SIMULECT 20 MG

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

BASILIXIMAB

זמין מ:

NOVARTIS ISRAEL LTD

קוד ATC:

L04AA09

טופס פרצבטיות:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

הרכב:

BASILIXIMAB 20 MG/VIAL

מסלול נתינה (של תרופות):

I.V

סוג מרשם:

Required

תוצרת:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

קבוצה תרפויטית:

BASILIXIMAB

איזור תרפויטי:

BASILIXIMAB

סממני תרפויטית:

Prophylaxis of acute organ rejection in de novo renal transplantation in combination with cyclosporin and corticosteroid based immunosuppression

תאריך אישור:

2014-01-31

עלון מידע

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ךיראת
-
12.06.2015
םש
רישכת
תילגנאב
רפסמו
םושירה
_
SIMULECT 20MG , [113-38-29524-00]
םש
לעב
םושירה :
NOVARTIS PHARMA SERVICES A.G
דבלב תורמחהה טורפל דעוימ הז ספוט
!
טסקט
רוחש
–
טסקט
רשואמ
טסקט
םע
וק
יתחת
–
תפסוה
טסקט
ןולעל
רשואמה
טסקט
םע
וק
הצוח
–
תקיחמ
טסקט
ןולעהמ
רשואמה
טסקט
ןמוסמה
בוהצב
–
הרמחה
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE
&
ADMINISTRATION
SPECIAL WARNINGS AND SPECIAL
PRECAUTIONS FOR USE
...
Heart transplantation
The efficacy and safety of Simulect for the
prophylaxis of acute rejection in recipients of
solid organ allografts other than renal have not
been demonstrated. In several small clinical trials
in heart transplant recipients, serious cardiac
adverse events such as cardiac arrest (2.2%),
atrial flutter (1.9%) and palpitations (1.4%) have
been reported more frequently with Simulect
than with other induction agents.
INTERACTION WITH OTHER
MEDICAMENTS AND OTHER FORMS OF
INTERACTION
FERTILITY, PREGNANCY AND LACTATION
ADVERSE EVENTS
ב"צמ
ובש ,ןולעה
נמוסמ
תו
תורמחהה
שקובמה
תו
לע
עקר
בוהצ
.
םייוניש
םניאש
רדגב
תורמחה
ונמוס
עבצב )ןולעב(
שי .הנוש
ןמסל
קר
ןכות
יתוהמ
אלו
םייוניש
םוקימב
.טסקטה
רבעוה
ראודב
ינורטקלא
ךיראתב
17.06.2015

מאפייני מוצר

SIM API Nov21 V3
REF EU SmPC Dec20
1.
NAME OF THE MEDICINAL PRODUCT
SIMULECT
® 20 MG
Powder and solvent for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20 mg basiliximab*.
One ml of the reconstituted solution contains 4 mg basiliximab.
*recombinant murine/human chimeric monoclonal antibody directed
against the interleukin-2
receptor
α
-chain (CD25 antigen) produced in a mouse myeloma cell line by
recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection or infusion
White powder
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Simulect
is
indicated
for
the
prophylaxis
of
acute
organ
rejection
in
_de _
_novo_
renal
transplantation in combination with ciclosporin and corticosteroid
based immunosuppression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Simulect should be prescribed only by physicians who are experienced
in the use of
immunosuppressive therapy following organ transplantation. Simulect
should be administered
under qualified medical supervision.
Simulect MUST NOT be administered unless it is absolutely certain that
the patient will receive
the graft and concomitant immunosuppression.
Simulect
is
to
be
used
concomitantly
with
ciclosporin
and
corticosteroid-based
immunosuppression.
_Posology _
_Adults _
The standard total dose is 40 mg, given in two doses of 20 mg each.
The first 20 mg dose should be given within 2 hours prior to
transplantation surgery. The
second 20 mg dose should be given 4 days after transplantation. The
second dose should be
Page 2
SIM API Nov21 V3
REF EU SmPC Dec20
withheld in the event of a severe hypersensitivity reaction to
Simulect or post-operative
complications such as graft loss (see section 4.4).
_Children and adolescents_
_(1-17 years)_
In paediatric patients weighing less than 35 kg, the recommended total
dose is 20 mg, given
in two doses of 10 mg each. In paediatric patients weighing 35 kg or
more, the recommended
dose is the adul