SANDOSTATIN LAR 30 Milligram Pdr+Solv for Susp for Inj

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OCTREOTIDE ACETATE

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

H01CB02

INN (International Name):

OCTREOTIDE ACETATE

Dosage:

30 Milligram

Pharmaceutical form:

Pdr+Solv for Susp for Inj

Prescription type:

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

Therapeutic area:

Somatostatin and analogues

Authorization status:

Authorised

Authorization date:

1998-07-13

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SANDOSTATIN LAR 10 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
SANDOSTATIN LAR 20 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
SANDOSTATIN LAR 30 MG POWDER AND SOLVENT FOR SUSPENSION 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 Sandostatin LAR is and what it is used for
2.
What you need to know before you use Sandostatin LAR
3.
How to use Sandostatin LAR
4.
Possible side effects
5.
How to store Sandostatin LAR
6.
Contents of the pack and other information
1.
WHAT SANDOSTATIN LAR IS AND WHAT IT IS USED FOR
Sandostatin LAR is a synthetic compound derived from somatostatin.
Somatostatin is normally found in
the human body, where it inhibits the release of certain hormones such
as growth hormone. The
advantages of Sandostatin LAR over somatostatin are that it is
stronger and its effects last longer.
SANDOSTATIN LAR IS USED

to treat acromegaly,
Acromegaly is 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 LAR markedly reduces the
symptoms of acromegaly, which include headache, excessive
perspiration, numbness of the hands and
feet, tiredness, and joint pain. In most cases, the overproduction of
growth hormone is caused by an
enlargement in the pituitary gland (a pituitary adenoma); Sandostat

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sandostatin LAR 30 mg Powder and Solvent for Suspension for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 30 mg octreotide (as octreotide acetate).
Excipients 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
Powder and solvent for suspension for injection.
Powder: White to white with yellowish tint.
Solvent for suspension for injection: clear, colourless to slightly
yellow or brown solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of patients with acromegaly in whom surgery is inappropriate
or ineffective, or in the interim period until radiotherapy
becomes fully effective (see section 4.2).
Treatment of patients with symptoms associated with functional gastro
-
entero
-
pancreatic endocrine tumours e.g. carcinoid
tumours with features of the carcinoid syndrome (see section 5.1).
Treatment of patients with advanced neuroendocrine tumours of the
midgut or of unknown primary origin where non-
midgut sites of origin have been excluded.
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_
It is recommended to start treatment with the administration of 20 mg
Sandostatin LAR at 4-week intervals for
3 months. Patients on treatment with s.c. Sandostatin can start
treatment with Sandostatin LAR the day after the last
dose of s.c. Sandostatin. Subsequent dosage adjustment should be based
on serum growth hormone (GH) and insulin-
like growth factor 1/somatomedin C (IGF
-
1) concentrations and clinical symptoms.
For patients in whom, within this 3-month period, clinical symptoms
and biochemical parameters (GH; IGF
-
1) are not
fully controlled (GH c