Milrinone Lactate in Dextrose (Page 4 of 4)

Dosage Adjustment in Renally Impaired Patients

Data obtained from patients with severe renal impairment (creatinine clearance = 0 to 30 mL/min) but without congestive heart failure have demonstrated that the presence of renal impairment significantly increases the terminal elimination half-life of milrinone. Reductions in infusion rate may be necessary in patients with renal impairment. For patients with clinical evidence of renal impairment, the recommended infusion rate can be obtained from the following table:

Creatinine Clearance(mL/min/1.73 m2)

Infusion Rate(mcg/kg/min)

5

0.20

10

0.23

20

0.28

30

0.33

40

0.38

50

0.43

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Milrinone Lactate in 5% Dextrose Injection is a clear, colorless to pale yellow solution.

DIRECTIONS FOR USE

When administering Milrinone Lactate in 5% Dextrose Injection by continuous infusion, it is advisable to use a calibrated electronic infusion device.

To open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

Preparation for Administration

Visually inspect the container. If the administration port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.

(Use aseptic technique)

1.
Suspend container from eyelet support.
2.
Remove protector from administration port at bottom of container.
3.
Attach administration set. Refer to complete directions accompanying set.

Caution: Do not administer simultaneously with blood. Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

HOW SUPPLIED

Baxter’s Milrinone Lactate in 5% Dextrose Injection is supplied in INTRAVIA Plastic Container as follows:

2J0900

NDC 0338-6010-48

100 mL (200 mcg/mL)

2J0901

NDC 0338-6011-37

200 mL (200 mcg/mL)

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature, 25° C (77° F); however, brief exposure up to 40° C (104° F) does not adversely affect the product.

Baxter Healthcare Corporation Deerfield, IL 60015 USA

Printed in USA

Baxter and Intravia are registered trademarks of Baxter International Inc.

07-19-00-0355

Rev. May 2018

PACKAGE LABELING — PRINCIPAL DISPLAY PANEL

Milrinone Lactate Representative Container Label
(click image for full-size original)

Container Label

Container Label

LOT EXP

200 mL 2J0901
NDC 0338-6011-37

MILRINONE
LACTATE

40 mg/200 mL
200 mcg (0.2 mg) per mL*
in 5% Dextrose Injection

*EACH ML CONTAINS MILRINONE LACTATE
EQUIVALENT TO 0.2 MG MILRINONE 0.282 MG
LACTIC ACID 54.3 MG DEXTROSE HYDROUS
USP IN WATER FOR INJECTION USP THE PH
IS ADJUSTED WITH LACTIC ACID AND/OR SODIUM
HYDROXIDE PH3.5 (3.2 — 4.0)

STERILE NONPYROGENIC SINGLE DOES NO PRESERVATIVE IS ADDED

USUAL DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE
PACKAGE INSERT

CAUTIONS CHECK FOR MINUTE LEAKS BY SQUEEZING BAG FIRMLY IF
LEAKS ARE FOUND DISCARD BAG AS STERILITY MAY BE IMPAIRED MUST
NOT BE USED IN SERIES CONNECTIONS DO NOT ADMINISTER
SIMULTANEOUSLY WITH BLOOD USE ONLY IF SOLUTION IS CLEAR
COLORLESS TO PALE YELLOW
RX ONLY

RECOMMENDED STORAGE STORE AT ROOM TEMPERATURE 25°C (77°F)
HOWEVER BRIEF EXPOSURE UP TO 40°C (104°F) DOES NOT ADVERSELY
AFFECT THE PRODUCT PROTECT FROM FREEZING AVOID EXCESSIVE HEAT

Baxter Logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

INTRAVIA CONTAINER
BAXTER AND INTRAVIA ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

US PAT NOS 5 849 843 5 998 019 PAT PENDING

Milrinone Lactate Representative Container Label  NDC 0338-6010-48
(click image for full-size original)

Container

Container

LOT EXP

100 mL 2J0900
NDC 0338-6010-48

MILRINONE LACTATE

20 mg/100 mL
200 mcg (0.2 mg) per mL*
in 5% Dextrose Injection

*EACH ML CONTAINS MILRINONE LACTATE EQUIVALENT TO 0.2 MG
MILRINONE 0.282 MG LACTIC ACID 54.3 MG DEXTROSE
HYDROUS USP IN WATER FOR INJECTION USP THE PH IS
ADJUSTED WITH LACTIC ACID AND/OR SODIUM HYDROXIDE PH
3.5 (3.2 — 4.0) NO PRESERVATIVE IS ADDED STERILE
NONPYROGENIC SINGLE DOSE

USUAL DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN
SEE PACKAGE INSERT

CAUTIONS CHECK FOR MINUTE LEAKS BY SQUEEZING BAG
FIRMLY IF LEAKS ARE FOUND DISCARD BAG AS STERILITY MAY
BE IMPAIRED MUST NOT BE USED IN SERIES
CONNECTIONS DO NOT ADMINISTER SIMULTANEOUSLY WITH
BLOOD USE ONLY IF SOLUTION IS CLEAR COLORLESS TO PALE YELLOW
RX ONLY

RECOMMENDED STORAGE STORE AT ROOM TEMPERATURE
25°C (77°F) HOWEVER BRIEF EXPOSURE UP TO 40°C
(104°F) DOES NOT ADVERSELY AFFECT THE PRODUCT
PROTECT FROM FREEZING AVOID EXCESSIVE HEAT

INTRAVIA CONTAINER BAXTER AND INTRAVIA
ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC

Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA

MILRINONE LACTATE IN DEXTROSE milrinone lactate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-6010
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MILRINONE LACTATE (MILRINONE) MILRINONE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTIC ACID 0.282 mg in 1 mL
DEXTROSE MONOHYDRATE 54.3 mg in 1 mL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-6010-48 10 BAG in 1 CARTON contains a BAG
1 100 mL in 1 BAG This package is contained within the CARTON (0338-6010-48)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075834 05/28/2002
MILRINONE LACTATE IN DEXTROSE milrinone lactate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-6011
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MILRINONE LACTATE (MILRINONE) MILRINONE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTIC ACID 0.282 mg in 1 mL
DEXTROSE MONOHYDRATE 54.3 mg in 1 mL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-6011-37 10 BAG in 1 CARTON contains a BAG
1 200 mL in 1 BAG This package is contained within the CARTON (0338-6011-37)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075834 05/28/2002
Labeler — Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 189326168 ANALYSIS (0338-6010), ANALYSIS (0338-6011), LABEL (0338-6010), LABEL (0338-6011), MANUFACTURE (0338-6010), MANUFACTURE (0338-6011), PACK (0338-6010), PACK (0338-6011), STERILIZE (0338-6010), STERILIZE (0338-6011)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 194684502 ANALYSIS (0338-6010), ANALYSIS (0338-6011)
Establishment
Name Address ID/FEI Operations
PACE ANALYTICAL INC. 362250102 ANALYSIS (0338-6010), ANALYSIS (0338-6011)

Revised: 05/2018 Baxter Healthcare Corporation

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