Osteocoll Collagen implant for periarticular injection 100 µg/2.0ml vial, 5pcs

Composition

Composition in 2 ml:

– collagen: 100 mcg

-Silicon [_{nSiO2 * mH2O}]: 1 mcg

-Sodium chloride [NaCl]: 18 mg

-Water for injection [H2o]: up to a volume of 2 ml

Characteristics

Appearance: pure colorless solution.

Implant density: 1.003-1.009 g / ml

Implant viscosity: 1.50-2.30 MPa * s

Implant pH: 5.2-7.0

Implant osmolality: 285-315 mOsm / kg

Mechanical impurities:

≥ 10 microns: ≤ 1000 particles / vial

≥ 25 microns: ≤ 100 particles / vial

Weight of the implant in the bottle: 2.06-2.18 g

Recoverable volume: ≥ 10 ml (x 5 vials)

Bacterial endotoxins: ≤ 0.5 IU / ml

Contraindications

During treatment, patients taking anticoagulants should be carefully monitored, either with a diagnosed vascular fragility or with a blood clotting disorder. There were no cases of hypersensitivity to the composition of OSTEOCOLL. However, patients with hypersensitivity to the components should perform a skin-allergic test in the form of a subcutaneous injection into the arm with an assessment of the result in 1 hour.

How to take, course of use and dosage

Treatment protocol:

1-2 injections weekly for 10 consecutive weeks.

Technique of periarticular injection (the injection site must be treated with an antiseptic; the needle is inserted to a depth of 2-4 mm).

We recommend using the following materials and equipment:

• Materials for antiseptic skin treatment: disposable gloves, iodine solution, alcohol solution, sterile gauze wipes, chloroethyl spray for skin treatment.
• Needles: sterile size 27G.
• Syringes: 5 or 10 cm3 in volume according to the volume of the injected solution.

Description

OSTEOCOLL is a collagen-containing implant for periarticular insertion, which helps to increase the volume of movement by slowing down the processes of degradation of the cartilage tissue of the articular surfaces and restoring damage caused as a result:

• aging
• postural disorders
• concomitant chronic diseases
• bruises and injuries
• toxic lesions of cartilage tissue

An OSTEOCOLL is a medical device that helps to facilitate the movement of the neck, in particular the cervical spine. It has the following therapeutic functions: :

The OSTEOCOLL medical device is intended for use by qualified personnel in private or public medical institutions for the following purposes: :

• Improving the mobility of the cervical spine.
• Increase the elasticity of the muscle tissue of the cervical spine.
• Strengthening the muscle tissue of the cervical spine.
• Support of muscle tissue in case of incorrect posture.
• Relieves pain during movements in the cervical spine.

Description

OSTEOCOLL can be used as an independent treatment or as a combination therapy (together with products of the same spectrum), which allows you to choose a personalized treatment and achieve positive clinical results.

The product can also be used as a mechanical support in the treatment of the following diseases:

* Neck pain due to degenerative diseases of the cartilage tissue of the cervical spine (cervical osteoarthritis). * Neck pain due to trigger points in the neck muscles. * Neck stiffness syndrome. * Common neck pain. * Whiplash injury. * Postural pain in the neck. * Mechanical imbalance. * Damage to the ligaments of the cervical spine. * Pain in the spinal nerve roots.

The treatment regimen is selected individually.

Special instructions

Warnings and precautions

Pain in the cervical spine requires differential diagnosis of cervical discopathy, primary or secondary cancer pain, and spondylolisthesis.

Slight redness at the injection site may be due to mechanical action of the needle or a skin reaction. When administered, there may be signs of burning/pain at the injection site, which usually disappear spontaneously within 5-10 minutes after the procedure.

Before and after use, the skin should be treated with an antiseptic. Pyogenic bacteria can cause an abscess to form at the injection site.

Environmental protection and disposal

Appropriate precautions must be taken to prevent the product from entering the public sewer system in an uncontrolled manner. Dispose of the product and its packaging at the waste collection point.

Used vials, syringes and needles should be disposed of as epidemiologically hazardous waste (infected and potentially infected waste, such as: materials and tools, objects contaminated with blood and/or other body fluids).

Follow national or local legislation on safe use and disposal.

Guarantees

The warranty period corresponds to the product’s expiration date. The shelf life of a medical device is 3 years.

The manufacturer guarantees the quality of products and compliance with the declared technical specifications during the entire shelf life, subject to the conditions of use, transportation and storage. The manufacturer or its authorized representative provides information and recommendations regarding risks, as well as prescriptions, methods and techniques for using the product.

The manufacturer disclaims all liability and disclaims warranty obligations in connection with patient injuries or damage that may occur as a result of:

KEEP OUT OF REACH OF CHILDREN

Do not use after the expiration date. The expiration date applies only to the product that is stored and transported under proper conditions in its original and undamaged packaging. Use the product immediately after opening the bottle.

Form of production

This medical device is available in the following packages: :

• Package: 5 vials (each bottle’s recoverable volume is 2 ml)

• Package: 10 vials (each bottle’s recoverable volume is 2 ml)

It contains vials, the final sterilization of which is carried out by steam.

Storage conditions

Avoid exposure to sunlight. Do not freeze it. Storage conditions: from 2 to 30°C, the product should be transported under the same conditions as the storage conditions.

Active ingredient

Collagen

Dosage form

implant