ULTRAVIST 300 INJECTION 300 mg Iodine/ml

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Therapeutic

Prescription Only

INJECTION

**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 _**Conventional Angiography**_ Recommended doses for single injections: Cerebral angiographyAortic arch angiography50 – 80ml Ultravist 300Retrograde carotid Angiography30 – 40ml Ultravist 300Selective angiography6 – 15 ml Ultravist 300 Thoracic aortography 50 – 80 ml Ultravist 300 Abdominal aortography 40 – 60 ml Ultravist 300 Angiography of the extremitiesUpper extremities:Arteriography8 – 12 ml Ultravist 300 Venography15 – 30 ml Ultravist 300 Lower extremities:Arteriography20 – 30 ml Ultravist 300Venography30 – 60 ml Ultravist 300 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_).