DIXANOL
Isotonic - Water Soluble - Non-ionic
Iodinated Contrast Media
- Solution of Iodixanol are hypotonic to blood, sodium chloride and calcium chloride have been added resulting in isotonic solutio with blood.
- Fewer and less severe osmolality related disturbances.
- Less painful, heat and burning sensation.
- Iodixanol injection has approximately 1/3rd the osmolality of non ionic media and 1/6th of monomeric ionic media.
- Lower osmolality 290 mOsm/kg water (Vapour pressure @37℃).
DIXANOL showed no significant metabolism in humans, did not cross intact blood brain barrier.
| COMPOSITION | DIXANOL 150 | DIXANOL 270 | DIXANOL 320 |
|---|---|---|---|
| Iodixanol | 30.5% | 55% | 65.2% |
| Iodine Concentration | 150mg/ml | 270mg/ml | 320mg/ml |
| pH | 7.25 + 0.45 | 7.25 + 0.45 | 7.25 + 0.45 |
| Viscosity (mPa*s) | |||
| @37℃ | 1.7 | 6.3 | 11.8 |
| @20℃ | 2.7 | 12.7 | 26.6 |
| Osmolality (mOsm/kg H2O) | |||
| @37℃ | 290 | 290 | 290 |
DOSAGE AND ADMINISTRATION:
The dosage may vary depending on the type of examination, the age, weight, cardiac output and general condition of the patient and the technique used. Usually approximately the same iodine concentration and volume is used as with other iodinated X-ray contrast media in current use, but adequate diagnostic information has also been obtained in some studies with iodixanol injection with somewhat lower iodine concentration. Adequate hydration should be assured before and after administration as for other contrast media. The product is for intravenous, intra-arterial and intrathecal use.
The following dosages may serve as a guide. The doses given for intra-arterial use are for single injection that may be repeated.
Guideline for Intra-arterial Use
| INDICATION | CONCENTRATION | VOLUME |
|---|---|---|
| Arteriographies; adults only Selective cerebral Selective cerebral i.a. DSA |
270/320(1) mg I/ml 150 mg I/ml |
5 - 10 ml per inj. 5 - 10 ml per inj. |
| Aortography Peripheral Peripheral i.a. DSA Selective Visceral i.a. DSA |
270/320 mg I/ml 270/320 mg I/ml 150 mg I/ml 270 mg I/ml |
40 - 60 ml per inj. 30 - 60 ml per inj. 30 - 60 ml per inj. 10 - 40 ml per inj. |
| Cardioangiography, Adults Left Ventricle and Aortic root inj. Selective coronary arteriography Children |
320 mg I/ml 320 mg I/ml 320 mg I/ml |
30 - 60 ml per inj. 4 - 8 ml per inj. Depending on age, weight and pathology (recommended max total dose 10 ml/kg.). |
Guideline for Intravenous Use
| INDICATION | CONCENTRATION | VOLUME | COMMENTS |
|---|---|---|---|
| Urography Adults Children < 7 kg. Children > 7 kg. |
270/320 mg I/ml 270/320 mg I/ml 270/320 mg I/ml |
40 - 80 ml (2) 2 - 4 ml/kg. 2 - 3 ml/kg. |
All dose depending on age, weight and pathology (max. 50ml.) |
| Venography; adults only | 270 mg I/ml | 50 - 150 ml/leg | ----- |
| CT-enhancement CT for the head, adult CT for the body, adult Children, CT of the head and body |
270/320 mg I/ml 270/320 mg I/ml 270/320 mg I/ml |
50 - 150 ml 75 - 150 ml 2 - 3 ml/kg upto 50ml (in a few cases up to 150 ml may be given) |
----- |
Guideline for Intrathecal Use
| INDICATION | CONCENTRATION | VOLUME |
|---|---|---|
| Lumbar and thoracic myelography (lumbar injection) |
270 mg I/ml Or 320 mg I/ml |
10 - 12 ml(3) 10 ml(3) |
| Cervical myelography (Cervical or lumbar injection) |
270 mg I/ml or 320 mg I/ml |
10 - 12 ml(3) 10 ml(3) |
Guideline for use in Body Cavities
| INDICATION | CONCENTRATION | VOLUME | COMMENTS |
|---|---|---|---|
| Arthrography, Adults only | 270 mg I/ml | 1 - 15 ml | The dosage must be adjusted individually to allow optimal visualisation. |
| Hysterosalpingography (HSG), Adults only | 270 mg I/ml | 5 - 10 ml | The recommended dose may be exceeded several times, for example, there is significant backflow into the vagina (up to 40ml has been studied). |
| Endoscopic retrograde cholangiopancreatography (ERCP), Adults only. |
270 mg I/ml | 50 - 150 ml/leg | The recommended dose may be exceeded several times if the contrast medium is injected into the duodenum (up to 140 ml has been studied). |
(1) Both strengths are documented, but 270 mg I/ml is recommended in most cases.
(2) In high-dose urography higher doses can be used.
(3) To minimize possible adverse reactions a total dose of 3.2g iodine should not be exceeded.
CONTRAINDICATIONS:
Manifest thyrotoxicosis. History of serious hypersensitivity reaction to DIXANOL.
PRESENTATION:
DIXANOL 150 : Single dose vial of 50 ml and 100 ml.
DIXANOL 270 : Single dose vial of 50 ml and 100 ml.
DIXANOL 320 : Single dose vial of 50 ml and 100 ml.
STORAGE:
DIXANOL should be stored according to instruction on the label, protected from light and secondary X rays. Preserve in well-closed, light-resistant containers. Store at 25℃, excursions permitted between 15℃ and 30℃. The product in glass containers of 50 ml and over in size may be stored at 37℃ for up to one month prior to use.
Discard the unused portion. Do not use, if it contains particulate matter.
Do not freeze. Do not use if the product is in advertently frozen.
