Signifor

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

pasireotide

Διαθέσιμο από:

Recordati Rare Diseases

Φαρμακολογική κατηγορία (ATC):

H01CB05

INN (Διεθνής Όνομα):

pasireotide

Θεραπευτική ομάδα:

Pituitary and hypothalamic hormones and analogues

Θεραπευτική περιοχή:

Acromegaly; Pituitary ACTH Hypersecretion

Θεραπευτικές ενδείξεις:

Signifor is indicated for the treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed.Signifor 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.

Περίληψη προϊόντος:

Revision: 14

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2012-04-24

Φύλλο οδηγιών χρήσης

89
B. PACKAGE LEAFLET
90
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIGNIFOR 0.3 MG SOLUTION FOR INJECTION
SIGNIFOR 0.6 MG SOLUTION FOR INJECTION
SIGNIFOR 0.9 MG SOLUTION FOR INJECTION
pasireotide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Signifor is and what it is used for
2.
What you need to know before you use Signifor
3.
How to use Signifor
4.
Possible side effects
5.
How to store Signifor
6.
Contents of the pack and other information
1.
WHAT SIGNIFOR IS AND WHAT IT IS USED FOR
Signifor is a medicine that contains the active substance pasireotide.
It is used to treat Cushing’s
disease in adult patients for whom surgery is not an option or for
whom surgery has failed.
Cushing’s disease is caused by an enlargement in the pituitary gland
(a gland at the base of the brain)
called a pituitary adenoma. This leads the body to over-produce a
hormone called adrenocorticotropic
hormone (ACTH), which in turn results in over-production of another
hormone called cortisol.
The human body naturally produces a substance called somatostatin,
which blocks the production of
certain hormones, including ACTH. Pasireotide works in a very similar
way to somatostatin. Signifor
is thus able to block the production of ACTH, helping to control the
over-production of cortisol and
improve the symptoms of Cushing’s disease.
If you have any questions about how Signifor works or why this
medicine has been prescribed for you,
ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SIGNIFOR
DO NOT US

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Signifor 0.3 mg solution for injection
Signifor 0.6 mg solution for injection
Signifor 0.9 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Signifor 0.3 mg solution for injection
One ampoule of 1 ml contains 0.3 mg pasireotide (as pasireotide
diaspartate).
Signifor 0.6 mg solution for injection
One ampoule of 1 ml contains 0.6 mg pasireotide (as pasireotide
diaspartate).
Signifor 0.9 mg solution for injection
One ampoule of 1 ml contains 0.9 mg pasireotide (as pasireotide
diaspartate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adult patients with Cushing’s disease for whom surgery
is not an option or for whom
surgery has failed.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended initial dose is 0.6 mg pasireotide by subcutaneous
injection twice a day.
Two months after the start of Signifor therapy, patients should be
evaluated for clinical benefit.
Patients who experience a significant reduction in urinary free
cortisol (UFC) levels should continue to
receive Signifor for as long as benefit is derived. A dose increase to
0.9 mg may be considered based
on the response to the treatment, as long as the 0.6 mg dose is well
tolerated by the patient. Patients
who have not responded to Signifor after two months of treatment
should be considered for
discontinuation.
Management of suspected adverse reactions at any time during the
treatment may require temporary
dose reduction of Signifor. Dose reduction by decrements of 0.3 mg
twice a day is suggested.
If a dose of Signifor is missed, the next injection should be
administered at the scheduled time. Doses
should not be doubled to make up for a missed dose.
_Switch from intramuscular to subcutaneous formulation _
There are no clinical data available on switching from the
intramuscular to the subcuta