ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
OPTISON 0.19 mg/ml dispersion for injection
2.
OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in
human albumin solution, 1%.
Concentration: Perflutren -containing microspheres, 5-8 x 10
8
/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
Each ml contains 0.15 mmol (3.45 mg) of sodium.
For a full list of excipients, see section 6.1.
3.
Dispersion for injection.
Clear solution with white microsphere layer on top.
4.
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.
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.
Dosage
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
2
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 patients
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.
Hypersensitivity to the active substance or to any of the excipients.
Pulmonary hypertension with a systolic pulmonary artery pressure > 90 mm Hg.
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.
Efficacy and safety in patients below 18 years has not been studied.
3
No interaction studies have been performed.
Use during anaesthesia with halothane and oxygen has not been studied.
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.
It is not known whether OPTISON is excreted in human milk. Therefore, caution should be exercised
when OPTISON is administered to breast-feeding women.
No studies on the effects on the ability to drive and use machines have been performed.
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
Common
Tinnitus, dizziness, paraesthesia
Rare
Eye disorders
Visual disturbances
Not known*
Cardiac disorders
Ventricular tachycardia
Rare
Respiratory, thoracic and
mediastinal disorders
Dyspnoea
Uncommon
Vascular disorders
Flushing
Common
Gastrointestinal disorders
Nausea
Common
General disorders and
administration site conditions
Warm sensation
Common
4
Chest pain
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”.
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.
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 10
8
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.
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 0.2ml above 25kg body weight and 0.1ml under 25kg, and in a second study 0.5ml above 20kg
5
body weight and 0.3ml under 20kg, by bolus peripheral intravenous injection followed by a saline
flush. Low mechanical index was used for ultrasound imaging.
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
125
I-labelled albumin microspheres indicated
that microspheres were rapidly cleared from the circulation, and radio-labelled microspheres, albumin
shells and
125
I 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 fetuses with dilated ventricles in the brain was observed (see
section 4.6). No such finding was observed in the rat embryotoxicity study.
6.
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.
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 (2
o
C - 8ºC).
Storage at room temperature (up to 25ºC) for 1 day is acceptable.
Do not freeze.
6.5 Nature and contents of container
6
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.
-
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.
7
-
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.
GE Healthcare AS
Nycoveien 1-2
P.O.BOX 4220 Nydalen
NO-0401 OSLO, Norway
8.
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: 18/05/1998
Date of latest renewal: 18/05/2008
8
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
9
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
GE Healthcare AS
Nycoveien 1-2
P.O. Box 4220 Nydalen
NO-0401 Oslo
Norway
B. CONDITIONS OF THE MARKETING AUTHORISATION
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Characteristics, 4.2)
OTHER CONDITIONS
The Marketing Authorisation Holder will continue to submit yearly Periodic Safety Update
Reports (PSURs), unless otherwise specified by the CHMP.
10
ANNEX III
LABELLING AND PACKAGE LEAFLET
11
A. LABELLING
12
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON
1.
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 10
8
, with a mean diameter range of 2.5 - 4.5
µ
m,
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.
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 REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
For single use only. Discard any unused portion.
8.
EXPIRY DATE
EXP:
13
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
GE Healthcare AS, Nycoveien 1-2, 0401 Oslo, Norway
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.
14
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
VIAL LABEL
1.
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
15
B. PACKAGE LEAFLET
16
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.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.
In this leaflet:
1.
What OPTISON is and what it is used for
2.
Before you use OPTISON
3.
How to use OPTISON
4.
Possible side effects
5.
How to store OPTISON
6.
Further 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.
BEFORE YOU USE OPTISON
Do not use OPTISON
-
if you are allergic (hypersensitive) to perflutren or to any of the ingredients of OPTISON.
-
if you have severe pulmonary hypertension (systolic pulmonary artery pressure > 90 mm Hg).
Take special care with 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.
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
17
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.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without prescription.
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.
Important information about some of the ingredients of OPTISON
This medicinal product 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.
If you are given more OPTISON than you should
Effects suspected to be due to overdose have not been reported.
18
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
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.
5.
HOW TO STORE OPTISON
Keep out of the reach and sight 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.
The contents of the OPTISON vial should be used within 30 minutes after the rubber stopper has been
penetrated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
19
6.
