Equipment Required - Vascular essential Instructions D'utilisation

therapies for living
PACLITAXEL ELUTING CORONARY BALLOON DILATATION CATHETER
7. Pharmacological interaction
The potential interactions of paclitaxel with the drugs administered concomitantly have not been inves-
tigated. Drug interactions at the systemic levels of paclitaxel are detailed in the product data sheet but,
considering that the amount of paclitaxel on the balloon surface corresponds approximately to a few hun-
dredths of the amount normally used in the antineoplastic treatment, it is considered very unlikely for
interactions with other drugs to occur.
Nevertheless, caution must be exercised when CYP3A4 or CYP2C8 substrates (such as terfenadine, cyclo-
sporin, lovastatin, midazolam y ondansetron)or drugs with high PPB (Plasma Protein Binding) are adminis-
tered concomitantly.
8. How to Use

8.1 Equipment Required

- Heparinised normal saline solution
- Contrast medium (use contrast media suitable for intravascular use)
- Medication suitable for the procedure
- 0.014" guide wire; do not use any other size of guide wire
- Inserter with a haemostatic valve
- Guide catheter
- Haemostasis valve
- Three-way stopcock
- Line extensions
- Inflating device (manual pump with built-in manometer)
- Several standard 10-20cc syringes with saline solution for washing the system
8.2 Preparing the Catheter
- In case of occlusion or very calcified lesions, it is recommended to predilate the lesion with a conven-
tional balloon, without drug.
- Remove the catheter from the protective dispenser. Check that it is the right size. Gently remove the
protective pod and stylet from the balloon.
- Purge the system of air.
• Couple a three-way stopcock to the luer connector on the balloon catheter (optionally, to improve
the mobility of the system, an extension can be coupled to the balloon connector and then the
three-way stopcock).
• Seal the air passage through the balloon.
• Couple a 10-20ml syringe with a third part of saline solution to the three-way stopcock.
• Open the connection in the three-way stopcock between the syringe and the catheter
• With the syringe in a vertical position, withdraw the plunger upwards allowing the air bubbles to
exit to the liquid.
• When bubbles stop coming in, leave a meniscus of solution in the key and close the three-way
stopcock at the catheter end. Remove the syringe.
• Connect the inflating device with a 1/3 mixture of contrast liquid and saline solution (duly purged)
to the three-way stopcock.
DANGER: If bubbles do not stop coming from the catheter into the syringe after 1 minute of negative
pressure, this may be a clear indication that the balloon catheter has leaks, is broken or the connec-
tions between the syringe and the three-way stopcock are not properly sealed. If bubbles continue
to be seen after checking the connections, do not use the device. Return it to the manufacturer or
distributor for inspection.
6
INSTRUCTIONS FOR USE
essential