Plexathron (Implant) Instructions for Use
Marketing Authorization Holder
MKNT Import LLC (Russia)
Manufactured By
Guna S.p.A. (Italy)
Trademark Owner
MKNT IMPORT, LLC (Russia)
Contact Information
MKNT IMPORT LLC (Russia)
Dosage Form
 |
Plexathron | Collagen-containing implant for intra-articular and periarticular administration: fl. 2 ml 5 or 10 pcs. |
Dosage Form, Packaging, and Product Composition
Collagen-containing implant for intra-articular and periarticular administration in the form of a clear, colorless solution.
| 1 fl. (2 ml) | |
| Collagen | 100 mcg |
| Implant density 1.003-1.009 g/ml Implant viscosity 1.5-2.3 mPa·s Implant pH 5.2-7.0 Implant osmolality 285-315 mOsm/kg Mechanical impurities in the implant ≥10 µm: ≤1000 particles/vial, ≥25 µm: ≤1000 particles/vial Implant weight in vial 2.06-2.18 g Extractable volume ≥10 ml (×5 vials) Bacterial endotoxins ≤0.5 IU/ml |
|
Excipients : calcium phosphate [Ca3(PO4)2] – 1 mcg, sodium chloride [NaCl] – 18 mg, water for injections [H2O] – up to a volume of 2 ml.
2 ml – glass vials (5) – cardboard boxes.
2 ml – glass vials (10) – cardboard boxes.
Therapeutic Category
Medical device for the treatment of musculoskeletal system diseases
Properties
Plexathron is a collagen-containing implant for intra-articular and periarticular administration.
It helps to increase the range of motion by slowing down the degradation processes of the cartilage tissue of the articular surfaces and restoring damage resulting from
- Aging;
- Postural disorders;
- Concomitant chronic diseases;
- Contusions and injuries;
- Toxic lesions of cartilage tissue.
Plexathron is particularly effective in the treatment of the hip joint.
It has the following therapeutic functions
- Barrier effect;
- Lubricating effect;
- Mechanical support during other drug therapy.
Scope of Application
Of the Plexathron product
The Plexathron medical device is intended for use by qualified personnel in private or public medical institutions for the purposes of
- Increasing the range of motion in the hip joint;
- Increasing the elasticity of muscle tissue in the lumbosacral region;
- Strengthening the periarticular muscle tissue;
- Local pain relief, pain on movement, and pain caused by postural disorders.
The product can also be used as mechanical support in the treatment of the following conditions
- Osteoarthritis of the hip joint;
- Inflammation of the hip joint capsule;
- Osteoarthritis of the hip joint combined with rheumatoid arthritis;
- Muscle pain in the hip joint area;
- Neuralgic pain in the hip joint area (burning);
- Hip joint pain caused by prolonged immobility.
ICD codes
| ICD-10 code | Indication |
| M16.9 | Unspecified coxarthrosis |
| M24.5 | Joint contracture |
| M24.9 | Joint lesion, unspecified |
| M25.6 | Stiffness of joint, not elsewhere classified |
| M53.9 | Dorsopathy, unspecified |
| M54.9 | Dorsalgia, unspecified |
| ICD-11 code | Indication |
| FA00.Z | Osteoarthritis of hip, unspecified |
| FA34 | Certain specified joint disorders |
| FA34.3 | Joint contracture |
| FB0Y | Other specified spondylopathies |
| ME84.Z | Back pain, unspecified |
| ME85 | Joint stiffness |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Plexathron can be used as a standalone treatment or as combination therapy (together with products of the same spectrum), which allows for personalized treatment and the achievement of positive clinical results.
The treatment regimen is selected individually.
Patients with hypersensitivity to the components of the Plexathron medical device must perform a skin allergy test in the form of a subcutaneous injection in the arm with the result evaluated after 1 hour.
Treatment protocol
For periarticular or intra-articular administration – 1 injection weekly for 10 consecutive weeks.
Periarticular administration technique (the injection site must be treated with an antiseptic; the needle is inserted to a depth of 6-8 mm)
It is recommended to use the following materials and equipment
- Materials for skin antisepsis: single-use gloves, iodine solution, alcohol solution, sterile gauze pads, chloroethyl spray for skin treatment;
- Needles: sterile, size 27 G;
- Syringes: volume of 5 or 10 cm3 according to the volume of the solution to be administered.
Intra-articular injection technique
It is recommended to use the following materials and equipment
- Materials for skin antisepsis: single-use gloves, iodine solution, alcohol solution, sterile gauze pads, chloroethyl spray for skin treatment. The use of a local anesthetic at the injection site is recommended;
- Needles: sterile, size 22 G;
- Syringes: volume of 2 cm3 according to the volume of the solution to be administered.
Hip joint – intra-articular injection
The trochanteric bursa is located above the lateral epicondyle of the greater trochanter of the femur. Access to the hip joint is achieved both anteriorly and laterally.
The patient is in a supine position.
The anatomical landmark is located 2 cm below the upper edge of the greater trochanter between the upper and lower edges. A mark is made on the skin and treated with an antiseptic.
A 22 G needle is inserted to a depth of 6-8 mm horizontally and perpendicular to the femoral shaft.
Instructions in case of damage to sterile vials
The vial contents are to be used directly after opening.
The device must not be used if the vial is damaged and the closure is not sealed. It must not be used if the packaging is damaged.
Side effects
No cases of hypersensitivity to the composition of Plexathron have been observed.
Local reactions mild redness at the injection site may be a consequence of mechanical action of the needle or a skin reaction; signs of burning/pain at the injection site may occur during administration, which usually resolve spontaneously within 5-10 minutes after the procedure; abscess formation at the injection site may occur due to the action of pyogenic bacteria (for prevention, the skin must be treated with an antiseptic before and after administration).
Contraindications
- Hypersensitivity to the components of the medical device.
Special instructions
During treatment, careful monitoring of patients taking anticoagulants or with diagnosed vascular fragility is necessary.
In case of hip joint pain, differential diagnosis is necessary to identify pain caused by primary and metastatic cancer, referred pain caused by neuralgia of the lumbar spine, and inguinal hernia.
Environmental protection and disposal
Appropriate precautions must be taken to prevent uncontrolled release of the product into the public sewerage system. The product and its packaging must be disposed of at a waste collection site. Used vials, syringes, and needles must be disposed of as epidemiologically hazardous waste (infected and potentially infected waste, such as materials and instruments, items contaminated with blood and/or other biological fluids). National or local legislation on safe use and disposal must be followed.
Dispensing Status
Available without a prescription.
Storage Conditions
The medical device should be stored out of the reach of children at a temperature from 2°C (35.6°F) to 30°C (86°F). Protect from sunlight. Do not freeze.
Shelf Life
Shelf life – 3 years. Do not use after the expiration date.
The product should be transported under the same conditions as the storage conditions.
The expiration date applies only to the device that is stored and transported under proper conditions in the original and intact packaging .
The warranty period corresponds to the shelf life of the device.
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical Disclaimer![Plexathron [Implant] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Plexathron [Implant] 2")