Optison

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
OPTISON 0.19 mg/ml dispersion for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in 
human albumin solution, 1%. 
 
Concentration: Perflutren-containing microspheres, 5-8 x 108/ml with a mean diameter range of 2.5 - 
4.5 µm. 
The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg. 
 
Excipient with known effect: 
Each ml contains 0.15 mmol (3.45 mg) of sodium. 

For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Dispersion for injection. 
 
Clear solution with white microsphere layer on top.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
This medicinal product is for diagnostic use only. 
 
OPTISON is a transpulmonary echocardiographic contrast agent for use in patients with suspected or 
established cardiovascular disease to provide opacification of cardiac chambers, enhance left 
ventricular endocardial border delineation with resulting improvement in wall motion visualisation. 
OPTISON should only be used in patients where the study without contrast enhancement is 
inconclusive. 
 
4.2 Posology and method of administration 
 
OPTISON should only be administered by physicians experienced in the field of diagnostic ultrasound 
imaging. 
 
Before administering OPTISON, please see section 6.6 for instructions for use/handling. 
 
This medicinal product is intended for left ventricular opacification after intravenous administration. 
Ultrasound imaging must be performed during injection of OPTISON as optimal contrast effect is 
obtained immediately after administration. 
 
Posology 
The recommended dose is 0.5 ml - 3.0 ml per patient. A dose of 3.0 ml is usually sufficient, but some  
 



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patients may need higher doses. The total dose should not exceed 8.7 ml per patient. The duration of 
the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml. OPTISON could be repeatedly 
administered, however, the clinical experience is limited. 
 
Paediatric population 
 
The safety and efficacy of OPTISON in children and adolescents below 18 years has not been 
established. 
Currently available data are described in section 5.1 but no recommendation on a posology can be 
made. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  Pulmonary 
hypertension with a systolic pulmonary artery pressure > 90 mm Hg. 
 
4.4 Special warnings and precautions for use 
 
Hypersensitivity has been reported. Care should therefore be exercised. A course of action should be 
planned in advance with necessary drugs and equipment available for immediate treatment, in case a 
serious reaction should occur. 
 
The experience of OPTISON in severely ill patients is limited. There is limited clinical experience 
with OPTISON in patients with certain severe states of cardiac, pulmonary, renal and hepatic disease. 
Such clinical states include adult respiratory distress syndrome, the use of artificial respiration with 
positive end-expiratory pressure, severe heart failure (NYHA IV), endocarditis, acute myocardial 
infarction with on-going angina or unstable angina, hearts with prosthetic valves, acute states of 
systemic inflammation or sepsis, known states of hyperactive coagulation system and/or recurrent 
thromboembolism, renal or hepatic end-stage disease. OPTISON should be used in these categories of 
patients only after careful consideration and monitored closely during and after administration. Other 
routes of administration not specified in section 4.2 above (e.g. intracoronary injection) are not 
recommended. 
 
Standard measures to prevent infections resulting from the use of medicinal products prepared from 
human blood or plasma include selection of donors, screening of individual donations and plasma 
pools for specific markers of infection and the inclusion of effective manufacturing steps for the 
inactivation/removal of viruses.  Despite this, when medicinal products prepared from human blood or 
plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.  
This also applies to unknown or emerging viruses and other pathogens. 
 
There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia 
specifications by established processes. 
 
It is strongly recommended that every time that OPTISON is administered to a patient, the name and 
batch number of the product are recorded in order to maintain a link between the patient and the batch 
of the product. 
 
OPTISON contrast echocardiography should be accompanied by ECG monitoring. 
 
In animal studies, the application of echo-contrast agents revealed biological side effects (e.g. 
endothelial cell injury, capillary rupture) by interaction with the ultrasound beam. Although these 
biological side effects have not been reported in humans, the use of a low mechanical index and end-
diastolic triggering is recommended. 
 



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Paediatric population 
Efficacy and safety in patients below 18 years has not been studied. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
Use during anaesthesia with halothane and oxygen has not been studied. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
The safety of OPTISON for use during human pregnancy has not been established. In pregnant rabbits 
exposed to daily doses of 2.5 ml/kg (approximately 15 x the maximum recommended clinical dose) 
during organogenesis, maternal toxicity and embryo-foetal toxicity including a slight to extreme 
dilation of ventricles in the brain of developing rabbit embryos was observed. The clinical relevance of 
this finding is unknown. Therefore, OPTISON should not be used in pregnancy unless benefit 
outweighs risk and it is considered necessary by the physician. 
 
