Octreotide 500micrograms/1ml solution for injection vials

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Octreotide acetate

Commercializzato da:

Pfizer Ltd

Codice ATC:

H01CB02

INN (Nome Internazionale):

Octreotide acetate

Dosaggio:

500microgram/1ml

Forma farmaceutica:

Solution for injection

Via di somministrazione:

Subcutaneous; Intravenous

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 08030403; GTIN: 5015997600350

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OCTREOTIDE 50 MICROGRAMS/1ML SOLUTION FOR INJECTION OCTREOTIDE 100 MICROGRAMS/1ML 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, there is over-production of som

Scheda tecnica

OBJECT 1
OCTREOTIDE 500 MICROGRAMS/1 ML SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 29-Sep-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Octreotide 500 micrograms/1 ml Solution for Injection
2. Qualitative and quantitative composition
The active substance is octreotide acetate.
Each 1 ml of Octreotide solution for injection contains 500 micrograms
of Octreotide as octreotide
acetate.
Octreotide solutions for injection contain less than 1 mmol (23 mg) of
sodium per 1 ml of solution (i.e.
essentially "sodium-free").
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. Octerotide 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 leve