ETOPOSIDE TEVA

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

ETOPOSIDE

Prieinama:

ABIC MARKETING LTD, ISRAEL

ATC kodas:

L01CB01

Vaisto forma:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sudėtis:

ETOPOSIDE 20 MG/ML

Vartojimo būdas:

I.V

Recepto tipas:

Required

Pagaminta:

PHARMACHEMIE B.V., (TEVA GROUP) ,THE NETHERLANDS

Farmakoterapinė grupė:

ETOPOSIDE

Gydymo sritis:

ETOPOSIDE

Terapinės indikacijos:

Hodgkin's disease. Malignant (non-Hodgkin's) Lymphomas, especially of the Histiocytic variety.Acute Non-Lymphocytic leukemia. Management of refractory testicular tumors and of small cell lung cancer.

Leidimo data:

2014-12-31

Pakuotės lapelis

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
_______
OCTOBER 21, 2014
__
םש
רישכת
תילגנאב
רפסמו
םושירה
ETOPOSIDE CONCENTRATE FOR SOLUTION FOR INFUSION
106
48
28897
05
םש
לעב
םושירה
SALOMON, LEVIN, & ELSTEIN LTD.; POBOX 3696, PETACH TIKVA 49133
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
Severe myelosuppression, unless when
this is caused by the underlying disease.
Liver impairment.
Hypersensitivity to etoposide or one of
the other constituents.
Breastfeeding
Patients with severe renal impairment
(creatinine clearance < 15 ml/min)
Severe myelosuppression, unless when this is caused by
the underlying disease.
Severe hepatic Liver impairment.
Hypersensitivity to etoposide or one of the other
constituents.
Breastfeeding (see section 4.6)
Concomitant use of yellow fever vaccine or other live
vaccines is contraindicated in immunosuppressed patients
(see section "Interaction with other medicinal products and
other forms of interaction")
Patients with severe renal impairment (creatinine clearance
< 15 ml/min)
POSOLOGY, DOSAGE & ADMINISTRATION
ETOPOSIDE
SHOULD
NOT
BE
ADMINISTERED
BY
RAPID
INTRAVENOUS INJECTION.
Hypotension
following
rapid
intravenous
administration
of
etoposide
has
been
reported.
Therefore, it is recommended that the
etoposide injection be administered by
slow i. v. infusion over a 30 to 60-
minute period or longer if it is not
tolerated. Generally 3 or 4 treatment
cycles are carried out.
Dosage of etoposide should be modified to take into
account the myelosuppressive effects of other drugs in the
combination or the effects of prior X-ray therapy or
chemotherapy which may have compromised bone
marrow reserve.
Etoposide is administered by slow intravenous infusion.
ETOPOSIDE SHOU

Prekės savybės

Etoposide Teva NA Notification 06/23
SUMMARY OF PRODUCT CHARACTERISTICS
Etoposide Teva
Concentrate for solution for infusion
For I.V. Infusion
1.
NAME OF THE MEDICINAL PRODUCT
Etoposide Teva
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Etoposide Teva concentrate for solution for infusion
contains 20 mg etoposide.
1 vial with 5 ml concentrate for solution for infusion contains 100 mg
etoposide.
1 vial with 10 ml concentrate for solution for infusion contains 200
mg etoposide.
1 vial with 50 ml concentrate for solution for infusion contains 1000
mg etoposide.
Excipient with known effect:
Each 5 ml vial contains up to 1.2 g of alcohol.
Each 10 ml vial contains up to 2.4 g of alcohol.
Each 50 ml vial contains up to 12 g of alcohol.
Each ml of concentrate for solution contains 241 mg ethanol absolute.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, yellowish, slightly viscous solution, essentially free from
visible particles.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
-
Hodgkin’s disease
-
Malignant (non-Hodgkin’s) lymphomas, especially of the histiocytic
variety
-
Acute non-lymphocytic leukemia
-
Management of refractory testicular tumours and of small cell lung
cancer.
4.2
Posology and method of administration
_Etoposide must not be given by intra-cavity injection_.
_Dose adjustments _
Dosage of etoposide should be modified to take into account the
myelosuppressive effects of other drugs in the
combination or the effects of prior X-ray therapy or chemotherapy
which may have compromised bone marrow reserve.
Etoposide is administered by slow intravenous infusion. ETOPOSIDE
SHOULD NOT BE ADMINISTERED BY
RAPID INTRAVENOUS INJECTION.
Hypotension
following
rapid
intravenous
administration
of
etoposide
has
been
reported.
Therefore,
it
is
recommended that the etoposide injection be administered by slow I.V.
infusion over a 30 to 60-minute period.
Longer infusion times may be required based on patient tolerance. As
with other potent