Collagen implant PLEXATHRON for intra-articular and periarticular injection (2 ml vials; boxes for 5 or 10 vials).
 Composition in 2 ml:
- collagen: 100 mcg
- calcium phosphate [Ca₃(PO₄)₂]: 1 mcg
- sodium chloride [NaCl]: 18 mg
- water for injection [H₂O]: q.s. to 2 ml
It contains sterile vials sterilized by steam

PLEXATHRON is a сollagen implant for intra-articular and periarticular injection designed to help movement by limiting a physiological degeneration of joints and tissues as well as by counterbalancing any damage caused by:
• aging
• bad posture
• concomitant chronic diseases
• blows and injuries
• pollutants.
PLEXATHRON is a medical device that helps hip movement. Its main therapeutic functions include:
1. A barrier effect.
2. A lubricating action.
3. Mechanical support while administering other pharmacological treatments.

PLEXATHRON is intended to be used by a qualified staff in private or public health Facilities to:

• Improve the movement of the hip joint.
• Help muscle stretching of the lumbosacral area.
• Support the periarticular muscle tissue.
• Sooth local pain, pain caused by joint movement or bad posture.

Therapeutic protocol:
1 treatment weekly for 10 consecutive weeks.

Periarticular injection technique (the site of application must be aseptic; insert the needle at 6-8 mm depth).
For this purpose the use of the following materials and accessories is recommended:
• Materials for aseptic skin preparation: single-use gloves, iodine solution, alcohol solution, sterile gauze pads, ethyl chloride spray for the skin.
• Needles: sterile 27 G.
• Syringes: 5 or 10 cc size, according to the volume of the solution to inject.

Intraarticular injection technique
For this purpose the use of the following materials and accessories is recommended:
• Materials for aseptic skin preparation: single-use gloves, iodine solution, alcohol solution, sterile gauze pads, ethyl chloride spray for the skin.
The application of a topical anaesthetic on the skin area to be treated is recommended.
• Needles: sterile 22 G.
• Syringes: 2 cc size, according to the volume of the solution to inject.

Hip – Intraarticular injection



The trochanteric bursa is located over the lateral prominence of the greater trochanter of the femur.
There can be an anterior or a lateral approach to the hip.
The patient is lying supine. The anatomic landmark is located 2 cm below the superior border of the greater trochanter in between its anterior and posterior borders. The skin overlying this location is marked and prepared in a sterile way. A 22 gauge needle is injected parallel to the floor and perpendicular to the femoral shaft.

PLEXATHRON may be used as a single treatment or mixed with other medical devices of the same range in order to make a customised treatment according to clinical evolution.


It may also be used as mechanical support while treating the following diseases:
• Hip joint osteoarthritis.
• Hip joint capsule inflammation.
• Hip joint osteoarthritis with rheumatoid arthritis
• Hip joint pain of muscle origin
• Hip joint pain of nerve origin (burning hip)
• Hip joint pain due to prolonged bed rest.

Administration may vary according to individual needs.

Patients treated with anticoagulants or with recognized vessel fragility should be carefully monitored during the therapy.
There is no history of hypersensitivity to PLEXATHRON. However, patients with known hypersensitivity to any ingredient or excipient should be tested before use, making a spot injection into one arm and be monitored for 1 hour.

Hip pain requires differential diagnosis for primary or metastatic cancer pain, referred nerve pain of lumbar origin, inguinal hernia.
A slight reddening at the injection site may be due to a mechanical effect of the needle or to a skin reaction. The application might cause symptoms of burning/pain at the injection site, that usually solve spontaneously within 5-10 minutes after the treatment.
Skin cleansing/disinfection is required before and after application. Pyogenic bacteria may produce injection site abscesses.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use after the expiration date. The expiration date refers to a product properly stored and transported in its original and undamaged package. Use the product immediately after opening.

Precautions for storage and transportation: Protect from sunlight and freezing.
Storage conditions: 2-30°C
Product should be transported under the same conditions required for storage.
Instructions in cases of damage to the sterile vials
Do not use if the seal is broken or if the vial is not perfectly sealed. Once open, the content of the vial must be immediately injected. Do not use if the package is damaged.
Environmental Protection and Disposal
Take adequate precautions to prevent uncontrolled spills into the public drains. Dispose of material and its container in a waste collection point.
The used vials, needle and syringe barrel must be disposed as epidemiologically dangerous waste (infected and potentially infected waste, such as: materials and tools, objects, contaminated with blood and / or body liquids). Do not spill the product in the drains.
Follow national or local guidelines for the safe use and disposal.

The warranty period is equal to the shelf life of the product. The shelf life of medical device is 3 years.
The manufacturer guarantees the quality of the products and compliance with the declared technical specifications for the entire medical devices shelf life in case of following the appropriate application, transportation and storage conditions. The manufacturer or its authorized representative provides information and recommendations regarding risks, as well as prescriptions, methods and techniques for the usage of the product.
The manufacturing company disclaims all responsibility and disclaims any warranty obligations arising from patient injuries or damage that may occur as a result of:
1. The selected method of application and technique for the implant injection in case of non-compliance with the established recommendations.
2. Improper appointments, a choice of use for a particular patient.
3. Medical device usage after the specified expiration date or in violation of storage and transportation conditions.

Guna S.p.a.
Via Palmanova 71 (legal address)
 Via Palmanova 69 (manufacturing site)
20132 Milano, Italy
 Phone : +3902280181
Authorized Representative of the Manufacturer: Limited liability company MCNT Import (MCNT Import, Ltd.)
Address: 12, Ordzhonikidze st., bld. 2, Moscow, 119071, Russia
Tel.: +7 495 786-39-63