SANDOSTATIN 500 microgram/1mL injection ampoule

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

octreotide, Quantity: 500 microgram/mL

Tilgjengelig fra:

Novartis Pharmaceuticals Australia Pty Ltd

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: lactic acid; mannitol; sodium bicarbonate; water for injections

Administreringsrute:

Subcutaneous

Enheter i pakken:

5 x 1mL ampoules

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

For symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy or dopamine agonist treatment. Sandostatin treatment is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. For the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: carcinoid tumours with features of the carcinoid syndrome; vasoactive intestinal peptide secreting tumours (VIPomas). Sandostatin is not curative in these patients. For reduction of the incidence of complications following pancreatic surgery.

Produkt oppsummering:

Visual Identification: Clear, colourless solution.; Container Type: Ampoule; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Autorisasjon status:

Registered

Autorisasjon dato:

1993-01-05

Informasjon til brukeren

SANDOSTATIN
®
_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.NOVARTIS.COM.AU.
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 using Sandostatin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING 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 three 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 and VIPoma.
By blocking hormones that are over-
produced in these conditions,
Sandostatin can relieve symptoms
such as flushing of the skin and
severe diarrhoea.
3.
Sandostatin is used for people
who are having surgery on the
pancreas. This medicine helps to
lower the chance of
complications after the surgery.
Sandostatin contains octreotide, a
man-made medicine derived from
somatostatin,

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION – SANDOSTATIN (OCTREOTIDE
AS ACETATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Octreotide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL ampoule contains 0.05 mg, 0.1 mg or 0.5 mg octreotide
(present as acetate).
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection. The solution for injection is clear and
colourless.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
For symptomatic control and reduction of growth hormone and IGF-1
plasma levels in
patients with acromegaly, including those who are inadequately
controlled by surgery,
radiotherapy, or dopamine agonist treatment. Sandostatin treatment is
also indicated in
acromegalic patients unfit or unwilling to undergo surgery, or in the
interim period until
radiotherapy becomes fully effective.
•
For the relief of symptoms associated with the following functional
tumours of the gastro-
entero-pancreatic endocrine system:
-
Carcinoid tumours with features of the carcinoid syndrome.
-
Vasoactive intestinal peptide secreting tumours (VIPomas).
Sandostatin is not curative in these patients.
•
For reduction of the incidence of complications following pancreatic
surgery.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ACROMEGALY
Initially 0.05-0.1 mg by subcutaneous 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 on clinical symptoms, and on tolerability. In most patients
the optimal daily dose will be
0.2 to 0.3 mg. A maximum dose of 1.5 mg per day should not be
exceeded. For patients on a stable
dose of Sandostatin, assessment of biochemical markers should be made
periodically.
If no relevant reduction of GH levels and no improvement of clinical
symptoms have been achieved
within three months of starting treatment with Sandostatin, therapy
should be discontinued.
2
GASTRO-ENTERO-PANCREATIC ENDOCRINE TUMOURS
Initially 0.05 mg once or twice daily