DIANEAL PD-2 with Dextrose

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the label: Peritonitis and Encapsulating Peritoneal Sclerosis [see Warnings and Precautions (5.1) ] Electrolyte and Fluid Imbalances [see Warnings and Precautions (5.4) ] To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience There are no data available on adverse reactions from controlled clinical trials conducted to evaluate the safety of DIANEAL peritoneal dialysis solutions. 6.2 Post-Marketing Experience The following adverse experiences have been identified during post-approval use of DIANEAL solutions or in conjunction with performing the peritoneal dialysis procedure. Because these experiences are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship during drug exposure. Most of these adverse experiences are believed to be consequences of peritoneal dialysis. INFECTIONS AND INFESTATIONS: Fungal peritonitis, Peritonitis bacterial, Catheter related infection METABOLISM AND NUTRITION DISORDERS: Hypovolemia, Hypervolemia, Fluid retention, Hypokalemia, Hyponatremia, Dehydration, Hypochloremia VASCULAR DISORDERS: Hypotension, Hypertension RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Dyspnea GASTROINTESTINAL DISORDERS: Sclerosing encapsulating peritonitis, Peritonitis, Peritoneal cloudy effluent, Vomiting, Diarrhea, Nausea, Constipation, Abdominal pain, Abdominal distension, Abdominal discomfort SKIN AND SUBCUTANEOUS DISORDERS: Stevens-Johnson syndrome, Urticaria, Rash, (including pruritic, erythematous and generalized), Pruritus MUSCULOSKELETAL, CONNECTIVE TISSUE DISORDERS: Myalgia, Muscle spasms, Musculoskeletal pain GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Generalized edema, Pyrexia, Malaise, Infusion site pain, Catheter related complication

4 CONTRAINDICATIONS DIANEAL peritoneal dialysis solutions are contraindicated in patients with severe lactic acidosis. • Pre-existing severe lactic acidosis ( 4 )

11 DESCRIPTION DIANEAL peritoneal dialysis solutions are sterile, nonpyrogenic solutions in flexible containers for intraperitoneal administration only. The peritoneal dialysis solutions contain no bacteriostatic or antimicrobial agents. DIANEAL solutions are hyperosmolar solutions. Table 4 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG Container for CAPD therapy AMBU-FLEX/Plastic Container with pull ring for APD therapy Composition/100 mL *Dextrose, Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride, USP (CaCl2•2H2O) Magnesium Chloride, USP (MgCl2•6H2O) DIANEAL PD-2 1.5% Dextrose 1.5 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL PD-2 2.5% Dextrose 2.5 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL PD-2 4.25% Dextrose 4.25 g 538 mg 448 mg 25.7 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 1.5 g 538 mg 448 mg 18.3 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 2.5 g 538 mg 448 mg 18.3 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 4.25 g 538 mg 448 mg 18.3 mg 5.08 mg Table 5 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy Composition/100 mL *Dextrose, Hydrous Sodium Chloride (NaCl) Sodium Lactate (C3H5NaO3) Calcium Chloride (CaCl2•2H2O) Magnesium Chloride (MgCl2•6H2O) DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 1.5 g 538 mg 448 mg 18.4 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 2.5 g 538 mg 448 mg 18.4 mg 5.08 mg DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 4.25 g 538 mg 448 mg 18.4 mg 5.08 mg The plastic container is fabricated from polyvinyl chloride (PVC Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the solution container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by cell culture toxicity studies. Structural Formula Dextrose Hydrous USP

