Somatuline Autogel 120mg prolonged-release solution for injection in a pre-filled syringe

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

LANREOTIDE ACETATE; LANREOTIDE ACETATE

Disponibil de la:

ZUELLIG PHARMA SDN BHD

INN (nume internaţional):

LANREOTIDE ACETATE; LANREOTIDE ACETATE

Unități în pachet:

1 Units

Produs de:

IPSEN PHARMA BIOTECH

Caracteristicilor produsului

SOMATULINE® AUTOGEL®
60 MG, 90 MG, 120 MG
Lanreotide
Prolonged-release solution for injection in a pre-filled syringe
Somatuline® Autogel® 60 mg, 90 mg and 120 mg is a prolonged-release
solution for injection in a pre-
filled syringe containing 60 mg, 90 mg and 120 mg of lanreotide
acetate respectively.
SOMATULINE® AUTOGEL® 60 MG
Each pre-filled syringe contains a supersaturated solution of
lanreotide acetate corresponding to 0.246
mg of lanreotide base/mg of solution, which ensures an actual
injection dose of 60 mg.
For full list of excipients, see List of excipients.
SOMATULINE® AUTOGEL® 90 MG
Each pre-filled syringe contains a supersaturated solution of
lanreotide acetate corresponding to 0.246
mg of lanreotide base/mg of solution, which ensures an actual
injection dose of 90 mg.
For full list of excipients, see List of excipients.
SOMATULINE® AUTOGEL® 120 MG
Each pre-filled syringe contains a supersaturated solution of
lanreotide acetate corresponding to 0.246
mg of lanreotide base/mg of solution, which ensures an actual
injection dose of 120 mg.
For full list of excipients, see List of excipients.
PHARMACEUTICAL FORM
Prolonged-release solution for injection in a pre-filled syringe.
White to pale yellow semi-solid formulation.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
SOMATULINE® AUTOGEL® 60 MG & 90 MG
•
Treatment of acromegaly when secretion of Growth Hormone (GH) and
Insulin-like Growth
Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy
•
Treatment of the clinical syndrome associated with acromegaly
•
Treatment of the clinical symptoms of neuroendocrine (particularly
carcinoid) tumours
SOMATULINE® AUTOGEL® 120 MG
•
Treatment of acromegaly when secretion of Growth Hormone (GH) and
Insulin-like Growth
Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy
•
Treatment of the clinical syndrome associated with acromegaly
•
Treatment of the clinical symptoms of neuroendocrine (particularly
carcinoid) tumours
•
Treatment of grade 1 and a subset of grade 2