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Idiomas disponibles
Idiomas disponibles
• Hypotension
• Infection
• Limb ischemia
• Dissection of the peripheral vessel
Pharmaceutical information on included drug
The very small quantity of paclitaxel in the blood plasma
means that known adverse reactions caused by paclitaxel
appear less relevant as compared to a systemic adminis-
tration of paclitaxel. However, yet unknown side effects
cannot be ruled out.
Possible undesirable effects
• Allergic or immunological reaction to the drug, similar
agents, or to the balloon coating matrix (resveratrol)
• Alopecia
• Anemia
• Gastrointestinal tract dysfunction
• Hematological dyscrasia (including leukocytopenia,
neutropenia, thrombocytopenia)
• Abnormal liver enzyme values
• Histological changes in the vascular wall, incl.
inflammation, cell damage or necrosis
• Disorders of the cardiac conduction system
• Myalgia/ arthralgia
• Peripheral neuropathy
• Pseudomembranous colitis
Caution:
Paclitaxel has been studied in vitro and in vivo for
mutagenic effects with inconclusive results. However, the
relevance of the specific potentially genotoxic mechanism
regarding a human carcinogenicity risk is currently not
known and cannot be completely excluded. This
pharmacodynamic action of Paclitaxel acts in interference
with the microtubule disassembly. The relevance of this
potentially genotoxic specific mechanism for human
cancerogenicity risk is currently not known. It is known
from the relevant scientific literature that coated, drug-
eluting implants (e. g. DES) may cause inflammatory
and/or thrombotic reactions. SeQuent® Please OTW does
not include any polymer layer, the drug is applied with a
degradable matrix on the balloon surface. Although not
demonstrated in pre-clinical studies with the SeQuent®
Please OTW balloon system, the abovementioned
incidences cannot be completely ruled out. Careful
analysis of the risk-benefit ratio should be done prior to
using the drug-coated balloon.
Allergies
If the patient has a known allergy to any component of the
balloon or its coating (paclitaxel or resveratrol) the
possibility of allergic/immunological reactions or local
inflammatory reactions resulting in possible damage to the
vascular wall cannot be excluded.
Interactions with other drugs
The amount of paclitaxel on the balloon surface corresponds
approximately to a few hundredth of the quantity usually
used in anti-neoplastic treatment, which makes it rather
improbable that interactions with other drugs will occur.
However, caution should be exercised when concomitantly
administering known CYP3A4 and/or CYP2C8 substrates
(including terfenadine, cyclosporin, lovastatin, midazolam,
ondansetron) or drugs with high plasma protein binding
(PPB) (especially sulfonureas, anticoagulants of the
coumarin type, salicylic acid, sulfonamides, digitoxin). For
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possible interactions of paclitaxel and additional drugs e.g.
administered for oncologic indications, the relevant
instructions for use should be consulted. A complete study
of possible interactions of paclitaxel in combination with
comedications has not been established.
Pregnancy
The use of paclitaxel during pregnancy is contraindicated. It
is not possible to state the effects of SeQuent® Please OTW
on the unborn child. No clinical data are available on the use
of SeQuent® Please OTW in pregnant women, reproduction
relevant contraindications and risks are unknown.
Instruction for use
Material required to perform a PTA balloon catheter
procedure
• PTA balloon catheter for dilation
• Inflation syringe with gauge
• Introducer sheath with dilator
• 0.014 inch, 0.018 inch or 0.035 inch guidewire of
suitable length to cross the lesion
• Contrast medium
Prior to use, it is essential that all the instruments, cathe-
ters and individual components are carefully checked. An
integrity test of the balloon (with the protective balloon
sheath left in place), a complete removal of air from the
system and a thorough control of the connector seals are
mandatory.
Preparation of the balloon catheter
1. The balloon filling fluid is typically a mixture of 50:50
contrast medium and sterile physiologic saline solution
or commercially available contrast medium with 200
mg/ml iodine.
2. Draw approximately 3 ml of the contrast medium
mixture into a 20 ml or 30 ml syringe. Connect the
syringe to the luer adapter of the catheter and hold,
with both components pointing downwards. Aspirate.
Repeat until no air bubbles can be seen.
3. The syringe system should be filled with a sufficient
amount of filling fluid (described in 1.).
4. Remove catheter from dispenser. Remove protective
sheath from balloon and transport safety wire from the
guide wire lumen. The catheter is now ready for use.
Technique for use
Note: SeQuent® Please OTW is not suitable for coronary use.
Percutaneous introduction techniques and arteriotomy are
both suitable when using introduction sets and guide wires.
• Insert an introducer sheath fitted with a hemostatic
adapter using standard technique.
• If necessary, the guide wire lumen can be irrigated with
physiological saline solution.
• Carefully introduce the guide wire and place the tip distal
of the stenosis.
• Predilate the target lesion
• Carefully introduce the fully deflated balloon-tipped
catheter over the proximal end of the guide wire and
through the hemostatic adapter of the introducer sheath.
• Slide the balloon catheter forward and place the catheter
under contrast media injection and x-ray control at the
lesion site.
