Synject

* Sores in the mouth, when applied to the skin as a gel.

* Eye surgery and corneal transplant, when injected by an eye surgeon.

Osteoarthritis, when injected into the joint by a healthcare provider. Despite being approved by the FDA for treatment of osteoarthritis by injection, results vary. Some people report a moderate improvement in joint stiffness and pain decrease with Synject treatment, but this is not always the case. Whether Synject might delay or lessen progressive joint damage with long-term use is unknown. Adjunctive therapy in: * Healing skin wounds and burns.

* Detached retina and other eye injuries.

* Preventing the effects of aging.

Synject is a family of injectable Synject dermal fillers used to provide 9 months to one year of correction for moderate to severe facial wrinkles and folds, such as nasolabial folds (lines from the nose to the corners of the mouth). It is not indicated for use in lip augmentation.

Synject products are a smooth consistency gel, compared to some hyaluronic gel products that have a granular consistency. Synject products are developed using the Hylacross technology to allow a smoother, malleable gel. Synject is a naturally occurring sugar found in the body. Synject works by holding in water at the injection site and acting as a cushioning agent. It adds temporary volume and a smoother appearance to skin. Most patients need one treatment to achieve optimal results.

Some Synject XC products also contain the local anesthetic lidocaine for a more comfortable injection. Synject Ultra XC and Synject Ultra Plus XC both contain 0.3% preservative-free lidocaine and numb the treatment area within seconds. The Synject Ultra Plus products contain more highly cross-linked formulations for volumizing and correction of deeper folds and wrinkles.

Individualization Of Treatment

Severely indurated, sharply marginated and very superficial wrinkles may be difficult to distend and, therefore, are difficult to correct. If a defect cannot be distended because of extensive scarring or non-elastic tissue, the course of correction will be prolonged, if correction is achievable.

Touch-up implantations may be required in areas with greater motion or mechanical stress (e.g., nasolabial folds). All patients should be counseled to anticipate supplemental implantations to achieve and maintain optimal correction.

How supplied

Synject gel is supplied in individual treatment syringes with needles, and is packaged for single patient use, ready for injection (implantation). The contents of the syringe are sterile and non-pyrogenic. The volume markings on the syringe are for reference only.

To Attach Needle To Syringe

1. Peel sealed cover off the needle guard.
2. Remove tip cap from syringe.
3. Attach needle to syringe and twist to secure. To assure proper needle attachment, use the needles provided or 30-gauge needles with similar needle guards. Fully seat hub of needle in syringe. Do not over tighten, as this may break the needle and/or dislodge the syringe.
4. Pull off the needle guard to expose needle.

Procedure To Change Needle

1. Peel sealed cover off new needle guard.
2. Twist used needle to disconnect it from the syringe.
3. Attach new needle to syringe and twist to secure.
4. Pull off the needle guard to expose needle.

To place an order, contact INAMED Corporation at (800) 624-4261.

Instructions For Use

1. Synject gel is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Prior to treatment with Synject gel, the patient should be fully apprised of the indications, contraindications, warnings, precautions, treatment responses, adverse reactions, and method of administration. Patients also should be advised that supplemental “touch-up implantations may be required to achieve and maintain maximum correction.
2. A complete medical history, including allergies, should be obtained to determine whether the patient is an appropriate candidate for Synject treatment.
3. The patient's soft tissue deficiencies should be characterized with regard to etiology, distensibility, stress at the site, and depth of lesion. Depending on the type of skin, best results are obtained when the defect is readily distensible and correction can be visualized by manual manipulation (stretching) of the skin. Pretreatment photographs are recommended.

