Optison

Package leaflet: Information for the user

OPTISON 0.19 mg/ml dispersion for injectable preparation

Microspheres containing perflutren
Please 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 questions, ask your doctor.
• If you get any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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. How to store 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 obtain a clearer image (scan) of the heart during echocardiography (a procedure in which an image of the heart is obtained using ultrasound).
OPTISON improves the visualization of the inner heart walls in patients in whom these walls are poorly visible.
OPTISON contains microspheres (tiny gas bubbles) which, once injected, travel through the veins to the heart and fill the left-sided chambers, enabling the physician to visualize and assess cardiac function.
This medicinal product is for diagnostic use only.

2. What you should know before using OPTISON

Do not use OPTISON

• If you are allergic (hypersensitive) to perflutren or to any of the other excipients of OPTISON (listed in section 6).
• If you have severe pulmonary hypertension (pulmonary arterial systolic pressure > 90 mm Hg).

Warnings and precautions
Consult your doctor before using OPTISON

• If you have known allergies.
• If you suffer from severe cardiac, pulmonary, renal, or hepatic disease. Experience with OPTISON in severely ill patients is limited.
• If you have an artificial heart valve.
• If you have acute inflammatory conditions or sepsis.
• If you have a known blood coagulation disorder.

Your heart activity and rhythm will be monitored during administration of OPTISON.
Children and adolescents
The efficacy and safety of use in patients under 18 years of age have not been established.
For medicines derived from human plasma or blood, specific measures are taken to prevent transmission of infections to patients. These include careful selection of plasma and blood donors to exclude individuals who may carry infections, and testing of each donation and pooled plasma for the presence of viruses/infections. In addition, manufacturing processes include steps that can inactivate or remove viruses. Despite these measures, when medicines derived from human plasma or blood are administered, the possibility of transmitting infectious agents cannot be completely ruled out. This also applies to unknown or emerging viruses or other types of infections.
No reports of viral infections have been associated with albumin manufactured according to procedures complying with European Pharmacopoeia specifications.
It is strongly recommended that, for each administration of OPTISON, the patient's name and the product batch number be recorded, in order to maintain a link between the patient and the product batch.
Other medicines and OPTISON
Inform your doctor if you are taking, or have recently taken, any other medicines.
Pregnancy and breastfeeding
The safety of OPTISON during human pregnancy has not been fully established.
Therefore, the medicine should not be used during pregnancy unless the benefits outweigh the risks and its use has been deemed necessary by the doctor. However, since OPTISON is based on human albumin (the main protein in blood), it is highly unlikely that it would have a harmful effect on pregnancy.
It is not known whether OPTISON passes into breast milk. Therefore, caution should be exercised when administering OPTISON to breastfeeding women.
Driving and using machines
No known effects.
OPTISON contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is practically 'sodium-free'.

3. How to use OPTISON

OPTISON should be administered only by physicians experienced in ultrasound diagnostic techniques.
OPTISON is administered by intravenous injection to allow the microspheres to enter the cardiac chambers and fill the left heart cavity. OPTISON should be injected during the ultrasound examination to enable the physician to assess cardiac function.
The recommended dose is 0.5 ml - 3.0 ml per patient. A dose of 3.0 ml is generally sufficient, but some patients may require higher doses. This administration may be repeated, if necessary. The duration of useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
Immediately after injection of OPTISON, inject 10 ml of an injectable solution of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) at a rate of 1 ml/s to optimize the effect of the contrast agent.
If you receive more OPTISON than you should
No effects potentially related to overdose have been reported.

4. Possible side effects

Like all medicines, OPTISON can cause side effects, although not everybody gets them.
Side effects with OPTISON are rare and usually not serious. In general, administration of human albumin may cause transient (not lasting) alterations in taste, nausea, flushing, skin rashes, headache, vomiting, chills, and fever. Severe allergic reactions (anaphylaxis) have rarely been observed after administration of products containing human albumin. Side effects reported following the use of OPTISON:

Common side effects (may affect from 1 to 10 users in 100):

• Dysgeusia (taste alteration)
• Headache
• Flushing
• Feeling of warmth
• Nausea

Uncommon side effects (may affect from 1 to 10 users in 1,000):

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

Rare side effects (may affect from 1 to 10 users in 10,000):

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

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

• Allergy-type symptoms, for example severe allergic reaction or allergic shock (anaphylaxis), facial swelling (facial oedema), skin rash associated with itching (urticaria).
• Visual disturbances

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. 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. How to store OPTISON

Keep this medicine out of the sight and reach of children.
Do not use OPTISON after the expiry date 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 pierced.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What OPTISON contains

• The active substance is human albumin microspheres (concentration of 5-8 x 10⁸/ml), heat-treated and containing perflutren, suspended in a 1% human albumin solution. The amount of gaseous perflutren in each ml of OPTISON is approximately 0.19 mg.
• The excipients are human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide, and water for injections.

