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 or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is OPTISON and what is it 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 is OPTISON and what is it 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, go through the veins to the heart and fill the left chambers of the heart, allowing the doctor to visualize and assess cardiac function.

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 components of this medicine (listed in section 6).
• if you have severe pulmonary hypertension (pulmonary artery systolic pressure ≥ 90 mm Hg).

Warnings and p

Consult your doctor before using OPTISON

• if you have any known allergies.
• 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 administered 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 medicines 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 viruses/infections. Manufacturers of these products also include steps in the processing of blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting infections cannot be completely excluded. This also applies to any unknown or emerging virus or other type of infection.

There have been 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 name and batch number of the product 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 breastfeeding

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 the doctor considers it necessary. However, since 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 breastfeeding women.

Driving and using machines

No effects are known.

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

3. How to use OPTISON

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

OPTISON is administered by intravenous injection to allow the microspheres to enter the heart chambers and fill the left ventricle of the heart. 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 need higher doses. This dose can 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 the 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 speed of 1 ml/s to optimize the effect of the contrast agent.

If you use more OPTISON than you should

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

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 related to 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 (alteration of taste)
• Headache
• Flushing (redness)
• Feeling of heat
• Feeling of nausea

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

• Eosinophilia (increase in the number of a type of white blood cell)
• Dyspnea (breathing difficulties)
• 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 or pharmacist. 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. Storage of OPTISON

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

Do not use this medicine 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 the rubber stopper being pierced.

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. Contents of the pack and other information

Composition of OPTISON

• The active substance is heat-treated human albumin microspheres containing perflutren 5-8 x 10^8/ml, which are suspended in a 1% human albumin solution. The approximate amount of perflutren gas is 0.19 mg per ml of OPTISON.
• The other ingredients are human albumin, sodium chloride, N-acetyltryptophan, capric acid, sodium hydroxide, and water for injections.

Appearance and pack contents

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

The product is presented 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

You can obtain further information on this medicine from 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

????????

GE Healthcare Bulgaria EOOD

36, Dragan Tzankov blvd

World Trade Centre

Office B/405-406

1040 Sofia

Tel: + 359 2 9712040

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

België/Belgique/Belgien

Tél/Tel: + 32 (0) 2 719 73 11

Ceskárepublika

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

Kvítková 1575

CZ-760 01 Zlín

Tel.: + 420 577 212 140

Magyarország

GE Healthcare SCE Handels GmbH

Hungary Representative Office

Akron u.2.

H-2040 BUDAÖRS

Tel. + 36 23 410 412

Danmark

GE Healthcare A/S

Park Allé 295

DK-2605 Brøndby

Tlf: + 45 70 22 22 03

Malta

Pharma-Cos Limited

Pharma-Cos House,

• 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

Ελλ?δα

GE Healthcare A.E

Σωρο? 8 -10

GR-15125 MΑΡΟΥΣΙ

ΑΘΗΝΑ

Τηλ: + 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

Hrvatska

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

România

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

Ísland

Icepharma hf.

Lyngháls 13

IS-110 Reykjavik

Sími: + 354 540 8000

Italia

GE Healthcare S.r.l.

Via Galeno 36

I-20126 Milano

Tel: + 39 02 26001 111

Κ?προς

Phadisco Ltd

Λεωφ?ρος Γι?ννου Κρανιδι?τη 185

CΥ-2234 Λατσι?

Τηλ: + 357 22 715000

Latvija

GE International Inc.

Meza 4

Riga, LV-1048

Tel: + 371 780 7086

Slovenská republika

MGP, spol. s r. o.

Šustekova 2

SK-85104 Bratislava

Tel.: + 421 2 5465 4841

Suomi/Finland

Oy GE Healthcare Bio-Sciences Ab

Kuortaneenkatu 2

FIN-00510 Helsinki

Puh/Tel: + 358 10 39411

Sverige

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

Date of last revision of this leaflet Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

The leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

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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 need 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 may be administered repeatedly; however, clinical experience is limited.

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

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

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 on 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 tap to the cannula.

• The OPTISON vial should be inverted and gently rotated 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.

• Before one minute has elapsed from resuspension, OPTISON should be carefully drawn up with a syringe.

• Any pressure within the vial should be avoided as it may cause destruction of the microspheres and loss of 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 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 rotating it rapidly back and forth for at least 10 seconds.

• Inject the suspension through a 20 G or larger plastic cannula at a maximum speed 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, it is mandatory to perform a careful visual inspection of the syringe to ensure complete suspension of the microspheres.

Immediately after the 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 speed of 1 ml/s.

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