Tolnexa 20 mg/ml, concentraat voor oplossing voor infusie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DOCETAXEL 0-WATER

Beschikbaar vanaf:

Krka d.d., Novo mesto Smarjeska cesta 6 8501 NOVO MESTO (SLOVENIË)

ATC-code:

L01CD02

INN (Algemene Internationale Benaming):

DOCETAXEL 0-WATER

farmaceutische vorm:

Concentraat voor oplossing voor infusie

Samenstelling:

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

Toedieningsweg:

Parenteraal

Therapeutisch gebied:

Docetaxel

Product samenvatting:

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

Autorisatie datum:

2013-02-27

Bijsluiter

1.3.1
Docetaxel
SPC, Labeling and Package Leaflet
NL
SmPCPIL160906_3
25.11.2020 – Updated: 04.12.2020
Page 54 of 62
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TOLNEXA 20 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE
20 mg/1 ml concentrate for solution for infusion
80 mg/4 ml concentrate for solution for infusion
160 mg/8 ml concentrate for solution for infusion
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 or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tolnexa is and what it is used for
2.
What you need to know before you use Tolnexa
3.
How to use Tolnexa
4.
Possible side effects
5.
How to store Tolnexa
6.
Contents of the pack and other information
1.
WHAT TOLNEXA IS AND WHAT IT IS USED FOR
The name of this medicine is Tolnexa. 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.
Tolnexa 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, Tolnexa 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, Tolnexa could
be administered in combination with doxorubicin and cyclophosphamide.
-
For the treatment of lung cancer, Tolnexa could be administered either
alone or in combination
with cisplatin.
-
For the treatment of prostate cancer, Tolnexa is administered in
combination with prednisone or
prednisolone.
-
For the treatment of metastatic gastric cancer, Tolnexa is
a

Productkenmerken

1.3.1
Docetaxel
SPC, Labeling and Package Leaflet
NL
SmPCPIL160906_3
25.11.2020 – Updated: 04.12.2020
Page 2 of 62
1.
NAME OF THE MEDICINAL PRODUCT
Tolnexa 20 mg/ml, concentraat voor oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 20 mg
docetaxel.
One vial of 1 ml of concentrate for solution for infusion contains 20
mg docetaxel.
One vial of 4 ml of concentrate for solution for infusion contains 80
mg docetaxel.
One vial of 8 ml of concentrate for solution for infusion contains 160
mg docetaxel.
Excipient with known effect:
One vial of 1 ml of concentrate for solution for infusion contains 0.5
ml anhydrous ethanol (395 mg).
One vial of 4 ml of concentrate for solution for infusion contains 2
ml anhydrous ethanol (1580 mg).
One vial of 8 ml of concentrate for solution for infusion contains 4
ml anhydrous ethanol (3160 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
anth