Ioversol

Registered South African indications:

• Angiography
• Intravenous digital subtraction angiography
• Aortography 
• Venography
• Left ventriculography 
• Intravenous urography
• Contrast enhanced computed tomography

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Proven hypersensitivity to iodine-containing contrast media 
• Pregnancy
• Breastfeeding
• Manifest hyperthyroidism

Cautions

• Renal impairment
  - Renal damage in diabetic patients 
  - Severely impaired renal function
  - Pre-existing renal damage
  - Renal vasopathy
  - Combined renal and hepatic disease
  - Anuria
• Hepatic impairment
• Elderly
• Paediatrics
  - Neonates
  - Asthma
  - Sensitivity to medication and/or allergies
  - Congestive heart failure
  - Serum creatinine >132.6μmol/l
  - Below 12 months of age
• Suspected hypersensitivity to iodinated contrast
• Iodine allergy
• History of increased sensitivity to iodine
• Known allergies
• Positive history of allergy
• Asthma
• Congestive heart failure
• Diabetes mellitus
• Homozygous sickle cell disease
• Multiple myeloma
• Paraproteinaemia
• Large doses 
• Preparatory dehydration
• Hyperthyroidism
• Autonomously functioning thyroid nodule
• General anaesthesia
• Known or suspected phaeochromocytoma
• Homocystinuria
• Prolonged contact of blood with contrast agent in syringes and catheters
• Advanced atherosclerosis
• Serious uncontrolled/severe hypertension
• Cardiac decompensation
• Procedural technique 
  - Intravascular administration technique
• Senility
• Severe arterial or venous disease
• Suspected phlebitis (for the indication of venography)
• Serious ischaemia (for the indication of venography)
• Local infections (for the indication of venography)
• Complete occlusion of the venous system (for the indication of venography)
• Preceding cerebral thrombosis or embolism
• Thromboangiitis obliterans (for the indication of peripheral angiography)
• Ascending infections in combination with serious ischaemia (for the indication of peripheral angiography)
• Pre-existing damage to the blood-brain barrier
• Recently received a cholecystographic contrast agent
• Coadministration with biguanides (e.g. metformin)

Forms avail. in SA and covered in this monograph: inj, pfs

Angiography 
- Throughout the cardiovascular system

Procedure	Strength	Dosage and administration
Cerebral angiography: Carotid or vertebral artery	320mg OR 300mg	IV: Initial: 2-12ml, immediately, as a single dose; Max: 200ml
Cerebral angiography: Aortic arch	320mg OR 300mg	IV: Initial: 20-50ml, immediately, as a single dose; Max: 200ml
Peripheral angiography: Aortic-iliac runoff	350mg OR 320mg OR 300mg	IV: Initial: 60ml (10-90ml), immediately, as a single dose; Max: 250ml
Peripheral angiography: Common iliac, femoral	350mg OR 320mg OR 300mg	IV: Initial: 40ml (10-50ml), immediately, as a single dose
Peripheral angiography: Subclavian, brachial	350mg OR 320mg OR 300mg	IV: Initial: 20ml (15-30ml), immediately, as a single dose; may be repeated as necessary
Visceral angiography	350mg OR 320mg OR 300mg	IV: Initial: 12-60ml, immediately, as a single dose; Max: 250ml; may be repeated as necessary Celiac IV: Initial: 45ml (12-60ml), immediately, as a single dose; Max: 250ml; may be repeated as necessary Superior mesenteric IV: Initial: 45ml (12-60ml) immediately, as a single dose; Max: 250ml; may be repeated as necessary
Renal angiography	350mg OR 320mg	IV: Initial: 6-15ml, immediately, as a single dose; Max: 250ml; may be repeated as necessary Renal or inferior mesenteric IV: Initial: 9ml (6-15ml), immediately, as a single dose; Max: 250ml; may be repeated as necessary
Coronary arteriography	350mg OR 320mg	IV: Initial: 1-10ml, immediately, as a single dose; Max: 250ml Left coronary artery IV: Initial: 8ml (2-10ml), immediately, as a single dose; Max: 250ml; may be repeated as necessary Right coronary artery IV: Initial: 6ml (1-10ml), immediately, as a single dose; Max: 250ml; may be repeated as necessary Several minutes should be permitted to elapse between each injection to allow for subsidence of possible haemodynamic disturbances

