Composition
Each ml
contains:
Hyaluronic
acid, stabilized - 20mg/ml
Phosphate
buffered saline – q.s
Description:
Macrolane
Volume Restoration Factor gels, Macrolane VRF 20 and VRF 30 are sterile,
transparent gels of stabilized hyaluronic acid of non-animal origin. The
products have a PH of 6.0-7.5. Macrolane VRF 20 and VRF 30 are designed for
deep tissue implantation and differ with respect to the physical structure of
the gel. Macrolane VRF 20 and VRF 30 are supplies in plastic syringes with
luer-look. Each syringe is terminally moist heat sterilized in its packaging
and packed in a paper carton. The products are for single use only. The volume
contained in each syringes is as stated on the outer package. A patient record
label is a part of the syringe label and extra labels are included in the
package. These labels are to be attached to patient records to ensure
traceability of the product.
Intended
use:
Macrolane
VRF 20 and VRF 30 are intended to be used for volume restoration and contouring
of body surfaces. The products are not intended for facial tissue augmentation.
In general, deep subcutaneous administration is recommended. For both products
sufficient tissue cover and support are important parameters to achieve a good
esthetic treatment outcome. A minimum of
1cm skin thickness, including subcutaneous fat, is usually required to attain
good results. The choice between Macrolane VRF 20 and VRF 30 is based on the
assessment f tissure cover as determined by skin fold measures. Macrolane VRF
30 is intended in areas where skin fold thickness is greater. The injection
should be made by physicians who have thorough knowledge of the anatomy of the
treatment site and are experienced with injection techniques in the relevant
area. The treatment facility must be suitable for performance of aseptic
procedures.
Mode of
Action.
Macrolane
gels act by adding volume to the tissue, thereby restoring and enhancing body
contours. The product will be degraded over time.
Warning
-
Do
not inject intravascularly. As for the injectable medical devices, inadvertent
injection into blood vessels could potentially lead to vascular occlusion,
ischemia and necrosis.
-
Do
not use in patients with bleeding disorders or in patient who are taking
thrombolytics or anticoagulants.
-
Macrolane
should not be used in the breast as the product may interfere with the reading
of mammograms.
-
Do
not use in the hands and penis because the benefit risk has not been adequately
investigated in prospective clinical studies.
-
Do
not use in patients previously treated with NASHA gel products and who in
connection therewith, have experienced delay inflammatory reactions or implant
complications that requited medical treatment.
-
Do
not use during pregnancy or lactation
-
Do
not resterillize Macrolane gels as this damages the product
-
Do
not mix with other products.
Precautions
-
Implantation
of medical devices is associated with a risk of infection, Aseptic technique
and standard practice to prevent perioperative infections are to be observed.
Soft tissue infections following injection treatment have been observed.
-
Special
caution should be exercised when treating areas in close proximity to permanent
implant or vulnerable structures such as nerves, vessels and viscera.
-
Do
not use where there is a condition, in or near the intended treatment size that
might increase the risk for development of adverse events following treatment,
eg. Inflammation, infections or tumours.
-
Patients
who are using substances that affect platelet functions, such as aspirin and
non steroidal anti inflammatory drugs may as with any injection, experience
increased bruising or bleeding at injections sites.
-
Patients
with unattainable expectations are not suitable candidates for treatment.
-
Scarring
might occur at the insertion site. Some patients are known to have a higher
risk for scarring, e.g. previous history of keloid formation or darker skin
type
-
Do
not use the product if the package is damaged.
Anticipated treatment related reactions.
After the injections of Macrolane gel, some
common injection related reactions might occur. There reactions include
erytherma, swelling, tenderness, pain, bruising or itching at the implant site.
Typically resolution is spontaneous within one or two weeks. Encapsulation of
macrolane occurs, similar to permanent implants, as part of the healing
process.
Adverse Events.
Local mobility, implant displacement and
implant site lumps have been observed. Adequate soft tissue cover and support,
as well as implant placement and injection technique are important parameters
to minimize occurrence of these events. If any of these described events are
disturbing, aspiration of gel can be attempted.
Symptoms of inflammation including a
combination of pain, redness and swelling have been reported. The possibility
of infection should be excluded in all cases of inflammation. Perioperative
infections have been reported. A few of these cases were associated with fever
or localized abscess formation. For more severe cases of infections, removal of
the gel by drainage was used in addition to antibiotics. Implant site leakage
and leakage that leads to a collection of Macrolane at insertion site have been
observed. To minimize the occurrence of leakage, see treatment procedure, point
7.
