Optison injectable suspension

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

OPTISON 0.19 mg/ml injectable dispersion

Microspheres containing perflutren

Read the entire leaflet carefully before you start using the medicine, as 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 adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Package leaflet 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. Package contents and additional information

1. What OPTISON is and what it is used for

OPTISON is an ultrasound contrast agent that helps produce clearer images of the heart during echocardiography (a procedure in which images of the heart are obtained using ultrasound). OPTISON improves the visualization of the inner heart walls in patients in whom these 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 chambers of the heart, enabling the physician to visualize and assess cardiac function.

This medicine is for diagnostic use only.

2. What you need to know before using OPTISON

Do not use OPTISON

• if you are allergic (hypersensitive) to perflutren or to 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 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. Experience with OPTISON in severely ill patients is limited.
• if you have an artificial heart valve.
• if you have severe acute inflammation or sepsis.
• if you have a known coagulation disorder.

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

Children and adolescents

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

When medicinal products are prepared from human blood or plasma, certain measures are applied to prevent the transmission of infections to patients. These include careful selection of blood and plasma donors to ensure exclusion of those with a risk of carrying infections, as well as testing of each individual 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 administering medicinal products derived from human blood or plasma, the possibility of transmitting infections cannot be completely ruled out. This also applies to any unknown or emerging virus or any other type of infection.

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

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

Use of OPTISON with other medicines

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

Pregnancy and lactation

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 physician considers it necessary. However, since OPTISON contains human albumin (the main protein found in our blood), it is highly unlikely to have any harmful effect on pregnancy.

It is unknown whether OPTISON is excreted in human milk. Therefore, precautions should be taken when administering OPTISON to nursing women.

Driving and use of machines

No known effect.

OPTISON contains less 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 physicians experienced in the field of diagnostic ultrasound imaging.

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

The recommended dose is 0.5 ml to 3.0 ml per patient. A dose of 3.0 ml is generally sufficient, but some patients may require higher doses. This dose may be repeated if necessary. The duration of useful imaging 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 administered at a rate of 1 ml/s to optimize the contrast agent effect.

If you use more OPTISON than you should

Adverse effects suspected to be due to an overdose have not been reported.

4. Possible adverse effects

Like all medicines, OPTISON may cause adverse effects, although not everyone experiences them.

Adverse effects reported with OPTISON are rare and generally not serious. In general, administration of human albumin has been associated with transient (non-persistent) taste disturbances, nausea, flushing, rash, headache, vomiting, chills, and fever. Administration of products containing human albumin has been linked to rare cases of serious allergic reactions (anaphylaxis). The adverse effects reported after the use of OPTISON are:

Frequent adverse effects (affect between 1 and 10 out of every 100 patients):

• Disgeusia (taste disturbance)
• Headache
• Flushing (reddening)
• Feeling of warmth
• Dizziness (nausea)

Uncommon adverse effects (affect between 1 and 10 out of every 1,000 patients):

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

Rare adverse effects (affect between 1 and 10 out of every 10,000 patients):

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

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

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

Reporting of adverse reactions

If you experience any adverse reactions, consult your doctor, even if they are not listed in this leaflet. You may also report them directly through the national reporting system. By reporting adverse reactions, 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 stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

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

Storage at room temperature (up to 25°C) is acceptable for one day. Do not freeze.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the container and additional information

Composition of OPTISON

• The active substance consists of 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 injections.

Appearance of the product and contents of the container

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturing Responsibility

GE Healthcare AS
Nycoveien 1,
NO-0485 Oslo, Norway

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

Belgium/Belgium/Belgium
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/Luxembourg
GE Healthcare BVBA
Kouterveldstraat 20
BE-1831 Diegem
Belgium/Belgium/Belgium
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,

• 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) 5307 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
Sorou 8-10
GR-15125 MΑΡΟΥΣΙ
ΑΘΗΝΑ
Tel: +30 (2)10 8930600

Austria
GE Healthcare Handels GmbH
Euro plaza, Building 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
Tél: +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
Sími: +354 540 8000

Italy
GE Healthcare S.r.l.
Via Galeno 36
I-20126 Milano
Tel: +39 02 26001 111

Cyprus
Phadisco Ltd
Leoforos Giannou Kraniditou 185
CY-2234 Latsia
Tel: +357 22 715000

Latvia
GE International Inc.
Meza 4
Riga, LV-1048
Tel: +371 780 7086

Slovakia
MGP, spol. s r. o.
Šustekova 2
SK-85104 Bratislava
Tel.: +421 2 5465 4841

Finland/Finland
Oy GE Healthcare Bio-Sciences Ab
Kuortaneenkatu 2
FIN-00510 Helsinki
Puh/Tel: +358 10 39411

Sweden
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 most recent review 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 patient information leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

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 must not exceed 8.7 ml per patient. The duration of useful imaging 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 providing adequate opacification of the cardiac chambers should be used, as higher doses may produce imaging artifacts that could obscure important information.

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

Vials are for single use only. Once the rubber stopper has been punctured, the contents should be used within 30 minutes, and any unused portion must be discarded.

After standing undisturbed, OPTISON shows a white layer of microspheres at the top of the liquid phase, requiring resuspension before use. After resuspension, it forms a homogeneous white suspension.

The following instructions must be followed:

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

• 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. Attach a three-way stopcock to the cannula.

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

• Complete resuspension is achieved when a uniform, opaque white suspension is obtained and no material remains adhering to the stopper or vial surface.

• Within one minute after resuspension, OPTISON should be carefully withdrawn into a syringe.

• Avoid creating pressure inside the vial, as this may destroy the microspheres and thus reduce contrast effect. Therefore, insert a sterile 18 G needle or similar into the vial to allow air to enter 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 after filling the syringe.

• Phase separation may occur if OPTISON is left standing in a syringe; resuspension must be performed before use.

• Immediately before injection, resuspend the microspheres in 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 a plastic cannula of at least 20 G gauge at a maximum rate of 1 ml/s.

Warning: Never use any route other than an open-flow connection. Injection by other means will destroy the OPTISON microbubbles.

• Immediately before injection, carefully perform a visual inspection of the syringe to ensure complete resuspension of the microspheres.

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

Alternatively, flushing may be performed by infusion. The infusion set should be connected to the three-way stopcock and intravenous infusion started at a "keep-vein-open" (KVO or TKO) rate. Immediately after injecting OPTISON, the infusion should be fully opened until the contrast begins to disappear from the left ventricle. The infusion rate should then be returned to the original KVO (TKO) rate.