-
Injection sessions must be conducted observing
Good Medical Practice
(G M P).
-
All injection procedures have contamination risk factors; observe Body Substance
isolation (BSI)
precautions and strict aseptic methods to prevent infection and / or
contagion associated with injectable materials.
-
Routinely clean and disinfect equipment and furnishings in patient care areas.
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Observe
Universal Precautions (UP) when handling syringes and
needles to avoid
injury and contamination during activation
and application of Derma
Veil.
-
Handle
and dispose of used vials, syringes and needles with
Universal Precautions
(UP) guidelines and applicable local government
regulations; avoid
recapping used needles, avoid removing used needles
from disposable syringes, avoid bending, or
manipulating used needles by hand. Place used sharps in
puncture-resistant
containers.
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The
use of
Derma Veil
in combination with other fillers and/or muscle inhibitors
(i.e., Botulinum toxin) during the same treatment session has not been
studied or
evaluated and should be avoided.
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There is an increased risk of bleeding
and hematoma formation at the injection
site for patients taking blood thinning
medications (anti coagulant therapy) or who
have a coagulation deficiency.
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Suspend the use of aspirin based products 5 days before the start of the
treatment.
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If
a treatment based on
an active dermal response (i.e., laser,
mechanical or
chemical peeling, UV irradiation) is considered prior to, or after
the application of
Derma Veil, there is the risk of causing an inflammatory reaction in the area where
Derma Veil
was implanted. For such treatments a
minimum of 30 days is
recommended before or after the last application of
Derma Veil.
-
The
patient should be informed to limit sun exposure of
the treated area and not
to use UV lamp systems for 48 hours following
the application of
Derma Veil
or until any swelling and/or redness has totally subsided.
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It
has not been determined if
Derma Veil
is radiopaque. The asymmetric micro particles of the compound may be visible on scans, ultrasound, standard
radiography, magneti resonance imaging (MRI), or computer tomography
(CT). Patients
should know that the device may be radiopaque and inform their treating
physician, specialist, radiologist or healthcare
professional of the presence of
Derma Veil.