Arthrease

Osteoarthritis

An indication is a term used to refer to a list of conditions, symptoms, or diseases for which a medication is prescribed or used by a patient. For example, acetaminophen or paracetamol is used by the patient for fever, or the doctor prescribes it for headaches or body aches. Now fever, headache, and body aches are all signs of paracetamol. The patient should be aware of the indications of medications used for common conditions, because they can be taken without a prescription at the pharmacy.

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

* Eye surgery and corneal transplantation by injection by an eye surgeon.

Osteoarthritis, when the doctor inserts it into the joint. Although it has been approved by the FDA for the treatment of osteoarthritis by injection, the results vary. Some people report moderate improvements in joint stiffness and pain reduction when treating arthrosis, but this is not always the case. It is not known whether Osteoarthritis can slow or reduce progressive joint damage with prolonged use. Auxiliary therapy for: * Healing of skin wounds and burns.

* Retinal detachment and other eye injuries.

* Prevention of the effects of aging.

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

Arthrease products are a gel of a smooth consistency, compared to some hyaluronic gel products that have a granular consistency. Arthrease products are designed using Hylacross technology to provide a smoother, more pliable gel. Osteoarthritis is a natural sugar found in the body. Arthrease works by holding water at the injection site and acting as a cushioning agent. It adds temporary volume and a smoother appearance to the skin. Most patients need a single treatment to achieve optimal results.

Some Arthrease HC products also contain the local anesthetic lidocaine, for more comfortable administration. Arthrease Ultra XC and Arthrease Ultra Plus XC contain 0.3% lidocaine without preservatives and numb within seconds. Arthrease Ultra Plus products contain more highly crosslinked formulations to increase volume and correct deeper creases and wrinkles.

Individualization Of Treatment

Highly compacted, sharply defined, and very superficial wrinkles can be difficult to stretch and therefore difficult to correct. If the defect cannot be expanded due to extensive scarring or inelastic tissue, the course of correction will be extended if correction is achievable.

Tint implantation may be required in areas with a lot of movement or mechanical stress (for example, nasolabial folds). All patients should be encouraged to anticipate additional implantations to achieve and maintain optimal correction.

As delivered

Arthrease gel is delivered in individual medical syringes with needles and is packaged for single use by the patient, ready for injection (implantation). The contents of the syringe are sterile and non-pyrogenic. The volume marking on the syringe is for reference only.

Attach The Needle To The Syringe

1. Remove the sealed cover from the needle guard.
2. Remove the tip cap from the syringe.
3. Attach the needle to the syringe and twist to secure. To ensure that the needle is properly secured, use the supplied needles or 30-gauge needles with similar needle fuses. Fully seated needle hub in the syringe. Do not tighten too tightly, as this may break the needle and/or dislodge the syringe.
4. Remove the needle guard to expose the needle.

Needle Change Procedure

1. Remove the sealed cover from the new needle guard.
2. Twist the used needle to detach it from the syringe.
3. Attach the new needle to the syringe and twist to secure it.
4. Remove the needle guard to expose the needle.

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

Instructions For Use

1. Arthrosis gel is indicated for injection into the middle and deep dermis to correct moderate to severe facial wrinkles and creases (such as nasolabial folds). Before starting treatment with Arthrease gel, the patient should be fully informed about the indications, contraindications, warnings, precautions, treatment responses, adverse reactions and the method of administration. Patients should also be advised that additional “touch-up " implants may be required to achieve and maintain maximum correction.
2. It is necessary to obtain a complete medical history, including allergies, to determine whether the patient is a suitable candidate for the treatment of osteoarthritis.
3. The patient's soft tissue deficiency should be characterized taking into account the etiology, extensibility, tension at the site and the depth of the lesion. Depending on the skin type, the best results are achieved when the defect is easily stretched and the correction can be visualized by manual manipulation (stretching) of the skin. Pre-processing of photos is recommended.

