Skip to Content

OPTIRAY 300MG IODINE/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): IOVERSOL

View full screen / Print PDF » Download PDF ⇩
Transcript
1. NAME OF THE MEDICINAL PRODUCT
Optiray™ 300 mg Iodine/ml, solution for injection or infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 636 mg ioversol equivalent to 300 mg iodine.
Osmolality: 645 mosmol/kg
Viscosity:
8.2 mPa • s (at 25°C)
Viscosity:
5.5 mPa • s (at 37°C)
Contains Iodine per ml: 300 mg
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for injection or infusion. Clear, colourless to faint yellow solution.

An effective hydration prior to the administration of Optiray is essential and
may decrease the risk of renal injury. Preparatory dehydration is dangerous and
may contribute to acute renal failure.
Administration of radiopaque materials to patients known or suspected of
having phaeochromocytoma should be performed with caution. If, in the
opinion of the physician, the possible benefits of such procedures outweigh
the considered risks, the procedure may be performed; however, the amount
of radiopaque medium injected should be kept to an absolute minimum.
Premedication with α- and ß-blockers is advisable when the contrast medium
is administered intravascularly due to the risk of a hypertensive crisis. The
blood pressure should be assessed throughout the procedure, and measures for
treatment of a hypertensive crisis should be available.

4.1. Therapeutic indications
This medicinal product is for diagnostic use only.

In patients with homozygous sickle cell disease, hyperosmolar agents such as
X-ray contrast media may effect sickling of erythrocytes. Hence, there is a need
for careful consideration before the intra-arterial administration of such agents
to patients with homozygous sickle cell disease.

Optiray 300 is a non-ionic X-ray contrast medium that is indicated in adults for
use in cerebral, peripheral and visceral angiography including intraarterial and
intravenous digital subtraction angiography (IA DSA and IV DSA), venography,
intravenous urography, and in computed tomography (CT) of the head and
body. Optiray 300 may also be used in children for cerebral, peripheral and
visceral angiography and for intravenous urography.

The anticoagulant effect of non-ionic X-ray contrast media has been shown,
in vitro, to be less than that of conventional ionic agents at comparable
concentrations. Similar results were found in some in vivo studies. For this
reason, meticulous angiographic techniques are recommended, e.g. frequent
flushing of standard angiographic catheters and avoiding prolonged contact of
blood with the contrast agent in syringes and catheters.

4.

CLINICAL PARTICULARS

4.2. Posology and method of administration
Adults:
Recommended dosage schedule
Procedure
Dosage
Cerebral angiography
- Carotid or vertebral artery
2-12 ml
- Aortic arch
20-50 ml
Peripheral angiography
10-90 ml
Venography
50-100 ml
Visceral angiography
12-60 ml
Urography
50-75 ml
Head CT
50-150 ml
Body CT
25-150 ml
IA DSA
5-80 ml
IV DSA
30-50 ml
Elderly:

Maximum Total Dose
200 ml
200 ml
250 ml
250 ml
250 ml
150 ml
150 ml
150 ml
250 ml
250 ml

Dosage as for adults. Where poor demonstration is to be expected, the
dosage can be increased to the maximum.

Paediatric population: Recommended dosage schedule
Procedure
Dosage
Cerebral angiography
1-3 ml/kg
Peripheral angiography
1-3 ml/kg
Visceral angiography
1-3 ml/kg
Intravenous urography
2 ml/kg (> 1 year of age)
3 ml/kg (< 1 year of age)

