Lactasol Solution For Haemofiltration And Haemodialysis
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Lactasol, solution for haemofiltration and haemodialysis
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Chloride (Dihydrate) 0.257 g/l
Magnesium Chloride (Hexahydrate) 0.152 g/l
Sodium Lactate solution 60% w/w 7.471 g/l
corresponding to Sodium Lactate anhydrous 4.483 g/l
Lactasol solution contains in mmol per litre: Sodium 140
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for haemofiltration and haemodialysis. Clear and colourless solution. pH of the solution: 5.0 - 7.5 Theoretical Osmolarity: 287.5 mosmol/l
CLINICAL PARTICULARS
4.
4.1 Therapeutic Indications
As a substitution solution in continuous haemofiltration and haemodiafiltration and as dialysis solution in continuous haemodialysis and haemodiafiltration for acute renal failure and in cases of drug poisoning with dialysable or filterable substances.
Lactasol is particularly indicated where patients are hyperkalaemic.
4.2. Posology and Method of Administration
Lactasol is administered into the venous return of the patient.
Lactasol, when used as a substitution solution, is administered into the circuit before (pre-dilution) or after the hemofilter (post-dilution).
The volume of the solution administered will depend upon the fluid balance of the individual patient, the target fluid balance to be achieved and the amount of fluid removed from their circulation during the process of haemofiltration. Dosage will therefore be at the discretion of the Physician.
In continuous haemodialysis or haemodiafiltration, the clearances obtained are directly proportional to the dialysate flow.
Commonly used flow rates for the substitution solution in haemofiltration and haemodiafiltration are:
Adult: 500 - 1500 ml/hour Children: 15 - 20 ml/kg/hour
Commonly used flow rates for the dialysis solution in haemofiltration or continuous haemodialysis are:
Adult: 500 - 2000 ml/hour Children: 15 - 20 ml/kg/hour
Treatment is continued for as long as necessary.
4.3. Contra-indications
• hypokalaemia
Lactate based substitution fluids should not be used if the patient has very severe metabolic acidosis or impaired metabolism of lactate.
4.4. Special Warnings and Special Precautions for Use
The solution is to be used only by or under the direction of a physician who should have a sound experience of intensive care nursing and/or haemofiltration and haemodiafiltration techniques.
The patient’s haemodynamic, fluid, electrolyte and acid-base balance should be closely monitored throughout the procedure. Close monitoring of potassium levels must be carried out to enable the correct selection of the most appropriate potassium concentration.
Severe metabolic acidosis should be corrected with a bicarbonate solution prior to using a lactate based haemofiltration solution.
When used with a monitor, only monitors for Continuous Renal Replacement Therapies must be used.
Do not use with haemodialysis monitor.
Special attention should be given to patients with severe liver dysfunction, sepsis or heart failure before using lactate based substitution fluids.
4.5. Interactions with other Medicinal Products and other forms of Interaction
Correction of the electrolyte concentration may precipitate symptoms of digitalis excess.
The blood concentration of filterable/ dialysable drugs may be reduced during treatment. Corresponding corrective therapy should be instituted if necessary.
4.6. Pregnancy and Lactation
No information is available on the use of this product in pregnancy or lactation.
Administer to pregnant or breast-feeding women only after risk/benefit assessment.
4.7. Effects on Ability to Drive and Use Machines
Does not affect the ability to drive or use machinery.
4.8. Undesirable Effects
Some undesirable effects related to the dialysis treatment can occur, such as nausea, vomiting, muscle cramps, convulsions and hypotension. Electrolyte disturbance may occur. As the solution is potassium-free, especially hypokalemia may occur.
4.9. Overdose
Overdose with Lactasol Solutions should not occur if the procedure is carried out correctly and the patient’s fluid, electrolyte and acid-base balance are monitored closely. However, overdose will result in fluid overload in patients with renal failure. Continued application of haemofiltration will remove excess fluid and electrolytes.
Overdose could lead to severe consequences, such as congestive cardiac failure, electrolyte or acid base disturbances.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Pharmacotherapeutic group: Haemofiltrates ATC code: B05Z B
Lactasol is pharmacologically inactive.
In the technique of haemofiltration, plasma water and solutes, including urea, are removed through a semi-permeable membrane, like glomerular filtration in the normal kidney. Because of the large volume of plasma water removed, the process of haemofiltration requires infusion of a sterile substitution solution. Lactasol contains sodium, calcium, magnesium and chloride ions at physiological concentrations, which provide a suitable substitution solution.
The lactate is metabolised via Cori cycle on an equimolar basis to bicarbonate which is required to help correct metabolic acidosis.
The composition of the solution also makes it a suitable exchange medium for use during continuous haemodiafiltration or continuous haemodialysis.
5.2. Pharmacokinetic Properties
Not applicable.
5.3. Preclinical Safety Data
There is no preclinical information that adds to the safety assessment.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Water for Injections Hydrochloric acid, 3.646% w/v
6.2. Incompatibilities
Do not mix with bicarbonate containing solution, as this will cause precipitation of calcium and magnesium carbonate.
6.3. Shelf Life
2 years.
Shelf life after first opening: for immediate and single use.
6.4. Special Precautions for Storage
Do not store below +4°C.
6.5. Nature and Contents of Container
PVC bag.
Pack size: 2 x 5000 ml.
The container features two administrative set ports - one with connector, the other one for spike insertion and drug addition.
The bag is overwrapped with a transparent overpouch made of multilayer copolymers.
6.6 Special precautions for disposal
Aseptic technique must be used during connection/disconnection of the line sets. The heating of this solution to body temperature must be carefully controlled.
Do not use if the container is damaged or the solution is cloudy. Press firmly on the bag to test for any leakage. If leakage is discovered, discard solution immediately since sterility is no longer guaranteed.
The containers are single use only. Any unused portion should be discarded.
7. MARKETING AUTHORISATION HOLDER
Gambro Lundia AB Trading style Hospal SE 220 10 Lund Sweden
8. MARKETING AUTHORISATION NUMBER(S)
PL 14983/0017
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/01/2007
10 DATE OF REVISION OF THE TEXT
02/01/2007