Capsular contractures and palpable lumps of gel
have been reported after treatment in the breasts. Isolated cases of late onset
infection after treatment on the back of hands and localized injection site
infection following implantation through previous scar have also been reported.
Rare cases of granuloma and hyperpigmentation at the injections site have been
reported. Erectile difficulties have been reported after treatment in the
penis.
Interactions,
Treatment with Macrolane gels in combination
with drugs and other devices has not been evaluated in controlled studies.
Other than use of lidocaine.
Cannulas.
It is recommended that Macrolane VRF 20 and VRF
30 are injected through a 16G, or wider, blunt cannula. In clinical studies,
where 20ml syringes were used. 12G blunt cannulas were preferred. The cannula
must be sterile.
Assembly of cannula to syringe
For safe use of Macrolane gels it is important
that the cannula is properly assembled to the syringe. It is important to use
an appropriate cannula with a hub that fits the luer-lock in order to tighten
the cannula hub to the bottom of the luer-lock of the syringe.remove the tip
cap of the syringe. Grasp the hub. Press and turn it clockwise on the syringe
until it is tight. Make sure that the hub is as tightly fixed to the bottom of
the luer- lock as possible. Different hubs may tighten at different levels.
Pretreatment planning
Before the treatment, the patient’s suitability
for the treatment and the need for sedation and pain relief should be assessed.
The patient should be informed about the indications, expected result,
precautions, warning and potential adverse event.
Treatment procedure
The injection techinique with regard to the
depth of injection and the administered quantity may vary. A correct injection
technique is important for the final result of the treatment. Before the first
treatment session, it is recommended to contact your local Q-Med representative
or macrolane distributor for more information about injection techniques and
training opportunities. Macrolane gels are only intended to be administered by
authorized personnel in accordance with local legislation.
1.
In
general, antibiotic prophylaxis should be considered at the discretion of the
physician. For indications that require treatment with larger volumes such as
buttock enhancements, prophylactic antibiotics are recommended prior to
injection treatment to minimize a risk of perioperative infection.
2.
The
treatment site should be cleaned with a suitable antiseptic solution and draped
in an appropriate manner.
3.
Local
anesthesia can be accomplished by injecting e.g. 0.5% lidocaine with
epinephrine at the planned incision sites and at the site of planned
implantation. Further anesthesia can be provided by regional nerve blocks or
general anesthesia depending on the extent and character of the procedure and
the preference of the treating physician and the patient.
4.
For
the administration of the product, a small incision (1-2mm) should be made with
an injection needle through the skin or a stab incision with scalpel. Avoid
deposition of product within 2cm of the cannula insertion site.
5.
Macrolane
gels should be administered with a cannula by injecting the material into the
subcutaneous fatty tissue. For further information regarding cannulas, see
under the heading cannulas. A separate cannula should be used for each
treatment site.
6.
Before
injecting, the air should be removed from the syringe up to the point where a
droplet is visible at the tip of the cannula.
7.
Do
not apply extensive pressure to the syringe at any time. If such resistance is
encountered the cannula should be partially withdrawn and repositioned or fully
withdrawn and checked for function. An injection too superficial my give rise
to lumps at the treatment site. Remove any access material from the injection
channel before closure by manual compression or flushing with saline. The
injection site should be closed with a stitch or a sterile strip. A dressing
should be applied.
8.
Inject
macrolane gel while pulling the cannula slowly outwards. The gel should be
injected in small aliquots spread into the area to be augmented and not
injected in one whole portion. Do not overcorrect. If needed, the correction
site should be gently massaged to conform to the contour of the surrounding
tissues.
The syringe and any unused materials
must be discarded immediately after the treatment session and must not be
reused due to risk for contamination of the unused material and the associated
risks including infections. Disposal should be in accordance with accepted
medical practice and applicable national, local or institutional guidelines.
Post treatment advice
To avoid a possible risk of local product mobility the patient should be
advised to avoid massaging the treatment site or applying pressure to the area
for at least 2 weeks following the injection. Activities that can be associated
with excessive movements such as jogging and jumping should also be avoided
during this time period. The use of supportive clothing for at least 2 weeks
after injection treatment may be useful. To reduce possible risk of infection,
the patient should be advised to keep the injection site dry for a few days
after treatment. After the first treatment, additional injections of macrolane
gel may be necessary to achieve and maintain the desired aesthetic result.
Individual variability exists.
Shelf life and storage
The expiry date is indicated on package. Store up to 25degree Celsius.
Protect from freezing and sunlight.
No comments:
Post a Comment