Octreotide 200 micrograms/ml solution for injection

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

OCTREOTIDE ACETATE

Διαθέσιμο από:

Pfizer Healthcare Ireland

Φαρμακολογική κατηγορία (ATC):

H01CB; H01CB02

INN (Διεθνής Όνομα):

OCTREOTIDE ACETATE

Δοσολογία:

200 microgram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Somatostatin and analogues; octreotide

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2007-06-22

Φύλλο οδηγιών χρήσης

Page 1 of 8
_2022-0077527_
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OCTREOTIDE 50 MICROGRAMS/1 ML SOLUTION FOR INJECTION
OCTREOTIDE 100 MICROGRAMS/1 ML SOLUTION FOR INJECTION
OCTREOTIDE 200 MICROGRAMS/ML SOLUTION FOR INJECTION
OCTREOTIDE 500 MICROGRAMS/1 ML SOLUTION FOR INJECTION
Octreotide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Octreotide is and what it is used for
2.
What you need to know before you use Octreotide
3.
How to use Octreotide
4.
Possible side effects
5.
How to store Octreotide
6.
Contents of the pack and other information
1. WHAT OCTREOTIDE IS AND WHAT IT IS USED FOR
Octreotide is a synthetic compound derived from somatostatin, a
substance normally found in
the human body which inhibits the effects of certain hormones such as
growth hormone. The
advantages of Octreotide over somatostatin are that it is stronger and
its effects last longer.
OCTREOTIDE IS USED
•
in
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. Octreotide 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 tumours, VIPomas, glucagonomas, gastrinomas, insulinomas).
In these
conditions, t

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
27 March 2023
CRN00CZ7Q
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Octreotide 200 micrograms/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is octreotide acetate.
Each 1 ml of Octreotide solution for injection contains 200 micrograms
of Octreotide as octreotide acetate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC 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. Octreotide 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, e.g. carcinoid tumours with
features of the carcinoid syndrome (see section 5.1).
Octreotide 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. Octreotide is to be used in association with specific
treatment such as endoscopic sclerotherapy.
Treatment of TSH-secreting pituitary adenomas:
• When secretion has not normalised after surgery and/or
radiotherapy;
• In patients in whom surgery is inappropriate;
• In irradiated patients, until radiotherapy is effective.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Acromegaly_
Initially 0.05 to 0.1 mg by subcutaneous (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