Maximum Total Dose
100 ml
100 ml
100 ml
100 ml

Safety and efficacy of Optiray 300 in children in any other indication have not
yet been established.
It is recommended that intravascularly administered iodinated contrast agents
are warmed up to body temperature prior to injection. As with all radiopaque
contrast agents, the lowest dose necessary to obtain adequate visualisation should
be used.
Appropriate resuscitation equipment should be available.
4.3. Contraindications
Hypersensitivity to iodine-containing contrast media, the active substance, or to
any of the excipients listed in section 6.1. Manifest hyperthyroidism.
4.4. Special warnings and precautions for use
Serious or fatal reactions have been associated with the administration of
iodinated X-ray contrast media. It is of utmost importance to be completely
prepared to treat any contrast medium reaction.
Such procedures should be performed under the direction of personnel skilled
and experienced in the particular procedure to be performed. A fully equipped
emergency cart, or equivalent supplies and equipment, and personnel competent
in recognising and treating adverse reactions of all types should always be
available. Since severe delayed reactions have been known to occur, the patient
should be observed and emergency facilities and competent personnel should be
available for at least 30 to 60 minutes after administration.
As with all other X-ray contrast media, Optiray may cause anaphylaxis or
other manifestations of pseudo-allergic intolerance reactions, e.g. nausea,
vomiting, dyspnoea, erythema, urticaria and hypotension. A higher incidence
of such reactions has been observed in patients with a history of previous
intolerance reactions to other contrast media, or any history of asthma, allergy
or hypersensitivity. In such patients, the benefit should clearly outweigh the risks
(see section 4.3 Contraindications).
The occurrence of severe idiosyncratic reactions has prompted the use of several
pre-testing methods. However, pre-testing cannot be relied upon to predict
severe reactions and may itself be hazardous to the patient. It is suggested that a
thorough medical history with emphasis on allergy and hypersensitivity, prior to
the injection of any contrast medium, may be more accurate than pre-testing in
predicting potential adverse reactions.
A positive history of allergies does not arbitrarily contraindicate the use
of a contrast agent when a diagnostic procedure is thought essential, but
caution should be exercised (see section 4.3 Contraindications). Appropriate
resuscitation measures should be immediately available.
Pre-medication with antihistamines and corticosteroids to avoid or minimise
allergic reactions should be considered. Reports indicate that such pre-treatment
does not prevent serious life-threatening reactions, but may reduce both their
incidence and severity.
General anaesthesia may be indicated in the performance of some procedures
in selected patients; however, a higher incidence of adverse reactions has been
reported in these patients, and may be attributable to the inability of the patient
to identify untoward symptoms or to the hypotensive effect of anaesthesia.
In angiographic procedures, the possibility of dislodging plaque or damaging or
perforating the vessel wall should be considered during catheter manipulation
and contrast medium injection. Test injections to ensure proper catheter
placement are recommended.
In patients with advanced atherosclerosis, serious hypertension, cardiac
decompensation, senility, preceding cerebral thrombosis or embolism, special
caution should be exercised. Cardiovascular reactions as bradycardia, rising or
falling of blood pressure may occur more often.
Angiography should be avoided whenever possible in patients with
homocystinuria due to an increased risk of thrombosis and embolism.
Patients with congestive heart failure should be observed for several hours
following the procedure to detect delayed haemodynamic disturbances, which may
be associated with a transitory increase in the circulating osmotic load. The patient
should also be informed that allergic reactions may develop up to several days post
administration; in such case, a physician should be consulted immediately.

Serious neurologic events have been observed following direct injection into
cerebral arteries or vessels supplying the spinal cord or in angiocardiography,
due to inadvertent filling of the carotids. A cause-effect relationship to the
contrast medium has not been established, since the patient’s pre-existing
condition and procedural techniques are causative factors in themselves.
Optiray should be injected with caution to avoid perivascular application. This is
especially important in patients with severe arterial or venous disease. However,
significant extravasation of Optiray may occur especially during the use of power
injectors. Generally, it is tolerated without substantial tissue injury applying
conservative treatment. However, serious tissue damage (e.g. ulceration) has
been reported in isolated cases requiring surgical treatment.
Special warnings and precautions for use that are applicable only for specific
indications are as follows:
Venography
In patients with suspected phlebitis, serious ischemia, local infections or a
complete occlusion of the venous system special caution should be exercised.
Peripheral angiography
There should be pulsation in the artery, into which the X-ray contrast medium
will be injected. In patients with thromboangiitis obliterans or ascending
infections in combination with serious ischemia the angiography should be
performed, if at all, with special caution.
Paediatric population
In neonates and particularly in premature neonates, it is recommended to
control TSH level and T4, 7-10 days and 1 month after the administration of
iodinated contrast media because of the risk of hypothyroidism due to iodine
overload.
4.5. Interactions with other medicinal products and other forms of
interaction
The following interactions have been reported after the administration of other
iodinated contrast media. They are generally accepted as being attributable to
this class of contrast media.
Renal toxicity has been reported in single patients with liver dysfunction,
who were given oral cholecystographic agents followed by intravascular
contrast agents. Administration of any intravascular X-ray contrast agent
should therefore be postponed in patients who have recently received a
cholecystographic contrast agent.
The literature reports that patients who had been treated with Interleukin
may develop a higher rate of adverse reactions as described in the section
“Undesirable Effects”. The reason has not yet been clarified. According to the
literature an increased or delayed occurrence of these reactions within a period
of 2 weeks was observed after administration of Interleukin.
The arterial injection of an X-ray contrast medium should never be made
following the administration of vasopressors, since they strongly potentiate
neurologic effects.
Acute renal failure has been associated with lactic acidosis in patients
receiving Metformin at the time of an X-ray examination involving parenteral
administration of iodinated contrast media. Therefore, in diabetic patients taking
Metformin, the examination should be performed and intake of Metformin
stopped before the examination. The use of Metformin should not be resumed
for 48 hours, and should only be restarted if renal function/serum creatinine
remains within the normal range or has returned to baseline.
Iodinated X-ray contrast media may reduce the capacity of the uptake of iodine
by the thyroid gland. For this reason the results of PBI (protein-bound iodine)
and radioactive iodine uptake studies, which depend on iodine estimation, will
not accurately reflect thyroid function for up to 16 days following administration
of iodinated X-ray contrast media. However, thyroid function tests not
depending on iodine estimations, e.g. T3 resin uptake and total or free thyroxine
(T4) assays are not affected.
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy
Animal studies do not indicate direct or indirect harmful effects with respect to
pregnancy, embryonal/foetal development, parturition or postnatal development.
There are, however, no adequate and well controlled studies in pregnant women.
It is not known whether ioversol crosses the placental barrier or reaches foetal
tissues. However, many injectable contrast agents cross the placental barrier in
humans and appear to enter foetal tissue passively.
Because animal teratology studies are not always predictive of human response,
caution should be exercised when prescribing to pregnant women. Since any
X-ray investigation during pregnancy may involve a potential risk, the risk/benefit
ratio should be carefully weighed. If a better and safer alternative is available, an
X-ray investigation involving X-ray contrast media should be avoided.
Breast-feeding
It is not known whether Ioversol is excreted in human breast milk. However,
many injectable contrast agents are excreted unchanged in breast milk to an
amount of approximately 1 % of the given dose. Although it has not been
established that adverse events occur to nursing infants, caution should be
exercised when intravascular X-ray contrast media are administered to nursing
women because of potential adverse events, and consideration should be given to
discontinuing nursing for one day.
Fertility
Animal studies did not indicate direct or indirect harmful effects with respect to
fertility in humans. There are, however, no adequate and well controlled clinical
studies on fertility.

Reports of thyroid storm following the intravascular use of iodinated radiopaque
agents in patients with hyperthyroidism or with an autonomously functioning
thyroid nodule suggest that the additional risk be evaluated in such patients
before use of any contrast medium (see section 4.3 Contraindications).

4.7. Effects on ability to drive and use machines
There is no known effect on the ability to drive and operate machines. However,
because of the risk of early reactions driving or operating machinery is not
advisable for 1 hour following the time of injection.

