"The US Food and Drug Administration's (FDA's) Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted yesterday to recommend premarket approval of the Cartiva Synthetic Cartilage Implant for use in pati"...
DOSAGE AND ADMINISTRATION
Detailed Device Description
The Monovisc™ device is a proprietary high molecular weight hyaluronic acid (HA) visco-supplementation intended for the treatment of pain in patients with moderate osteoarthritis (OA) of the knee who have failed conservative non-pharmacological therapy and simple analgesics. The device is administered by a single injection via the para-patellar approach under sterile conditions. The dosage delivered by the single injection is equivalent to three injections of Anika's FDA approved (P030019) Orthovisc HA product.
Sodium hyaluronate is a natural complex sugar of the glycosaminoglycan family. The sodium hyaluronate polymer consists of repeating disaccharide units of sodium glucuronate-N-acetylglucosamine. The molecular weight range of hyaluronic acid in Monovisc™ is between 1 and 2.9 million Daltons. Monovisc™ has a nominal sodium hyaluronate concentration of 22 mg/mL, dissolved in physiologic saline. It is supplied in a 5.0 mL syringe containing 4.0 mL of Monovisc™ The contents of the syringe are sterile, non-pyrogenic and non-inflammatory.
Monovisc™ is prepared by cross-linking hyaluronan (hyaluronic acid, HA) with proprietary cross-linking agent. The HA is derived from bacterial fermentation (Streptococcus equi). The HA used in Monovisc™ is the same grade and specification that is used in Orthovisc® (P030019), and delivers a comparable amount of HA to the 3-injection Orthovisc® regimen.
Each pre-filled syringe with 4 mL of Monovisc™ contains:
|Hyaluronan||88 mg* (nominal)|
|Sodium Chloride||36 mg|
|Potassium Chloride||0.8 mg|
|Sodium Phosphate, Dibasic||4.6 mg|
|Potassium Phosphate, Monobasic||0.8 mg|
|USP water for injection||q.s. to 4 mL|
|*equivalent to 3 Orthovisc® injections|
Directions For Use
Monovisc™ is injected into the knee joint and is administered as a single intra-articular injection. Standard intra-articular injection site preparation and precautions should be used. Strict aseptic administration technique must be followed.
- Using an 18 – 20 gauge needle, remove synovial fluid or effusion before injecting Monovisc™. Do not use the same syringe for removing synovial fluid and for injecting Monovisc™; however, the same 18 – 20 gauge needle should be used.
- Remove the protective rubber cap on the tip of the syringe and securely attach a small gauge needle (18 - 20 gauge) to the tip. Twist the tip cap before pulling it off, as this will minimize product leakage.
- To ensure a tight seal and prevent leakage during administration, secure the needle tightly while firmly holding the luer hub. Do not over tighten or apply excessive leverage when attaching the needle or removing the needle guard, as this may break the syringe tip.
- Inject the full 4 mL in one knee only (do not overfill the joint). If treatment is bilateral, a separate syringe should be used for each knee.
Monovisc™ is supplied in a single-use 5 mL syringe containing a 4 mL dose of treatment. Each syringe is labeled Monovisc™ for ready identification. The contents of the syringe are sterile and non-pyrogenic. The syringe components contain no latex.
Manufactured by Anika Therapeutics, Inc., 32 Wiggins Avenue, Bedford, MA 01730. Distributed by DePuy Mitek, Inc., 325 Paramount Drive, Raynham, MA 02767. Revised: Dec 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/21/2014
Additional Monovisc Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options