Cerezyme
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
03-04-2023
Valmisteyhteenveto
(SPC)
03-04-2023
Julkisesta arviointikertomuksesta
(PAR)
06-10-2010
Aktiivinen ainesosa:
imiglucerase
Saatavilla:
Sanofi B.V.
ATC-koodi:
A16AB02
INN (Kansainvälinen yleisnimi):
imiglucerase
Terapeuttinen ryhmä:
Other alimentary tract and metabolism products,
Terapeuttinen alue:
Gaucher Disease
Käyttöaiheet:
Cerezyme (imiglucerase) is indicated for use as longterm enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant nonneurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions:anaemia after exclusion of other causes, such as iron deficiencyThrombocytopeniaBone disease after exclusion of other causes such as Vitamin D deficiencyhepatomegaly or splenomegaly
Tuoteyhteenveto:
Revision: 31
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
1997-11-17
Pakkausseloste
18
B. PACKAGE LEAFLET
19 PACKAGE LEAFLET: INFORMATION FOR THE USER
CEREZYME 400 UNITS POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Imiglucerase
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 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 Cerezyme is and what it is used for.
2.
What you need to know before you are given Cerezyme.
3.
How Cerezyme is given.
4.
Possible side effects.
5.
How Cerezyme is stored.
6.
Contents of the pack and other information.
1.
WHAT CEREZYME IS AND WHAT IT IS USED FOR
Cerezyme contains the active substance imiglucerase and is used to
treat patients who have a
confirmed diagnosis of Type I or Type 3 Gaucher disease, who show
signs of the disease such as:
anaemia (low number of red blood cells), a tendency to bleed easily
(due to low numbers of platelets –
a type of blood cell), spleen or liver enlargement or bone disease.
People with Gaucher disease have low levels of an enzyme called acid
-glucosidase. This enzyme
helps the body control levels of glucosylceramide. Glucosylceramide is
a natural substance in the
body, made of sugar and fat
_._
In Gaucher disease glucosylceramide levels can get too high.
Cerezyme is an artificial enzyme called imiglucerase - this can
replace the natural enzyme acid
-glucosidase which is lacking or not active enough in patients with
Gaucher disease.
The information in this leaflet applies to all patient groups
including children, adolescents, adults and
the elderly.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEREZYME
DO NOT USE CEREZYME
-
if you are allergic to imiglu
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Valmisteyhteenveto
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cerezyme 400 Units Powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 400 units* of imiglucerase**.
After reconstitution, the solution contains 40 units (approximately
1.0 mg) of imiglucerase per ml
(400 U/10 ml). Each vial must be further diluted before use (see
section 6.6).
* An enzyme unit (U) is defined as the amount of enzyme that catalyses
the hydrolysis of one
micromole of the synthetic substrate para-nitrophenyl
-D-glucopyranoside (pNP-Glc) per minute at
37°C.
** Imiglucerase is a modified form of human acid
-glucosidase and is produced by recombinant
DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell
culture, with mannose
modification for targeting macrophages.
Excipients with known effect:
Each vial contains 41 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Cerezyme is a white to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cerezyme (imiglucerase) is indicated for use as long-term enzyme
replacement therapy in patients
with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic
neuronopathic (Type 3) Gaucher
disease who exhibit clinically significant non-neurological
manifestations of the disease.
The non-neurological manifestations of Gaucher disease include one or
more of the following
conditions:
•
anaemia after exclusion of other causes, such as iron deficiency
•
thrombocytopenia
•
bone disease after exclusion of other causes such as Vitamin D
deficiency
•
hepatomegaly or splenomegaly
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Disease management should be directed by physicians knowledgeable in
the treatment of Gaucher
disease.
Posology
3
Due to the heterogeneity and the multi-systemic nature of Gaucher
disease, dosage should be
individualised for each patient based on a comprehensive evaluation of
all cl
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