DIANEAL PD4 CAPD SOLUTION WITH 4.25% DEXTROSE AND 2.5MEQ/L CALCIUM

Canada - English - Health Canada

Buy It Now

Active ingredient:
DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE
Available from:
BAXTER CORPORATION
ATC code:
B05ZA
INN (International Name):
HEMODIALYTICS, CONCENTRATES
Dosage:
4.25G; 538MG; 448MG; 18.3MG; 5.08MG
Pharmaceutical form:
SOLUTION
Composition:
DEXTROSE 4.25G; SODIUM CHLORIDE 538MG; SODIUM LACTATE 448MG; CALCIUM CHLORIDE 18.3MG; MAGNESIUM CHLORIDE 5.08MG
Administration route:
DIALYSIS
Units in package:
1500/2000/2500/3000/5000 ML
Prescription type:
Ethical
Therapeutic area:
HEMODIALYSIS SOLUTION
Product summary:
Active ingredient group (AIG) number: 0500162030; AHFS: 40:34.00
Authorization status:
APPROVED
Authorization number:
00865117
Authorization date:
2002-06-28

Documents

Page 1 of 18

PRESCRIBING INFORMATION

Dianeal PD4

Dianeal PD101

In Viaflex Plastic Container

Peritoneal Dialysis Solution

Baxter Corporation

Mississauga, Ontario L5N 0C2

Canada

Date of Revision:

February 2, 2015

Submission Control No: 180887

BAXTER and VIAFLEX are Trademarks of Baxter International Inc.

Page 2 of 18

Baxter

DIANEAL Peritoneal Dialysis Solution

For Intermittent Peritoneal Dialysis (IPD), Continuous Ambulatory Peritoneal Dialysis

(CAPD), or Automated Peritoneal Dialysis (APD)

For Intraperitoneal Administration Only

DESCRIPTION

DIANEAL is a sterile, nonpyrogenic solution for intraperitoneal administration only.

DIANEAL contains no bacteriostatic or antimicrobial agents or added buffers.

Composition, approximate osmolarity, approximate pH, and approximate ionic concentrations

are shown in Table 1.

The osmolarities shown in Table 1 are calculated values. As an example, measured osmolarity

by freezing point depression determination of DIANEAL with 1.5% dextrose is approximately

347 mOsmol/L, compared with measured values in normal human serum of 275 - 290

mOsmol/L.

The plastic container is fabricated from a specially formulated polyvinyl chloride (PL146

Plastic). Water can permeate from inside the container into the overpouch in amounts

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 tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

Peritoneal dialysis is a procedure for removing toxic substances and metabolites normally

excreted by the kidneys, and for aiding in the regulation of fluid and electrolyte balance.

The procedure is accomplished by instilling peritoneal dialysis fluid through a conduit into the

peritoneal cavity. With the exception of lactate, which is present as a bicarbonate precursor, the

ion concentration of electrolytes in similar to those in physiological extracellular fluid. Osmosis

and diffusion occur across the peritoneal membrane between the plasma of the patient and the

dialysis fluid. These processes result in plasma electrolyte concentrations which approach those

found in the dialyzing fluid, and passage of toxic substances and metabolites, present in high

concentrations in the blood, across the peritoneal membrane into the dialyzing fluid. Dextrose in

the dialyzing fluid is used to produce a solution hyperosmolar to the plasma, creating an osmotic

gradient which facilitates fluid removal from the patient’s plasma into the peritoneal cavity.

After a period of time (dwell time), the fluid is drained by gravity from the cavity.

Page 3 of 18

INDICATIONS AND USAGE

Peritoneal dialysis is indicated for patients in acute or chronic renal failure when nondialytic

medical therapy is judged to be inadequate (Vaamonde and Perez 1977). It may also be

indicated in the treatment of certain fluid and electrolyte disturbances, and for patients

intoxicated with certain poisons and drugs (Knepshield et al. 1977). However, for many

substances other methods of detoxification have been reported to be more effective than

peritoneal dialysis (Vaamonde and Perez 1977; Chang 1977).

CONTRAINDICATIONS

DIANEAL is contraindicated in patients with:

Pre-existing severe lactic acidosis.

Uncorrectable mechanical defects that prevent effective peritoneal dialysis or increase

the risk of infection.

Documented loss of peritoneal function or extensive adhesions that compromise

peritoneal function.

WARNINGS AND PRECAUTIONS

Encapsulating Peritoneal Sclerosis (EPS) is considered to be a known, rare complication of

peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions

including DIANEAL. Infrequently, fatal outcomes of EPS have been reported with DIANEAL.

If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of

identification and sensitivity studies of the isolated organism(s) when possible. Prior to

identification of the involved organism(s), broad-spectrum antibiotics may be indicated.

Solutions containing dextrose should be used with caution in patients with a known allergy to

corn or corn products. Hypersensitivity reactions such as those due to a corn starch allergy,

including anaphylactic/anaphylactoid reactions, may occur. Stop the infusion immediately and

drain the solution from the peritoneal cavity if any signs or symptoms of a suspected

hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as

clinically indicated.

Patients with severe lactic acidosis should not be treated with lactate-based peritoneal dialysis

solutions (See Contraindications). It is recommended that patients with conditions known to

increase the risk of lactic acidosis [e.g., severe hypotension or sepsis that can be associated with

acute renal failure, inborn errors of metabolism; treatment with drugs such as

nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] must be monitored for

occurrence of lactic acidosis before the start of treatment and during treatment with lactate-based

peritoneal dialysis solutions.

Page 4 of 18

When prescribing the solution to be used for an individual patient, consideration should be given

to the potential interaction between the dialysis treatment and therapy directed at other existing

illnesses. Serum potassium, calcium and magnesium levels should be monitored carefully in

patients treated with cardiac glycosides.

Diabetics require careful monitoring of blood-glucose levels during and following dialysis with

dextrose (glucose)-containing solutions. Dosage of insulin or other treatments for hyperglycemia

should be adjusted.

The use of 5 liters of dialysis solution is not indicated in a single exchange.

DIANEAL is intended for intraperitoneal administration only. Not for intravenous

administration.

Do not administer if the solution is discoloured, cloudy, contains particulate matter or shows

evidence of leakage or if seals are not intact.

The drainage fluid should be inspected for the presence of fibrin or cloudiness, which may

indicate the presence of peritonitis.

Significant losses of protein, amino acids, water soluble vitamins, and other medicines may

occur during peritoneal dialysis. Replacement therapy should be provided as necessary.

Peritoneal dialysis should be done with caution in patients with: 1) abdominal conditions,

including disruption of the peritoneal membrane and diaphragm by surgery, from congenital

anomalies or trauma until healing is complete, abdominal tumors, abdominal wall infection,

hernias, fecal fistula, colostomy, large polycystic kidneys, or other conditions that compromise

the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity; (Vaamonde

and Perez 1977) and 2) other conditions including aortic graft placement (Misra et al. 1998) and

severe pulmonary disease.

When assessing peritoneal dialysis as the mode of therapy in these

situations, the benefits to the patient must be weighed against the possible complications.

An accurate fluid balance record must be kept and the weight of the patient carefully monitored

to avoid over or under hydration with severe consequences such as congestive heart failure,

volume depletion, or shock.

Excessive use of DIANEAL with higher dextrose during a peritoneal dialysis treatment can

result in significant removal of water from the patient.

Potassium is omitted from DIANEAL due to risk of hyperkalemia. In situations in which there

is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a

concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia and should be made

after careful evaluation of serum and total body potassium, only under the direction of a

physician.

Page 5 of 18

Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium and

phosphate), blood chemistry (including parathyroid hormone and lipid parameters) and

hematological parameters should be evaluated periodically.

Low Calcium DIANEAL PD solution (i.e. DIANEAL PD4) should be considered for

management of hypercalcemia. Patients receiving this solution should have their calcium levels

monitored for the development of hypocalcemia or worsening of hypercalcemia. In these

circumstances, adjustments to the dosage of the phosphate binders and/or vitamin D analogs,

and/or calcimimetics should be considered by the physician.

Overinfusion of DIANEAL volume into the peritoneal cavity may be characterized by

abdominal distension/abdominal pain and/or shortness of breath.

Treatment of DIANEAL overinfusion is to drain DIANEAL from the peritoneal cavity.

Use in Children: The safety and efficacy in children have not been established.

Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity,

which may result in abdominal pain and/or peritonitis.

PREGNANCY AND LACTATION

Pregnancy Category C. Animal reproduction studies have not been conducted with DIANEAL

Peritoneal Dialysis solutions. It is also not known whether DIANEAL Peritoneal Dialysis

solutions can cause fetal harm when administered to a pregnant woman or can affect

reproduction capacity. Therefore DIANEAL Peritoneal Dialysis solutions should not be used

during pregnancy and lactation

ADVERSE REACTIONS

The adverse reactions within this section represent those adverse reactions that are thought to

have an association with the use of DIANEAL or in conjunction with performing the peritoneal

dialysis procedure.

Adverse Reactions from Clinical Trials

There are no data available on adverse reactions from controlled clinical trials conducted to

evaluate the safety of DIANEAL.

Adverse Reactions: General

Adverse reactions to peritoneal dialysis include mechanical and solution related problems as

well as the results of contamination of equipment or improper technique in catheter placement.

Examples of peritoneal dialysis therapy related class effects include: ileus, bleeding.

Post-Marketing Adverse Reactions

Page 6 of 18

The following adverse reactions have been reported in the post-marketing experience. These

reactions are listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of

severity.

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

DOSAGE AND ADMINISTRATION

DIANEAL solutions are intended for intraperitoneal administration only. Not for intravenous

administration.

DIANEAL should be administered at a rate that is comfortable for the patient. The volume

administered is determined by the prescribing physician.

The mode of therapy (Intermittent Peritoneal Dialysis [IPD], Continuous Ambulatory Peritoneal

Dialysis [CAPD] or Automated Peritoneal Dialysis [APD]), the frequency of treatment,

formulation, exchange volume, duration of dwell, and length of dialysis should be selected by

the physician responsible for and supervising the treatment of the individual patient.

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 each exchange. Typically the majority of

exchanges will utilize 1.5% and 2.5% dextrose containing peritoneal dialysis solutions, with

4.25% dextrose containing solutions being used when extra fluid removal is required. Patient

Page 7 of 18

weight is used as the indicator of the need for fluid removal such that therapy can be

individualized according to the patient’s need for ultrafiltration (Popovich et al. 1978). As the

patient’s body weight becomes close to the ideal dry weight, lowering the dextrose (glucose)

concentration of DIANEAL is recommended. DIANEAL 4.25% dextrose-containing solution is

a high osmotic pressure fluid and using it for all exchanges may cause dehydration.

It has been reported in the literature that, the fill volume per exchange depends on body size,

usually from 2.0 to 2.5 liters per 1.73 m

(Ronco et al. 2000; Keshaviah et al. 1994).

For pediatric patients > 2 years old, 800 to 1400 mL/m

per cycle up to a maximum of 2000 mL,

as tolerated, is recommended. (Potter et al. 1981; Irwin et al. 1981; Ronnholm and Holmberg,

2006)

Peritoneal dialysis solutions may be warmed in the overpouch to 37 C (98.6 F) to enhance

patient comfort. However, only dry heat (for example heating pad, warming plate) should be

used. Solutions should not be heated in water or in a microwave oven due to the potential for

contamination, patient injury or discomfort.

It has been reported in the literature that, the addition of heparin to the dialysis solution may be

indicated to aid in prevention of catheter blockage in patients with peritonitis, or when the

solution drainage contains fibrinous or proteinaceous material. 500 to 1000 USP units of heparin

per liter of solution has been recommended for adults. For children, 50 USP units per 100 mL of

dialysis fluid has been recommended (Goel et al. 1998).

Aseptic technique must be employed throughout the peritoneal dialysis procedure.

Do not administer if the solution is discoloured, cloudy, contains particulate matter or shows

evidence of leakage, or if seals are not intact.

The drained fluid should be inspected for the presence of fibrin or cloudiness, which may

indicate the presence of peritonitis.

Discard any unused remaining solution.

For single use only.

It is recommended that adult patients being placed on peritoneal dialysis or, in the case of

pediatric patients, the selected caretaker, (as well as the patient, when suitable), should be

appropriately trained in a program which is under the supervision of a physician.

Intermittent Peritoneal Dialysis (IPD)

For dialysis of acute renal failure patients and maintenance dialysis of chronic renal failure

patients, the cycle of instillation, dwell and removal of dialysis fluid is repeated sequentially

over a period of hours (8 to 36 hours) as many times per week as indicated by the condition of

Page 8 of 18

the patient. For chronic renal failure patients who have residual renal function, maintenance

dialysis is often accomplished by periodic dialysis (3 to 5 times weekly) for shorter time periods

(8 to 14 hours per session) (Mattocks and El-Bassiouni, 1971).

Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis

(APD)

For maintenance of chronic renal failure patients

Patients on CAPD typically perform 4 cycles per day (24 hours). In CAPD, the solution remains

in the cavity for dwell times of 4 to 6 hours during the day and approximately 8 hours overnight.

At the conclusion of each dwell period, the access device is opened, the solution drained and

fresh solution instilled (Ronco et al. 2000; Keshaviah et al. 1994).

