SOMAVERT 10 MG

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

PEGVISOMANT

Disponible depuis:

PFIZER PHARMACEUTICALS ISRAEL LTD

Code ATC:

H01AX01

forme pharmaceutique:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

PEGVISOMANT 10 MG

Mode d'administration:

S.C

Type d'ordonnance:

Required

Fabriqué par:

PFIZER MANUFACTURING BELGIUM NV/SA

Groupe thérapeutique:

PEGVISOMANT

Domaine thérapeutique:

PEGVISOMANT

indications thérapeutiques:

Treatment of adult patient with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated.

Date de l'autorisation:

2021-08-31

Notice patient

Somavert 10 mg, 15 mg, 20 mg, 25 mg, 30 mg PIL CC technical change 24
June 2021
0069070
-
2021
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
SOMAVERT
®
10 MG
SOMAVERT
®
15 MG
SOMAVERT
®
20 MG
SOMAVERT
®
25 MG
SOMAVERT
®
30 MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
COMPOSITION:
Each vial
contains:
pegvisomant
10 mg
Each vial
contains:
pegvisomant
15 mg
Each vial
contains:
pegvisomant
20 mg
Each vial
contains:
pegvisomant
25 mg
Each vial
contains:
pegvisomant
30 mg
Inactive ingredients and allergens: See section 2 under ‘Important
information
about some of this medicine’s ingredients’ and section 6
‘Further information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet
contains concise information about this medicine. If you have any
further questions
about using this medicine, consult your 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?
Treatment of adult patients with acromegaly (gigantism) who are
responding
inadequately to surgery and/or radiation therapy, and in whom medical
treatment
with synthetic somatostatin analogues did not normalize IGF-I growth
factor levels
or was not tolerated.
Acromegaly (gigantism) is a hormonal disorder resulting from the
increased
secretion of growth hormone (GH) and insulin-like growth factor 1
(IGF-1), which is
characterised by overgrowth of bone, soft tissue swelling, heart
disease and other
related disorders.
THERAPEUTIC GROUP:
growth hormone receptor antagonist.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients in this medicine (see section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
CONSULT YOUR DOCTOR BEFORE STARTING TREATMENT WITH SOMAVERT
®
.

Résumé des caractéristiques du produit

Somavert
®
10 mg, 15 mg, 20 mg, 25 mg, 30 mg LPD CC 021022
2021-0073283
1
1.
NAME OF THE MEDICINAL PRODUCT
SOMAVERT
®
10 mg powder and solvent for solution for injection
SOMAVERT
®
15 mg powder and solvent for solution for injection
SOMAVERT
®
20 mg powder and solvent for solution for injection
SOMAVERT
®
25 mg powder and solvent for solution for injection
SOMAVERT
®
30 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOMAVERT
®
10 mg powder and solvent for solution for injection
One vial contains 10 mg of pegvisomant.
After reconstitution, 1 ml of solution contains 10 mg of pegvisomant.*
Excipient with known effect
The 10 mg strength of the medicinal product contains 0.4 mg of sodium
per vial of powder.
SOMAVERT
®
15 mg powder and solvent for solution for injection
One vial contains 15 mg of pegvisomant.
After reconstitution, 1 ml of solution contains 15 mg of pegvisomant.*
Excipient with known effect
The 15 mg strength of the medicinal product contains 0.4 mg of sodium
per vial of powder.
SOMAVERT
®
20 mg powder and solvent for solution for injection
One vial contains 20 mg of pegvisomant.
After reconstitution, 1 ml of solution contains 20 mg of pegvisomant.*
Excipient with known effect:
The 20 mg strength of the medicinal product contains 0.4 mg of sodium
per vial of powder.
SOMAVERT
®
25 mg powder and solvent for solution for injection
One vial contains 25 mg of pegvisomant.
After reconstitution, 1 ml of solution contains 25 mg of pegvisomant.*
Excipient with known effect
The 25 mg strength of the medicinal product contains 0.5 mg of sodium
per vial of powder.
SOMAVERT
®
30 mg powder and solvent for solution for injection
One vial contains 30 mg of pegvisomant.
After reconstitution, 1 ml of solution contains 30 mg of pegvisomant.*
Excipient with known effect
The 30 mg strength of the medicinal product contains 0.6 mg of sodium
per vial of powder.
*produced in
_ Escherichia coli _
cells by recombinant DNA technology.
For the full list of excipients, see se