PACLIAVENIR

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PACLITAXEL

Available from:

BIOAVENIR LTD, ISRAEL

ATC code:

L01CD01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

PACLITAXEL 6 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BIOLYSE PHARMA CORPORATION, CANADA

Therapeutic group:

PACLITAXEL

Therapeutic area:

PACLITAXEL

Therapeutic indications:

Paclitaxel is indicated alone or in combination, for the treatment of advanced carcinoma of the ovary. 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, 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. Keposi's sarcoma: Paclitaxel is indicated in the second- line treatment of AID'S related Kaposi's sarcoma.Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.For the treatment of advanced gastric carcinoma.

Authorization date:

2014-05-31

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ךיראת
___
28.5.15
____________________
םש
רישכת
__תילגנאב
SOL. FOR INJ. _ PACLIAVENIR
_____________
רפסמ
__םושיר
1308930941
_________________________________
םש
לעב
_םושירה
LTD._BIOAVENIR
_______________________________
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
WARNINGS
Given the possibility of extravasation, it is advisable
to closely monitor the infusion site for possible
infiltration during drug administration.
PACLIAVENIR SOLUTION
FOR
INJECTION should be administered as a diluted infusion.
Patients receiving PACLIAVENIR SOLUTION FOR
INJECTION should be pretreated with corticosteroids,
antihistamines, and H
2
antagonists (such as dexamethasone,
diphenhydramine and cimetidine or ranitidine) to minimize
hypersensitivity reactions (see
DOSAGE
AND
ADMINISTRATION
).
Anaphylaxis, and severe hypersensitivity reactions
characterized by dyspnea and hypotension requiring treatment,
angioedema, and generalized urticaria have occurred in patients
receiving paclitaxel. These reactions are probably histamine-
mediated. Literature reports indicate that rare fatal reactions
have occurred in patients despite pre-treatment. In case of a
severe hypersensitivity reaction, PACLIAVENIR SOLUTION
FOR INJECTIONinfusion should be discontinued immediately
and the patient should not be rechallenged with the drug (see
ADVERSE
REACTIONS
).
Patients should be observed closely during the initial cycles of
treatment. Appropriate supportive therapies should be readily
available in case of a severe hypersensitivity reaction.
PACLIAVENIR SOLUTION
FOR INJECTION should not be
administered to patients with baseline neutrophil counts of less
than 1,500 cells/mm
3
. Bone marrow suppression (primarily
neutropenia) is dose and schedule dependent and is the dose-
limiting toxicity within a regimen. Neutro

Summary of Product characteristics

1
P
RODUCT
P
RESCRIBING
I
NFORMATION
NAME
OF
THE
DRUG
P
ACLI
A
VENIR SOLUTION FOR INJECTION
(Paclitaxel)
6mg/mL
THERAPEUTIC
CLASSIFICATION
Antineoplastic Agent
P
ACLI
A
VENIR SOLUTION FOR INJECTION
(
PACLITAXEL
) SHOULD BE ADMINISTERED UNDER THE SUPERVISION OF A PHYSICIAN
EXPERIENCED IN THE USE OF CANCER CHEMOTHERAPY AGENTS
.
P
ATIENTS RECEIVING
P
ACLI
A
VENIR SOLUTION FOR INJECTION
MUST BE PRE
-
TREATED WITH CORTICOSTEROIDS
, ANTIHISTAMINES
, AND
H
2 ANTAGONISTS
(
SUCH AS DEXAMETHASONE
, DIPHENHYDRAMINE AND CIMETIDINE OR RANITIDINE
) TO MINIMIZE HYPERSENSITIVITY
REACTIONS
(
SEE DOSAGE AND ADMINISTRATION
).
S
EVERE HYPERSENSITIVITY REACTIONS CHARACTERIZED BY DYSPNEA AND
HYPOTENSION REQUIRING TREATMENT
, ANGIOEDEMA
, AND GENERALIZED URTICARIA HAVE OCCURRED IN PATIENTS RECEIVING
PACLITAXEL
.
T
HESE REACTIONS ARE PROBABLY HISTAMINE MEDIATED
.
R
ARE FATAL REACTIONS HAVE OCCURRED IN PATIENTS
DESPITE PRE
-
TREATMENT
. PATIENTS WHO EXPERIENCE SEVERE HYPERSENSITIVITY REACTIONS TO
PACLITAXEL SHOULD NOT BE
RECHALLENGED WITH THE DRUG
.
Paclitaxel therapy should not be given to patients with solid tumors
who have baseline neutrophil counts of less than 1500
cells/mm
3
and should not be given to patients with AIDS-related Kaposi’s
sarcoma if the baseline neutrophil count is less than
1000 cells/mm
3
. In order to monitor the occurrence of bone marrow suppression,
primarily neutropenia, which may be severe
and result in infection, it is recommended that frequent peripheral
blood cell counts be performed on all patients receiving
paclitaxel.
ACTION
AND
CLINICAL
PHARMACOLOGY
P
ACLI
A
VENIR SOLUTION FOR INJECTION
(paclitaxel) is a novel antimicrotubule agent that promotes the
assembly of microtubules
from tubulin dimers and stabilizes microtubules by preventing
depolymerisation. _ _This stability results in the inhibition of the
normal dynamic reorganization of the microtubules network that is
essential for vital interphase and mitotic cellular functions. In
addition, paclitaxel induces abnormal arrays or "bundles" of
microtubu