Patients on APD typically perform 3-5 cycles at night and up to 2 cycles during the day. After

the last outflow during the night, the equipment is then disconnected from the patient and the

dialysate remains in the peritoneum until the next cycle. Additional exchanges can be infused by

the cycler machine into the peritoneum during the daytime (Blake et al. 1996; Blake et al. 2011).

DRUG INTERACTIONS

No interaction studies have been conducted with DIANEAL. The blood concentration of the

dialyzable drugs may be reduced by peritoneal dialysis.

OVERDOSE

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.

Management of Overdose

Hypervolemia may be managed by using hypertonic peritoneal dialysis solutions and fluid

restriction. Hypovolemia may be managed by fluid replacement either orally or intravenously,

depending on the degree of dehydration.

Electrolyte disturbances may be managed according to the specific electrolyte disturbance

verified by blood testing. The most probable disturbance, hypokalemia, many be managed by the

oral ingestion of potassium or by the addition of potassium chloride in the peritoneal dialysis

solution prescribed by the treating physician (see Incompatibilities section).

Hyperglycemia in diabetic patients may be managed by adjusting the insulin dose or adjusting

other treatments for hyperglycemia.

Page 9 of 18

INCOMPATIBILITIES

Consult with physician. If, in the informed judgment of the physician, it is deemed advisable to

introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced.

Do not store solutions containing additives.

Refer to directions for use accompanying drugs to obtain full information on additives.

If the resealable rubber plug on the medication port is missing or partially removed, do not use

product if medication is to be added.

Some drug additives may be incompatible with DIANEAL.

Addition of Potassium

Potassium is omitted from DIANEAL solutions because dialysis may be performed to

correct hyperkalemia. In situations where there is a normal serum potassium level or

hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be

indicated to prevent severe hypokalemia. The decision to add potassium chloride should be

made by the physician after careful evaluation of serum potassium.

Addition of Insulin

Addition of insulin to DIANEAL was evaluated in 6 insulin-dependent diabetic patients

undergoing CAPD for ESRD. No interference of DIANEAL with insulin absorption from the

peritoneal cavity or with insulin’s ability to control blood glucose was observed. Appropriate

monitoring of blood glucose should be performed when initiating DIANEAL in diabetic

patients and insulin dosage adjusted if needed.

Addition of Heparin

No human drug interaction studies with heparin were conducted. In vitro studies

demonstrated no evidence of incompatibility of heparin with DIANEAL (Voges et al. 2004).

Addition of Antibiotics

No formal clinical drug interaction studies have been performed. It has been reported in the

literature that, in vitro studies of the following anti-infectives have demonstrated stability

with several different peritoneal dialysis formulations: amphotericin B, ampicillin, azlocillin,

cefapirin, cefazolin, cefepime, cefotaxime, ceftazidime, ceftriaxone, ciprofloxacin,

clindamycin, cotrimoxazole, deferoxamine, erythromycin, gentamicin, linezolid, mezlocillin,

miconazole, moxifloxacin, nafcillin, ofloxacin, penicillin G, piperacillin, teicoplanin,

ticarcillin, tobramycin, and vancomycin. However, aminoglycosides should not be mixed

with penicillins due to chemical incompatibility (de Vin et al. 2009; Henderson et al. 1981,

Novarro et al. 1986).

HOW SUPPLIED

DIANEAL solutions are available in nominal size containers with fill volumes and dextrose

concentrations as indicated in Table 1.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Page 10 of 18

DIRECTIONS FOR USE

Use aseptic technique.

For complete system preparation, see directions accompanying ancillary equipment.

Warming the DIANEAL solution, if desired, should be done in the overpouch using dry heat

only. For patient comfort, the solution container should be at body temperature (37 C, 98.6 F).

The solution should be comfortably warm to the touch. Store at 15

C to 25

To Open

Tear overpouch down side at slit and remove solution container. If supplemental medication is

desired, follow the directions below before preparing for administration. Check for minute leaks

by squeezing container firmly.

To Add Medication

Additives may be incompatible.

If the resealable rubber plug on the medication port is missing or partially removed, do not use

product if medication is to be added.

Prepare medication site.

Using a syringe with a 1 inch long 19 to 25 gauge needle, puncture resealable medication

port and inject.

Position container with ports up and evacuate the medication port by squeezing and tapping

Mix solution and medication thoroughly.

Page 11 of 18

TABLE 1

Fill

Volume

(mL)

Bag

Size

(mL)

COMPOSITION/100 mL

Approx

mOsmol

Approx

pH

APPROX mEq/L

Dex

Sod Chl

Sod

Lact

Cal Chl

Mag Chl

Na

Ca

Mg

Cl

Lact

APD – Automated Peritoneal Dialysis

PD101 w/ 0.5% Dex

JB4821L

2000

2000

0.5 g

567 mg

392 mg

23.9 mg

15.2 mg

3.25

101.75

PD101 w/ 1.5% Dex

JB5618L

2500

3000

1.5 g

567 mg

392 mg

23.9 mg

15.2 mg

3.25

101.75

JB5619L

5000

5000

PD101 w/ 2.5% Dex

JB5658L

2500

3000

2.5 g

567 mg

392 mg

23.9 mg

15.2 mg

3.25

101.75

JB5659L

5000

5000

PD101 w/ 4.25% Dex

JB5669L

5000

5000

4.25 g

567 mg

392 mg

23.9 mg

15.2 mg

3.25

101.75

PD4 w/ 1.5% Dex and

2.5 mEq Cal

JB4769L

3000

3000

1.5 g

538 mg

448 mg

18.3 mg

5.08 mg

JB9719L

5000

5000

PD4 w/ 2.5% Dex and

2.5 mEq Cal

JB4770L

3000

3000

2.5 g

538 mg

448 mg

18.3 mg

5.08 mg

JB9729L

5000

5000

PD4 w/ 4.25% Dex and

2.5 mEq Cal

JB4771L

3000

3000

4.25 g

538 mg

448 mg

18.3 mg

5.08 mg

JB9749L

5000

5000

CAPD – Continuous Ambulatory Peritoneal Dialysis

PD101 w/ 0.5% Dex

JB9806

2000

2000

0.5 g

567 mg

392 mg

23.9 mg

15.2 mg

3.25

101.75

PD101 w/ 1.5% Dex

JB9816

2000

2000

1.5 g

567 mg

392 mg

23.9 mg

15.2 mg

3.25

101.75

JB9818

2500

3000

PD101 w/ 2.5% Dex

JB9826

2000

2500

2.5 g

567 mg

392 mg

23.9 mg

15.2 mg

3.25

101.75

JB9828

2500

3000

PD101 w/ 4.25% Dex

JB9836

2000

2000

4.25 g

567 mg

392 mg

23.9 mg

15.2 mg

3.25

101.75

Page 12 of 18

Fill

Volume

(mL)

Bag

Size

(mL)

COMPOSITION/100 mL

Approx

mOsmol

Approx

pH

APPROX mEq/L

Dex

Sod Chl

Sod

Lact

Cal Chl

Mag Chl

Na

Ca

Mg

Cl

Lact

PD4 w/ 1.5% Dex and

2.5 mEq Cal

JB9413

3000

3000

1.5 g

538 mg

448 mg

18.3 mg

5.08 mg

JB9415

1500

2000

JB9416

2000

2000

JB9418

2500

3000

PD4 w/ 2.5% Dex and

2.5 mEq Cal

JB9423

3000

3000

2.5 g

538 mg

448 mg

18.3 mg

5.08 mg

JB9425

1500

2000

JB9426

2000

2000

JB9428

2500

3000

PD4 w/ 4.25% Dex and

2.5 mEq Cal

JB9435

1500

2000

4.25 g

538 mg

448 mg

18.3 mg

5.08 mg

JB9436

2000

2000

JB9438

2500

3000

Page 13 of 18

References

Blake, P et al. Recommended Clinical Practices for Maximizing PD Clearances. Perit Dial Int. 1996

Sep-Oct;16(5):448-56.

Blake PG, et al. Clinical Practice Guidelines and Recommendations on Peritoneal Dialysis Adequacy

2011. Perit Dial Int. 2011; 31: 218-239.

Chang, T.M.S. Criteria, evaluation, and perspectives of various microencapsulated charcoal

hemoperfusion systems. Dial and Transplant. 1977; 6:50-3.

de Vin F, Rutherford P, Faict D. Intraperitoneal administration of drugs in peritoneal dialysis patients:

A review of compatibility and guidance for clinical use. Perit Dial Int. 2009 Jan-Feb; 29(1):5-15.

Goel S, Misra M, Saran R, Khanna R. The Rationale for, and Role of, Heparin in Peritoneal Dialsis.

Adv Perit Dial. 1998; 14:111-6.

Henderson JL, Polk RE, Kline BJ. In vitro inactivation of gentamicin, tobramycin, and netilmicin by

carbenicillin, azlocillin, or mezlocillin. Am J Hosp Pharm. 1981 Aug; 38(8):1167-70.