Description of the appearance of OPTISON and package contents
OPTISON is a dispersion for injectable preparation. It is a clear solution with a white layer of microspheres at the top.
OPTISON is supplied in packs containing either 1 vial of 3 ml or 5 vials of 3 ml.
Not all pack 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:

België/Belgique/Belgien Lietuva
GE Healthcare BVBA GE International Inc.
Kouterveldstraat 20 Konstitucijos pr. 7
BE-1831 Diegem LT-09308 Vilnius
Tél/Tel: + 32 (0) 2 719 73 11 Tel.: + 370 68 723 753

България Luxembourg/Luxemburg
GE Healthcare Bulgaria EOOD GE Healthcare BVBA
36, Dragan Tzankov blvd Kouterveldstraat 20
World Trade Centre BE-1831 Diegem
Office B/405-406
België/Belgique/Belgien
1040 Sofia
Tél/Tel: + 32 (0) 2 719 73 11
Tel: + 359 2 9712040

Česká republika Magyarország
M.G.P. spol. s r.o. GE Healthcare SCE Handels GmbH
Kvítková 1575 Hungary Representative Office
CZ-760 01 Zlín Akron u.2.
Tel.: + 420 577 212 140 H-2040 BUDAÖRS
Tel. + 36 23 410 412

Danmark Malta
GE Healthcare A/S Pharma-Cos Limited
Park Allé 295 Pharma-Cos House,
DK-2605 Brøndby C. Portanier Street
Tlf: + 45 70 22 22 03 MT-Santa Venera SVR 1732
Tel: + 35 6 2144 1870

Deutschland Nederland
GE Healthcare Buchler GmbH & Co. KG GE Healthcare B.V.
Gieselweg 1 De Rondom 8
D-38110 Braunschweig NL-5612 AP, Eindhoven
Tel: + 49 (0) 5 307 93 00 Tel: + 31 (0) 40 299 10 00

Eesti Norge
GE Healthcare Estonia OÜ GE Healthcare AS
Mustamäe tee 46 Nycoveien 1
EE-10621 Tallinn NO-0485 Oslo
Tel: + 372 6260 061 Tlf: + 47 23 18 50 50

Ελλάδα Österreich
GE Healthcare A.E GE Healthcare Handels GmbH
Σωρού 8 -10 Euro plaza, Gebäude E
GR-15125 MΑΡΟΥΣΙ Technologiestrasse 10
ΑΘΗΝΑ A-1120 Wien
Τηλ: + 30 (2)10 8930600 Tel: + 43 1 972 72-0

España Polska
GE Healthcare Bio-Sciences, S.A.U. GE Medical Systems Polska Sp. z o.o.
C/ Gobelas, 35-37 Woloska St. 9
E-28023 La Florida (Madrid) PL-02-583 Warsaw
Tel: + 34 91 663 25 00 Tel: + 48 22 330 83 00

France Portugal
GE Healthcare SAS Satis - GE Healthcare
22/24, avenue de l’Europe Edificio Ramazzotti
F-78-140 Velizy Villacoublay Av. do Forte, N 6-6A
Tél: + 33 1 34 49 54 54 P-2790-072 Carnaxide
Tel: + 351 214251352

Hrvatska România
GE Healthcare d.o.o. S.C. GENERAL ELECTRIC MEDICAL
Josipa Marohnića 1 SYSTEMS ROMANIA S.R.L.
10 000 Zagreb Calea Floreasca 169 A, Floreasca Business Park,
Tel: + 385 1 6170 280 Entrance A, Floor 7
RO-014459 BUCHAREST
Tel. + 40 37 2074527

