SANDOSTATIN LAR 10 MG

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

OCTREOTIDE

Tersedia dari:

NOVARTIS ISRAEL LTD

Kode ATC:

H01CB02

Bentuk farmasi:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Komposisi:

OCTREOTIDE 10 MG

Rute administrasi :

INTRAGLUTEALLY

Jenis Resep:

Required

Diproduksi oleh:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Kelompok Terapi:

OCTREOTIDE

Area terapi:

OCTREOTIDE

Indikasi Terapi:

Treatment of acromegaly in: Patients already adequately controlled on standard doses of Sandostatin s.c. Patients in whom surgery or radiotherapy are inappropriate or ineffective, or who are in the latency period before radiotherapy becomes fully effective. Endocrine gastro-entero- pancreatic (GEP) tumors, carcinoid tumors.

Tanggal Otorisasi:

2013-09-30

Selebaran informasi

SAS LAR APL OCT22 V4 UK PIL July 2022
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
SANDOSTATIN
® LAR
® 10 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
Name and quantity of active ingredient:
EACH VIAL OF POWDER CONTAINS 10 MG OCTREOTIDE (AS OCTREOTIDE ACETATE)
SANDOSTATIN
® LAR
® 20 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
Name and quantity of active ingredient:
EACH VIAL OF POWDER CONTAINS 20 MG OCTREOTIDE (AS OCTREOTIDE ACETATE)
SANDOSTATIN
® LAR
® 30 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
Name and quantity of active ingredient:
EACH VIAL OF POWDER CONTAINS 30 MG OCTREOTIDE (AS OCTREOTIDE ACETATE)
Inactive ingredients and allergens: see section 6 ‘Additional
information’.
See also in
section 2 ‘Important information about some of the ingredients of
the medicine’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult the doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
it seems to you that their medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
SANDOSTATIN LAR is used:
•
to treat people with acromegaly:
-
whose illness is adequately controlled by standard doses of
Sandostatin given by
injection under the skin (subcutaneously)
-
when surgery or radiotherapy are inappropriate or ineffective
-
to cover the interim period until the radiotherapy becomes fully
effective
•
to treat endocrine gastro-entero-pancreatic (GEP) tumors, carcinoid
tumors
THERAPEUTIC GROUP:
somatostatin analogues
SANDOSTATIN LAR is a synthetic compound derived from somatostatin.
Somatostatin is
normally found in the human body, where it inhibits the release of
certain hormones such as
growth hormone. SANDOSTATIN LAR has advantages over somatostatin; it
is stronger and
its effect

Karakteristik produk

SAS LAR API OCT22 V4
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Sandostatin

LAR

10 mg powder and solvent for suspension for injection
Sandostatin

LAR

20 mg powder and solvent for suspension for injection
Sandostatin

LAR

30 mg powder and solvent for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 10 mg, 20 mg or 30 mg octreotide (as octreotide
acetate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
Powder: White to white with yellowish tint.
Solvent:Colourless to slightly yellow or brown solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of acromegaly in: Patients already adequately controlled on
standard doses of
sandostatin s.c. Patients in whom surgery or radiotherapy are
inappropriate or ineffective, or
who are in the latency period before radiotherapy becomes fully
effective.
Endocrine Gastro-Entero-Pancreatic (GEP) tumors, carcinoid tumors.
4.2.
POSOLOGY 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 6.6
Instructions for use/handling).
Posology
_Acromegaly _
_ _
_For_
_patients who are adequately controlled_
with s.c. Sandostatin, it is recommended to start
treatment with the administration of 20 mg Sandostatin LAR at 4-week
intervals for 3 months.
Treatment with Sandostatin LAR can be started the day after the last
dose of s.c. Sandostatin.
Subsequent dosage adjustment should be based on serum growth hormone
(GH) and insulin-
like growth factor 1/somatomedin C (IGF 1) concentrations and clinical
symptoms.
For patients in whom, within this 3-month period, clinical symptoms
and biochemical
parameters (GH; IGF 1) are not fully controlled (GH concentrations
still above
2.5 microgram/L), the dose may be increased to 30 mg every 4 weeks.
SAS LAR API OCT22 V4
For patients whose GH