LAMZEDE

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

VELMANASE ALFA

Tilgjengelig fra:

KAMADA LTD, ISRAEL

ATC-kode:

A16AB15

Legemiddelform:

POWDER FOR SOLUTION FOR INFUSION

Sammensetning:

VELMANASE ALFA 10 MG/VIAL

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

CHIESI FARMACEUTICI S.P.A., ITALY

Terapeutisk område:

VELMANASE ALFA

Indikasjoner:

Enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha mannosidosis.

Autorisasjon dato:

2021-08-18

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lamzede
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 10 mg of velmanase alfa*.
After reconstitution with 5 mL water for injections (WFI), 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. For infusion rate see
section “Method of administration”.
_Special populations _
_ _
_Renal or hepatic impairment _
No dose adjustment is necessary for patients with renal or hepatic
impairment.
_Elderly _
No data are available and no relevant use in elderly patients is
described.
_Paediatric population _
No dose adjustment is necessary for the paediatric population.
2
Method of administration
For intravenous infusion use only.
Instructions on reconstitution of the medicinal product before
administration
The reconstituted solution should be clear. Do not use if opaque
particles are observed or if the
solution is discoloured (see section 6.6).
The reconstituted solution of Lamzede should be administered using an
infusion set equipped with a
pump and