ULTRAVIST 300 INJECTION 300 mg Iodine/ml

Bayer AG (Berlin, Müllerstraße) (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: May 14, 1991
Approval ID: 9050908f631fcb7a
Company: Bayer AG (Berlin, Müllerstraße) (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: 9050908f631fcb7a
Drug Name: ULTRAVIST 300 INJECTION 300 mg Iodine/ml
Product Name: ULTRAVIST 300 INJECTION 300 mg Iodine/ml
Approval Number: SIN05841P
Approval Date: 1991-05-14
Registrant: BAYER (SOUTH EAST ASIA) PTE LTD
Licence Holder: BAYER (SOUTH EAST ASIA) PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION
Dosage: 4.2 Dosage and method of administration 4.2.1 General information Contrast media which are warmed to body temperature before administration are better tolerated and can be injected more easily because of reduced viscosity. For additional instructions, see section ‘Instructions for use/handling’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. 4.2.2 Dosage regimen Intravenous urography Adults The dose should not be less than 1 ml Ultravist 300 (0.8 ml Ultravist 370)/kg body weight if the clinical problem also requires adequate filling of the ureters. Increasing the dose is possible if this is considered necessary in special indications. Children The physiologically poor concentrating ability of the still immature nephron of infantile kidneys demands relatively high doses of contrast medium, e.g. with the use of Ultravist 300: Neonates: 1.2 g l/kg body weight, corresponding to 4.0 ml/kg body weight Babies: 1.0 g l/kg body weight, corresponding to about 3.0 ml/kg body weight Small children: 0.5 g l/kg body weight, corresponding to about 1.5 ml/kg body weight Filming times When the above dosage guidelines are observed and Ultravist 300/370 is injected over 1 to 2 minutes, the renal parenchyma is usually highly opacified 3 to 5 minutes and the renal pelvis with the urinary tract 8 to 15 minutes after the start of administration. The earlier time should be chosen for younger patients and the later time for older patients. In babies and young children it is advisable to take the first film as early as about 2 minutes after the administration of the contrast medium. Insufficient contrast can necessitate later films. Computerized tomography (CT) Whole-body CT In whole-body computerized tomography, the necessary doses of contrast medium and the rates of administration depend on the organs under investigation, the diagnostic problem and, in particular, the different scan and image reconstruction times of the scanners in use. The infusion should be preferred for slow scanners and the injection as a bolus for fast scanners. Cranial CT The following dosages are recommended for cranial CT: Ultravist 300: 1.0 – max. 2.0 ml/kg body weight Ultravist 370: 1.0 – max. 1.5 ml/kg body weight Contrast-enhanced mammography (CEM) Ultravist should be injected intravenously, preferably using an injector. Imaging begins approximately 2 minutes post contrast administration. Adults: Ultravist 300/370: 1.5ml/kg bodyweight Conventional Angiography Recommended doses for single injections: <table class="borderless-100"> <tbody> <tr> <td colspan="2">Cerebral angiography</td> </tr> <tr> <td>Aortic arch angiography</td> <td>50 – 80ml Ultravist 300</td> </tr> <tr> <td>Retrograde carotid Angiography</td> <td>30 – 40ml Ultravist 300</td> </tr> <tr> <td>Selective angiography</td> <td>6 – 15 ml Ultravist 300</td> </tr> <tr> <td> Thoracic aortography</td> <td> 50 – 80 ml Ultravist 300</td> </tr> <tr> <td> Abdominal aortography</td> <td> 40 – 60 ml Ultravist 300 </td> </tr> </tbody> </table> <table class="borderless-100"> <tbody> <tr> <td colspan="2"> Angiography of the extremities</td> </tr> <tr> <td colspan="2">Upper extremities:</td> </tr> <tr> <td>Arteriography</td> <td>8 – 12 ml Ultravist 300 </td> </tr> <tr> <td>Venography</td> <td>15 – 30 ml Ultravist 300</td> </tr> <tr> <td colspan="2"> Lower extremities:</td> </tr> <tr> <td>Arteriography</td> <td>20 – 30 ml Ultravist 300</td> </tr> <tr> <td>Venography</td> <td>30 – 60 ml Ultravist 300</td> </tr> </tbody> </table> Angiocardiography Selective, in the individual cardiac cavities: 40 – 60ml Ultravist 370 Coronary angiography 5 – 8ml Ultravist 370 Intravenous Digital subtraction angiography (DSA) The i.v. injection of 30 – 60 ml Ultravist 300 or 370 as a bolus (flow rate: 8 – 12 ml/second into the cubital vein; 10 – 20 ml/second into the vena cava) is only recommended for contrast demonstrations of great vessels of the trunc. The amount of contrast medium remaining in the veins can be reduced and diagnostically used by flushing with isotonic sodium chloride solution as a bolus immediately afterwards. Adults: 30 – 60 ml Ultravist 300/370 4.2.3 Additional information on special populations 4.2.3.1 Newborns (< 1 month) and infants (1 month – 2 years) Young infants (age <1 years) and especially newborns are susceptible to electrolyte imbalance and hemodynamic alterations. Care should be taken regarding the dose of contrast medium to be given, the technical performance of the radiological procedure and the patient status. 4.2.3.2 Patients with renal impairment Since iopromide is excreted almost exclusively in an unchanged form via the kidneys, the elimination of iopromide is prolonged in patients with renal impairment. In order to reduce the risk of additional contrast media-induced kidney injury in patients with pre-existing renal impairment, the minimum possible dose should be used in these patients (see also sections ‘Special warnings and precautions for use’ and ‘Pharmacokinetic properties’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: INTRAVENOUS, INTRAVASCULAR, INTRACAVITARY, INTRA-ARTERIAL
Indication Info: 4.1 Indications This medicinal product is for diagnostic use only. Ultravist 300: Contrast enhancement in computerized tomography (CT), digital subtraction angiography (DSA), intravenous urography, phlebography of the extremities, venography, arteriography, visualization of body cavities (e.g. arthrography, hysterosalpingography, fistulography) with the exception of myelography, ventriculography, cisternography. Ultravist 370: Contrast enhancement in computerized tomography (CT), digital subtraction angiography (DSA), intravenous urography, arteriography and especially angiocardiography, visualization of body cavities (e.g. arthrography, fistulography) with the exception of myelography, ventriculography, cisternography. Ultravist 300/370: For use in contrast-enhanced mammography to assess and detect known or suspicious lesions of the breast in adult women as an adjunct to mammography (with or without ultrasound).
Contraindications: 4.3 Contraindications There are no absolute contraindications to the use of Ultravist.
Atc Code: V08AB05
Atc Item Name: iopromide
Pharma Manufacturer Name: BAYER (SOUTH EAST ASIA) PTE LTD

Active Ingredients

IOPROMIDE EQV IODINE

300 mg/ml

IOPROMIDE EQV IODINE

300 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 14, 1991

Approval ID

9050908f631fcb7a

Type

Therapeutic

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