SUBCUVIA 160 g/l. Solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Human plasma protein >95% immunoglobulins

Available from:

Baxalta Innovations GmbH

ATC code:

J06BA; J06BA01

INN (International Name):

Human plasma protein >95% immunoglobulins

Dosage:

160 gram(s)/litre

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular injection

Units in package:

pack size of 1 or 20

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic group:

immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration

Therapeutic area:

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

Therapeutic indications:

Replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency - IgG subclass deficiencies with recurrent infections

Authorization status:

Not marketed

Authorization date:

2005-06-24

Patient Information leaflet

Package leaflet: Information for the user
SUBCUVIA 160 g/l Solution
for Injection
Active substance:
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 SUBCUVIA is and what it is used for
2. What
you
need
to
know
before
you
use
SUBCUVIA
3. How to use SUBCUVIA
4. Possible side effects
5. How to store SUBCUVIA
6. Contents of the pack and other information
1. What SUBCUVIA is and what it is used for
SUBCUVIA
belongs
to
a
class
of
medicines
called immunoglobulins. These medicines contain
antibodies which are normally found in your blood.
Antibodies
are
proteins
that
help
you
to
fight
infection
by
neutralising
bacteria,
viruses,
and
other foreign bodies. SUBCUVIA is used in the
treatment of certain diseases that are caused by
a lack of antibodies in your blood. These types of
diseases are called antibody deficiency syndromes.
If you do not have enough antibodies, you become
vulnerable
to
frequent
infections.
Regular
and
sufficient doses of SUBCUVIA can correct this lack
of antibodies.
Adults and children can be prescribed SUBCUVIA
as
antibody
replacement
therapy.
The
most
common
reasons
for
people
being
prescribed
antibody replacement therapy are:
•
People who are born with an inability to make
their
own
immune
antibodies
(congenital
agammaglobulinaemia)
•
People who cannot make enough own immune
antibodies (hypogammaglobulinaemia)
•
People who have a mixed group of reasons for
not
making
enough
own
immune
antibodies
(common variable immunodeficienc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SUBCUVIA 160 g/l. Solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Normal Immunoglobulin (SCIg and IMIg)
One ml
contains:
Human normal immunoglobulin …… 160 mg
(purity of at least 95% IgG)
Each vial of 5 ml contains 0.8 g of human normal immunoglobulin
Each vial of 10 ml contains 1.6 g of human normal immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG1 45-75%
IgG2 20-45%
IgG3 3-10%
IgG4 2-8%
The maximum IgA content is 4800 micrograms/ml
Produced from plasma of human donors.
Excipient with known effects:
This medicinal product contains 1.4 mg sodium per ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
The product is a clear or slightly opalescent, colourless to pale
yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Replacement therapy in adults, children and adolescents (0-18) in:_
Primary immunodeficiency syndromes with impaired antibody production
(see section 4.4)
Hypogammaglobulinaemia and recurrent bacterial infections in patients
with chronic lymphocytic leukemia
(CLL), in whom prophylactic antibiotics have failed or are
contra-indicated.
Hypogammaglobulinaemia and recurrent bacterial infections in multiple
myeloma (MM) patients
Hypogammaglobulinaemia in patients pre- and post- allogenic
haematopoietic stem cell transplant (HSCT)
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_3_
_0_
_/_
_1_
_1