SANDOSTATIN LAR 20 Milligram Pdr+Solv for Susp for Inj

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

OCTREOTIDE ACETATE

Fáanlegur frá:

Novartis Pharmaceuticals UK Ltd

ATC númer:

H01CB02

INN (Alþjóðlegt nafn):

OCTREOTIDE ACETATE

Skammtar:

20 Milligram

Lyfjaform:

Pdr+Solv for Susp for Inj

Gerð lyfseðils:

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

Lækningarsvæði:

Somatostatin and analogues

Leyfisstaða:

Authorised

Leyfisdagur:

1998-07-13

Upplýsingar fylgiseðill

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

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sandostatin LAR 20 mg Powder and Solvent for Suspension for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 20 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: 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 concentrations still above 2.