4. Local or injectable anesthesia can be used to treat pain during and after the injection.

5. After the patient has thoroughly washed the treated area with soap and water, it should be wiped with alcohol or other antiseptic. Before injecting Arthrease gel, press the plunger rod until the product flows out of the needle.
6. The arthrosis gel is injected with a fine gauge needle (30 g ½ in). The injection technique may vary depending on the angle and orientation of the bevel, the depth of the injection, and the amount to be injected. For optimal results, linear threading techniques, sequential puncture injections, or a combination of both were used. Subderma! use should be avoided, as such use may not provide optimal correction. If the Arthrease gel is injected too deeply, the duration of the effect will be shorter. If the Arthrease gel is injected too superficially, it may cause visible lumps and/or discoloration.
7. Inject the Arthrease gel by pressing evenly on the plunger rod and slowly pulling the needle back. The wrinkle should be raised and eliminated by the end of the injection. It is important that the injection is stopped just before the needle is removed from the skin to prevent the material from leaking or getting too shallow into the skin.
8. The only correct one for 100% of the required volume effect. Don't overdo it. The degree and duration of correction depends on the nature of the treated defect, the tension of the tissues at the implantation site, the depth of the implant insertion into the tissue, and the injection technique. Visibly hardened defects can be difficult to fix.
9. If there is an immediate pallor, the injection should be stopped and the area massaged until it returns to its normal color.
10. After the injection is complete, the treated area should be gently massaged to match the contour of the surrounding tissues. If there is an excessive correction, massage the area between the fingers or against the underlying surface bone to get the optimum! Results.
11. if the wrinkle needs further treatment, the same procedure should be repeated until a satisfactory result is obtained. In patients with localized edema, the degree of correction is sometimes difficult to assess during treatment. In these cases, it is better to invite the patient to a touch-up session in 1-2 weeks.
12. Patients may experience mild to moderate reactions at the injection site, which usually resolve after a few days. If the treated area swells immediately after the injection, an ice pack can be applied to it for a short time.
13. After the initial treatment (1 to 2 weeks later), additional treatment with Arthrease gel may be required to achieve the desired level of correction. The need for additional treatment may vary from patient to patient and depends on many factors, such as the severity of wrinkles, the elasticity of the skin and the thickness of the skin at the treatment site.
14. The doctor should instruct the patient to immediately inform him of any signs of problems that may be associated with the use of Arthrosis gel.

Storage location

Arthrease gel should be stored at room temperature, 2°-30°C (36°-86°F). DON'T FREEZE.

The hyaform gel has a clear appearance. If the syringe contains obscure material, do not use the syringe and immediately notify INAMED Corporation by calling (800) 624-4261.

Sterility

Arthrease gel is packaged for single use by the patient. Do not re-sterilize the product. Do not use if the packaging is open or damaged.

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

See also:
What is the most important information I need to know about arthrosis?

• Arthrease gel is contraindicated for use in breast augmentation or for implantation in bone, tendon, ligament or muscle,
• Arthrotic gel is contraindicated in patients with a known history of hypersensitivity to avian proteins.
• Arthrotic gel should not be injected into the blood vessels. The introduction of an arthrotic gel into the vascular network can lead to blockage of blood vessels and cause a heart attack or embolization.

Follow all the instructions on the label of your recipe. 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 as you.

Application of sodium hyaluronate on the skin:

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

• Apply enough of the medicine to completely cover the wound or affected area of the skin.

• If you use an Arthrotic gel, foam, or cream on an open skin wound, apply a thin layer of the medicine to the affected area, rubbing as little as possible.

• To prevent contamination of the drug tube or vial, use a sterile rubber glove or finger pad during topical application of Arthrosis.

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

• Osteoarthritis for topical application to the skin is usually applied 2 or 3 times a day. Follow your doctor's instructions.

For the use of oral Arthrease gel:

• Tear the bag of gel and pour all the contents into a drinking glass. Add 1 or 2 tablespoons of water and mix the mixture well.

