GAMUNEX - C

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

IMMUNOGLOBULINS, NORMAL HUMAN

متاح من:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC رمز:

J06BA02

الشكل الصيدلاني:

SOLUTION FOR INFUSION

تركيب:

IMMUNOGLOBULINS, NORMAL HUMAN 0.1 G/ML

طريقة التعاطي:

I.V, S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GRIFOLS THERAPEUTICS LLC., USA

المجموعة العلاجية:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

المجال العلاجي:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

الخصائص العلاجية:

Gamunex is indicated as replacement therapy of primary immunodeficiency (PI) states in which severe impaiment of antibody forming capacity has been shown, such as congential agammaglobulinemia, common variable immunodeficiency, X-limked immunodeficiency with hyper IgM, Wiskott- Aldrich syndrom, and severed combined immunodeficiencies. Gamunex is also indicated in Idiopathic Thrombocytopenia Purpura (ITP) to raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

تاريخ الترخيص:

2020-05-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS)
– 1986
The medicine is dispensed with
a doctor’s prescription only
.
GAMUNEX
®
-C
Solution for infusion
Immunoglobulins, Normal Human 0.1 g/mL (10%)
For a list of inactive and allergenic ingredients in the preparation,
please see section 6
"Further Information". READ THE LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine.
If you have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat your
ailment. Do not pass it on to
others. It may harm them even if it seems to you that their ailment is
similar.
IMPORTANT INFORMATION ABOUT THE MEDICINE
Gamunex-C
is
intended
for
administration
by
subcutaneous
infusion
(into
the
subcutaneous tissue). Do not inject Gamunex-C directly into a blood
vessel or muscle.
IV administration (directly into a blood vessel) of Gamunex-C will
only be performed by
the medical staff (not by the patient) in a clinic or hospital.
WARNING: THROMBOSIS, RENAL FAILURE AND ACUTE RENAL INSUFFICIENCY
●
Thrombosis may occur with the use of immunoglobulins, including
Gamunex-C.
Risk factors for this can include: older age, prolonged immobility,
conditions that
cause hypercoagulability of the blood, history of venous or arterial
thrombosis,
use of estrogen, use of central vascular catheter(s), hyperviscosity
of the blood,
and cardiovascular risk factors.
●
Renal failure, acute renal insufficiency, impairment of renal function
and death
may occur when using immunoglobulin products for intravenous use in
patients
at risk for this.
●
Renal failure and acute renal insufficiency may occur more frequently
in patients
receiving intravenous immunoglobulin products that contain sucrose.
Gamunex-
C does not contain sucrose.
1. WHAT IS THE MEDICINE INTENDED FOR?
●
Gamunex-C is used as an alternative treatment in primary
immunodeficiency (PI)
situations in which the body's ability to produce antibodies is

خصائص المنتج

1 PRESCRIBING INFORMATION
GAMUNEX
®
-C, Immunoglobulin Normal Human 0.1g/mL (10%)
Solution for infusion
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
•
THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING
GAMUNEX-C. RISK FACTORS MAY
INCLUDE: ADVANCED AGE, PROLONGED IMMOBILIZATION, HYPERCOAGULABLE
CONDITIONS, HISTORY OF VENOUS OR
ARTERIAL THROMBOSIS, USE OF ESTROGENS, INDWELLING CENTRAL VASCULAR
CATHETERS, HYPERVISCOSITY, AND
CARDIOVASCULAR RISK FACTORS. THROMBOSIS MAY OCCUR IN THE ABSENCE OF
KNOWN RISK FACTORS. _(SEE_
_WARNINGS AND PRECAUTIONS_ _[5.4])_
•
FOR PATIENTS AT RISK OF THROMBOSIS, ADMINISTER GAMUNEX-C AT THE
MINIMUM DOSE AND INFUSION RATE
PRACTICABLE. ENSURE ADEQUATE HYDRATION IN PATIENTS BEFORE
ADMINISTRATION. MONITOR FOR SIGNS AND
SYMPTOMS OF THROMBOSIS AND ASSESS BLOOD VISCOSITY IN PATIENTS AT RISK
FOR HYPERVISCOSITY. _(SEE _
_DOSAGE AND ADMINISTRATION [2.5], WARNINGS AND PRECAUTIONS [5.4])_
•
RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS, AND DEATH
MAY OCCUR WITH IMMUNE
GLOBULIN INTRAVENOUS (IGIV) PRODUCTS IN PREDISPOSED PATIENTS. PATIENTS
PREDISPOSED TO RENAL
DYSFUNCTION INCLUDE THOSE WITH ANY DEGREE OF PRE-EXISTING RENAL
INSUFFICIENCY, DIABETES MELLITUS, AGE
GREATER THAN 65, VOLUME DEPLETION, SEPSIS, PARAPROTEINEMIA, OR
PATIENTS RECEIVING KNOWN
NEPHROTOXIC DRUGS.
•
RENAL DYSFUNCTION AND ACUTE RENAL FAILURE OCCUR MORE COMMONLY IN
PATIENTS RECEIVING IGIV PRODUCTS
CONTAINING SUCROSE. GAMUNEX-C DOES NOT CONTAIN SUCROSE.
•
FOR PATIENTS AT
RISK OF RENAL DYSFUNCTION OR FAILURE, ADMINISTER GAMUNEX-C AT
THE MINIMUM
CONCENTRATION AVAILABLE AND THE MINIMUM INFUSION RATE PRACTICABLE.
_(SEE WARNINGS AND PRECAUTIONS _
_[5.2])_
1
INDICATIONS AND USAGE
- GAMUNEX-C is indicated as replacement therapy of primary
immunodeficiency (PI) states in which
severe impairment of antibody forming capacity has been shown, such as
congenital
agammaglobulinemia, common variable immunodeficiency, X-linked
immunodeficiency with hyper IgM,
Wiskott- Aldrich syndrome, and severe combi