DOCETAXEL STADA CONCENTRATE FOR SOLUTION FOR INFUSION 20MGML

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Docetaxel

Commercializzato da:

DCH AURIGA SINGAPORE

Codice ATC:

L01CD02

Forma farmaceutica:

INJECTION, SOLUTION, CONCENTRATE

Composizione:

Docetaxel 20mg/ml

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

Prescription Only

Prodotto da:

Actavis Italy S.p.A. (Nerviano Plant)

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2017-12-12

Scheda tecnica

DOCETAXEL STADA
® CONCENTRATE FOR SOLUTION FOR INFUSION 20MG / ML
COMPOSITION:
Each single dose vial contains docetaxel 20 mg/ml
Each 1 ml single dose vial contains 20 mg docetaxel
Each 4 ml single dose vial contains 80 mg docetaxel
Each 7 ml single dose vial contains 140 mg docetaxel
Excipients: Ethanol absolute 400 mg/ml, Citric acid anhydrous,
Povidone, Polysorbate 80
DESCRIPTION
Concentrate for solution for infusion
The concentrate is a clear, pale yellow solution
INDICATIONS
_BREAST CANCER _
Docetaxel STADA
®
is indicated for the treatment of patients with locally advanced or
metastatic
breast carcinoma.
_NON-SMALL CELL LUNG CANCER _
Docetaxel STADA
®
is indicated for the treatment of patients with locally advanced or
metastatic
non- small cell lung cancer.
_PROSTATE CANCER _
Docetaxel
STADA
®
in
combination
with
prednisone
or
prednisolone
is
indicated
for
the
treatment of patients with hormone refractory metastatic prostate
cancer.
_GASTRIC ADENOCARCINOMA _
Docetaxel STADA
®
in combination with cisplatin and 5-fluorouracil is indicated for the
treatment
of
patients
with
metastatic
gastric
adenocarcinoma,
including
adenocarcinoma
of
the
gastroesophageal junction, who have not received prior chemotherapy
for metastatic disease.
_HEAD AND NECK CANCER _
Docetaxel STADA
®
in combination with cisplatin and 5-fluorouracil is indicated for the
induction
treatment of patients with locally advanced squamous cell carcinoma of
the head and neck.
POSOLOGY AND METHOD OF ADMINISTRATION
_RECOMMENDED DOSAGE _
For breast, non-small cell lung, gastric, and head and neck cancers,
premedication consisting
of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8
mg BID) for 3 days starting
1 day prior to docetaxel administration, unless contraindicated, can
be used (see section on
Special warnings and Precautions for use).
Prophylactic G-CSF may be used to mitigate the risk of hematological
toxicities.
For prostate cancer, given the concurrent use of prednisone or
prednisolone the recommended
premedication re