Dianeal PD4 is indicated whenever peritoneal dialysis is employed, including:
1. Acute and chronic renal failure;
2. Severe water retention;
3. Electrolyte disorders;
4. Drug intoxication, when a more adequate therapeutic alternative is not available.
Dianeal PD4 is particularly useful for the control of serum calcium and phosphate levels in renal failure patients receiving calcium or magnesium-containing phosphate binders.

Posology
The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of
dialysis should be initiated and supervised by the prescribing physician.
Adults

Patients on continuous ambulatory peritoneal dialysis (CAPD) typically perform 4 cycles per day (24 hours). Patients on automated peritoneal dialysis (APD) typically perform 4-5
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 litres.
Paediatric population (i.e., newborn to 18 years of age)
800 to 1400 ml/m2 per cycle up to a maximum amount of 2000 ml, as tolerated, is
recommended. Fill volumes of 500 to 1000 ml/m2 are recommended in children less than 2 years of age.
As the patient’s body weight becomes closer to the ideal dry weight, lowering the glucose concentration of DIANEAL PD4 is recommended.
To avoid the risk of severe dehydration, hypovolaemia and to minimise the loss of proteins, it is
advisable to select the peritoneal dialysis solution withthe lowest level of osmolarity consistent
with fluid removal requirements for each exchange.

Method of administration
Precautions to be taken before handling or administering the medicinal Dianeal PD4.
DIANEAL PD4 solutions are intended for intraperitoneal administration only. Not for
intravenous administration.
Peritoneal dialysis solutions may be warmed to 37°C 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 patient injury or discomfort.
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.

 

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. DIANEAL PD4 is contraindicated in patients with: • pre-existing severe lactic acidosis, • uncorrectable mechanical defects that prevent effective PD or increase the risk of infection, • documented loss of peritoneal function or extensive adhesion s that compromise peritoneal function

• 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 tumours, abdominal wall infection, hernias, faecal fistula,
colostomy or iliostomy, frequent episodes of diverticulitis, inflammatory or ischemic
bowel disease, large polycystic kidneys, or other conditions that compromise the
integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity
2) other conditions including recent aortic graft replacement and severe pulmonary disease.
• 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 PD4. Infrequently, fatal outcomes of EPS have been reported with DIANEAL PD4.
• 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 glucose should be used with caution in patients with a known allergy to corn or corn Dianeal PD4s. 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 section 4.3) 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 metformin and 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.
• 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.
• 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 including congestive heart failure, volume depletion and shock.

• Protein, amino acids, water-soluble vitamins, and other medicines may be lost during peritoneal dialysis and may require replacement.

• Low calcium DIANEAL PD4 PD solution should be considered for use in patients with hypercalcemia. Patients receiving this solution should have their calcium levels monitored
for the development of hypocalcaemia or worsening of hypercalcaemia. 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.
• Treatment of DIANEAL PD4 overinfusion is to drain the solution from the peritoneal cavity.
• Overinfusion of a DIANEAL PD4 volume into the peritoneal cavity may be characterised by abdominal distension/abdominal pain and/or shortness of breath.
• Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis.
• Excessive use of DIANEAL PD4 peritoneal dialysis solution with higher glucose during a peritoneal dialysis treatment may result in excessive removal of water from the patient.
• Potassium is omitted from DIANEAL PD4 solutions due to the risk of hyperkalaemia.

o In situations in which there is a normal serum potassium level or hypokalaemia, the addition of potassium chloride (up to a concentration of 4 mEq/l) may be indicated
to prevent severe hypokalaemia and should be made after careful evaluation of serum and total body potassium, only under the direction of a physician.
• Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium and phosphate), blood chemistry (including parathyroid hormone and lipid
parameters) and haematological parameters should be evaluated periodically.
• Diabetics require careful monitoring of blood-glucose levels during and following dialysis with glucose-containing solutions. Dosage of insulin or other treatments for
hyperglycaemia should be adjusted.

 

No interaction studies have been conducted with DIANEAL PD4. The blood concentration of dialysable drugs may be reduced by peritoneal dialysis.
Plasma levels of potassium, calcium and magnesium in patients using cardiac glycosides must be carefully monitored, as there is a risk of digitalis intoxication. Potassium supplements may be necessary.

Pregnancy
There are no or limited amount of data from the use of DIANEAL PD4 in pregnant women.

Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
DIANEAL PD4 is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breastfeeding
It is unknown whether DIANEAL PD4 metabolites are excreted in human milk.

A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from
DIANEAL PD4 therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There are no clinical data on fertility.

