Summary of Product Characteristics
last updated on the eMC:
26/10/2011
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 26/10/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 6. 3 - Shelf Life
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 29-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In the section 4.2 the following paragraph:
Method of administration
TEPADINA must be administered by a qualified healthcare professional as a 2-4 hours intravenous infusion via a central venous catheter.
TEPADINA must be reconstituted with 1.5 ml of sterile water for injection and further diluted with 500 ml of sodium chloride 9 mg/ml (0.9%) solution for injection prior to administration. For instructions on reconstitution and further dilution prior to administration, see section 6.6.
is replaced by:
Method of administration
TEPADINA must be administered by a qualified healthcare professional as a 2-4 hours intravenous infusion via a central venous catheter.
Each TEPADINA vial must be reconstituted with 1.5 ml of sterile water for injection. The total volume of reconstituted vials to be administered should be further diluted in 500 ml of sodium chloride 9 mg/ml (0.9%) solution for injection prior to administration (1000 ml if the dose is higher than 500 mg). In children, if the dose is lower than 250 mg, an appropriate volume of sodium chloride 9 mg/ml (0.9%) solution for injection may be used in order to obtain a final TEPADINA concentration between 0.5 and 1 mg/ml. For instructions on reconstitution and further dilution prior to administration, see section 6.6.
In the section 6.3 is inserted the stability data after dilution of 4 hours when stored at 25°C.
In the section 6.6 the following paragraph:
Further dilution in the infusion bag
The reconstituted solution is hypotonic and must be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
is replaced by:
Further dilution in the infusion bag
The reconstituted solution is hypotonic and must be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection (1000 ml if the dose is higher than 500 mg) or
with an appropriate volume of sodium chloride 9 mg/ml (0.9%) in order to obtain a final TEPADINA concentration between 0.5 and 1 mg/ml.
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Updated on 14/02/2011 and displayed until 26/10/2011
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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