Gadobutrol

Instructions for use: This medicinal product is a clear, colourless to pale yellow solution.​​​‍​​‍​​​​‍​​‍‍ It should be visually inspected before use. Gadobutrol should not be used in case of severe discolouration, the occurrence of particulate matter or a defective container. Presentations for single-dose use only: 2 ml, 7.5 ml and 15 ml vials Presentations for single or multi-dose use: 30 ml vials and 65 ml bottles. For multi-dose use, gadobutrol must be administered in conjunction with an automatic injector which has been approved for multi-patient use. Handling of the contrast medium should be performed using aseptic technique. The rubber stopper should never be pierced more than once. Gadobutrol should only be drawn up into the syringe or the automatic injector immediately before use. The date and time of piercing of the stopper should be noted on the vial/bottle label in the space provided. The automatic injector used must have been approved for single or multi-patient use. The device manufacturer must demonstrate the suitability of the automatic injector and its disposable components for the intended use. Any additional instructions from the respective equipment manufacturer must also be strictly adhered to. The peel-off tracking label(s) on the vials/bottles should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record. For multi-dose use, the single use disposable components must be replaced between each patient. Contrast medium not used in one examination (single-dose use), or not used in a single, continuous 24-hour period after opening (multi-dose use) must be discarded (see Section 6.3). Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements.