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279132
TAXOTERE vials should be stored between 2C and 25C and protected from light.
TAXOTERE should not be used after the expiry date shown on the pack.
20 mg concentrate and
2.1 TAXOTERE 20 mg vial:
solvent for solution for infusion
The TAXOTERE 20 mg vial is a 7 ml clear glass vial with a green flip-off cap.
The TAXOTERE 20 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of
40 mg/ml.
docetaxel
Each TAXOTERE 20 mg vial contains 0.5 ml of a 40 mg/ml solution of docetaxel in polysorbate 80
(fill volume: 24.4 mg/0.61 ml). This volume has been established during the development of
TAXOTERE to compensate for liquid loss during preparation of the premix (see section 4) due to
foaming, adhesion to the walls of the vial and dead-volume. This overfill ensures that after
dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal
extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the
labelled amount of 20 mg per vial.
PREPARATION GUIDE FOR USE WITH TAXOTERE 20 MG CONCENTRATE FOR SOLUTION FOR
INFUSION AND SOLVENT FOR TAXOTERE 2.2 Solvent for TAXOTERE 20 mg vial:
The solvent for TAXOTERE 20 mg vial is a 7 ml clear glass vial with a transparent colourless flip-off
It is important that you read the entire contents of this procedure prior to the preparation of either the cap.
TAXOTERE premix solution or the TAXOTERE infusion solution
The solvent for TAXOTERE composition is a 13% w/w solution of ethanol in water for injections.
1. FORMULATION Each solvent for TAXOTERE 20 mg vial contains 1.98 ml. This volume has been established based on
the fill volume of the TAXOTERE 20 mg vial. The addition of the entire contents of the solvent vial
TAXOTERE 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution to the contents of the TAXOTERE 20 mg vial ensures a premix concentration of 10 mg/ml docetaxel.
containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80. The solvent for TAXOTERE is a 13% w/w
solution of ethanol in water for injections.
3. RECOMMENDATIONS FOR THE SAFE HANDLING
2. PRESENTATION TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be
exercised when handling it and preparing TAXOTERE solutions. The use of gloves is recommended.
TAXOTERE is supplied as single-dose vials.
If TAXOTERE concentrate, premix solution or infusion solution should come into contact with skin, wash
Each box contains one TAXOTERE vial (20 mg) and one corresponding solvent for TAXOTERE vial in a blister immediately and thoroughly with soap and water. If TAXOTERE concentrate, premix solution or infusion
pack. solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
4. PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
4.1 Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)
4.1.1 If the vials are stored under refrigeration, allow the required number of
TAXOTERE boxes to stand at room temperature for 5 minutes.
4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents
of the solvent for TAXOTERE vial by partially inverting the vial.
4.1.3 Inject the entire contents of the syringe into the corresponding TAXOTERE
vial.
4.1.4 Remove the syringe and needle and mix manually by repeated inversions for
at least 45 seconds. Do not shake.
4.1.5 Allow the premix vial to stand for 5 minutes at room temperature and then 4.2.3 Mix the infusion bag or bottle manually using a rocking motion.
check that the solution is homogenous and clear (foaming is normal even
after 5 minutes due to the presence of polysorbate 80 in the formulation).
The premix solution contains 10 mg/ml docetaxel and should be used imme-
diately after preparation. However the chemical and physical stability of the
premix solution has been demonstrated for 8 hours when stored either
between +2C and +8C or at room temperature.
4.2.4 The TAXOTERE infusion solution should be used within 4 hours and should be aseptically
administered as a 1-hour infusion under room temperature and normal lighting conditions.
4.2 Preparation of the infusion solution
4.2.1 More than one premix vial may be necessary to obtain the required dose for
the patient. Based on the required dose for the patient expressed in mg,
aseptically withdraw the corresponding premix volume containing 10 mg/ml
docetaxel from the appropriate number of premix vials using graduated 4.2.5 As with all parenteral products, TAXOTERE premix solution and infusion
syringes fitted with a needle. For example, a dose of 140 mg docetaxel would solution should be visually inspected prior to use, solutions containing a
require 14 ml docetaxel premix solution. precipitate should be discarded.
5. DISPOSAL
4.2.2 Inject the required premix volume into a 250 ml infusion bag or bottle
containing either 5% glucose solution or 0.9% sodium chloride solution. If a All materials that have been utilised for dilution and administration should be disposed of according to
dose greater than 200 mg of docetaxel is required, use a larger volume of the standard procedures.
infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not
exceeded.

