Vigam Liquid 5g immunoglobulin G sterile liquid

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IMMUNOGLOBULIN G, HUMAN

Available from:

Bio Products Laboratory Limited Dagger Lane, Elstree Hertfordshire, WD6 3BX, United Kingdom

ATC code:

J06BA02

INN (International Name):

IMMUNOGLOBULIN G, HUMAN 5 % (W/V)

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

IMMUNOGLOBULIN G, HUMAN 5 % (W/V)

Prescription type:

POM

Therapeutic area:

IMMUNE SERA AND IMMUNOGLOBULINS

Authorization status:

Withdrawn

Authorization date:

2006-11-22

Patient Information leaflet

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 suscepti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

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) (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. 
Page 1 of 11 

_ _
_ _
_ _
•  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: