Taxespira (previously Docetaxel Hospira UK Limited )

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

docetaxel trihydrate

Tilgængelig fra:

Hospira UK Limited

ATC-kode:

L01CD02

INN (International Name):

docetaxel

Terapeutisk gruppe:

Antineoplastic agents

Terapeutisk område:

Stomach Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung

Terapeutiske indikationer:

Breast cancerTaxespira 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.Taxespira 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.Taxespira 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.Taxespira 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.Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small cell lung cancer Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.Taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancer Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinoma Taxespira 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 Taxespira 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.

Produkt oversigt:

Revision: 8

Autorisation status:

Withdrawn

Autorisation dato:

2015-08-28

Indlægsseddel

62
B. PACKAGE LEAFLET
Medicinal product no longer authorised
63
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAXESPIRA 20 MG/1 ML CONCENTRATE FOR SOLUTION FOR INFUSION
TAXESPIRA 80 MG/4 ML CONCENTRATE FOR SOLUTION FOR INFUSION
TAXESPIRA 120 MG/6 ML CONCENTRATE FOR SOLUTION FOR INFUSION
TAXESPIRA 140 MG/7 ML CONCENTRATE FOR SOLUTION FOR INFUSION
TAXESPIRA 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, 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 Taxespira is and what it is used for
2. What you need to know before you use Taxespira
3. How to use Taxespira
4. Possible side effects
5. How to store Taxespira
6. Contents of the pack and other information
1.
WHAT TAXESPIRA IS AND WHAT IT IS USED FOR
The name of this medicine is Taxespira. 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.
Taxespira 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, Taxespira 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, Taxespira
could be administered in combination with doxorubicin and
cyclophosphamide.

For the treatment of lung cancer, Taxespira could be administered
either alone or in
combination with cisplatin.

For the treatment of prostate cancer, Taxespira is administ

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Taxespira 20 mg/1 ml concentrate for solution for infusion
Taxespira 80 mg/4 ml concentrate for solution for infusion
Taxespira 120 mg/6 ml concentrate for solution for infusion
Taxespira 140 mg/7 ml concentrate for solution for infusion
Taxespira 160 mg/8 ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
20mg/1 ml
One vial of 1 ml of concentrate contains 20 mg docetaxel.
80mg/4 ml
One vial of 4 ml concentration contains 80 mg docetaxel.
120mg/6 ml
One vial of 6 ml concentration contains 120 mg docetaxel.
140mg/7 ml
One vial of 7 ml concentration contains 140 mg docetaxel.
160mg/8 ml
One vial of 8 ml concentration contains 160 mg docetaxel.
Excipient with known effect
20mg/1 ml
Each 1 ml vial of concentrate contains 0.5 ml of ethanol anhydrous
(395 mg).
80mg/4 ml
Each 4 ml vial of concentrate contains 2 ml of ethanol anhydrous (1580
mg).
120mg/6 ml
Each 6 ml vial of concentrate contains 3 ml of ethanol anhydrous (2370
mg).
140mg/7 ml
Each 7 ml vial of concentrate contains 3.5 ml of ethanol anhydrous
(2765 mg).
160mg/8 ml
Each 8 ml vial of concentrate contains 4 ml of ethanol anhydrous (3160
mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The concentrate is a pale yellow to brownish-yellow solution.
Medicinal product no longer authorised
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
Taxespira 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 canc