Irwin, M.A. et al. Continuous ambulatory peritoneal dialysis in pediatrics. AANNT J. 1981; 8:11-13,

Keshaviah P, Emerson PF, Vonesh EF, Brandes JC. Relationship Between Body Size, Fill Volume, and

Mass Transfer Area Coefficient in Peritoneal Dialysis. J. Am. Soc. Nephrol. 1994; 4: 1820-6.

Knepshield, J.H. et al. Dialysis of poisons and drugs – update. Trans Am Soc Artif Intern Organs.

1977; 23:762-842.

Mattocks, A.M. and El-Bassiouni, E.A. Peritoneal dialysis: a review. J Pharm Sci. 1971; 60: 1767-82.

Misra M, Goel S, Khanna R. Peritoneal dialysis in patients with abdominal vascular prostheses. Adv

Perit Dial. 1998; 14:95-7.

Navarro AS, Lanao JM, Dominguesz-Gil Hurlé A. In-vitro interaction between dibekacin and

penicillins. J Antimicrob Chemother. 1986 Jan; 17(1):83-9.

Popovich, R.P. et al. Continuous ambulatory peritoneal dialysis. Ann Intern Med 1978; 8:449-56.

Potter, D.E. Continuous ambulatory dialysis (CAPD) in children. Trans Am Soc Artif Intern Organs

1981; 27:64-7.

Ronco C, Kliger AS, Amici G, Virga G. Automated Peritoneal Dialysis: Clinical Prescription and

Technology. Peritoneal Dialysis International. 2000; 20(Suppl. 2): S70-6.

Ronnholm K, Holmberg C. Peritoneal dialysis in infants. Pediatric Nephrol. 2006; 21:751-6.

Page 14 of 18

Vaamonde, C.A. and Perez, G.O. Peritoneal dialysis today. Kidney. 1977; 10:31-6.

Voges M, Faict D, Lechien G, Taminne M. Stability of drug additives in peritoneal dialysis solutions in

a new container. Perit Dial Int. 2004 Nov-Dec; 24(6):590-5.

IMPORTANT: PLEASE READ

Page 15 of 18

PART III: CONSUMER INFORMATION

DIANEAL

(glucose, sodium chloride, calcium chloride,

magnesium chloride, sodium lactate solution for

peritoneal dialysis)

Read this carefully before you start using DIANEAL

and

each

time

you

get

a

refill.

This

leaflet

is

a

summary

and

will

not

tell

you

everything

about

DIANEAL. Talk to your doctor, nurse, or pharmacist

about your medical condition and treatment and ask

if there is any new information about DIANEAL.

ABOUT THIS MEDICATION

What the medication is used for:

DIANEAL is a sterile peritoneal dialysis solution used in

patients whose kidneys are not working properly. It

removes waste products and water from the blood.

DIANEAL can also be used in some cases of drug

intoxication and to correct fluid and electrolyte

imbalances.

DIANEAL has not been studied for use in children

(younger than 18 years old).

What it does:

DIANEAL contains glucose which draws fluid and

wastes from your blood stream into your peritoneal

cavity (the space inside your abdomen). The fluids and

wastes are removed from your body when the DIANEAL

solution is drained.

When it should not be used:

Do not use DIANEAL if you:

have a problem involving your abdominal wall or

cavity that cannot be corrected by surgery (e.g. hernia,

ileus, adhesions, imperfections in the muscle that

separate the abdomen from the chest, or tumours)

have a problem that increases your risk of an abdominal

infection (e.g., skin infections, burns, bowel perforations

or recent abdominal surgery)

have severe peritoneal scarring

have high levels of lactic acid in your blood (lactic

acidosis)

What the medicinal ingredients are:

Glucose

Sodium chloride

Calcium chloride

Magnesium chloride

Sodium lactate

What the nonmedicinal ingredients are:

Water for injection

What dosage forms it comes in:

DIANEAL PD4 and PD101 solutions for peritoneal

dialysis are available in 1.5L, 2L, 2.5L, 3L and 5L

Viaflex plastic containers.

WARNINGS AND PRECAUTIONS

BEFORE you use DIANEAL talk to your doctor,

nurse or pharmacist if you:

have an aortic graft placement.

have breathing problems.

have elevated lactate levels or have a condition

known to increase the risk of lactic acidosis

(severe low blood pressure, sepsis, liver or

kidney failure, inborn errors of metabolism,

taking drugs such as metformin and

nucleoside/nucleotide reverse transcriptase

inhibitors (NRTIs)).

have diabetes. Blood glucose levels should be

monitored and your dosage of insulin or other

treatment for hyperglycemia should be adjusted

by your doctor.

