Information
Dispensing is only permitted with a valid medical prescription (after ordering by email to info@stakonmed.de). This regulation does not apply to healthcare professionals, practitioners, or institutions serving health purposes.
Injections may only be administered by a doctor skilled in the technique of this injection.
Can I also order with a prescription?
Yes, you are welcome to send us the prescription after your order at info@stakonmed.de.
Are there any additional volume discounts?
Yes, if you want to order regularly as a practice, you can benefit even more with our existing customer program.
Write to us at info@stakonmed.de or via the contact form
How quickly will my order arrive?
The delivery time is usually 1-3 business days.
How can I pay?
Paypal, ApplePay, Klarna, Visa, Mastercard, Maestro, Amex
Clinics and companies can also pay by invoice
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Description
KD Intra-Articular® Gel
KD Intra-Articular® Ultra One Gel
Sodium hyaluronate intra-articular
Description
The product contains a prefilled syringe with hydrogel made of highly purified sodium hyaluronate obtained by bacterial fermentation without sodium hyaluronate obtained from genetic modifications with high molecular weight, which is used to improve serves the viscosity in the intra-articular connective tissue. It has undergone steam sterilization for injectable products and is non-pyrogenic.
Depending on the product variant and concentration, 1 ml of aqueous, physiological phosphate buffer solution contains 10 mg, 16 mg, 22 mg, 25 mg or 30 mg sodium hyaluronate. The sodium hyaluronate hydrogel is in a weak, sterile, isotonic, and apyrogenic phosphate-buffered saline solution with a pH value from 7.2 (6.8 – 7.4) in sufficient volume for injection. Fill volumes vary depending on the variant from 1 to 4.8 ml. The translation of the chemical components is listed in the table in English (weight per volume as mg substance per 1 ml hydrogel):
(a) Sodium hyaluronate, (b) Sodium chloride, (c) Disodium hydrogen phosphate 2 H2O,
(d) Sodium dihydrogen phosphate 2 H2O, (e) Water for injection purposes
Properties and mode of action
An essential component of healthy synovial fluid is the widespread glycosaminoglycan hyaluronic acid. This natural biopolymer provides viscoelasticity and, thanks to its lubricating and shock-absorbing properties, enables pain-free physiological movements; it also supplies nutrients to the cartilage. The KD Intra-Articular® Gel The contained sodium hyaluronate is a salt of hyaluronic acid.
Indications
Pain and limitation of joint mobility in degenerative changes of the knee joint and other synovial joints, including osteoarthritis.
Contraindications
The product must not be used in patients
- with known hypersensitivity to any of the components
- with inflammation in the joint
- with septic arthritis
- with skin infections or skin diseases in the injection area
- with natural or medication-induced coagulation disorders such as hemophilia or under useuse of anticoagulants such as Marcumar (phenprocoumon) or Coumadin (warfarin)
Since there are no clinical data on the use of hyaluronic acid in children, pregnant or breastfeeding women, use in these patients is not recommended.
Precautions
Since septic arthritis can be a serious complication of treatment, please observe all precautions usually necessary for surgical procedures. Injections of the hydrogel must be administered directly into the joint cavity; injections into blood vessels and surrounding tissue must be avoided. Do not use if the prefilled syringe or sterile packaging is damaged.
The opened product must not be resterilized, resealed, or reused. It is intended for use by a single patient at a single treatment session.
Possible side effects
No adverse effects were observed in biocompatibility tests with the product. In the treated- affected joint, local symptoms such as pain, redness, warmth, and swelling may occur. These symptoms can be reduced if the treated area is cooled with an ice pack for 5 to 10 minutes after injection. During the first days of treatment, the simultaneous oral intake of pain and anti-inflammatory medications (NSAIDs) may be beneficial. In cases of intense If pain or inflammation occurs, treatment should be discontinued. Treatment of adverse reactions should only be carried out under the supervision of the attending physician. Immediately after the injection, strenuous physical activity should be avoided and other instructions from the doctor should be followed. Medical personnel should inform the patient
- about possible adverse events related to the product.
- that the patient must report any adverse event or complication to a doctor.
Pharmacological and chemical interactions
So far, there are no data on the incompatibility of the product with other solutions for intra-articular use.
There is a chemical incompatibility between sodium hyaluronate and quaternary ammonium compounds. such as benzalkonium chloride, which can lead to crystalline precipitation. Therefore, this product must never come into contact with surgical instruments or other products that contain these, or with Solutions containing quaternary ammonium compounds as biocidal preservatives.
Dosage, type, and duration of use
The prefilled syringe is to be removed from its packaging. The protective cap is to be removed from the Luer-Lock thread. A suitable sterile injection needle is to be screwed onto the syringe. The use of a single-use needle is recommended. Air should be evacuated from the needle before injection. The skin area intended for injection must be cleaned with an appropriate topical antiseptic. In the case of joint effusion, it is recommended that solutions containing quaternary ammonium compounds as biocidal preservatives be rinsed before injection. KD Intra-Articular® Gel initially reduce the effusion by aspiration and examine it for bacterial etiology. The hydrogel can be injected 1 to 5 times at intervals determined by the physician. Injected intra-articularly at intervals. The beneficial effects of a treatment last at least 6 months. Treatment cycles can be repeated if necessary.
Depending on the fill volume, several joints of a patient can be treated simultaneously. Unused product must be disposed of.
Dosage form
A box with one prefilled syringe of 1 ml - 4.8 ml.
Durability
The product must not be used after the expiration date. The expiration date (month/year) is printed on the Syringe blister and printed on the carton.
Storage instructions
The product should be stored dry between 2° and 25°C and protected from light and impact in the original packaging. Accordingly, warning symbols on the packaging must be observed.
Keep the product out of reach of children.
Recommended user group
Intended exclusively for use by physicians.
For single use only. Do not resterilize. Do not use syringes, needles, or hydrogel from open or damaged packaging or attempt to reseal packaging.
Syringe content is non-toxic and non-flammable.
When using a product from damaged packaging or reusing with other patients or the same patient at a different time are the intended properties and the Sterility is not guaranteed. Otherwise, possible transmission of material contamination and pathogens from the environment, the clinical area, or (other) patients could lead to health complications lead to. Resealing or resterilization does not constitute an allowed or guaranteed restoration of usable condition.
Unused syringes and their contents are not infectious and can be disposed of before or after the expiration date, observing national and local regulations. Used syringes and needles must be treated as epidemiologically hazardous waste, and national and local regulations for safe use and disposal must be followed.
Status of information 05/2021
Joint injections
Dermafiller
Supplements