2 DOSAGE AND ADMINISTRATION For intraperitoneal administration only. ( 2 ) 2.1 Basic Dosing Information DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only. Not for intravenous or intra-arterial administration.. Select mode of therapy, frequency of treatment, formulation, fill volume, duration of dwell, and length of dialysis based on the patient’s clinical condition, fluid, electrolyte and specific needs. The fill volume depends on body size, usually from 2.0 to 2.5 liters per 1.73m 2 for adults. DIANEAL peritoneal dialysis solutions are intended for use in Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD). Refer to directions accompanying ancillary equipment for CAPD and APD system preparation. Product Selection To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange. As the patient’s body weight becomes closer to the ideal dry weight, lowering the dextrose concentration of DIANEAL solution is recommended. DIANEAL 4.25% dextrose-containing solution has the highest osmolarity of the DIANEAL solutions and using it for all exchanges may cause dehydration [see Dosage Forms and Strengths (3) ]. 2.2 Adding Medications If the resealable rubber plug on the medication port is missing or partly removed, do not use the product if medication is to be added. To add a medication: 1. Put on mask. Clean and/or disinfect hands. 2. Prepare medication port site using aseptic technique. 3. Using a syringe with a 1-inch long, 25- to 19-gauge needle, puncture the medication port and inject additive. 4. Reposition container with container ports up and evacuate medication port by squeezing and tapping it. 5. Mix solution and additive thoroughly. 2.3 Directions for Use Warming DIANEAL peritoneal dialysis solution can be warmed to 37°C (98.6°F). Only dry heat should be used. For CAPD, it is best to warm solutions within the overwrap using a heating pad. Do not immerse DIANEAL solutions in water for warming. Do not use a microwave oven to warm DIANEAL solutions. To Open To open, tear the overwrap down at the slit and remove the solution container. Do not use sharp objects to remove the overwrap. Product Inspection Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage. Some opacity of the plastic, due to moisture absorption during the sterilization process, may be observed. This does not affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap. The opacity should diminish gradually. Inspect the bag connector to ensure the tip protector (pull ring or blue pull tip) is attached. Do not use if the tip protector is not attached to the connector. Inspect the DIANEAL solution for signs of leakage and check for minute leaks by squeezing the container firmly. If the container has frangible(s), inspect that they are positioned correctly and are not broken. Do not use DIANEAL solution if the frangible(s) are broken or leaks are suspected as sterility may be impaired. For DIANEAL solutions in ULTRABAG containers, inspect the tubing and drain container for presence of solution. Small droplets are acceptable, but if solution flows past the frangible prior to use, do not use and discard the units. CAPD therapy using ULTRABAG containers Select appropriate formulation from Table 1. Put on mask. Clean and/or disinfect hands. Using aseptic technique; 1. Uncoil tubing and drain bag, ensuring that the transfer set is closed. 2. Break the connector (Y-set) frangible. 3. Remove the tip protector from connector of solution container. Do not reuse the solution or container once the tip protector is removed. 4. Immediately attach the solution container to patient connector (transfer set). 5. Clamp solution line and then break frangible near solution bag. Hang solution container and place the drainage container below the level of the abdomen. 6. Open transfer set to drain the solution from abdomen. If drainage cannot be established, contact your clinician. When drainage complete, close transfer set. 7. Remove clamp from solution line and flush new solution to flow into the drainage container for 5 seconds to prime the line. Clamp drain line after flush complete. 8. Open transfer set to fill. When fill complete, close transfer set. 9. Disconnect ULTRABAG container from transfer set and apply MINICAP disconnect cap. 10. Upon completion of therapy, discard any unused portion. APD therapy using AMBU-FLEX containers with pull rings or plastic containers with blue pull tips or pull rings Select appropriate formulation from Table 1, 2 or 3. Put on mask. Clean and/or disinfect hands. Using aseptic technique; 1. Remove the tip protector from connector of solution container. Do not reuse the solution or container once the tip protector is removed. 2. Immediately attach the solution container to an appropriate automated peritoneal dialysis set. 3. Continue therapy as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis. 4. Upon completion of therapy, discard any unused portion.

1 INDICATIONS AND USAGE DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure. For management of acute or chronic renal failure.

10 OVERDOSAGE There is a potential for overdose resulting in hypervolemia, hypovolemia, electrolyte disturbances or hyperglycemia. Excessive use of DIANEAL peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

7 DRUG INTERACTIONS As with other dialysis solutions, blood concentrations of dialyzable drugs may be reduced by dialysis. Dosage adjustment of concomitant medications may be necessary. Diabetic patients may require dosage adjustments of insulin or other treatments for hyperglycemia [see Warnings and Precautions (5.5) ].