Have high or low levels of calcium in your

blood.

are pregnant or intend to become pregnant.

are breastfeeding.

If you are allergic to corn or corn products, undesirable

allergic reactions, including development of rash, hives,

throat and/or facial swelling, wheezing, shortness of

breath, low blood pressure, and other

anaphylactic/anaphylactoid reactions, may occur. Stop

the infusion immediately and drain the solution from the

peritoneal cavity if any signs or symptoms of a suspected

allergic reaction develop and seek immediate medical

help.

Tell your doctor, nurse or pharmacist about any other

conditions you have that may affect the inside, outside or

the wall of your abdomen.

Patients on DIANEAL may experience high or low levels

of potassium, calcium, or magnesium in their blood.

Your doctor will monitor your blood test results.

Keep a written note of your weight, a record of the

volume liquids added to your body including peritoneal

dialysis solutions infused and liquids drunk and the

volume of liquids removed from your body including the

volume of the peritoneal dialysis solution drained and

urine volume, together with any other measurements

which your doctor has asked you to record. Contact your

IMPORTANT: PLEASE READ

Page 16 of 18

doctor, nurse or pharmacist if your drained volume is

more than expected.

Protein, amino acids, water soluble vitamins and other

medicines may be removed during peritoneal dialysis.

Your doctor may recommend supplementation to

your diet and other changes.

Improper clamping or priming sequence may result in

infusion of air into the peritoneal cavity, which may

result in abdominal pain and/or peritonitis (inflamed

peritoneum) or infection.

Driving and using machines: Before doing tasks which

require special attention, wait until you know how you

respond to DIANEAL. Do not drive or operate

machinery if you experience weakness, blurred vision or

dizziness.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are

possible. Tell your doctor, nurse, or pharmacist about all

the medicines you take, including drugs prescribed by

other doctors, vitamins, minerals, natural supplements, or

alternative medicines.

The blood concentration of drugs that can be removed

from the body using dialysis may be reduced by

peritoneal dialysis.

If you are taking heart medicines known as cardiac

glycosides (such as digoxin), or insulin your doctor will

monitor you closely during treatment.

PROPER USE OF THIS MEDICATION

DIANEAL is to be administered into your peritoneal

cavity. This is the cavity in your abdomen (belly)

between your skin and the peritoneum. The peritoneum is

the membrane surrounding your internal organs such as

your intestines and liver. This solution is only for

intrapertioneal usage, and will be adminisered via a

catheter directly to the peritoneal cavity. It is not for

intravenous use.

Always use this medicine exactly as instructed by the

medical team specialised in peritoneal dialysis. Check

with them if you are not sure.

Usual adult dose:

The kind of treatment (Intermittent Peritoneal

Dialysis [IPD], Continuous Ambulatory Peritoneal

Dialysis [CAPD] or Automated Peritoneal Dialysis

[APD]), frequency of treatment, exchange volume,

the time that the dialysis solution remains in the

abdominal cavity and length of dialysis will be

selected by your doctor. Infuse DIANEAL at a rate

that is comfortable for you.

Patients on intermittent peritoneal dialysis (IPD)

typically perfome 3 to 5 cycles in a week.

Patients on continuous ambulatory peritoneal

dialysis (CAPD) typically perform 4 cycles per day

(24 hours).

Patients on automated peritoneal dialysis (APD)

typically perform 3-5 cycles at night and up to 2

cycles during the day.

The fill volume depends on body size, usually from

2.0 to 2.5 liters per 1.73 m

.To reduce the risk of

dehydration, it is important to use the solution(s)

your doctor has chosen for you.

Directions for use:

Detailed instructions and training on the peritoneal

dialysis exchange procedure will be given to you, in

a specialized training centre, before you use

DIANEAL at home.

You should practice infection free technique

throughout the bag change procedure.

Examine the bag before use and discard the package

if it is broken, damaged, or the solution is

discoloured, cloudy or any solids are floating in the

solution.

To make using DIANEAL more comfortable, you

can warm it to 37˚C (98.6˚F) before use. This

should only be done using dry heat, such as a

heating pad or cycler warming plate. To avoid

increased risk of infection, do not place DIANEAL

in water to heat the bags. Do not microwave.

Tear the overpouch down the side at the slit and

remove the solution container. The container should

be squeezed firmly to check for leaks. If leaks are

found, discard the bag.

When draining the fluid after the dwell, always

check your drained fluid for cloudiness or fibrin.

