Legal mentions
Optivantage DH Contrast Media Injectors is a medical device intended for use by qualified healthcare
professionals, it is a contrast delivery system and is designed to inject radiopaque contrast media intoa patient's vascular system to obtain diagnostic images when used with computed tomography (i.e.
"CT") equipment.
Ensure that injection from multi-dose containers and to more than one patient respects the valid rulesof good practice and the marketing authorization (MA) of the contrast agent and local regulatory
requirements.
Class IIb/CETÜV SÜD 0123
Manufacturer: Liebel-Flarsheim Company LLC
EC Rep: Guerbet
Optistar Elite Contrast Delivery System is a medical device intended for use by qualified healthcare
professionals. It is intended to inject MR contrast media and flushing solutions into a patient's
vascular system to obtain diagnostic images when used in conjunction with Magnetic Resonance (MR)Imaging equipment.
Class IIb/CETÜV SÜD 0123
Manufacturer: Liebel-Flarsheim Company LLC
EC Rep: Guerbet
For complete information about precautions and optimal usage conditions, we recommend consulting
the instruction for use supplied with the device or by your local Guerbet representative(s). For use onlyin countries with applicable health authority registrations.

OPTIRAY™ is a sterile, non-pyrogenic, aqueous solution intended for intravascular and subarachnoid
administration.
Composition:(*) OPTIRAY™ 160 Ioversol, 339 mg/ml, which is equivalent to 160 mg/ ml of organicallybound iodine. OPTIRAY™ 240 Ioversol, 509 mg/ml, which is equivalent to 240 mg/ ml of organicallybound iodine. OPTIRAY™ 300 Ioversol, 636 mg/ml, which is equivalent to 300 mg/ml of organicallybound iodine. OPTIRAY™ 320 Ioversol, 678 mg/ml, which is equivalent to 320 mg/ml of organicallybound iodine. OPTIRAY™ 350 Ioversol, 741 mg/ml, which is equivalent to 350 mg/ml of organicallybound iodine.
Indications (*): OPTIRAY™ non-ionic X-ray contrast medium for diagnostic use only.
OPTIRAY™ 350 is indicated in adults for angiography, including intra-arterial, digital subtraction
angiography (IA-DSA), throughout the cardiovascular system, except selective cerebral angiography.
OPTIRAY™ 350 is also indicated for contrast enhanced computed tomographic imaging of the headand body, intravenous excretory urography, intravenous digital subtraction angiography andvenography. OPTIRAY™ 350 is indicated in children for angiocardiography.
OPTIRAY™ 320 is indicated in adults for angiography, including digital subtraction angiography (DSA),
throughout the cardiovascular system. The uses include but are not limited to cerebral, coronary,
peripheral, visceral and renal arteriography, venography, aortography, and left ventriculography.
OPTIRAY™ 320 is also indicated for contrast enhanced computed tomographic imaging of the headand body, and intravenous excretory urography. OPTIRAY™ 320 is indicated in children forangiocardiography, contrast enhanced computed tomographic imaging of the head and body, andintravenous excretory urography.
OPTIRAY™ 300 is indicated for cerebral, peripheral, and abdominal arteriography, including digital
subtraction angiography (DSA), in adults. OPTIRAY™ 300 is also indicated for contrast enhanced
computed tomographic imaging of the head and body, venography, and intravenous excretoryurography. OPTIRAY™ 300 is indicated in children for cerebral, peripheral and abdominal angiography,
including digital subtraction angiography (DSA), computed tomography of the head and body, andintravenous excretory urography.