Breast-feeding 
It is not known whether OPTISON is excreted in human milk. Therefore, caution should be exercised 
when OPTISON is administered to breast-feeding women. 
 
4.7 Effects on the ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. 
 
4.8 Undesirable effects 
 
Adverse reactions to OPTISON are rare and usually of a non-serious nature. In general, the 
administration of human albumin has been associated with transient altered taste, nausea, flushing, 
rash, headache, vomiting, chills and fever. Anaphylactic reactions have been associated with the 
administration of human albumin products. The reported adverse events following the use of 
OPTISON in Phase III human clinical studies have been mild to moderate with subsequent full 
recovery. 
 
In clinical trials with OPTISON, undesirable effects were reported as adverse events with the 
following frequencies given in the table below: very common (≥1/10); common (≥1/100 to <1/10); 
uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known 
(cannot be estimated from the available data). Within each frequency grouping, undesirable effects are 
presented in order of decreasing seriousness. 
 
System Organ Class Undesirable Effects Frequency 

 
Blood and lymphatic system 
disorders 

Eosinophilia Uncommon 
 

Nervous system disorders Dysgeusia (altered taste), headache 
 
Tinnitus, dizziness, paraesthesia 

Common 
 
Rare 

Eye disorders Visual disturbances Not known* 
Cardiac disorders Ventricular tachycardia Rare 
Respiratory, thoracic and 
mediastinal disorders 

Dyspnoea Uncommon 
 

Vascular disorders Flushing Common 



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Gastrointestinal disorders Nausea Common 
General disorders and 
administration site conditions 

Warm sensation 
 
Chest pain 

Common 
 
Uncommon 

Immune system disorders 
 

Allergic type symptoms (e.g. 
anaphylactoid reaction or -shock, face 
oedema, urticaria) 

Not known* 

* Reactions for which no frequency rate can be provided due to lack of clinical trial data have  
   been classified as “Not known”. 
 
Reporting of suspected adverse reactions  
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.  
 
4.9 Overdose 
 
No case of overdose has been reported. 
In the Phase I trial, healthy volunteers have received up to 44.0 ml of OPTISON and experienced no 
significant adverse events. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Ultrasound contrast medium, ATC Code: V08D A01 
 
When used in conjunction with diagnostic ultrasound, OPTISON provides opacification of cardiac 
chambers, improvement in delineation of endocardial borders, enhancement of the Doppler signal, and 
visualisation of wall motion and blood flow within the heart. 
 
The ultrasound echoes from blood and biological soft tissues such as fat and muscles are generated at 
interfaces due to small differences in the ultrasonic properties of the tissues. The ultrasonic properties 
of microspheres containing perflutren are very different from that of soft tissue and will generate 
strong echoes. 
 
OPTISON consists of perflutren -containing microspheres. The microspheres have a mean diameter of 
2.5 - 4.5 microns and concentrations of 5-8 x 108 microspheres/ml. Microspheres in this size range 
contribute to the contrast effect by generating strongly enhanced echoes. 
 
As OPTISON consists of microspheres that are stable and small enough for transpulmonary passage, it 
will also give enhanced echo signals in the left heart cavities. 
 
As a consequence of the complex relationship between the concentration of the microspheres and the 
ultrasound signal, data processing within the ultrasound equipment and the fact that each individual 
responds differently due to variability in cardiac and pulmonary function, a strict dose/response 
relationship cannot be defined. The dose of OPTISON will therefore have to be adjusted individually, 
although clinical studies have shown that an initial dose of 0.5 - 3.0 ml per patient can be 
recommended for left heart opacification. Higher doses produce greater contrast effect of longer 
duration. Duration of useful contrast effect at the recommended dose is adequate to perform a 
complete echocardiographic examination including Doppler assessment. 



 6 

Use the smallest dose for adequate opacification of cavities since larger doses produce image blocking 
effects with the possibility of obscuring important information. 
 
