Description
Description
A medical device useful for improving the mobility of the articularity of the lumbosacral spine area, the primary therapeutic treatment of which consists of the following functions:
1. Barrier effect.
2. Lubricating activity.
3. Mechanical support in case of ongoing drug therapy.
It is recommended that MD-LUMBAR be used by qualified health care professionals, at Private or Public Health Facilities for:
– improve lumbar mobility; – promote muscle relaxation in the lumbosacral area;
– Support lumbar muscle structures;
– Relieve localized pain, pain at rest or caused by movement and postural vices.
Mode of use.
MD-LUMBAR can be used alone or combined with other medical devices belonging to the same line in order to ensure personalized treatment according to the individual clinical picture.
In cases where supportive treatment is required when acute pain occurs, MD-LUMBAR can be combined with MD-NEURAL, MD-POLY and MD-MUSCLE (one or more of these).
In addition, in cases where tissue matrix support therapy is required or physiological aging slowing is needed, MD-LUMBAR can be combined with MD-MATRIX and MD-TISSUE.
Therapeutic protocol by periatricular route:
2 treatments for the first 2 weeks; 1 treatment until symptoms improve (average 8-10 sessions).
Chronic conditions: continue with 1 treatment per week for 1 month until symptoms improve, and thereafter with 1 treatment per month, or-as needed-every 45-50 days.
The area of application should be aseptic; introduce the needle near the lumbar and lumbosacral joints to a depth of 3-4 mm.
The following materials and accessories are recommended for this use of the medical device:
– Material to ensure skin asepsis: disposable glove, iodine solution, alcohol solution, sterile gauze, ethyl chloride skin spray.
– Needles: sterile 27 G needles.
– Syringes: 5 or 10 cc, depending on the amount of solution to be injected.
Components
Collagen of porcine origin.
Excipients: Witch hazel, NaCl, water for injection.
Warnings
Disposable.
No cases of hypersensitivity to MD-LUMBAR have been reported.
Contains collagen of animal origin from porcine species. Patients with established hypersensitivity to the component or excipients should be previously tested for injection into the arm and kept under observation for one hour.
Low back pain requires differential diagnosis from herniated discs, algias secondary to primary or metastatic tumors; reflex or referred pain of visceral origin.
Slight redness in the injection area may be due to the mechanical effect of the needle or a skin reaction.
Application may cause symptoms of burning/pain at injection sites, which generally resolve within 5-10 minutes after treatment is completed.
Skin cleansing/disinfection is required before and after application.
Any pyogenic bacteria could produce abscess in the injection area.
Keep out of the reach and sight of children.
Do not use after the expiration date.
Use the product immediately after opening.
Do not use if the seal is broken or tampered with.
After opening, the contents of the vial should be injected immediately.
Do not use in case of damage to packaging.
Conservation
Store at a temperature of 2°C to 30°C, protect from sunlight and frost.
Expiration date refers to the product in unopened package, properly stored.
Format
Pack of 10 sterile 2-mL vials
Code. MD04
