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Glycophos | Glycophos [Fresenius Kabi USA, LLC] | BioPortfolio

18:46 EST 26th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

IMPORTANT PRESCRIBING INFORMATION October 30, 2017

Subject: Temporary importation of Glycophos to address drug shortage issues

Dear Healthcare Professional, Due to the critical shortage of phosphate injection in the U.S. market, Fresenius Kabi USA, LLC (Fresenius Kabi USA) is coordinating with the U.S. Food and Drug Administration (FDA) to provide an alternative treatment option during this critical shortage period. Fresenius Kabi USA has initiated temporary importation of a Glycophos 20 mL Injection Single Dose Plastic Vial into the U.S. market. This product is marketed in Europe, and is manufactured in the Fresenius Kabi Norway plant.

At this time, no other entity except Fresenius Kabi USA is authorized by the FDA to import or distribute Glycophos 20 mL Injection Single Dose Plastic Vial in the U.S. FDA has not approved Fresenius Kabi's Glycophos in the United States.

Effective immediately, and during this temporary period, Fresenius Kabi USA will offer the following presentation of phosphate injection:

The vial and carton labels will display the text used when marketing the product in English speaking countries.

It is important to note that there are some key differences in the formulation and labeling between the current U.S. marketed phosphate injection products and Glycophos that you need to be aware of: Refer to the Glycophos package insert for full prescribing information This communication and product information is available on the Fresenius Kabi USA web site http://products.fresenius-kabi.us/product-323.html as well as on the FDA Drug Shortage web site. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.

To report adverse events or quality problems experienced with the use of this product, call Fresenius Kabi USA Vigilance or Medical Affairs at 1-800-551-7176, Monday – Friday, between the hours of 8 a.m. and 5 p.m. (CST), or e-mail adverse.events.USA@fresenius-kabi.com or productcomplaint.USA@fresenius-kabi.com. 

Fresenius Kabi USA CONTACT  NUMBERS: Please use the following contact numbers as appropriate:

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Sincerely, Melanie Power-Burns Vice President, Quality and Compliance Key Differences between U.S. Marketed Phosphate Injection Products and Glycophos

1. Data on file. Comparison Table of U.S. Phosphate Injection Products to Glycophos

Phosphate Label Product Comparison Table


Glycophos 20 mL
Sterile Concentrate
Single Dose Plastic Vial
Chemical Name Sodium Glycerophosphate 
Phosphate Concentration  1 mMol per mL.
Type of Phosphate  Organic
Sodium  2 mEq per mL.
Fill Volume  20 mL.
Description  Single Dose Plastic Vial
Manufacturer  Fresenius Kabi Norge A/S
 Reason To Call  Department Number  
ADE Reporting  Vigilance Department  1-800-551-7176
Clinical/Technical
Info. Or Product
Complaint
 Medical Affairs Department
Product Availability & Ordering  Customer Service Department  1-888-386-1300
Current U.S. Marketed
Inorganic Phosphate Injection, USP
Glycophos What does this mean to you,
as a Healthcare Professional?
Indications and contraindications:
see package insert
Indications and contraindications:
see package insert 
Glycophos is indicated in adult patients and
infants as a supplement in intravenous nutrition
to meet the requirements of phosphate.
Glycophos is contraindicated in patients
in a state of dehydration or with hypernatremia,
hyperphosphatemia, severe renal insufficiency or shock.
Sodium Phosphates and
Potassium Phosphates
contain 3 mMol of
phosphate per mL.
Glycophos contains 1 mMol
of phosphate per mL.
 
Glycophos contains 20 mLs in each plastic vial
for a total concentration of 20 mMols of phosphate per vial.
Glycophos must be diluted before administration.
 
Sodium Phosphates and
Potassium Phosphates are
INORGANIC PHOSPHATE.
 Glycophos is an
ORGANIC PHOSPHATE.
Organic phosphates tend to be more calcium compatible1.
This means:
At higher concentrations, solutions of calcium and phosphate may
exist together without precipitating into an insoluble salt complex.
In high pH solutions (admixtures above pH 6.0), organic
phosphate is less likely to precipitate.
 
Barcode on container label
 No unit of use barcode Any barcodes on Glycophos product will not be
appropriately recognized by scanning systems
used in the United States and should NOT be used. 
Institutions should manually input the product into their
systems and to confirm that barcode systems do not
provide incorrect information when the product is scanned.
 For questions regarding Glycophos in the United States, please contact
Fresenius Kabi USA Medical Affairs at 1-800-551-7176 Option 4,
Monday – Friday, between the hours of 8 a.m. and 5 p.m. (CST), or e-mail nutrition.medinfo.USA@fresenius-kabi.com.
Product Name   Potassium Phosphates  Sodium Phosphates Glycophos 
Chemical Name  Potassium Phosphate  Sodium Phosphate  Sodium Glycerophosphate
Phosphate Concentration  3 mMol per mL  3 mMol per mL  1 mMol per mL
Type of Phosphate  Inorganic  Inorganic  Organic
Sodium  Does not contain  4 mEq per mL  2 mEq per mL
Potassium  4.4 mEq per mL  Does not contain  Does not contain
Fill Volume  5 mL, 15 mL, 50 mL  5 mL, 15 mL, 50 mL  20 mL
Description  Single Dose Vial  Single Dose Vial  Single Dose Plastic Vial
Companies  Fresenius Kabi USA, Pfizer  American Regent,
Fresenius Kabi USA, Pfizer
 Fresenius Kabi Norge A/S

1.     QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of Glycophos contains

Active ingredient                                               Quantity            

Sodium glycerophosphate pentahydrate            306.1 mg*

*Corresponds to 216 mg sodium glycerophosphate           

The active ingredient in 1 ml of Glycophos correspond to

Phosphate        1 mmol

Sodium            2 mmol

For excipients, see 5.1

PRODUCT PROPERTIES

•    Osmolality: 2760 mosm/kg water

•    pH: 7.4

2.     PHARMACEUTICAL FORM

Concentrate for solution for infusion.