In two uncontrolled studies including a total of 42 children and adolescents, aged 8 months to 19 
years, the safety profile appeared to be similar to that seen in adults. Doses administered in one study 
were 0.2 ml above 25 kg body weight and 0.1ml under 25 kg, and in a second study 0.5ml above 20 
kg body weight and 0.3 ml under 20 kg, by bolus peripheral intravenous injection followed by a saline 
flush. Low mechanical index was used for ultrasound imaging. 
 
The effect of OPTISON on pulmonary haemodynamics was studied in a prospective, open-label study 
of 30 patients scheduled for pulmonary artery catheterisation, including 19 with an elevated baseline 
pulmonary arterial systolic pressure (PASP) (>35 mmHg; mean 70.1±33.0 mmHg; range 36.0-176.0 
mmHg) and 11 with a normal PASP (≤35 mmHg; mean 29.3±4.6 mmHg; range 22.0-35.0 mmHg). 
Systemic haemodynamic parameters and ECGs were also evaluated. No clinically important 
pulmonary haemodynamic, systemic haemodynamic, or ECG changes were observed. This study did 
not assess the effect of OPTISON on visualisation of cardiac or pulmonary structures. 
 
5.2  Pharmacokinetic properties 
 
Following intravenous injection of 0.21 to 0.33 ml/kg of OPTISON to healthy volunteers, the 
perflutren component of OPTISON was rapidly and nearly completely eliminated in less than 10 
minutes with a dominating pulmonary elimination half-life of 1.3±0.7 minutes. The perflutren levels 
detected in blood following this dosage were too low and transient to accurately determine 
pharmacokinetic parameters. 
 
The disposition and elimination of the albumin microspheres have not been studied in humans. 
Information obtained from a preclinical study in rats with 125I-labelled albumin microspheres indicated 
that microspheres were rapidly cleared from the circulation, and radio-labelled microspheres, albumin 
shells and 125I were taken up primarily in the liver. The primary route of elimination of radioactivity 
was the urine. High levels of radioactivity were also retained in lungs for a considerable time, approx. 
10% of the total dose 40 minutes after dose administration (cf. 35% in liver). 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, acute and repeated dose toxicity and genotoxicity. In the rabbit embryotoxicity study, a 
significant increase in the number of foetuses with dilated ventricles in the brain was observed (see 
section 4.6). No such finding was observed in the rat embryotoxicity study. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1  List of excipients 
 
Human albumin  
Sodium chloride  
N-acetyltryptophan  
Caprylic acid 
Sodium hydroxide (pH adjustment) 
Water for injections  
 
6.2 Incompatibilities 
 
OPTISON must not be mixed with other medicinal products. A separate syringe should be used. 



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6.3 Shelf life  
 
Unopened vial in the outer packaging: 2 years. 
 
Finished product after rubber stopper perforation: 30 minutes.  
 
6.4 Special precautions for storage 
 
Store upright in a refrigerator (2oC - 8ºC). 
Storage at room temperature (up to 25ºC) for 1 day is acceptable. 
Do not freeze. 
 
6.5 Nature and contents of container 
 
3 ml type I glass vial, closed with bromobutyl rubber stopper, and sealed with aluminium cap with 
coloured plastic flip-off top. 
 
OPTISON is supplied as: 1 vial of 3 ml or 5 vials of 3 ml. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the 
container. 
 
Vials are intended for single use only. Once the rubber stopper has been penetrated, the contents 
should be used within 30 minutes and any unused product discarded. 
 
OPTISON in the non-resuspended form has a white layer of microspheres on top of the liquid phase 
that requires resuspension before use. Homogenous 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 particulate matter or 

precipitates before resuspension. 
 
- Insert a 20 G plastic cannula in a large antecubital vein, preferably of the right arm. Attach a 

three-way stopcock to the cannula. 
 
- The OPTISON vial must be inverted and gently rotated for approximately three minutes to 

completely resuspend the microspheres. 
 
- Complete resuspension is indicated by a uniformly opaque white suspension and absence of any 

material on stopper and vial surfaces. 
 
- OPTISON should be withdrawn with care into a syringe within 1 minute after resuspension. 
 
