PREFIJECT-M

Organization name

Rompharm Company SRL

SRN

RO-MF-000002517

Manufacturer status

Active

11 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW999

  Contraindications: is contraindicated in patients with: •known allergy (hypersensitivity) to sodium hyaluronate, chondroitin sulfate, N-acetylglucosamine or to any components of PREFIJECT-M • pre-existing infections or skin diseases in the area of the intended injection site • known infection of the index joint • known systemic bleeding disorders, bleeding or tendency to bleeding PREFIJECT-M may contain trace amounts of gram-positive bacterial proteins and is contraindicated for patients with a history of such allergies. PREFIJECT-M should not be used in patients with known allergy to derived bovine material. PREFIJECT-M should not be used in patients with known allergy to material derived from shrimps, crabs or seafoods.
• CW999

  PREFIJECT-M should be administered in the synovial knee joint space only by medical professionals trained in intra-articular administration technique.
• CW999

  Due to limited information, caution is advised regarding the PREFIJECT-M administration in patients taking anticoagulants or antiplatelet agents.
• CW999

  Exacerbation of asthma symptoms after initiation of glucosamine supplements have been described (symptoms resolved after withdrawal of glucosamine), therefore, asthmatic patients should be aware of potential worsening of symptoms.
• CW999

  The product is administered only if the solution is clear.
• CW999

  After opening, the contents of the syringe should be used immediately.

Primary placement in EL; available across 1 country total.

Trade name

not provided

UDI-DI code

05944728007086

Basic UDI-DI

B-05944728007086

Reference / catalog number

PREFIJECT-M

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

PREFIJECT-M is a bio-matrix in the form of a sterile, viscoelastic solution consisting of two highly purified cross-linked biopolymers, sodium hyaluronate and chondroitin sodium sulfate, and N-acetylglucosamine (NAG), a naturally amino sugar. PREFIJECT-M contains sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain, chondroitin sodium sulfate sourced from bovine cartilage, and NAG sourced from chitin, a naturally long-chain polymer of N-acetylglucosamine. PREFIJECT-M is a sterile viscoelastic solution processed by aseptic technique and supplied in a disposable glass syringe delivering 2.25 mL of solution.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2.25 MU03

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES