Sandostatin LAR 20mg powder and solvent for suspension for injection vials

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Octreotide acetate

Saatavilla:

Novartis Pharmaceuticals UK Ltd

ATC-koodi:

H01CB02

INN (Kansainvälinen yleisnimi):

Octreotide acetate

Annos:

20mg

Lääkemuoto:

Powder and solvent for suspension for injection

Antoreitti:

Intramuscular

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 08030403; GTIN: 5013054190424

Pakkausseloste

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);
Sandostatin

Valmisteyhteenveto

OBJECT 1
SANDOSTATIN LAR 10 MG POWDER AND SOLVENT FOR
SUSPENSION FOR INJECTION
Summary of Product Characteristics Updated 20-Mar-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Sandostatin
®
LAR
®
10 mg, 20mg or 30mg powder and solvent for suspension for injection
2. Qualitative and quantitative composition
One vial contains 10 mg, 20mg or 30mg 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