Kiovig
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
27-06-2022
Produktets egenskaber
(SPC)
27-06-2022
Offentlige vurderingsrapport
(PAR)
24-04-2019
Aktiv bestanddel:
human normal immunoglobulin (IVIg)
Tilgængelig fra:
Takeda Manufacturing Austria AG
ATC-kode:
J06BA02
INN (International Name):
human normal immunoglobulin
Terapeutisk gruppe:
Immune sera and immunoglobulins,
Terapeutisk område:
Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome
Terapeutiske indikationer:
Replacement therapy in adults, and 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, 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;multifocal motor neuropathy (MMN).
Produkt oversigt:
Revision: 26
Autorisation status:
Authorised
Autorisation dato:
2006-01-18
Indlægsseddel
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
KIOVIG 100 MG/ML 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.
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 KIOVIG is and what it is used for
2.
What you need to know before you use KIOVIG
3.
How to use KIOVIG
4.
Possible side effects
5.
How to store KIOVIG
6.
Contents of the pack and other information
1.
WHAT KIOVIG IS AND WHAT IT IS USED FOR
KIOVIG belongs to a class of medications called immunoglobulins. These
medicines contain human
antibodies, which are also present in your blood. Antibodies help your
body to fight infections.
Medicines like KIOVIG are used in patients who do not have enough
antibodies in their blood and
tend to get frequent infections. They can also be used in patients who
need additional antibodies for
the cure of certain inflammatory disorders (autoimmune diseases).
KIOVIG IS USED FOR
TREATMENT OF PATIENTS WHO DO NOT HAVE SUFFICIENT ANTIBODIES
(REPLACEMENT THERAPY). THERE ARE
TWO GROUPS:
1.
Patients with inborn lack of antibody production (primary
immunodeficiency syndromes).
2.
Patients with secondary immunodeficiencies (SID) who suffer from
severe or recurrent
infections, ineffective antimicrobial treatment and either PROVEN
SPECIFIC ANTIBODY FAILURE
(PSAF)* or serum IgG level of <4 g/l.
*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide
and polypeptide antigen vaccines
TREATMENT OF PATIENTS WITH CERTAIN INFLAMMATORY DISORDERS
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
KIOVIG 100 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin ……………100 mg
(purity of at least 98% IgG)
Each vial of 10 ml contains: 1 g of human normal immunoglobulin
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 IgG subclasses (approx. values):
IgG1 ≥56.9%
IgG2 ≥26.6%
IgG3 ≥3.4%
IgG4 ≥1.7%
The maximum IgA content is 140 micrograms/ml.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
The solution is clear or slightly opalescent and colourless or pale
yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replacement therapy in adults, and children and adolescents (0-18
years) in:
Primary immunodeficiency syndromes (PID) with impaired antibody
production (see
section 4.4).
Secondary immunodeficiencies (SID) in patients who suffer from severe
or recurrent infections,
ineffective antimicrobial treatment and either PROVEN SPECIFIC
ANTIBODY FAILURE (PSAF)* or
serum IgG level of <4 g/l.
*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide
and polypeptide antigen vaccines
3
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 (in conjunction with acetylsalicylic acid; see 4.2).
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Multifocal Motor Neuropathy (MMN).
4.
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