What Levetiracetam Hexal infuus contains:
The active substance is called Levetiracetam. Other ingredients are:
Sodium acetate trihydrate, Sodium chloride, Glacial acetic acid, Water for injection
What Levetiracetam Hexal infuus looks like and the contents of the pack
Levetiracetam Hexal infuus is a clear, colourless, concentrate
Levetiracetam Hexal infuus concentrate 5 ml vial is packed in a cardboard box of
1, 10 vials
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hexal AG
Industriestrasse 25
83607 Holzkirchen
Germany
Manufacturer
Haupt Pharma Wülfing GmbH
Bethelner Landsrasse 18,
31028 Gronau/Leine
Germany
Lek Pharmaceuticals d.d
Verovškova 57, 1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany
Marketing Authorisation number:
RVG 108507
This medicines product is authorised in the Member States of the EEA under the following names:
RMS (NL): Levetiracetam Hexal infuus 100 mg/ml, concentraat voor oplossing
voor | infusie |
DE: | Levetiracetam HEXAL 100mg/ml Konzentrat zur Herstellung einer |
| Infusionslösung |
This leaflet was last approved in November 2012.
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The following information is intended for doctor and nurses only:
Direction for the proper use of Levetiracetam Hexal infuus is provided in section 3.
One vial of Levetiracetam Hexal infuus concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml). See Table 1 for the recommended preparation and administration of Levetiracetam Hexal infuus concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000
mg, or 3000 mg in two divided doses.
Table 1. Preparation and administration of Levetiracetam Hexal infuus concentrate.
Dose | Withdrawal Volume | Volume | Infusion | Frequency | Total Daily |
| | of | Time | of | Dose |
| | diluent | | administrati | |
| | | | on | |
250 mg | 2.5 ml (half 5 ml vial) | 100 ml | 15 minutes | Twice daily | 500 mg/day |
500 mg | 5 ml (one 5 ml vial) | 100 ml | 15 minutes | Twice daily | 1000 mg/day |
1000 mg | 10 ml (two 5 ml vials) | 100 ml | 15 minutes | Twice daily | 2000 mg/day |
1500 mg | 15 ml (three 5 ml | 100 ml | 15 minutes | Twice daily | 3000 mg/day |
vials) | |
This medicinal product is for single use only, any unused solution should be discarded.
In use shelf life: from a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage time 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 dilution has taken place in controlled and validated aseptic conditions.
Levetiracetam Hexal infuus concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15-25°C.
Diluents:
- Sodium chloride (0.9%) injection
- Lactated Ringer’s injection
- Dextrose 5% injection