CRESPINE® GEL PLUS

Description

Product: CRESPINE® GEL PLUS
Active Substance(s): CROSS-LINKED HA, NON-CROSSLINKED HA, PRILOCAINE
Strength: 14mg/ml, 1mg/ml, 3mg/ml
Volume & Packaging: 1-2ml prefilled syringe.
Manufacturer: BioPolymer
Also Included: Package insert, 4 traceability labels.
Remarks: Steryl packaging.
Package Content: 1 x 14ml Pre-Filled Syringe

Crespine Gel Plus is an orthopaedic injectable filler formulated to ease symptoms of osteoarthritis, like pain and swelling. The active ingredients are 14mg/mL cross-linked hyaluronic acid, 1mg/mL non-crosslinked hyaluronic acid, and 3mg/mL of prilocaine. Both versions of the hyaluronic acid lubricate and improve mobility in knees, hips, and other affected joints by reducing friction. Prilocaine offers a pain-free experience during injection. This intra-articular implant is manufactured by BioPolymer, a company specialising in manufacturing medical devices. The synthetic gel is sterile, viscoelastic, biocompatible, resorbable, and free from endotoxins and animal sources. Each package of Crespine Gel Plus comes in 1 preloaded 2mL syringe, 4 traceability labels, and a product leaflet. Please store this local injection item in a clean room away from extreme heat or freezing temperatures (between 2℃ and 25℃).

Crespine Gel Plus is an intra-articular implant designed to treat pain and immobility from degenerative osteoarthritis disorders. The high-purity hyaluronic acid forms a protective layer over the worn-out ends of bones. The layer ensures that bones do not grind against each other and erode. This allows joint movements to be smoother and more flexible.

A joint is the point at which 2 or more bones meet. There are actually 3 structural types of joints in the body:

1. Fibrous joints: These joints are immovable. They are noticeably marked by the absence of synovial fluid as the bones are held together by fibrous connective tissues like collagen fibres. An example of such joint would be the sutures connecting skull plates together.
2. Cartilaginous joints:These joints are semi-movable and are connected via cartilages. Once again, no synovial fluid is present. A good example of cartilaginous joint is the one holding the spinal column intact.
3. Synovial joints:These joints are freely movable and are encapsulated within flexible synovial membrane. Inside the membrane, the bones are covered with a thin yet strong layer of articular cartilage for smooth, frictionless movement. The spaces between the bones are filled with a slippery and viscous joint fluid called synovial fluid. The fluid lubricates the joints and absorbs shock. Prime examples of such synovial joints would be the ones in the shoulders and knees.

Osteoarthritis is an inflammatory and degenerative disease of the joints that occurs when the articular cartilage breaks down. The exposed bones start to rub against each other leading to drastic joint damage. Patients suffering from osteoarthritis often complain of debilitating pain, swelling, stiffness, and reduced joint movement.

Crespine Gel Plus was designed to relief patients from those painful symptoms. This single-injection treatment provides fast and long-lasting pain reduction. The injected hyaluronic acid gel shares a similar consistency and viscoelasticity as the synovial fluid. The gel covers, lubricates and cushions the bones in order to stop painful grinding. The repaired joints can then perform with improved efficiency and further degeneration is thwarted. In many cases, joint replacement surgeries can be postponed until absolutely necessary. The combination of prilocaine––an anaesthetic––makes the injections more comfortable.

Just like any other medical procedure, patients’ medical conditions, degree of osteoarthritic damage on the joints, presence of any allergic reactions or hypersensitivities and other important medical information prior to treatment should be evaluated. Advise patients to stop taking anticoagulants (e.g. warfarin, aspirin, ginkgo biloba) a few days before the procedure to reduce the risk of bleeding. Thoroughly clean and disinfect the affected joints before injecting. Attach a suitable and sterile needle to the preloaded syringe and aspirate it. If blood is aspirated, reposition the needle in the correct place. Inject the affected joints with the implant. A single 2mL syringe prefilled with the viscosupplement is sufficient for 1 treatment session. Discard any unused gels, syringes and needles. An entire treatment session can be completed in under 20 minutes.

Do not inject it into blood vessels as it may cause blood clots and stroke. The injection technique is very important for gel placement. For this reason, only authorised doctors with expertise in orthopaedic treatments and injection methods can safely perform this procedure. Refer to the product leaflet for more precautions and instructions.

The desirable pain-relieving results of Crespine Gel Plus are usually experienced 5 to 7 days after initial treatment. Patients get to enjoy pain-free motions of the joints for about 6 to 8 months, after which they can get repeat injections to prolong the effects. However, these results may vary on an individual basis.

Yes, Crespine Gel Plus is a safe and well-tested single-use implant. Its active ingredient—hyaluronic acid—is a naturally occurring complex sugar substance in the human body. Hence, the affected joints will respond and be repaired effectively after treatments with minimal undesirable effects. However, the safety of this implant in the following groups of people has not been determined:

• Young people below 18 years of age;
• Pregnant people;
• People who are breastfeeding.

In addition, certain people must steer clear from this hyaluronic acid-based implant due to heightened risk of hypersensitivity.

Pay extra attention to the affected joints during treatment and do not inject the filler in joints with active infections or inflammation as this could worsen the side effects. Please refer to the product manual for a complete list of contraindications.

Crespine Gel Plus may result in some adverse after-effects, usually associated with the injection process itself.

• Transient erythema (temporary redness)
• Warm sensation
• Swelling
• Pain and tenderness

The severity of these reactions are mild. Patients should recover from the common side effects within 5 days. Remind your patients that hypersensitive reactions can occur instantly after treatment or be delayed for 2 to 4 weeks after injections. Patients should always monitor their conditions until healing is properly completed.

Patients may even display some rare and serious reactions as a result of:

1. Depressed cardiovascular function from a vasovagal reaction (e.g. fainting, sudden drop in blood pressure and heart rate);
2. Overdose of prilocaine affecting the central nervous system (e.g. light-headedness, tingling sensation, confusion, drowsiness, etc.).

Please inform patients to get immediate medical help if the symptoms do not subside within the stipulated time. Refer to the product manual for a complete list of adverse reactions.

Crespine Gel Plus is an injectable intra-articular implant that contains hyaluronic acid (both cross-linked and non-crosslinked) and prilocaine. The hyaluronic acid is extracted via biofermentation and is tolerated well by the human body. Hyaluronic acid replenishes the lost synovial fluid (the shock-absorbing liquid) that actually lubricates joints to allow for a wide range of motion. The joint fluid of patients suffering from osteoarthritis is worn-out, which causes the bone ends to grind against each other painfully. When the fluid is replenished, normal movements can happen without pain. Prilocaine temporarily numbs the treated areas so that patients can enjoy a pain-free procedure.

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.