OCTREOTIDE GH octreotide as acetate 50 micrograms/1 mL injection ampoule

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

octreotide, Quantity: 50 microgram

Sẵn có từ:

Generic Health Pty Ltd

INN (Tên quốc tế):

Octreotide

Dạng dược phẩm:

Injection, solution

Thành phần:

Excipient Ingredients: mannitol; glycine; water for injections; dilute hydrochloric acid

Tuyến hành chính:

Subcutaneous

Các đơn vị trong gói:

5 ampoules

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

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. Octreotide 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). Octreotide is not an antitumour therapy and is not curative in these patients. For reduction of the incidence of complications following pancreatic surgery.

Tóm tắt sản phẩm:

Visual Identification: Clear, colourless solution, free from visible particulates; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2009-10-28

Tờ rơi thông tin

Octreotide GH v3.0
Page 1 of 4
(octreotide acetate) solution for injection
CONSUMER MEDICINE INFORMATION
OCTREOTIDE GH
(OCTREOTIDE ACETATE) SOLUTION FOR INJECTION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Octreotide GH.
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
Octreotide GH 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 OCTREOTIDE GH IS
USED FOR
Octreotide GH has three uses:
1. OCTREOTIDE GH 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,
Octreotide GH can relieve
many of these symptoms.
2. OCTREOTIDE GH 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, Octreotide GH
can relieve symptoms such
as flushing of the skin and
severe diarrhoea.
3. OCTREOTIDE GH IS USED FOR
PEOPLE WHO ARE HAVING
SURGERY ON THE PANCREAS.
THIS MEDICINE HELPS TO
LOWER THE CHANCE OF
COMPLICATIONS AFTER THE
SURGERY.
Octreotide GH contains
octreotide, a man-made
medicine derived from
somatostatin, a substance found
in the human body. Octreotide is
used instead of somatostatin
because its effects are stronger
and last longer so that it needs
to be given only 2 or 3 times a
day.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
OCTREOTIDE GH HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed this medicine f

Đặc tính sản phẩm

Octreotide GH v5.0
Page 1 of 14
(octreotide as acetate) solution for injection
AUSTRALIAN PRODUCT INFORMATION – OCTREOTIDE GH
(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
The solution is clear and colourless.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC 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. Octreotide 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).
Octreotide is not curative in these patients.
•
For reduction of the incidence of complications following pancreatic
surgery.
4.2 DOSE 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 octreotide,
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 octreotide, therapy
should be discontinued.
Octreotide GH v5.0
Page 2 of 14
(octreotide as