What Tolnexa contains
- The active substance is docetaxel. Each ml of concentrate for solution for infusion contains 20 mg docetaxel. One vial of 1 ml of concentrate contains 20 mg docetaxel. One vial of 4 ml of concentrate contains 80 mg docetaxel. One vial of 8 ml of concentrate contains 160 mg docetaxel.
- The other ingredients are polysorbate 80, anhydrous ethanol and anhydrous citric acid.
What Tolnexa looks like and contents of the pack
Tolnexa concentrate for solution for infusion is a clear pale yellow to brownish-yellow solution.
The concentrate is supplied in a 5 ml clear glass (type I) vial with fluorotec plus rubber stopper and aluminium seal and an orange flip-off cap.
The concentrate is supplied in a 5 ml clear glass (type I) vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.
The concentrate is supplied in a 10 ml clear glass (type I) vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.
Pack size:
Each box contains one vial of 1 ml concentrate. Each box contains one vial of 4 ml concentrate. Each box contains one vial of 8 ml concentrate.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenië
Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenië
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, D-27472 Cuxhaven, Duitsland
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| 1.3.1 | Docetaxel |
| SPC, Labeling and Package Leaflet | NL |
Dit geneesmiddel is in het register ingeschreven onder:
RVG 111582
Dit geneesmiddel is geregistreerd in lidstaten van de EEA onder de volgende namen:
| Naam van de lidstaat | Naam van het geneesmiddel |
| Bulgarije, Duitsland, Estland, Hongarije, Letland, Litouwen, | Tolnexa |
| Nederland, Polen, Roemenië, Slovenië, Slowakije, Tsjechië | |
This leaflet was last revised in februari 2013.
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The following information is intended for healthcare professionals only:
PREPARATION GUIDE FOR USE WITH TOLNEXA CONCENTRATE FOR SOLUTION FOR INFUSION
It is important that you read the entire contents of this guide prior to the preparation of the Tolnexa infusion solution.
Recommendations for the safe handling:
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions. The use of gloves is recommended.
If Tolnexa concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Preparation of the intravenous administration:
Preparation of the infusion solution
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Tolnexa 20 mg/ml concentrate for solution for infusion,
which contains only 1 vial) (20 mg/1 ml, 80 mg/4 ml, 160 mg/8 ml).
Tolnexa concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
- Each vial is for single use and should be used immediately after opening. If not used immediately, in-use storage times and conditions are the responsibility of the user. More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient. For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
- Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe.
In Tolnexa vial the concentration of docetaxel is 20 mg/ml.
- Then, inject via a single injection (one shot) into a 250 ml infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. If a dose greater than 190 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.
- Mix the infusion bag manually using a rocking motion. Avoid vigorous shaking or excessive
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| 1.3.1 | Docetaxel |
| SPC, Labeling and Package Leaflet | NL |
agitation.
- From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 24 hours. It should be used within 24 hours (including the one hour infusion intravenous administration). In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 7 days when stored between 2°C to 8°C. It is recommended to avoid excessive agitation of the bags. Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.
- As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Disposal:
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.
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