4. Topical or injectable anesthesia may be used to manage pain during and after injection.

5. After ensuring that the patient has thoroughly washed the treatment area with soap and water, the area should be swabbed with alcohol or other antiseptic. Prior to injecting Synject gel, depress the plunger rod until the product flows out of the needle.
6. Synject gel is administered using a thin gauge needle (30G ½”). The injection technique with regard to the angle and orientation of the bevel, the depth of injection, and the quantity administered may vary. A linear threading technique, serial puncture injections, or a combination of the two have been used to achieve optimal results. Subderma! application should be avoided because such application may not provide optimal correction. If Synject gel is injected too deep, the duration of the effect will be shorter. If Synject gel is injected too superficially this may result in visible lumps and/or discoloration.
7. Inject Synject gel applying even pressure on the plunger rod while slowly pulling the needle backwards. The wrinkle should be lifted and eliminated by the end of the injection. It is important that the injection is stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.
8. Only correct to 100% of the desired volume effect. Do not overcorrect. The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the implant site, the depth of the implant in the tissue and the injection technique. Markedly indurated defects may be difficult to correct.
9. If immediate blanching occurs, the injection should be stopped and the area massaged until it returns to a normal color.
10. When injection is completed, the treated site should be gently massaged so that it conforms to the contour of the surrounding tissues. If an over correction has occurred, massage the area between your fingers or against an underlying superficial bone to obtain optima! results.
11. if the wrinkle needs further treatment, the same procedure should be repeated until a satisfactory result is obtained. With patients who have localized swelling the degree of correction is sometimes difficult to judge at the time of treatment. In these cases, it is better to invite the patient to a touch-up session after 1-2 weeks.
12. Patients may have mild to moderate injection site reactions, which typically resolve in a few days. If the treated area is swollen immediately after the injection, an ice pack can be applied to the site for a short period.
13. After the initial treatment (from 1 to 2 weeks later), an additional treatment of Synject gel may be necessary to achieve the desired level of correction. The need for an additional treatment may vary from patient to patient and is dependent upon a variety of factors such as wrinkle severity, skin elasticity and dermal thickness at the treatment site.
14. The physician should instruct the patient to promptly report to her/him any evidence of problems possibly associated with the use of Synject gel.

Storage

Synject gel should be stored at room temperature, 2°-30°C (36°-86°F). DO NOT FREEZE.

Hyiaform gel has a clear appearance. In the event that a syringe contains material that is not clear do not use the syringe and notify INAMED Corporation immediately at (800) 624-4261.

Sterility

Synject gel is packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged.

Manufactured by: Genzyme Biosurgery, 1125 Pleasant View Terrace, Ridgefield, New Jersey 07657 USA. Distributed by: INAMED Aesthetics, 5540 Ekwill Street, Santa Barbara, CA 93111 USA (800) 624-4261

See also:
What is the most important information I should know about Synject?

• Synject gel is contraindicated for use in breast augmentation, or for implantation into bone, tendon, ligament, or muscle,
• Synject gel is contraindicated for patients with a history of known hypersensitivity to avian proteins.
• Synject gel must not be injected into blood vessels. Introduction of Synject gel into the vasculature may occlude the vessels and could cause infarction or embolization.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not share this medicine with another person, even if they have the same symptoms you have.

To use sodium hylauronate on the skin:

• Clean and disinfect the skin area before applying Synject topical cream, gel, film, or spray.

• Apply enough of the medication to cover the wound or affected skin area entirely.

• If you use Synject gel, foam or cream on an open skin wound, dab a thin layer of the medicine onto the affected area with as little rubbing as possible.

• To prevent contaminating the medication tube or bottle, use a sterile rubber glove or finger cot while applying Synject topical.

• Cover the treated skin area with a sterile gauze pad or other dressing recommended by your doctor.

• Synject topical for use on the skin is usually applied 2 or 3 times per day. Follow your doctor's instructions.

To use the Synject oral gel:

• Tear open the gel packet and pour the entire contents into a drinking glass. Add 1 or 2 tablespoons of water and stir this mixture well.

• If you do not have water available while using the oral gel, you may use it undiluted.

• Rinse your mouth thoroughly by swishing and gargling with the mixture in your mouth for at least 1 minute.

• Make sure your gums, teeth, tongue, and insides of your cheeks are well coated with the medicine before spitting it out.

• Avoid eating or drinking anything for at least 1 hour after using the oral gel.

• Synject oral gel may be used 3 times per day. Follow your doctor's instructions.

Stop using this medicine and call your doctor if your symptoms do not improve or if they get worse, or if you develop new symptoms.

Store at room temperature away from moisture and heat. Keep the tube bottle tightly closed when not in use. Do not tear open an oral gel packet until you are ready to use it.

