MD SHOULDER Pack of 10 Ampoules of 2ml

Intended use:

To improve shoulder- and arm-joint mobility, help muscle stretching, help to support the muscle tissue, soothe local pain and pain due to movement.

MD-SHOULDER is a medical device finalized 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

MD-SHOULDER is a medical device finalized to help shoulder joint movement. Its main therapeutic functions include:

1. a barrier effect
2. a lubricating activity
3. a mechanical support while administering other pharmacological treatments

Performance:

MD-SHOULDER may be used as a single treatment or mixed with other medical devices of the same range, in order to make a customized treatment according to clinical evolution.

When a supportive treatment is needed for acute pain, MD-SHOULDER can be associated with MD-NEURAL, MD-POLY and MD-MUSCLE (together with one or more than one of these).

Moreover, when a supportive treatment is needed for the connective tissue matrix or when the physiological aging process should be slowed down, MD-SHOULDER can be associated with MD-MATRIX and MD-TISSUE.

It may also be used as a mechanical support while treating the following diseases:

Shoulder-arm polyarthritis (in association with MD-POLY)
Rotator cuff syndrome (in association with MD-MUSCLE)
Shoulder-arm syndrome (in association with MD-NEURAL and MD-MUSCLE)
Frozen shoulder (in association with MD-MUSCLE)
Shoulder pain due to dislocation (therapeutic rest, in association with MD-NEURAL)
Epicondylitis (in association with MD-NEURAL and MD-POLY)

Direction for use:

Treatment protocol: 1-2 treatments weekly for 10 weeks.

Periarticular technique:
the site of application must be sterile; insert the needle at a 3-6 mm depth.

For this purpose the use of the following materials and accessories is recommended:

Materials for aseptic skin preparation: sterile 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 technique:

For this purpose the use of the following materials and accessories is recommended:

Materials for aseptic skin preparation: sterile gloves, Iodine solution, Alcohol solution, sterile gauze pads, Ethyl chloride spray for skin.
The application of a topical anaesthetic on the skin area to be treated is recommended.
Needles: sterile 22 G.
Syringes: 5 or 10 cc size, according to the volume of the solution to inject.

Contraindications / Side effects:

There is no history of hypersensitivity to MD-SHOULDER. However, patients with a recognized hypersensitivity to any ingredient or excipient should be tested before use, making a spot into one arm and be monitored for 1 hour.

Composition:

Collagen

Warnings and precautions:

Shoulder pain requires differential diagnosis for chronic cervical syndrome, ischemic heart disease (acute/chronic, only on the left side), gallbladder disease (only on the right side), cervical-brachial nerve pain, muscle trigger on the trapezium muscle.

A slight reddening at the site may be due to a mechanical effect of the needle or to a skin superficial reaction.
Skin cleansing/disinfection is required before and after application. Saprophytic bacteria may produce site abscesses. KEEP AWAY FROM THE REACH AND THE SIGHT OF CHILDREN.

Do not use after the expiration date. The expiration date refers to the product properly stored in an unopened package. Use the product immediately after opening the package.

Instructions in case of damage to the sterile vials / ampoules:

Do not use if the seal is open or if the vial/ampoule is not perfectly sealed.
Once open, the vial/ampoule must be immediately injected. Do not use if the package is damaged.