Patient Information Leaflet: Product Information

OPTISON 0.19 mg/ml Injectable Suspension

Microspheres containing perflutren

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

Table of Contents

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

OPTISON is a contrast agent for ultrasound that helps obtain clearer images of the heart during an echocardiogram (a procedure that uses ultrasound to obtain images of the heart). OPTISON improves visualization of the internal 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 cavities, allowing the doctor to visualize and evaluate heart function.

This medication is solely for diagnostic use.

No use OPTISON

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

Warnings and Precautions

Consult your doctor before starting to use OPTISON

• If you have any known allergy.
• If you have severe heart, lung, kidney, or liver disease. The experience with OPTISON in severely ill patients is limited.
• If you have an artificial heart valve.
• If you have a severe acute inflammation or sepsis.
• If you have a known coagulation disorder.

When OPTISON is administered to you, your heart activity and rhythm will be monitored.

Children and Adolescents

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

When medications are prepared from human blood or plasma, certain measures are applied to prevent the transmission of infections to patients. Among others, a careful selection of blood and plasma donors is made to ensure that those who pose a risk of carrying infections are excluded, as well as analysis of each donation and plasma mixture to detect signs of viruses/infections. The manufacturers of these products also include stages in the processing of blood or plasma that can inactivate or eliminate viruses. Despite these measures, when medications derived from human blood or plasma are administered, the possibility of transmission of infections cannot be entirely ruled out. This also affects any unknown or emerging virus or any other type of infection.

No reports of viral infections have been reported with albumin manufactured in accordance with the specifications of the European Pharmacopoeia and in accordance with the established procedures.

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

Use of OPTISON with Other Medications

Inform your doctor if you are using or have recently used any other medication.

Pregnancy and Breastfeeding

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

The elimination of OPTISON in breast milk is unknown. Therefore, precautions should be taken when OPTISON is administered to women during lactation.

Driving and Operating Machines

No effects are known.

OPTISON containsless than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

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

OPTISON is administered via intravenous injection to allow microspheres to enter cardiac chambers and fill the left ventricle of the heart. OPTISON is injected during the ultrasound examination to allow the physician to evaluate the function of the heart.

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 as necessary. The duration of the useful image is 2.5-4.5 minutes for a dose of 0.5-3.0 ml.

Immediatelyafter the injection of OPTISON, 10 ml of 9 mg/ml sodium chloride injection or 50 mg/ml glucose injection should be injected at a rate of 1 ml/s to optimize the effect of the contrast medium.

If you use more OPTISON than you should

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

Like all medications, OPTISON may cause adverse effects, although not everyone will experience them.

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

Frequent Adverse Effects (affect between 1 and 10 patients per 100):

Infrequent Adverse Effects (affect between 1 and 10 patients per 1,000):

Rare Adverse Effects (affect between 1 and 10 patients per 10,000):

Unknown Frequency (adverse effects in which the frequency cannot be estimated from available data):

Reporting Adverse Effects

If you experience any, consult your doctor, even if they do not appear in this prospectus. You can also report them directly through the national notification system.. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C) in 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 must be used within 30 minutes following the puncture of the rubber stopper.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of OPTISON

• The active principle is heat-treated human albumin microspheres containing perflutren 5-8 x 108/ml, suspended in a 1% human albumin solution. The approximate amount of perflutren gas is 0.19 mg per ml of OPTISON.
• The other components are human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide, and water for injection.

Appearance of the product and contents of the container

OPTISON is an injectable dispersion. It is a transparent solution with a white microsphere layer at the top.

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

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

GE Healthcare AS

Nycoveien 1,

NO-0485 Oslo, Norway

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Belgium/Belgique/Belgien

GE Healthcare BVBA

Kouterveldstraat 20

BE-1831 Diegem

Tel: + 32 (0) 2 719 73 11

????????

GE Healthcare Bulgaria EOOD

36, Dragan Tzankov blvd

World Trade Centre

Office B/405-406

1040 Sofia

Tel: + 359 2 9712040

Lithuania

GE International Inc.

Konstitucijos pr. 7

LT-09308 Vilnius

Tel.: + 370 68 723 753

Luxembourg/Luxemburg

GE Healthcare BVBA

Kouterveldstraat 20

BE-1831 Diegem

Belgium/Belgique/Belgien

Tel: + 32 (0) 2 719 73 11

Czech Republic

M.G.P. spol. s r.o.

Kvítková 1575

CZ-760 01 Zlín

Tel.: + 420 577 212 140

Hungary

GE Healthcare SCE Handels GmbH

Hungary Representative Office

Akron u.2.

