Calcium Chloride Dihydrate/ Magnesium Chloride Hexahydrate/ Sodium Chloride/ Sodium Bicarbonate

Registered South African indications:

• Acute and chronic renal failure primarily intended for use in patients with hyperkalaemia
  - As substitution solution in haemofiltration and haemodiafiltration
  - As dialysis solution in haemodialysis and haemodiafiltration

Contraindications

• Hypersensitivity to the active ingredient or to any of its excipients
• Haemofiltration/ haemodialysis/ haemodiafiltration dependent contraindications due to the technical procedure:
  - Renal failure with increased hypercatabolism in cases where uraemic symptoms can no longer be relieved by haemofiltration
  - Inadequate blood flow from vascular access
  - High risk of haemorrhage on account of systemic anticoagulation
• Hypokalaemia, if no simultaneous adapted potassium supplementation
• Metabolic alkalosis

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Precipitation of the solution (See additional prescribing points)
• Hypokalaemia (See additional prescribing points)
• Hyperkalaemia (See additional prescribing points)
• Diabetes mellitus
• Fluid balance
• Acid-base balance
• Electrolyte balance (Pre-existing chloraemia, phosphataemia, calcaemia, magnesaemia or natraemia)

Forms avail. in SA and covered in this monograph: sol

South African manufacturer recommendations

Acute renal failure  
- As substitution solution in haemofiltration and haemodiafiltration

• IV: 20-35ml/kg/hr

Chronic renal failure
- As substitution solution in haemofiltration and haemodiafiltration

• IV: 7-35ml/kg/hr

The solution is primarily intended for use in patients with hyperkalaemia

The amount of substitution solution to be administered in adults is determined by the ultrafiltration rate and is set for each individual case to ensure an adequate electrolyte fluid balance

These fluid volume recommendations may be adjusted by the prescribing medical practitioner according to the patient’s clinical status

The solution can be administered into the extracorporeal blood circuit either in pre- and/or postdilution mode according to the medical practitioner’s prescription

Acute and chronic renal failure
- As dialysis solution in haemodialysis and haemodiafiltration

The prescription and amount of dialysis solution depend upon the mode of therapy, frequency and duration of treatment and will be selected by the prescribing medical practitioner according to the patient’s clinical status

The solution is primarily intended for use in patients with hyperkalaemia

See additional prescribing points for method of administration and instructions for use and handling

The solution must only be used by or under the direction of a medical practitioner experienced in haemofiltration, haemodialysis or haemodiafiltration techniques

Not established for use in children 

Pregnancy

• Caution; no information available
• There are no preclinical or clinical data on use during pregnancy. Administer only to pregnant women if clearly needed

Breastfeeding

• Caution; no information available
• There are no preclinical or clinical data on use during breastfeeding. Administer only to breastfeeding women if clearly needed

Fertility

• No data on male and female fertility is available

Renal Impairment

• Caution; no dose adjustment recommended
• Renal failure with increased hypercatabolism in cases where uraemic symptoms can no longer be relieved by haemofiltration: Contraindicated
  In haemofiltration/ haemodialysis/ haemodiafiltration due to the technical procedure itself

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Cardiovascular Disorders

• Hypotension (Due to the haemofiltration or haemodialysis solutions)
• Hypertension

Gastrointestinal Disorders

• Nausea and vomiting (Due to the haemofiltration or haemodialysis solutions)

Endocrine and Metabolic Disorders

• Metabolic alkalosis
• Electrolyte disturbances
• Fluid imbalances
• Hypophosphataemia
• Hypoglycaemia

Musculoskeletal Disorders

• Muscle cramps (Due to the haemofiltration or haemodialysis solutions)

Immune, Blood and Lymphatic System Disorders

• Hypovolaemia
• Hypervolaemia
• Bleeding (Due to the haemofiltration or haemodialysis solutions)
• Clotting (Due to the haemofiltration or haemodialysis solutions)
• Infection (Due to the haemofiltration or haemodialysis solutions)
• Air embolism (Due to the haemofiltration or haemodialysis solutions)

• Digoxin
• Vitamin D
• Calcium

• Fluid balance
• Acid-base balance
• Electrolytes
• Blood glucose
• Potassium level (Including when coadministered with digoxin)

Method of administration

• Haemodialysis: Administer via the dialysis compartment of the dialyser
• Haemofiltration: Administer via the arterial or venous blood line
• After removal of the overpouch, immediately open the long-seal (interchamber seal) to mix the two solutions and then open the short seal (seal near access port) to allow administration of the mixed solution

• In case the long-seal (interchamber seal) is not opened (i.e. only short seal near access port opens) and the solution of the small chamber “B” is given, alkalosis may arise. Most common clinical signs/ symptoms of alkalosis are nausea, lethargy, headache, dysrhythmia, respiratory depression

Instructions for use and handling

• Check the integrity of the medicine. If one of the seals is opened prematurely, do not use the bag. In case of damage, discard the container
• Do not administer unless the solution is clear
• Aseptic technique should be observed throughout the whole procedure
• Concomitant medicine may be added through the medication port in the larger chamber. Medicine compatibility must be checked before admixture. Add the medicine and activate the long-seal (interchamber seal) immediately. The medicine must be used immediately after any medicine addition
• After removal of the overpouch, immediately open the long seal (interchamber seal) to mix the two solutions. Ensure the long-seal (interchamber seal) is completely activated and the two solutions are completely mixed. Then open the short seal (seal near access port) to allow administration of the mixed solution. Connect to the patient line and activate the access port. The solution must be used within 24 hours of mixing
• Discard any unused remaining solution

Precipitation of the solution

• Precipitation of the solution may occur several hours after the start of therapy and if precipitate is formed, the solution and CRRT tubing lines must be replaced immediately and the patient carefully monitored

Potassium levels

• Kalaemia must be monitored regularly before and during treatment
• If hypokalaemia is present or starts to develop, supplementation of potassium and/or changing to a substitution solution with higher potassium concentration may be required
• If hyperkalaemia starts to develop, an increase in the filtration rate and/or changing to a substitution solution with a lower potassium concentration may be indicated as well as usual measures of intensive care medicine

Calcium Chloride Dihydrate/ Magnesium Chloride Hexahydrate/ Sodium Chloride/ Sodium Bicarbonate is pharmacologically inactive. The solution consists of ions that are present at concentrations similar to physiological level in plasma. As substitution solution, it provides a continuous source of electrolytes and water for hydration and acts as an alkalinising medicine. As dialysis solution, it removes metabolic waste products from the blood and helps to manage the serum electrolytes and/or fluid imbalances. 

COMBINATION PREPARATIONS

Calcium Chloride Dihydrate/ Magnesium Chloride Hexahydrate/ Sodium Chloride/ Sodium Bicarbonate

Solution 0.343g/ 0.136g/ 7.52g/ 13.4g

• Accusol 35 K0 (Adcock Ingram)