OPTIRAY™ 240 is indicated for cerebral, peripheral, and abdominal angiography, including intraarterial, digital subtraction angiography (IA-DSA), and venography in adults. OPTIRAY™ 240 is also
indicated for contrast enhanced computed tomographic imaging of the head and body and intravenous
excretory urography. OPTIRAY™ 240 is indicated in children for cerebral, peripheral and abdominal
angiography, including digital subtraction angiography (DSA), computed tomography of the head andbody, and intravenous excretory urography. OPTIRAY™ 240 is indicated for subarachnoid
administration in adults for lumbar, thoracic and cervical myelography, in some countries.
OPTIRAY™ 160 is only indicated for intra-arterial digital subtraction angiography (IADSA) in adults.
Posology and Method of Administration (*): The dosage may vary between 1 ml and 150 ml,
maximum total dose 250 ml or less depending on the indications, the composition of OPTIRAY, thepatient’s factors and other technical factors. Please refer to the Summary of Product Characteristics
for the recommended dosage schedule.
Contraindications: Hypersensitivity to ioversol ot to any of the excipients. Manifest hyperthyroidism.
Special Warnings and Precautions for Use: Diagnostic procedures which involve the use of iodinatedintravascular contrast agents should be carried out under the direction of personnel skilled andexperienced in the particular procedure to be performed. A fully equipped emergency cart, or equivalent
supplies and equipment, and personnel competent in recognizing and treating adverse reactions of all
types should always be available. Since severe delayed reactions have been known to occur,
emergency facilities and competent personnel should be available for at least 30 to 60 minutes afteradministration. Preparatory dehydration is dangerous and may contribute to acute renal failure inpatients with advanced vascular disease, diabetic patients and in susceptible nondiabetic patients (often
elderly with pre-existing renal disease). Patients should be well hydrated prior to and following theadministration of Optiray. The possibility of a reaction, including serious, life-threatening, fatal,
anaphylactoid or cardiovascular reactions, should always be considered (See Adverse Reactions).
Severe, life-threatening, systemic hypersensitivity reactions such as drug rash with eosinophilia andsystemic symptoms (DRESS) have been reported in patients administered Optiray. Early or late
manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash
is not evident. If such signs or symptoms are present, the patient should be evaluated immediately.
Increased risk is associated with a history of previous reaction to a contrast medium, and known allergies(i.e., bronchial asthma, hay fever and food allergies) or hypersensitivities. 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 issuggested that a thorough medical history with emphasis on allergy and hypersensitivity, prior to theinjection of any contrast medium, may be more accurate than pre-testing in predicting potential adverse
reactions. A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of
a contrast agent when a diagnostic procedure is thought essential, but caution should be exercised.
Pre-medication with antihistamines or corticosteroids to avoid or minimize possible allergic reaction insuch patients 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 anesthesia may be
indicated in the performance of some procedures in selected patients. However, a higher incidence ofadverse reactions has been reported in these patients and may be attributable to the inability of thepatient to identify untoward symptoms or to the hypotensive effect of anesthesia. In angiographic
procedures, the risk of dislodging plaques or damaging or perforating the vessel wall should beconsidered during catheter manipulations and contrast medium injection. Test injections to ensure
proper catheter placement are suggested. Angiography should be avoided whenever possible inpatients with homocystinuria because of the risk of inducing thrombosis and embolism. Patients withcongestive heart failure should be observed for several hours following the procedure to detect delayed
hemodynamic disturbances which may be associated with a transitory increase in the circulating osmotic
load. About procedural risks, selective coronary arteriography should be performed only in selectedpatients and those in whom the expected benefits outweigh the procedural risk. The inherent risks ofangiocardiography in patients with chronic pulmonary emphysema must be weighed against thenecessity for performing this procedure. Caution during injection of a contrast medium is necessary to
avoid extravasation. This is especially important in patients with severe arterial or venous disease.
Specific warnings related to Intravascular administration: Caution must be exercised in patientswith hyperthyroidism or with an autonomously functioning thyroid nodule, severely impaired renal
function, renal and hepatic disease, multiple myeloma or other paraproteinemia, anuria,
pheochromocytoma, sickle cell disease and in neonates. Meticulous intravascular administration
technique is necessary, particularly during angiographic procedures, to minimize thromboembolic
events. Specific warnings related to Subarachnoid administration: Myelography should not be
performed in the presence of significant local or systemic infection where bacteremia is likely or when
lumbar or cervical puncture is contraindicated. Myelography should be performed only in hospitalized
patients under close medical observation, which is to be continued for 24 hours following the procedure.
Gravitational displacement of a concentrated bolus of Optiray above the level of C1 and especially into
the intracranial subarachnoid spaces is to be avoided. Caution must be exercised in patients with historyof seizure, epilepsy and elderly patients. Please refer to the Summary of Product Characteristics
for complete information about specific warnings.
Interactions with other medicinal products and other forms of interaction: With metformine,vasopressor and the results of protein-bound iodine (PBI) 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 contrast media. Please refer to summary of product characteristics. Fertility,
pregnancy and lactation: There are no adequate and well controlled studies in pregnant women. This
drug should be used during pregnancy only if clearly needed. Although it has not been established thatadverse reactions occur in nursing infants, caution should be exercised when intravascular contrast
media are administered to nursing women because of potential adverse reactions, and consideration
should be given to temporarily discontinuing nursing.
Effects on ability to drive and use machines: There is no known effect on the ability to drive andoperate machines. However, because of the risk of early reactions, driving or operating machinery is
not advisable for 30 to 60 min following administration.
Undesirable effects:
Adverse reactions following the use of OPTIRAY™ 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 lifethreatening 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. Injections of contrast
media are very commonly associated with sensations of warmth, and commonly associated with pain.
Adverse reactions may be classified as follows: • Hypersensitivity or anaphylactoid reactions aremostly mild to moderate with symptoms like rash, pruritus, urticaria, rhinitis and blister. These symptoms
may occur independent of dose and route of administration and may be the first signs of an evolving
shock with symptoms like pronounced decrease in blood pressure, tachycardia, dyspnoea, pallor anddecrease in consciousness. Fatal cases were reported. • Vasovagal reactions with symptoms ranging
from dizziness and hypotension to syncope. Vasovagal reactions may be caused either by the contrast
media or by the procedure. • Cardiologic side effects during cardiac catheterization may include ECGchanges, arrhythmia, conductivity disorders as well as coronary spasm. Such reactions may be causedby the contrast media or by the procedure. • Nephrotoxic reactions with acute renal failure may occur inpatients with pre-existing renal damage. • Neurotoxic reactions after intra-arterial injection of the contrast
medium like confusion, visual disorders, convulsions or fits. The symptoms are generally transient andabate spontaneously within several hours. • Local reactions at the injection site may occur and include
rashes, swelling, inflammation and edema. Such reactions occur probably in most cases due toextravasation of the contrast agent. Extended paravasation may necessitate surgical treatment. For
subarachnoid administration: Any adverse reactions known to occur with the intravascular use of
OPTIRAY™ can also occur during myelography, especially those which originate in the CNS. The mostcommonly observed adverse reaction was headache, which had an incidence of 8.6%.