H-2040 BUDAÖRS

Tel. + 36 23 410 412

Denmark

GE Healthcare A/S

Park Allé 295

DK-2605 Brøndby

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

Germany

GE Healthcare Buchler GmbH & Co. KG

Gieselweg 1

D-38110 Braunschweig

Tel: + 49 (0) 53 07 93 00

Netherlands

GE Healthcare B.V.

De Rondom 8

NL-5612 AP, Eindhoven

Tel: + 31 (0) 40 299 10 00

Estonia

GE Healthcare Estonia OÜ

Mustamäe tee 46

EE-10621 Tallinn

Tel: + 372 6260 061

Norway

GE Healthcare AS

Nycoveien 1

NO-0485 Oslo

Tlf: + 47 23 18 50 50

Greece

GE Healthcare A.E

Sorou8 -10

GR-15125 MAROUSI

ATHENS

Tel: + 30(2)10 8930600

Austria

GE Healthcare Handels GmbH

Euro plaza, Gebäude E

Technologiestrasse 10

A-1120 Wien

Tel: + 43 1 972 72-0

Spain

GE Healthcare Bio-Sciences, S.A.U.

C/ Gobelas, 35-37

E-28023 La Florida (Madrid)

Tel: + 34 91 663 25 00

Poland

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

Tel: + 33 1 34 49 54 54

Croatia

GE Healthcare d.o.o.

Josipa Marohnica 1

10 000 Zagreb

Tel: + 385 1 6170 280

Portugal

Satis - GE Healthcare

Edificio Ramazzotti

Av. do Forte, No 6-6A

P-2790-072 Carnaxide

Tel: + 351 214251352

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

Slovenia

Biomedis M.B. trgovina d.o.o.

Slokanova 12

SI-2000 Maribor

Tel: + 386 2 4716300

Iceland

Icepharma hf.

Lyngháls 13

IS-110 Reykjavik

Tel: + 354 540 8000

Italy

GE Healthcare S.r.l.

Via Galeno 36

I-20126 Milano

Tel: + 39 02 26001 111

Cyprus

Phadisco Ltd

LeoforosGinnouKranidioti185

CY-2234Laci

Tel: + 357 22 715000

Latvia

GE International Inc.

Meza 4

Riga, LV-1048

Tel: + 371 780 7086

Slovak Republic

MGP, spol. s r. o.

Šustekova 2

SK-85104 Bratislava

Tel.: + 421 2 5465 4841

Sweden/Finland

Oy GE Healthcare Bio-Sciences Ab

Kuortaneenkatu 2

FIN-00510 Helsinki

Tel: + 358 10 39411

Switzerland

GE Healthcare AB

Vendevägen 89

S-182 82 Stockholm

Tel: + 46 (0)8 559 504 00

United Kingdom

GE Healthcare Limited

Amersham Place

Little Chalfont HP7 9NA-UK

Tel: + 44 (0) 1 494 54 4000

Last review date of this leaflet Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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This information is intended only for healthcare professionals:

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 need higher doses. The total dose should not exceed 8.7 ml per patient. The useful image duration is 2.5-4.5 minutes for a dose of 0.5-3.0 ml.

OPTISON may be administered repeatedly, however, clinical experience is limited.

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

As with all parenteral products, a visual inspection of the OPTISON vials should be performed to check the integrity of the container.

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

After standing, OPTISON forms a white microsphere layer at the top of the liquid phase, which requires resuspension before use. Homogeneous white suspension after resuspension.

Follow these instructions:

• Do not inject cold solutions taken directly from the refrigerator.

• Allow the vial to reach room temperature and inspect the liquid phase to observe if there are particles or precipitates before shaking it for resuspension.

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

• The OPTISON vial should be inverted and gently shaken for approximately 3 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 and on the surface of the vial.

• Before 1 minute has elapsed since resuspension, OPTISON should be carefully extracted with a syringe.

• Any pressure should be avoided within the vial as it may cause destruction of the microspheres and loss of the contrast effect. Therefore, a sterile 18 G or similar needle should be placed to allow air to enter the vial as the suspension is withdrawn with the syringe. Do not inject air into the vial as it will damage the product.

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

• Separation of phases will occur if OPTISON is left standing in a syringe and it should be resuspendedbefore use.

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

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

Warning: Never use any other type of access that is not an open flow connection. If it is injected otherwise, the bubbles of OPTISON will be destroyed.

• Immediately before injection, a careful visual inspection of the syringe should be performed to ensure complete resuspension of the microspheres.

Immediatelyafter the injection of OPTISON, 10 ml of sodium chloride 9 mg/ml (0.9%) injection or glucose 50 mg/ml (5%) injection should be injected at a rate of 1 ml/s.

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