- Any pressure instability within the vial should be avoided since it may cause disruption of 

microspheres and loss of contrast effect. Thus, vent the vial with a sterile spike or with a sterile 
18 G needle before withdrawing the suspension into the injection syringe. Do not inject air into 
the vial as this will damage the product. 



 8 

 
- Use the suspension within 30 minutes after withdrawal. 
 
- OPTISON will segregate in an undisturbed syringe and must be resuspended before use. 
 
- Resuspend the microspheres in the syringe immediately before injection by holding the syringe 

horizontally between the palms of the hands and rolling it quickly back and forth for no less 
than 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: Never use any other type of route but the open flow connection. If injected otherwise 

OPTISON bubbles will be destroyed. 
 
- Immediately before injection a careful visual inspection of the syringe is mandatory in order to 

ensure complete suspension of the microspheres. 
 
Immediately after 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 rate of 1 ml/s. 
Alternately, the flushing may be performed by infusion. The infusion set should then be attached to 
the three-way stopcock and intravenous infusion started at a “to keep open” (TKO) rate. Immediately 
after OPTISON injection, the intravenous infusion should be wide open until contrast begins to fade 
from the left ventricle. The infusion should then be returned to a TKO rate. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
GE Healthcare AS 
Nycoveien 1 
NO-0485 Oslo, Norway 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
1 x 3 ml presentation: EU/1/98/065/001 
5 x 3 ml presentation: EU/1/98/065/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 18 May 1998 
Date of latest renewal: 12 June 2008 
 
 
10. DATE OF REVISION OF THE TEXT  
 



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ANNEX II 
 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 

RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE  
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION   
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



 10 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
GE Healthcare AS 
Nycoveien 1 
NO-0485 Oslo 
Norway 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION   
 

• Periodic Safety Update Reports 
 
The marketing authorisation holder shall submit periodic safety update reports for this product 
in accordance with the requirements set out in the list of Union reference dates (EURD list) 
provided for under Article 107c (7) of Directive 2001/83/EC and published on the European 
medicines web-portal. 

 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE 
AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 

  
Not applicable. 

 
 
 
 
 
 
 

   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



 11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 13 

 PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
 OUTER CARTON 
 
1. NAME OF THE MEDICINAL PRODUCT 

 
OPTISON 0.19 mg/ml dispersion for injection 
Perflutren-containing microspheres 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 
1 ml contains: Perflutren-containing microspheres 5 - 8 x 108, with a mean diameter range of 2.5 - 4.5 µm, 
equivalent to 0.19 mg perflutren gas per ml.  
 
3. LIST OF EXCIPIENTS 

 
Excipients: Human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, sodium hydroxide 
and water for injections. See the package leaflet for further information. 
 
4. PHARMACEUTICAL FORM AND CONTENTS 

 
1 x 3 ml 
5 x 3 ml 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 
Ultrasound contrast medium.  
Intravenous use.  
Resuspend before use.  
Do not inject air into the vial. 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 
For single use only. Discard any unused portion. 
 
8. EXPIRY DATE 

 
EXP 
 
9. SPECIAL STORAGE CONDITIONS 

 
Store upright in a refrigerator. 
Do not freeze. 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



 14 

 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 
GE Healthcare AS, Nycoveien 1, 0485 Oslo, Norway 
 
12. MARKETING AUTHORISATION NUMBER(S) 

 
EU/1/98/065/001 
EU/1/98/065/002 
 
13. BATCH NUMBER 

 
Lot 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 

 
Medicinal product subject to medical prescription.  
 
15. INSTRUCTIONS ON USE 

 
 
 16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 

 
Not applicable. 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 
Not applicable. 
 
 



 15 

 PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
 VIAL LABEL 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 
OPTISON 0.19 mg/ml dispersion for injection 
Perflutren-containing microspheres 
Intravenous use 
 
2. METHOD OF ADMINISTRATION 

 
 
3. EXPIRY DATE 

 
EXP 
 
4. BATCH NUMBER 

 
Lot 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 
3 ml 
 
6. OTHER 

GE Healthcare  
 

 



 16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 17 

 Package leaflet: Information for the user 
 

OPTISON 0.19 mg/ml dispersion for injection 
Perflutren-containing microspheres 

 
 
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. 
- If you get any side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet. See section 4. 
 

