PACLITAXEL TEVA

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

PACLITAXEL

Dostupno od:

SALOMON,LEVIN & ELSTEIN LTD

ATC koda:

L01CD01

Farmaceutski oblik:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sastav:

PACLITAXEL 6 MG/ML

Administracija rute:

I.V

Tip recepta:

Required

Proizveden od:

PHARMACHEMIE BV, HOLLAND (TEVA GROUP)

Terapijska grupa:

PACLITAXEL

Područje terapije:

PACLITAXEL

Terapijske indikacije:

Ovarian carcinoma : Paclitaxel Teva is indicated alone or in combination for the treatment of advanced carcinoma of the ovary. Breast carcinoma : Paclitaxel Teva is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin - containing combination chemotherapy. Paclitaxel Teva is indicated for the treatment of metastatic breast cancer after failure of combination chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Advanced non small cell lung cancer : Paclitaxel Teva associated with cisplatium is indicated for the treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Kaposis sarcoma : Paclitaxel Teva is indicated in the second- line treatment of AID'S related Kaposi's sarcoma. Gastric carcinoma : Paclitaxel Teva for the treatment of advanced gastric carcinoma.

Datum autorizacije:

2012-02-28

Uputa o lijeku

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
_______
JANUARY 8, 2015
__
םש
רישכת
תילגנאב
רפסמו
םושירה
PACLITAXEL TEVA 6MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
136
41
31278
00 ,
136
41
31278
01
םש
לעב
םושירה
SALOMON, LEVIN & ELSTEIN LTD. POBOX 3696 PETACH
TIKVA
_
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE & ADMINISTRATION
SPECIAL WARNINGS AND SPECIAL
PRECAUTIONS FOR USE
ADVERSE EVENTS
SKIN AND SUBCUTANEOUS TISSUE
DISORDERS
_Very common_: alopecia
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
_Very common_: alopecia
_Alopecia_ was observed in >80% of the patients treated
with paclitaxel. The majority of alopecia events occurred
less than one month after initiation of paclitaxel.
Pronounced hair loss ≥50% is expected for the majority
of patients who experience alopecia.
PHARMACODYNAMIC PROPERTIES
OVERDOSE
PHARMACOKINETIC PROPERTIES
PHARMACEUTICAL PARTICULARS

Svojstava lijeka

93.130.565-H
PACLITAXEL TEVA
CONCENTRATE FOR SOLUTION FOR INFUSION
FOR I.V. INFUSION
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paclitaxel Teva, Concentrate for Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 6mg of the active ingredient, paclitaxel.
1 vial of 5ml contains 30mg of paclitaxel.
1 vial of 16.7ml contains 100mg of paclitaxel.
1 vial of 50ml contains 300mg of paclitaxel.
Excipient with known effect:
1ml contains 527mg of the excipient, macrogolglycerol ricinoleate
(castor
oil polyoxyl) and 396 mg of the excipient ethanol anhydrous.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear, colourless or slightly yellow viscous solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Ovarian cancer: paclitaxel is indicated alone or in combination, for
the
treatment of advanced carcinoma of the ovary.
•
Breast Cancer:
-
Paclitaxel is indicated for the treatment of metastatic breast cancer
after failure of combination chemotherapy. Prior therapy should
have included an anthracycline unless clinically containdicated.
-
Paclitaxel is indicated for the adjuvant treatment of node-positive
breast cancer administered sequentially to standard doxorubicin-
containing combination chemotherapy.
•
Advanced non-small cell lung cancer: paclitaxel associated with
cisplatinum is indicated for the treatment of non-small cell lung
cancer
in patients who are not candidates for potentially curative surgery
and/or radiation therapy.
•
Kaposi’s sarcoma: paclitaxel is indicated in the second-line
treatment
of AIDS related Kaposi’s sarcoma.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
FIRST-LINE CHEMOTHERAPY OF OVARIAN CANCER
Since
other
dosage
regimens
have
not
yet
been
evaluated,
the
recommended first-line treatment of ovarian cancer is 135 mg/m
2
of
paclitaxel as an infusion over 24 hours, followed by 75 mg/m
2
of cisplatin
and a therapy-free interval of three weeks (see section 4.5).
SECOND-LINE C