• If you do not have water when using the oral gel, you can use it undiluted.

• Rinse your mouth thoroughly, whistling and gargling the mixture in your mouth for at least 1 minute.

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

• Do not eat or drink anything for at least 1 hour after using the oral gel.

• Oral Arthrosis gel can be used 3 times a day. Follow your doctor's instructions.

Stop using this medicine and see your doctor if your symptoms do not improve, or if they worsen, or if you develop new symptoms.

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

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

See also:
What other drugs will affect Arthritis?

To date, there are no reports of incompatibility (interaction) Arthrease with other solutions for intra-articular administration. The patient may benefit from the simultaneous use of oral analgesics and anti-inflammatory drugs during the first days of treatment.

Incompatibilities: There is a known incompatibility between arthrosis and quaternary ammonium salts, such as benzalkonium chloride, which can be used as skin disinfectants. Therefore, Osteoarthritis should never come into contact with such products, as well as with medical or surgical equipment treated with these types of products, since Osteoarthritis can precipitate in their presence.

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

Clinical evaluation of Arthrease Gel

In a randomized controlled clinical trial to evaluate the safety and efficacy of Arthrease gel as a dermal filler for nasolabial folds, 261 patients aged 30 to 55 years were randomized between treatment (Arthrease) and a control implant (Zyplast) . At the initial stage of the study, each patient was injected with an appropriate dermal filler in the nasolabial folds to correct wrinkles. Patients were followed up for 12 weeks. After completion of the initial phase, each of the patients who were initially treated with Arthrease gel was offered repeated treatment with Arthrease drugs in both nasolabial folds and evaluated for safety for an additional 4 weeks

Initial Phase Of Treatment

Adverse events reported within 12 weeks of treatment were classified according to reported severity.

Table 1: Side effects associated with the injection procedure, by maximum severity, occurring in > 5% of patients [Number ( % ) of patients]

Table 2: Duration of procedure or Device-related events occurring in more than 5% of patients

Side effects associated with the device occurred infrequently in both groups and were mostly mild in intensity, 2 patients (2%) experienced 3 events in the Arthritis group and 9 patients (7%) experienced 14 events in the Cyplast group. Side effects associated with the arthrosing device were erythema, compaction, and itching.

Non-injection-related adverse events reported in the Arthrosis treatment group in more 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 The Processing Step

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

Of the 133 patients who received Arthrotic gel at the initial stage, 96 were re-treated with Arthrotic gel preparations and followed up for 4 weeks to ensure safety. The types of adverse events observed after repeated treatment with Arthritis drugs were similar to those observed in the initial clinical assessment. The most commonly reported adverse events included erythema at the injection site, bruising, swelling, pain, nodules, itching, and soreness. Side effects associated with the device were reported in 3 patients during repeated treatment with Arthrease gel and included involuntary muscle contraction, described as eye fasciculation in one patient and dizziness in another. The third patient had a bilateral aseptic abscess formation at the injection site, but no increase in the titer of anti-hylan B antibodies was observed either at the initial or at the second phase of the study

Surveillance outside the United States

Post-market monitoring of the safety of Arthritis in countries outside the United States shows that the most commonly reported adverse events include: erythema at the injection site, nodule, swelling, and compaction. These side effects are similar in frequency and duration to those observed in clinical trials.

Each bottle contains 100 ml of soln plus 1 nasal applicator and 1 in-ear applicator, sealed in a bag.

Inside the metal bottle, the fuel remains insulated and does not come into contact with the fuel, because it is contained in a bag made of non-toxic material. Air is used as fuel, and it is pressurized throughout the space surrounding the bag inside the metal bottle. The inhalation of arthritis occurs through a valve located above the bag.

With the system: Air is used as a gas fuel, so Arthritis does not damage the ozone layer. It is necessary to use preservatives to reduce the likelihood of an allergic reaction. The bottle can be used in any direction, so Arthrease is practical and easy to use.