Overdose: The adverse effects of overdosage are life-threatening and affect mainly the pulmonary andcardiovascular system. Treatment of an overdosage is directed toward the support of all vital functions
and prompt institution of symptomatic therapy.
Pharmacological properties: Pharmacotherapeutic group: water-soluble, nephrotropic, low-osmolar
X-ray contrast media ATC code: V08AB07.
Incompatibilities: No medicinal product should be mixed with OPTIRAY™.
Nature and content of container: (*) OPTIRAY™ is supplied in glass bottles and plastic pre-filled
syringes.
Marketing authorization holder: (*) Information: Guerbet – BP 57400 – F-95943 Roissy CdG cedex- France. Tel: 33 (0) 1 45 91 50 00. Date of revision: 13/12/2020

For current and complete prescribing information refer to the local Summary of Product Characteristics(SmPC) and /or contact your local Guerbet organization.
(*) Marketing Authorization Information: The marketing authorization holder, number and date of
approval may differ from one country to another. Volume, presentation, indication and Posology andMethod of Administration may also differ.

Reporting of suspected adverse reactions is important as it helps to continuously assess thebenefit-risk balance. Therefore, Guerbet encourages you to report any adverse reactions to yourhealth authorities or to our local Guerbet representative.

DOTAREM 0.5 mmol/mL, solution for injection. Composition: For 100 mL of solution: active
ingredient: Gadoteric Acid 27.932 g corresponding to: DOTA 20.246 g corresponding to gadolinium
oxide 9.062 g. Indications (*): Medicinal product for diagnostic use only: Magnetic Resonance Imaging
for cerebral and spinal disease, diseases of the vertebral column, and other whole-body pathologies(including angiography). Dotarem should be used only when diagnostic information is essential andnot available with unenhanced magnetic resonance imaging (MRI). Posology and method ofadministration: The recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg in adults and children. The
lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The doseshould be calculated based on the patient’s body weight, and should not exceed the recommended
dose per kilogram of body weight detailed in this section. In angiography, depending on the results ofthe examination being performed, a second injection may be administered during the same session if
necessary. Angiography with Gadoteric acid is not recommended in children (0-18 years). In
Encephalic and spinal MRI, in some exceptional cases, as in the confirmation of isolated metastasis or
the detection of leptomeningeal tumours, a second injection of 0.2 mmol/kg may improve tumor
characterisation and facilitate therapeutic decision making. For patients with impaired renal function
and paediatric population (0-18 years) more than one dose should not be used during a scan,
injections should not be repeated unless the interval between injections is at least 7 days. The productmust be administered by strict intravenous injection. Depending on the amount of gadoteric acid tobe given to the child, it is preferable to use gadoteric acid vials with a single use syringe of a volume
adapted to this amount in order to have a better precision of the injected volume. In neonates andinfants the required dose should be administered by hand. Contraindications: Hypersensitivity togadoteric acid, to meglumine or to any medicinal products containing gadolinium. Special warnings
and precautions for use: Dotarem must not be administered by subarachnoid (or epidural) injection.
The usual precaution measures for MRI examination should be taken such as exclusion of patientswith pacemakers, ferromagnetic vascular clips, infusion pumps, nerve stimulators, cochlear implants