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action DIANEAL peritoneal dialysis solutions are a pharmacologically inactive, hypertonic peritoneal dialysis solution containing dextrose, a monosaccharide, as the primary osmotic agent. An osmotic gradient must be created between the peritoneal membrane and the dialysis solution in order for ultrafiltration to occur. The hypertonic concentration of glucose in DIANEAL solutions exert an osmotic pressure across the peritoneal membrane resulting in transcapillary ultrafiltration. Like other peritoneal dialysis solutions, DIANEAL solutions contain electrolytes to facilitate the correction of electrolyte abnormalities. DIANEAL solutions contain a buffer, lactate, to help normalize acid-base abnormalities. 12.3 Pharmacokinetics Absorption Glucose is rapidly absorbed from the peritoneal cavity by diffusion and appears quickly in the circulation due to the high glucose concentration gradient between DIANEAL solutions compared to blood capillary glucose level. Absorption per unit time will be the highest at the start of an exchange and decreases over time. The rate of glucose absorption will be dependent upon the transport characteristics of the patient’s peritoneal membrane as determined by a peritoneal equilibration test (PET). Glucose absorption will also depend upon the concentration of glucose used for the exchange and the length of the dwell. Transport of other molecules will be dependent upon the molecular size of the solute, the concentration gradient, and the effective peritoneal surface area as determined by the PET. Metabolism and Elimination Glucose is metabolized by normal cellular pathways (i.e., glycolysis). Metabolism of lactate occurs in the liver and results in the generation of the bicarbonate. Glucose not absorbed during PD exchange procedure is removed by drainage of the PD solution from the peritoneal cavity. Drug Interaction Studies Heparin No human drug interaction studies with heparin were conducted. In vitro studies demonstrated no evidence of incompatibility of heparin with DIANEAL solutions. Antibiotics No formal clinical drug interaction studies have been performed. In vitro studies of the following medications have demonstrated stability with DIANEAL solutions: amphotericin B, ampicillin, cefazolin, cefepime, cefotaxime, ceftazidime, ceftriaxone, ciprofloxacin, clindamycin, deferoxamine, erythromycin, gentamicin, linezolid, mezlocillin, miconazole, moxifloxacin, nafcillin, ofloxacin, penicillin G, piperacillin, sulfamethoxazole/trimethoprim, ticarcillin, tobramycin, and vancomycin. However, aminoglycosides should not be mixed with penicillins due to chemical incompatibility.

12.1 Mechanism of Action DIANEAL peritoneal dialysis solutions are a pharmacologically inactive, hypertonic peritoneal dialysis solution containing dextrose, a monosaccharide, as the primary osmotic agent. An osmotic gradient must be created between the peritoneal membrane and the dialysis solution in order for ultrafiltration to occur. The hypertonic concentration of glucose in DIANEAL solutions exert an osmotic pressure across the peritoneal membrane resulting in transcapillary ultrafiltration. Like other peritoneal dialysis solutions, DIANEAL solutions contain electrolytes to facilitate the correction of electrolyte abnormalities. DIANEAL solutions contain a buffer, lactate, to help normalize acid-base abnormalities.

