Hospira Docetaxel Concentrate for Solution for Infusion 160 mg 16 ml

দেশ: সিঙ্গাপুর

ভাষা: ইংরেজি

সূত্র: HSA (Health Sciences Authority)

সক্রিয় উপাদান:

Docetaxel (anhydrous)

থেকে পাওয়া:

PFIZER PRIVATE LIMITED

এটিসি কোড:

L01CD02

ডোজ:

160mg per 16ml

ফার্মাসিউটিকাল ফর্ম:

INFUSION, SOLUTION

রচনা:

Docetaxel (anhydrous) 160mg per 16ml

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

Prescription Only

Manufactured by:

Zydus Hospira Oncology Private Limited (ZHOPL)

অনুমোদন অবস্থা:

ACTIVE

অনুমোদন তারিখ:

2012-08-27

পণ্য বৈশিষ্ট্য

1
NAME OF THE MEDICINAL PRODUCT
Hospira Docetaxel Concentrate for Solution for Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 10 mg docetaxel.
One vial of 2 mL contains 20 mg docetaxel (for single-dose
application).
One vial of 8 mL contains 80 mg docetaxel (for single-dose
application).
One vial of 16 mL contains 160 mg docetaxel (for single-dose
application).
Excipient with known effect
Each vial contains ethanol anhydrous 182 mg/mL (23% v/v).
See Section 4.4 Special warnings and
precautions for use, Alcohol content.
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Solution for Infusion
A clear colourless to pale yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
•
Hospira Docetaxel Concentrate for Solution for Infusion 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.
•
Hospira Docetaxel Concentrate for Solution for Infusion 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.
•
Hospira Docetaxel Concentrate for Solution for Infusion 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
•
Hospira Docetaxel Concentrate for Solution for Infusion is indicated
for the treatment of patients
with locally advanced or metastatic non-small cell lung cancer after
failure of prior chemotherapy.
•
Hospira Docetaxel Concentrate for Solution for Infusion 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 re