Signifor 40mg powder and solvent for suspension for injection vials

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Pasireotide pamoate

Saatavilla:

Novartis Pharmaceuticals UK Ltd

ATC-koodi:

H01CB05

INN (Kansainvälinen yleisnimi):

Pasireotide pamoate

Annos:

40mg

Lääkemuoto:

Powder and solvent for suspension for injection

Antoreitti:

Intramuscular

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: ; GTIN: 5010678919301

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIGNIFOR
® 10 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
SIGNIFOR
® 20 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
SIGNIFOR
® 30 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
SIGNIFOR
® 40 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
SIGNIFOR
® 60 MG POWDER AND SOLVENT FOR SUSPENSION 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 acromegaly in
adult patients. It is also used to treat Cushing’s disease in adult
patients for whom surgery is not an
option or for whom surgery has failed.
Acromegaly
Acromegaly is caused by a type of tumour called a pituitary adenoma
which develops in the pituitary
gland at the base of the brain. The adenoma leads the body to
over-produce hormones that control
growth of tissues, organs and bones, resulting in an increase in the
size of bones and tissues, especially
in the hands and feet.
Signifor reduces the production of these hormones and possibly also
the size of the adenoma. As a
result, it reduces the symptoms of acromegaly, which include headache,
increased sweating, numbness
of the hands and feet, tiredness and jo

Valmisteyhteenveto

OBJECT 1
SIGNIFOR 60 MG POWDER AND SOLVENT FOR SUSPENSION
FOR INJECTION
Summary of Product Characteristics Updated 01-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Signifor
®
10 mg powder and solvent for suspension for injection
Signifor
®
20 mg powder and solvent for suspension for injection
Signifor
®
30 mg powder and solvent for suspension for injection
Signifor
®
40 mg powder and solvent for suspension for injection
Signifor
®
60 mg powder and solvent for suspension for injection
2. Qualitative and quantitative composition
Signifor 10 mg powder and solvent for suspension for injection
One vial contains 10 mg pasireotide (as pasireotide pamoate).
Signifor 20 mg powder and solvent for suspension for injection
One vial contains 20 mg pasireotide (as pasireotide pamoate).
Signifor 30 mg powder and solvent for suspension for injection
One vial contains 30 mg pasireotide (as pasireotide pamoate).
Signifor 40 mg powder and solvent for suspension for injection
One vial contains 40 mg pasireotide (as pasireotide pamoate).
Signifor 60 mg powder and solvent for suspension for injection
One vial contains 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 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
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.
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 wee