Replagal

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

agalsidase alfa

Διαθέσιμο από:

Takeda Pharmaceuticals International AG Ireland Branch

Φαρμακολογική κατηγορία (ATC):

A16AB03

INN (Διεθνής Όνομα):

agalsidase alfa

Θεραπευτική ομάδα:

Other alimentary tract and metabolism products,

Θεραπευτική περιοχή:

Fabry Disease

Θεραπευτικές ενδείξεις:

Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency).

Περίληψη προϊόντος:

Revision: 28

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2001-08-03

Φύλλο οδηγιών χρήσης

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
REPLAGAL 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
agalsidase alfa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Replagal is and what it is used for
2.
What you need to know before you are given Replagal
3.
How Replagal is given
4.
Possible side effects
5.
How to store Replagal
6.
Contents of the pack and other information
1.
WHAT REPLAGAL IS AND WHAT IT IS USED FOR
The active substance in Replagal is agalsidase alfa (1 mg/ml).
Agalsidase alfa is a form of the human
enzyme α-galactosidase. It is produced by switching on the gene for
α-galactosidase A in cells. The
enzyme is then removed from the cells and made into a sterile
concentrate for solution for infusion.
Replagal is used to treat adult patients, as well as adolescents and
children from the age of 7, with
confirmed diagnosis of Fabry Disease. It is used as long-term enzyme
replacement therapy when the
level of enzyme in the body is absent or lower than normal as in Fabry
Disease.
After 6 months of therapy Replagal significantly reduced pain in
patients when compared to placebo
(dummy) treated patients. Replagal reduced left ventricle mass in
treated patients compared to placebo
treated patients. These results suggest the symptoms of the disease
are improving or the disease is
becoming stable.
2.
WHAT YOU NEED TO KNOW BEFORE REPLAGAL IS GIVEN
YOU MUST NOT BE GIVEN REPLAGAL
-
if you are allergic to agalsidase alfa or any of the other ingredients
of this medicine (li

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Replagal 1 mg/ml concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 1 mg of
agalsidase alfa*.
Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa.
*agalsidase alfa is the human protein α-galactosidase A produced in a
human cell line by genetic
engineering technology.
Excipient(s) with known effect
This medicinal product contains 14.2 mg sodium per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replagal is indicated for long-term enzyme replacement therapy in
patients with a confirmed
diagnosis of Fabry Disease (α-galactosidase A deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Replagal treatment should be supervised by a physician experienced in
the management of patients
with Fabry Disease or other inherited metabolic diseases.
Posology
Replagal is administered at a dose of 0.2 mg/kg body weight every
other week by intravenous infusion
over 40 minutes.
_Special populations_
_Elderly patients_
Studies in patients over the age of 65 years have not been performed
and no dosage regimen can
presently be recommended in these patients as safety and efficacy have
not yet been established.
_Patients with hepatic impairment_
No studies have been performed in patients with hepatic impairment.
_Patients with renal impairment_
No dose adjustment is necessary in patients with renal impairment.
3
The presence of extensive renal damage (eGFR < 60mL/min) may limit the
renal response to enzyme
replacement therapy. Limited data are available in patients on
dialysis or post-kidney transplantation,
no dose adjustment is recommended.
_Paediatric population_
The safety and efficacy of Replagal in children aged 0-6 years has not
yet been established. Currently
available data are described in s