MD-LUMBAR

MD-LUMBAR is an injectable class III medical device:
- Treatment can be combined with other therapies.
- It improves the movement of the lumbosacral spine joint and reduces the associated pain.
- It counteracts physiological or pathological deterioration of the joints and tissues involved.
- It can be combined with other treatments.

- GUNA S.P.A.
- NAME: MD-LUMBAR
- COMPOSITION: Collagen of porcine origin, Hamamelis virginiana, Sodium chloride, Water for injection.
- PRESENTATION: 10 x 2ml.
- INDICATIONS: Reduces pain in the lumbosacral segment of the spine.
- INJECTION DEPTH:
Peri-articular: 26G x 16 mm needle.
Note: Carry out thorough skin disinfection with iodopovidone or chlorhexidine.
Peri-articular route: introduce the needle near the lumbar, lumbo-sacral and sacro-iliac joints to a depth of 10-12 mm.
Intra-muscularly: introduce the needle into the trigger points at a depth of 10-12 mm.
- PROTOCOL: Peri-articular administration: 1 treatment per week: injection
subcutaneously into the trigger points and/or peri-articular area of one (2 ml) or two vials (4 ml) per treatment. Results are already evident from the third week but, depending on the patient's clinical situation, treatment can be continued up to the tenth week without risk.
- USE: Strict medical use.

- Vials: 10 x 2ml.

Lumbosacral area.

Collagen of porcine origin, Hamamelis virginiana, Sodium chloride, Water for injection.

- The product should only be injected by trained operators, in a suitable environment, using aseptic technique.
- Injection test in patients with suspected hypersensitivity: if there is a history of allergic reactions, a preliminary intradermal/injective test and observation of the patient for at least 1 hour is recommended.
- Avoid immediate exercise/prolonged mobilisation of the treated area unless indicated.
- Do not extend treatment beyond 10 weeks unless clinically assessed; follow protocols indicated by the manufacturer.
- Do not use after the expiry date; use immediately after opening; do not use if the bottle is damaged.

MD-LUMBAR is contraindicated in the following cases:
- Known hypersensitivity to components (e.g. collagen of porcine origin or other excipients).
- Septic processes or active local/articular infections: do not inject into infected areas or in the presence of an ongoing joint infection.

Clinical evidence shows the effectiveness and safety of MD-LUMBAR in improving movement and reducing lower back pain due to various causes and origins, such as:
- Lumbar instability from degenerative spondylolisthesis, lumbar spondylosis, herniated discs in the lumbar vertebrae, and non-specific low back pain, such as prolonged bed rest or poor walking.
- Chronic lumbosciatica:
- from ageing phenomena
- from postural defects
- by concomitant chronic diseases
- from trauma and injuries.
- Facet joint syndrome.