{"effective_time":"20180813","health_care_provider_letter":["La Jolla Pharmaceutical AGUETTANT ESSENTIAL MEDICINES Important Prescribing Information Subject: Temporary importation of Potassium Chloride Proamp ® 0.15 g/mL (equivalent to 2 mEq/mL), concentrate for solution for infusion to address drug shortage June, 2018 Dear Healthcare Professional, Due to the critical shortage of Potassium Chloride for Injection Concentrate 2 mEq/mL, USP in the United States (U.S.) market, Laboratoire Aguettant (Aguettant) is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of Potassium Chloride for Injection. Aguettant has initiated temporary importation of its Potassium Chloride Proamp® 0.15 g/mL (equivalent to 2 mEq/mL) concentrate for solution for infusion. This product is manufactured and marketed in France by Aguettant. Given the scale of this shortage, FDA is coordinating with several firms to import Potassium Chloride for Injection 2 mEq/mL. At this time, however, no other entity except La Jolla Pharmaceutical Company is authorized by the FDA to import or distribute Aguettant's Potassium Chloride Proamp® 0.15 g/mL (equivalent to 2 mEq/mL) concentrate for solution for infusion. FDA has not approved Aguettant's Potassium Chloride Proamp® 0.15 g/mL concentrate for solution for infusion, but allows its temporary importation into the United States. You may be provided with additional letters for other imported products you receive. Please read each letter in its entirety because each letter may contain different, product-specific information. Effective immediately, and during this temporary period, Aguettant will offer the following presentation of Potassium Chloride for Injection: Product name and description Size Pack factor NDC Number Potassium Chloride Proamp ® 0.15 g/mL, concentrate for solution for infusion (equivalent to 2 mEq/mL) 10 mL 50 ampules per box 60710-015-50 There are key differences between the labeling of the FDA approved Potassium Chloride for Injection 2 mEq/mL products and Aguettant's imported Potassium Chloride Proamp ® 0.15 g/mL. It is important to note the following: Aguettant's product is labeled Potassium Chloride Proamp® 0,15 g/mL which means 0.15 g/mL in the U.S. and is equal to 2 mEq/mL of potassium chloride. We have affixed the following sticker with this information on the carton for the imported product. The ampule label of Aguettant's product is in French without English translation. However, the carton and the prescribing information for Aguettant's product is translated into English. Institutions should develop a strategy, which may include labeling the ampules with key information, to ensure safe use of the product. Aguettant's product does not contain a barcode . Institutions should manually input the product into their systems. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients. Inspect the solution visually for particulate matter and discoloration prior to administration. The imported product is packaged in polypropylene 10 mL ampules. To use the ampule, hold it upright, twist off the cap, and withdraw the solution using a syringe. A side by side comparison of the key differences in the labeling between the FDA-approved product and the imported product is displayed in the product comparison table at the end of this letter. Please refer to the package insert for the FDA-approved Potassium Chloride for Injection Concentrate, USP drug product for full prescribing information. To order or if you have questions about Aguettant's Potassium Chloride Proamp® 0.15 g/mL ampules, please contact La Jolla Pharmaceutical Company at 1-800-651-3861. To report an adverse event concerning the imported Potassium Chloride Proamp® 0.15 g/mL ampules, please contact La Jolla Pharmaceutical Company at 1-800-651-3861. Adverse events or quality problems experienced with the use of the Potassium Chloride Proamp® 0.15 g/mL ampules may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by 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. If you have any questions about the information contained in this letter or use of Aguettant's Potassium Chloride Proamp® 0.15 g/mL ampules, please contact La