Prostate cancer of your blood tests. Such information will allow him/her to decide whether a dose reduction is Common (experienced in less than 1 in 10 but more than 1 in 100 patients) Pakistan Lietuva
8. TAXOTERE (docetaxel) in combination with prednisone or prednisolone is indicated for the needed. If you have any further questions on the use of this product, ask your doctor or hospital oral candidiasis sanofi-aventis Pakistan limited UAB sanofi-aventis Lietuva
20 mg concentrate and
treatment of patients with hormone refractory metastatic prostate cancer. pharmacist.
dehydration
Tel.: +92 21 5060221-35 Tel: +370 5 2755224
Gastric Adenocarcinoma 4. POSSIBLE SIDE EFFECTS dizziness Belgique/Belgi/Belgien Luxembourg/Luxemburg
solvent for solution for infusion 9. TAXOTERE (docetaxel) in combination with cisplatin and 5-fluorouracil is indicated for the Like all other anticancer medicines, TAXOTERE can cause side effects, although not everybody gets hearing impaired sanofi-aventis Belgium sanofi-aventis Belgium
treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the them. Tl/Tel: +32 (0)2 710 54 00 Tl/Tel: +32 (0)2 710 54 00
docetaxel gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. decrease in blood pressure; irregular or rapid heart beat (Belgique/Belgien)
Your doctor will discuss these with you and will explain the potential risks and benefits of your
Head and neck cancer treatment. heart failure
oesophagitis sanofi-aventis Bulgaria EOOD Magyarorszg
10. TAXOTERE (docetaxel) in combination with cisplatin and 5-fluorouracil is indicated for the The most commonly reported adverse reactions of TAXOTERE alone are: decrease in the number of : +359 (0)2 970 53 00 sanofi-aventis zrt., Magyarorszg
induction treatment of patients with inoperable locally advanced squamous cell carcinoma of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and dry mouth Tel: +36 1 505 0050
the head and neck. tiredness.
difficulty or painful swallowing esk republika
The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in sanofi-aventis, s.r.o. Malta
2. BEFORE YOU USE TAXOTERE haemorrhage
combination with other chemotherapeutic agents. Tel: +420 233 086 111 sanofi-aventis Malta Ltd.
You should not be given TAXOTERE if: raised liver enzymes (hence the need for regular blood tests) Tel: +356 21493022
During the infusion at the hospital the following allergic reactions (experienced in more than
PACKAGE LEAFLET: INFORMATION FOR THE USER you experienced in the past a severe allergic reaction to it or to polysorbate 80 which is Uncommon: (experienced in more than 1 in 1,000 but less than 1 in 100) Danmark
1 person in 10) may occur:
TAXOTERE 20 mg concentrate and solvent for solution for infusion contained in the product. sanofi-aventis Denmark A/S Nederland
docetaxel flushing, skin reactions, itching fainting
Tlf: +45 45 16 70 00 sanofi-aventis Netherlands B.V.
the number of white blood cells is too low. at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
chest tightness; difficulty in breathing Tel: +31 (0)182 557 755
Read all of this leaflet carefully before you start using this medicine. you have a severe liver disease. inflammation of the colon, small intestine; intestinal perforation Deutschland
- Keep this leaflet. You may need to read it again. fever or chills
you are pregnant or breast feeding. Sanofi-Aventis Deutschland GmbH Norge
back pain If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- If you have any further questions, ask your doctor or your hospital pharmacist. Tel: +49 (0)180 2 222010 sanofi-aventis AS
Take special care with TAXOTERE: tell your doctor or hospital pharmacist.
low blood pressure Tlf: +47 67 10 71 00
- If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, Eesti
please tell your doctor or hospital pharmacist. Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood More severe reactions may occur. 5. HOW TO STORE TAXOTERE
cells and sufficient liver function to receive TAXOTERE. In case of white blood cell disturbances, you sanofi-aventis Estonia O sterreich
The hospital staff will monitor your condition closely during treatment. Tell them immediately if you Keep out of the reach and sight of children. Tel: +372 627 34 88 sanofi-aventis GmbH
In this leaflet: may experience associated fever or infections.
notice any of these effects. TAXOTERE should not be used after the expiry date shown on the pack. Tel: +43 1 80 185 0
1. What Taxotere is and what it is used for You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone,
one day prior to TAXOTERE administration and to continue for one or two days after it in order to Between infusions of TAXOTERE the following may occur, and the frequency may vary with the Do not store above 25C or below 2C.
2. Before you use Taxotere combinations of drugs that are received: sanofi-aventis AEBE Polska
minimise certain undesirable effects which may occur after the infusion of TAXOTERE in particular Store in the original package in order to protect from light.
3. How to use Taxotere .: +30 210 900 16 00 sanofi-aventis Sp. z o.o.
allergic reactions and fluid retention (swelling of the hands,feet, legs or weight gain). Very Common: (experienced in more than 1 in 10 patients)
The premix solution should be used immediately after preparation. However the chemical and Tel: +48 22 541 46 00
4. Possible side-effects During treatment, you may be given medication to maintain the number of your blood cells. infections, decrease in the number of red (anaemia), or white blood cells (which are important Espaa
physical stability of the premix solution has been demonstrated for 8 hours when stored either
5. How to store Taxotere in fighting infection) and platelets, between 2C and 8C or at room temperature. sanofi-aventis, S.A.U. Portugal
Taking/using other medicines:
fever: if this happens you must tell your doctor immediately Tel: +34 93 485 94 00 sanofi-aventis - Produtos Farmacuticos, S.A.
6. Further information The infusion solution should be used within 4 hours at room temperature.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other Tel: +351 21 35 89 400
