Somavert

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Pegvisomant

Available from:

Pfizer Europe MA EEIG

ATC code:

H01AX01

INN (International Name):

pegvisomant

Therapeutic group:

Pituitary and hypothalamic hormones and analogues

Therapeutic area:

Acromegaly

Therapeutic indications:

Treatment of adult patients 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.Treatment of adult patients 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.

Product summary:

Revision: 28

Authorization status:

Authorised

Authorization date:

2002-11-12

Patient Information leaflet

59
B. PACKAGE LEAFLET
60
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
pegvisomant
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What SOMAVERT is and what it is used for
2.
What you need to know before you use SOMAVERT
3.
How to use SOMAVERT
4.
Possible side effects
5.
How to store SOMAVERT
6.
Contents of the pack and other information
1.
WHAT SOMAVERT IS AND WHAT IT IS USED FOR
SOMAVERT is used for the treatment of acromegaly, a hormonal disorder
resulting from the
increased secretion of growth hormone (GH) and IGF-I (Insulin-like
growth factors), which is
characterised by overgrowth of bone, soft tissue swelling, heart
disease and related disorders.
The active substance in SOMAVERT, pegvisomant is known as a growth
hormone receptor
antagonist. These substances decrease the action of GH and levels of
IGF-I circulating in the blood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SOMAVERT
DO NOT USE SOMAVERT

If you are allergic to pegvisomant or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using SOMAVERT.
-
If you experience disturbed vision or headaches you must contact your
doctor immediately.
-
Yo

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 section 6.1.
3
3.
PHARMACEUTICAL FORM
Powder and solvent for s