Caution must be exercised in patients with severely impaired renal function,
combined renal and hepatic disease, diabetes mellitus, homozygous sickle cell
disease, multiple myeloma or other paraproteinaemia, anuria, particularly
when large doses are administered. Serious renal effects, including acute renal
failure, may occur in these patients. Although neither the contrast agent nor

4.8. Undesirable effects
Frequencies for adverse drug reactions are defined as follows:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)

1

2

IN 1332GB-0315

dehydration has been proved separately to be the cause of renal failure, it has
been speculated that the combination of both may be causative. The risk in
patients with impaired renal function is not a contraindication to the procedure:
however, special precautions, including maintenance of normal hydration and
close monitoring, are required.

Optiray 300-GB PIL-03/2015

IN 1332GB-0315
Optiray 300-GB TL-03/2015

TECHNICAL LEAFLET

Package leaflet: Information for the user

Optiray™ 300 mg Iodine/ml,
solution for injection or infusion
Active substance: Ioversol
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 or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Optiray is and what it is used for
2. What you need to know before you use Optiray
3. How to use Optiray
4. Possible side effects
5. How to store Optiray
6. Contents of the pack and other information

1. What Optiray is and what it is used for
Optiray is used for several types of X-ray procedures including:
• imaging of vessels, both arteries and veins (in adults and children)
• kidneys (in adults and children)
• CT scans (in adults)
Optiray is an X-ray contrast medium containing iodine. The iodine blocks the
X-rays, allowing vessels and the inner organs supplied with blood to be seen.
2. What you need to know before you use Optiray
Do not use Optiray
• if you are allergic to contrast media substances containing iodine or to any of
the other ingredients of this medicine (listed in section 6)
• if you have an overactive thyroid gland
Warnings and precautions
Talk to your doctor before using Optiray if you have
• asthma or previously had allergic reactions such as nausea, vomiting, low
blood pressure, skin symptoms
• heart failure, high blood pressure, circulation disorders, or had a stroke, and if
you are very elderly
• diabetes
• kidney or liver disease
• brain disorders
• problems with bone marrow, such as certain blood cancers known as
paraproteinaemia, multiple myeloma
• certain red blood cell abnormalities, known as sickle cell anaemia
• a tumour of the adrenal gland, which affects your blood pressure, known as
phaeochromocytoma
• increased homocysteine amino acid level, due to abnormal metabolism
• recent gall bladder investigation with contrast media
• a planned thyroid gland investigation using a substance containing iodine
This should be postponed as Optiray may influence results for up to 16 days.
Children younger than 18 years
Optiray 300 is used for imaging of vessels or kidneys in this age group.
With newborn babies and particularly for premature infants, controls of
thyroid hormones known as TSH and T4 are recommended. These checks take
place 7-10 days and 1 month after administration of Optiray.
Other medicines and Optiray
Tell your doctor or X-ray specialist if you are using, have recently used or might
use any other medicines.
The following medicines can influence or be influenced by Optiray
• metformin: a medicine to treat diabetes
Your doctor will measure your kidney function before and after Optiray use.
Metformin should be stopped before the investigation. It should not be
re-started for at least 48 hours after the investigation and only when your kidney
function has returned to its previous level.
• interleukin: medicines to treat certain tumours
• certain medicines to increase blood pressure due to narrowing of blood
vessels
To prevent any risk of nervous disorders, Optiray should never be used while
using these medicines.
• general anaesthetics
A higher frequency of side effects has been reported.
Optiray with food and drink
Limit your food intake prior to the examination. Please, ask your doctor for
advice. If you have kidney disease, do not limit your liquid intake as this may
further reduce kidney function.
Pregnancy and breast-feeding
• Pregnancy
Tell your doctor if you are pregnant or think you could be. Your doctor will
only administer Optiray during pregnancy if it is absolutely necessary, as it
could harm the unborn child.
• Breast-feeding
Discontinue breast-feeding for one day after the injection, as insufficient
information exists concerning safety. Discuss this with your doctor or X-ray
specialist.
Driving and using machines
Driving or operating machines is not advisable for up to 1 hour after injection.
In addition, symptoms such as dizziness, drowsiness, fatigue and visual
disturbances have been reported. If this affects you, do not attempt any activities
which require concentration and the ability to react appropriately.
3. How to use Optiray
Optiray investigations will only be performed by a doctor or X-ray specialist,
who will also decide the dose.
Optiray is injected into a blood vessel and distributed throughout the body
by the blood stream. It will be warmed to body temperature before use, then
injected once or more during the X-ray procedure.
The dose depends on the specific procedure you are having and other factors
such as your health and age.
The lowest dose possible will be used to produce adequate X-ray images.
If more Optiray is given than it should
Overdoses are potentially dangerous and may affect the breathing, heart and
circulation system. Inform your doctor or X-ray specialist immediately if you
notice any of these symptoms after receiving Optiray.
If you have any further questions on the use of this medicine, ask your doctor or
X-ray specialist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them. Side effects associated with Optiray are generally independent of the
dose given. In the majority of cases they are mild or moderate and very rarely
serious or life-threatening.
Inform your doctor immediately if you develop any of the following signs of
serious side effects:
• heart or breathing arrest
• heart vessel spasms or blood clots
• stroke, blue lips, fainting
• loss of memory
• speech disorders
• sudden movements
• temporary blindness
• acute kidney failure
• severe skin rash with fever and blisters
• signs of allergic reactions, such as
- allergic shock
- tightened airways
- swelling of the voice box, throat, tongue
- breathing difficulties
1

- cough, sneezing
- reddening and/or swelling of the face and eyes
- itching, rash and hives
Side effects can occur with the following frequencies:
very common, occurs in more than 1 of 10 users
• feeling hot
common, occurs in 1 to 10 per 100 users
• pain
uncommon, occurs in 1 to 10 per 1,000 users
• nausea
• hives
rare, occurs in 1 to 10 per 10,000 users
• fainting
• uncontrollable shaking
• dizziness, light-headedness
• headache
• abnormal sensation, such as pricking, tingling
• taste disturbance
• blurred vision
• racing pulse
• low blood pressure
• flushing
• larynx cramps
• swelling and narrowing of airways, including throat tightness, wheezing
• difficult breathing
• inflammation inside the nose which causes sneezing and blocked nose
• cough, throat irritation
• vomiting
• dry mouth
• skin redness, itching, rash
• urgent urination
• swelling of the face including eyes
• chills, feeling cold
very rare, occurs in fewer than 1 per 10,000 users
• severe allergic reaction
• confusion, anxiety, restlessness
• loss of consciousness, numbness
• paralysis
• drowsiness
• speech disorders
• reduced sense of touch or sensation
• allergic eye inflammation causing red, watery and itchy eyes
• ringing or buzzing in the ears
• irregular heartbeats, slow pulse
• chest pain
• heart activity changes measured using ECG
• disease which disturbs blood flow through the brain
• high blood pressure
• vein inflammation, blood vessel dilation
• fluid accumulation in the lung
• sore throat
• low oxygen in the blood
• abdominal pain
• salivary gland inflammation, swelling of the tongue
• difficulty in swallowing, increased salivation
• mostly painful severe swelling of deep skin layers, mainly in the face
• increased sweating
• muscle cramps
• acute kidney failure or abnormal kidney function
• urinary incontinence, blood in urine, low urination
• tissue swelling caused by excess fluid
• injection site reactions including pain, reddening, bleeding or degeneration of
cells
• feeling unwell or abnormal, tiredness, sluggishness
not known: frequency cannot be estimated from the available data
• severe allergic shock reaction
• temporarily underactive thyroid in newborns
• fits
• movement disorder
• loss of memory
• temporary blindness
• heart arrest, life-threatening irregular heartbeat
• extra heartbeat
• heart artery cramps, pounding of the heart
• blue skin colouration due to low oxygen in the blood
• shock
• blood clot or spasm in a blood vessel
• breathing arrest, asthma, tightened airways
• reduced ability to produce voice sounds using the vocal organs
• diarrhoea
• mild to severe inflammatory skin rash, sometimes with fever and blisters
• paleness
• absent or painful/difficult urination
• fever
If you get any side effects, talk to your doctor or X-ray specialist. This includes
any side effects not listed in this leaflet.
You can also report side effects directly via Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Optiray
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The
expiry date refers to the last day of that month.
Keep the container in the outer carton in order to protect from light. Protect
from X-rays. Do not store above 30°C. Optiray 300 can be stored for one month
at 37°C in a contrast media warmer with circulating air.
Do not use this medicine if you notice discolouration or particulate matter.
6. Contents of the pack and other information
What Optiray contains
• The active substance is Ioversol.
One millilitre of Optiray contains 636 mg Ioversol, which is equal to 300 mg
of organically bound iodine.
• The other ingredients are sodium calcium edetate (stabiliser), trometamol and
trometamol hydrochloride (buffer), and water for injections.
Sodium hydroxide and hydrochloric acid may be used for adjustment pH of
6.0 to 7.4.
What Optiray looks like and contents of the pack
Optiray is packaged in uncoloured bottles. Bottles are fitted with either 20 mm
or 32 mm bromobutyl rubber closures and aluminium cap seals.
10, 20, 50, 75, 100, 150 ml (box of 1 and 10)
Optiray is also supplied in prefilled hand held syringes and power injector
syringes made of polypropylene. Syringe tip cap and piston are made of natural
rubber.
Prefilled hand-held syringes: 30, 50 ml (box of 1 and 10)
Power injector syringes: 50, 75, 100, 125 ml (box of 1 and 10)
Not all pack sizes and box sizes may be marketed in all countries.
Marketing Authorisation Holder and Manufacturer
• Marketing Authorisation Holder
Mallinckrodt UK Commercial Ltd., Building 1000, Lakeside, Portsmouth, PO6
3EZ, United Kingdom
• Manufacturer
Mallinckrodt Medical Imaging Ireland, Damastown, Mulhuddart, Dublin 15,
Ireland
This leaflet was last revised in 05/2015.
2

