SIGNIFOR 0.9 MG 1 ML

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

PASIREOTIDE AS DIASPARTATE

Inapatikana kutoka:

MEDISON PHARMA LTD

ATC kanuni:

H01CB05

Dawa fomu:

SOLUTION FOR INJECTION

Tungo:

PASIREOTIDE AS DIASPARTATE 0.9 MG/ML

Njia ya uendeshaji:

S.C

Dawa ya aina:

Required

Viwandani na:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Kundi la matibabu:

PASIREOTIDE

Eneo la matibabu:

PASIREOTIDE

Matibabu dalili:

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

Idhini ya tarehe:

2018-07-31

Taarifa za kipeperushi

Signifor-0.3 mg-0.6 mg-0.9 mg_1 ml-PIL-ENG-D11-F
Page 1 of 8
Signifor 0.3mg/1ml-0.6mg/1ml-0.9mg/1ml-PIL-1221-V1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
Signifor
®
0.3 mg/1 ml
Solution for injection
Active ingredient
Each ampoule contains:
0.3 mg pasireotide (as pasireotide diaspartate)
Signifor
®
0.6 mg/1 ml
Solution for injection
Active ingredient
Each ampoule contains:
0.6 mg pasireotide (as pasireotide diaspartate)
Signifor
®
0.9 mg/1 ml
Solution for injection
Active ingredient
Each ampoule contains:
0.9 mg pasireotide (as pasireotide diaspartate)
Inactive ingredients and allergens:
See section 6 ‘Further information’. Also see “Important
information
about some of the ingredients of the medicine” section.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet contains concise
information about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It may harm them even
if it seems to you that their ailment is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is used to treat adult patients with Cushing’s disease
for whom surgery is not an option or for
whom surgery has failed.
Therapeutic group:
Pasireotide is a synthetic compound derived from somatostatin.
The medicine belongs to the group of somatostatin analogs.
Cushing’s disease is caused by an enlargement in the pituitary gland
(a gland at the base of the brain) called
a benign pituitary tumor (adenoma). This condition leads the body to
over-produce a hormone called
adrenocorticotropic hormone (ACTH), which leads to the 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 similar way to the
way somatostatin works. Signifor is thus
a

Tabia za bidhaa

Signifor 0.3mg/1ml-0.6mg/1ml-0.9mg/1ml-SPC-1221-V1
- 1 -
1.
NAME OF THE MEDICINAL PRODUCT
Signifor 0.3 mg/1ml solution for injection
Signifor 0.6 mg/1ml solution for injection
Signifor 0.9 mg/1ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Signifor 0.3 mg/1ml solution for injection
One ampoule of 1 ml contains 0.3 mg pasireotide (as pasireotide
diaspartate).
Signifor 0.6 mg/1ml solution for injection
One ampoule of 1 ml contains 0.6 mg pasireotide (as pasireotide
diaspartate).
Signifor 0.9 mg/1ml 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.
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.
Signifor 0.3mg/1ml-0.6mg/1ml-0.9mg/1ml-SPC-1221-V1
- 2 -
_Special populations _
_Paediatric population _
The safety and ef