FDA Label for Cardioxane
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Cardioxane Product Label
The following document was submitted to the FDA by the labeler of this product Clinigen Healthcare Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Important Drug Information
Subject: Temporary Importation of Cardioxane 500 mg Powder for Solution for Infusion (dexrazoxane hydrochloride) to address drug shortage issues
Dear Healthcare Professional,
Comparison Of Cardioxane And Fda-Approved Zinecard
It is important to note the following differences between the U.S. FDA approved Dexrazoxane for Injection products and Cardioxane (a comparison of the carton and vial labels is appended to this letter for reference):
Dexrazoxane for Injection (U.S.) | Cardioxane (UK) | Action to Take |
Packaged with complete prescribing Information. | Packaged with a Patient Information Leaflet, with information for Healthcare Professionals – this does not provide complete information for use. | Please refer to the package insert for the U.S. FDA approved Zinecard (dexrazoxane) for Injection for full prescribing information. |
Presentation 250 mg/vial and 500 mg/vial. | Presentation 500 mg/vial only. | Prescribers and pharmacists must be alert to this difference in presentation in order to prevent medication errors. |
Zinecard 500 mg/vial is reconstituted with 50 mL of Sterile Water for Injection USP. Reconstituted solution has a concentration of 10 mg/mL. | Cardioxane 500mg/vial is reconstituted with 25 mL of Water for Injection. Reconstituted solution has a concentration of 20 mg/mL. | The Cardioxane reconstituted solution will have a concentration of 20 mg/mL, this must be considered when further diluting to give an infusion solution. Prescribers and pharmacists must be alert to this difference in order to prevent medication errors. |
Following reconstitution with Sterile Water for Injection, USP, Zinecard is stable for 30 minutes at room temperature or if storage is necessary, up to 3 hours from the time of reconstitution when stored under refrigeration, 2° to 8°C (36° to 46°F). | No storage recommendations are given for the reconstituted solution – it should be immediately diluted for infusion. | Use the reconstituted solution immediately. |
The reconstituted solution is diluted further with Lactated Ringer's Injection, USP to a concentration of 1.3 mg/mL to 3 mg/mL in intravenous infusion bags for intravenous infusion. | The reconstituted solution is diluted further with Lactated Ringer’s Injection or Sodium Lactate 0.16 M to a concentration between 4 mg/mL to 10 mg/mL. | Recall that the reconstitution solution will have a concentration of 20 mg/mL. Follow the instructions given within the Zinecard Prescribing Information – dilute with Lactated Ringer’s Injection USP to 1.3 mg/mL to 3 mg/mL in intravenous infusion bags for intravenous infusion. |
The diluted infusion solutions are stable for one hour at room temperature or if storage is necessary, up to 4 hours when stored under refrigeration, 2° to 8°C (36° to 46°F). | Reconstituted and subsequently diluted product should be used immediately or within 4 hours if stored between 2°C and 8°C. | The diluted infusion solution should be used immediately or stored for a maximum of 4 hours under refrigeration, 2° to 8°C (36° to 46°F). |
Please note that no barcode appears on the carton for Cardioxane 500 mg Powder for Solution for Infusion, therefore it will not be appropriately recognized by scanning systems used in the United States. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.
To order Cardioxane 500 mg Powder for Solution for Infusion, please contact the distributor Cumberland Pharmaceuticals Inc., at 615-255-0068, or by email at [email protected].
To report adverse events or other safety-related information, including medication errors to Clinigen Healthcare, you may complete the available form at http://www.clinigengroup.com/node/99 and send via email to [email protected] or fax to 1-800-861-9362. Adverse events and medication errors, or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, or regular mail, or by fax:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
We urge you to contact our Medical Information Department at toll-free 888-758-7954 during office hours (Monday to Friday, 8am to 5:30pm Eastern Time), or at 913-339-8424 out of office hours, or email [email protected], if you have any questions about the information contained in this letter or the safe and effective use of Cardioxane 500 mg Powder for Solution for Infusion.
Comparison Of Carton And Vial Labels (Zinecard And Cardioxane 500 Mg Powder For Solution For Infusion)
Item | Zinecard (US) | Cardioxane 500 mg Powder for Solution for Infusion |
Carton Label | Principal Panel NDC 0013-8727-89 Single-Dose Vial Zinecard® (dexrazoxane) for injection 500 mg* Sterile, Pyrogen-Free Lyophilizate For Intravenous Use Only Pfizer Injectables Rx only Side Panel 1 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Upon reconstitution with 50 mL of Sterile Water for Injection, USP, the pH of the resultant solution is 1.0 to 3.0. Reconstituted solutions are stable for 30 minutes at room temperature or if storage is necessary, up to 3 hours from the time of reconstitution when stored under refrigeration, 2° to 8°C (36° to 46°F). Further dilution with Lactated Ringer’s, USP, is necessary prior to administration via IV drop. DO NOT ADMINISTER RECONSTITUTED SOLUTION DIRECTLY. Discard unused solutions. DOSAGE AND USE: See accompanying prescribing information. *Each vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. The pH is adjusted with Hydrochloric Acid, NF. Side Panel 2 Barcode MADE IN ITALY Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc NY, NY 10017 | Principal Panel Cardioxane® 500mg Powder for solution for infusion Dexrazoxane Intravenous use Do not store above 25°C. Store in the original container in order to protect from light. Side Panel 1 Use as directed by a health professional. Refer to instructions for safe handling of product before administration. Reconstitute and dilute the contents of each vial in accordance with the instructions in the package insert before administering by intravenous infusion to the patient. Cardioxane is for single use only. Reconstituted and subsequently diluted product should be used immediately or within 4 hours if stored between 2°C and 8°C. Any unused medicinal product should be discarded in accordance with local requirements. Read the package leaflet before use. Keep out of the sight and reach of children.
Pack of 1 vial 1 vial contains 500 mg dexrazoxane as its hydrochloride salt POM Marketing Authorisation number: PL 31644/0002 Marketing Authorisation holder: Clinigen Healthcare Ltd., Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, United Kingdom. |
Carton Label Image |
Item | Zinecard (US) | Cardioxane 500 mg Powder for Solution for Infusion |
Vial Label | Principal Panel NDC 0013-8727-89 Single-Dose Vial Zinecard® (dexrazoxane) for injection 500 mg* Sterile, Pyrogen-Free Lyophilizate For Intravenous Use Only Rx only Side Panel Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Upon reconstitution with 50 mL of Sterile Water for Injection, USP, the pH of the resultant solution is 1.0 to 3.0. Reconstituted solutions are stable for 30 minutes at room temperature or if storage is necessary, up to 3 hours from the time of reconstitution when stored under refrigeration, 2° to 8°C (36° to 46° F). Further dilution with Lactated Ringer’s, USP, is necessary prior to administration via IV drop. DO NOT ADMINISTER RECONSTITUTED SOLUTION DIRECTLY. Discard unused solutions. DOSAGE AND USE: See accompanying prescribing information. Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc NY, NY 10017 MADE IN ITALY LOT EXP | Principal Panel Cardioxane® 500 mg Powder for Solution for Infusion Dexrazoxane (as its hydrochloride salt) Intravenous use for short infusion. Do not store above 25°C. Store in the original container. Protect from direct sunlight. Marketing Authorisation number: PL 31644/0002 Keep out of the reach and sight of children. POM Side Panel Clinigen Healthcare Ltd. Pitcairn House, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, UK. |
Vial Label Image |
* Please review the disclaimer below.
