Vueway

1 mL/kg) administered intravenously at approximately 2 mL/sec. 1 mL/kg) administered intravenously. 9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age. Use aseptic technique for all handling and administration of Vueway.

Visually inspect Vueway for particulate matter and discoloration prior to administration. Do not use the solution if any particulate matter is present or the solution is discolored. Do not mix with other medications because of the potential for chemical incompatibility.

Prime intravenous line before use. Contrast MRI can begin immediately following the injection of Vueway. 3 Directions for Use of Single-Dose Vial and Pre-filled Syringe Vial Pierce the rubber stopper only once. Aseptically draw up Vueway into a disposable syringe and use immediately.

If solidification occurs in the vial due to cold exposure, bring the vial of Vueway to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration.

Discard any unused portion. Pre-filled syringe Remove the tip cap of the syringe, screw the plunger rod and use immediately. All luer connections should be gently hand tightened without over tightening, to ensure secure connections and to prevent damage to the device.

Pre-filled syringes must not be frozen. Frozen pre-filled syringes of Vueway should be discarded. Discard any unused portion. 4 Directions for Use of Pharmacy Bulk Package Vueway Pharmacy Bulk Package (PBP) is not for direct infusion.

Perform the transfer of Vueway from the PBP in an aseptic work area, such as laminar flow hood, using aseptic technique and suitable transfer device for filling empty sterile syringes. Penetrate the closure only one time. Once the container closure is punctured, do not remove the PBP from the aseptic work area.

Use each individual dose of Vueway promptly following withdrawal from the PBP. Use the contents of the PBP within 24 hours at room temperature after puncture. If solidification occurs in the PBP due to cold exposure, bring the PBP of Vueway to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration.

2%) are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, localized swelling, and erythema. 1 ) To report SUSPECTED ADVERSE REACTIONS contact Bracco Diagnostics Inc. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

3 mmol/kg (six times the recommended dose). 05 mmol/kg. Among patients who received the recommended dose, the average age was 49 years (range from less than one month to 88 years) and 55% were female. The race distribution was 80% White, 10% Asian, 6% American Indian or Alaska native, 2% Black, and 2% patients of other or unspecified race groups.

6% of subjects receiving the labeled dose reported one or more adverse reactions. 05 mmol/kg Vueway. Table 1. 05 mmol/kg Vueway included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, injection site paresthesia, Cystatin C increase, and blood creatinine increase.

4 )] . 2 Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of Vueway or other GBCAs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders:

Acute pancreatitis with onset within 48 hours after GBCA administration. 4 )] .

Respiratory, Thoracic and Mediastinal Disorders:

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with GBCAs. Monitor patients closely for need of emergency cardiorespiratory support. 3 ) Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs.

1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of Vueway have not been established with intrathecal use.

1 )] . 2 Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Vueway among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.

73 m 2 ) as well as patients with acute kidney injury. 73 m 2 ). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Report any diagnosis of NSF following Vueway administration to Bracco Diagnostics Inc.

gov/medwatch ). Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity.

Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. , age >60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing. Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and the degree of renal impairment at the time of exposure.

Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended Vueway dose and allow a sufficient period of time for elimination of the drug prior to re-administration.

4 CONTRAINDICATIONS Vueway is contraindicated in patients with history of hypersensitivity reactions to Vueway. History of hypersensitivity reactions to Vueway ( 4 )