What Docetaxel Seacross contains
- The active substance is docetaxel.
[Docetaxel Seacross 20 mg/1 ml]
One ml docetaxel concentrate contains 20 mg docetaxel.
[Docetaxel Seacross 80 mg/4 ml]
One ml docetaxel concentrate contains 20 mg docetaxel.
- The other ingredients are polysorbate 80, ethanol 96% and citric acid monohydrate.
What Docetaxel Seacross looks like and contents of the pack
Docetaxel Seacross concentrate for solution for infusion is a clear viscous, colourless to brownish-yellow sterile solution.
[Docetaxel Seacross 20 mg/1 ml]
The concentrate is supplied in a 2 ml colourless glass vial with a green flip-off closure. Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
[Docetaxel Seacross 80 mg/4 ml]
The concentrate is supplied in a 4 ml colourless glass vial with a red flip-off closure. Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Marketing Authorisation Holder
Seacross Pharmaceuticals Limited
Landmark House
17 Hanover Square
Mayfair
LONDON
W1S 1HU
United Kingdom
Manufacturer
Aegis Ltd
17, Athinon Street, Ergates, Industrial Area
(P.O. Box 28629)
2081 Nicosia
Zypern
Thymoorgan Pharmazie GmbH
Schiffgraben 23
38690 Vienenburg
Deutschland
Tecnimede – Sociedade Técnico-Medicinal, SA Quinta da Cerca, Caixaria
2565-187 Dois Portos Portugal
Docetaxel Seacross 20 mg/1 ml, concentraat voor oplossing voor infusie: RVG 108100 Docetaxel Seacross 80 mg/4 ml, concentraat voor oplossing voor infusie: RVG 108101
This leaflet was last revised in oktober 2013
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The following information is intended for healthcare professionals only:
PREPARATION GUIDE FOR USE WITH Docetaxel Seacross 20 mg/1 ml [ Docetaxel Seacross 80 mg/4 ml ] CONCENTRATE FOR SOLUTION FOR INFUSION
It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Seacross infusion solution.
RECOMMENDATIONS FOR THE SAFE HANDLING
Docetaxel Seacross is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling and preparing its solutions. The use of gloves is recommended.
If Docetaxel Seacross 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 several vials (concentrate and solvent) with this medicinal product (Docetaxel Seacross 20 mg/1 ml [ Docetaxel Seacross 80 mg/4 ml ] concentrate for solution for infusion, which contains only 1 vial).
Docetaxel Seacross 20 mg/1 ml [Docetaxel Seacross 80 mg/4 ml] 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 Seacross 20 mg/1 ml [Docetaxel Seacross 80 mg/4 ml] vial the concentration of docetaxel is 20 mg/ml.
- Then, inject via a single injection (one shot) into a 250 ml 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 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 or bottle manually using a rocking motion.
- From microbiological point of view, reconstitution /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 (PP) or infusion bottle (PE), the docetaxel infusion solution, if stored below 25°C, is stable for 8 hours in infusion bottle or for 6 hours in infusion bag. It should be used within 6-8 hours (including the one hour infusion IV 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 48 hours when stored between 2°C to 8°C.
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.