FURTHER INFORMATION
What OPTISON contains
-
The active substance is perflutren-containing microspheres of heat treated human albumin 5-
8 x 10
8
/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 1-2,
P.O.BOX 4220 Nydalen
NO-0401 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 74 01
Luxembourg/Luxemburg
GE Healthcare BVBA
Kouterveldstraat 20
BE-1831 Diegem
België/Belgique/Belgien
Tél/Tel: + 32 (0) 2 719 74 01
България
GE Healthcare SCE Handels GmbH
Representative Office Bulgaria
World Trade Centre, Office 405-406
бул. Драган Цанков 36
София 1040
Teл.: + 35 92 973 3170
Magyarország
GE Healthcare SCE Handels GmbH
Hungary Representative Office
Akron u.2.
H-2040 BUDAÖRS
Tel. + 36 23 410 410
Česká republika
GE Healthcare SCE Handels GmbH
Branch Office Czech Republic
Vyskočilova 1422/1a
CZ-140 28 Praha 4
Tel: + 420 224 446 179
Malta
Pharma-Cos Ltd
Triq C. Portanier
MT-Santa Venera HMR 11
Tel: +356 21 441870
20
Danmark
GE Healthcare A/S
Park Allé 295
DK-2605 Brøndby
Tlf: + 45 70 22 22 03
Nederland
GE Healthcare BV
Cygne Centre
De Rondom 8
NL-5612 AP Eindhoven
Tel: + 31 40 299 10 00
Deutschland
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
D-38110 Braunschweig
Tel: + 49 5307 9300
Norge
GE Healthcare AS
Nycoveien 1-2
NO-0401 Oslo
Tlf: + 47 23 18 50 50
Eesti
GE Healthcare Estonia OÜ
Mustamäe tee 46
EE – 10621 Tallinn
Tel: + 372 6260 061
Österreich
GE Healthcare Handels GmbH
Europlaza, Gebäude E
Technologiestrasse 10
A-1120 Wien
Tel: + 43 1 972 72-0
Ελλάδα
GE Healthcare A.E.
ΣΩΡΟΥ 8-10
151 25 ΜΑΡΟΥΣΙ
ATHENS
Τηλ: +30 1 805 08 64
Polska
GE Healthcare SCE Handels GmbH
Poland Representative Office
2 Stawki Str.
PL – 00193 Warszawa
Tel.: + 48 22 635 6886/6113
España
GE Healthcare Bio-Sciences, S.A.U
C/ Gobelas, 35-37
28023 La Florida (Madrid)
Tel: + 34 91 663 25 00
Portugal
Satis Lda.
Edificio Ramazzotti
Av. do Forte, N
o
6-6A
P-2790-072 Carnaxide
Tel: + 351 214 25 1300
France
GE Healthcare SA
11, avenue Morane Saulnier
F-78 140 Velizy Villacoublay
Tél: + 33 1 34 49 54 54
România
GE Healthcare SCE Handels GmbH
Representative Office Romania
Str. Navodari Nr. 42
Sc.2, et.2
RO-014108 BUCHAREST
Tel: + 40 21 23 211 53
Ireland
GE Healthcare Limited
Amersham Place
Little Chalfont HP7 9NA - UK
Tel: + 44 (0) 1 494 54 4000
Slovenija
HIGIEA d.o.o.
Blatnica 10
SI-1236 Trzin
Tel: + 386 1 589 7221
Ísland
Isfarm ehf.
Lyngháls 13
IS-110 Reykjavik
Sími: +354 540 8024
Slovenská republika
GE Healthcare SCE Handels GmbH
Branch Office Slovakia
Floriánske nám. 2
SK-811 07 Bratislava
Tel: + 421 2 5542 5948
Italia
Suomi/Finland
21
GE Healthcare Srl
Via Galeno 36
I-20126 Milano
Tel: + 39 02 26001 111
Oy GE Healthcare Bio-Sciences Ab
Kuortaneenkatu 2
FIN-00510 Helsinki
Puh/Tel: + 35 810 394 11
Κύπρος
Phadisco Ltd
Λεωφόρος Γιάννου Κρανιδιώτη 185
CΥ-2235 Λατσιά
Τηλ: +357 22 715000
Sverige
GE Healthcare AB
Solna Strandväg 98
S-171 75 Stockholm
Tel: + 46 (0)8 559 504 00
Latvija
Instrumentarium Medical SiA
Meza Str. 4
LV-1048 Riga
Tel: + 371 780 7086
United Kingdom
GE Healthcare Limited
Amersham Place
Little Chalfont HP7 9NA – UK
Tel: + 44 (0) 1 494 54 4000
Lietuva
Nycomed East Europe
Marketing Service GmbH
Šeimyniškiu 3
LT – 09312 Vilnius
Tel. +370 5210 9071
This leaflet was last approved in
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The following information is intended for medical or 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:
-
Cold solutions taken directly from the refrigerator should not be injected.
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-
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.
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Source: European Medicines Agency
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