OMNISCAN is a brand name for Gadodiamide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Omniscan (gadodiamide injection) is indicated for: contrast enhancement of magnetic resonance imaging (MRI), in adults and the pediatric population, of lesions of the central nervous system with expected abnormal vascularity or those thought to cause abnormalities in the blood-brain barrier. Omniscan has been shown…
Verbatim from this product's HC label. Tap a section to expand.
Omniscan (gadodiamide) injection should be drawn into the syringe and used immediately. If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents. OMNISCAN (gadodiamide injection) Page 6 of 31 Contrast-enhanced MRI should start shortly after administration of the contrast medium.
Optimal enhancement is generally observed within 45 minutes after injection of Omniscan. T1- weighted scanning sequences are particularly suitable for contrast-enhanced examinations with Omniscan. 5 Tesla, the relative image contrast was found to be independent of the applied field strength.
1 Dosing Considerations Use of macrocyclic agents may be preferable in certain patients such as those for whom repeated GBCA doses may need to be considered due to individual clinical circumstances and in other potentially vulnerable patients such as children and pregnant women (see 7 WARNINGS AND PRECAUTIONS).
1 mmol/kg) administered as a bolus intravenous injection. (See the Dosage Chart). , sedatives) may be administered according to the normal routine for MR examinations. 3 mmol/kg), administered as a bolus intravenous injection (See the Dosage Chart).
1 mmol/kg) administered as a bolus intravenous injection at an injection rate of 1–4 mL/sec. The lowest effective dose should be used. Calculate the dose based on the patient’s body weight, and do not exceed the recommended dose per kilogram of body weight.
0 * The heaviest patient in clinical studies weighed 136 kg. 9% sodium chloride. The imaging procedure should be completed within 1 hour of administration of Omniscan. 4 Administration Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not use the solution if it is discolored or particulate matter is present. Any unused portion must be discarded.
). 73 m2) needs to be weighed against the risk of performing alternative medical imaging by health care professionals. Omniscan should be used with caution in infants less than 1 year of age. 4 DOSAGE AND ADMINISTRATION Omniscan (gadodiamide) injection should be drawn into the syringe and used immediately.
If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents. OMNISCAN (gadodiamide injection) Page 6 of 31 Contrast-enhanced MRI should start shortly after administration of the contrast medium.
Optimal enhancement is generally observed within 45 minutes after injection of Omniscan. T1- weighted scanning sequences are particularly suitable for contrast-enhanced examinations with Omniscan. 5 Tesla, the relative image contrast was found to be independent of the applied field strength.
1 Dosing Considerations Use of macrocyclic agents may be preferable in certain patients such as those for whom repeated GBCA doses may need to be considered due to individual clinical circumstances and in other potentially vulnerable patients such as children and pregnant women (see 7 WARNINGS AND PRECAUTIONS).
1 mmol/kg) administered as a bolus intravenous injection. (See the Dosage Chart). , sedatives) may be administered according to the normal routine for MR examinations. 3 mmol/kg), administered as a bolus intravenous injection (See the Dosage Chart).
1 mmol/kg) administered as a bolus intravenous injection at an injection rate of 1–4 mL/sec. The lowest effective dose should be used. Calculate the dose based on the patient’s body weight, and do not exceed the recommended dose per kilogram of body weight.
0 * The heaviest patient in clinical studies weighed 136 kg. 9% sodium chloride. The imaging procedure should be completed within 1 hour of administration of Omniscan. 4 Administration Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
). 2 Geriatrics Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness. 73m2 acute kidney injury neonates up to 4 weeks of age due to their immature renal function Omniscan is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. OMNISCAN (gadodiamide injection) Page 5 of 31
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Do not use the solution if it is discolored or particulate matter is present. Any unused portion must be discarded. 5 OVERDOSAGE Clinical consequences of overdosage have not been reported and acute symptoms of toxicity are unlikely in patients with normal renal function.
Treatment is symptomatic. There is no antidote for this contrast medium. In patients with delayed elimination due to renal insufficiency and in patients who have received excessive doses, the contrast medium may theoretically be eliminated by hemodialysis.
It is unknown if hemodialysis reduces the risk of NSF. For management of a suspected drug overdose, contact your regional poison control centre. 5 mmol/mL)/ gadodiamide 10 mL vial, box of 10 Caldiamide sodium, hydrochloric acid and/or sodium hydroxide, water for injection.
5 mol/L solution of the gadolinium complex of diethylenetriaminepentaacetic acid bismethylamide. It is a nonionic extracellular enhancing agent for magnetic resonance imaging and is provided as a sterile, clear, colorless to slightly yellow, aqueous solution.
Each mL contains 287 mg gadodiamide, 12 mg caldiamide sodium and water for injection. 0 with hydrochloric acid and/or sodium hydroxide. 8 times that of plasma (285 mOsm/kg water) at 37oC and is hypertonic under conditions of use. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Diagnostic procedures involving the use of contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed. Omniscan (gadodiamide) injection should be drawn into the syringe and used immediately.
If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents. Accumulation of Gadolinium in Brain OMNISCAN (gadodiamide injection) Page 9 of 31 The current evidence suggests that gadolinium may accumulate in the brain after multiple administrations of GBCAs.
Increased signal intensity on non-contrast T1 weighted images of the brain has been observed after multiple administrations of GBCAs in patients with normal renal function. Gadolinium has been detected in brain tissue after multiple […]