OMR-IGG-AM 5 %

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IMMUNOGLOBULINS, NORMAL HUMAN

Available from:

OMRIX BIOPHARMACEUTICALS

ATC code:

J06BA02

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

IMMUNOGLOBULINS, NORMAL HUMAN 50 MG/ML MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

OMRIX BIOPHARMACEUTICALS LTD. PLASMA FRACTIONATION INSTITUTE (PFI), ISRAEL

Therapeutic group:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Therapeutic area:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.

Therapeutic indications:

Replacement therapy * PRIMARY immunodeficiency (patients with PRIMARY defective antibody synthesis such as agammaglobulinemia OR hypogammaglobulinemia) * Myeloma OR chronic Lymphocytic Leukemia (CLL) with severe secondary hypogammaglobulinemia AND recurrent infections. * Children with congenital AIDS AND recurrent infections - Immunomodulation * Idiopathic Thrombocytopenic Purpura (ITP) * Guillain Barre Syndrome * Kawasaki Disease - Allogenic Bone Marrow Transplantation

Authorization date:

2023-06-30

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
13.5.2013
םש
רישכת
תילגנאב
רפסמו
_םושירה
OMR-IGG-AM 127 54 30698 00
_
םש
לעב
םושירה
____
OMRIX BIOPHARMACEUTICALS LTD
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE &
ADMINISTRATION
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS
FOR USE
Adequate hydration prior
to the initiation of IVIG
infusion is required.
Certain severe adverse
drug reactions may be
related to the rate of
infusion
Patients naive to
immunoglobulin G (IgG)
usually experience a
higher frequency of
events than those well
maintained on regular
therapy. The
recommended infusion
General
Adequate hydration prior to the initiation of
IVIG infusion is required.
Potential complications can often be avoided
by ensuring that patients:

Are not sensitive to human
immunoglobulin by initial injecting the
product slowly.

Are carefully monitored for any
symptoms throughout the infusion
period. In particular patients naïve to
human immunoglobulin, patients
switched from an alternative IVIg
product or when there has been a
long interval since the previous
infusion should be monitored during
the first infusion and for the first hour
after the first infusion, in order to
detect potential adverse signs. All
other patients should be observed for
at least 20 minutes after
administration.
Certain severe adverse drug reactions may
be related to the rate of infusion, therefore
recommended infusion rate given under
“Dosage and Administration” must be closely
followed.
PATIENTS NAIVE TO IMMUNOGLOBULIN G (IGG)
Patients naive to immunoglobulin G (IgG)
usually experience a higher frequency of
events than those well maintained on regular
therapy. The recommended infusion rate
given unde

Summary of Product characteristics

1
ודי לע רשואו קדבנ ונכותו תואירבה דרשמ
י"ע עבקנ הז ןולע טמרופ ךיראתב
07.8.16
This leaflet has been determined by the Ministry of Health and the
content thereof has been checked and approved
Physician’s leaflet
OMR-IGG-AM ™ 5% IV
NANOFILTERED AND SD VIRUS INACTIVATED
THE METHOD OF PREPARATION INCLUDES A STEP TO REMOVE DETECTABLE
THROMBOSIS-GENERATING
AGENTS
COMPOSITION:
OMR-IGG-AM ™ 5% IV is a sterile solution containing 5% protein (50
mg in 1 ml solution of which at least 95% is
Human Normal Immunoglobulin G as the active ingredient), 10% maltose
and Water for Injections. The
Immunoglobulin A (IgA) content is

0.15mg/ml.
OMR-IGG-AM ™ 5% IV DOES NOT CONTAIN SUCROSE. No preservatives are
added.
DESCRIPTION
OMR-IGG-AM ™ 5% IV is manufactured from human plasma by Cohn
(ethanol) fractionation (this step has been
shown in literature to be a primary virus inactivation step). After a
first ultra - /diafiltration, the product undergoes a
second virus inactivation step by the solvent-detergent method using
TnBP/Triton-X-100, and a third inactivation by
nanofiltration at pH-4. MANUFACTURING PROCESS INCLUDES A SPECIFIC STEP
TO REMOVE DETECTABLE THROMBOSIS-
GENERATING AGENTS (see Warnings and Special Precautions).
PHARMACEUTICAL FORM
OMR-IGG-AM ™ 5% IV is a clear or slightly opalescent, almost
odorless, colorless to pale yellow liquid for
intravenous infusion.
PHARMACOLOGICAL PROPERTIES
_Pharmacodynamic properties _
As Human Normal Immunoglobulin, the product contains mainly IgG having
a broad spectrum of antibodies against
various infectious agents (viruses and bacteria) currently prevalent
in the population.
Opsonization and neutralization of micro-organisms and toxins have
been documented.
OMR-IGG-AM ™ 5% IV contains all the immunoglobulin G activities
which are present in the normal population. It is
prepared from pooled source material from not fewer than 1000
prescreened donors.
The product has a distribution of IgG sub-classes closely proportional