3.     CLINICAL PARTICULARS

3.1   Therapeutic indications

Glycophos is indicated in adult patients and infants as a supplement in intravenous nutrition to meet the requirements of phosphate.

3.2    Posology and method of administration

Glycophos must not be given undiluted.

Adults:

The recommended dosage is individual. The recommended daily dosage of phosphate during intravenous nutrition would normally be 10-20 mmol. This can be met by using 10-20 ml of Glycophos added to the infusion solution or to the admixture for which compatibility has been proved.

Infants:

The recommended dosage is individual. The recommended dose for infants and neonates is 1.0-1.5 mmol/Kg body weight/day.

3.3    Contra-indications

Glycophos should not be given to patients in a state of dehydration or with hypernatraemia, hyperphosphataemia, severe renal insufficiency or shock.

3.4    Special warnings and special precautions for use

Glycophos should be used with caution in patients with impaired renal function. The phosphate status of all patients should be monitored regularly.

Glycophos must not be given undiluted.

3.5    Interaction with other medicaments and other forms of interaction

No interactions with other drugs have been observed, but a moderate fall in serum phosphate can be seen during carbohydrate infusions.

3.6    Pregnancy and lactation

Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Glycophos. However, the requirements of phosphate in a pregnant woman are slightly increased compared to non-pregnant women.

No adverse events are to be expected when Glycophos is administered during pregnancy.

3.7    Effects on ability to drive and use machines

No effects on the ability to drive and use machines are to be expected.

3.8    Undesirable effects

No adverse effects related to glycerophosphate have been reported.

3.9    Overdose

No adverse effects of an overdose have been reported. Most patients in need of intravenous nutrition have an increased capacity to handle glycerophosphate. See also 3.3 "Contra-indications".

4.      PHARMACOLOGICAL PROPERTIES

4.1    Pharmacodynamic properties

Glycerophosphate is a metabolic intermediate in fat metabolism and any pharmacodynamic effects other than maintaining the normal metabolic pathways are unlikely.

4.2    Pharmacokinetic properties

To become available it is necessary for the phosphate group to be hydrolysed from the glycerophosphate molecule. The hydrolysis occurs maximally at a plasma concentration of >0.7 mmol/l. Assuming that all hydrolysis of glycerophosphate takes place in plasma, about 12-15 mmol of sodium glycerophosphate will be hydrolysed each day in individuals with normal serum alkaline phosphatase.

No pharmacokinetical data is available for infants, however with the recommended dosage hyperphosphataemia is unlikely.

4.3    Preclinical safety data

Preclinical safety studies on Glycophos demonstrated good tolerance.

5.      PHARMACEUTICAL PARTICULARS

5.1    List of excipients

Hydrochloric acid

Water for Injections                       

5.2    Incompatibilities

Glycophos may only be added to or mixed with other medicinal products for which compatibility has been documented. See 5.6.

5.3    Shelf life

3 years

5.4    Special precautions for storage

Do not store above 25°C. Do not freeze.

5.5    Nature and contents of container

Polypropylene vial.           

Pack size: 10 x 20 ml

5.6    Instructions for use/handling

Glycophos must not be given undiluted.

Compatibility

Additions should be made aseptically.

Up to 120 ml of Glycophos and 48 mmol of calcium (as CaCl) can be added to 1000 ml Vamin Glucose, Vamin 9 Electrolyte Free, Vamin 14, Vamin 14 Electrolyte Free, Vamin 18 Electrolyte Free and Vaminolact.

Up to 10 ml of Glycophos and 10 mmol of calcium (as CaCl) can be added to 1000 ml Glucose 50 mg/ml.

Up to 20 ml of Glycophos and 20 mmol of calcium (as CaCl) can be added to 1000 ml Glucose 200 mg/ml.

Up to 60 mmol of Glycophos and 24 mmol of calcium (as CaCl) can be added to 1000 ml Glucose 500 mg/ml.

Infusion time

The infusion time should not be less than 8 hours.

Stability

When additions are made to an infusion solution, the infusion should be completed within 24 hours from preparation to prevent microbiological contamination. The left over contents of opened bottles/vials/ampoules should be discarded and not kept for later use.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Glycophos 20 mL Vial Label

20 ml

Glycophos™

Sterile concentrate

 

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Glycophos 20 mL Vial Carton Panel

10 vials of 20 ml

Glycophos™

Sterile concentrate

 

Manufacturer

Fresenius Kabi USA, LLC

Active Ingredients

Source

Drugs and Medications [0 Results]

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