paravasation may necessitate surgical treatment.
g. Extravasation can cause serious tissue reactions including blistering and
skin exfoliation, the extent of which is dependent on the amount and
strength of the contrast solution in the tissues.

Uncommon (≥ 1/1000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1000)
Very rare (< 1/10,000)
Not known (cannot be estimated from the available data)
a. Summary of the safety profile
Adverse reactions following the use of Optiray formulations are generally
independent of the dose administered. Usually, they are mild to moderate, of
short duration and resolve spontaneously (without treatment). However, even
mild adverse reactions may be the first indication of a serious, generalized
reaction that can occur rarely after iodinated contrast media. Such serious
reactions may be life-threatening and fatal, and usually affect the cardiovascular
system. Most adverse drug reactions to Optiray formulations occur within
minutes after administration, however contrast related hypersensitivity reactions
may occur with a delay of some hours up to several days.
b. Tabulated summary of adverse reactions
From clinical studies, mild discomfort, including sensation of heat or cold, pain
during the injection, and/or transient taste perversion, was noted in 10% to 50%
of patients. In a large post-marketing study, other side effects occurred in a total
of 1.1% of the patients; the most frequent were nausea (0.4%), skin reactions
such as urticaria or erythema (0.3%), and vomiting (0.1%). All other events
occurred in less than 0.1% of the patients.
Immune system disorders:
Very rare
anaphylactoid (hypersensitivity) reaction
Not known
anaphylactic shock
Endocrine disorders:
Not known
transient neonatal hypothyroidism
Psychiatric disorders:
Very rare
confusional state; agitation; anxiety
Nervous system disorders:
Rare
syncope; tremor; vertigo (including dizziness, light-headedness);
headache; paraesthesia; dysgeusia
Very rare
loss of consciousness; paralysis; speech disorders; somnolence;
stupor; aphasia; dysphasia; hypoaesthesia
Not known
convulsions; dyskinesia; amnesia
Eye disorders:
Rare
vision blurred
Very rare
conjunctivitis allergic (including eye irritation, ocular
hyperaemia, watery eyes, swelling of conjunctiva, etc.)
Not known
blindness transient
Ear and labyrinth disorders:
Very rare
tinnitus
Cardiac disorders:
Rare
tachycardia
Very rare
heart block; arrhythmia; angina; ECG abnormal; bradycardia;
atrial fibrillation
Not known
cardiac arrest; ventricular fibrillation; coronary artery spasm;
cyanosis; extrasystole; palpitations
Vascular disorders:
Rare
hypotension; flushing
Very rare
cerebrovascular disorder; phlebitis; hypertension; vasodilation
Unknown
Shock; thrombosis; vasospasm
Respiratory, thoracic and mediastinal disorders:
Rare
laryngeal spasm, oedema and obstruction (incl. throat
tightness, stridor, etc.); dyspnoea; rhinitis (incl. sneezing, nasal
congestion); throat irritation; cough
Very rare
pulmonary oedema; pharyngitis; hypoxia
Not known
respiratory arrest; asthma; bronchospasm; dysphonia
