VUEWAY Solution for injection Ref.[108266] Active ingredients: Gadopiclenol

This medicinal product should only be administered by trained healthcare professionals with technical expertise in performing gadolinium enhanced MRI.

Posology

The recommended dose of Vueway is 0.1 mL/kg body weight (BW) (equivalent to 0.05 mmol/kg BW) to provide diagnostically adequate contrast for all indications.

The dose should be calculated based on the patient’s BW and should not exceed the recommended dose per kilogram of BW detailed in this section.

Table 1 below indicates the volume to be administered according to BW.

Table 1. Volume of Vueway to be administered per BW:

Elderly

No dose adjustment is necessary. Caution should be exercised in elderly patients (see section 4.4 and 5.2).

Renal impairment

No dose adjustment is necessary for patients with any level of renal impairment. Gadopiclenol should only be used in patients with severe renal impairment (GFR <30 mL/min/1.73 m²) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4). If it is necessary to use gadopiclenol, the dose should not exceed 0.1 mL/kg BW (equivalent to 0.05 mmol/kg BW). More than one dose should not be used during a scan. Because of the lack of information on repeated administration, gadopiclenol injections should not be repeated unless the interval between injections is at least 7 days.

Hepatic impairment

No dose adjustment is considered necessary for patients with hepatic impairment. Caution is recommended, especially in the case of perioperative liver transplantation period (see above “renal impairment”).

Paediatric population (2 years and older)

The recommended and maximum dose of Vueway is 0.1 mL/kg BW (equivalent to 0.05 mmol/kg BW) for all indications. More than one dose should not be used during a scan.

The safety and efficacy of Vueway in children less than 2 years has not yet been established. No data are available.

Method of administration

The medicinal product is for intravenous use only.

The recommended dose is administered intravenously as a bolus injection at approximatively 2 mL/sec followed by a flush of sodium chloride 9 mg/ml (0.9%), solution for injection via manual injection or power injector.

Intravenous administration of contrast agent should, if possible, be done with the patient lying down. Since experience shows that most undesirable effects occur within minutes after administration, the patient should be kept under observation during and following administration for at least half an hour (see section 4.4).

For instructions on the medicinal product before administration, see section 6.6.

Paediatric population

In children, Vueway in vials with a single use syringe of a volume adapted to the amount to be injected should be used in order to have better precision of the injected volume.

Image acquisition

Contrast-enhanced MRI can start after the injection depending on the pulse sequences used and the protocol for the examination. Optimal signal enhancement is generally observed during arterial phase and within a period of about 15 minutes after injection. Longitudinal relaxation times (T₁)-weighted sequences are particularly suitable for contrast-enhanced examinations.

The maximum daily single dose tested in humans was 0.6 mL/kg BW (equivalent to 0.3 mmol/kg BW), which corresponds to 6 times the recommended dose.

No signs of intoxication from an overdose have so far been reported.

Gadopiclenol can be removed by haemodialysis. However, there is no evidence that haemodialysis is suitable for prevention of nephrogenic systemic fibrosis (NSF).

3 years.

For vials:

Chemical and physical in-use stability has been demonstrated for 24 hours at up to 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the opening has taken place in controlled and validated aseptic conditions.

For vials:

This medicinal product does not require any special storage conditions.

For storage conditions after first opening of the medicinal product, see section 6.3.

For pre-filled syringes:

Do not freeze.

3 mL solution for injection in a 10 mL vial (glass type I) with elastomeric stopper in pack size of 1.

7.5 mL solution for injection in a 10 mL vial (glass type I) with elastomeric stopper in pack sizes of 1 or 25.

10 mL solution for injection in a 10 mL vial (glass type I) with elastomeric stopper in pack sizes of 1 or 25.

15 mL solution for injection in a 20 mL vial (glass type I) with elastomeric stopper in pack sizes of 1 or 25.

30 mL solution for injection in a 50 mL vial (glass type I) with elastomeric stopper in pack size of 1.

50 mL solution for injection in a 50 mL vial (glass type I) with elastomeric stopper in pack size of 1.

100 mL solution for injection in a 100 mL vial (glass type I) with elastomeric stopper in pack size of 1.

7.5 mL, 10 mL or 15 mL of solution for injection in a 15 mL plastic (polypropylene) pre-filled syringe, graduated every 0.5 mL, without a needle, with an elastomeric (bromobutyl) plunger stopper and capped with an elastomeric (bromobutyl) tip cap. Pack size of 1 or a multipack containing 10 (10 packs of 1) prefilled syringes.

7.5 mL, 10 mL or 15 mL of solution for injection in 15 a mL plastic (polypropylene) pre-filled syringe, graduated every 0.5 mL, with an elastomeric (bromobutyl) plunger stopper and capped with an elastomeric (bromobutyl) tip cap with administration set for manual injection (one extension line and one catheter) in pack size of 1.

7.5 mL, 10 mL or 15 mL of solution for injection in 15 mL plastic (polypropylene) pre-filled syringe, graduated every 0.5 mL, with an elastomeric (bromobutyl) plunger stopper and capped with an elastomeric (bromobutyl) tip cap with administration set for Optistar Elite injector (one extension line, one catheter and one empty 60 mL plastic syringe) in pack size of 1.

7.5 mL, 10 mL or 15 mL of solution for injection in 15 mL plastic (polypropylene) pre-filled syringe, graduated every 0.5 mL, with an elastomeric (bromobutyl) plunger stopper and capped with an elastomeric (bromobutyl) tip cap with administration set for Medrad Spectris Solaris EP injector (one extension line, one catheter and one empty 115 mL plastic syringe) in pack size of 1.

Not all pack sizes may be marketed.

Do not use if the medicinal product including packaging is opened or damaged.

The solution for injection should be inspected visually prior to use.

Solution with visible signs of deterioration (such as particles in the solution, fissures in the vial) must not be used.

Before and during the use of the product, follow the safety, hygiene and asepsis rules.

For vials:

The vial stopper should be pierced only once.

For pre-filled syringes:

Do not use the pre-filled syringe if there are any signs of leakage.

The pre-filled syringe is for single use only. Do not attempt to re-use even after cleaning or sterilizing the single use pre-filled syringe.

Screw the push rod into the syringe plunger. It is important to rotate and push the push rod an additional ½ turn so that the plunger can rotate freely.

Before using the pre-filled syringe, remove the tip cap by spinning it.

Connection is compatible with luer 6%.

All luer connections should be gently hand tightened without over tightening to ensure secure connection and to prevent damage to the device.

Before connecting to the patient, prime completely the intravenous line and check the absence of air: hold the syringe erect and push plunger forward until all of the air is evacuated and fluid either appears at the tip of the needle or the tubing is filled.

The dose volume accuracy has been checked and is conform to ISO 7886-1.

The delivered dose accuracy for 15 mL syringes, graduated every 0.5 mL, depends on the injected volume. For a volume range of 5 to 15 mL, it may vary up to ± 0.6 mL.

When used with a power injector, follow injector instructions for use.

Any unused product should be discarded at the end of the examination session.

The peel-off tracking label available on the vial or the pre-filled syringe 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.

Any unused portions and waste material derived from disposal and items which come into contact with the product when administering this product with an automatic application system should be disposed of in accordance with local requirements.