What Topotecan Actavis contains
- The active substance is topotecan. Each vial contains 1 mg (with 10% overage of fill) or 4 mg topotecan (as hydrochloride). After reconstitution 1 ml concentrate contains 1 mg topotecan.
- The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
What Topotecan Actavis looks like and contents of the pack
Topotecan Actavis is supplied in type I colourless glass vials with grey bromobutylic stopper and aluminium seals with plastic flip-off caps.
Packs:
1 vial containing 1 mg topotecan
1 vial containing 4 mg topotecan
Marketing Authorisation Holder
Actavis Group PTC ehf.Reykjavíkurvegi 76-78
Hafnarfjörður
Iceland
Manufacturer
S.C. Sindan-Pharma S.R.L.
11 Ion Mihalache Blvd
Bucharest
Romania
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien ALL-in-1 bvba TélTel 32 032 86 88 88 LuxembourgLuxemburg ALL-in-1 bvba BelgiqueBelgien TélTel 32 032 86 88 88
Te. 359 2 9321 680 Magyarország Actavis Hungary Kft Tel. 3652431-313314
eská republika Actavis CZ a.s. Tel 420251001680 Malta Actavis Ltd. Tel 35621693533
Danmark Actavis AS Tlf 45 72 22 30 00 Nederland Actavis B.V. Tel 035 -54 299 33
Deutschland Actavis Deutschland GmbH Co. KG Telefon 49 021731674 0 Norge Actavis Norway AS Tlf 47 815 22 099
Eesti UAB Actavis Baltics Eesti Filiaal Tel 372 6100 565 Österreich Actavis GmbH Tel 43 0662 435 235 00
Polska Actavis Polska Tel. 48 22 814 12 39 PharOS - Pharmaceutical Oriented Services Ltd Tel 30 210 66 64 667 8
España Ramón Sala S.L. Tfno. 34 93 480 67 19 Portugal Actavis AS Sucursal Tel 351 21 722 06 50
France Actavis Tél 33 1 40 83 77 77 România Actavis SRL Tel 40 21 318 17 77
Slovenija Sanolabor d.d. phone 386 01 585-4211 Ireland Actavis UK Limited United Kingdom Tel 441271311234
Ísland Actavis Group PTC ehf Sími 354-535 2326 Slovenská republika Actavis s.r.o. Tel 421 2 3255 3801
Italia Actavis Italy S.p.A. Tel 39 0331 583111 SuomiFinland Actavis Oy PuhTel 358 09 348 233
A. Potamitis Medicare Ltd 35722313611 Sverige Actavis AB Tel 46 8 13 63 70
Latvija Actavis Baltics prstvniecba Latvij Tel 371 67067873 United Kingdom Actavis UK Limited Tel 441271311234
Lietuva
UAB ?Actavis Baltics?
Tel: +370 5 260 9615
This leaflet was last approved in {MM/YYYY}.
-------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Topotecan Actavis
INSTRUCTIONS ON USE
Guidelines for the safe handling and disposal of antineoplastic agents
1. Reconstitution and dilution of the medicinal product must be performed by trained personnel.
2. The preparation should be performed in a designated area under aseptic conditions.
3. Adequate protective disposable gloves, goggles, gown and mask should be worn.
4. Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes. In the event of contact with the eyes, irrigate with large amounts of water. Then seek medical evaluation by a physician.
5. In case of skin contact, thoroughly wash the affected area with large amount of water. Always wash hands after removing gloves.
6. Pregnant staff should not handle the cytotoxic preparation.
7. Adequate care and precautions should be taken in the disposal of items (syringes, needles etc) used to reconstitute and/or dilute cytotoxic medicinal products. Any unused product or waste material should be disposed of in accordance with local requirements.
Reconstitution and dilution prior to administration
Before infusion, Topotecan Actavis powder for concentrate for solution for infusion must be reconstituted with an appropriate volume of water for injections, as follows:
- Topotecan Actavis 1 mg with 1.1 ml water for injections (as it contains 10% overage of fill)
- Topotecan Actavis 4 mg with 4 ml water for injections
Reconstitution will result in a concentrate containing 1 mg topotecan per ml.
This concentrate (1 mg/ml) must be diluted prior to administration.
The volume of reconstituted concentrate corresponding to the calculated individual dose, should be further diluted with either sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for infusion, to a final concentration of between
25 and 50 microgram per ml in the solution for infusion, for example:
Volume for 25 microgramml solution Volume for 50 microgramml solution 1 ml of 1 mgml topotecan solution Add 39 ml to give 40 ml Add 19 ml to give 20 ml 4 ml of 1 mgml topotecan solution Add 156 ml to give 160 ml Add 76 ml to give 80 ml
Storage after reconstitution and dilution
Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2 to 8°C, protected from light.
Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions .The concentrates tested were reconstituted and stored at 25 ± 2°C for 12 hours and 24 hours respectively after reconstitution, and then diluted.
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 24 hours at 2 to 8°C, unless reconstitution/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. 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.