Gastrointestinal disorders:
Uncommon
nausea
Rare
vomiting; dry mouth
Very rare
sialoadenitis; abdominal pain; tongue oedema; dysphagia;
hypersalivation
Not known
diarrhoea

d. Paediatric population
Frequency, type and severity of adverse reactions in children are expected to
be the same as in adults. Transient hypothyroidism was observed in neonates
following the administration of iodinated radiopaque agents.
e. 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 Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard.
4.9. Overdose
As with all iodinated X-ray contrast media, overdoses of Optiray are potentially
fatal and may affect the respiratory and cardiovascular system. Treatment should
be symptomatic. Dialysis can be used to remove Optiray from the blood.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Watersoluble, nephrotropic, low osmolar X-ray
contrast media
ATC code: V08AB07
Optiray 300 is a non-ionic X-ray contrast medium. Intravascular injection of
Optiray opacifies those vessels in the path of the flow of the contrast medium,
permitting radiographic visualisation of the internal structures until significant
haemodilution occurs.
5.2. Pharmacokinetic properties
The pharmacokinetic profile of Optiray, together with its hydrophilic properties
and a very low level of binding to serum and plasma proteins, indicate that
Optiray is distributed within the extracellular fluid space and eliminated quickly
through the kidneys by glomerular filtration. The mean (± se) half-lives after
doses of 50 ml and 150 ml were 113 ± 8.4 and 104 ± 15 minutes respectively.
Elimination via the faeces is negligible. No significant metabolism, deiodination,
or biotransformation of Optiray has been observed.
5.3. Preclinical safety data
There were no findings in the preclinical testing of Optiray which could be of
relevance for the prescriber in recognising the safety of this product used for the
authorised indications, and which are not already included in other sections of
the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Trometamol, trometamol hydrochloride,
sodium hydroxide and/or hydrochloric acid (for pH: 6.0 to 7.4),
sodium calcium edetate,
water for injections.
6.2. Incompatibilities
No other medicinal product should be mixed with Optiray.
6.3. Shelf life
3 years.
After use, discard the remaining solution.
6.4. Special precautions for storage
Keep the container in the outer carton in order to protect from light. Protect
from X-rays. Do not store above 30°C. Optiray can be stored for one month at
37°C in a contrast medium warmer with circulating air. Discard the solution in
case of discolouration or particulate matter.
6.5. Nature and contents of container
Optiray 300 is packaged in uncoloured bottles composed of type I glass
(Ph. Eur.). Bottles are fitted with either 20 mm or 32 mm bromobutyl rubber
closures and aluminium cap seals.
10, 20, 50, 75, 100, 150 ml (box of 1 and 10)
Optiray 300 is also supplied in prefilled hand-held syringes and power injector
syringes made of polypropylene. Syringe tip cap and piston are made of natural
rubber.

