Mepsevii

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

vestronidase alfa

Dostupné z:

Ultragenyx Germany GmbH

ATC kód:

A16AB18

INN (Medzinárodný Name):

vestronidase alfa

Terapeutické skupiny:

Enzymes

Terapeutické oblasti:

Mucopolysaccharidosis VII

Terapeutické indikácie:

Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).

Prehľad produktov:

Revision: 7

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2018-08-23

Príbalový leták

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEPSEVII 2
MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
vestronidase alfa
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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.
-
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. This includes any
possible side effects not listed
in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1.
What Mepsevii is and what it is used for
2.
What you need to know before you are given Mepsevii
3.
How Mepsevii is given
4.
Possible side effects
5.
How to store Mepsevii
6.
Contents of the pack and other information
1.
WHAT MEPSEVII IS AND WHAT IT IS USED FOR
WHAT MEPSEVII IS
Mepsevii contains an enzyme called vestronidase alfa. This belongs to
a group of medicines called
enzyme replacement therapies. It is used in adults and children of all
ages with MPS VII to treat non-
neurological manifestations of the disease (mucopolysaccharidosis VII,
also known as Sly Syndrome).
WHAT IS MPS VII
MPS VII is an illness that runs in families, where the body does not
produce enough of an enzyme
called beta–glucuronidase.
-
This enzyme helps to break down sugars in the body called
mucopolysaccharides.
-
Mucopolysaccharides are made in the body and they help build bones,
cartilage, skin, and
tendons.
-
These sugars are re-cycled all the time – new ones are made and old
ones are broken down.
-
Without enough beta–glucuronidase, parts of these sugars build up in
cells, leading to damage
in the body.
HOW MEPSEVII WORKS
This medici

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Mepsevii 2 mg/mL concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 2 mg vestronidase alfa*. Each vial of
5 mL concentrate contains
10 mg vestronidase alfa.
*Vestronidase alfa is a recombinant form of human beta-glucuronidase
(rhGUS) and is produced in
Chinese Hamster Ovary cell culture by recombinant DNA technology.
Excipient(s) with known effect
Each vial contains 17.8
_ _
mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mepsevii is indicated for the treatment of non-neurological
manifestations of Mucopolysaccharidosis
VII (MPS VII; Sly syndrome).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be supervised by a healthcare professional
experienced in the management of
patients with MPS VII or other inherited metabolic disorders.
Administration of vestronidase alfa
should be carried out by an appropriately trained healthcare
professional with the ability to manage
medical emergencies.
Posology
The recommended dose of vestronidase alfa is 4 mg/kg of body weight
administered by intravenous
infusion every two weeks.
To minimise the risk of hypersensitivity reactions, a non-sedating
antihistamine with or without an
antipyretic medicinal product should be administered 30-60 minutes
prior to the start of the infusion
(see section 4.4). Infusion should be avoided if the patient has an
acute febrile or respiratory illness at
the time.
_Special populations _
_ _
_Elderly _
3
The safety and efficacy of vestronidase alfa in patients ol