End stage renal disease (ESRD) patients undergoing peritoneal dialysis may experience undesirable effects, which could affect the ability to drive or use machines.

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.
The adverse drug reactions listed in this section are given following the recommended frequency convention:

very common (>1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from available data).

System Organ Class Preferred term Frequency METABOLISM AND NUTRITION DISORDERS Hypokalaemia Fluid retention Hypervolaemia Hypovolaemia Hyponatraemia Dehydration Hypochloraemia Not known VASCULAR DISORDERS Hypertension Hypotension Not known RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS Dyspnoea Not known GASTROINTESTINAL DISORDERS Sclerosing encapsulating peritonitis Peritonitis Peritoneal cloudy effluent Vomiting Diarrhoea Nausea Constipation Abdominal pain Abdominal distension Abdominal discomfort Not known SKIN AND SUBCUTANEOUS TISSUE DISORDERS Stevens-Johnson syndrome Urticaria Rash (including pruritic, erythematous and generalised) Pruritus Not known MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Myalgia Muscle spasms Musculoskeletal pain Not known GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS Generalised oedema Pyrexia Malaise Infusion site pain Not known

Other undesirable effects of peritoneal dialysis related to the procedure: Fungal peritonitis,
bacterial peritonitis, catheter related infection, catheter related complication.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the national reporting
system listed below. By reporting side effects you can help provide more information on
the safety of this medicine.

Saudi Arabia:

- The National Pharmacovigilance and Drug Safety Centre (NPC) - Fax: +966-11-205-7662 - Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340. - Toll free phone: 8002490000 - E-mail: npc.drug@sfda.gov.sa - Website: www.sfda.gov.sa/npc Other GCC States: - Please contact the relevant competent authority.

 

There is potential for overdose resulting in hypervolaemia, hypovolaemia, electrolyte disturbances or hyperglycaemia. Excessive use of DIANEAL PD4 peritoneal dialysis solution
with 3.86% glucose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

Management of overdose:
• Hypervolaemia may be managed by using hypertonic peritoneal dialysis solutions and fluid restriction. Hypovolaemia 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, hypokalaemia, may 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 section 6.2).
• Hyperglycaemia in diabetic patients shall be managed by adjusting the insulin dose or other treatments for hyperglycaemia.

Pharmacotherapeutic group: Hypertonic solutions, ATC code: B05DB
For patients with renal failure, peritoneal dialysis is a procedure for removing toxic substances
produced by nitrogen metabolism and normally excreted by the kidneys, and for aiding the
regulation of fluid and electrolyte as well as acid base balances.
This procedure is accomplished by administering peritoneal dialysis fluid through a catheter into
the peritoneal cavity. Transfer of substances between the dialysis fluid and the patient's
peritoneal capillaries is made across the peritoneal membrane according to the principles of
osmosis and diffusion. After a few hours of dwell time, the solution is saturated with toxic
substances and must be changed.
With exception of lactate, present as a bicarbonate precursor, electrolyte concentrations in the
fluid have been formulated in an attempt to normalise plasma electrolyte concentrations.
Nitrogenous waste products, present in high concentration in the blood, cross the peritoneal
membrane into the dialysing fluid. Glucose produces a solution hyperosmolar to the plasma,
creating an osmotic gradient which facilitates fluid removal from the plasma to the solution,
necessary to compensate for the over-hydration observed in chronic renal failure patients.

Intraperitoneally administered glucose is absorbed into the blood and metabolised by the usual pathways.

Not appropriate.

Water for injections to 100% w/v

Addition of Potassium
Potassium is omitted from DIANEAL PD4 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 Antibiotics
No formal clinical drug interaction studies have been performed. In vitro studies of the following anti-infectives have demonstrated stability with the Dianeal PD4: 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.

The shelf life of the product as packaged for sale is 24 months. The product, once removed from its over pouch, should be used immediately.

Store below 30C° and not less than 4 C° and don’t freeze.

The fluid is hermetically sealed inside a bag manufactured from medical grade plasticised PVC, designated PL-146. The bag is fitted with a port for connection to a suitable administration set,
or alternatively the bag may be connected to an integral administration set and empty drainage bag. The bag is also fitted with a resealable latex injection port for the addition of medication to
the solution prior to administration, if appropriate. The bag is then sealed inside an overpouch manufactured from high density polyethylene or polypropylene.
Container Sizes: 2000ml, 2500ml, 3000ml, 5000ml and 6000ml.

For details on the conditions of administration see section 4.2.
Detailed instruction on the CAPD exchange procedure is given to patients by means of specialised training, and in the leaflet.
Discard any unused remaining solution.