DIANEAL FOR PERITONEAL DIALYSIS anhydrouse dextrose sodium chloride lactate calcium magnesium injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Available from:

Baxter Healthcare Corporation

INN (International Name):

ANHYDROUS DEXTROSE

Composition:

ANHYDROUS DEXTROSE 13.6 g in 1000 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Unapproved drug for use in drug shortage

Summary of Product characteristics

DIANEAL FOR PERITONEAL DIALYSIS- ANHYDROUSE DEXTROSE, SODIUM CHLORIDE,
SODIUM
LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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DIANEAL® SOLUTION FOR PERITONEAL DIALYSIS
IMPORTANT DRUG INFORMATION
October 2014
SUBJECT: TEMPORARY IMPORTATION OF DIANEAL® SOLUTION FOR PERITONEAL
DIALYSIS
Dear Healthcare Professional,
Due to current critical shortage of Dianeal peritoneal dialysis
solutions for new and existing patients in
the US market, Baxter Healthcare Corporation (Baxter) is coordinating
with the Food and Drug
Administration (FDA) to increase the availability of the drug. Baxter
has initiated temporary importation
of Dianeal peritoneal dialysis solutions manufactured at Baxter’s
Castlebar, Ireland facility and
marketed within the European Union (EU). The FDA has not approved this
product in the United States.
Prior to its use, it is important to check for leaks by squeezing the
inner bag firmly. If leaks are found,
do not use solution as sterility may be impaired. Additionally, check
to see that solution is clear and free
of foreign matter. Solutions that are cloudy, discolored, contain
visible particulate matter, or show
evidence of leakage should not be used or discarded, but reported to
Baxter Product Surveillance
immediately. To report product quality issues, please contact Baxter
Product Surveillance at 1-800-
437-5176.
There are no clinically relevant differences in the composition of the
European-manufactured product
and the US-manufactured product (see Table 1). However, because the
imported product is only
available in one size (5000 ml), the number of solution bags patients
use per treatment may require
modification. Although the frangible, medication ports, and connection
caps may appear different for the
European-manufactured product, they function in a simil