VPRIV 400units powder for solution for infusion vials

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Velaglucerase alfa

Հասանելի է:

Shire Pharmaceuticals Ltd

ATC կոդը:

A16AB10

INN (Միջազգային անվանումը):

Velaglucerase alfa

Դոզան:

400unit

Դեղագործական ձեւ:

Powder for solution for infusion

Կառավարման երթուղին:

Intravenous

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF:

Տեղեկատվական թերթիկ

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VPRIV 400 UNITS POWDER FOR SOLUTION FOR INFUSION
velaglucerase alfa
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. This includes any
possible side effects not listed
in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What VPRIV is and what it is used for
2.
What you need to know before you use VPRIV
3.
How to use VPRIV
4.
Possible side effects
5.
How to store VPRIV
6.
Contents of the pack and other information
1.
WHAT VPRIV IS AND WHAT IT IS USED FOR
VPRIV is a long-term enzyme replacement therapy (ERT) for patients
with type 1 Gaucher disease
Gaucher disease is a genetic disorder caused by a missing or defective
enzyme named
glucocerebrosidase. When this enzyme is missing or does not work
properly, a substance called
glucocerebroside builds up inside cells in the body. The build-up of
this material causes the signs and
symptoms found in Gaucher disease.
VPRIV is designed to replace the missing or defective enzyme,
glucocerebrosidase, in patients with
Gaucher disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VPRIV
DO NOT USE VPRIV:
-
If you are allergic to velaglucerase alfa or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using VPRIV
-
If you are treated with VPRIV, you may experience side effects during
or following the
infusion (see section 4, possible side effects). These are called
infusion related reactions
and might appear as a hypersensitivity reaction with symptoms like
nausea, rash,
difficulty in breathing, back pain, chest discomfort (chest
tightness), hives, joint pain or
headache.
-
Apart from symptoms of hypersensitivity reactions infusion-related
reactions might
show as dizziness, high blood pressure, tiredness, fever, or itching.
-
If you experience any of th

Ապրանքի հատկությունները

OBJECT 1
VPRIV 400 UNITS POWDER FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 26-Apr-2018 | Shire
Pharmaceuticals Limited
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 37°C.
** 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
s