EOVIST is supplied in single-dose, rubber stoppered containers (vials) containing 181.43 mg/mL of gadoxetate disodium (equivalent to 0.25 mmol/mL gadoxetate disodium), in the following sizes:
- 10 mL single-dose containers (vials) filled with 10 mL, boxes of 5 (NDC 50419-320-05)
Store at temperatures between 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59 to 86) [see USP Controlled Room Temperature].
EOVIST is a ready-to-use solution for single use only. Visually inspect EOVIST for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or if particulate matter is present. The rubber stopper should not be pierced more than once. Use EOVIST immediately after opening. Unused portions should be discarded.
- Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Nephrogenic Systemic Fibrosis
Instruct patients to inform their physician if they:
- Have a history of kidney disease and/or liver disease
- Have recently received a GBCA
GBCAs increase the risk of NSF among patients with impaired elimination of drugs. To counsel patients at risk of NSF:
- Describe the clinical manifestations of NSF
- Describe procedures to screen for the detection of renal impairment
Instruct the patients to contact their physician if they develop signs or symptoms of NSF following EOVIST administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.
Common Adverse Reactions
Inform patients that they may experience:
- Reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site
- Side effects of headache, nausea, abnormal taste and feeling hot
- Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs [see Warnings and Precautions (5.3)].
Instruct patients receiving EOVIST to inform their physician if they:
- Are pregnant or breastfeeding
- Have a history of allergic reaction to contrast media, bronchial asthma or allergic respiratory disorder
© 2008, Bayer HealthCare Pharmaceuticals Inc., All rights reserved.
Bayer HealthCare Pharmaceuticals Inc.Whippany, NJ 07981
Manufactured in Germany
(gadoxetate disodium) Injection for intravenous use
What is Eovist?
What is the most important information I should know about Eovist?
Do not receive Eovist if you have had a severe allergic reaction to Eovist.
Before receiving Eovist, tell your healthcare provider about all your medical conditions, including if you:
What are the possible side effects of Eovist?
The most common side effects of Eovist include: nausea, headache, feeling hot, dizziness, and back pain.
These are not all the possible side effects of Eovist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of EOVIST.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about EOVIST that is written for health professionals.
What are the ingredients in Eovist?
Active ingredient: gadoxetate disodium
Inactive ingredients: caloxetate trisodium, trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment), and water for injection.
Manufactured for Bayer HealthCare Pharmaceuticals Inc.
Manufactured in Germany
© 2008 Bayer HealthCare Pharmaceuticals Inc. All rights reserved.
For more information, go to www.eovist.com or call 1-888-842-2937.
5 vials of 10 mL
Eovist® 10 mL
Each mL contains 181.43 gadoxetate disodium and the excipients caloxetate trisodium, trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment), and water for injection. Eovist® contains no antimicrobial preservative.
Discard unused portion.
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C [See USP Controlled Room Temperature.]
For intravenous administration.
Dosage: See package insert.
Bayer HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470
Mfd. in Germany
|EOVIST gadoxetate disodium injection, solution|
|Labeler — Bayer HealthCare Pharmaceuticals Inc. (005436809)|
|Bayer AG||315097875||MANUFACTURE (50419-320)|
|QUALITY PACKAGING SPECIALISTS INTERNATIONAL LLC||080629831||RELABEL (50419-320)|
Revised: 12/2021 Bayer HealthCare Pharmaceuticals Inc.
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