMEGALY
Initially 0.05 to 0.1 mg by 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 withi