GRAFALON

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

RABBIT IMMUNOGLOBULIN

Verfügbar ab:

CURE MEDICAL & TECHNICAL SUPPLY

ATC-Code:

J06BB05

Darreichungsform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Zusammensetzung:

RABBIT IMMUNOGLOBULIN 20 MG/ML

Verabreichungsweg:

I.V

Verschreibungstyp:

Required

Hergestellt von:

NEOVII BIOTECH GMBH, GERMANY

Therapiebereich:

RABIES IMMUNOGLOBULIN

Anwendungsgebiete:

- Prophylaxis and therapy of rejection crises in organ and tissue transplantations.- Prevention of graft-versus-host disease (GVHD) in adults after allogeneic stem cell transplantation (SCT) Grafalon is indicated for prevention of graft-versus-host disease (GVHD) in adults with haematological malignancies following stem cell transplantation from matched unrelated donors in combination with standard Cyclosporin A/methotrexate prophylaxis

Berechtigungsdatum:

2023-05-31

Gebrauchsinformation

העדוה
לע
הרמחה
(
עדימ
ןולעב )תוחיטב
ל
אפור
(
ןכדועמ
05.2013
) :ךיראת
7/10/2014
םש
רישכת
תילגנאב
רפסמו :םושירה
ATG FRESENIUS S
םש
לעב
םושירה :
CURE MEDICAL & TECHNICAL SUPPLY
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.2
POSOLOGY AND
METHOD OF
ADMINISTRATION
_Method of administration_
ATG-Fresenius S is a hypotonic concentrate for
solution for infusion with pH 3.7

0.3 and is not for
direct injection. It has to be diluted in sodium chloride
9 mg/ml (0.9%) solution before intravenous
administration to the patient.
Recommended dilution volume is 250 - 500 ml. The
standard infusion time in organ transplantation is 4
hours while in stem cell transplantation, 4 to 12 hour
infusion times are recommended. In case of intra-
operative administration, infusion time of 0.5 to 2
hours has been usually used.
_Method of administration_
ATG-Fresenius S is a hypotonic concentrate for solution for infusion
with
pH 3.7

0.3 and is not for direct injection. It has to be diluted in sodium
chloride 9 mg/ml (0.9%) solution before intravenous administration to
the
patient. A dilution ratio of 1:7 is recommended (per 1 ml
ATG-Fresenius
S 6 ml sodium chloride solution should be added) to maintain the
required
level of osmolality. Higher dilution ratios, with attendant higher pH
levels
of the infusion solution, may result in particle formation. Solutions
containing visible particles must not be used.
Recommended dilution volume is 250 - 500 ml.
The standard infusion
time in organ transplantation is 4 hours while in stem cell
transplantation,
4 to 12 hour infusion times are recommended. In case of
intra-operative
administration, infusion time of 0.5 to 2 hours has been usually used.
ב"צמ
ובש ,ןולעה
נמוסמ
תו
תורמחהה
שקובמה
תו
לע
עקר
בוהצ
.
םייוניש
םניאש
רדגב
תורמחה
ונמוס
)ןולעב(
ע

Fachinformation

Grafalon, SmPC Israel, Version October 2022_Grafalon
®
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Grafalon
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of the concentrate contains 20 mg anti-human T-lymphocyte
immunoglobulin from rabbits.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to slightly opalescent and colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis and therapy of rejection crisis in organ and tissue
transplantations.
Prevention of graft-versus-host disease (GVHD) in adults after
allogeneic stem cell transplantation (SCT)
Grafalon is indicated for prevention of graft-versus-host disease
(GVHD) in adults with haematological
malignancies following stem cell transplantation from matched
unrelated donors in combination with
standard Cyclosporin A/methotrexate prophylaxis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Grafalon should be prescribed only by physicians who are experienced
in the use of immunosuppressive
therapies. Grafalon must be administered under qualified medical
supervision.
Posology
The dose of Grafalon is dependent on the indication. Dose
recommendations are based on body weight
(BW).
Prevention of acute transplant rejection in patients receiving
allogeneic solid organ transplants
The recommended dose range is 2 to 5
mg/kg BW/d Grafalon. The most common doses are in the range of
3 to 4 mg/kg BW/d. Therapy should commence on the day of
transplantation pre-, intra-, or immediately
post-operatively. Depending on the patient's condition, selected daily
dose and the concomitant
immunosuppressive regimen, the recommended duration of therapy is in
the range of 5 to 14 days.
Therapy of acute corticosteroid-resistant rejection after allogeneic
solid organ transplantation
The recommended dose range is 3 to 5 mg/kg BW/d Grafalon. The most
common dosages are in the range of
3 to 4 mg/kg BW/d. Duration of therapy will vary according to the
conditio