The Hyaluronan Soft Tissue Filling Gel, trade name: Aqualuna Aqua,
is for single use composed of a 1 ml colourless, transparent,
sterile, implantable dermal filler gel containing 12 mg/ml
cross-linked sodium hyaluronate (biofermentation) and 3 mg/ml
lidocaine hydrochloride presented in a non-invasive, sterilized,
and with measuring function syringe, which contains a glass barrel
and is closed with a tip cap on the luer lock fitting and a
plunger stopper with a backstop and plunger rod.
It has a temporary aesthetic purpose (Non-medical purpose) and is
used on facial dermal tissue to correct forehead wrinkles.
The gel is supplied in a 1 mL syringe which is the sterile barrier
system. The gel is sterilized by moist heat. The syringe
containing the sterile gel is assembled with plunger rod and
backstop and corresponds to the injection device. The prefilled
syringe is packed with two CE marked 30G needles in a blister
package.
Correct forehead wrinkles
Adults, both men and women, with mild to severe forehead wrinkles
Only to be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law.
On average, with 1 mL injected into forehead in one session, 93%
of subjects are improved in correction of forehead wrinkles at 6
months (clinical study results obtained with the Wrinkle Severity
Rating Scale Response Rate).
Lidocaine, which has been added into Hyaluronan Soft Tissue
Filling Gel, relieves the pain of the patients during the
injection.
The product will eventually be completely degraded in human body, and the expected absorption time in vivo is 6 months.
Do not resterilise.
Do not re-use (to avoid infection).
Do not use if package is damaged.
Product is only for intradermal injection. Do not inject
intravenously.
Only to be administered by appropriately trained healthcare
professionals who are qualified or accredited in accordance with
national law.
Do not use after expiry date.
The aseptic operating procedures for surgical treatment should be
strictly followed in the process of injection and local disinfection
of injection site is required to avoid infections.
Do not expose the injection site to extreme temperatures (e.g. high
temperatures such as sunbathing or extremely cold environments) and
avoid massage and facial mask care within 7 days following the
implantation by injection.
Patients who are using substances that affect platelet function,
such as aspirin and non-steroidal anti-inflammatory drugs may, as
with any injection, experience increased bruising or bleeding at
injection sites.
Lidocaine should be used with caution in patients with epilepsy,
renal or liver insufficiency, block of cardiac conduction system,
patients with reduced cardiovascular function, or with
bradycardia.
Lidocaine should be used with caution in patients receiving other
local anaesthetics or agents structurally related to amide-type
local anaesthetics e.g. certain anti-arrhythmics, since the systemic
toxic effects can be additive.
Product should not be used in persons who are less than 18 years
old.
Product should not be used in patients allergic to hyaluronic acid
or with a history of severe allergic reactions.
Do not use in patients with known hypersensitivity to lidocaine and
amide-type local anaesthetics.
Product should not be used in patients with bleeding disorders (i.e.
coagulopathy), patients receiving any thrombolytic agent,
anticoagulant or platelet aggregation inhibitor within two weeks and
in menstruating, pregnant or lactating women.
Product should not be used on or around damaged or inflamed skin due
to skin disease, infection or similar conditions.
Product should not be used together with any other implantable or
injectable product within 6 months.
Product should not be used in patients who undergo laser treatment,
chemical peeling or any skin-irritating therapies before confirmed
fully skin healing or within 1 month after implantation of this
product to avoid possible inflammatory reactions.
Considering the composition of Aqualuna Aqua, there is no warning, precaution and/or measure to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures.
Draft - Summary of Safety and Clinical Performance_Aqualuna
Aqua