OPTISON 5-8X10^8/ML, 0.22 MG Injectable suspension

Зміст інструкції

1. OPTISON 0.19 mg/ml dispersion for injectable preparation
   1. What is OPTISON and what is it 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. Package Contents and Other Information

OPTISON 0.19 mg/ml dispersion for injectable preparation

Microspheres containing perflutren

Read this leaflet carefully before 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 any side effects occur, 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 you use 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 is OPTISON and what is it used for

OPTISON is an ultrasound contrast agent that helps to obtain a clearer image (scan) of the heart during an echocardiogram (a procedure used to obtain an image of the heart using ultrasound).
OPTISON improves the visualization of the internal heart walls in patients where such walls are difficult to see.
OPTISON contains microspheres (tiny gas bubbles) that, once injected, travel through the veins to reach the heart, and fill the left cavities, allowing the doctor to visualize and evaluate cardiac function.
This medicine is only for diagnostic use.

2. What you need to know before using 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 suffer from severe pulmonary hypertension (pulmonary arterial systolic blood pressure > 90 mm Hg).

Warnings and precautions
Talk to your doctor before using OPTISON

• If you have known allergies.
• If you suffer from severe heart, lung, kidney or liver diseases. Experience with OPTISON in severely ill patients is limited.
• If you have an artificial heart valve.
• If you suffer from acute forms of inflammation or sepsis.
• If you have a known blood coagulation problem.

Your heart rate and rhythm will be monitored during the administration of OPTISON.

Children and adolescents
The efficacy and safety of use in patients under the age of 18 have not been established.
In the case of medicines derived from plasma or human blood, specific measures are implemented for the
prevention of infection transmission to patients. These include careful selection of
plasma and blood donors to ensure exclusion of potentially infected subjects and
examination of each donation and collected plasma for the detection of any
viruses/infections. In addition, production of such medicines includes steps that can
inactivate or eliminate viruses. Despite the implementation of these measures, when administered
medicines derived from plasma or human blood, the possibility of transmission of infectious agents cannot
be totally excluded. This also applies to unknown or emerging viruses or other types of
infections.
No reports are available regarding viral infections with albumin produced according to procedures
compliant with the European Pharmacopoeia specifications.
It is strongly recommended that with each administration of OPTISON, the
registration of the patient's name and the batch number of the product is carried out in order to be able to maintain a
link between the patient and the product batch

Other medicines and OPTISON
Tell 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 determined.
Therefore, the medicine should not be used during pregnancy unless the benefits outweigh the
risks and use has been deemed necessary by the doctor. However, as OPTISON is based on
human albumin (the main protein found in blood), it is highly unlikely to
have a harmful effect on pregnancy.
It is not known whether OPTISON passes into breast milk. Caution should therefore be exercised when administering
OPTISON to breastfeeding women.

Driving and using machines
No known effects.

OPTISON containsless than 1 mmol (23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.

3. How to use OPTISON

OPTISON must only be administered by physicians experienced in ultrasound diagnostic methods.
OPTISON must be administered by intravenous injection to allow the microbubbles to enter the
cardiac cavities and fill the left cavity. OPTISON must be injected during the ultrasound examination to
allow the physician to assess cardiac function.
The recommended dose is 0.5 ml - 3.0 ml per patient. Generally, a dose of 3.0 ml is sufficient, but
some patients may require higher doses. This administration may be repeated, if
necessary. The duration of the useful visualization time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0
ml.
Immediately after the injection of OPTISON, inject 10 ml of a sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) injectable solution at a rate of 1 ml/s, to optimize the
effect of the contrast agent.

If you receive more OPTISON than you should
No adverse effects potentially attributable to overdose have been reported.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people):

• Dysgeusia (altered taste)
• Headache
• Flushing
• Warm sensation
• Nausea

Uncommon side effects (may affect up to 1 in 1000 people):

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

Rare side effects (may affect up to 1 in 10,000 people):

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

Frequency not known (side effects for which it is not possible to estimate frequency on the basis of

available data):

• Allergic-type symptoms, such as severe allergic reaction or allergic shock (anaphylaxis), facial swelling (facial edema), itchy skin rash (urticaria).
• Vision disorders

Reporting of side effects
If you get 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 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 which is stated on the label after Exp. The expiry date refers to the last day of that month.
Store in an upright position 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 must be used within 30 minutes after the rubber stopper has
been pierced.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment .

6. Package Contents and Other Information

What OPTISON contains

• The active ingredient consists of thermally treated human albumin microspheres (concentration of 5-8 x 10⁶/ml) 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 contents of the pack
OPTISON is a dispersion for preparation of an injectable solution. It is a clear solution with a white layer of
microspheres at the top.
OPTISON is supplied in packs of 1 vial of 3 ml, or 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 further information on this medicinal product, 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

България
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

Česká republika
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,

• 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

Norge
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Tlf: + 47 23 18 50 50

Ελλάδα
GE Healthcare A.E
Σωρού 8 -10
GR-15125 MΑΡΟΥΣΙ
ΑΘΗΝΑ
Τηλ: + 30 (2)10 8930600

Eesti
GE Healthcare Estonia OÜ
Mustamäe tee 46
EE-10621 Tallinn
Tel: + 372 6260 061

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 Marohnića 1
10 000 Zagreb
Tel: + 385 1 6170 280

Portugal
Satis - GE Healthcare
Edificio Ramazzotti
Av. do Forte, N 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

Κύπρος
Phadisco Ltd
Λεωφόρος Γιάννου Κρανιδιώτη 185
CΥ-2234 Λατσιά
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

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
website of the European Medicines Agency.
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The following information is intended exclusively for healthcare professionals:
The recommended dose is 0.5 ml - 3.0 ml per patient. Generally, a dose of 3.0 ml is sufficient, but
some patients may require higher doses. The total dose should not exceed 8.7 ml per patient.
The duration of the useful visualization time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml.
OPTISON can be administered repeatedly, but clinical experience is limited.
Use the lowest dose for adequate opacification of the cavities, as higher doses
produce image blocking effects that can mask important information.
As with all parenteral products, the vials of OPTISON must be examined
visually to check their integrity.
The vials are for single use. After piercing the rubber stopper, the
contents must be used within 30 minutes and any unused quantity must be discarded.
OPTISON in the non-resuspended form presents a whitish layer of microspheres above the liquid
phase which must be resuspended before use. Homogeneous white dispersion after resuspension.
The following instructions must be followed:

• Do not inject cold solutions taken directly from the refrigerator.
• Before resuspending the product, wait for 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 of the right arm. Connect the cannula to a three-way valve.
• Invert the OPTISON vial and rotate it slowly for about three minutes to completely resuspend the microspheres.
• Resuspension is complete when the suspension is uniformly white-opaque in color and no material is visible on the stopper and vial surfaces.
• Slowly draw OPTISON into the syringe within one minute of resuspension.
• Pressure imbalances within the vial should be avoided, as they can cause destruction of the microspheres with loss of contrast effect. Therefore, before drawing the suspension into the syringe, open a ventilation hole in the stopper with a sterile 18 G tip or needle. Do not inject air into the vial, as this would damage the product.
• Use the suspension within 30 minutes of drawing it into the syringe.
• If left unused in the syringe for some time, OPTISON tends to separate again, so it should be resuspended before use.
• Resuspend the microspheres within the syringe immediately before injecting them, keeping the syringe horizontal between the palms of your 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 a maximum injection rate of 1.0 ml/s. Warning: Do not use any other route of administration except the open-flow connection. If injected differently, the OPTISON bubbles will be destroyed.
• Immediately before injection, it is important to carefully examine the syringe to ensure that the microsphere suspension is complete.

Immediately after injecting OPTISON, inject 10 ml of a 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 can be performed by infusion. The infusion equipment should be connected
to the three-way valve to start the intravenous infusion at a rate sufficient to
maintain the vessel patent. Immediately after the OPTISON injection, the intravenous infusion should
be performed at a higher flow rate until the contrast begins to disappear from the left ventricle,
after which it should be resumed to the initial conditions.