Lamzede

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

velmanase alfa

Saatavilla:

Chiesi Farmaceutici S.p.A.

ATC-koodi:

A16AB15

INN (Kansainvälinen yleisnimi):

velmanase alfa

Terapeuttinen ryhmä:

Other alimentary tract and metabolism products,

Terapeuttinen alue:

alpha-Mannosidosis

Käyttöaiheet:

Treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.,

Tuoteyhteenveto:

Revision: 6

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-03-23

Pakkausseloste

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMZEDE 10 MG POWDER FOR SOLUTION FOR INFUSION
velmanase 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.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lamzede is and what it is used for
2.
What you need to know before you use Lamzede
3.
How to use Lamzede
4.
Possible side effects
5.
How to store Lamzede
6.
Contents of the pack and other information
1.
WHAT LAMZEDE IS AND WHAT IT IS USED FOR
Lamzede contains the active substance velmanase alfa which belongs to
a group of medicines known
as enzyme replacement therapies. It is used to treat patients with
mild to moderate alpha-mannosidosis
disease. It is given for the treatment of non-neurological symptoms of
the disease.
Alpha-mannosidosis disease is a rare genetic disorder caused by a lack
of an enzyme named
alpha-mannosidase, which is needed to break down certain sugar
compounds (called ‘mannose-rich
oligosaccharides’) in the body. When this enzyme is missing or does
not work properly, these sugar
compounds build up inside cells and cause the signs and symptoms of
the disease. The typical
manifestations of the disease include distinctive facial features,
mental retardation, difficulty in
controlling movements, difficulties in hearing and speaking, frequent
infections, skeletal problems,
muscle pain and weakness.
Velmanase alfa is designed to replace the missing enzyme in patients
with alpha-mannosidosis
disease.
2.
WHAT YOU NEED TO KNOW BEFORE Y

Valmisteyhteenveto

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
Lamzede 10 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 10 mg of velmanase alfa*.
After reconstitution, one mL of the solution contains 2 mg of
velmanase alfa (10 mg/5 mL).
For the full list of excipients, see section 6.1.
*Velmanase alfa is produced in mammalian Chinese Hamster Ovary (CHO)
cells using recombinant
DNA technology.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Enzyme replacement therapy for the treatment of non-neurological
manifestations in patients with
mild to moderate alpha-mannosidosis. See sections 4.4 and 5.1._ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be supervised by a physician experienced in the
management of patients with
alpha-mannosidosis or in the administration of other enzyme
replacement therapies (ERT) for
lysosomal storage disorder. Administration of Lamzede should be
carried out by a healthcare
professional with the ability to manage ERT and medical emergencies.
Posology
The recommended dose regimen is 1 mg/kg of body weight administered
once every week by
intravenous infusion at a controlled speed.
The effects of treatment with velmanase alfa should be periodically
evaluated and discontinuation of
treatment considered in cases where no clear benefits could be
observed.
_Special populations _
_ _
_Elderly _
No data are available and no relevant use in elderly patients is
described.
_Renal or hepatic impairment _
No dose adjustment is necessary for patients with renal or hepatic
impairment.
3
_Paediatric population _
No dose adjustment is necessary for the paediatric population.
Method of