DBL™ Docetaxel, Concentrated Injection

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Docetaxel 10 mg/mL

Tilgængelig fra:

Pfizer New Zealand Limited

INN (International Name):

Docetaxel 10 mg/mL

Dosering:

10 mg/mL

Lægemiddelform:

Solution for infusion

Sammensætning:

Active: Docetaxel 10 mg/mL Excipient: Citric acid Ethanol Macrogol 300 Nitrogen As needed Polysorbate 80

Enheder i pakken:

Vial, glass, Type 1 clear glass 2 ml vial, grey chlorobutyl closure, aluminium seal, flip off top, 2 mL

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

ScinoPharm Taiwan Ltd

Terapeutiske indikationer:

Treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. DBL Docetaxel, Concentrated Injection in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. DBL™ Docetaxel, Concentrated Injection in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.

Produkt oversigt:

Package - Contents - Shelf Life: Vial, glass, Type 1 clear glass 2 ml vial, grey chlorobutyl closure, aluminium seal, flip off top - 2 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, Type 1 clear glass 8 ml vial, grey chlorobutyl closure, aluminium seal, flip off top - 8 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, Type 1 clear glass 16 ml vial, grey chlorobutyl closure, aluminium seal, flip off top - 16 mL - 36 months from date of manufacture stored at or below 25°C

Autorisation dato:

2011-02-02

Indlægsseddel

DBL™ DOCETAXEL CONCENTRATED INJECTION
1
DBL™ DOCETAXEL
CONCENTRATED INJECTION
_docetaxel_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Docetaxel
Concentrated Injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking DBL
Docetaxel Concentrated Injection
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DBL DOCETAXEL
CONCENTRATED
INJECTION IS USED FOR
Docetaxel is used to treat:

breast cancer

non small cell lung cancer

ovarian cancer

prostate cancer

head and neck cancer
This medicine belongs to a group of
medicines called antineoplastic or
cytotoxic medicines. You may also
hear of these being called
chemotherapy medicines.
It works by stopping cells from
growing and multiplying.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
You may have taken another
medicine to treat your breast, non
small cell lung cancer, ovarian,
prostate or head and neck cancer.
However, your doctor has now
decided to treat you with docetaxel.
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU ARE GIVEN
DBL DOCETAXEL
CONCENTRATED
INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT _
DO NOT USE DBL DOCETAXEL
CONCENTRATED INJECTION IF YOU HAVE
AN ALLERGY TO:

any medicine containing
docetaxel or polysorbate 80

any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing
or a tight feeling in you

Produktets egenskaber

Version: pfdddoci10224
Supersedes: pfdddoci11222
Page 1 of 50
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DBL™ Docetaxel Concentrated Injection 10 mg/mL Solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Docetaxel Concentrated Injection contains docetaxel 10 mg/mL and
the excipients
ethanol, citric acid, Polysorbate 80 and Macrogol 300. DBL Docetaxel
Concentrated
Injection is available as 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL
single dose vials.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Ethanol (182 mg/mL) (see section 4.4).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
DBL Docetaxel Concentrated Injection is a sterile clear, colourless to
pale yellow solution
free from visible particulates. It must be diluted prior to
intravenous administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Docetaxel Concentrated Injection is indicated for:
BREAST CANCER
_METASTATIC BREAST CANCER _
Treatment of patients with locally advanced or metastatic breast
cancer in whom previous
chemotherapy has failed.
DBL Docetaxel Concentrated Injection in combination with capecitabine
is indicated for
the treatment of patients with locally advanced or metastatic breast
cancer after failure of
prior anthracycline containing chemotherapy.
DBL Docetaxel Concentrated Injection in combination with trastuzumab
is indicated for
the treatment of patients with metastatic breast cancer whose tumours
overexpress HER2
and who previously have not received chemotherapy for metastatic
disease.
Version: pfdddoci10224
Supersedes: pfdddoci11222
Page 2 of 50
_ADJUVANT TREATMENT OF BREAST CANCER _
Docetaxel in combination with doxorubicin and cyclophosphamide is
indicated for the
adjuvant treatment of patients with node positive breast cancer.
Doxorubicin and cyclophosphamide followed by DBL Docetaxel
Concentrated Injection
in combination with trastuzumab (AC-TH) is indicated for the adjuvant
treatment of
patients with operable breast cancer whose tumours overexpress HER2.
DBL Docetaxe