OPTISON SUSPENSION FOR INJECTION

Introduction

Package Leaflet: Information for the Patient

OPTISON 0.19 mg/ml injectable dispersion

Microspheres containing perflutren

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor.
• If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What OPTISON is and what it is used for
2. What you need to know before you use OPTISON
3. How to use OPTISON
4. Possible side effects
5. Storage of OPTISON
6. Contents of the pack and other information

1. What OPTISON is and what it is used for

OPTISON is an ultrasound contrast agent that helps to obtain clearer images of the heart during an echocardiogram (a procedure that uses ultrasound to obtain images of the heart). OPTISON improves the visualization of the inner walls of the heart in patients whose walls are difficult to see.

OPTISON contains microspheres (small gas bubbles) that, after injection, travel through the veins to the heart and fill the left heart chambers, allowing the doctor to visualize and assess cardiac function.

This medicinal product is for diagnostic use only.

2. What you need to know before you use OPTISON

Do not use OPTISON

• if you are allergic (hypersensitive) to perflutren or any of the other components of this medicinal product (listed in section 6).
• if you have severe pulmonary hypertension (pulmonary artery systolic pressure > 90 mm Hg).

Warnings and precautions

Talk to your doctor before you start using OPTISON

• if you have any known allergy.
• if you have severe heart, lung, kidney, or liver disease. Experience with OPTISON in severely ill patients is limited.

• if you have an artificial valve in your heart.
• if you have acute severe inflammation or sepsis.
• if you have a known coagulation problem.

When you are given OPTISON, your heart activity and rhythm will be monitored.

Children and adolescents

The efficacy and safety of OPTISON have not been established in patients under 18 years of age.

When medicinal products are prepared from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients. These include careful selection of blood and plasma donors to ensure that those who may be at risk of carrying infections are excluded, as well as testing of each donation and plasma pool for signs of virus/infection. The manufacturers of these products also include steps in the processing of blood or plasma that can inactivate or eliminate viruses. Despite these measures, when medicinal products derived from human blood or plasma are administered, the possibility of transmitting infections cannot be totally excluded. This also applies to any unknown or emerging virus or other type of infection.

There are no reports of viral infections with albumin manufactured in accordance with the specifications of the European Pharmacopoeia and according to established procedures.

It is highly recommended that each time you receive a dose of OPTISON, the product name and batch number should be recorded in order to maintain a record of the batches used.

Using OPTISON with other medicines

Tell your doctor if you are using or have recently used any other medicines.

Pregnancy and breast-feeding

The safety of OPTISON during pregnancy is not fully established. Therefore, this product should not be used during pregnancy unless the benefit outweighs the risk and your doctor considers it necessary. However, as OPTISON contains human albumin (the main protein found in our blood), it is unlikely to have any harmful effects on pregnancy.

It is not known whether OPTISON is excreted in breast milk. Therefore, precautions should be taken when administering OPTISON to breast-feeding women.

Driving and using machines

No effects are known.

OPTISON containsless than 23 mg (1 mmol) of sodium per dose, and is therefore considered essentially "sodium-free".

3. How to use OPTISON

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

OPTISON is administered by intravenous injection to allow the microspheres to enter the heart chambers and fill the left heart chamber. OPTISON is injected during the ultrasound examination to allow the doctor to assess your heart function.

The recommended dose is 0.5 ml to 3.0 ml per patient. Generally, a dose of 3.0 ml is sufficient, but some patients may require higher doses. This dose may be repeated if necessary. The duration of useful image is 2.5-4.5 minutes for a dose of 0.5-3.0 ml.

Immediately after injection of OPTISON, 10 ml of sodium chloride 9 mg/ml injectable solution or glucose 50 mg/ml injectable solution should be injected at a speed of 1 ml/s to optimize the effect of the contrast agent.

If you use more OPTISON than you should

No adverse effects that are suspected to be due to overdose have been reported.

4. Possible side effects

Like all medicines, OPTISON can cause side effects, although not everybody gets them.

