VPRIV

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Velaglucerase alfa 400 U;  

Disponible desde:

Takeda New Zealand Limited

Designación común internacional (DCI):

Velaglucerase alfa 400 U

Dosis:

400 U

formulario farmacéutico:

Powder for infusion concentrate

Composición:

Active: Velaglucerase alfa 400 U   Excipient: Citric acid monohydrate Polysorbate 20 Sodium citrate dihydrate Sucrose

tipo de receta:

Prescription

Fabricado por:

Shire Human Genetic Therapies Inc

indicaciones terapéuticas:

VPRIV is indicated for long-term enzyme replacement therapy (ERT) for paediatric and adult patients with type I Gaucher disease.

Resumen del producto:

Package - Contents - Shelf Life: Vial, glass, single dose, Type 1 (20 mL) borosilicate, with butyl rubber stopper - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Fecha de autorización:

2015-01-05

Ficha técnica

NEW ZEALAND DATA SHEET
VPRIV V3 (CCDS V10, V11) 1
1 PRODUCT NAME
VPRIV 400 Units powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
VPRIV is supplied in 400 U/vial (10 mg) of velaglucerase alfa ghu.
_Excipient with known effects: _
One vial contains 12.15 mg of sodium.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
VPRIV is a sterile, white to off‐white, preservative‐free
lyophilised powder in single‐use vials.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
VPRIV is indicated for long‐term enzyme replacement therapy (ERT)
for paediatric and adult patients
with type 1 Gaucher disease.
4.2
Dose and method of administration
Dose
VPRIV treatment should only be initiated or continued by a physician
experienced in the
management of patients with Gaucher disease. VPRIV should be
administered under the supervision
of a healthcare professional. Home administration may be considered
for patients who have
received at least three infusions in hospital and are tolerating their
infusions well. Home infusions
should only be provided by healthcare professionals trained in
recognising and medically managing
serious infusion related reactions under the direction of a practising
physician.
The recommended dose is 60 U/kg administered every other week as a
60‐minute intravenous
infusion.
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 U/kg every other
week.
Patients currently being treated with other ERT for type 1 Gaucher
disease may be switched to
VPRIV using the same dose and frequency.
_Impaired renal or hepatic function: _
There is no clinical experience in patients with renal or hepatic
insufficiency. However, no dosing
adjustment is recommended in patients with renal or hepatic impairment
based on current
knowledge of the pharmacokinetics and pharmacodynamics of
velaglucerase alfa ghu (see