HyQvia 2.5g25ml solution for infusion and 1.25ml vials

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Disponibil de la:

Baxalta UK Ltd

Codul ATC:

J06BA02

Forma farmaceutică:

Not applicable

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: ; GTIN: 5413760415611

Prospect

1
B. PACKAGE LEAFLET
2 PACKAGE LEAFLET: INFORMATION FOR THE USER
HYQVIA 100 MG/ML SOLUTION FOR INFUSION FOR SUBCUTANEOUS USE
HUMAN NORMAL IMMUNOGLOBULIN
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of
section 4 for how to report side effects.
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 two 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) and one vial of recombinant human hyaluronidase (a
substance which helps the human
normal immunoglobulin 10% reach your blood).
Human normal immunoglobulin 10% belongs 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 vial of immunoglobulins has been prepared from the blood of
healthy people. The medicine
works in exactly the same way as the immunoglobulins naturally present
in the

Caracteristicilor produsului

OBJECT 1
HYQVIA 100 MG/ML SOLUTION FOR INFUSION FOR
SUBCUTANEOUS USE
Summary of Product Characteristics Updated 24-May-2017 | Shire
Pharmaceuticals Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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.
Excipients with known effects:
• Recombinant human hyaluronidase (rHuPH20)
Recombinant human hyaluronidase is 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. Pharmaceutical form
Solution for infusion (infusion).
IG 10% is a clear or slightly opalescent and colourless or pale yellow
solution.
Recombinant human hyaluronidase is a clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Replaceme