Octreotide

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Octreotide acetate 0.112 mg/mL equivalent to octreotide 100 mcg/mL

Disponível em:

Max Health Limited

DCI (Denominação Comum Internacional):

Octreotide acetate 0.112 mg/mL (equivalent to octreotide 100 mcg/mL)

Dosagem:

100 mcg/mL

Forma farmacêutica:

Solution for injection

Composição:

Active: Octreotide acetate 0.112 mg/mL equivalent to octreotide 100 mcg/mL Excipient: Glycine Hydrochloric acid Mannitol Water for injection

Unidades em pacote:

Ampoule, glass, Type I, box of five 1 mL ampoules, 5 mL

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

BCN Peptides SA

Indicações terapêuticas:

Symptomatic control and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. Octreotide treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.

Resumo do produto:

Package - Contents - Shelf Life: Ampoule, glass, Type I, box of five 1 mL ampoules - 5 mL - 60 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 2 weeks not refrigerated stored at or below 25°C protect from light

Data de autorização:

2011-07-11

Características técnicas

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Octreotide 0.05 mg/mL, 0.1 mg/mL and 0.5 mg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL ampoule of Octreotide solution for injection contains 0.05
mg, 0.1 mg or 0.5
mg of octreotide as octreotide acetate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Octreotide is a clear colourless solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For symptomatic control and reduction of growth hormone (GH) and IGF-1
plasma levels in
patients
with
acromegaly
who are inadequately controlled by surgery or
radiotherapy.
Octreotide treatment is also indicated for acromegalic patients unfit
or unwilling to undergo
surgery, or in the interim period until radiotherapy becomes fully
effective.
For
the
relief
of
symptoms
associated
with
functional
gastro-entero-pancreatic
(GEP)
endocrine tumours:
•
Carcinoid tumours with features of the carcinoid syndrome
•
Vasoactive intestinal peptide secreting tumours (VIPomas)
•
Glucagonomas
•
Gastrinomas/Zollinger-Ellis
syndrome,
usually
in
conjunction
with
proton
pump
inhibitors, or H2-antagonist therapy
•
Insulinomas, for pre-operative control of hypoglycaemia and for
maintenance therapy
•
GRFomas.
Octreotide is not an antitumour therapy and is not curative in these
patients.
For prevention of complications following pancreatic surgery.
Emergency management to stop bleeding and to protect from re-bleeding
owing to gastro-
oesophageal varices in patients with cirrhosis. Octreotide is to be
used in association with
specific treatment such as endoscopic sclerotherapy.
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4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Acromegaly
Initially 0.05 to 0.1 mg by subcutaneous injection every 8 or 12
hours. Dosage adjustment
should be based on monthly assessment of GH and IGF-1 levels (target:
GH <2.5 ng/mL;
IGF-1 within normal range) and clinical symptoms and on tolerability.
In most patients, the
optimal daily dose will be 0.3 mg. A maximum dose of 1.