12.3 Pharmacokinetics Absorption Glucose is rapidly absorbed from the peritoneal cavity by diffusion and appears quickly in the circulation due to the high glucose concentration gradient between DIANEAL solutions compared to blood capillary glucose level. Absorption per unit time will be the highest at the start of an exchange and decreases over time. The rate of glucose absorption will be dependent upon the transport characteristics of the patient’s peritoneal membrane as determined by a peritoneal equilibration test (PET). Glucose absorption will also depend upon the concentration of glucose used for the exchange and the length of the dwell. Transport of other molecules will be dependent upon the molecular size of the solute, the concentration gradient, and the effective peritoneal surface area as determined by the PET. Metabolism and Elimination Glucose is metabolized by normal cellular pathways (i.e., glycolysis). Metabolism of lactate occurs in the liver and results in the generation of the bicarbonate. Glucose not absorbed during PD exchange procedure is removed by drainage of the PD solution from the peritoneal cavity. Drug Interaction Studies Heparin No human drug interaction studies with heparin were conducted. In vitro studies demonstrated no evidence of incompatibility of heparin with DIANEAL solutions. Antibiotics No formal clinical drug interaction studies have been performed. In vitro studies of the following medications have demonstrated stability with DIANEAL solutions: amphotericin B, ampicillin, cefazolin, cefepime, cefotaxime, ceftazidime, ceftriaxone, ciprofloxacin, clindamycin, deferoxamine, erythromycin, gentamicin, linezolid, mezlocillin, miconazole, moxifloxacin, nafcillin, ofloxacin, penicillin G, piperacillin, sulfamethoxazole/trimethoprim, ticarcillin, tobramycin, and vancomycin. However, aminoglycosides should not be mixed with penicillins due to chemical incompatibility.

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3 DOSAGE FORMS AND STRENGTHS DIANEAL peritoneal dialysis solution is formulated with the following ionic concentrations: Table 1 - DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG Container for CAPD therapy AMBU-FLEX Container with pull ring for APD therapy Ionic Concentration (mEq/L) OSMOLARITY (mOsmol/L) (calc) pH Sodium Calcium Magnesium Chloride Lactate DIANEAL PD-2 1.5% Dextrose 346 5.2 (4.0 to 6.5) 132 3.5 0.5 96 40 DIANEAL PD-2 2.5% Dextrose 396 5.2 (4.0 to 6.5) 132 3.5 0.5 96 40 DIANEAL PD-2 4.25% Dextrose 485 5.2 (4.0 to 6.5) 132 3.5 0.5 96 40 DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 344 5.2 (4.0 to 6.5) 132 2.5 0.5 95 40 DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 395 5.2 (4.0 to 6.5) 132 2.5 0.5 95 40 DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 483 5.2 (4.0 to 6.5) 132 2.5 0.5 95 40 Table 2 - DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy Ionic Concentration (mEq/L) OSMOLARITY (mOsmol/L) (calc) pH Sodium Calcium Magnesium Chloride Lactate DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 344 5.0 to 6.5 132 2.5 0.5 95 40 DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 395 5.0 to 6.5 132 2.5 0.5 95 40 DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 483 5.0 to 6.5 132 2.5 0.5 95 40 Table 3 – DIANEAL PD-2 and DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with pull ring for APD therapy OSMOLARITY (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Sodium Calcium Magnesium Chloride Lactate DIANEAL PD-2 1.5% Dextrose 346 5.0 to 5.6 132 3.5 0.5 96 40 DIANEAL PD-2 2.5% Dextrose 396 5.0 to 5.6 132 3.5 0.5 96 40 DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 344 5.0 to 5.6 132 2.5 0.5 95 40 DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 395 5.0 to 5.6 132 2.5 0.5 95 40 DIANEAL solutions are available in multiple combinations of ingredients and in composition, calculated osmolarity, pH, and ionic concentrations. See full prescribing information for detailed descriptions of each formulation. ( 3 )

DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE LACTIC ACID SODIUM CATION CALCIUM CHLORIDE CALCIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE LACTIC ACID SODIUM CATION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE LACTIC ACID SODIUM CATION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER

NDA020163

DIANEAL PD-2 with Dextrose

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

0941-0427

HUMAN PRESCRIPTION DRUG

INTRAPERITONEAL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0941-0411-11 (07-25-00-0740) Container Label L5B9710 6000 mL NDC 0941-0411-11(APPROX 225 mL EXCESS) BaxterLogo Dianeal PD-2 Peritoneal Dialysis Solution with1.5% Dextrose EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5 CHLORIDE - 96 LACTATE - 40 OSMOLARITY - 346 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN SEE PACKAGE INSERT FOR DOSAGE INFORMATION USE AS DIRECTED BY PHYSICIAN FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex II CONTAINER PL 146 PLASTIC BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA PD-2 1.5% Dextrose Bar Code (01)00309410411117 NDC 0941-0413-07 (07-25-00-0677) Container Label L5B5194 5000 mL NDC 0941-0413-07 (APPROX 150 mL EXCESS) Baxter Logo Dianeal PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5 CHLORIDE - 96 LACTATE - 40 OSMOLARITY - 396 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN SEE PACKAGE INSERT FOR DOSAGE INFORMATION USE AS DIRECTED BY PHYSICIAN FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex II CONTAINER PL 146 PLASTIC BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA PD-2 2.5% Dextrose Bar Code (01) 00309410413074 NDC 0941-0415-06 (07-25-56-591) Container Label L5B5187 2000 mL NDC 0941-0415-06 (APPROX 80 mL EXCESS) 3000 mL NOMINAL SIZE CONTAINER BaxterLogo Dianeal PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5 CHLORIDE - 96 LACTATE - 40 OSMOLARITY - 346 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN SEE PACKAGE INSERT FOR DOSAGE INFORMATION USE AS DIRECTED BY PHYSICIAN FOR INTRAPERITONEAL ADMINISTRATION ONLY WARNING EXTENSIVE USE OF THIS SOLUTION DURING ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex II CONTAINER PL 146 PLASTIC BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA PD-2 4.25% Dextrose NDC 0941-0409-07 (07-25-00-0676) Container Label L5B4826 5000 mL NDC 0941-0409-07 (APPROX 150 mL EXCESS) BaxterLogo Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5 CHLORIDE - 95 LACTATE - 40 OSMOLARITY - 344 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN SEE PACKAGE INSERT FOR DOSAGE INFORMATION USE AS DIRECTED BY PHYSICIAN FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex II CONTAINER PL 146 PLASTIC BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA Low Calcium 1.5% Dextrose Bar Code (01)00309410409077 NDC 0941-0457-08 (07-25-00-0739) Container Label L5B9727 2000 mL NDC 0941-0457-08 (APPROX 80 mL EXCESS) 3000 mL NOMINAL SIZE CONTANER BaxterLogo Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5 CHLORIDE - 95 LACTATE - 40 OSMOLARITY - 346 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN SEE PACKAGE INSERT FOR DOSAGE INFORMATION USE AS DIRECTED BY PHYSICIAN FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex II CONTAINER PL 146 PLASTIC BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA Low Calcium 2.5% Dextrose Bar Code (01)00309410457085 NDC 0941-0459-08 Container Label L5B9747 2000 mL NDC 0941-0459-08 (APPROX 80 mL EXCESS) 3000 mL NOMINAL SIZE CONTANER BaxterLogo Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5 CHLORIDE - 95 LACTATE - 40 OSMOLARITY - 346 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN SEE PACKAGE INSERT FOR DOSAGE INFORMATION USE AS DIRECTED BY PHYSICIAN FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT Ambu-Flex II CONTAINER PL 146 PLASTIC BAXTER DIANEAL AMBU-FLEX II AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA 07-25-56-642 Low Calcium 4.25% Dextrose NDC 0941-0426-52 Container Label 07-25-47-851 