• As soon as the balloon catheter has crossed the stenotic
lesion, inflate the balloon to dilate the artery. Depending
on the patient situation and vessel morphology the
inflation should be kept (in general) for a period of at least
30 seconds. After dilatation, the balloon must be
completely deflated and under x-ray control, pull the
balloon tipped catheter back into the introducer sheath.
Check the results of dilatation angiographically.
• If necessary, it is possible to use another balloon-tipped
catheter via the guide wire that remains in the vessel. In the
case of an unsatisfactory primary result, a repeated dilatation
of a balloon with larger outer diameter can be done. For
prevention of local overdosage it is not indicated to use
another SeQuent® Please OTW in the same target lesion.
Use in special populations
The safety and efficacy of the SeQuent® Please OTW
balloon catheter to treat supraaortic and cerebrovascular
arterial occlusive disease was not examined.
Warnings / Precautionary measures:
• This product should be used only by physicians with
experience in angiography and in percutaneous
transluminal angioplasty.
• When removing SeQuent® Please OTW from the packaging
and when passing the hemostatic valve, great care must
be taken to ensure that the balloon system does not
become damaged or non-sterile.
• Direct touching of the balloon, wiping the balloon surface
or contact with liquids should be strictly avoided, since
this may cause delamination of the balloon coating.
• It is possible to rinse the guide wire lumen with
sterile/isotonic saline solution.
• Do not inflate the balloon prematurely. The recommended
inflation pressure of the balloon must not be exceeded. It
is also recommended that a pressure gauge is used to
measure the inflation pressure.
• Do not treat the same lesion segment with more than one
SeQuent® Please OTW.
• If any resistance becomes apparent at any time during the
insertion procedure, the catheter must not be pushed with
applied force. The resistance can indicate damage to the
balloon catheter. If resistance occurs while advancing
through the introducer sheath, the entire delivery system
should be pulled back.
• Predilation with a non-coated balloon is recommended.
The catheter should be placed as soon as possible in the
target lesion. Extended manipulation of SeQuent® Please
OTW can cause delamination of the coating.
Handling and Precautions
The inflated diameter of the balloon should correspond to
the lumen of the target artery. Never use a balloon with
a larger diameter. Never shake the catheter before use to
de-air the balloon. Do not advance the guide wire into the
balloon catheter guide wire lumen if resistance is felt
without first identifying the cause for the resisting force
and taking remedial action. The balloon catheter is 99.9%
resistant to the indicated maximum pressure with a
confidence interval of 95% (rated burst pressure).
Inflation in excess of the maximum inflation pressure is
not recommended as the pressure may cause the balloon
to rupture, or cause the balloon joints to fail respectively.
Should this occur, deflate the balloon and remove it.
Note: Before use, SeQuent® Please OTW must be
inspected to ensure that it was not damaged during
transport. Do not use if the sterile packaging is damaged
or open. Do not re-sterilize.
Note: For treatment to be successful and to ensure long-term
satisfactory results, the entire lesion length should be ideally
covered by the coated SeQuent® Please OTW balloon section.
Note: Do not bend or squeeze the balloon portion of the
SeQuent® Please OTW before the procedure.
Note: Use only the appropriate liquid balloon inflation
medium. Failure to use the appropriate fluid (e.g. having
a higher concentration of contrast dye) may lead to
prolonged in- and deflation times. Never use air or
gaseous inflation media.
Note: After dilatation of the vessel segment with the
SeQuent® Please OTW stent can be implanted.
Note: The diameter of the balloon should not be less than
the reference diameter of the target vessel.
Note: Do not expose the catheter to organic solvents, e.
g. alcohol.
Before the angioplasty procedure is started, all equipment to
be used for the procedure, including the balloon catheter
should be carefully examined to verify its functionality. The
appropriate anticoagulant and vasodilator therapy must be
provided to the patient prior to the angioplasty procedure
and must be maintained during the procedure.
These catheters should only be manipulated in the body while
they are under fluoroscopic observation with high quality
radiographic imaging equipment. To decrease the potential
for the introduction of air into the catheter system, special
attention must be paid to ensure that tight catheter
connections are maintained. Use the protective balloon
sheath until the catheter is being prepared for insertion.
Medication schedule
For all medications please refer to established and current
guidelines. On admission to the hospital, the laboratory
findings for prothrombin time (PT) and partial
thromboplastin time (PTT) as well as the platelet count
should be documented for every patient. The following
medication schedule is intended as a possible guideline,
and should not be seen as a strict medical regimen.
Before balloon inflation:
• Acetylic Salicylic Acid (ASA) 250 to 500 mg 1 x daily p. o.
• Clopidogrel (loading dose) 300 mg/day
During balloon inflation:
• Heparin 70 IU/kg body weight i. v.
• Repeated bolus administration of 2,500 IU heparin i. v.,
to keep the activated clotting time (ACT) value above
250 seconds
After balloon inflation:
• ASA 75 to 300 mg 1 x daily p. o.
• Clopidogrel 75 mg/d p. o. for 4 weeks (without
additional stent) and 12 weeks in case an additional
stent is implanted
• Introducer removal normally when ACT value is below
180 seconds and no additional administration of heparin
is applied
• In the event of sub-optimal results and/or residual
dissections, low-molecular weight heparin can be given
subcutaneously 2 × daily for 2 weeks
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