Intravenous digital subtraction angiography

Procedure	Strength	Dosage and administration
Digital subtraction angiography (DSA):  Intra-arterial (IA DSA)	350mg OR 300mg	IV: Initial: 5-80ml, immediately, as a single dose; Max: 250ml
Digital subtraction angiography (DSA):  Intravenous (IV DSA)	350mg OR 300mg	IV: Initial: 30-50ml, immediately, as a single dose; Max: 250ml; may be repeated as necessary

Aortography

Procedure	Strength	Dosage and administration
Aortography	350mg OR 320mg	IV: Initial: 10-80ml, immediately, as a single dose; Max: 250ml; may be repeated as necessary Aorta IV: Initial: 45ml (10-80ml),  immediately, as a single dose; Max: 250ml; may be repeated as necessary

Venography

Procedure	Strength	Dosage and administration
Venography	350mg OR 300mg	IV: Initial: 50-10ml per extremity, immediately, as a single dose; Max: 250ml Following the procedure, the venous system should be flushed with sodium chloride injection USP (United States Pharmacopeia) or 5% dextrose in water. Massage and elevation are also helpful for clearing the extremities

Left ventriculography 

Procedure	Strength	Dosage and administration
Left ventriculography	350mg OR 320mg	IV: Initial: 30-50ml, immediately, as a single dose; Max: 250ml; may be repeated as necessary Left ventricle IV: Initial: 40ml, immediately, as a single dose; Max: 250ml; may be repeated as necessary Several minutes should be permitted to elapse between each injection to allow for subsidence of possible haemodynamic disturbance

Intravenous urography

Procedure	Strength	Dosage and administration
Urography	350mg OR 320mg OR 300mg	IV: Initial: 50-75ml, immediately, as a single dose; Max: 150ml

Contrast enhanced computed tomography (CT)

Procedure	Strength	Dosage and administration
Head imaging (Head CT)	350mg OR 320mg OR 300mg	IV: Initial: 50-150ml, immediately, as a single dose; Max: 150ml Scanning may be performed immediately after IV administration
Body imaging (Body CT)	350mg OR 320mg OR 300mg	IV: Initial: 25-150ml, immediately, as a single dose; Max: 150ml

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Diagnostic procedures which involve the use of iodinated intravascular contrast agents such as ioversol should be carried out under the direction of personnel skilled and experienced in the particular procedure to be performed (See additional prescribing points)

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It is recommended that intravascularly administered iodinated contrast agents are warmed to body temperature prior to injection

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The lowest dose necessary to obtain adequate visualisation should be used

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Patients should be well-hydrated prior to, and following administration

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No other medicines should be mixed with the solution due to the risk of chemical incompatibility

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Sterile technique must be used in all vascular injections involving contrast media. All solutions should be inspected visually for particulate matter and discolouration prior to administration and should not be used if particles are observed or discolouration has occurred

Paed. forms avail. in SA and covered in this monograph: inj, pfs

Younger than 4 weeks

• Not established for use (300mg & 320mg)

Older than 4 weeks

• See tables below 

Angiography
- Cerebral, peripheral and visceral 

Procedure	Strength	Dosage
Cerebral angiography	300mg	IV: Initial: 1-3ml/kg, immediately, as a single dose; Max: 100ml
Peripheral angiography	300mg	IV: Initial: 1-3ml/kg, immediately, as a single dose; Max: 100ml
Visceral and renal angiography and aortography	300mg	IV: Initial: 1-3ml/kg, immediately, as a single dose; Max: 100ml

