Vpriv

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

velaglucerase alfa

Saatavilla:

Takeda Pharmaceuticals International AG Ireland Branch

ATC-koodi:

A16AB10

INN (Kansainvälinen yleisnimi):

velaglucerase alfa

Terapeuttinen ryhmä:

Other alimentary tract and metabolism products,

Terapeuttinen alue:

Gaucher Disease

Käyttöaiheet:

Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.

Tuoteyhteenveto:

Revision: 20

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2010-08-26

Pakkausseloste

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
VPRIV 400 UNITS POWDER FOR SOLUTION FOR INFUSION
velaglucerase alfa
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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1.
What VPRIV is and what it is used for
2.
What you need to know before VPRIV is used
3.
How VPRIV is used
4.
Possible side effects
5.
How to store VPRIV
6.
Contents of the pack and other information
1.
WHAT VPRIV IS AND WHAT IT IS USED FOR
VPRIV is a long-term enzyme replacement therapy (ERT) for patients
with type 1 Gaucher disease.
Gaucher disease is a genetic disorder caused by a missing or defective
enzyme named
glucocerebrosidase. When this enzyme is missing or does not work
properly, a substance called
glucocerebroside builds up inside cells in the body. The build-up of
this material causes the signs and
symptoms found in Gaucher disease.
VPRIV contains a substance called velaglucerase alfa which is designed
to replace the missing or
defective enzyme, glucocerebrosidase, in patients with Gaucher
disease.
2.
WHAT YOU NEED TO KNOW BEFORE VPRIV IS USED
DO NOT USE VPRIV
-
if you are severely allergic to velaglucerase alfa or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before VPRIV is used
-
If you are treated with VPRIV, you may experience side effects during
or following the infusion
(see section 4, possible side effects). These are called infusion
related reactions and might
appear as a hypersensitivity reaction with symptoms like nausea, rash,
difficulty in breathing,
back pain, chest discomfort (chest tightness), hives, joint pain or
headache.
-
Apart from symptoms of hypersensitivity reactions infusion-related
reactions m

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
VPRIV 400 Units powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 400 Units* of velaglucerase alfa**.
After reconstitution, one ml of the solution contains 100 Units of
velaglucerase alfa.
*An enzyme unit is defined as the amount of enzyme that is required to
convert one micromole of
p-nitrophenyl β-D-glucopyranoside to p-nitrophenol per minute at 37
ºC.
**produced in an HT-1080 human fibroblast cell line by recombinant DNA
technology.
Excipient with known effect
Each vial contains 12.15 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VPRIV is indicated for long-term enzyme replacement therapy (ERT) in
patients with type 1 Gaucher
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
VPRIV treatment should be supervised by a physician experienced in the
management of patients with
Gaucher disease.
Posology
The recommended dose is 60 Units/kg administered every other week.
Dose adjustments can be made on an individual basis based on
achievement and maintenance of
therapeutic goals. Clinical studies have evaluated doses ranging from
15 to 60 Units/kg every other
week. Doses higher than 60 Units/kg have not been studied.
Patients currently treated with imiglucerase enzyme replacement
therapy for type 1 Gaucher disease
may be switched to VPRIV, using the same dose and frequency.
Special populations
_Elderly (≥ 65 years old) _
Elderly patients may be treated within the same dose range (15 to 60
Units/kg) as other adult patients
(see section 5.1).
3
Renal impairment
No dosing adjustment is recommended in patients with renal impairment
based on current knowledge
of the pharmacokinetics and pharmacodynamics of velaglucerase alfa
(see section 5.2).
Hepatic impairment
No dosing adjustment is recommended in patients with hepatic
impairment based on curr