Unique combination therapy of hyaluronic acid and costicosteroid
Cingal® is a single injection that provides the quick pain relief of a corticosteroid with the long-term pain relief of a viscosupplement.
Therapeutic Class (Orthopedics):
Cingal® is the only viscosupplement that combines a corticosteroid for fast pain relief with a viscosupplement, a clear gel-like substance containing hyaluronic acid, for sustained osteoarthritis knee pain relief.
Sterile, non-pyrogenic suspension of micronized steroid particles in a viscoelastic hyaluronic acid (HA) gel contained in a single-use syringe
Each 4 mL pre-filled syringe contains a combination of high molecular weight cross-linked hyaluronic acid combined with a corticosteroid
Each 4 mL pre-filled syringe of Cingal® contains 88mg of cross-linked hyaluronic acid Monovisc® combined with 18mg of triamcinolone hexacetonide
Cingal® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen). Cingal® includes an ancillary steroid to provide additional short-term pain relief.
Dosage and Directions for Use:
Cingal® is a single dose preparation. The recommended dose is 4 mL (one syringe) per knee joint.
The required amount of Cingal® is injected through a sterile, disposable, hypodermic needle of suitable gauge into the selected joint. The sterile needle should be attached to the Cingal® syringe by a health care professional using a health care facility-approved aseptic technique. Common needle gauges for injections into the knee are 18-20 gauge. The final needle selection for any procedure is determined by the physician. The health care provider should ensure proper penetration into joint synovial space prior to injecting Cingal®. The syringe is intended for single injection only.
The following pre-existing conditions may constitute relative or absolute contraindications to the use of Cingal®:
- Do not administer to patients with known hypersensitivity (allergy) to hyaluronate preparations
- Do not administer to patients with known hypersensitivity (allergy) to triamcinolone hexacetonide preparations.
- Do not administer to patients with known sensitivity to any of the materials contained in Cingal®.
- Do not administer to pregnant women, or women who suspect they might be pregnant; as the safety of Cingal® in pregnant women has not been tested.
- Do not inject Cingal® in the knees of patients with infections or skin diseases in the area of the injection site or joint.
Warnings and Precautions:
- Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation as hyaluronan can precipitate in their presence.
- Transient increases in inflammation in the injected knee following intra-articular injection have been reported in some patients with inflammatory osteoarthritis.
- Cingal® should be used with great caution in patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned.
- Strict aseptic injection technique should be used during the application of Cingal®.
- The safety and effectiveness of the use of Cingal® in joints other than the knee have not been demonstrated.
- The effectiveness of Cingal® has not been established for more than one course of treatment.
- STERILE CONTENTS. The pre-filled syringe is intended for single use only. The contents of the syringe should be used immediately after opening. Discard any unused Cingal®. Do not resterilize.
- Do not use Cingal® if the package has been opened or damaged.
- Remove joint effusion, if present, before injecting Cingal®.
- Only medical professionals trained in accepted injection techniques for delivering agents into the knee joint should inject Cingal® for the indicated use.
Store Cingal® in its original package at room temperature (below 77°F/25°C). DO NOT FREEZE.
For more information, visit www.cingal.ca.
Cingal® is a registered trademark of Anika Therapeutics, Inc. used under license by Pharmascience Inc.
These products may not be suitable for everyone. Read the labels and follow the directions of use.
For additional information, contact us at 1-888-550-6060 or by email at email@example.com.