Sandostatin

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Octreotide acetate 0.056 mg/mL equivalent to 0.05 mg/mL octreotide base

Boleh didapati daripada:

Novartis New Zealand Ltd

INN (Nama Antarabangsa):

Octreotide acetate 0.056 mg/mL (equivalent to 0.05 mg/mL octreotide base)

Dos:

0.05 mg/mL

Borang farmaseutikal:

Solution for injection

Komposisi:

Active: Octreotide acetate 0.056 mg/mL equivalent to 0.05 mg/mL octreotide base Excipient: Lactic acid Mannitol Sodium bicarbonate Water for injection

Unit dalam pakej:

Ampoule, glass, 5x1ml, 5 mL

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Novartis Ringaskiddy Ltd

Ringkasan produk:

Package - Contents - Shelf Life: Ampoule, glass, 5x1ml - 5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Tarikh kebenaran:

1987-12-17

Risalah maklumat

__________________________________________________________________________________________________
Sandostatin

1
SANDOSTATIN

_0.05, 0.1 and 0.5mg/ml injection _
_octreotide_
_____________________________________________________________________________________
CONSUMER MEDICINE INFORMATION
__________________
WHAT IS IN THIS LEAFLET
_________________________________
This leaflet answers some common
questions about Sandostatin.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
the medicine. You can also download
the most up to date leaflet from
www.medsafe.govt.nz.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
________________________
WHAT SANDOSTATIN IS
USED FOR
________________________
Sandostatin has 4 uses:
1.
Sandostatin is used to treat
acromegaly
In people with acromegaly the body
makes too much growth hormone,
which controls the growth of tissues,
organs and bones. This leads to
enlargement of the bones, especially
of the hands and feet. Other
symptoms include headaches,
increased sweating, tiredness,
numbness of the hands and feet, pain
and stiffness in the joints and loss of
sexual function. By blocking the
excess growth hormone, Sandostatin
can relieve many of these symptoms.
2.
Sandostatin is used to relieve
symptoms of certain types of
cancer such as carcinoid
syndrome, VIPomas,
glucagonomas, gastrinomas,
insulinomas and GRFomas

Ciri produk

NEW ZEALAND DATA SHEET
SANDOSTATIN
®
0.05 MG/1 ML, 0.1 MG/1 ML, 0.5 MG/1 ML
SOLUTION FOR INJECTION
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Solution for injection (s.c). The solution is clear and colourless.
ACTIVE SUBSTANCE
The active substance is octreotide acetate.
1 mL ampoules containing 0.05, 0.1 or 0.5 mg octreotide (as free
peptide).
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
tumours:

Carcinoid tumours 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 hypoglycaemia and for
maintenance therapy.

GRFomas.
Sandostatin is not an anti-tumour 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-
oesophageal varices in patients with cirrhosis. Sandostatin is to be
used in association with
specific treatment such as endoscopic sclerotherapy.
DOSAGE AND ADMINISTRATION
DOSAGE
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 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 Sandostatin,