Promedon Opsys Instrucciones De Uso página 5

approximately 8 mm. The correct position of the needle in the submucosal
tissue can be checked by injecting a small amount of the product. If the
needle is positioned correctly, tissue bulkiness will be immediately observed
in the urethral submucosa.
5. Inject a volume of 2 ml of Opsys, or larger, at the 6 o'clock position until
bulkiness is observed. Wait for about 15-30 seconds before removing the
needle from the implantation site.
6. Then, inject a volume of 1 ml of Opsys, or larger, at the 2 o'clock position
and the 10 o'clock position until bulkiness and closing of the urethral lumen
are observed. Wait for about 15-30 seconds before removing the needle
from the implantation site.
7. Remove the needle before removing the cystoscope from the urethra.
Avoid moving the cystoscope forward through the implantation site, since it
could deform the implanted material bulkiness.
8. Empty the bladder using a small caliber (not larger than 12-Fr) temporary
catheter. Do not leave a permanent catheter for bladder evacuation after the
surgical procedure.
Reimplantation after 3 Months: The need to perform a reimplantation
procedure will depend on the results of the assessment following the first
procedure. The procedure is the same as the one described above. It is
recommended that the reimplantation be performed in the areas of the
urethra where there has not been tissue bulkiness.
* NOTES:
• Take into consideration that approximately 0.6 ml of the product remains
in the injection needle. The remaining product can be used by pushing it
down with physiological solution.
SYMBOLS USED IN LABELS
CATALOG NUMBER
LOT NUMBER
CAUTION
EXPIRY DATE
DO NOT REUSE
MANUFACTURE DATE
STERILE. STERILIZATION METHOD:
MOIST HEAT
DO NOT RESTERILIZE
MANUFACTURER
AUTHORIZED REPRESENTATIVE IN
THE EUROPEAN COMMUNITY
SERIAL NUMBER
CONSULT INSTRUCTIONS FOR USE
DO NOT USE IF PACKAGE IS DAMAGED
KEEP AWAY FROM SUNLIGHT
KEEP DRY