Docetaxel 160mg16ml concentrate for solution for infusion vials

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Docetaxel

থেকে পাওয়া:

Pfizer Ltd

এটিসি কোড:

L01CD02

INN (আন্তর্জাতিক নাম):

Docetaxel

ডোজ:

10mg/1ml

ফার্মাসিউটিকাল ফর্ম:

Solution for infusion

প্রশাসন রুট:

Intravenous

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: ; GTIN: 5015997807810

তথ্য লিফলেট

DOCETAXEL HOSPIRA 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Docetaxel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Docetaxel Hospira is and what it is used for
2.
Before you are given Docetaxel Hospira
3.
How Docetaxel Hospira is used
4.
Possible side effects
5
How to store Docetaxel Hospira
6.
Further information
1.
WHAT DOCETAXEL HOSPIRA IS AND WHAT IT IS USED FOR
Docetaxel Hospira is an anti-cancer drug and is used either alone or
in combination
with other anti-cancer medicines to treat:
•
Early breast cancer with or without lymph node involvement; Docetaxel
Hospira is used in combination with doxorubicin and cyclophosphamide.
•
Advanced
breast
cancer;
Docetaxel
Hospira
is
used
either
alone
or
in
combination
•
with doxorubicin, capecitabine or trastuzumab.
•
Special forms of lung cancer (non-small cell lung cancer); Docetaxel
Hospira
is used either alone or in combination with cisplatin.
•
Prostate cancer; Docetaxel Hospira is used in combination with
prednisone or
prednisolone.
•
Gastric cancer; where the cancer has spread, Docetaxel Hospira is used
in
combination with cisplatin and 5-fluorouracil.
•
Head
and
neck
cancer;
Docetaxel
Hospira
is
used
in
combination
with
cisplatin and 5-fluorouracil.
2.
BEFORE YOU ARE GIVEN DOCETAXEL HOSPIRA
DO NOT USE DOCETAXEL HOSPIRA:
if you are hypersensitive (allergic) to docetaxel or any of the other
ingredients
if you already have a reduced number of white blood cells
if you have severe liver disease.
SPECIAL CARE WILL BE TAKEN WITH DOCETAXEL HOSPIRA:
if the number of white cells in your blood is too low. Your doctor
will check
this.
if you develop a hypersensitivity (allergic) reaction to this medicine
if you develop reddening or swelling on your hands or

পণ্য বৈশিষ্ট্য

OBJECT 1
DOCETAXEL HOSPIRA 10 MG/ML CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 23-May-2018 | Hospira UK
Ltd
1. Name of the medicinal product
Docetaxel Hospira 10 mg/ml Concentrate for Solution for Infusion
2. Qualitative and quantitative composition
1ml concentrate for solution for infusion contains 10 mg docetaxel.
20 mg/2 ml vial
One vial of 2 ml contains 20 mg docetaxel.
80 mg/8 ml vial
One vial of 8 ml contains 80 mg docetaxel.
160 mg/16 ml vial
One vial of 16 ml contains 160 mg docetaxel.
Excipient with known effect
20 mg/2 ml vial
Each 2 ml vial of concentrate contains 0.46 ml of ethanol anhydrous
(363 mg).
80 mg/8 ml vial
Each 8 ml vial of concentrate contains 1.84 ml of ethanol anhydrous
(1452 mg).
160 mg/16 ml vial
Each 16 ml vial of concentrate contains 3.68 ml of ethanol anhydrous
(2904 mg).
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Concentrate for Solution for Infusion
A clear colourless to pale yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Breast Cancer
• Docetaxel Hospira 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 Hospira 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 Hospira 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 Hospira in combination with trastuzumab