Description
MD-LUMBAR
Description
Medical device useful for improving the mobility of the joints of the lumbosacral area of the spine, whose primary therapeutic treatment consists of the following functions:
1. Barrier effect.
2. Lubricating activity.
3. Mechanical support in case of ongoing drug therapy.
The use of MD-LUMBAR by qualified healthcare personnel in private or public healthcare facilities is recommended for:
- improve lumbar mobility; - promote muscle relaxation in the lumbosacral area;
- support the lumbar muscle structures;
- relieve localized pain, pain at rest or caused by movement and postural defects.
How to use
MD-LUMBAR can be used alone or in combination with other medical devices from the same line, in order to guarantee personalized treatment based on the individual clinical picture.
In cases where supportive treatment is required for the onset of acute pain, MD-LUMBAR can be combined with MD-NEURAL, MD-POLY and MD-MUSCLE (one or more of these).
Furthermore, in cases where tissue matrix support therapy is required or a slowing down of physiological aging is necessary, MD-LUMBAR can be combined with MD-MATRIX and MD-TISSUE.
Periatric therapeutic protocol :
2 treatments for the first 2 weeks; 1 treatment until symptoms improve (on average 8-10 sessions).
Chronic conditions: continue with 1 treatment per week for one month until symptoms improve, and then with 1 treatment per month, or - as needed - every 45-50 days.
The application area must be aseptic; insert the needle close to the lumbar and lumbosacral joints to a depth of 3-4 mm.
For this use of the medical device, the use of the following materials and accessories is recommended:
• Material to ensure skin asepsis: disposable glove, iodine-based solution, alcohol solution, sterile gauze, ethyl chloride-based skin spray.
• Needles: sterile 27 G.
• Syringes: 5 or 10 cc, depending on the quantity of solution to be injected.
Components
Collagen of porcine origin.
Excipients: Hamamelis, NaCl, water for injection.
Warnings
Disposable.
No case of hypersensitivity to MD-LUMBAR has been reported.
Contains collagen of animal origin from porcine species. Patients with known hypersensitivity to the component or excipients must first undergo an injection test in the arm and be kept under observation for one hour.
Low back pain requires differential diagnosis from herniated discs, pain secondary to primary or metastatic tumors; reflected or referred pain of visceral origin.
Slight redness at the injection area may be due to the mechanical effect of the needle or a skin reaction.
The application may cause burning/pain symptoms at the injection sites, which generally resolve within 5-10 minutes after the end of treatment.
Skin cleaning/disinfection is required before and after application.
Any pyogenic bacteria may produce an abscess in the injection area.
Keep out of the reach and sight of children.
Do not use after expiration.
Use the product immediately after opening.
Do not use if seal is broken or tampered with.
After opening, the contents of the vial must be injected immediately.
Do not use if packaging is damaged.
Conservation
Store at a temperature between 2°C and 30°C, protect from sunlight and frost.
The expiry date refers to the product in its intact packaging, stored correctly.
Format
Pack of 10 sterile 2 ml vials
Cod. MD04
Medical device useful for improving the mobility of the joints of the lumbosacral area of the spine, whose primary therapeutic treatment consists of the following functions:
1. Barrier effect.
2. Lubricating activity.
3. Mechanical support in case of ongoing drug therapy.
The use of MD-LUMBAR by qualified healthcare personnel in private or public healthcare facilities is recommended for:
- improve lumbar mobility; - promote muscle relaxation in the lumbosacral area;
- support the lumbar muscle structures;
- relieve localized pain, pain at rest or caused by movement and postural defects.
How to use
MD-LUMBAR can be used alone or in combination with other medical devices from the same line, in order to guarantee personalized treatment based on the individual clinical picture.
In cases where supportive treatment is required for the onset of acute pain, MD-LUMBAR can be combined with MD-NEURAL, MD-POLY and MD-MUSCLE (one or more of these).
Furthermore, in cases where tissue matrix support therapy is required or a slowing down of physiological aging is necessary, MD-LUMBAR can be combined with MD-MATRIX and MD-TISSUE.
Periatric therapeutic protocol :
2 treatments for the first 2 weeks; 1 treatment until symptoms improve (on average 8-10 sessions).
Chronic conditions: continue with 1 treatment per week for one month until symptoms improve, and then with 1 treatment per month, or - as needed - every 45-50 days.
The application area must be aseptic; insert the needle close to the lumbar and lumbosacral joints to a depth of 3-4 mm.
For this use of the medical device, the use of the following materials and accessories is recommended:
• Material to ensure skin asepsis: disposable glove, iodine-based solution, alcohol solution, sterile gauze, ethyl chloride-based skin spray.
• Needles: sterile 27 G.
• Syringes: 5 or 10 cc, depending on the quantity of solution to be injected.
Components
Collagen of porcine origin.
Excipients: Hamamelis, NaCl, water for injection.
Warnings
Disposable.
No case of hypersensitivity to MD-LUMBAR has been reported.
Contains collagen of animal origin from porcine species. Patients with known hypersensitivity to the component or excipients must first undergo an injection test in the arm and be kept under observation for one hour.
Low back pain requires differential diagnosis from herniated discs, pain secondary to primary or metastatic tumors; reflected or referred pain of visceral origin.
Slight redness at the injection area may be due to the mechanical effect of the needle or a skin reaction.
The application may cause burning/pain symptoms at the injection sites, which generally resolve within 5-10 minutes after the end of treatment.
Skin cleaning/disinfection is required before and after application.
Any pyogenic bacteria may produce an abscess in the injection area.
Keep out of the reach and sight of children.
Do not use after expiration.
Use the product immediately after opening.
Do not use if seal is broken or tampered with.
After opening, the contents of the vial must be injected immediately.
Do not use if packaging is damaged.
Conservation
Store at a temperature between 2°C and 30°C, protect from sunlight and frost.
The expiry date refers to the product in its intact packaging, stored correctly.
Format
Pack of 10 sterile 2 ml vials
Cod. MD04
