What Docetaxel Egis 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 of Docetaxel. One vial of 4 ml of concentrate contains 80 mg of Docetaxel. One vial of 8 ml of concentrate contains 160 mg of Docetaxel.
- The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.
What Docetaxel Egis looks like and contents of the pack
Docetaxel Egis concentrate for solution for infusion is a clear pale yellow to brownish-yellow solution. The concentrate is supplied in:
20 mg/1 ml: 5 ml clear glass (type I) vial with fluorotec plus rubber stopper and aluminium seals with orange flip-off cap.
80 mg/4 ml: 5 ml clear glass (type I) vial with fluorotec plus rubber stopper and aluminium seals with red flip-off cap.
160 mg/8 ml: 10 ml clear glass (type I) vial with fluorotec plus rubber stopper and aluminium seals with red flip-off cap.
Pack size:
20 mg/1 ml: Each box contains one vial of 1 ml concentrate (20 mg docetaxel). 80 mg/4 ml: Each box contains one vial of 4 ml concentrate (80 mg docetaxel). 160 mg/8 ml: Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Marketing Authorisation Holder
EGIS Pharmaceuticals PLC
H-1106 Budapest, Keresztúri út 30-38
Hongarije
Manufacturer
Accord Healtcare Limited
1st floor, Sage house, 319 Pinner road, Harrow, HA1 4HF Verenigd Koninkrijk
EGIS Pharmaceuticals PLC
H-1165 Budapest, Bökényföldi út 118-120.
Hongarije
In het register ingeschreven onder: RVG 110259
The medicinal product is authorized in the Member States of the EEA under the following names:
| Name of member state | : Name of medicinal product |
| NL | : Docetaxel Egis 20 mg/ml Concentraat voor oplossing voor |
| | | infusie |
| CZ | : Docetaxel Egis 20 mg/ml Koncentrát pro infuzní roztok |
| HU | : Docetaxel Egis 20 mg/ml koncentrátum oldatos infúzióhoz |
| PL | : | Docetaxel Egis |
| RO | : Docetaxel Egis 20 mg/ml concentrat pentru soluţie perfuzabilă |
| SK | : | Docetaxel Egis 20 mg/ml infúzny koncentrát |
This leaflet was last approved in oktober 2012.
To be completed nationally.
The following information is intended for healthcare professionals only:
PREPARATION GUIDE FOR USE WITH DOCETAXEL EGIS CONCENTRATE FOR SOLUTION FOR INFUSION
It is important that you read the entire contents of this guide prior to the preparation of the Taxegis 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 Docetaxel Egis 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 (Docetaxel Egis 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Egis 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent)
with this medicinal product (Docetaxel Egis 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Docetaxel Egis 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 Docetaxel Egis 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 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.
