HEPAGAM B

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

HEPATITIS B IMMUNOGLOBULIN

Beschikbaar vanaf:

TZAMAL BIO-PHARMA LTD

ATC-code:

J06BB04

farmaceutische vorm:

SOLUTION FOR INJECTION

Samenstelling:

HEPATITIS B IMMUNOGLOBULIN 312 IU/ML

Toedieningsweg:

I.M, I.V

Prescription-type:

Required

Geproduceerd door:

EMERGENT BIOSOLUTION CANADA INC., CANADA

Therapeutische categorie:

HEPATITIS B IMMUNOGLOBULIN

Therapeutisch gebied:

HEPATITIS B IMMUNOGLOBULIN

therapeutische indicaties:

Prevention of hepatitis B recurrence following liver transplantation : Hepagam B is indicated for the prevetion of hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients. Hepagam B should be administered intravenously for this indication.Postexposure prophylaxis : Hepagam B is indicated for the treatment of acute exposure to blood containing HBsAg perinatal exposure of infants born to HBsAg-positive mothers sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection in the following settings: Acute exposure to blood containing HBsAg Following either parenteral exposure (needlestick bite sharps) direct mucous membrane contact (accidental splash) or oral ingestion (pipetting accident) involving HBsAg - positive materials such as blood plasma or serum. Perinatal exposure of infants born to HBsAg-positive mothers Infants born to mothers positive for HBsAg with or without HBeAg. Perinatal exposure of infants born to HBsAg-positive persons Sexual partners of HBsAg-positive persons. Household exposure to persons with acute HBV infection Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. Other household contacts with an identifiable blood exposure to the index patient. Hepagam B is indicated for intramuscular use only for these post-exposure prophylaxis indications.

Autorisatie datum:

2014-03-31

Bijsluiter

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ךיראת
17.07.2012
םש
רישכת
תילגנאב
HEPAGAM B
רפסמ
םושיר
140
62
31748
00
םש
לעב
םושירה
TZAMAL BIO-PHARMA LTD
.
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
2.
DOSAGE AND
ADMINISTRATION
NA
For intravenous administration, administer HepaGam
B through a separate intravenous line using an
infusion pump. Use normal saline as the diluent if
dilution of HepaGam B is preferred prior to
intravenous administration. Do not use dextrose (5%)
in water (D5W)
.
5.
WARNING AND
PRECAUTIONS -
5.7 THROMBOTIC
EVENTS
NA
5.7 THROMBOTIC EVENTS
Thrombotic events may occur during or following
treatment with IGIV products. Patients at risk include
those with a history of atherosclerosis, multiple
cardiovascular risk factors, advanced age, impaired
cardiac output, coagulation disorders, prolonged
periods of immobilization, and/or known/suspected
hyperviscosity.
Consider baseline assessment of blood viscosity in
patients at risk for hyperviscosity including those with
cryoglobulins, fasting chylomicronemia/markedly high
triacylglycerols (triglycerides), or monoclonal
gammopathies. For patients who are at risk of
developing thrombotic events, administer HepaGam
B at the minimum rate of infusion practicable.
15.
PATIENT
COUNSELING
INFORMATION
NA
Liver transplant patients should be informed about
the potential interference with non-glucose specific
monitoring systems.
ובש ,ןולעה
םינמוסמ
םייונישה
םישקובמה
לע
עקר
בוהצ
רבעוה
ראודב
ינורטקלא
ךיראתב
17.07.2012
תמיתח
חקורה
הנוממה

Productkenmerken

1
1. NAME OF THE MEDICINAL PRODUCT
HepaGam B
™
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains greater than 312 IU/mL of antibodies to hepatitis B
surface antigen
)
anti-HBs
(
.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
HepaGam B
™
, Hepatitis B Immunoglobulin (Human), solution for injection IM/IV, is
a sterile solution of purified
gamma globulin (5% or 50 mg/mL) fraction containing polyclonal
antibodies to hepatitis B surface antigen (anti-
HBs). 4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
4.1.1 PREVENTION OF HEPATITIS B RECURRENCE FOLLOWING LIVER
TRANSPLANTATION
HepaGam B
™
is indicated for the prevention of hepatitis B recurrence following
liver transplantation, in HBsAg-
positive liver transplant patients.
HepaGam B
™
should be administered intravenously for this indication.
4
.1.2 POSTEXPOSURE PROPHYLAXIS
HepaGam B
™
is indicated for the treatment of acute exposure to blood containing
HBsAg, perinatal exposure of
infants born to HBsAg-positive mothers, sexual exposure to
HBsAg-positive persons and household exposure to
persons with acute HBV infection in the following settings:
Acute Exposure to Blood Containing HBsAg:
Following either parenteral exposure (needlestick, bite, sharps),
direct mucous membrane contact (accidental
splash), or oral ingestion (pipetting accident), involving
HBsAg-positive materials such as blood, plasma or
serum.
Perinatal Exposure of Infants Born to HBsAg-positive Mothers:
Infants born to mothers positive for HBsAg with or without HBsAg.
Perinatal exposure of infants born to HBsAg-positive persons
Sexual Exposure to HBsAg-positive Persons:
Sexual partners of HBsAg-positive persons.
Household Exposure to Persons with Acute HBV Infection:
Infants less than 12 months old whose mother or primary caregiver is
positive for HBsAg. Other household
contacts with an identifiable blood exposure to the index patient.
HepaGam B
™
is indicated for intramuscular use only for these post-exposure
prophylaxis indications. 4.2 POSOLOGY