medicine, including medicines obtained without a prescription. This is because TAXOTERE or the allergic reactions as described above France
1. WHAT TAXOTERE IS AND WHAT IT IS USED FOR 6. FURTHER INFORMATION
other medicine may not work as well as expected and you may be more likely to get a side effect. loss of appetite (anorexia) sanofi-aventis france Romnia
The name of this medicine is TAXOTERE. Its common name is docetaxel. Docetaxel is a substance What TAXOTERE contains: Tl : 0 800 222 555 sanofi-aventis Romnia S.R.L.
derived from the needles of yew trees. Pregnancy and breast-feeding: insomnia
- The active substance is docetaxel. Each ml of docetaxel solution contains 40 mg of docetaxel
Appel depuis ltranger : +33 1 57 63 23 23 Tel: +40 (0) 21 317 31 36
Docetaxel belongs to the group of anti-cancer medicines called taxoids. TAXOTERE must NOT be administered if you are pregnant or if you are planning to become feeling of numbness or pins and needles or pain in the joints of muscles
anhydrous. One vial contains 20 mg docetaxel.
pregnant. You must take adequate contraceptive precautions during therapy and for at least three headache Ireland Slovenija
TAXOTERE has been prescribed by your doctor for the treatment of breast cancer, special forms of months after TAXOTERE is no longer administered to you. If pregnancy occurs during - The other ingredient is polysorbate 80.
lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: sanofi-aventis Ltd. sanofi-aventis d.o.o.
your treatment, you must immediately inform your doctor. alteration in sense of taste
What TAXOTERE looks like and contents of the pack:
Tel: +353 (0) 1 403 56 00 Tel: +386 1 560 48 00
When should this drug be used (Therapeutic Indications) You must NOT breast-feed while you are treated with TAXOTERE. inflammation of the eye or increased tearing of the eyes
TAXOTERE 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown-yellow sland Slovensk republika
Breast cancer If you are thinking of becoming pregnant or breastfeeding discuss it with your doctor first. swelling caused by faulty lymphatic drainage
solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80. Vistor hf. sanofi-aventis Pharma Slovakia s.r.o.
1. TAXOTERE (docetaxel) in combination with doxorubicin and cyclophosphamide is indicated for shortness of breath Smi: +354 535 7000 Tel: +421 2 57 103 777
Driving and using machines: Each blister carton of TAXOTERE 20 mg concentrate and solvent for solution for infusion contains:
the adjuvant treatment of patients with operable node- positive breast cancer. nasal drainage; inflammation of the throat and nose; cough
There is no reason why you cannot drive between courses of TAXOTERE except if you feel dizzy or one single-dose TAXOTERE vial and,
2. TAXOTERE (docetaxel) in combination with doxorubicin is indicated for the treatment of bleeding from the nose
Italia Suomi/Finland
are unsure of yourself. one single-dose solvent for TAXOTERE vial
patients with locally advanced or metastatic breast cancer who have not previously received sanofi-aventis S.p.A. sanofi-aventis Oy
cytotoxic therapy for this condition. sores in the mouth Tel. +39 02 393 91 Puh/Tel: +358 (0) 201 200 300
3. HOW TO USE TAXOTERE Marketing Authorisation Holder:
3. TAXOTERE (docetaxel) monotherapy is indicated for the treatment of patients with locally stomach upsets including nausea, vomiting and diarrhea, constipation
TAXOTERE will be administered to you by a healthcare professional. Aventis Pharma S.A. Sverige
advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy abdominal pain 20 avenue Raymond Aron sanofi-aventis Cyprus Ltd. sanofi-aventis AB
should have included an anthracycline or an alkylating agent. Usual dosage
indigestion 92165 Antony Cedex .: +357 22 871600 Tel: +46 (0)8 634 50 00
4. TAXOTERE (docetaxel) in combination with trastuzumab is indicated for the treatment of The dose will depend on your weight and your general condition. Your doctor will calculate your France
short term hair loss (in most cases normal hair growth should return)
patients with metastatic breast cancer whose tumors overexpress HER2 and who previously body surface area in square meters (m2) and will determine the dose you should receive. Latvija United Kingdom
have not received chemotherapy for metastatic disease. redness and swelling of the palms of your hands or soles of your feet which may cause your skin Manufacturer:
Method and route of administration sanofi-aventis Latvia SIA sanofi-aventis
to peel (this may also occur on the arms, face, or body) Aventis Pharma, Dagenham Tel.: +371 7 33 24 51 Tel: +44 (0) 1483 505 515
5. TAXOTERE (docetaxel) in combination with capecitabine is indicated for the treatment of
patients with locally advanced or metastatic breast cancer after failure of cytotoxic TAXOTERE will be given by infusion into one of your veins. The infusion will last approximately one change in the color of your nails, which may detach Rainham Road South
chemotherapy. Previous therapy should have included an anthracycline. hour during which you will be in the hospital. Dagenham
muscle aches and pains; back pain or bone pain
Essex RM10 7XS
Non-small cell lung cancer Frequency of administration change or absence of menstrual period United Kingdom
6. TAXOTERE (docetaxel) is indicated for the treatment of patients with locally advanced or You should usually receive your infusion once every 3 weeks. This leaflet was last updated in January 2007
swelling of the hands, feet, legs
metastatic non-small cell lung cancer after failure of prior chemotherapy. Your doctor may change the dose and frequency of dosing depending on your blood tests, your For any information about this medicinal product, please contact the local representative of the
tiredness; or flu-like symptoms
7. TAXOTERE (docetaxel) in combination with cisplatin is indicated for the treatment of patients general condition and your response to TAXOTERE. In particular, please inform your doctor in case of Marketing Authorisation Holder.
with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give him/her results weight gain or loss
have not previously received chemotherapy for this condition.

