Active Ingredient and Strength	IOPROMIDE EQV IODINE - 300 MG/ML
Dosage Form	INJECTION
Manufacturer and Country	BAYER AG (BERLIN, MÜLLERSTRAßE) - GERMANY
Registration Number	SIN05841P
Licence Holder	BAYER (SOUTH EAST ASIA) PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	V08AB05

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).

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 caption

Cerebral angiography
Aortic arch angiography	50 – 80ml Ultravist 300
Retrograde carotid Angiography	30 – 40ml Ultravist 300
Selective angiography	6 – 15 ml Ultravist 300
Thoracic aortography	50 – 80 ml Ultravist 300
Abdominal aortography	40 – 60 ml Ultravist 300

Table caption

Angiography of the extremities
Upper extremities:
Arteriography	8 – 12 ml Ultravist 300
Venography	15 – 30 ml Ultravist 300
Lower extremities:
Arteriography	20 – 30 ml Ultravist 300
Venography	30 – 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).

4.3 Contraindications

There are no absolute contraindications to the use of Ultravist.