OPTISON Dispersion for injection Ref.[9485] Active ingredients: Perflutren

OPTISON should only be administered by physicians experienced in the field of diagnostic ultrasound imaging.

Before administering OPTISON, please see section 6.6 for instructions for use/handling.

This medicinal product is intended for left ventricular opacification after intravenous administration. Ultrasound imaging must be performed during injection of OPTISON as optimal contrast effect is obtained immediately after administration.

Posology

The recommended dose is 0.5-3.0 ml per patient. A dose of 3.0 ml is usually sufficient, but some patients may need higher doses. The total dose should not exceed 8.7 ml per patient. The duration of the useful imaging time is 2.5-4.5 minutes for a dose of 0.5-3.0 ml. OPTISON could be repeatedly administered, however, the clinical experience is limited.

Paediatric population

The safety and efficacy of OPTISON in children and adolescents below 18 years has not been established.

Currently available data are described in section 5.1 but no recommendation on a posology can be made.

No case of overdose has been reported.

In the Phase I trial, healthy volunteers have received up to 44.0 ml of OPTISON and experienced no significant adverse events.

Shelf life

Unopened vial in the outer packaging: 2 years.

Finished product after rubber stopper perforation: 30 minutes.

Store upright in a refrigerator (2°C-8°).

Storage at room temperature (up to 25°) for 1 day is acceptable.

Do not freeze.

3 ml type I glass vial, closed with bromobutyl rubber stopper, and sealed with aluminium cap with coloured plastic flip-off top.

OPTISON is supplied as: 1 vial of 3 ml or 5 vials of 3 ml.

Not all pack sizes may be marketed.

Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the container.

Vials are intended for single use only. Once the rubber stopper has been penetrated, the contents should be used within 30 minutes and any unused product discarded.

OPTISON in the non-resuspended form has a white layer of microspheres on top of the liquid phase that requires resuspension before use. Homogenous white suspension after resuspension.

The following instructions should be followed:

Cold solutions taken directly from the refrigerator should not be injected.

• Allow the vial to reach room temperature and inspect the liquid phase for particulate matter or precipitates before resuspension.
• Insert a 20 G plastic cannula in a large antecubital vein, preferably of the right arm. Attach a three-way stopcock to the cannula.
• The OPTISON vial must be inverted and gently rotated for approximately three minutes to completely resuspend the microspheres.
• Complete resuspension is indicated by a uniformly opaque white suspension and absence of any material on stopper and vial surfaces.
• OPTISON should be withdrawn with care into a syringe within 1 minute after resuspension.
• Any pressure instability within the vial should be avoided since it may cause disruption of microspheres and loss of contrast effect. Thus, vent the vial with a sterile spike or with a sterile 18 G needle before withdrawing the suspension into the injection syringe. Do not inject air into the vial as this will damage the product.

Use the suspension within 30 minutes after withdrawal.

• OPTISON will segregate in an undisturbed syringe and must be resuspended before use.
• Resuspend the microspheres in the syringe immediately before injection by holding the syringe horizontally between the palms of the hands and rolling it quickly back and forth for no less than 10 seconds.
• Inject the suspension through the plastic cannula, no smaller than 20 G at a maximum injection rate of 1.0 ml/s. Warning: Never use any other type of route but the open flow connection. If injected otherwise OPTISON bubbles will be destroyed.
• Immediately before injection a careful visual inspection of the syringe is mandatory in order to ensure complete suspension of the microspheres.

Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection should be injected at a rate of 1 ml/s. Alternately, the flushing may be performed by infusion. The infusion set should then be attached to the three-way stopcock and intravenous infusion started at a “to keep open” (TKO) rate. Immediately after OPTISON injection, the intravenous infusion should be wide open until contrast begins to fade from the left ventricle. The infusion should then be returned to a TKO rate.