HyQvia

Land: Den europeiske union

Språk: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv ingrediens:

Human normal immunoglobulin

Tilgjengelig fra:

Baxalta Innovations GmbH

ATC-kode:

J06BA01

INN (International Name):

human normal immunoglobulin

Terapeutisk gruppe:

Immune sera and immunoglobulins,

Terapeutisk område:

Immunologic Deficiency Syndromes

Indikasjoner:

Replacement therapy in adults, children and adolescents (0-18 years) in:Primary immunodeficiency syndromes with impaired antibody production.Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra‑indicated.Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.Hypogammaglobulinaemia in patients pre‑ and post‑allogeneic hematopoietic stem cell transplantation (HSCT).

Produkt oppsummering:

Revision: 20

Autorisasjon status:

Authorised

Autorisasjon dato:

2013-05-16

Informasjon til brukeren

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
HYQVIA 100 MG/ML SOLUTION FOR INFUSION FOR SUBCUTANEOUS USE
HUMAN NORMAL IMMUNOGLOBULIN
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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What HyQvia is and what it is used for
2.
What you need to know before you use HyQvia
3.
How to use HyQvia
4.
Possible side effects
5.
How to store HyQvia
6.
Contents of the pack and other information
1.
WHAT HYQVIA IS AND WHAT IT IS USED FOR
WHAT HYQVIA IS
HyQvia contains 2 solutions for infusion (drip) under the skin
(subcutaneous or SC infusion).
It is supplied as a package containing:
•
one vial of human normal immunoglobulin 10% (the active substance)
•
one vial of recombinant human hyaluronidase (a substance which helps
the human normal
immunoglobulin 10% reach your blood).
Human normal immunoglobulin 10% belong to a class of medicines called
“human normal
immunoglobulins”. Immunoglobulins are also known as antibodies and
are found in healthy people’s
blood. Antibodies are part of the immune system (the body’s natural
defences) and help your body to
fight infections.
HOW HYQVIA WORKS
The recombinant human hyaluronidase is a protein that makes it easier
for the immunoglobulins to be
infused (dripped) under the skin and to reach your blood system.
The vial of immunoglobulins has been prepared from the blood of
healthy people. Immunoglobulins
are produced by the human body’s immune system. They help your body
to fight infections caused by
bacteria and viruses or maintain

Preparatomtale

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
HyQvia 100 mg/mL solution for infusion for subcutaneous use
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
HyQvia is a dual vial unit consisting of one vial of human normal
immunoglobulin
(Immune Globulin 10% or IG 10%) and one vial of recombinant human
hyaluronidase (rHuPH20).
Human normal immunoglobulin (SCIg)*
One mL contains:
Human normal immunoglobulin.
100 mg
(purity of at least 98% IgG)
Each vial of 25 mL contains: 2.5 g of human normal immunoglobulin
Each vial of 50 mL contains: 5 g of human normal immunoglobulin
Each vial of 100 mL contains: 10 g of human normal immunoglobulin
Each vial of 200 mL contains: 20 g of human normal immunoglobulin
Each vial of 300 mL contains: 30 g of human normal immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG
1
≥ 56.9%
IgG
2
≥ 26.6%
IgG
3
≥ 3.4%
IgG
4
≥ 1.7%
The maximum IgA content is 140 micrograms/mL.
*Produced from the plasma of human donors.
Recombinant human hyaluronidase (rHuPH20)
One mL contains:
Recombinant human hyaluronidase.
160 units
Each vial of 1.25 mL contains: 200 units of recombinant human
hyaluronidase
Each vial of 2.5 mL contains: 400 units of recombinant human
hyaluronidase
Each vial of 5 mL contains: 800 units of recombinant human
hyaluronidase
Each vial of 10 mL contains: 1600 units of recombinant human
hyaluronidase
Each vial of 15 mL contains: 2400 units of recombinant human
hyaluronidase
Excipients with known effects:
•
Recombinant human hyaluronidase (rHuPH20)
The rHuPH20is a purified glycoprotein of 447 amino acids produced in
Chinese Hamster Ovary
(CHO) cells by recombinant DNA technology
•
Sodium (as chloride and as phosphate)
The total sodium content of recombinant human hyaluronidase is 4.03
mg/mL.
For the full list of excipients, see section 6.1.
3
3.
PHARMACEUTICAL FORM
Solution for infusion.
IG 10% is a clear or slightly opalescent and colourless or pale-yellow
solution. The solution has a
pH of 4.6 to 5.1 and an osmolality of 240