or suspected intracorporal metallic foreign bodies, particularly in the eye. General particulars
corresponding to all gadolinium contrast agents: All gadolinium based contrast media can cause
minor or major hypersensitivity reactions that can be life-threatening. These can occur immediately(within 60 minutes) or be delayed (within 7 days) and are often unpredictable. Because of the risk ofmajor reactions, emergency resuscitation equipment should be available for immediate use.
Hypersensitivity reactions can be aggravated in patients on betablockers and particularly in thepresence of bronchial asthma. These patients may be refractory to standard treatment ofhypersensitivity reactions with beta agonists. Impaired renal function: Prior to administration ofgadoteric acid, it is recommended that all patients are screened for renal dysfunction by obtaining
laboratory tests. There have been reports of Nephrogenic Systemic Fibrosis (NSF) associated with useof some gadolinium-containing contrast agents in patients with severe renal impairment (GFR < 30
ml/min/1.73 m2). As there is a possibility that NSF may occur with Dotarem, it should only be used inthese patients after careful consideration. CNS disorders: As with other contrast agents containing
gadolinium, special precautions should be taken in patients with a low seizure threshold.
Precautionary measures, e.g. close monitoring, should be taken. All equipment and drugs necessary
to counter any convulsions which may occur must be made ready for use beforehand. Interactions
with other medicinal products and other forms of interaction: No interactions with other medicinal
products have been observed. Formal drug interaction studies have not been carried out. Fertility,
pregnancy and lactation: Gadoteric acid should not be used during pregnancy unless the clinicalcondition of the woman requires use of gadoteric acid. Continuing or discontinuing breast feeding fora period of 24 hours after administration of gadoteric acid, should be at the discretion of the doctor
and lactating mother. Effects on ability to drive and use machines: No studies on the effects on theability to drive and use machines have been performed. Ambulant patients while driving vehicles oroperating machinery should take into account that nausea may incidentally occur. Undesirable
effects: Uncommon (≥1/1000 to <1/100): hypersensitivity, headache, dysgeusia, dizziness,
somnolence, paraesthesia (including burning sensation), hypotension, hypertension, nausea,
abdominal pain, rash, feeling hot, feeling cold, asthenia, injection site reactions (extravasation, pain,
discomfort, oedema, inflammation, coldness). Rare (≥1/10 000 to <1/1 000): anxiety, presyncope,eyelid edema, palpitations, sneezing, throat tightness, vomiting, diarrhea, salivary hypersecretion,
Urticaria, pruritus, hyperhidrosis, chest pain, chills. Very rare (<1/10 000): anaphylactic reaction,
anaphylactoid reaction, agitation, coma, convulsion, syncope, tremor, parosmia, conjunctivitis, ocular
hyperaemia, vision blurred, lacrimation increased, tachycardia, cardiac arrest, arrhythmia,
bradycardia, flushing, pallor, vasodilatation, hot flush, cough, dyspnoea, nasal congestion, respiratoryarrest, bronchospasm, throat irritation, laryngospasm, pharyngeal oedema, dry throat, pulmonary
oedema, erythema, angioedema, eczema, muscle cramps, muscular weakness, back pain, arthralgia,
malaise, chest discomfort, pyrexia, face oedema, injection site necrosis (in case of extravasation),
phlebitis superficial, decreased oxygen saturation, Not known : nephrogenic systemic fibrosis.
Overdose: Gadoteric acid can be removed by haemodialysis. However there is no evidence that
haemodialysis is suitable for prevention of nephrogenic systemic fibrosis. Please note: The peel-off
tracking label on the vials or syringes should be stuck onto the patient record to enable accurate
recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic
patient records are used, the name of the product, the batch number and the dose should be enteredinto the patient record. Pharmacological properties: Pharmacotherapeutic group: paramagnetic
contrast media for MRI, ATC code: V08CA02. Presentation (*): 5, 10, 15, 20, 60 & 100 mL in vial (glass)and 10, 15 & 20 mL in a prefilled syringe (glass). Marketing authorization holder: (*) Information:
Guerbet - BP 57400 - F-95943 Roissy CdG cedex – FRANCE. Tel: 33 (0) 1 45 91 50 00. Date of revisionof this document: February 2018
For current and complete prescribing information refer to the package insert and/or contact your local
Guerbet organization.
(*) Indications, presentations and marketing authorization holder may differ from country to country.

Reporting of suspected adverse reactions is important as it helps to continuously assess the benefitrisk balance. Therefore, Guerbet encourages you to report any adverse reactions to your healthauthorities or to our local Guerbet representative.

March 2021