What is in 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 OPTISON is and what it is used for  
 
OPTISON is an ultrasound contrast agent that helps to obtain clearer pictures (scan) of the heart during 
an echocardiography (a procedure where an image of the heart is obtained by using ultrasound). 
OPTISON improves the visualization of the inner cardiac walls in patients where the 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 heart chambers, allowing the doctor to visualise and asses the function of the heart.   
 
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 ingredients of OPTISON (listed 

in section 6).  
- if you have severe pulmonary hypertension (systolic pulmonary artery pressure > 90 mm Hg). 
 
Warnings and precautions 
Talk to your doctor before using OPTISON   
- if you have any known allergies 
- if you have a severe heart, lung, kidney or liver disease. The experience of 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 blood clotting problem 
 
Your heart activity and rhythm will be monitored when you get OPTISON. 
 
 



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Children and adolescents 
Efficacy and safety in patients below 18 years has not been established. 
 
When medicines are made from human blood or plasma, certain measures are put in place to prevent 
infections being passed on to patients.  These include careful selection of blood and plasma donors to 
make sure those at risk of carrying infections are excluded, and the testing of each donation and pools 
of plasma for signs of virus/infections.  Manufacturers of these products also include steps in the 
processing of the blood or plasma that can inactivate or remove viruses.  Despite these measures, when 
medicines prepared from human blood or plasma are administered, the possibility of passing on 
infection cannot be totally excluded.  This also applies to any unknown or emerging viruses or other 
types of infections. 
 
There are no reports of virus infections with albumin manufactured to European Pharmacopoeia 
specifications by established processes. 
 
It is strongly recommended that every time you receive a dose of OPTISON the name and batch 
number of the product are recorded in order to maintain a record of the batches used. 
 
Other medicines and OPTISON  
Tell your doctor if you are taking or have recently taken any other medicines.   
 
Pregnancy and breast-feeding  
The safety of OPTISON for use during human pregnancy has not been fully established. Therefore, the 
medicine should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by 
the doctor. However, because OPTISON is based on human albumin (the main protein in our blood), it is 
highly unlikely that it will have any harmful effects in pregnancy.  
 
It is not known whether OPTISON passes into human milk. Therefore, caution should be exercised when 
OPTISON is administered to nursing women.  
 
Driving and using machines 
No effects are known. 
 
OPTISON contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”. 
 
 
3. How to use OPTISON 
 
OPTISON should only be administered by doctors experienced in the field of diagnostic ultrasound 
imaging. 
 
OPTISON is administered via an intravenous injection to allow the microspheres to enter the heart 
chamber and fill the left heart chamber. OPTISON is injected during the ultrasound examination in order 
to allow the doctor to assess the function of your heart.  
 
The recommended dose is 0.5 ml - 3.0 ml per patient. A dose of 3.0 ml is usually sufficient, but some 
patients may need higher doses. This dose might be repeated if needed. The duration of the useful 
imaging time 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 injected at a rate of 1 ml/s to optimise the effect of the 
contrast agent. 



 19 

If you are given more OPTISON than you should 
Effects suspected to be due to overdose have not been reported. 
 
 
4. Possible side effects 
 
Like all medicines, OPTISON can cause side effects, although not everybody gets them. 
 
Side effects to OPTISON are rare and usually not serious. In general the administration of human albumin 
has been associated with transient (non lasting) altered taste, nausea, flushing, rash, headache, vomiting, 
chills and fever. Rare severe allergic reactions (anaphylaxis) have been associated with the administration 
of human albumin products. Reported side effects following the use of OPTISON:  
 
Common side effects (affects 1 to 10 users in 100): 

• Dysgeusia (altered taste) 
• Headache 
• Flushing (redness) 
• Warm sensation 
• Feeling sick (nausea) 

 
Uncommon side effects (affects 1 to 10 users in 1,000): 

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

 
Rare side effects (affects 1 to 10 users in 10,000): 

• Tinnitus (noises in the ear) 
• Dizziness 
• Paraesthesia (tingling sensations) 
• Ventricular tachycardia (a series of rapid heartbeats) 

 
Unknown frequency (side effects where frequency cannot be estimated from the available data): 

• Allergic type symptoms, for example, a severe allergic reaction or – shock (anaphylaxis), 
swelling of the face (face oedema), an itchy skin eruption (urticaria). 

