Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
For contrast enhancement in direct magnetic resonance arthrography.
This medicinal product is for diagnostic use by intraarticular administration only.
Magnevist 2 mmol/l should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI) and when another authorised product cannot be used.
The usual precautions for MRI (e.g. exclusion of cardiac pacemakers and other ferro-magnetic objects including vascular clips etc) must be observed.
The recommendations for the use of Magnevist 2 mmol/l apply to a field strength between 0.2 Tesla and 1.5 Tesla.
Intraarticular administrations of contrast agents are to be given with the patient lying or sitting. After the end of the injection, the patient should be kept under supervision for at least half an hour.
The lowest dose that provides sufficient enhancement for diagnostic purposes should be used.
In general, for all joints the administration of up to 20 ml (knee joint up to 50 ml) Magnevist 2 mmol/l is sufficient for good opacification and to answer all the relevant clinical questions. A volume leading to a slight distension of the joint capsule should be injected. Only so much contrast medium should be injected until discrete resistance is felt and/or the patient experiences a mild feeling of pressure.
Guidelines on volumes to be administered:
| Joint | Volume required |
|---|---|
| Shoulder | 15-20 ml |
| Elbow | ~10 ml |
| Wrist | 4 ml |
| Finger joint | 1-2 ml |
| Hip | 10-20 ml |
| Knee | 25-50 ml |
| Ankle | 12-20 ml |
The safety and efficacy of Magnevist 2 mmol/l in children aged up to 18 years has not yet been established. No data are available. Magnevist 2 mmol/l is not recommended in the paediatric age group until further data become available.
The dose required is administered via intraarticular injection under strict aseptic technique and according to the instructions provided in section 6.6. Contrast-enhanced MRI can be commenced immediately afterwards.
No signs of intoxication secondary to an overdose have so far been observed or reported on clinical use.
Shelf life: 3 years.
None.
Colourless Type I, glass pre-filled syringe with chlorinated butyl rubber stopper and combined luer lock adapter, tip cap (chlorobutyl rubber), safety cap.
Pack size: syringe containing 20 ml of Magnevist solution; individual syringe is blister packaged, with one syringe per carton.
The prefilled syringe must be taken from the pack and prepared for the injection immediately before the examination and injected under sterile conditions.
The tip cap should be removed from the prefilled syringe immediately before use.
Any contrast medium solution not used in one examination must be discarded.
Mixture of Magnevist 2 mmol/l with X-ray contrast media before injection is not recommended as it may reduce efficacy. The minimal amount of X-ray contrast medium required for control of the needle position in the joint may be separately injected prior to the administration of Magnevist 2 mmol/l (0.5 ml to a maximum of 1.0 ml).
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