Aquamid.co.uk

INSTRUCTIONS FOR USE
PRODUCT DESCRIPTION
Aquamid® is a non-absorbable, injectable transparent, hydrophilic gel for soft tissue augmentation. Aquamid® consists of approximately 2.5% cross-linked polyacrylamide and 97.5% non pyrogenic water. Aquamid® is a biocompatible, non-biodegradable polyacrylamide hydrogel. The hydrogel is supplied in a sterile, pre-filled 1 mL syringe sealed with a Luer Lock fitting. Aquamid® is intended to be injected subcutaneously with a sterile 27G needle. A 3-part label with the LOT number is available on the blister pack. Attach one label to the patient record to ensure product traceability and one to the patient consent MODE OF ACTION
Aquamid® acts by adding volume to the soft tissue, thereby restoring skin contours or augmenting skin to the desired level. The injected hydrogel becomes a stable part of the connective and fat tissue.
INDICATIONS AND USAGE
Aquamid® is designed for aesthetic correction of facial soft tissue contours. Aquamid® can be used for the following indications: Glabella, Naso-labial folds, Mento-labial folds, Cheeks, Chin, and Lip augmentation. See illustration.
Aquamid® can be used to correct aesthetic defects caused by congenital, traumatic, or ageing alterations. Aquamid® is intended for use in the subcutaneous CONTRAINDICATIONS
Aquamid® must not be injected in actively infected areas or areas with an active skin disease. Aquamid® should not be used in patients with autoimmune diseases. Outbreaks of herpes labialis or active acne are contraindications for Aquamid® injections. Aquamid® is not recommended for use in patients with chronic diseases receiving treatment with systemic corticosteroids. Do not inject Aquamid® above the infraorbital ridge, in the crow’s feet, eye circle, eyelid, WARNINGS
Avoid the use of corticosteroids, for details refer to Adverse events. The use of steroids will prolong and worsen the duration and treatment
of the potential bacterial infection. Anamnesis data of ongoing infections, concomitant medication, surgery, dental work etc. must be reviewed
prior to injection in order to prevent possible infections. When injecting fillers including Aquamid® there is an increased risk of local infection due to the limited immune system access. Avoid the use of non-steroid anti-inflammatory Drugs (NSAIDS). Aquamid® should not be used in patients with unrealistic expectations. Injection of Aquamid® is not recommended for patients with recurring herpes labialis or acne. Aquamid® should not be injected in patients receiving anticoagulant treatment. Aquamid® should not be injected during pregnancy or lactation. Aquamid® must not be injected in a site where non- absorbable and / or long-lasting soft tissue fillers are present. Other non-absorbable and/or long-lasting soft tissue fillers must not be injected in a site where Aquamid® is present. If the injection site has previously been treated with absorbable soft tissue filler, absorption of this filler must be complete prior to injection with Aquamid® (minimum 6 months). Cosmetic treatments including injection of fillers in a site previously treated with Aquamid® may increase the risk of iatrogenic infection, so caution should be taken. Do not inject Aquamid® intradermally, intramuscularly or intravascularly. Do not mix Aquamid® with any other substances. Do not inject any pharmaceuticals into the hydrogel. Do not use Aquamid® if the package is opened or damaged. Do not resterilize Aquamid®. The Aquamid® syringe is intended for single use and single patient only – do not store un-sealed syringes and reuse. Reuse
increases the risk of contamination and hereby increases the risk of infection. Do not use Aquamid® once expired.
PRECAUTIONS
In patients, who have undergone laser, waxing, peeling, skin resurfacing, lip tattoos, pigmentation, teeth bleaching using UV light or other aesthetic treatments, Aquamid® should not be injected until the skin surface has healed and become fully revitalised. These treatments must not be performed in the injected area for 6 months pre and post Aquamid® injection. Do not pierce the injected area. Avoid surgery and major dental work 6 months pre and post Aquamid® injection. Should the patient need surgery or major dental work post injection, antibiotic treatment is recommended. Special attention must be paid to patients suffering from diabetes. Only well regulated diabetics should be considered for Aquamid® injections. Safety and effectiveness of treatment in the periorbital area have not been established. Caution should be taken when injecting patients pre-disposed to kelloid formation and/or patients in the high end of the Fitzpatrick scale, since the aesthetic result may be unsatisfactory. Safety and effectiveness have not been established in patients under the Sydmarken 23 • 2860 Soeborg • Denmark [email protected] • www.aquamid.com • www.contura.com METHOD OF ADMINISTRATION
Aquamid® must be administered by a qualified physician familiar with the procedure. If prophylactic antibiotic treatment is prescribed, the following combination is recommended: macrolides and quinolones administered as a single dose 2 - 6 hours prior to injection. The above combination of antibiotics will reach a high concentration in the tissue and should be given only once. This combination of antibiotics will cover most bacterial strains. However, some strains e.g. MRSA may not be sensitive to above mentioned treatment. The procedure must be conducted under aseptic conditions. It is essential that at least 5 cm around the injection site is swabbed prior to injection using, e.g. chlorhexidine with alcohol twice with a five minute interval. The injection of the hydrogel may be performed under local anaesthesia. Remove the protective Tip Cap by turning it in the same direction as is used to tighten the needle. Secure the needle firmly into the Luer Lock socket and make sure the needle is mounted correctly. Do not increase the pressure on the plunger should the needle be clogged. Stop the injection and replace the needle. Inject the desired amount of Aquamid® subcutaneously in a retrograde, fan-shaped manner. Inject the hydrogel while withdrawing the needle. Avoid overcorrection. The injected hydrogel must not cause excessive pressure on the tissue. Carefully consider the volume of Aquamid® to be injected depending on the site of injection. When the desired volume of hydrogel has been administered, release the pressure on the plunger before removing the needle. Post injection perform a light manipulation to obtain an even distribution of the hydrogel. Additional injections can be performed when swelling has disappeared, with a minimum interval of 14 days, Aquamid® should be injected with consideration to tissue elasticity and the blood supply.