• Visual disturbances 
 

Reporting of side effects 
If you get any side effects, talk to your doctor. 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. 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 upright in a refrigerator (2°C - 8°C). 
Storage at room temperature (up to 25°C) for 1 day is acceptable. 
Do not freeze. 



 20 

The contents of the OPTISON vial should be used within 30 minutes after the rubber stopper has been 
penetrated.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information   
 
What OPTISON contains 
- The active substance is perflutren-containing microspheres of heat treated human albumin 5-

8 x 108/ml, suspended in human albumin solution 1%. The approximate amount of perflutren 
gas in each ml of OPTISON is 0.19 mg 

- The other ingredients are human albumin, sodium chloride, N-acetyltryptophan, caprylic acid, 
sodium hydroxide and water for injections. 

 
What OPTISON looks like and contents of the pack 
 
OPTISON is a dispersion for injection. It is a clear solution with white microsphere layer on top. 
The product is supplied 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 
 
For any information about this medicinal product, please 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 
 



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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 
 

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 
 

Ελλάδα 
GE Healthcare A.E 
Σωρού 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 Marohnića 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 
 



 22 

 
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 
 

  
This leaflet was last revised in   
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
This leaflet is available in all EU/EEA languages on the European Agency website. 
----------------------------------------------------------------------------------------------------------------------- 
The following information is intended for healthcare professionals only: 
 
The recommended dose is 0.5 ml - 3.0 ml per patient. A dose of 3.0 ml is usually sufficient, but some 
patients may need higher doses. The total dose should not exceed 8.7 ml per patient. The duration of 
the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml. OPTISON could be repeatedly 
administered, however, the clinical experience is limited. 
 
Use the smallest dose for adequate opacification of cavities since larger doses produce image blocking 
effects with the possibility of obscuring important information. 
 
Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the 
container. 
 
Vials are intended for single use only. Once the rubber stopper has been penetrated, the contents should be 
used within 30 minutes and any unused product discarded. 
 
OPTISON in the non-resuspended form has a white layer of microspheres on top of the liquid phase that 
requires resuspension before use.  Homogenous white suspension after resuspension. 
 
The following instructions should be followed: 



 23 

- Cold solutions taken directly from the refrigerator should not be injected. 
 
- Allow the vial to reach room temperature and inspect the liquid phase for particulate matter or 

precipitates before resuspension. 
 
- Insert a 20 G plastic cannula in a large antecubital vein, preferably of the right arm. Attach a three-

way stopcock to the cannula. 
 
- The OPTISON vial must be inverted and gently rotated for approximately three minutes to 

completely resuspend the microspheres. 
 
- Complete resuspension is indicated by a uniformly opaque white suspension and absence of any 

material on stopper and vial surfaces. 
 
- OPTISON should be withdrawn with care into the syringe within 1 minute after resuspension. 
 
- Any pressure instability within the vial should be avoided since it may cause disruption of 

microspheres and loss of contrast effect. Thus, vent the vial with a sterile spike or with a sterile 
18 G needle before withdrawing the suspension into the injection syringe. Do not inject air into 
the vial as this will damage the product. 

 
- Use the suspension within 30 minutes after withdrawal. 
 
- OPTISON will segregate in an undisturbed syringe and must be resuspended before use. 
 
- Resuspend the microspheres in the syringe immediately before injection by holding the syringe 

horizontally between the palms of the hands and rolling it quickly back and forth for no less than 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: Never use any other type of route but the open flow connection. If injected otherwise 

OPTISON bubbles will be destroyed. 
 
- Immediately before injection a careful visual inspection of the syringe is mandatory in order to 

ensure complete resuspension of the microspheres. 
 
Immediately after 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 rate of 1 ml/s.  
 
Alternatively, the flushing may be performed by infusion. The infusion set should then be attached to the 
three-way stopcock and intravenous infusion started at a ”to keep open” (TKO) rate. Immediately after 
OPTISON injection the intravenous infusion should be wide open until contrast begins to fade from the 
left ventricle. The infusion should then be returned to a TKO rate. 
 


	ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET