Optison - patient leaflet, side effects, dosage

1. What OPTISON is and what it is used for

OPTISON is an ultrasound contrast agent that helps to obtain clearer pictures (scan) of the heart during an echocardiography (a procedure where an image of the heart is obtained by using ultrasound).

OPTISON improves the visualization of the inner cardiac walls in patients where the walls are difficult to see.

OPTISON contains microspheres (tiny gas bubbles) that after injection travel through the veins to the heart and fill the left heart chambers, allowing the doctor to visualise and asses the function of the heart.

This medicine 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 ingredients of OPTISON (listed

in section 6).

• – if you have severe pulmonary hypertension (systolic pulmonary artery pressure > 90 mm Hg).

Warnings and precautions

Talk to your doctor before using OPTISON

• – if you have any known allergies

• – if you have a severe heart, lung, kidney or liver disease. The experience of 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 blood clotting problem

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”.

3. How to use OPTISON

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

OPTISON is administered via an intravenous injection to allow the microspheres to enter the heart chamber and fill the left heart chamber. OPTISON is injected during the ultrasound examination in order to allow the doctor to assess the function of your heart.

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. This dose might be repeated if needed. The duration of the useful imaging time 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 solution for injection or glucose 50 mg/ml solution for injection should be injected at a rate of 1 ml/s to optimise the effect of the contrast agent.

If you are given more OPTISON than you should

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

4. Possible side effects

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

Side effects to OPTISON are rare and usually not serious. In general the administration of human albumin has been associated with transient (non lasting) altered taste, nausea, flushing, rash, headache, vomiting, chills and fever. Rare severe allergic reactions (anaphylaxis) have been associated with the administration of human albumin products. Reported side effects following the use of OPTISON:

Common side effects (affects 1 to 10 users in 100):

• Dysgeusia (altered taste)
• Headache
• Flushing (redness)
• Warm sensation
• Feeling sick (nausea)

Uncommon side effects (affects 1 to 10 users in 1,000):

• Eosinophilia (increased number of a type of white blood cells in the blood)
• Dyspnoea (difficulty in breathing)
• Chest pain

Rare side effects (affects 1 to 10 users in 10,000):

• Tinnitus (noises in the ear)
• Dizziness
• Paraesthesia (tingling sensations)
• Ventricular tachycardia (a series of rapid heartbeats)

Unknown frequency (side effects where frequency cannot be estimated from the available data):

• Allergic type symptoms, for example, a severe allergic reaction or – shock (anaphylaxis), swelling of the face (face oedema), an itchy skin eruption (urticaria).
• Visual disturbances

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OPTISON

Keep this medicine out of the sight and reach of children.

Do not use OPTISON after the expiry date which is stated on the label, after EXP.

The expiry date refers to the last day of that month.

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

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

Do not freeze.

The contents of the OPTISON vial should be used within 30 minutes after the rubber stopper has been penetrated.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What OPTISON contains

• – The active substance is perflutren-containing microspheres of heat treated human albumin 5

8 × 108/ml, suspended in human albumin solution 1%. The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg

– The other ingredients are human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide and water for injections.

What OPTISON looks like and contents of the pack

OPTISON is a dispersion for injection. It is a clear solution with white microsphere layer on top.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GE Healthcare AS

Nycoveien 1,

NO-0485 Oslo, Norway

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien GE Healthcare BVBA Kouterveldstraat 20 BE-1831 Diegem Tél/Tel: + 32 (0) 2 719 73 11 Efc^rapufl GE Healthcare Bulgaria EOOD 36, Dragan Tzankov blvd World Trade Centre Office B/405–406 1040 Sofia Tel: + 359 2 9712040 Česká republika M.G.P. spol. s r.o. Kvítková 1575 CZ-760 01 Zlín Tel.: + 420 577 212 140

Lietuva GE International Inc. Konstitucijos pr. 7 LT-09308 Vilnius Tel.: + 370 68 723 753 Luxembourg/Lu­xemburg GE Healthcare BVBA Kouterveldstraat 20 BE-1831 Diegem Belgie/Belgiqu­e/Belgien Tel/Tel: + 32 (0) 2 719 73 11 Magyarorszag GE Healthcare SCE Handels GmbH Hungary Representative Office Akron u.2. H-2040 BUDAORS Tel. + 36 23 410 412

Danmark GE Healthcare A/S Park Allé 295 DK-2605 Brondby Tlf: + 45 70 22 22 03	Malta Pharma-Cos Limited Pharma-Cos House, C. Portanier Street MT-Santa Venera SVR 1732 Tel: + 35 6 2144 1870
Deutschland GE Healthcare Buchler GmbH & Co. KG Gieselweg 1 D-38110 Braunschweig Tel: + 49 (0) 5 307 93 00	Nederland GE Healthcare B.V. De Rondom 8 NL-5612 AP, Eindhoven Tel: + 31 (0) 40 299 10 00
Eesti GE Healthcare Estonia OÜ Mustamäe tee 46 EE-10621 Tallinn Tel: + 372 6260 061	Norge GE Healthcare AS Nycoveien 1 NO-0485 Oslo Tlf: + 47 23 18 50 50
EXÀàôa GE Healthcare A.E Zœpoù 8 –10 GR-15125 MAPOYÏI A0HNA Tql: + 30 (2)10 8930600	Österreich GE Healthcare Handels GmbH Euro plaza, Gebäude E Technologiestrasse 10 A-1120 Wien Tel: + 43 1 972 72–0
España GE Healthcare Bio-Sciences, S.A.U. C/Gobelas, 35–37 E-28023 La Florida (Madrid) Tel: + 34 91 663 25 00	Polska GE Medical Systems Polska Sp. z o.o. Woloska St. 9 PL-02–583 Warsaw Tel: + 48 22 330 83 00
France GE Healthcare SAS 22/24, avenue de l’Europe F-78–140 Velizy Villacoublay Tél: + 33 1 34 49 54 54	Portugal Satis – GE Healthcare Edificio Ramazzotti Av. do Forte, No 6–6A P-2790–072 Carnaxide Tel: + 351 214251352
Hrvatska GE Healthcare d.o.o. Josipa Marohnica 1 10 000 Zagreb Tel: + 385 1 6170 280	Romania S.C. GENERAL ELECTRIC MEDICAL SYSTEMS ROMANIA S.R.L. Calea Floreasca 169 A, Floreasca Business Park, Entrance A, Floor 7 RO-014459 BUCHAREST Tel. + 40 37 2074527
Ireland GE Healthcare Limited Amersham Place Little Chalfont HP7 9NA – UK Tel: + 44 (0) 1 494 54 4000	Slovenija Biomedis M.B. trgovina d.o.o. Slokanova 12 SI-2000 Maribor Tel: + 386 2 4716300

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

This leaflet is available in all EU/EEA languages on the European Agency website.

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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 threeway 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.