Descrizione Clinica
Medical devices - medical devices Md-lumbar italia 10fl iniet2ml
MD-LUMBAR
Description
Medical device useful for improving the mobility of the joint of the lambosacral area of the spine, whose primary therapeutic treatment consists of the following functions:
1. Barrier effect.
2. Lubricant activity.
3. Mechanical support in case of ongoing drug therapy.
It is recommended to use MD-LUMBAR by qualified health personnel, at private or public health facilities for:
- improve lumbar mobility; - promote muscle relaxation of the lombosacral area;
- support lumbar muscle structures;
- relieve localized pain, resting pain or caused by movement and postural vices.
Mode of use
MD-LUMBAR can be used alone or associated with other medical devices belonging to the same line, in order to ensure a personalized treatment according to the individual clinical framework.
In cases where acute pain is required, MD-LUMBAR may be associated with MD-NEURAL, MD-POLY and MD-MUSCLE (one or more of these).
In addition, in cases where a tissue matrix support therapy is required or a physiological aging slowdown action is required, MD-LUMBAR may be associated with MD-MATRIX and MD-TISSUE.
Therapeutic protocol:
2 treatments for the first 2 weeks; 1 treatment up to improvement of symptomatology (average 8-10 sessions).
Chronic pathologies: continue with 1 treatment per week for a month until the improvement of symptomatology, and then with 1 treatment per month, or – according to need – every 45-50 days.
The application area must be aseptic; introduce the needle in proximity to the lumbar and lombo-sacral joints to a depth of 3-4 mm.
For this use of the medical device it is recommended to use the following materials and accessories:
• Material to ensure skin axle: disposable glove, iodine based solution, alcohol solution, sterile garzes, skin spray based on ethyl chloride.
• Needles: 27 G sterile.
• Syringes: from 5 to 10 cc, according to the amount of solution to inject.
Components
Collagen of suine origin.
Excipients: Hamamelis, NaCl, injectable water.
Warnings
Disposable.
No hypersensitivity to MD-LUMBAR has been reported.
Contains collagen of animal origin of suine species. Patients with proven hypersensitivity to the component or excipients must be previously subjected to injective tests in the arm and kept under observation for an hour.
Lombalgies require differential diagnosis from disc hernias, secondary algies to primitive or metastatic tumors; reflex or reported pain of visceral origin.
A slight redness in the injection area can be due to the mechanical effect of the needle or a skin reaction.
The application may cause symptoms of burning/dollar in injection sites, which generally resolve within 5-10 minutes from the end of treatment.
Skin cleaning/disinfection is necessary before and after application.
Any pyogenic bacteria could produce abscess in the injection area.
Keep out of reach and sight of children.
Do not use after expiry.
Use the product immediately after opening.
Do not use in case of breakage or tampering of the seal.
After opening, the contents of the bottle must be injected immediately.
Do not use in case of packaging damage.
Conservation
Store at a temperature of 2°C and 30°C, protect against sunlight and frost.
The expiration date refers to the product in an integrated package, properly preserved.
Format
Pack of 10 2 ml sterile bottles
Cod. MD04
Medical device useful for improving the mobility of the joint of the lambosacral area of the spine, whose primary therapeutic treatment consists of the following functions:
1. Barrier effect.
2. Lubricant activity.
3. Mechanical support in case of ongoing drug therapy.
It is recommended to use MD-LUMBAR by qualified health personnel, at private or public health facilities for:
- improve lumbar mobility; - promote muscle relaxation of the lombosacral area;
- support lumbar muscle structures;
- relieve localized pain, resting pain or caused by movement and postural vices.
Mode of use
MD-LUMBAR can be used alone or associated with other medical devices belonging to the same line, in order to ensure a personalized treatment according to the individual clinical framework.
In cases where acute pain is required, MD-LUMBAR may be associated with MD-NEURAL, MD-POLY and MD-MUSCLE (one or more of these).
In addition, in cases where a tissue matrix support therapy is required or a physiological aging slowdown action is required, MD-LUMBAR may be associated with MD-MATRIX and MD-TISSUE.
Therapeutic protocol:
2 treatments for the first 2 weeks; 1 treatment up to improvement of symptomatology (average 8-10 sessions).
Chronic pathologies: continue with 1 treatment per week for a month until the improvement of symptomatology, and then with 1 treatment per month, or – according to need – every 45-50 days.
The application area must be aseptic; introduce the needle in proximity to the lumbar and lombo-sacral joints to a depth of 3-4 mm.
For this use of the medical device it is recommended to use the following materials and accessories:
• Material to ensure skin axle: disposable glove, iodine based solution, alcohol solution, sterile garzes, skin spray based on ethyl chloride.
• Needles: 27 G sterile.
• Syringes: from 5 to 10 cc, according to the amount of solution to inject.
Components
Collagen of suine origin.
Excipients: Hamamelis, NaCl, injectable water.
Warnings
Disposable.
No hypersensitivity to MD-LUMBAR has been reported.
Contains collagen of animal origin of suine species. Patients with proven hypersensitivity to the component or excipients must be previously subjected to injective tests in the arm and kept under observation for an hour.
Lombalgies require differential diagnosis from disc hernias, secondary algies to primitive or metastatic tumors; reflex or reported pain of visceral origin.
A slight redness in the injection area can be due to the mechanical effect of the needle or a skin reaction.
The application may cause symptoms of burning/dollar in injection sites, which generally resolve within 5-10 minutes from the end of treatment.
Skin cleaning/disinfection is necessary before and after application.
Any pyogenic bacteria could produce abscess in the injection area.
Keep out of reach and sight of children.
Do not use after expiry.
Use the product immediately after opening.
Do not use in case of breakage or tampering of the seal.
After opening, the contents of the bottle must be injected immediately.
Do not use in case of packaging damage.
Conservation
Store at a temperature of 2°C and 30°C, protect against sunlight and frost.
The expiration date refers to the product in an integrated package, properly preserved.
Format
Pack of 10 2 ml sterile bottles
Cod. MD04
