Octreotide

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Octreotide acetate 0.056 mg/mL equivalent to octreotide 50 mcg/mL

제공처:

Max Health Limited

INN (International Name):

Octreotide acetate 0.056 mg/mL (equivalent to octreotide 50 mcg/mL)

복용량:

50 mcg/mL

약제 형태:

Solution for injection

구성:

Active: Octreotide acetate 0.056 mg/mL equivalent to octreotide 50 mcg/mL Excipient: Glycine Hydrochloric acid Mannitol Water for injection

패키지 단위:

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

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

BCN Peptides SA

치료 징후:

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.

제품 요약:

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

승인 날짜:

2011-07-11

제품 특성 요약

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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.