The side effects reported with OPTISON are rare and generally not serious. In general, the administration of human albumin has been associated with transient (non-lasting) alterations of taste, nausea, flushing, rash, headache, vomiting, chills, and fever. The administration of products containing human albumin has been associated with the occurrence of rare severe allergic reactions (anaphylaxis). The side effects reported after the use of OPTISON are:

Common side effects (affect 1 to 10 patients in 100):

• Dysgeusia (altered taste)
• Headache
• Flushing (redness)
• Feeling of heat
• Feeling of dizziness (nausea)

Uncommon side effects (affect 1 to 10 patients in 1,000):

• Eosinophilia (increased number of a type of white blood cell)

• Dyspnea (difficulty breathing)
• Chest pain

Rare side effects (affect 1 to 10 patients in 10,000):

• Tinnitus (ringing in the ear)
• Dizziness
• Paresthesia (tingling sensation)
• Ventricular tachycardia (series of rapid heartbeats)

Frequency not known (side effects for which the frequency cannot be estimated from the available data):

• Allergic-type symptoms, for example, severe allergic reaction or shock (anaphylaxis), facial swelling (facial edema), itchy skin rash (urticaria).

• Visual disturbances

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of OPTISON

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton after EXP.

The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C) in an upright position.

It is acceptable to store at room temperature (up to 25°C) for one day.

Do not freeze.

The contents of the OPTISON vial should be used within 30 minutes of piercing the rubber stopper.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of OPTISON

• The active ingredient is heat-treated human albumin microspheres, which contain perflutrén 5-8 x 10^8/ml, suspended in a 1% human albumin solution. The approximate amount of perflutrén gas is 0.19 mg per ml of OPTISON.

• The other components are human albumin, sodium chloride, N-acetyltryptophan, capric acid, sodium hydroxide, and water for injectable preparations.

Product Appearance and Container Contents

OPTISON is an injectable dispersion. It is a clear solution with a layer of white microspheres at the top.

The product is presented as 1 vial of 3 ml and 5 vials of 3 ml.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

GE Healthcare AS

Nycoveien 1,

NO-0485 Oslo, Norway

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

This leaflet can be found in all EU/EEA languages on the European Medicines Agency website.

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This information is intended for healthcare professionals only:

The recommended dose is 0.5 ml to 3.0 ml per patient. Generally, a dose of 3.0 ml is sufficient, but some patients may require higher doses. The total dose should not exceed 8.7 ml per patient. The duration of useful image is 2.5-4.5 minutes for a dose of 0.5-3.0 ml. OPTISON can be administered repeatedly; however, clinical experience is limited.

The smallest dose should be used for adequate opacification of the cavities, as higher doses may produce blocking effects on the image that can hide important information.

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

The vials are for single use. Once the rubber stopper is pierced, the contents should be used within 30 minutes and any unused product should be discarded.

After standing, OPTISON presents a white layer of microspheres at the top of the liquid phase, which requires resuspension before use. Homogeneous 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 particles or precipitates before shaking for resuspension.

• Insert a 20 G plastic cannula into the antecubital vein, preferably in the right arm. Connect a 3-way valve to the cannula.

• Invert and gently rotate the OPTISON vial for approximately three minutes to achieve complete resuspension of the microspheres.

• Complete resuspension is achieved when a uniform opaque white suspension is obtained and there is no material in the stopper or on the surface of the vial.

• Within one minute of resuspension, carefully draw up OPTISON with a syringe.

• Avoid exerting any pressure within the vial, as this may cause destruction of the microspheres and loss of contrast effect. Therefore, place a sterile 18 G or similar needle to allow air to enter the vial as the suspension is withdrawn with the syringe. Do not inject air into the vial, as this will damage the product.

• Use the suspension within 30 minutes of filling the syringe.

• Phase separation will occur if OPTISON is left standing in a syringe and should be resuspended before use.

• Resuspend the microspheres in the syringe immediately before injection, holding it horizontally between the palms of the hands and rapidly rotating it back and forth for at least 10 seconds.

• Inject the suspension through a 20 G or larger plastic cannula at a maximum rate of 1 ml/s.

Warning: Never use any other type of connection than an open flow connection. If injected otherwise, the OPTISON bubbles will be destroyed.

• Immediately before injection, carefully inspect the syringe to ensure complete suspension of the microspheres.

Immediately after injection of OPTISON, inject 10 ml of sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution at a rate of 1 ml/s.

Alternatively, the flush may be performed by infusion. The infusion equipment should be connected to the 3-way valve and the intravenous infusion started at a rate to "keep open" (TKO). Immediately after injecting OPTISON, fully open the intravenous infusion until the contrast starts to disappear from the left ventricle. Then, reduce the infusion rate to TKO.