Paclitaxel 150mg/25ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paclitaxel

Available from:

Accord-UK Ltd

ATC code:

L01CD01

INN (International Name):

Paclitaxel

Dosage:

6mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5055565704752

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PACLITAXEL 6 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION
Paclitaxel
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 further questions, ask your doctor, pharmacist or nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Paclitaxel Injection is and what it is used for
2.
What you need to know before you use Paclitaxel Injection
3.
How Paclitaxel Injection is given to you
4.
Possible side effects
5.
How to store Paclitaxel Injection
6.
Contents of the pack and other information
1.
WHAT PACLITAXEL INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Paclitaxel 6 mg/ml, Concentrate for
Solution for Infusion’ but in the rest of
the leaflet it will be called “Paclitaxel Injection”.
Paclitaxel belongs to a group of anti-cancer medicines called taxanes.
These_ _agents inhibit the growth of
cancer cells.
Paclitaxel Injection is used to treat:
OVARIAN CANCER:

as first therapy (after initial surgery in combination with the
platinum-containing medicine cisplatin).

after standard platinum-containing medicines have been tried but did
not work.
BREAST CANCER:

as first therapy for advanced disease or disease which has spread to
other parts of the body (metastatic
disease). Paclitaxel Injection is either combined with an
_anthracycline_ (e.g. doxorubicin) or with a
medicine called _trastuzumab_ (for patients for whom anthracycline is
not suitable and whose cancer cells
have a protein on their surface called HER 2, see package leaflet of
trastuzumab).

after initial surgery following treatment with anthracycline and
cyclophosphamide (AC) as an additional
treatment.

as a second-line treatment for patients who have not responded to
standard treatments using
anthracyclines,

Summary of Product characteristics

OBJECT 1
PACLITAXEL 6 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 18-Jan-2018 | Accord
Healthcare Limited
1. Name of the medicinal product
Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
2. Qualitative and quantitative composition
Each ml of concentrate for solution for infusion contains 6 mg of
paclitaxel.
A vial of 5 ml contains 30 mg of paclitaxel.
A vial of 16.7 ml contains 100 mg of paclitaxel.
A vial of 25 ml contains 150 mg of paclitaxel.
A vial of 50 ml contains 300 mg of paclitaxel.
A vial of 100 ml contains 600 mg of paclitaxel.
Excipient(s) with known effect:
Polyoxyl 35 castor oil (Macrogolglycerol ricinoleate 35) 527.0 mg/ml
and anhydrous ethanol 391 mg/ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion
Paclitaxel 6 mg/ml, concentrate for solution for infusion is a clear
colourless to slightly yellow solution
free from visible particles with a pH in range of 3.0 – 5.5 and an
osmolarity of > 4000 mOsm/l.
4. Clinical particulars
4.1 Therapeutic indications
OVARIAN CARCINOMA: in the first-line chemotherapy of ovarian cancer,
paclitaxel is indicated for the
treatment of patients with advanced carcinoma of the ovary or with
residual disease (> 1 cm) after initial
laparotomy, in combination with cisplatin.
In the second-line chemotherapy of ovarian cancer, paclitaxel is
indicated for the treatment of metastatic
carcinoma of the ovary after failure of standard, platinum containing
therapy.
BREAST CARCINOMA: in the adjuvant setting, Paclitaxel is indicated for
the treatment of patients with node-
positive breast carcinoma following anthracycline and cyclophosphamide
(AC) therapy. Adjuvant
treatment with Paclitaxel should be regarded as an alternative to
extended AC therapy.
Paclitaxel is indicated for the initial treatment of locally advanced
or metastatic breast cancer either in
combination with an anthracycline in patients for whom anthracycline
therapy is suitable, or in
combination with tr