Introx 2% (1 prefilled syringe)

Organization name

GRUPPO FARMAIMPRESA SRL

SRN

IT-MF-000012625

Manufacturer status

Active

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• CW999

  Introx 2% is suitable only for intra-articular injections and must only be dispensed by a doctor who has received specific training on the intra-articular injection technique. Before use, check the integrity of the syringe and the expiration date. Do not use needles other than those listed. The product should not be injected in the presence of a infected or severely inflamed joint. The infiltration must be avoided in the case of infections in place or inflammatory conditions of the skin in proximity of the injection. As no clinical experience is available for the use of Hyaluronan in children, treatment with Introx 2% is not recommended in these cases. After the intra-articular injection it is advisable to recommend to the patient to avoid physical activities demanding stress for the articulation and resume normal activities after a few days. Introx 2% is a disposable product, the quality and sterility are guaranteed only if the syringe is sealed. Any residue must be discarded and not reused even after new sterilisation. Do not use the product if the package is already opened or damaged. The assembled syringe must be discarded immediately after use, regardless of whether or not the solution has been completely administered. After use, dispose according to applicable national practice. Do not reuse: reuse of the product may result in serious infections. In case of a serious accident occurring in relation to the medical device report the incident to the Manufacturer and the Competent Authority. Pregnancy and Lactation: There are not adequate data on the use of the product in pregnant women and during lactation, so it should not be used unless a real need and after evaluation by the doctor. Do not use in case of patients with severe liver disease.

Primary placement in Italy; available across 1 country total.

Trade name

Introx 2% (1 prefilled syringe)

UDI-DI code

08055748843671

Basic UDI-DI

805574884FTMDR74YE

Reference / catalog number

FT.MDR.74

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Introx 2% is a sterile, biodegradable, isotonic, injectable gel, for intra-articular use. Introx 2% consists of medium chain (1.0-1.5 x 10^6 Dalton) hyaluronic acid, obtained from Streptococcus equi bacteria, formulated to a concentration of 20 mg/ml in a physiologic buffer.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• A02010799PREFILLED SYRINGES - OTHER