SANDOSTATIN LAR octreotide (as acetate) 20 mg modified release injection vial plus diluent prefilled syringe composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

octreotide, Quantity: 20 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Octreotide

Pharmaceutical form:

Injection, modified release

Composition:

Excipient Ingredients: mannitol; polyglactin glucose

Administration route:

Intramuscular

Units in package:

One 6 mL vial of powder with one 3 mL prefilled syringe of diluent

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Acromegaly: For the 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, but who are adequately controlled on subcutaneous treatment with Sandostatin. Sandostatin LAR is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,Gastro-entero-pancreatic tumours: 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) in patients who are adequately controlled on subcutaneous treatment with Sandostatin. Sandostatin LAR is not curative in these patients.,Advanced neuroendocrine tumours of the midgut: Treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.

Product summary:

Visual Identification: White to white with yellowish tint powder in glass vial sealed with rubber stopper and aluminium fliptop seal.; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-03-03

Patient Information leaflet

SANDOSTATIN
® LAR
®
_Octreotide (as acetate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sandostatin LAR.
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 having Sandostatin
LAR against the benefits they expect
it will give you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SANDOSTATIN LAR
IS USED FOR
Sandostatin LAR is a long acting
form of Sandostatin injection. It is
injected into the buttocks once every
4 weeks, instead of having frequent
injections of the short-acting
Sandostatin under the skin.
•
Sandostatin LAR 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. Too much growth
hormone 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 LAR can relieve many of
these symptoms.
•
Sandostatin LAR is used to
relieve symptoms of certain types
of cancer such as carcinoid
tumour and VIPoma.
By blocking hormones that are over-
produced in these conditions,
Sandostatin LAR can relieve
symptoms such as flushing of the
skin and severe diarrhoea.
Sandosta

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – SANDOSTATIN
® LAR
®
(OCTREOTIDE) MODIFIED RELEASE INJECTION
1
NAME OF THE MEDICINE
Octreotide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SANDOSTATIN LAR octreotide (as acetate) 10 mg modified release
injection plus diluent
SANDOSTATIN LAR octreotide (as acetate) 20 mg modified release
injection plus diluent
SANDOSTATIN LAR octreotide (as acetate) 30 mg modified release
injection plus diluent
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Modified release, injection
Sandostatin LAR is a modified release injection of octreotide. The
octreotide is distributed within
polymer microspheres. The powder is a white to white with yellowish
tint.
Diluent
The vehicle is a clear, colourless to slightly yellow or brown
solution. The pH of the reconstituted
suspension is 5-8.
Single glass vials of 10, 20 or 30 mg octreotide modified release
injection to be suspended in 2 mL
diluent prior to injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Acromegaly
For the 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 but who are adequately controlled on s.c.
treatment with Sandostatin.
Sandostatin LAR is also indicated in acromegalic patients unfit or
unwilling to undergo surgery, or in
the interim period until radiotherapy becomes fully effective.
2
Gastro-entero-pancreatic tumours
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) in patients
who are adequately
controlled on subcutaneous treatment with Sandostatin
Sandostatin LAR is not curative in these patients.
Advanced Neuroendocrine Tumours of the Midgut
Treatment of patients with progression of well-differentiated,
advanced neuroend