Octreotide 50micrograms/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Octreotide acetate

Available from:

Sun Pharma UK Ltd

ATC code:

H01CB02

INN (International Name):

Octreotide acetate

Dosage:

50microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030403; GTIN: 5060176820012

Patient Information leaflet

Page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTREOTIDE 50 MICROGRAMS/ML SOLUTION FOR INJECTION
OCTREOTIDE 100 MICROGRAMS/ML SOLUTION FOR INJECTION
OCTREOTIDE 500 MICROGRAMS/ML SOLUTION FOR INJECTION
OCTREOTIDE 200 MICROGRAMS/ML SOLUTION FOR INJECTION
OCTREOTIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist.
-
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 or pharmacist. 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 take 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 overproduction of some specific hor

Summary of Product characteristics

OBJECT 1
OCTREOTIDE 50MICROGRAMS / ML SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 05-Apr-2018 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Octreotide 50 micrograms/ml solution for injection
2. Qualitative and quantitative composition
One ampoule of 1 ml solution for injection contains octreotide acetate
equivalent to 0.05 milligrams of
octreotide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
A clear colourless solution.
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 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 Thyroid Stimulating Hormones (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 - 0.1 mg 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
<2.5ng/ml, IGF-1 within normal range)
and clinical symptoms, and on tolerability. In most patients t