KAM-RHO D I.M.

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

ANTI-D IMMUNOGLOBULINS

Fáanlegur frá:

KAMADA LTD, ISRAEL

ATC númer:

J06BB01

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

ANTI-D IMMUNOGLOBULINS 150 MCG/ML

Stjórnsýsluleið:

I.M

Gerð lyfseðils:

Required

Framleitt af:

KAMADA LTD, ISRAEL

Meðferðarhópur:

ANTI-D (RH) IMMUNOGLOBULIN

Lækningarsvæði:

ANTI-D (RH) IMMUNOGLOBULIN

Ábendingar:

Pregnancy/other obstetric conditions, Suppression of Rh immunization in non-sensitized Rh0 (D) negative women delivering an Rh0 positive baby or when the baby's Rh type is unknown. Suppression of Rh immunization after spontaneous or induced abortions threatened abortion associated with maternal bleeding amniocentesis chorionic villus sampling ruptured tubal pregnancy and significant abdominal trauma. Kam Rh0 -D IM should be given within 72 hours of the event. It may be given even after up to one month although efficacy may be somewhat reduced.Transfusion: Suppression of Rh isoimmunization in Rh0 (D) antigen-negative patients transfused with Rh0 (D) antigen-positive RBCs of blood components containing Rh0 (D) antigen-positive RBCs . Initate treatment within 72 hours of exposure.

Leyfisdagur:

2022-01-31

Upplýsingar fylgiseðill

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
__________
14-7-13
_____________
םש
רישכת
תילגנאב
רפסמו
םושירה
KAM-RHO D I.M., 108-73-28991
םש
לעב
םושירה
__________
KAMADA LTD
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
WARNINGS
RECOMMENDATIONS REGARDING THROMBOSIS

Care should be used when immune globulin products
are given to individuals determined to be at increased
risk of thrombosis.

Patients at increased risk of thrombosis include those
with acquired or hereditary hypercoagulable states,
prolonged immobilization, in-dwelling vascular
catheters, advanced age, estrogen use, a history of
venous or arterial thrombosis, cardiovascular risk
factors (including history of atherosclerosis and/or
impaired cardiac output), and hyperviscosity
(including cryoglobulins, fasting chylomicronemia
and/or high triglyceride levels, and monoclonal
gammopathies).

As noted in product labeling, patients at risk for
thrombosis should receive immune globulin products
at the slowest rate practicable, and these individuals
should be monitored for thrombotic complications.

Consideration should also be given to measurement
of baseline blood viscosity in individuals at risk for
hyperviscosity.
RECOMMENDATIONS REGARDING HEMOLYSIS

Heightened awareness of the potential for hemolysis
is recommended in individuals receiving immune
globulin
products,
particularly
those
who
are
determined to be at increased risk.

Patients
at
increased
risk
for
hemolysis
following treatment with immune globulins include
those with non-O blood group types, those who have
underlying associated inflammatory conditions, and
those receiving high cumulative doses of immune
globulins over the course of several days.

As noted in product labeling, p

Vara einkenni

Rh
o
(D) Immune Globulin (Human) for intramuscular
use only.
DESCRIPTION
KAMRH
O
-D I.M. is a sterile non-pyrogenic aqueous
solution, containing 150
µ
g/ml of immune globulin
anti-D. It is prepared from pooled Human venous plasma
with a high content of anti-D antibodies. Each unit of
plasma and each plasma pool used in the manufacture
of this product has been tested and found to be non-
reactive to Hepatitis B Surface Antigen (HBsAg), anti
HIV I-II and anti-HCV. Kamada’s manufacturing process includes
a Solvent/Detergent step, that is, treatment with tri-(n-butyl)
phosphate and Triton X-100, a step designed to increase the
safety of the product by eliminating the risk of transmission of
lipid enveloped viruses. In addition the process includes heat-
treatment at 60°C for 10 hours, a process long-known to inactivate
viruses. Finally the purification process itself has been found to be
capable of reducing the concentration of a non-enveloped type
virus by several logs.
The product is stabilized with 0.3 M Glycine and is preservative
free.
COMPOSITION
Each vial of KAMRH
O
-D I.M. contains:
Rh
o
(D) Immune Globulin 150
µ
g/ml
Glycine 2.25% W/V = 0.3 M.
ACTIONS AND CLINICAL PHARMACOLOGY
PHARMACOLOGY
KAMRH
O
-D I.M. is a sterile non-pyrogenic purified gamma globulin
(IgG) solution, manufactured from human plasma containing
high titers of anti-Rh
o
(D). The manufacturing process includes
a solvent/detergent treatment and heat - treatment at 60°C for
10 hours, steps that are effective in inactivating viruses such as
hepatitis B, hepatitis C, HIV and others. These steps are designed to
increase product safety by reducing the risk of virus transmission.
KAMRH
O
-D immune globulin is prepared from human plasma by
an ion-exchange column chromatography method.
KAMRH
O
-D I.M. is used to suppress the immune response of
non-sensitized Rh
o
(D) antigen-negative individuals following
Rh
o
(D) antigen-positive red blood cell exposure by fetomaternal
hemorrhage during delivery of a Rh
o
(D) antigen-positive infant,
abortion (