INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ISOVIST 240 10 mL
ISOVIST 240 20 mL
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ISOVIST 240 10 mL
ISOVIST 240 20 mL
Non-ionic contrast medium solutions

COMPOSITION
1 mL Isovist 240 contains iotrolan (5,5-(N,N'-dimethylmalonyldiimino)-bis-[2,4,6-triiodo-isophthalic acid-bis-(2,3-dihydroxy-1-hydroxymethylpropyl)-diamide]) 512,59 mg in aqueous solution.

Iodine concentration (mg/mL)         240
Iodine content (g) per
        bottle of 10 mL
        bottle of 20 mL		        
        2,4
        4,8
Contrast medium concentration
        (mg/mL)		        
        512,59
Contrast medium content (g) per
        bottle of 10 mL
        bottle of 20 mL		        
        5,13
        10,26
Osmolality at 37°C (osm/kg H2O)         0,27
Osmotic pressure at 37°C
        (MPa)
        (atm)		        
        0,70
        7,0
Viscosity (mPa.s or cP)
        at 20°C
        at 37°C		        
        6,8
        3,9

PHARMACOLOGICAL CLASSIFICATION
A. 28 Contrast media.

PHARMACOLOGICAL ACTION
Following lumbar injection of 10 mL Isovist 240 in patients who were kept in the sitting position, maximum levels of contrast medium in the blood (6-8% of the dose in total plasma volume) were reached 1 hour post injection in most cases. Iotrolan from the subarachnoid space entered the blood stream with an average half-life of 3,6 hours (median of 9 patients), the range being 2,5-5,9 hours. Renal excretion of iotrolan following lumber injection was 32% of the dose by 6 hours, 80% by 24 hours and 90% by 72 hours post injection. Only about 0,5% of the dose was found in the faeces up to 72 hours post injection.

INDICATIONS
Radiculography; lumbar myelography including the medullary cone; thoracic myelography; cervical myelography; panmyelography; ventriculography; for evaluation of the fluid circulation, particularly in hydrocephalus, using computerised tomography; cisternography using computerised tomography.

CONTRA-INDICATIONS
Manifest hyperthyroidism and bland nodular goitre.
Patients allergic to iodine.
Pregnancy and lactation.

WARNINGS
Fatal reactions have been associated with the administration of water-soluble contrast media. It is therefore of the utmost importance that a course of action be carefully planned in advance for the treatment of serious reactions, and that adequate and appropriate facilities and personnel be readily available in case of a severe reaction. Patients should be observed for a possible severe reaction during and for at least 30-60 minutes after administration.

