KIOVIG 100 MGML

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

IMMUNOGLOBULINS, NORMAL HUMAN

Disponibil de la:

TAKEDA ISRAEL LTD

Codul ATC:

J06BA02

Forma farmaceutică:

SOLUTION FOR INFUSION

Compoziție:

IMMUNOGLOBULINS, NORMAL HUMAN 100 MG / 1 ML

Calea de administrare:

I.V

Tip de prescriptie medicala:

Required

Produs de:

BAXTER AG, AUSTRIA

Grupul Terapeutică:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Zonă Terapeutică:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Indicații terapeutice:

IVIg can be used in all age ranges, unless otherwise specified below.Replacement therapy 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.Children and adolescents (age 0-18) with congenital AIDS and recurrent bacterial infections.Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT).ImmunomodulationPrimary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.Guillain Barré syndrome.Kawasaki disease.

Data de autorizare:

2016-06-30

Prospect

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ןולעב )תוחיטב
אפורל
אפורל
אפורל
יאמ ןכדועמ ,דבלב תורמחהה טורפל דעוימ
הז ספוט
5102
ךיראת
2 NOV 2015
תילגנאב רישכת םש
KIOVIG 100 MG/ ML SOLUTION FOR INFUSION
םושירה רפסמ
641-44-55643
םושירה לעב םש
TEVA MEDICAL MARKETING LTD תורמחהה
קובמה
ש תו
ןולעב קרפ
יחכונ טסקט
שדח טסקט
SPECIAL
WARNINGS AND
SPECIAL
PRECAUTIONS FOR
USE

In
all
patients,
IVIg
administration requires:

adequate hydration prior
to
the
initiation
of
the
infusion of IVIg

monitoring
of
urine
output

monitoring
of
serum
creatinine levels

avoidance
of
concomitant use of loop
diuretics.
[…]
Thromboembolism
… Caution should be exercised
in prescribing and infusion of
IVIg in obese patients and in
patients with pre-existing risk
factors for thrombotic events
(such as a history of
atherosclerosis, multiple
cardiovascular risk factors,
advanced age, impaired cardiac
output, hypertension, diabetes
mellitus and a history of
vascular disease or thrombotic
episodes, patients with acquired
or inherited thrombophilic
disorders, hypercoagulable
disorders, patients with
prolonged periods of
immobilisation, severely
hypovolemic patients, patients
with diseases which increase
blood viscosity).
[…]
Acute renal failure
...
In
most
cases,
risk
factors
have
been
identified,
such
as
pre-existing renal insufficiency,
In all patients, IVIg administration requires:

adequate hydration prior to the initiation of
the infusion of IVIg

monitoring of urine output

monitoring of serum creatinine levels

monitoring
for
signs
and
symptoms
of
thrombosis

assessment of blood vicosity in patients at
risk for hyperviscosity

avoidance
of
concomitant
use
of
loop
diuretics.
[…]
Thromboembolism
… Caution should be exercised in prescribing and
infus

Caracteristicilor produsului

1
1.
NAME OF THE MEDICINAL PRODUCT
_ _
KIOVIG 100 mg/ml
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin ……………...100 mg
(purity of at least 98% is 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.
2
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
IVIg can be used in all age ranges, unless otherwise specified below
Replacement therapy in:
•
Primary immunodeficiency syndromes
(
PID
)
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).
•
Children and adolescents (age 0-18) with congenital AIDS and recurrent
bacterial infections.
Immunomodulation:
•
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
Replacement therapy should be initia