Sandostatin 1mg/5ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Octreotide acetate

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

H01CB02

INN (International Name):

Octreotide acetate

Dosage:

200microgram/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: 5013054190349

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SANDOSTATIN
®
50 MICROGRAM/1 ML, SOLUTION FOR INJECTION/INFUSION
SANDOSTATIN
®
100 MICROGRAM/1 ML, SOLUTION FOR INJECTION/INFUSION
SANDOSTATIN
®
500 MICROGRAM/1 ML, SOLUTION FOR INJECTION/INFUSION
SANDOSTATIN
®
1000 MICROGRAM/5 ML, SOLUTION FOR INJECTION/INFUSION
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 Sandostatin is and what it is used for
2.
What you need to know before you use Sandostatin
3.
How to use Sandostatin
4.
Possible side effects
5.
How to store Sandostatin
6.
Contents of the pack and other information
1.
WHAT SANDOSTATIN IS AND WHAT IT IS USED FOR
Sandostatin 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
Sandostatin over somatostatin are that it is stronger and its effects
last longer.
SANDOSTATIN 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. Sandostatin 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, gastrinom

Summary of Product characteristics

OBJECT 1
SANDOSTATIN 50 MICROGRAM/1 ML, SOLUTION FOR
INJECTION/INFUSION
Summary of Product Characteristics Updated 20-Mar-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Sandostatin
®
50 microgram/1 ml, solution for injection/infusion
Sandostatin
®
100 microgram/1 ml, solution for injection/infusion
Sandostatin
®
500 microgram/1 ml, solution for injection/infusion
Octreotide
®
50 microgram /1 ml, solution for injection/infusion
Octreotide
®
100 microgram/1 ml, solution for injection/infusion
Octreotide
®
500 microgram/1 ml, solution for injection/ infusion
2. Qualitative and quantitative composition
Sandostatin
®
50 microgram/1 ml, solution for injection/infusion
One ampoule of 1 ml contains 50 microgram octreotide (as octreotide
acetate)
Sandostatin
®
100 microgram/1 ml, solution for injection/infusion
One ampoule of 1 ml contains100 microgram octreotide (as octreotide
acetate)
Sandostatin
®
500 microgram/1 ml, solution for injection/infusion
One ampoule of 1 ml contains 500 microgram octreotide (as octreotide
acetate)
Excipient(s) with known effect
Contains less than 1 mmol (23 mg) sodium per dose, i.e. is essentially
“sodium-free”.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Solution for injection/infusion.
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.
Sandostatin 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).
Sandostatin is not an anti-tumour therapy and is not curative in these
patients.
Prevention of complications following pancreatic surgery.
Emergency management to