Docetaxel 140mg7ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Docetaxel

Available from:

Teva UK Ltd

ATC code:

L01CD02

INN (International Name):

Docetaxel

Dosage:

20mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5012617021038

Patient Information leaflet

Docetaxel 20mg/ml Concentrate for Solution for Infusion PIL - UK
item no: AAAI5260
print proof no: 3
origination date: 20.11.15
originated by: S.Anson
revision date: 17.03.16
revised by: S.Anson
dimensions: 124 x 700
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 20.11.15
supplier: Actavis Nerviano
technically app. date: 20.11.15
min pt size: 9
TECHNICAL APPROVAL
DOCETAXEL 20MG/ML CONCENTRATE
FOR SOLUTION FOR INFUSION
The following information is intended for medical or healthcare
professionals only:
DOCETAXEL 20MG/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
INSTRUCTIONS ON USE
Docetaxel is an antineoplastic agent
and, as with other potentially toxic
compounds, caution should be
exercised when handling it and
preparing Docetaxel solutions.
Cytotoxic agents should be prepared
for administration only by personnel
who have been trained in the safe
handling of such preparations.
Refer to local cytotoxic guidelines
before commencing. The use
of gloves is recommended. If
Docetaxel concentrate or infusion
solution should come into contact
with skin, wash immediately and
thoroughly with soap and water. If
Docetaxel concentrate or infusion
solution should come into contact
with mucous membranes, wash
immediately and thoroughly with
water.
PREPARATION OF THE SOLUTION FOR
INFUSION
More than one vial of Docetaxel
20mg/ml concentrate for solution for
infusion may be necessary to obtain
the required dose for individual
patients. Based on the required
dose for the patient expressed
in mg, aseptically withdraw the
corresponding volume of 20mg/
ml docetaxel from the appropriate
number of vials using graduated
syringes fitted with a needle. For
example, a dose of 140mg docetaxel
would require 7ml of Docetaxel
20mg/ml concentrate for solution for
infusion.
For doses below 192mg of docetaxel,
inject the required volume of
Docetaxel 20mg/ml concentrate for
solution for infusion into a 250ml
infusion bag or bottle containing
either 250ml of 50mg/ml (5%)
glucose solutio

Summary of Product characteristics

DOCETAXEL ACTAVIS 20MG/ML CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 01-Apr-2016 | Actavis UK
Ltd
1. Name of the medicinal product
Docetaxel Actavis 20mg/ml Concentrate for Solution for Infusion
2. Qualitative and quantitative composition
Each single dose vial contains docetaxel 20 mg/ml
Each 1 ml single dose vial contains 20 mg docetaxel
Each 4 ml single dose vial contains 80 mg docetaxel
Each 7 ml single dose vial contains 140 mg docetaxel
Each 8 ml single dose vial contains 160 mg docetaxel
Excipient with known effect: Ethanol absolute 400 mg/ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion
The concentrate is a clear, pale yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
_BREAST CANCER_
Docetaxel Actavis 20mg/ml Concentrate for Solution for Infusion 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 Actavis 20mg/ml 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.
Docetaxel Actavis 20mg/ml 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.
Docetaxel Actavis 20mg/ml Concentrate for Solution for Infusion in
combination with trastuzumab is
indicated for the treatment of patients with metastatic breast cance