Sandostatin LAR

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

octreotide 10 mg

Verfügbar ab:

Novartis Pharmaceuticals UK Limited

ATC-Code:

H01CB02

INN (Internationale Bezeichnung):

octreotide

Darreichungsform:

powder and solvent for suspension for injection

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2005-10-27

Gebrauchsinformation

SANDOSTATIN
®
  LAR
®
  10,  20  AND  30MG  POWDER  AND  SOLVENT  FOR  SUSPENSION  FOR 
INJECTION (OCTREOTIDE) 
Note:  Doctors  and  other  health  professionals  involved  in  the  administration  of  Sandostatin 
LAR please consult the  Summary of Product Characteristics (SmPC) and the administration 
instructions following Section 6 of this leaflet. 

PATIENT INFORMATION LEAFLET 

This product will be referred to as Sandostatin LAR in this leaflet. 

WHAT YOU NEED TO KNOW ABOUT SANDOSTATIN LAR 

Your doctor has decided that you need this medicine to help treat your condition.  
Please read this leaflet carefully before you start to have your medicine.  It contains important 
information.  Keep the leaflet in a safe place because you may want to read it again. 
If you have any other questions, or if there is something you don’t understand, please ask your 
doctor or pharmacist.  
This medicine has been prescribed for you. Never give it to someone else. It may not be the 
right medicine for them even if their symptoms seem to be the same as yours.   
If any of the side effects gets serious, or if you notice any effects not listed in this leaflet, 
please tell your doctor or nurse. 
IN THIS LEAFLET 
1 
What Sandostatin
®
 LAR
® 
is and what it is used for 
2 
Things to consider before you start to take Sandostatin LAR 
3 
Taking Sandostatin LAR 
4 
Possible side effects 
5 
How to store Sandostatin LAR 
6 
Further information 
1. SANDOSTATIN LAR

AND WHAT IT’S USED FOR 
Sandostatin
®
  LAR
® 
is  a  long-acting  injection,  often  called  a  ‘depot’  injection  because  the 
active ingredient is released into the body slowly.  This means that  you don’t have to have an 
in

Fachinformation

1. 
NAME OF THE MEDICINAL PRODUCT 

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. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

The active substance is octreotide free peptide, 10 mg, 20 mg or 30
mg nominally 4.15% of fill weight 
equivalent to 4.65% of octreotide acetate. 

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 powder  
Solvent for suspension for injection: clear, colorless
to slightly yellow or brown solution. 

Sandostatin
®
 LAR
®
 is a long-acting depot injection form of octreotide. Powder
(microspheres for 
suspension for injection) to be suspended in
a vehicle immediately prior to i.m. injection. 

Sandostatin LAR suspension contains less than 1 mmol (23 mg) of
sodium per dose, i.e. essentially 
‘sodium-free’. 

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 ADMIN