VPRIV POWDER FOR SOLUTION FOR INFUSION 400 UNITSVIAL

Pajjiż: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ingredjent attiv:

Velaglucerase alfa

Disponibbli minn:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Kodiċi ATC:

A16AB10

Għamla farmaċewtika:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Kompożizzjoni:

Velaglucerase alfa 10 mg/vial

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

Vetter Pharma-Fertigung GmbH & Co. KG (bulk production and primary packager)

L-istatus ta 'awtorizzazzjoni:

ACTIVE

Data ta 'l-awtorizzazzjoni:

2021-02-24

Karatteristiċi tal-prodott

1.
NAME OF THE MEDICINAL PRODUCT
VPRIV 400 Units powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 400 Units* of velaglucerase alfa**.
After reconstitution, one ml of the solution contains 100 Units of
velaglucerase alfa.
*An enzyme unit is defined as the amount of enzyme that is required to
convert one micromole of
p-nitrophenyl β-D-glucopyranoside to p-nitrophenol per minute at
37ºC.
** produced in an HT-1080 human fibroblast cell line by recombinant
DNA technology.
Excipient with known effect:
One vial contains 12.15 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VPRIV is indicated for long-term enzyme replacement therapy (ERT) in
patients with type 1 Gaucher
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
VPRIV treatment should be supervised by a physician experienced in the
management of patients with
Gaucher disease.
Posology
The recommended dose is 60 Units/kg administered every other week.
Dose adjustments can be made on an individual basis based on
achievement and maintenance of
therapeutic goals. Clinical studies have evaluated doses ranging from
15 to 60 Units/kg every other
week. Doses higher than 60 Units/kg have not been studied.
Patients currently treated with imiglucerase enzyme replacement
therapy for type 1 Gaucher disease
may be switched to VPRIV, using the same dose and frequency.
_ _
Special populations
_Renal or hepatic impairment _
No dosing adjustment is recommended in patients with renal or hepatic
impairment based on current
knowledge of the pharmacokinetics and pharmacodynamics of
velaglucerase alfa. See section 5.2.
_Elderly (≥65 years old) _
Elderly patients may be treated within the same dose range (15 to 60
units/kg) as other adult patients.
See section 5.1.
_Paediatric population _
Twenty of the 94 patients (21%) who received velaglucerase alfa during
clinical studies were in the
pae