Generic Name

Drug Description

Presentation

Indications

Adult Dosage

Omniscan should be drawn into the syringe immediately before use. All the recommended doses below can be administered as bolus intravenous injections. To ensure complete injection of Omniscan, the intravenous line may be flushed with 5 ml sodium chloride 9 mg/ml (0.9 %) solution for injection after injection.

CNS examinations

The recommended dosage to adults and children is 0.2 ml/kg body weight (b.w.) (0.1 mmol/kg b.w.) up to 100 kg. Above 100 kg body weight 20 ml is usually sufficient. When brain metastases are suspected, a dosage of 0.6 ml/kg b.w. (0.3 mmol/kg b.w.) can be administered to adults up to 100 kg. Above 100 kg bodyweight a total of 60 ml is usually sufficient. The dose of 0.6 ml/kg can be administered as a single injection. Alternatively a second bolus injection of 0.4 ml/kg b.w. (0.2 mmol/kg b.w.) may be administered within 20 minutes of the first injection of 0.2 ml/kg b.w. (0.1mmol/kg b.w.).

Whole body examinations

The recommended dosage to adults and children above 6 months of age is 0.2 ml/kg b.w. (0.1 mmol/kg b.w.) up to 100 kg. Above 100 kg body weight 20 ml is usually sufficient. If needed 0.6 ml/kg b.w. (0.3 mmol/kg b.w.) can be administered to adults up to 100 kg body weight. Above 100 kg body weight a total of 60 ml is usually sufficient. The MRI examination should start shortly after administration of Omniscan, depending on the pulse sequences used and the protocol for the examination. Optimal enhancement is observed within the first minutes after injection, time depending on type of lesion/tissue. Enhancement is generally lasting up to 45 minutes after contrast medium injection. T₁ -weighted scanning sequences are particularly suitable for contrast enhanced examinations with Omniscan. If this medicinal product is intended to be used with an automatic application system, its suitability for the intended use has to be demonstrated by the manufacturer of the medical device. Instructions for use of the medical device must be followed absolutely.

Child Dosage

Elderly Dosage

Contra Indications

Hypersensitivity to the active substance gadodiamide or to any of the excipients. Gadodiamide is contraindicated in patients with severe renal impairment (GFR <30 ml/min/1.73m2), and those who have had or are undergoing liver transplantation.

Special Precautions

The usual precaution measures for MRI examination should be taken, such as exclusion of pacemakers and ferro-magnetic implants.

• Hypersensitivity

Allergoid and other idiosyncratic reactions may occur with all contrast media for intravenous application, also with Omniscan, which could become manifest in form of cardiovascular, respiratory and skin reactions up to shock. Most of these reactions occur within half an hour after administering the contrast medium. As with all other contrast media of the same class, late reactions may occur (after hours or days) in rare cases.

If hypersensitivity reactions occur, the administration of the contrast medium must be discontinued immediately.

To enable immediate action in emergencies, the necessary medicinal products and equipment for intubation and adequate ventilation support must be immediately available.

The risk of hypersensitivity reactions is increased in the following cases:
- patients with allergic predisposition
- patients with bronchial asthma; in these patients especially the risk of bronchospasm is
increased
- patients with a history of severe reactions on contrast agents

• Renal impairment and liver transplant patients:

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of gadodiamide and some other gadolinium-containing contrast agents in patients with severe renal impairment (GFR <30ml/min/1.73m2) and those who have had or are undergoing liver transplantation. Therefore Omniscan should not be used in these populations.

Cases of NSF have also been reported in patients with moderate renal impairment (GFR <60ml/min/1.73m2) with gadodiamide. Omniscan should be used in these patients with caution.

Gadodiamide is dialyzable.
Haemodialysis shortly after Omniscan administration in patients currently receiving haemodialysis may be useful at removing Omniscan from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

• Neonates and Infants:

Due to immature kidney function in neonates and infants up to 1 year of age, Omniscan should only be used in these patients after careful consideration. Experience with Omniscan in children below 6 months with severe liver- or renal disease and in preterm new-born infants below 4 weeks of age or with gestational age below 30 weeks is not available.

• Patients taking beta-blocker

It should be noted that patients using beta-blockers do not necessarily respond to the beta-agonists usually used for the treatment of hypersensitivity reactions.

• Patients with cardiovascular disease

In this group of patients hypersensitivity reactions may be more severe. Especially in patients with serious heart diseases (e.g. severe heart failure, coronary artery disease) cardiovascular reactions may deteriorate.

• Central nervous system disorders

In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased, as it was rarely observed with other contrast media of the same class. Precautions are necessary when examining these patients (e.g. monitoring of the patient) and the equipment and medicinal products needed for rapid treatment of possible convulsions should be available. The glass container of this medicinal product contains latex rubber. May cause severe allergic reactions.

Interactions

None known.Omniscan interferes with serum calcium measurements with some complexometric (colorimetric) methods commonly used. It may also interfere with determinations of other electrolytes (e.g. iron). Thus it is recommended not to use such methods for 12-24 hours after administration of Omniscan. If such measurements are necessary, the use of other methods is recommended.

Adverse Reactions

Adverse reactions have been reported in approximately 6 % of the patients in clinical trials. The most commonly reported spontaneous adverse effects after Omniscan are hypersensitivity reactions, nausea and vomiting.

Late adverse reactions can occur hours to days after administration of Omniscan. Transient changes in serum iron have been observed in some patients, but all these patients remained asymptomatic.

Manufacturer

Drug Availability

Updated