5B9866 2000 mL NDC 0941-0426-52 (APPROX 80 mL EXCESS) BaxterLogo Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5 CHLORIDE - 96 LACTATE - 40 OSMOLARITY - 346 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN READ PACKAGE INSERT FOR FULL INFORMATION FOR INTRAPERITONEAL ADMINISTRATION ONLY USE AS DIRECTED BY PHYSICIAN CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT UltraBag CONTAINER PL 146 PLASTIC BAXTER DIANEAL ULTRABAG AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA US PAT NOS 4340049 4346703 4439188 4573980 PD-2 1.5% Dextrose NDC 0941-0427-52 Container Label 07-25-47-854 5B9876 2000 mL NDC 0941-0427-52 (APPROX 80 mL EXCESS) Baxter Logo Dianeal PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose EACH 100 mL CONTAINS 2.5 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5 CHLORIDE - 96 LACTATE - 40 OSMOLARITY - 346 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN READ PACKAGE INSERT FOR FULL INFORMATION DOSAGE AS DIRECTED BY PHYSICIAN CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT UltraBag CCONTAINER PL 146 PLASTIC BAXTER DIANEAL ULTRABAG AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA US PAT NOS 4340049 4346703 4439188 4573980 PD-2 2.5% Dextrose NDC 0941-0429-52 Container Label 07-25-47-876 5B9896 2000 mL NDC 0941-0429-52 (APPROX 80 mL EXCESS) Baxter Logo Dianeal PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 3.5 MAGNESIUM - 0.5 CHLORIDE - 96 LACTATE - 40 OSMOLARITY - 346 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN READ PACKAGE INSERT FOR FULL INFORMATION WARNING EXTENSIVE USE OF THIS SOLUTION DURING ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT FOR INTRAPERITONEAL ADMINISTRATION ONLY DOSAGE AS DIRECTED BY A PHYSICIAN CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT UltraBag CONTAINER PL 146 PLASTIC BAXTER DIANEAL ULTRABAG AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA US PAT NOS 4340049 4346703 4439188 4573980 PD-2 4.25% Dextrose NDC 0941-0424-52 Container Label 07-25-47-842 5B9766 2000 mL NDC 0941-0424-52 (APPROX 80 mL EXCESS) BaxterLogo Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5 CHLORIDE - 95 LACTATE - 40 OSMOLARITY - 346 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN READ PACKAGE INSET FOR FULL INFORMATION FOR INTRAPERITONEAL ADMINISTRATION ONLY DOSAGE AS DIRECTED BY PHYSICIAN CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT UltraBag CONTAINER PL 146 PLASTIC BAXTER DIANEAL ULTRABAG AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA US PAT NOS 4340049 4346703 4439188 4573980 Low Calcium 1.5% Dextrose NDC 0941-0430-52 (07-25-00-0683) Container Label 5B9776 2000 mL NDC 0941-0430-52 (APPROX 80 mL EXCESS) BaxterLogo Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose EACH 100 mL CONTAINS 1.5 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5 CHLORIDE - 95 LACTATE - 40 OSMOLARITY - 346 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN READ PACKAGE INSET FOR FULL INFORMATION FOR INTRAPERITONEAL ADMINISTRATION ONLY DOSAGE AS DIRECTED BY PHYSICIAN CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT UltraBag CONTAINER PL 146 PLASTIC BAXTER DIANEAL ULTRABAG AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA US PAT NOS 4340049 4346703 4439188 4573980 Low Calcium 2.5% Dextrose NDC 0941-0433-52 Container Label 07-25-47-848 5B9796 2000 mL NDC 0941-0433-52 (APPROX 80 mL EXCESS) BaxterLogo Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose EACH 100 mL CONTAINS 4.25 g DEXTROSE HYDROUS USP 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (4.0 TO 6.5) mEq/L SODIUM - 132 CALCIUM - 2.5 MAGNESIUM - 0.5 CHLORIDE - 95 LACTATE - 40 OSMOLARITY - 346 