METRONIDAZOLE (Page 4 of 4)

HOW SUPPLIED

Metronidazole Injection USP, sterile, is supplied in 100 mL fill PAB® containers, each containing an isotonic, buffered solution of 500 mg metronidazole; packaged 24 per case. Metronidazole injection is sterile premixed solution intended for single use only.

NDC	REF	Fill Volume
Metronidazole Injection USP0264-5535-32	D5353-5224	100 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); however, brief exposure up to 40°C does not adversely affect the product.

Protect from light until use.

REFERENCES

1. Ralph ED, Kirby WMM: Bioassay of Metronidazole With Either Anaerobic or Aerobic Incubation, J. Infect. Dis. 132:587-591 (Nov.) 1975, or Gulaid, et al.: Determination of Metronidazole and its Major Metabolites in Biological Fluids by High Pressure Liquid Chromatography, Br. J. Clin. Pharmacol. 6:430-432, 1978.

Revised: December 2021

PAB is a registered trademark of B. Braun Medical Inc.

ATCC is a registered trademark of the American Type Culture Collection.

Directions for Use of PAB® Container

CAUTION: ADDING ADDITIVES INTO THE PAB CONTAINER IS PROHIBITED. DO NOT ADD SUPPLEMENTARY MEDICATIONS .

For intravenous infusion only.

Store the individual container in the storage carton until ready to use.

Aseptic technique is required.

Before use, perform the following checks:
Read the label. Ensure solution is the one ordered and is within the expiration date.
Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.
Use only if solution is clear and container and seals are intact.
Single dose plastic container.

Discard unused portion.
Consult Package Insert for complete product information.

WARNING: DO NOT USE PLASTIC CONTAINER IN SERIES CONNECTION.

1. Identify Set Port (See Figure A).
   
   
2. Caution – Adding additives into the Metronidazole Injection USP solution bag is prohibited. If used with a primary intravenous fluid system, the primary solution should be discontinued during metronidazole infusion. Do not use equipment containing aluminum (e.g., needles, cannulae, etc.) that may contact the drug solution.
   
3. To Attach Administration Set
   To aseptically remove the set port closure: hold container below the set port and grasp the foil tab between the thumb and forefinger then pull the tab in two steps as shown in Figure B Steps 1 and 2.
   
   
4. Push spike through the diaphragm of the port (See Figure C). Hang container using hole on the lower flap. Prime set in accordance with the Directions for Use provided with the set in use.
   

PAB® containers can be safely transported in a standard 6-inch carrier through a pneumatic tube system that is well maintained and running properly.

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
Prepared in USA. API from Italy.

Y36-003-049 LD-438-10

PRINCIPAL DISPLAY PANEL — 100 mL fill Bag

Metronidazole Injection USP

METRONIDAZOLE
500 mg/ 100 mL (5 mg/mL)

NDC 0264-5535-32
100 mL fill

PAB^® Container

For Intravenous Infusion Only.

CAUTION: ADDING ADDITIVES INTO THE PAB CONTAINER IS
PROHIBITED. DO NOT ADD SUPPLEMENTARY MEDICATIONS.

Single dose plastic container. Discard unused portion.
Protect from light until use.

Each 100 mL contains: Metronidazole USP 500 mg; Sodium
Chloride USP 740 mg; Dibasic Sodium Phosphate•7H₂ O USP
112 mg; Citric Acid Anhydrous USP 40 mg; Water for Injection USP, qs

pH: 5.8 (4.5-7.0) Calc. Osmolarity: 297 mOsmol/liter
Sodium content: 13.5 mEq/container

Sterile, nonpyrogenic. Use only if solution is clear and container and
seals are intact. For intravenous use only.

Recommended Storage: Room temperature (25°C). Avoid
excessive heat. Protect from freezing. See Package Insert.

Not made with natural rubber latex, PVC or DEHP.

Rx only

PAB is a registered trademark of B. Braun Medical Inc.

REF D5353-5224 HK 41283
B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862Prepared in USA. API from Italy.

Y94-003-379 LD-491-4

LOT

EXP

PRINCIPAL DISPLAY PANEL — 100 mL fill Container Carton

Metronidazole Injection USP

METRONIDAZOLE 500 mg/ 100 mL (5 mg/mL)

Four 100 mL fill PAB® Containers

NDC 0264-5535-32

For Intravenous Infusion Only.

CAUTION: ADDING ADDITIVES INTO THE PAB CONTAINER IS PROHIBITED. DO NOT ADD SUPPLEMENTARY MEDICATIONS.

Single dose plastic container. Discard unused portion.
Protect from light until use.

Each 100 mL contains: Metronidazole USP 500 mg; Sodium Chloride
USP 740 mg; Dibasic Sodium Phosphate•7H₂ O USP 112 mg;
Citric Acid Anhydrous USP 40 mg; Water for Injection USP, qs

pH: 5.8 (4.5-7.0) Calc. Osmolarity: 297 mOsmol/liter
Sodium content: 13.5 mEq/container

Sterile, nonpyrogenic. Use only if solution is clear and container
and seals are intact. For intravenous use only.

Recommended Storage: Room temperature (25°C). Avoid
excessive heat. Protect from freezing. See Package Insert.

Not made with natural rubber latex, PVC or DEHP.

Rx only

PAB is a registered trademark of B. Braun Medical Inc.

REF D5353-5224 HK 41283

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862
Prepared in USA. API from Italy.

X12-002-495 LD-492-4

LOT

EXP

METRONIDAZOLE metronidazole solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-5535 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 500 mg in 100 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 740 mg in 100 mL SODIUM PHOSPHATE, DIBASIC 112 mg in 100 mL ANHYDROUS CITRIC ACID 40 mg in 100 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0264-5535-32 6 CARTON in 1 CASE contains a CARTON 1 4 CONTAINER in 1 CARTON This package is contained within the CASE (0264-5535-32) and contains a CONTAINER 1 100 mL in 1 CONTAINER This package is contained within a CARTON and a CASE (0264-5535-32)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018900 09/29/1983

Labeler — B. Braun Medical Inc. (002397347)

Revised: 12/2021 B. Braun Medical Inc.