Ireland Slovenija
GE Healthcare Limited Biomedis M.B. trgovina d.o.o.
Amersham Place Slokanova 12
Little Chalfont HP7 9NA - UK SI-2000 Maribor
Tel: + 44 (0) 1 494 54 4000 Tel: + 386 2 4716300

Ísland Slovenská republika
Icepharma hf. MGP, spol. s r. o.
Lyngháls 13 Šustekova 2
IS-110 Reykjavik SK-85104 Bratislava
Sími: + 354 540 8000 Tel.: + 421 2 5465 4841

Italia Suomi/Finland
GE Healthcare S.r.l. Oy GE Healthcare Bio-Sciences Ab
Via Galeno 36 Kuortaneenkatu 2
I-20126 Milano FIN-00510 Helsinki
Tel: + 39 02 26001 111 Puh/Tel: + 358 10 39411

Κύπρος Sverige
Phadisco Ltd GE Healthcare AB
Λεωφόρος Γιάννου Κρανιδιώτη 185 Vendevägen 89
CΥ-2234 Λατσιά S-182 82 Stockholm
Τηλ: + 357 22 715000 Tel: + 46 (0)8 559 504 00

Latvija United Kingdom
GE International Inc. GE Healthcare Limited
Meza 4 Amersham Place
Riga, LV-1048 Little Chalfont HP7 9NA-UK
Tel: + 371 780 7086 Tel: + 44 (0) 1 494 54 4000

This leaflet was last updated on
Other sources of information
More detailed information on this medicinal product 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 European Medicines Agency website.

The following information is intended exclusively for healthcare professionals:

The recommended dose is 0.5 ml to 3.0 ml per patient. In general, a dose of 3.0 ml is sufficient, but
some patients may require higher doses. The total dose must not exceed 8.7 ml per patient.
The duration of useful opacification is 2.5 to 4.5 minutes for a dose of 0.5 to 3.0 ml.
OPTISON may be administered repeatedly, but clinical experience is limited.
Use the lowest dose sufficient to achieve adequate opacification of the chambers, as higher doses
may cause image blooming artifacts that can obscure important information.
As with all parenteral products, OPTISON vials should be inspected visually for integrity before use.
Vials are for single use only. After piercing the rubber stopper, the contents must be used within 30 minutes, and any unused portion must be discarded.
In its non-resuspended form, OPTISON presents a whitish layer of microspheres above the liquid phase, which must be resuspended before use. After resuspension, a homogeneous, white, opaque dispersion is obtained.
Follow the instructions below:

• Do not inject cold solutions taken directly from the refrigerator.
• Before resuspending the product, allow the vial to reach room temperature and examine the liquid phase for particles or other precipitates.
• Insert a 20 G plastic cannula into a large antecubital vein, preferably in the right arm. Connect the cannula to a three-way stopcock device.
• Invert the OPTISON vial and gently rotate it for approximately three minutes to completely resuspend the microspheres.
• Resuspension is complete when the suspension appears uniformly white and opaque, with no visible material adhering to the stopper or vial surfaces.
• Slowly aspirate OPTISON into a syringe within one minute after resuspension.
• Avoid pressure imbalances within the vial, as these may destroy the microspheres and result in loss of contrast effect. Therefore, before aspirating the suspension into the syringe, create a vent hole in the stopper using a sterile 18 G needle or spike. Do not inject air into the vial, as this may damage the product.
• Use the suspension within 30 minutes after aspiration into the syringe.
• If left unused in the syringe for some time, OPTISON may separate again; therefore, it must be resuspended before use.
• Immediately before injection, resuspend the microspheres within the syringe by 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 the plastic cannula, no smaller than 20 G, at an injection rate not exceeding 1.0 ml/s. Warning: Do not use any administration route other than an open-flow connector. If administered differently, the microbubbles of OPTISON will be destroyed.
• Immediately before injection, carefully inspect the syringe to ensure complete resuspension of the microsphere suspension.

Immediately after injection of OPTISON, inject 10 ml of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) injectable solution at a rate of 1 ml/s.
Alternatively, this flush may be administered by infusion. The intravenous infusion apparatus should be connected to the three-way stopcock to initiate intravenous infusion at a rate sufficient to maintain patency of the vein. Immediately after OPTISON injection, increase the infusion rate until contrast begins to disappear from the left ventricle, then return to the initial infusion rate.