DOSAGE AND DIRECTIONS FOR USE
•        General information
The patient should attend for examinations in the subarachnoid space fasting but adequately hydrated. Disorders of the water and electrolyte balance must be corrected. This applies in particular to patients who are predisposed to such disorders.
In exceptional cases, particularly nervous patients can be given sedation. No anaesthetic is required if thin puncture needles are used. If antiemetics are administered, they should not display any neuroleptic effects.
After every examination in the subarachnoid space - particularly of higher sections - the contrast material should be drained as far as possible into the lumbar region. This is effected by sitting the patient up for a few minutes. After this, the patient should rest in bed for at least 24 hours, the first 6 hours of which should be spent with the trunk horizontal and the head of the bed raised to 15°.
Patients in whom it must be suspected that the seizure threshold is reduced must be kept under careful observation for 8 hours.
Isovist should not be drawn into the syringe until immediately before use. Contrast medium solution not used in one examination session must be discarded.
Vials containing contrast medium solutions are not intended for the withdrawal of multiple doses. The rubber stopper should never be pierced more than once. The use of cannulas with a long tip and a diameter of maximally 18 G is recommended for piercing the stopper and drawing up the contrast medium (dedicated withdrawal cannulas with a side hole, eg Nocore-Admix cannulas, are particularly suitable).
•        Dosage
Myelography, cisternography
The concentration and volume of the contrast medium also depend on the radiological equipment. If equipment is available which allows films in all necessary projections without the patient having to move and with which the instillation can be performed under fluoroscopic control, then iodine concentrations at the lower limit of each specified range and also lower volumes are sufficient. Higher concentrations are indicated if it is necessary to reposition the patient during the myelographic examination, since the contrast medium becomes diluted more quickly as a result of turbulence and the clarity of detail deteriorates.
The following recommendations for dosage act as general guidelines.
Lumbar myelography         7-10 mL
Lumbar myelography with thoracic transition         7-12 mL
Thoracic myelography         10-15 mL
Panmyelography (instillation in the lumbar region)         10-15 mL
Cervical myelography 
        Direct (lateral access between C1/C2)         8-12 mL
        Indirect (instillation in the lumbar region)         15 mL
CT cisternography (instillation in the lumbar region)         4-12 mL
After removal of the volume intended for the fluid examinations, the above-specified dose of Isovist is instilled.
NB: The more the patient moves after the administration, the quicker the contrast medium will mix with the fluid of other regions of no interest. As a consequence, the contrast density decreases more quickly than usual.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Cerebral convulsive disease is regarded as a relative contra-indication for examinations in the subarachnoid space. If, after careful consideration, these examinations are nevertheless performed, all equipment and medicines necessary to counter any convulsions which may occur must be prepared ready for use beforehand (cf "Tolerance and side effects"). Neuroleptics or antidepressants should be discontinued 48 hours before the examination because they reduce the seizure threshold. Caution must also be exercised in alcoholics and drug addicts because of the possibility of a reduced seizure threshold.
Following the administration of iodinated renal contrast media, the capacity of the thyroid tissue to take up radioisotopes for diagnosing disorders of the thyroid is reduced for up to 2 weeks, and even longer in individual cases.
•        Hypersensitivity
Experience shows that patients with an allergic disposition are more prone to hypersensitivity reactions.
Suggestions for the management of life-threatening acute hypersensitivity reactions or acute anaphylaxis after administration of contrast media.
Give adrenaline solution 1 mL of 1:1000 concentration (1 mg) subcutaneously. Repeat if necessary 5-10 minutes later. If the patient does not respond immediately give 0,1-0,4 mL of 1:1000 concentration diluted in 10 mL physiological saline intravenously SLOWLY.
Maintain an open airway. An emergency tracheostomy may be necessary. Positive pressure oxygen administration may be required.
In the event of urticaria or angio-oedema, administer adrenaline subcutaneously followed by an antihistamine intravenously (eg diphenhydramine hydrochloride 20 mg).
For prolonged or severe reactions give hydrocortisone sodium succinate 250 mg or methylprednisolone sodium succinate 100 mg, intravenously over 30 seconds after adrenaline and the antihistamine.
Aminophylline injection 250-500 mg should be given slowly intravenously in the presence of bronchospasm.
Intravenous fluids may be required to correct hypovolemia.
•        Tolerance and side effects
The cerebrospinal cell count increases somewhat after administration into the cerebrospinal fluid.
The most frequent subjective complaints are headaches, nausea and vomiting.
Severe headaches lasting several days may occur.
Minor side effects are pain or an increase of existing pain in the back, nape or extremities and non-specific EEG changes.
Following administration of Isovist for myelography aseptic meningitis with fever, stiff neck, headache and an increased cell count in the cerebrospinal fluid may occur.
Muscular tension or paraesthesia has been observed.
Delayed reactions may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See "Side effects and special precautions". Treatment is symptomatic and supportive.

IDENTIFICATION
Clear, colourless or faintly yellowish aqueous solution.

PRESENTATION
10 bottles of 10 or 20 mL.

STORAGE INSTRUCTIONS
Store below 30°C. Protect from light and secondary X-rays. Keep out of reach of children.

REGISTRATION NUMBER
Isovist 240 10 mL: X/28/210
Isovist 240 20 mL: X/28/211

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
Randjespark
Midrand        1685
P O Box 5278
Halfway House        1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
9 April 1996

SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Subsidiary of
Schering AG        Germany

Updated on this site: March 2004
Current: January 2005
Source: Pharmaceutical Industry

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