What Topotecan Teva contains
- The active substance is topotecan hydrochloride. One vial of 1 ml of concentrate contains 1 mg topotecan (as hydrochloride).
- The other ingredients are: tartaric acid (E334), hydrochloric acid (E507), sodium hydroxide (E524) and water for injections.
What Topotecan Teva looks like and contents of the pack
Topotecan Teva is a clear pale yellow liquid in a colourless glass vial with bromobutyl rubber stopper, aluminium seal and snap-cap.
Each vial contains 1 ml of the concentrate for solution for infusion. Topotecan Teva is supplied in cartons containing 1 vial or 5 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands
Manufacturer
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
TEVA Pharmaceutical Works Private Limited Company
Táncsics Mihály út 82
H-2100 Gödöll-
Hungary
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. Tél 32 3 820 73 73
Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00
eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099
Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400
Deutschland Teva Generics GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00
Österreich Teva Generics GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409
Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00
España Teva Genéricos Española, S.L.U. Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910
France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 212 08 90
Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390
Ísland Teva UK Limited Sími 44 1323 501 111. Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911
Italia Teva Italia S.r.l. Tel 39 0289179805 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00
Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00
Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111
Lietuva
UAB ?Sicor Biotech?
Tel: +370 5 266 02 03
This leaflet was last approved in
The following information is intended for medical or healthcare professionals only:
Instructions on how to dilute, store and dispose of Topotecan Teva
General precautions
The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted:
- Staff should be trained to dilute the medicinal product.
- Pregnant staff should be excluded from working with this medicinal product.
- Staff handling this medicinal product during dilution should wear protective clothing including mask, goggles and gloves.
- All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
- Liquid waste may be flushed with large amounts of water.
- Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Instructions for dilution
The concentrate is pale yellow in colour and contains 1 mg per ml of topotecan. Futher dilution of the appropriate volume of the concentrate with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection to reach a final topotecan concentration of between 25 and 50 microgram/ml in the solution for infusion.
Storage of the diluted solution
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours if stored below 25°C or 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.