Demotaxel Mono 20 mg/ml, concentraat voor oplossing voor infusie

Nchi: Uholanzi

Lugha: Kiholanzi

Chanzo: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Viambatanisho vya kazi:

DOCETAXEL 0-WATER 20 mg/ml

Inapatikana kutoka:

Demo SA Pharmaceutical Industry 21st Km Nat. Rd. Athens-Lamia 14568 KRIONERI, ATTICA (GRIEKENLAND)

ATC kanuni:

L01CD02

INN (Jina la Kimataifa):

DOCETAXEL 0-WATER 20 mg/ml

Dawa fomu:

Concentraat voor oplossing voor infusie

Tungo:

CITROENZUUR 0-WATER (E 330) ; ETHANOL 395 mg/ml ; POLYSORBAAT 80 (E 433) ; STIKSTOF (HEAD SPACE) (E 941),

Njia ya uendeshaji:

Intraveneus gebruik

Eneo la matibabu:

Docetaxel

Bidhaa muhtasari:

Hulpstoffen: CITROENZUUR 0-WATER (E 330); ETHANOL 395 mg/ml; POLYSORBAAT 80 (E 433); STIKSTOF (HEAD SPACE) (E 941);

Idhini ya tarehe:

1900-01-01

Taarifa za kipeperushi

Module 1.3.1 Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEMOTAXEL MONO 20 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
docetaxel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION
for YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, hospital
pharmacist or nurse.

If you get any side effects talk to your doctor, hospital pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Docetaxel is and what it is used for
2.
What you need to know before you use Docetaxel
3.
How to use Docetaxel
4.
Possible side effects
5.
How to store Docetaxel
6.
Contents of the pack and other information
1.
WHAT DOCETAXEL IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel Its common name is docetaxel.
Docetaxel is a substance
derived from the needles of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called
taxoids.
Docetaxel has been prescribed by your doctor for the treatment of
breast cancer, special forms of lung
cancer (non-small cell lung cancer), prostate cancer, gastric cancer
or head and neck cancer:
-
For the treatment of advanced breast cancer, Docetaxel could be
administered either alone or in
combination with doxorubicin, or trastuzumab, or capecitabine.
-
For the treatment of early breast cancer with or without lymph node
involvement, Docetaxel could
be administered in combination with doxorubicin and cyclophosphamide.
-
For the treatment of lung cancer, Docetaxel could be administered
either alone or in combination
with cisplatin.
-
For the treatment of prostate cancer, Docetaxel is administered in
combination with prednisone or
prednisolone.
-
For the treatment of metastatic gastric cancer, Docetaxel is
administered in combination with
cisplatin and 5-fluorouracil.
-
For the treatment of head and neck cancer, Docetaxel is administered
in combination with
cisplatin a

Tabia za bidhaa

Module 1.3.1 Page: 1 of 40
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAME OF THE MEDICINAL PRODUCT
Demotaxel Mono 20 mg/ml, concentraat voor oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 20 mg docetaxel.
One vial of 1 mL of concentrate contains 20 mg of docetaxel.
Excipient with known effect:
Each vial of concentrate contains 0.5 mL of ethanol anhydrous (395
mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear pale yellow to brownish-yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
Docetaxel in combination with doxorubicin and cyclophosphamide is
indicated for the adjuvant
treatment of patients with:

operable node-positive breast cancer

operable node-negative breast cancer .
For patients with operable node-negative breast cancer, adjuvant
treatment should be restricted to
patients eligible to receive chemotherapy according to internationally
established criteria for primary
therapy of early breast cancer (see section 5.1).
Docetaxel in combination with doxorubicin is indicated for the
treatment of patients with locally
advanced or metastatic breast cancer who have not previously received
cytotoxic therapy for this
condition.
Docetaxel monotherapy is indicated for the treatment of patients with
locally advanced or metastatic
breast cancer after failure of cytotoxic therapy. Previous
chemotherapy should have included an
anthracycline or an alkylating agent.
Docetaxel in combination with trastuzumab is indicated for the
treatment of patients with metastatic
breast cancer whose tumours over express HER2 and who previously have
not received chemotherapy
for metastatic disease.
Docetaxel in combination with capecitabine is indicated for the
treatment of patients with locally
Module 1.3.1 Page: 2 of 40
advanced or metastatic breast cancer after failure of cytotoxic
chemotherapy. Previous therapy should
have included a