Intravenous urography

Procedure	Strength	Dosage
Intravenous urography	300mg	>1 year of age IV: Initial: 2ml/kg, immediately, as a single dose; Max: 100ml <1 year of age IV: Initial: 3ml/kg, immediately, as a single dose; Max: 100ml

Angiocardiography

Procedure	Strength	Dosage
Paediatric angiocardiography	320mg	IV: Initial: 1-1.5ml/kg, immediately, as a single dose; Max: 250ml Usual single injection dose - 1.25ml/kg body mass When multiple injections are given, total administered dose should not exceed 5ml/kg

Contrast enhanced computed tomography of the head and body

Procedure	Strength	Dosage
Computed tomography: Head imaging or body imaging	320mg	IV: Initial: 1-3ml/kg, immediately, as a single dose; Max: 100ml

Intravenous urography

Procedure	Strength	Dosage
Intravenous urography	320mg	IV: Initial: 0.5-3ml/kg, immediately, as a single dose; Max: 100ml Paediatric doses of 0.5-3ml/kg have produced diagnostic opacification of the excretory tract. The usual dose is 1-1.5ml/kg Dosage for infants and children should be administered in proportion to age and body mass. The total administered dose should not exceed 3ml/kg

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Safety and effectiveness of 350mg in children have not yet been established and should therefore not be used in children until further data becomes available

Pregnancy

• Contraindicated
• Safety in pregnancy has not been established
• There has been limited human use in pregnancy. However, since any X-ray investigation during pregnancy may involve a potential foetal risk, the risk/benefit ratio should be carefully weighed
• If a better known and safer alternative is available, an X-ray investigation involving ioversol should be avoided

Breastfeeding

• Contraindicated 
• Safety in breastfeeding has not been established
• It is not known whether ioversol is excreted in human breastmilk. However, ioversol may be excreted unchanged in breast milk
• Caution should be exercised when ioversol is administered to women breastfeeding their infants, because of potential adverse events, and mothers given ioversol should discontinue breastfeeding for one day

Fertility

• No information available 

Renal Impairment

• Caution; no dose adjustment recommended 
  Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, or anuria

Hepatic Impairment

• Caution; no dose adjustment recommended  
  Caution must be exercised in patients with combined renal and hepatic disease

Elderly

• Caution; no information available

Porphyria

• Not porphyrinogenic (NP) 

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Syncope
• Disorientation
• Paralysis
• Seizures 
• Confusional state
• Agitation
• Anxiety 
• Paraesthesia
• Tremor
• Headache
• Somnolence 
• Dysphasia
• Hypoesthesia 
• Stupor 
• Dyskinesia
• Amnesia  
• Vertigo
  - Dizziness
  - Lightheadedness
• Aphasia 
• Loss of consciousness
• Asthenic conditions
  - Malaise
  - Tiredness
  - Sluggishness

Cardiovascular Disorders

• Tachycardia
• Hypotension 
• Angina pectoris
• Electrocardiogram (ECG) changes
• Conductivity disorders
• Dysrhythmia
• Atrial fibrillation
• Bradycardia
• Circulatory failure
• Heart block
• Cardiac arrest
• Ventricular fibrillation
• Coronary artery spasm
• Cyanosis
• Extrasystole
• Palpitations
• Cerebrovascular disorder
• Thrombophlebitis
• Shock
• Thrombosis
• Vasospasm
• Chest pain

Respiratory Disorders

• Laryngeal spasm
• Stridor
• Cough
• Dyspnoea
• Rhinitis
  - Sneezing
  - Nasal congestion
• Hypoxia
• Pulmonary oedema
• Respiratory arrest
• Bronchospasm
• Dysphonia
• Throat irritation

Gastrointestinal Disorders

• Nausea and vomiting
• Dry mouth
• Abdominal pain
• Sialoadenitis
• Hypersalivation
• Tongue oedema
• Dysphagia
• Diarrhoea

Genitourinary Disorders

• Incontinence
• Acute renal failure
• Increased blood urea
• Abnormal renal function
• Decreased creatinine clearance
• Elevated creatinine
• Haematuria
• Anuria
• Painful/difficult micturition
• Micturition urgency 

