SANDOSTATIN LAR FOR INJECTION 30 mg

Страна: Сингапур

Язык: английский

Источник: HSA (Health Sciences Authority)

Активный ингредиент:

OCTREOTIDE ACETATE 33.6MG EQV OCTREOTIDE

Доступна с:

NOVARTIS (SINGAPORE) PTE LTD

код АТС:

H01CB02

дозировка:

30 mg/vial

Фармацевтическая форма:

INJECTION

состав:

OCTREOTIDE ACETATE 33.6MG EQV OCTREOTIDE 30 mg/vial

Администрация маршрут:

INTRAMUSCULAR

Тип рецепта:

Prescription Only

Производитель:

Novartis Pharmaceutical Manufacturing GmbH

Статус Авторизация:

ACTIVE

Дата Авторизация:

2001-08-20

тонкая брошюра

SANDOSTATIN

 LAR


Anti-growth hormone 
COMPOSITION AND PHARMACEUTICAL FORM 
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. 
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’. 
For a full list of excipients, see section EXCIPIENTS. 
Certain dosage strengths may not be available in all countries. 
INDICATIONS 
Treatment of patients with acromegaly: 


_who are adequately controlled_ on s.c. treatment with Sandostatin
®
, 


_in  whom_  surgery  or  radiotherapy  or  dopamine  agonist  treatment  is  inappropriate  or 
ineffective,  or  in  the  interim  period  until  radiotherapy  becomes  fully  effective  (see 
DOSAGE AND ADMINISTRATION). 
Treatment  of  patients  with  symptoms  associated  with  functional  gastro-entero-pancreatic 
endocrine  tumors  _in  whom  symptoms  are  adequately  controlled_  on  s.c.  treatment  with 
Sandostatin: 


Carcinoid tumors with features of the carcinoid syndrome. 


VIPomas. 


Glucagonomas. 


Gastrinomas/Zollinger-Ellison syndrome. 


Insulinomas, for pre-operative control of hypoglycemia and for
maintenance therapy. 


GRFomas. 
Treatment  of  patients  with  advanced  Neuroendocrine  Tumors  of  the�

Характеристики продукта

Sandostatin LAR Feb2023.SIN
Page 1 of 21
SANDOSTATIN
 LAR

Anti-growth hormone
DESCRIPTION AND COMPOSITION
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.
ACTIVE SUBSTANCE
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.
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
VIAL
Poly(DL-lactide-co-glycolide) 78.35% of nominal fill weight; sterile
mannitol 17.0% of
nominal fill weight.
One
PREFILLED
SYRINGE
(solvent
for
parenteral
use),
containing:
sodium
carboxymethylcellulose
(14
mg),
mannitol
(12
mg),
poloxamer
188
(4
mg);
water
for
injection qs ad 2 mL.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of patients with acromegaly:
•
_who are adequately controlled on s.c. treatment with Sandostatin_
®
Sandostatin LAR Feb2023.SIN
Page 2 of 21
•
_in whom_
surgery or radiotherapy or dopamine agonist treatment is inappropriate
or
ineffective, or in the interim period until radiotherapy becomes fully
effective (see
DOSAGE AND ADMINISTRATION).
Treatment of patients with symptoms associated with functional
gastro-entero-pancreatic
endocrine tumors
_in whom symptoms are adequately controlled_
on s.c. treatment with
Sandostatin:
•
Carcinoid tumors with features of the carcinoid syndrome.
•
VIPomas.
•
Glucagonomas.
•
Gastrinomas/Zollinger-Ellison syndrome.
•
Insulinomas, for pre-operative control of hypoglycemia and for
maintenance therapy.
•
GRFomas.
Treatment of patients with advanced Neuroendocrine Tumors of the
midgut or unknown
primary tumor location where non-midgut sites of origin have been
excluded.
D