Sandostatin LAR

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Octreotide acetate 33.6mg equivalent to octreotide 30 mg;  

Saatavilla:

Novartis New Zealand Ltd

INN (Kansainvälinen yleisnimi):

Octreotide acetate 33.6 mg (equivalent to octreotide 30 mg)

Annos:

30 mg

Lääkemuoto:

Powder for injection

Koostumus:

Active: Octreotide acetate 33.6mg equivalent to octreotide 30 mg   Excipient: Mannitol Polyglactin Carmellose sodium Mannitol Poloxamer Water for injection Carmellose sodium Mannitol Water for injection

Kpl paketissa:

Combination pack, microspheres vial + diluent syringe, 30 mg

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Novartis Ringaskiddy Ltd

Käyttöaiheet:

Treatment of patients with acromegaly: · in whom surgery or radiotherapy is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective. Treatment of patients with symptoms associated with functional gastro-entero-pancreatic endocrine tumours: · Carcinoid tumours with features of the carcinoid syndrome. · VIPomas · Glucagonomas · Gastrinomas/Zollinger-Ellison syndrome · Insulinomas, for pre-operative control of hypoglycaemia and for maintenance therapy. · GRFomas

Tuoteyhteenveto:

Package - Contents - Shelf Life: Combination pack, Vial + diluent + safety injection needle + vial adapter - 30 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, Prefilled syringe with chlorobutyl rubber stopper containing diluent only - 2 mL - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1 glass vial with bromobutyl rubber stopper containing microspheres - 30 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Valtuutus päivämäärä:

1994-09-09

Pakkausseloste

__________________________________________________________________________________________________
Sandostatin

LAR

1
SANDOSTATIN
® LAR
®
_10mg, 20mg and 30mg injection _
_octreotide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sandostatin LAR
.
It does not contain all the available
information
.
It does not take the place
of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Sandostatin
LAR
against the benefits they expect
it will give you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SANDOSTATIN LAR
IS USED FOR
Sandostatin LAR is a long acting
form of Sandostatin injection. It is
injected into the buttocks once every
4 weeks, instead of having frequent
injections of the short-acting
Sandostatin under the skin.
Sandostatin LAR contains octreotide,
a man-made medicine derived from
somatostatin. Somatostatin is a
substance found in the human body
which controls the effects of certain
hormones such as insulin and growth
hormone. Sandostatin LAR is used
instead of somatostatin because its
effects are stronger and last longer.
•
Sandostatin LAR is used to treat
acromegaly
In people with acromegaly the body
makes too much growth hormone
which controls the growth of tissues,
organs and bones. Too much growth
hormone leads to enlargement of the
bones, especially of the hands and
feet. In most cases, the
overproduction of growth hormone is
caused

Valmisteyhteenveto

NEW ZEALAND DATA SHEET
Page 1 of 22
1. PRODUCT NAME
Sandostatin LAR 10mg, 20mg and 30mg powder and diluent for suspension
for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Octreotide acetate
ACTIVE SUBSTANCE
The active substance is octreotide free peptide. One vial contains 10
mg, 20 mg or 30 mg octreotide
(as octreotide acetate).
Excipient with known effect
Sandostatin LAR suspension contains less than 1 mmol (23 mg) of sodium
per dose, i.e. essentially
‘sodium-free’.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for injection and diluent.
Powder: white to white with yellowish tint.
Diluent: clear, colourless 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.
The pH of the reconstituted suspension is 5-8.
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of patients with acromegaly:
•
in whom surgery or radiotherapy is inappropriate or ineffective, or in
the interim period until
radiotherapy becomes fully effective.
Treatment of patients with symptoms associated with functional
gastro-entero-pancreatic endocrine
tumours:
•
Carcinoid tumours with features of the carcinoid syndrome.
•
VIPomas.
•
Glucagonomas.
•
Gastrinomas/Zollinger-Ellison syndrome.
•
Insulinomas, for pre-operative control of hypoglycaemia and for
maintenance therapy.
•
GRFomas.
Treatment of patients with progression of well-differentiated,
advanced neuroendocrine tumours of
the midgut or suspected midgut origin.
NEW ZEALAND DATA SHEET
Page 2 of 22
4.2
Dose and method of administration
Sandostatin LAR may only be administered by deep intragluteal
injection. The site of repeat
intragluteal injections should be alternated between the left and
right gluteal muscle (see
Instructions for use/handling).
DOSAGE
GENERAL TARGET POPULATION
ACROMEGALY
It is recommended to start treatment with