Synject is used to treat knee pain caused by osteoarthritis (a disorder of joints that causes stiffness, pain and loss of movement due to breakdown of lubricating fluid between joints) when treatment with common painkillers or other physical therapy (exercise, physiotherapy etc.) does not provide adequate relief. It is also used for treatment of mouth sores, prevention of skin aging and during cataract surgery.

See also:
What other drugs will affect Synject?

To date, there are no reports of incompatibilities (interactions) of Synject with other solutions for intra-articular administration. The patient may benefit from the concurrent use of oral analgesic and anti-inflammatory agents during the first days of treatment.

Incompatibiliies: There is a known incompatibility between Synject and quaternary ammonium salts eg, benzalkonium chloride which can be used as skin disinfectants. Synject must therefore never come into contact with such products, nor with medical or surgical equipment treated with these types of products, since Synject can precipitate in their presence.

See also:
What are the possible side effects of Synject?

Clinical Evaluation of Synject Gel

In a randomized, controlled clinical trial to evaluate the safety and effectiveness of Synject gel as a dermal filler for nasolabial folds, 261 patients 30 to 55 years of age were randomized between the treatment (Synject) and the control (Zyplast) implant. During the initial phase of the study, each patient was injected with the respective dermal filler in the nasolabial folds for wrinkle correction. Patients were followed for 12 weeks. Following completion of the initial phase, each of the patients who initially received Synject gel treatment was offered repeat treatment with Synject products in both nasolabial folds and evaluated for safety for an additional 4 weeks.

Initial Treatment Phase

Adverse events reported during the 12 weeks following treatment were categorized according to the reported severity.

Table 1 : Injection Procedure Related Adverse Events by Maximum Severity Occurring in > 5% of Patients [Number (%) of Patients]

Table 2: Duration of Procedure or Device Related Events Occurring in Greater thaii 5% of Patients

Device related adverse events occurred infrequently in both groups and were primarily of mild intensity; 2 patients (2%) experienced 3 events in the Synject group, and 9 patients (7%) experienced 14 events in the Zyplast group. The Synject device related adverse events were erythema, induration and pruritus.

Clinical trial adverse events unrelated to the injection procedure reported in the Synject treatment group occurring in greater than 1% of patients (n=133) were nasopharyngitis (5.3%), headache (4.5%), influenza (3.8%), rash (3%), conjunctivitis (1.5%), and sinusitis (1.5%).

Repeat Treatment Phase

During the initial and repeat treatment phases of the study, hylan B IgG antibody titers were measured at baseline and throughout treatment. Only one patient exhibited a positive antibody response after treatment with hylan B. This patient experienced adverse events of injection site bruising and headache lasting 11 days and 2 days after initial treatment, respectively. These adverse events were not reported as device-related and were not considered to be associated with the increased antibody titer level. None of the other study patients developed similar increases in antibody titer levels during the initial or repeat study phases.

Of the 133 patients treated with Synject gel during the initial phase, 96 underwent repeat treatment with Synject products and were followed for up to 4 weeks for safety. The types of adverse events seen after repeat treatment with Synject products were similar to those seen during the initial clinical evaluation. The most frequently reported adverse events included injection site erythema, bruising, swelling, pain, nodules, pruritus and tenderness. Device-related adverse events were reported in 3 patients during repeat treatment with Synject gel and included involuntary muscle contraction described as eye fasciculations in one patient and dizziness in another. A third patient experienced bilateral aseptic abscess formation at the site of injection, but did not develop increased hylan B antibody titers throughout either the initial or repeat phase of the study.

Surveillance outside the US

Synject post market safety surveillance in countries outside of the United States indicates that the most frequently reported adverse events include: injection site erythema, nodule, swelling, and induration. These adverse events are similar in frequency and duration to what has been noted during clinical trials.

Each bottle contains 100 mL soln plus 1 applicator for nasal use and 1 applicator for the use in the ear, sealed in a bag.

Inside the metal bottle, the soln remains isolated and not in contact with the propellant because it is contained within a bag made of nontoxic material. The propellant used is air and it is pressurized within the entire space surrounding the bag inside the metal bottle. The inhalation of Synject occurs via valve positioned above the bag.

With the system: The air is used like a gas propellant, so Synject does not damage the ozone layer. It is necessary to use preservatives so the possibility of allergic reaction is reduced. The bottle can be used in any direction so Synject is practical and easy to use.