POST-OPERATIVE PROCEDURES
If oedema occurs, a cold pack can be applied locally. Do not treat oedema with NSAIDs or corticosteroids. The patient should be advised -not to touch the injected area for at least 6 hours -not to kiss or perform oral sex on the day of injection in lips or around the lips -not to use make-up and skin care products on the treated area on the day of injection -not to pierce or wax the injected area -to avoid exposure to direct sunlight (including solarium and other sun tanning devices) or extreme cold conditions in the first 4 weeks post injection -to avoid sunburn or frostbite in the area where Aquamid® is injected ADVERSE EVENTS
Adverse events are limited to local reactions at injection site. Injection related, transient, local reactions that resolve spontaneously including slight redness, bruising, swelling, hematoma formation, itching, mild oedema, discoloration, change in pigmentation and moderate pain. Rare adverse events (less than 0.1% of treatments): Infections can occur at the injection site and must be treated immediately with antibiotics. Symptoms include tingling sensation, swelling or redness. Superficial injection or overcorrecting may lead to hydrogel accumulation (lumps) or displacement. Very rare adverse events (less than 0.01% of treatments): Poorly treated or unrecognised, "low grade" infections may result in tissue hardening, lumps and nodules that emerge years post injection. This may lead to increased dermal sensitivity and pain in the injected area. Tissue necrosis may occur if Aquamid® is injected too superficially or if overcorrection has been As with any transcutaneous procedures, when injecting Aquamid®, there is a risk of infection. Standard precautions associated with any injectable product should be adhered to. Adverse events are related to infections or effects following infections. Should an infection be suspected, antibiotic treatment must be initiated immediately. Combinations or monotherapy with macrolides, quinolones and tetracycline will in most cases cover the bacteriae that may cause infection after use of fillers. However some bacteria strains, e.g. MRSA may not be sensitive to above mentioned treatment. To determine an effective treatment a fine needle biopsy should be taken, under aseptic conditions, and a microbiologist should be consulted. The treatment should not be delayed. A negative culture does not exclude the presence of bacteria. If necessary, detection of most bacteria can be performed by PCR analysis. Normally the foreign body reaction after injection with Aquamid® is minor and not clinically detectable. This reaction will markedly increase in the presence of a bacterial infection. In case of persistent infection it may be necessary to surgically remove the implant. This may cause scarring. Do not administer steroids or
NSAID’s as this will prolong and worsen the duration and treatment of the bacterial infection.
REPORTING OF ADVERSE EVENTS
All adverse events/complications must be reported to the local distributor or directly to Contura International A/S via e-mail to: [email protected]. Download Incident Report Form at www.aquamid.com/physician/documents or report the incident via the online Incident Report Form.
PATIENT INFORMATION
The patient should be informed about indications, expected results, contraindications, warnings, precautions and potential complications. The patient must Sydmarken 23 • 2860 Soeborg • Denmark [email protected] • www.aquamid.com • www.contura.com sign an informed consent form provided by the distributor or download the form from http://www.aquamid.com/Physician/Injection-guidelines/Selecting- patients. In case of complications the patient should contact the injecting physician immediately for treatment.
SUPPLY AND STORAGE
Sterile: Aquamid® is sterilized by moist heat. The hydrogel must be stored protected from direct sunlight. Do not freeze. Keep out of reach of children.
GB Injectable hydrophilic gel for facial correction of the soft tissue. The gel must be stored protected from direct sunlight. Do not freeze.
Use before the date printed on the label.
Sydmarken 23 • 2860 Soeborg • Denmark [email protected] • www.aquamid.com • www.contura.com

Source: http://www.aquamid.co.uk/files/Documents/IFU%20Ferrosan/IFU_UK.pdf