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279132.qxd:279132 6/7/07 13:29 Page 2

GMID 279132
Description Lea - Taxotere 20mg
Market/s Pakistan
PCI E4280
Replaces code 209145
Style number LF25
Pharmacode number 474
Colours (PMS reference) Reflex Blue
Logo Version SCV A1 - 08.09.2005
Min. point size (legal text) 8
Proof by & Date Anthea Castles 05/07/2007
Proof Version 1
Printing layout for CUT SHEET LEAFLETS
(to be used in conjunction with current issue of Leaflet Specification)
Paper As specification
Flat/Folded Folded
Perforation Yes at 120mm from top across width
Proofs required No, unless re-set
Artwork supplied ISDN
File name 279132.pdf
Software/Platform PDF/Mac
Linked Graphics embedded
Fonts embedded

ARTWORK CHECK COMPLETED :

To confirm artwork checks have been completed before sending file to printer.
To confirm that the version number of this document matches the approved PDF.

Signature __________________________________________

Print Name __________________________________________

Date __________________________________________

Version 4 - 12/06/07

11/07/2007 - 08:51:48 - Packaging material 279132 - Vista folder 239128 Page 2 / 3

 This document has been digitally signed within the VISTA system, following the sanofi-aventis group guidelines

279132 LEA TAXOTERE 20MG F3 PK

Uploaded by : Anthea Castles

Date : 06/07/2007 15:17:16

Vista step : Market regulatory validation

Signed by : Michelle Azbakh
Date : 09/07/2007 15:55:16

Vista step : Plant final technical validation

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Date : 09/07/2007 16:46:51

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