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN READ PACKAGE INSET FOR FULL INFORMATION WARNING EXTENSIVE USE OF THIS SOLUTION DURING ONE PERITONEAL DIALYSIS PROCEDURE CAN RESULT IN SIGNIFICANT REMOVAL OF WATER FROM THE PATIENT FOR INTRAPERITONEAL ADMINISTRATION ONLY DOSAGE AS DIRECTED BY PHYSICIAN CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT UltraBag CONTAINER PL 146 PLASTIC BAXTER DIANEAL ULTRABAG AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA US PAT NOS 4340049 4346703 4439188 4573980 Low Calcium 2.5% Dextrose NDC 0941-0484-01 Container Label EZPB5245R NDC 0941-0484-01 5000 mL (APPROX 135 mL EXCESS) BAXTER LOGO Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose Low Calcium 1.5% Dextrose EACH 100 mL CONTAINS 448 mg SODIUM LACTATE pH 5.0 to 6.5 1.5 g DEXTROSE HYDROUS 18.4 mg CALCIUM CHLORIDE 538 mg SODIUM CHLORIDE 5.08 mg MAGNESIUM CHLORIDE mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40 OSMOLARITY – 344 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN SEE PACKAGE INSERT FOR DOSAGE INFORMATION USE AS DIRECTED BY PHYSICIAN FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT PL 146 PLASTIC BAXTER DIANEAL AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN IRELAND CB-35-03-813 0941-0487-01 Container Label EZPB5255R NDC 0941-0487-01 5000 mL (APPROX 135 mL EXCESS) BAXTER LOGO Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose Low Calcium 2.5% Dextrose EACH 100 mL CONTAINS 448 mg SODIUM LACTATE pH 5.0 to 6.5 2.5 g DEXTROSE HYDROUS 18.4 mg CALCIUM CHLORIDE 538 mg SODIUM CHLORIDE 5.08 mg MAGNESIUM CHLORIDE mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40 OSMOLARITY – 395 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN SEE PACKAGE INSERT FOR DOSAGE INFORMATION USE AS DIRECTED BY PHYSICIAN FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25ºC/77ºF) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT PL 146 PLASTIC BAXTER DIANEAL AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN IRELAND CB-35-03-814 NDC 0941-0490-01 Container Label EZPB5265R NDC 0941-0490-01 5000 mL (APPROX 135 mL EXCESS) BAXTER LOGO Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose Low Calcium 4.25% Dextrose EACH 100 mL CONTAINS 448 mg SODIUM LACTATE pH 5.0 to 6.5 4.25 g DEXTROSE HYDROUS 18.4 mg CALCIUM CHLORIDE 538 mg SODIUM CHLORIDE 5.08 mg MAGNESIUM CHLORIDE mEq/L SODIUM – 132 CALCIUM – 2.5 MAGNESIUM – 0.5 CHLORIDE – 95 LACTATE – 40 OSMOLARITY – 483 mOsmol/L (CALC) STERILE NONPYROGENIC POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN SEE PACKAGE INSERT FOR DOSAGE INFORMATION USE AS DIRECTED BY PHYSICIAN FOR INTRAPERITONEAL ADMINISTRATION ONLY CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION Rx ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25ºC/77ºF) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT PL 146 PLASTIC BAXTER DIANEAL AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN IRELAND CB-35-03-815 NDC 0941-0411-11 Representative Container Label NDC 0941-0413-07 Representative Container Label NDC 0941-0415-06 Representative Container Label NDC 0941-0409-07 Representative Container Label NDC 0491-0457-08 Representative Container Label NDC 0941-0459-08 Representative Container Label NDC 0941-0426-52 Representative Container Label NDC 0941-0427-52 Representative Container Label NDC 0941-0429-52 Representative Container Label NDC 0941-0424-52 Representative Container Label NDC 0941-0430-52 Representative Container Label NDC 0941-0433-52 Representative Container Label NDC 0941-0484-01 Representative Container Label NDC 0941-0487-01 Representative Container Label NDC 0941-0490-01 Representative Container Label

