solution for injection
60 vials solvent
60 3 ml syringes
60 1 ml syringes
180 alcohol swabs
6.6 Special precautions for disposal and other handling
Any unused medicinal product should be disposed of in accordance with local requirements.
Patients should be instructed on the use and administration of Fuzeon by a healthcare professional before using for the first time.
Fuzeon must only be reconstituted with 1.1 ml of Water for Injections. Patients must be instructed to add the water for injections and then gently tap the vial with their fingertip until the powder begins to dissolve. They must never shake the vial or turn it upside down to mix—this will cause excessive foaming. After the powder begins to dissolve they can set the vial aside to allow it to completely dissolve. The powder may take up to 45 minutes to dissolve into solution. The patient can gently roll the vial between their hands after adding the water for injections until it is fully dissolved and this may reduce the time it takes for the powder to dissolve. Before the solution is withdrawn for administration, the patient should inspect the vial visually to ensure that the contents are fully in solution, and that the solution is clear and without bubbles or particulate matter. If there is evidence of particulate matter, the vial must not be used and should be discarded or returned to the pharmacy.
The solvent vials contain 2 ml Water for Injections, of which 1.1 ml must be withdrawn for the reconstitution of the powder. Patients should be instructed to discard the remaining volume in the solvent vials.
Fuzeon contains no preservative. Once reconstituted, the solution should be injected immediately. If the reconstituted solution cannot be injected immediately, it must be kept refrigerated until use and used within 24 hours. Refrigerated reconstituted solution should be brought to room temperature before injection.
1 ml of the reconstituted solution should be injected subcutaneously in to the upper arm, abdomen or anterior thigh. The injection should be given at a site different from the preceding injection site and where there is no current injection site reaction. A vial is suitable for single use only; unused portions must be discarded.
7. Marketing authorisation holder
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
8. Marketing authorisation number(s)
EU/1/03/252/001
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 27 May 2003
Date of latest renewal: 27 May 2008
10. Date of revision of the text
16 December 2015
Detailed information on this medicinal product is available on the web site of the European Medicines Agency: http://www.ema.europa.eu/
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