Jolla's Medical Information Contact Center (MICC) at 1-800-651-3861. Sincerely, Jérôme JOLY Laboratoire Aguettant Director, Global QP Cécile BAILLY Laboratoire Aguettant Medical Director George F. Tidmarsh, MD, PhD Chief Executive Officer La Jolla Pharmaceutical Company Doranne Frano Vice President, Regulatory Affairs La Jolla Pharmaceutical Company PRODUCT COMPARISON TABLE Import Product U.S. Marketed Product AGUETTANT HOSPIRA Presentation Drug Name Potassium chloride Proamp ® 0.15 g/mL, concentrate for solution for infusion Potassium Chloride for Injection Concentrate, USP Active Ingredient Concentration Potassium: 2.012 mmol/mL Equivalent to: (2 mEq K+/mL) (149 mg/mL) Each mL contains potassium chloride, 2 mEq (149 mg) Unit Volume / Volume 10 ml polypropylene ampules The ampules are made by polypropylene compliant to the 3.1.6. European pharmacopoeia monograph. They are formed through blow fill seal process and are terminally sterilized at 121°C, assuring a maximal level of sterility of the contained solution. 5 mL single dose vials Semi-rigid plastic vials fabricated from a specially formulated polyolefin. Indication and Usage Concentrate for solution for infusion administered to patients suffering from low potassium blood levels (hypokalemia). Potassium is naturally present in body fluids and is needed for normal body function. It can also be used as a potassium supply for patients who are unable to be fed orally and receive total parenteral nutrition. Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. Figure Figure Figure"],"health_care_provider_letter_table":["
Product name and description Size Pack factor NDC Number
Potassium Chloride Proamp® 0.15 g/mL, concentrate for solution for infusion (equivalent to 2 mEq/mL) 10 mL 50 ampules per box 60710-015-50
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Jérôme JOLY Laboratoire Aguettant Director, Global QP Cécile BAILLY Laboratoire Aguettant Medical Director George F. Tidmarsh, MD, PhD Chief Executive Officer La Jolla Pharmaceutical Company Doranne Frano Vice President, Regulatory Affairs La Jolla Pharmaceutical Company
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Import Product U.S. Marketed Product
AGUETTANT HOSPIRA
Presentation
Drug Name Potassium chloride Proamp® 0.15 g/mL, concentrate for solution for infusion Potassium Chloride for Injection Concentrate, USP
Active Ingredient Concentration Potassium: 2.012 mmol/mL Equivalent to: (2 mEq K+/mL) (149 mg/mL) Each mL contains potassium chloride, 2 mEq (149 mg)
Unit Volume / Volume 10 ml polypropylene ampules The ampules are made by polypropylene compliant to the 3.1.6. European pharmacopoeia monograph. They are formed through blow fill seal process and are terminally sterilized at 121°C, assuring a maximal level of sterility of the contained solution. 5 mL single dose vials Semi-rigid plastic vials fabricated from a specially formulated polyolefin.
Indication and Usage Concentrate for solution for infusion administered to patients suffering from low potassium blood levels (hypokalemia). Potassium is naturally present in body fluids and is needed for normal body function. It can also be used as a potassium supply for patients who are unable to be fed orally and receive total parenteral nutrition. Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
"],"id":"d9d09d39-83c2-4447-8171-22ef87173883","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 mL Ampule Label POTASSIUM chlorure PROAMP ® 1,5 g - 10 mL 0,15 g/mL 2,012 mmol/mL d'ion K + Solution à diluer pour perfusion - IV A diluer avant utilisation K 15% PRINCIPAL DISPLAY PANEL - 10 mL Ampule Label","PRINCIPAL DISPLAY PANEL - 10 mL Ampule Box CHLORURE DE POTASSIUM PROAMP ® 0, 15 g/mL AGUETTANT POTASSIUM CHLORIDE CAUTION Potassium Chloride for Injection Concentrate Each ampule contains 20 mEq/10 mL (2 mEq/mL) 0,15 g/mL = 2 mEq/mL Must be diluted before use IV use AGUETTANT 50 polypropylene ampoules 1,5 g 10 mL PRINCIPAL DISPLAY PANEL - 10 mL Ampule Box"],"set_id":"d7d402fb-ac55-4f53-91e7-345df18c2d53","spl_product_data_elements":["Chlorure de potassium Proamp potassium chloride potassium chloride POTASSIUM CATION WATER"],"version":"2"}