Skin and subcutaneous tissue disorders:
Uncommon
urticaria
Rare
erythema; pruritus; rash
Very rare
angioedema; hyperhidrosis (incl. cold sweat)
Not known
toxic epidermal necrolysis; acute generalized erythematous
pustulosis; erythema multiforme; pallor

Prefilled hand-held syringes:
30, 50 ml (box of 1 and 10)

Musculoskeletal, connective tissue and bone disorders:
Very rare
muscle cramps

6.6. Instruction for use, handling and disposal
Hand-held syringes and power injector syringes:

Renal and urinary disorders:
Rare
micturition urgency
Very rare
acute renal failure; abnormal renal function; incontinence;
haematuria; decreased creatinine clearance; BUN increased
Not known
anuria; dysuria

The medicinal product and fluid pathway are sterile; the outside of the syringe is
not sterile.

General disorders and administration site conditions:
Very common feeling hot
Common
pain
Rare
face oedema (incl. eye swelling, periorbital oedema, etc.);
pharyngeal oedema; chills (incl. shaking chills, feeling cold)
Very rare
oedema; injection site reactions (incl. pain, erythema, and
haemorrhage up to necrosis especially after extravasation); chest
pain; asthenic conditions (incl. malaise, tiredness, sluggishness,
etc.); feeling abnormal
Not known
pyrexia
c. Description of selected adverse reactions
Adverse reactions may be classified as follows:
a. Hypersensitivity or anaphylactoid reactions are mostly mild to moderate
with symptoms like rash, pruritus, urticaria and rhinitis.
However, serious reactions may occur. Serious anaphylactic reactions
generally affect the cardiovascular and respiratory system. These may be
life-threatening and include anaphylactic shock, cardiac and respiratory
arrest, or pulmonary oedema. Fatal cases were reported.
Patients with a history of allergic reactions are at increased risk of
developing a hypersensitivity reaction. Other type 1 (immediate) reactions
include symptoms like nausea and vomiting, skin rashes, dyspnoea, rhinitis,
paraesthesia or hypotension.
b. Vasovagal reactions e.g. dizziness or syncope which may be caused either by
the contrast medium, or by the procedure.
c. Cardiologic side effects during cardiac catheterisation e.g. angina pectoris,
ECG changes, cardiac arrhythmias, conductivity disorders, as well as
coronary spasm and thrombosis. Such reactions are very rare and may be
caused by the contrast medium or by the procedure.
d. Nephrotoxic reactions in patients with pre-existing renal damage or renal
vasopathy, e.g. decrease in renal function with creatinine elevation. These
adverse effects are transient in the majority of cases. In single cases, acute
renal failure has been observed.
e. Neurotoxic reactions after intra-arterial injection of the contrast medium
e.g. visual disorders, disorientation, paralysis, convulsions, or fits. These
symptoms are generally transient and abate spontaneously within several
hours or days. Patients with pre-existing damage of the blood-brain barrier
are at increased risk of developing neurotoxic reactions.
f. Local reactions at the injection site may occur in very rare cases and
include rashes, swelling, inflammation and oedema. Such reactions occur
probably in most cases due to extravasation of the contrast agent. Extended
3

Power injector syringes:
50, 75, 100, 125 ml (box of 1 and 10)
Not all pack sizes and box sizes may be marketed.

Instructions for assembly and inspection are stated on the outer carton of the
syringes.
7. MARKETING AUTHORISATION HOLDER
Mallinckrodt UK Commercial Ltd.
Building 1000, Lakeside, Portsmouth, PO6 3EZ, United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 41744/0011
9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 30 October 1992
Date of latest renewal: 3 March 2006
10. DATE OF REVISION OF THE TEXT
01/05/2015

4

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide