Osteocoll Collagen implant 100 µg/2, 0 ml, 5 pcs.

OSTEOKOLL can be used as a stand-alone treatment or as a combination therapy (together with products of the same spectrum), allowing for personalized treatment and positive clinical results.

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

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

The treatment regimen is chosen 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 the mechanical impact of the needle or a skin reaction. During injection, there may be signs of burning/pain at the injection site, which usually resolve spontaneously within 5-10 minutes after the procedure.

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

Environmental protection and recycling

Adequate precautions must be taken to prevent uncontrolled release of product into public sewer systems. The product and its packaging must be disposed of at a waste collection point.

Used vials, syringes and needles must be disposed of as epidemiologically hazardous waste (infected and potentially infectious waste, such as materials and instruments, items contaminated with blood and/or other biological fluids).

Follow national or local regulations for safe handling and disposal.

Guarantees

The warranty period corresponds to the shelf life of the product. The shelf life of the medical product is 3 years.

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

The manufacturer declines all responsibility and disclaims any warranty for patient injury or damage that may occur as a result of:

The chosen method of application and technical technique for inserting the implant in case of non-compliance with established recommendations.
Inappropriate prescribing, selection of use for a particular patient.
Use of the product after the expiration of the specified expiration date or in violation of the rules of storage and transportation.

KEEP OUT OF REACH OF CHILDREN

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

Composition

Composition in 2 ml:

– collagen: 100 mcg

– silicon [nSiO2•mH2O]: 1 μg

– sodium chloride [NaCl]: 18 mg

– water for injection [H2O]: up to a volume of 2 ml

Contraindications

During treatment, patients receiving anticoagulants or diagnosed with vascular fragility or bleeding disorders should be closely monitored.
There were no cases of hypersensitivity to the composition of OSTEOCOLL. However, patients with hypersensitivity to the components must undergo a skin allergy test in the form of a subcutaneous injection into the arm with an assessment of the result after 1 hour.

Specifications

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 µm: ≤ 1000 particles/vial

≥ 25 µm: ≤ 100 particles/vial

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

Extractable volume: ≥ 10ml (x 5 bottles)

Bacterial endotoxins: ≤ 0.5 IU/ml

Prescribing

OSTEOCOLL is a collagen-containing implant for periarticular injection, which helps increase range of motion by slowing down the degradation of cartilage tissue of the articular surfaces and restoring damage resulting from:

aging
posture disorders
concomitant chronic diseases
bruises and injuries
toxic damage to cartilage tissue

OSTEOCOLL is a medical device that helps facilitate movements of the neck, in particular the cervical spine. Has the following therapeutic functions:

Barrier effect
Lubricating effect
Mechanical support during other drug treatments.

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

Improved mobility of the cervical spine.
Increasing the elasticity of muscle tissue of the cervical spine.
Strengthening the muscle tissue of the cervical spine.
Supports muscle tissue with incorrect posture.
Relieving pain during movements in the cervical spine.

Storage conditions

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

Manufacturer

GUNA S.p.A, Italy