Product: CINGAL® 1-4ml prefilled syringe
Active Compositions: Sodium hyaluronate.
Volume & Packaging: 1-4ml prefilled syringe.
Manufacturer: Anika Therapeutics
Also Included: Package insert, 1 traceability label.
Remarks: Steryl packaging.
WHAT IS CINGAL?
Cingal is a CE-marked intra-articular injection made of hyaluronic acid gel that contains micronized triamcinolone hexacetonide particles that are designed for patients suffering from osteoarthritis (OA), which is characterized by symptoms like pain, swelling, and stiffness. The hyaluronic acid is manufactured via bacterial fermentation before it is purified and cross-linked into a viscoelastic gel that mimics the physiology and performance of naturally-occurring synovial fluid. As for triamcinolone hexacetonide, it is a type of steroid that has remarkable rapid and long-lasting anti-inflammatory and analgesic properties. Each ml of this pyrogen-free, sterile, latex-free, and viscous viscosupplement contain 22mg of high molecular weight cross-linked hyaluronic acid and 4.5mg of triamcinolone hexacetonide. When you purchase a box of Cingal, you get a single 5mL syringe that is preloaded. This medical device must be kept in its original packaging at room temperature (25°C) and should be kept away from freezing conditions. Cingal is a product of Anika Therapeutics.
WHAT IS IT USED FOR?
Cingal is used for alleviating pain associated with OA by reducing the inflammation that is also associated with the disease. It can be safely injected into all synovial joints (e.g. knees, hips, shoulders, thumbs, etc.). Patients who are not able to improve their OA condition by exercise, physical therapy, and oral analgesics are indicated to receive Cingal injections. Just one injection is adequate to provide pain relief.
HOW DOES IT WORK?
Osteoarthritis (OA) is a degenerative disease of a synovial joint and is triggered by numerous factors, such as previous joint injuries, overuse of a joint, and being overweight or obese. Under normal circumstances, a healthy synovial joint is composed of a flexible synovial membrane in which the ends of the bones are contained. The ends of bones are also covered with a thin layer of tough articular cartilage that allows the joint to be highly mobile with very minimal friction. Besides that, the intra-articular space between the bones is also filled with synovial fluid that protects the joint by lubricating it and absorbing sudden impacts. Unfortunately, the aforementioned factors can affect the integrity of articular cartilage, resulting in the debilitating symptoms of OA, which can include pain, swelling, joint stiffness, and reduced mobility. If left untreated, OA and its symptoms reduce one’s quality of life drastically.
Cingal is designed with a combination of high molecular weight, cross-linked hyaluronic acid gel that contains micronized triamcinolone hexacetonide particles. The hyaluronic acid mimics the action of synovial fluid and helps to lubricate the affected synovial joint. The other active ingredient — micronized triamcinolone hexacetonide — is a type of rapid and long-lasting synthetic glucocorticosteroid with excellent immunosuppressive and anti-inflammatory activities that help to alleviate inflammatory symptoms of OA. Following an intra-articular injection of Cingal, the pain of OA is successfully suppressed.
HOW TO USE IT?
Cingal administration is considered a medical procedure that can only be done by a licensed and experienced physician; aseptic guidelines should be followed during the administration of Cingal. A patient who is presenting symptoms of OA must be assessed carefully to ensure that he/she is free from any contraindicating conditions. Once the patient is deemed suitable, he or she can be prepared for the procedure by obtaining their consent after the possible side effects of Cingal are explained to them. Commence the procedure by cleaning and disinfecting the affected joint that requires correction. Remove any joint effusion or fluid buildup surrounding the joint using an 18 to 20-gauge sterile needle; discard the used needle afterwards. Next, remove the protective rubber cap on the tip of the prefilled syringe and securely attach another 18 to 20-gauge sterile needle onto the syringe. Inject the full content of the syringe intra-articularly into one affected joint. Use a separate syringe if the treatment is bilateral. All used medical supplies, including needles and the syringe, are contaminated wastes that must be discarded into proper biological waste bins upon the completion of treatment.
HOW LONG DOES IT LAST?
An intra-articular injection session of Cingal typically takes about less than an hour to complete. The pain relief effects of Cingal set in approximately 24 hours after administration and last for up to 26 weeks, depending on a patient’s physiological factors and lifestyle. Once the initial effects wear off, patients can return for maintenance treatment sessions.
IS IT SAFE?
Yes, Cingal is renowned for its safety and effectiveness at providing relief for OA-related pain for any synovial joint. In fact, this intra-articular implant has a CE certification, which is proof of its high quality and strong safety profile. The triamcinolone hexacetonide of this injection is also approved for use by the U.S. Food and Drug Administration. Though this viscosupplement can be safely used to treat all synovial joints affected by OA, its usage is contraindicated in the following patients due to a high risk of adverse health reactions.
- Patients with a known hypersensitivity to hyaluronate preparations.
- Patients with a known hypersensitivity to triamcinolone hexacetonide preparations.
- Patients with a known hypersensitivity to any ingredients or excipients present in Cingal.
- Patients with a dermal disorder or disorders (e.g. infections, inflammations, rashes, etc.) in the proposed injection site.
- Patients who are pregnant or suspected to be pregnant.
Not only that, extra caution must be exercised when administering Cingal in patients with medical conditions (e.g. endocrine disorder, impaired cardio-renal function, etc.) in which the use of corticosteroid is warned. Always read the package insert for detailed information on contraindications, precautions, and warnings.
WHAT ARE THE SIDE EFFECTS?
Patients are at risk of developing common inflammatory reactions on the injection site. Common side effects include swelling, pain, redness, and skin atrophy. Patients may even experience other rare but serious side effects such as infection, tendinopathy, and Nicolau syndrome (dermatitis).
As part of the pre-procedural consultation session, a patient must be educated on the proper aftercare methods; these include avoiding physical exertion and prolonged weight bearing activities, such as tennis, jogging, and standing for too long, for 48 hours after receiving a Cingal injection.
Refer to the package insert for additional information on all possible side effects.
WHAT IS IT MADE OF?
Cingal is made of hyaluronic acid gel that contains micronized triamcinolone hexacetonide particles. Another active ingredient is triamcinolone hexacetonide, a potent steroid with rapid and long-lasting anti-inflammatory and analgesic properties. Each preloaded syringe of Cingal contains 88mg of hyaluronic acid and 18mg of triamcinolone hexacetonide. The excipients in this injectable gel are sorbitol, polysorbate 80, dibasic sodium phosphate, monobasic sodium phosphate, and water for injection.
Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.