Vigam Liquid 5g/100ml solution for infusion vials

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Normal immunoglobulin human

Tilgængelig fra:

Bio Products Laboratory Ltd

ATC-kode:

J06BA02

INN (International Name):

Normal immunoglobulin human

Dosering:

50mg/1ml

Lægemiddelform:

Solution for infusion

Indgivelsesvej:

Intravenous

Klasse:

No Controlled Drug Status

Recept type:

Caution - AMP level prescribing advised

Produkt oversigt:

BNF: 14050100; GTIN: 5019943000010

Indlægsseddel

VIGAM
® LIQUID 2.5 G, 5 G AND 10 G
5% W/V SOLUTION FOR INFUSION
HUMAN NORMAL IMMUNOGLOBULIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
VLL12
•
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 VIGAM LIQUID IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIGAM LIQUID
3. HOW TO USE VIGAM LIQUID
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE VIGAM LIQUID
6. CONTENT OF PACK AND OTHER INFORMATION
1. WHAT VIGAM LIQUID IS AND WHAT IT IS USED FOR
Vigam Liquid is a solution containing the active substance
called human normal immunoglobulin (a protein in the body
used to fight infections) which is obtained from blood plasma
from screened donors. These donors are selected from the
USA.
The product is given by injection into a vein (intravenous
infusion). It can be given in a hospital or for use at home and
is only available on a doctor’s prescription.
This medicine is used to replace antibodies which are missing
from your body in primary antibody deficiencies (lack of certain
proteins protective against infection that you may either have
been born with or may develop during life) such as:
•
agammaglobulinaemia (deficiency of gamma globulins in
the blood),
•
hypogammaglobulinaemia (low levels of immunoglobulin
G (IgG), IgA and/or IgM),
•
common variable immunodeficiency (failure of the immune
system to produce antibodies against infections),
•
severe combined immunodeficiency (a severe genetic
disorder of the immune system making you susceptible to
infections),
•
Wiskott Aldrich syndrome (hereditary disord

Produktets egenskaber

OBJECT 1
VIGAM LIQUID IS A STERILE LIQUID OF 5 G% NORMAL
IMMUNOGLOBULIN
Summary of Product Characteristics Updated 23-Nov-2015 | Bio Products
Laboratory Limited
1. Name of the medicinal product
Vigam Liquid is a 5 % w/v normal immunoglobulin sterile liquid.
2. Qualitative and quantitative composition
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin 50 mg
(Purity of at least 95% IgG)
Each 2.5 g vial of 50 mL contains: 2.5 g of Human normal
immunoglobulin.
Each 5 g vial of 100 mL contains: 5 g of Human normal immunoglobulin.
Each 10 g vial of 200 mL contains: 10 g of Human normal
immunoglobulin.
Distribution of the IgG subclasses is similar to plasma (approximate
values):
IgG1: 64 %
IgG2: 29 %
IgG3: 6 %
IgG4: 1 %
The maximum IgA content is 14 micrograms/ml.
Produced from the plasma of human donors.
Excipient(s):
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Vigam Liquid is a sterile liquid for intravenous administration which
varies from colourless to pale amber
or pale green.
4. Clinical particulars
4.1 Therapeutic indications
Replacement therapy in adults, and children and adolescents (0-18
years) in:
• Primary immunodeficiency syndromes with impaired antibody
production (see section 4.4).
• Hypogammaglobulinaemia and recurrent bacterial infections in
patients with chronic lymphocytic
leukaemia, in whom prophylactic antibiotics have failed.
• Hypogammaglobulinaemia and recurrent bacterial infections in
plateau phase multiple myeloma
patients who have failed to respond to pneumococcal immunisation.
• Hypogammaglobulinaemia in patients after allogeneic haematopoietic
stem cell transplantation (HSCT).
• Congenital AIDS and recurrent bacterial infections
Immunomodulation in adults, and children and adolescents (0-18 years)
in:
• Primary immune thrombocytopenia (ITP), in patients at high risk of
bleeding or prior to surgery to
correct the platelet count
• Guillain Barré Syndrome
• Kawasaki disease.
4.2 Posology and method of administration
Replace