Fibrin looks like clumps or stringy material in the

drained solution. Cloudy drained fluid or fibrin may

mean you have an infection. Call your doctor if

your drained fluid is cloudy or contains fibrin.

Your doctor may prescribe other injectable drugs to

be added directly into the DIANEAL bag. In that

situation, add the drug through the medication port.

If the resealable rubber plug on the medication

port is missing or partially removed do not use

the DIANEAL bag if medication is to be added.

You must use infection free technique

when adding any medications to

DIANEAL.

Prepare the medication site.

IMPORTANT: PLEASE READ

Page 17 of 18

Using a syringe with a 1 inch long 19

to 25 gauge needle, puncture the

resealable medication port and inject.

Position the container with ports up and

evacuate the medication port by

squeezing and tapping it.

Mix the solution and medication

thourghouly.

Use the product immediately after

addition of the drug.

DIAEAL is for single use only. Discard any

unused remaining solution.

Overdose:

If you think you have taken too much DIANEAL,

contact your doctor, nurse, pharmacist, hospital

emergency department or regional Poison Control

Centre immediately, even if there are no symptoms.

Missed Dose:

If you have missed an exchange, continue with the next

scheduled treatment.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

Rash, itching

Vomiting, nausea, diarrhea, constipation

Abdominal pain, distention and/or discomfort

Muscle pain/cramps

If any of these affects you severely, tell your doctor,

nurse or pharmacist.

Sometimes, too much DIANEAL can get into your

peritoneal cavity. If you experience abdominal distention,

feeling of fullness and, or shortness of breath, contact

your doctor, nurse, pharmacist or peritoneal dialysis unit.

Encapsulating Peritonitis Sclerosis (EPS) is a rare but

serious side effect that happens to patients taking

DIANEAL. In EPS the bowels become blocked due to

the growth of a thick layer of fibrin within the

peritoneum. Symptoms include fever, abdominal

discomfort, constipation, nausea, vomiting or lack of

appetite, lack or decreased bowel movements or of

passing gas. If this happens to you seek immediate

medical help.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor, nurse or

pharmacist

Seek

immediate

medical

help

Only if

severe

In all

cases

Allergic Reaction: rash, hives,

swelling of the face, lips, tongue

or throat, difficulty swallowing

or breathing

Dehydration:

dizziness,

weakness, fainting, thirst,

dry mouth,

constipation, muscle cramps

Catheter Blockage/

Infection: Redness, pus,

swelling or pain around exit site

of your catheter

Peritonitis (infection in the

peritoneal cavity):

cloudy or bloody

drained fluid,

abdominal pain, fever, redness,

nausea, upset

stomach, vomiting,

lack of appetite,

weight loss,

constipation

Edema: Swollen ankles or legs,

swelling of the eyes or face

Steven-Johnson Syndrome:

painful red or purple rash,

blisters on your skin, mouth,

nose, eyes and genitals

High Blood Pressure:

headaches, vision problems,

dizziness, shortness of breath

Shortness of breath or chest

pain

Abnormal Bleeding

Increased Blood Sugar:

frequent urination, thirst, and

hunger

Electrolyte Imbalance:

weakness, drowsiness, muscle

pain or cramps, irregular

heartbeat

This is not a complete list of side effects. For any

unexpected effects while taking DIANEAL, contact

your doctor, nurse or pharmacist.

HOW TO STORE IT

Store in the original package. Store at 15°C to 30°C. Do

not freeze. Do not use DIANEAL after the expiry date

on the label.

Keep DIANEAL out of reach and sight of children.

IMPORTANT: PLEASE READ

Page 18 of 18

Do not use DIANEAL unless the solution is clear and

the container undamaged. Any unused portion should

be discarded.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with

the use of health products to the Canada Vigilance Program by

one of the following 3 ways:

--------------------------------------------------------------------------

Report online at www.healthcanada.gc.ca/medeffect

Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and:

- Fax toll-free to 1-866-678-6789, or

- Mail to:

Canada Vigilance Program

Health Canada

Postal Locator 0701E

Ottawa, Ontario

K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form

and the adverse reaction reporting guidelines are

available on the MedEffect

Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management

of side effects, contact your health professional. The Canada

Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared

for health professionals can be found at:

http://www.baxter.ca

or by contacting the sponsor, Baxter Corporation, at:

1-800-387-8399

This leaflet was prepared by Baxter Corporation

Mississauga, Ontario, Canada L5N 0C2

BAXTER and VIAFLEX are trademarks of Baxter

International Inc.

Last revised: February 2, 2015

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