SIGNIFOR LAR 30 MG

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

PASIREOTIDE AS PAMOATE

Disponible des:

MEDISON PHARMA LTD

Codi ATC:

H01CB05

formulario farmacéutico:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Composición:

PASIREOTIDE AS PAMOATE 30 MG/VIAL

Vía de administración:

I.M

tipo de receta:

Required

Fabricat per:

RECORDATI RARE DISEASES, FRANCE

Área terapéutica:

PASIREOTIDE

indicaciones terapéuticas:

Treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.

Data d'autorització:

2023-03-21

Informació per a l'usuari

Signifor LAR 10 mg-20 mg-30 mg-40 mg-60 mg-PIL-1023-V1
Signifor LAR-10mg_20mg_30mg_40mg_60mg-PIL-ENG-D17-F
Page 1 of 12
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s
prescription only
SIGNIFOR
® LAR
1
0 MG, POWDER AND SOLVENT FOR SUSPENSION FOR
INJECTION
The active ingredient and its quantity:
Each vial of powder contains: 10 mg pasireotide (as pamoate)
SIGNIFOR
® LAR 20 MG, POWDER AND SOLVENT FOR SUSPENSION FOR
INJECTION
The active ingredient and its quantity:
Each vial of powder contains: 20 mg pasireotide (as pamoate)
SIGNIFOR
® LAR 30 MG, POWDER AND SOLVENT FOR SUSPENSION FOR
INJECTION
The active ingredient and its quantity:
Each vial of powder contains: 30 mg pasireotide (as pamoate)
SIGNIFOR
® LAR 40 MG, POWDER AND SOLVENT FOR SUSPENSION FOR
INJECTION
The active ingredient and its quantity:
Each vial of powder contains: 40 mg pasireotide (as pamoate)
SIGNIFOR
® LAR 60 MG, POWDER AND SOLVENT FOR SUSPENSION FOR
INJECTION
The active ingredient and its quantity:
Each vial of powder contains: 60 mg pasireotide (as pamoate)
INACTIVE AND ALLERGENIC INGREDIENTS:
see section 6 'Additional information' and section 2
'Important information about some of this medicine's ingredients'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet
contains concise information about this medicine. If you have further
questions, refer to the
doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Signifor LAR is indicated for the treatment of adult patients with
acromegaly for whom
surgery is not an option or has not been curative and who are
inadequately controlled on
treatment with other somatostatin analogues.
It is also indicated for treatment of Cushing’s disease in adult
patients
for whom surgical
treatment is not an option or for whom

Fitxa tècnica

Signifor LAR 10 mg-20 mg-30 mg-40 mg-60 mg-SPC-1023-V1
Page 1 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Signifor LAR 10 mg
Signifor LAR 20 mg
Signifor LAR 30 mg
Signifor LAR 40 mg
Signifor LAR 60 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains:
Signifor LAR 10 mg: 10 mg pasireotide (as pasireotide pamoate).
Signifor LAR 20 mg: 20 mg pasireotide (as pasireotide pamoate).
Signifor LAR 30 mg: 30 mg pasireotide (as pasireotide pamoate).
Signifor LAR 40 mg: 40 mg pasireotide (as pasireotide pamoate).
Signifor LAR 60 mg: 60 mg pasireotide (as pasireotide pamoate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
Powder: slightly yellowish to yellowish powder.
Solvent: clear, colourless to slightly yellow or slightly brown
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Signifor LAR is indicated for the treatment of adult patients with
acromegaly for whom surgery is not
an option or has not been curative and who are inadequately controlled
on treatment with another
somatostatin analogue.
Treatment of adult patients with Cushing’s disease for whom surgery
is not an option or for whom
surgery has failed.
The 60 mg strength is only to be used in the treatment of acromegaly.
The 10 mg and 30 mg are
only to be used in the treatment of Cushing’s disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Acromegaly _
The recommended initial dose for the treatment of acromegaly
is 40 mg of pasireotide every 4 weeks.
The dose may be increased to a maximum of 60 mg for patients whose
growth hormone (GH) and/or
insulin-like growth factor-1 (IGF-1) levels are not fully controlled
after 3 months of treatment with
Signifor LAR at 40 mg.
Signifor LAR 10 mg-20 mg-30 mg-40 mg-60 mg-SPC-1023-V1
Page 2 of 19
Management of suspected adverse reactions or over-response to
treatment (IGF-1 < lower limit of
normal) may require temporary dose reduction of Signifor LAR. The dose
may be decreased either
temporarily or permanently.
_Cushing