eeze. If accidentally frozen, discard product.
Once the bottle is connected to the infusion set, use Omegaven immediately. Complete infusion within 12 hours when using a Y-connector [see Dosage and Administration (2.1)].
Infuse admixtures containing Omegaven immediately. If not used immediately, admixtures can be stored for up to 6 hours at room temperature or up to 24 hours under refrigeration. Complete the infusion within 24 hours after removal from storage [see Dosage and Administration (2.2)].
17 PATIENT COUNSELING INFORMATION
Inform patients, their families, or caregivers of the following risks of Omegaven:
Risk of death in preterm infants due to pulmonary lipid accumulation [see Warnings and Precautions (5.1)]
Hypersensitivity reactions [see Warnings and Precautions (5.2)]
Risk of infections [see Warnings and Precautions (5.3)]
Fat overload syndrome [see Warnings and Precautions (5.4)]
Refeeding syndrome [see Warnings and Precautions (5.5)]
Hypertriglyceridemia [see Warnings and Precautions (5.6)]
Aluminum toxicity [see Warnings and Precautions (5.7)]
Fresenius Kabi and Omegaven are registered trademarks of Fresenius Kabi.
Manufactured by:
Figure
Graz, Austria
www.fresenius-kabi.com/us
451555
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Label
NDC 63323-205-21 255050
Omegaven®
(fish oil triglycerides) Injectable emulsion
5 grams per 50 mL
(0.1 grams per mL)
Energy: 56 kcal per 50 mL
For intravenous use only. Rx only
50 mL Single-Dose bottle - Discard Unused Portion
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Label
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PRINCIPAL DISPLAY PANEL
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Carton Label
NDC 63323-205-50 255050
Omegaven®
(fish oil triglycerides) Injectable emulsion
5grams per 50 mL
(0.1 grams per mL)
For intravenous use only. Rx only
Sterile.
Store below 25°C. (77°F). Do not freeze.
Use only if the emulsion is homogeneous.
See prescribing information.
Not made with natural rubber latex
10 x 50 mL
Single-Dose bottle-
Discard Unused Portion
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Carton Label
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PRINCIPAL DISPLAY PANEL
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Label
NDC 63323-205-31 255100
Omegaven®
(fish oil triglycerides) Injectable emulsion
10 grams per 100 mL
(0.1 grams per mL)
Energy: 112 kcal per 100 mL
For intravenous use only. Rx only
100 mL Single-Dose bottle - Discard Unused Portion
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Label
CLOSE
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Carton Label
NDC 63323-205-00 255100
Omegaven®
(fish oil triglycerides) Injectable emulsion
10 grams per 100 mL
(0.1 grams per mL)
For intravenous use only. Rx only
Sterile.
Store below 25°C. (77°F). Do not freeze.
Use only if the emulsion is homogeneous.
See prescribing information.
Not made with natural rubber latex
10 x 100 mL Single-Dose bottle-
Discard Unused Portion
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Carton Label
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INGREDIENTS AND APPEARANCE
OMEGAVEN
fish oil injection, emulsion
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-205
Route of Administration&n |