Baxter, Ambu-Flex, Dianeal, MiniCap and UltraBag are trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA 0719001298

17 PATIENT COUNSELING INFORMATION Inspection: Advise patients to inspect DIANEAL peritoneal dialysis solutions before use, and not to use if the solution is cloudy, discolored, contains particulate matter or if there is evidence of leakage. Administration: Advise patients on proper administration and the importance of using aseptic technique throughout the entire PD procedure. Advise patients only to use dry heat to warm solution to about 37°C (98°F) and not to microwave or submerge in water. Peritonitis: Advise patients to seek medical attention if they experience signs or symptoms of peritonitis.

8.5 Geriatric Use Safety and effectiveness have been established based on published clinical data.

8.4 Pediatric Use Safety and effectiveness have been established based on published clinical data. No adequate and well-controlled studies have been conducted with DIANEAL solutions in pediatric patients.

8.1 Pregnancy DIANEAL peritoneal dialysis solution is a pharmacologically inactive solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of DIANEAL solutions, with appropriate monitoring of hematology, electrolytes, blood chemistry and fluid status is not expected to cause fetal harm. Animal reproduction studies have not been conducted with DIANEAL solutions. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy DIANEAL peritoneal dialysis solution is a pharmacologically inactive solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of DIANEAL solutions, with appropriate monitoring of hematology, electrolytes, blood chemistry and fluid status is not expected to cause fetal harm. Animal reproduction studies have not been conducted with DIANEAL solutions. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation The components of DIANEAL solutions are excreted in human milk. 8.4 Pediatric Use Safety and effectiveness have been established based on published clinical data. No adequate and well-controlled studies have been conducted with DIANEAL solutions in pediatric patients. 8.5 Geriatric Use Safety and effectiveness have been established based on published clinical data.

16 HOW SUPPLIED/STORAGE AND HANDLING DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 6-7: Table 6 - DIANEAL Peritoneal Dialysis Solutions for CAPD therapy Container Fill Volume (mL) Container Size (mL) Product Code NDC ULTRABAG Container DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 2000 2500 3000 2000 3000 5000 5B9866 5B9868 5B9857 0941-0426-52 0941-0426-53 0941-0426-55 DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose 2000 2500 3000 2000 3000 5000 5B9876 5B9878 5B9858 0941-0427-52 0941-0427-53 0941-0427-55 DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose 2000 2500 3000 2000 3000 5000 5B9896 5B9898 5B9859 0941-0429-52 0941-0429-53 0941-0429-55 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose 1500 2000 2500 3000 2000 2000 3000 5000 5B9765 5B9766 5B9768 5B9757 0941-0424-51 0941-0424-52 0941-0424-53 0941-0424-55 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 1500 2000 2500 3000 2000 2000 3000 5000 5B9775 5B9776 5B9778 5B9758 0941-0430-51 0941-0430-52 0941-0430-53 0941-0430-55 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose 1500 2000 2500 3000 2000 2000 3000 5000 5B9795 5B9796 5B9798 5B9759 0941-0433-51 0941-0433-52 0941-0433-53 0941-0433-55 Table 7 - DIANEAL Peritoneal Dialysis Solutions for APD therapy Container Fill Volume (mL) Container Size (mL) Product Code NDC AMBU-FLEX / Plastic Container with pull ring DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 1000 2000 3000 5000 6000 1000 3000 3000 6000 6000 L5B5163 L5B5166 L5B5169 L5B5193 L5B9710 0941-0411-05 0941-0411-06 0941-0411-04 0941-0411-07 0941-0411-11 DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose 1000 2000 3000 5000 6000 1000 3000 3000 6000 6000 L5B5173 L5B5177 L5B5179 L5B5194 L5B9711 0941-0413-05 0941-0413-06 0941-0413-04 0941-0413-07 0941-0413-01 DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose 1000 2000 3000 5000 6000 1000 3000 3000 6000 6000 L5B5183 L5B5187 L5B5189 L5B5195 L5B9712 0941-0415-05 0941-0415-06 0941-0415-04 0941-0415-07 0941-0415-01 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5%Dextrose 2000 3000 5000 6000 3000 3000 6000 6000 L5B4825 L5B9901 L5B4826 L5B9770 0941-0409-06 0941-0409-05 0941-0409-07 0941-0409-01 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 2000 3000 5000 6000 3000 3000 6000 6000 L5B9727 L5B9902 L5B5202 L5B9771 0941-0457-08 0941-0457-02 0941-0457-05 0941-0457-01 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose 2000 3000 5000 6000 3000 3000 6000 6000 L5B9747 L5B9903 L5B5203 L5B9772 0941-0459-08 0941-0459-02 0941-0459-05 0941-0459-01 Plastic container with blue pull tip DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose 5000 5000 EZPB5245R 0941-0484-01 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000 5000 EZPB5255R 0941-0487-01 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose 5000 5000 EZPB5265R 0941-0490-01 All DIANEAL peritoneal dialysis solutions have overfills which are declared on container labeling. Freezing of solution may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product. Store in moisture barrier overwrap and in carton until ready to use.