KAM-RHO (D) I.V.

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

ANTI-D IMMUNOGLOBULINS

Disponible depuis:

KAMADA LTD, ISRAEL

Code ATC:

J06BB01

forme pharmaceutique:

SOLUTION FOR INJECTION

Composition:

ANTI-D IMMUNOGLOBULINS 150 MCG / 1 ML

Mode d'administration:

I.V

Type d'ordonnance:

Required

Fabriqué par:

KAMADA LTD, ISRAEL

Groupe thérapeutique:

ANTI-D (RH) IMMUNOGLOBULIN

Domaine thérapeutique:

ANTI-D (RH) IMMUNOGLOBULIN

indications thérapeutiques:

Suppression of Rh immunization in non-sensitized Rho(D) negative women delivering an Rh 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-Rho should be given within 72 hours of event. Immune thrombocytopenic purpura (ITP): Rho (d)-positive adults with chronic ITP, children with chronic or acute ITP, and patients with Thrombocytopenia secondary to HIV infection in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage.

Date de l'autorisation:

2013-03-31

Notice patient

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
__________
11-7-13
_____________
םש
רישכת
תילגנאב
רפסמו
םושירה
_
127-78-28761
_
KAM-RHO
(D) I.V
.
_
םש
לעב
םושירה
__________
KAMADA LTD
! דבלב תורמחהה טורפל דעוימ הז ספוט
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 infusion 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.

For patients judged to be a risk of developing thrombotic
events, administer Rh0D immune Globulins at a
minimum rate of infusion.
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
infl

Résumé des caractéristiques du produit

1
KAM_RH_
_O_
-D I.V.
Rh
0
(D) Immune Globulin (Human) for intravenous use only.
WARNING: INTRAVASCULAR HEMOLYSIS (IVH)
INTRAVASCULAR HEMOLYSIS (IVH) LEADING TO DEATH HAS BEEN REPORTED IN
PATIENTS TREATED FOR IMMUNE
THROMBOCYTOPENIC PURPURA (ITP) WITH RH
0
D IMMUNE GLOBULINS.
IVH CAN LEAD TO CLINICALLY COMPROMISING ANEMIA AND MULTI-SYSTEM ORGAN
FAILURE INCLUDING ACUTE
RESPIRATORY DISTRESS SYNDROME (ARDS).
SERIOUS COMPLICATIONS INCLUDING SEVERE ANEMIA, ACUTE RENAL
INSUFFICIENCY, RENAL FAILURE AND
DISSEMINATED INTRAVASCULAR COAGULATION (DIC) HAVE ALSO BEEN REPORTED.
Closely monitor patients treated with KAM_RH_
_O_
-D I.V. for ITP in a health care setting for at least eight
hours after administration. Perform a dipstick urinalysis at baseline,
2 hours, 4 hours after administration
and prior to the end of the monitoring period. Alert patients and
monitor the signs and symptoms of IVH,
including back pain, shaking chills, fever, and discolored urine or
hematuria. Absence of these signs
and/or symptoms of IVH within eight hours do not indicate IVH cannot
occur subsequently. If signs and/or
symptoms of IVH are present or suspected after KAM_RH_
_O_
-D I.V. administration, post-treatment laboratory
tests should be performed, including plasma hemoglobin, haptoglobin,
LDH, and plasma bilirubin (direct
and indirect).
DESCRIPTION
KAM_RH_
_O_
-D I.V. is a sterile non-pyrogenic aqueous solution, containing 150

g/mL (1500 IU/2 ml) of
immune globulin anti-D. KAM_RH_
_O_
-D I.V. immune globulin is prepared from Human plasma by an ion -
exchange column chromatography method, and it is manufactured from
pooled Human venous plasma
with a high content of anti-D antibodies. Each unit of plasma used in
the manufacture of this product has
been tested and found to be negative/non-reactive to Hepatitis B
Surface Antigen (HBsAg), HIV-1
antigen, anti-HIV I-II and anti-HCV. In addition, the plasma has been
tested by a NAT method and found
to be negative for HAV, HIV, HBV and HCV and to contain < 10
4
I.U/mL Parvovirus B-19. The plasma
p