​​​​​Endocrine and Metabolic Disorders

• Transient neonatal hypothyroidism 

Musculoskeletal Disorders

• Muscle cramps

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Erythema
• Pruritus
• Rash
• Increased sweating
• Stevens-Johnson syndrome
• Pallor
• Acute generalised exanthematous pustulosis (AGEP)
• Erythema multiforme
• Injection site reactions
  - Pain 
  - Erythema 
  - Haemorrhage up to necrosis especially after extravasation 
  - Rashes
  - Swelling
  - Vasospasm
  - Inflammation

Immune, Blood and Lymphatic System Disorders

• Anaphylactoid (hypersensitivity) reactions
• Serious anaphylactic reactions
  - Anaphylactic shock
  - Cardiac and respiratory arrest
  - Pulmonary oedema
• Extravasation
• Oedema
• Angioedema 
• Chills
  - Shaking
  - Feeling cold
• Fever

Sensory Disorders

• Taste perversion
• Blurred vision
• Visual disorders
• Allergic conjunctivitis
  - Eye irritation
  - Ocular hyperaemia
  - Watery eyes
  - Swelling of conjunctiva
• Transient cortical blindness
• Tinnitus
• Hot flushes
• Face oedema
  - Eye swelling
  - Periorbital oedema

Others

• Pain
• Abnormal crying

• Interleukin
• Vasopressors

Other interactions

• Cholecystographic contrast agent
• PBI (protein-bound iodine) studies
• Radioactive iodine uptake studies

• Electrocardiogram (ECG)
• Renal function

Specific cases may require

• Vital signs (coronary arteriography and left ventriculography)
• Thyroid function (paediatric patients 0-3 years)

Additional observations

• Signs and symptoms of hypersensitivity (See additional prescribing points)
• Infusion site

Hypersensitivity reactions

• 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
• Appropriate and adequate facilities and personnel should be readily available in case of a severe reaction
• A fully equipped emergency cart, or equivalent supplies and equipment, and healthcare professional competent in recognising and treating adverse reactions of all types, should always be available
• Patients should be observed for a possible severe reaction, during, and for at least 30 to 60 minutes after administration
• Patients with known or suspected hypersensitivity to iodinated contrast media should be closely observed
• If, during administration, a reaction occurs, the injection should be stopped until the reaction has subsided

The contrast media allows for radiographic visualization via opacification of the vessels and anatomical structures in the path of flow.

Injection (per ml) 300mg

• Optiray 300-30 Ml (Guerbet) originator

Pre-filled syringe (per ml) 300mg

• Optiray 300-50 Ml  (Guerbet) originator

Injection (per ml) 300mg

• Optiray 300-50 Ml  (Guerbet) originator

Injection (per ml) 300mg

• Optiray 300-100 Ml  (Guerbet) originator 

Pre-filled syringe (per ml) 300mg

• Optiray 300-100 Ml  (Guerbet) originator

Injection (per ml) 300mg

• Optiray 300-125 Ml (Guerbet) originator 

Pre-filled syringe (per ml) 300mg

• Optiray 300-125 Ml (Guerbet) originator 

Injection (per ml) 320mg

• Optiray 320-50 Ml  (Guerbet) originator

Injection (per ml) 320mg

• Optiray 320-100 Ml (Guerbet) originator

Injection (per ml) 350mg

• Optiray 350-50 Ml (Guerbet) originator 

Pre-filled syringe (per ml) 350mg

• Optiray 350-50 Ml  (Guerbet) originator

Injection (per ml) 350mg

• Optiray 350 - 100 Ml (Guerbet) originator 

Pre-filled syringe (per ml) 350mg

• Optiray 350-100 Ml (Guerbet) originator

Pre-filled syringe (per ml) 350mg

• Optiray 350-125 Ml (Guerbet) originator 

Injection (per ml) 350mg

• Optiray 350 (Guerbet) originator

Injection (per ml) 350mg 

• Optiray 350 (Guerbet) originator