CUTAQUIG, 165 mg/ml, solution for injection

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Human normal immunoglobulin

Disponibil de la:

Octapharma (IP) SPRL

Codul ATC:

J06BA; J06BA01

INN (nume internaţional):

Human normal immunoglobulin

Dozare:

165 milligram(s)/millilitre

Forma farmaceutică:

Solution for injection

Zonă Terapeutică:

Immunoglobulins, normal human; immunoglobulins, normal human, for extravascular adm.

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2020-05-01

Prospect

_20231108_81x_PIL_IE_09.08_en _
_ _
_1 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
CUTAQUIG, 165 MG/ML
, solution for injection
Human normal immunoglobulin (SCIg)
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 or pharmacist.
-
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 you doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cutaquig is and what it is used for
2.
What you need to know before you use Cutaquig
3.
How to use Cutaquig
4.
Possible side effects
5.
How to store Cutaquig
6.
Contents of the pack and other information
1.
WHAT CUTAQUIG IS AND WHAT IT IS USED FOR
WHAT CUTAQUIG IS
Cutaquig belongs to a class of medicines called “human normal
immunoglobulins”. Immunoglobulins
are also known as antibodies and are proteins found in healthy
people’s blood. Antibodies are part of
the immune system (the body’s natural defense) and help your body to
fight infections.
HOW CUTAQUIG WORKS
Cutaquig contains immunoglobulins that have been prepared from the
blood of healthy people. The
medicine works in exactly the same way as the immunoglobulins
naturally present in your blood.
WHAT CUTAQUIG IS USED FOR
Cutaquig is used in patients who do not have enough antibodies to
fight off infections and therefore
tend to have frequent infections. Regular administration of sufficient
doses of Cutaquig can raise
abnormally low immunoglobulin levels in your blood to normal levels
(replacement therapy).
Cutaquig is prescribed to adults and children (aged 0-18 years) in the
following situations:
Treatment of patients who are born with a reduced ability or inability
to produce antibodies (primary
immunodeficiency).
Patients wit

Caracteristicilor produsului

Health Products Regulatory Authority
17 November 2023
CRN00DJTX
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CUTAQUIG, 165 mg/ml, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (SCIg)
One ml contains:
Human normal immunoglobulin……………………………..165 mg
(purity of at least 95% IgG)
Each vial of 6 ml contains: 1 g of human normal immunoglobulin.
Each vial of 10 ml contains: 1.65 g of human normal immunoglobulin.
Each vial of 12 ml contains: 2 g of human normal immunoglobulin.
Each vial of 20 ml contains: 3.3 g of human normal immunoglobulin.
Each vial of 24 ml contains: 4 g of human normal immunoglobulin.
Each vial of 48 ml contains: 8 g of human normal immunoglobulin.
Distribution of the IgG subclasses (approx. values):
IgG
1
……….. 71%
IgG
2
……….. 25%
IgG
3
……….. 3%
IgG
4
………… 2%
The maximum IgA content is 300 micrograms/ml.
Produced from the plasma of human donors.
Excipient(s) with known effect:
This medicinal product contains 33.1 mg sodium per vial of 48 ml and
13.8 mg per vial of 20 ml, see section 4.4.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
The liquid preparation is clear and colourless.
During storage the liquid may turn to slightly opalescent and
pale-yellow.
The osmolality of the liquid preparation is 310 to 380 mosmol/kg.
The pH of the solution is 5-5.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Replacement therapy in adults, children and adolescents (0-18 years)
in _

Primary immunodeficiency (PID) syndromes 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 <4g/l.*PSAF =
failure to mount at least a 2-fold rise in IgG antibody titre to
pneumococcal polysaccharide and polypeptide
antigen vaccines
4.2 POSOL