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AstraZeneca

Docetaxel Teva
docetaxel

Package leaflet: Information for the patient


Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion

docetaxel


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


Marketing Authorisation Holder

Teva B.V. Swensweg 5

2031 GA Haarlem The Netherlands

Manufacturer: Pharmachemie B.V. Swensweg 5

PO Box 552

2003 RN Haarlem The Netherlands


TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82

H-2100 Gödöllő,

Hungary


For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73

Lietuva

UAB Teva Baltics Tel: +370 5 266 02 03


България

Актавис ЕАД

Teл.: +359 2 489 95 85

Luxembourg/Luxemburg

Teva Pharma Belgium N.V./S.A./AG Tél: +32 3 820 73 73


Česká republika

Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111

Magyarország

Teva Gyógyszergyár Zrt. Tel.: +36 1 288 64 00


Danmark

Medicinal product no longer authorised

Teva Denmark A/S Tlf: +45 44 98 55 11

Malta

Teva Pharmaceuticals Ireland L-Irlanda

Τel: +353 19127700


Deutschland

Teva GmbH

Tel: +49 731 402 08

Nederland

Teva Nederland B.V. Tel: +31 800 0228 400


Eesti

UAB Teva Baltics Eesti filiaal Tel: +372 661 0801

Norge

Teva Norway AS Tlf: +47 66 77 55 90


Ελλάδα

Specifar A.B.E.E.

Τηλ: +30 211 880 5000

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007 0


España

Teva Pharma, S.L.U. Tel: +34 91 387 32 80

Polska

Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00


France

Teva Santé

Tél: +33 1 55 91 78 00

Portugal

Teva Pharma - Produtos Farmacêuticos Lda Tel: +351 21 476 75 50


Hrvatska

Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000

România

Teva Pharmaceuticals S.R.L Tel: +40 21 230 65 24

Ireland

Teva Pharmaceuticals Ireland Tel: +353 19127700

Slovenija

Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390


Ísland

Teva Finland Oy

Sími: +358 20 180 5900

Slovenská republika

Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 2 5726 7911


Italia

Teva Italia S.r.l.

Tel: +39 0289 17981

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 20 180 5900


Κύπρος

Specifar A.B.E.E.

Ελλάδα

Τηλ: +30 211 880 5000

Latvija

UAB Teva Baltics filiāle Latvijā

Tel: +371 67 323 666

Sverige

Teva Sweden AB Tel: +46 42 12 11 00


United Kingdom

Teva UK Limited

Tel: +44 1977 628 500


This leaflet was last revised in {MM/YYYY}.

Medicinal product no longer authorised

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The following information is intended for healthcare professionals only:


PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 20 mg/0.72 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION


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It is important that you read the entire contents of this guide prior to the preparation of either the Docetaxel Teva premix solution or the Docetaxel Teva infusion solution


  1. FORMULATION


    Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel in polysorbate 80. The solvent for Docetaxel Teva is water for injections.


  2. PRESENTATION


    Docetaxel Teva is supplied as single-dose vials.


    Each box contains one Docetaxel Teva vial (20 mg/0.72 ml) and one corresponding solvent for Docetaxel Teva vial in a carton.


    Docetaxel Teva vials should not be stored above 25°C and should be protected from light. Docetaxel Teva should not be used after the expiry date shown on the carton and vials.


    1. Docetaxel Teva 20 mg/0.72 ml vial:


      Medicinal product no longer authorised

      • The Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.


      • The Docetaxel Teva 20 mg/0.72 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.


      • Each vial contains 20 mg/0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml). This volume has been established during the development of docetaxel 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 docetaxel 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/0.72 ml per vial.


    2. Solvent for Docetaxel Teva 20 mg/0.72 ml vial:


      • The solvent for Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.


      • The solvent for Docetaxel Teva composition is water for injections.


      • Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml). The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.


  3. RECOMMENDATIONS FOR THE SAFE HANDLING

    Docetaxel Teva is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Teva solutions. The use of gloves is recommended.


    If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.


  4. PREPARATION FOR THE INTRAVENOUS ADMINISTRATION


    1. Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)


      1. If the vials are stored under refrigeration, allow the required number of Docetaxel Teva boxes to stand at room temperature (below 25°C) for 5 minutes.


      2. Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial.


      3. Inject the entire contents of the syringe into the corresponding Docetaxel Teva vial.


      4. Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds. Do not shake.


        Medicinal product no longer authorised

      5. Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then 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 immediately after preparation. However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between +2°C and +8°C or at room temperature (below 25°C).


    2. Preparation of the infusion solution


      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 syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.


      2. Inject the required premix volume into a 250 ml non-PVC infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.


      3. Mix the infusion bag or bottle manually using a rocking motion.


      4. The Docetaxel Teva infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.


      5. As with all parenteral products, Docetaxel Teva premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

  5. DISPOSAL


Medicinal product no longer authorised

All materials that have been utilised for dilution and administration should be disposed of according to standard procedures. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.