OPTISON 0.19 MG / ML DISPERSION FOR INJECTION - patient leaflet, side effects, dosage

What is in this leaflet

Your heart activity and rhythm will be monitored when you get OPTISON.

Children and adolescents

Efficacy and safety in patients below 18 years has not been established.

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes.

It is strongly recommended that every time you receive a dose of OPTISON the name and batch number of the product are recorded in order to maintain a record of the batches used.

Other medicines and OPTISON

Tell your doctor if you are taking or have recently taken any other medicines.

Pregnancy and breast-feeding

The safety of OPTISON for use during human pregnancy has not been fully established. Therefore, the medicine should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the doctor. However, because OPTISON is based on human albumin (the main protein in our blood), it is highly unlikely that it will have any harmful effects in pregnancy.

It is not known whether OPTISON passes into human milk. Therefore, caution should be exercised when OPTISON is administered to nursing women.

Driving and using machines

No effects are known.

OPTISON contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.

If you are given more OPTISON than you should

Effects suspected to be due to overdose have not been reported.

United Kingdom

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GE Healthcare

O ptison™

(0.19 mg/ml ]

Perflutren-containing microspheres

The following information is intended for healthcare professionals only:

The recommended dose is 0.5 ml – 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.

Use the smallest dose for adequate opacification of cavities since larger doses produce image blocking effects with the possibility of obscuring important information.

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 the 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 resuspension 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.

Alternatively 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.

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