Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Supplement of water, carbohydrates and electrolytes to patients where normal intake is insufficient or when there is a deficiency.
Dosage, rate, and duration of administration are to be individualised and depend upon the indication for use, the patient’s age, weight, clinical condition, and concomitant treatment, and on the patient’s clinical and laboratory response to treatment.
Fluid balance, blood glucose, and serum electrolytes should be monitored before and during administration (see sections 4.4, 4.5, 4.6 and 4.8).
Recommended dose for adults is 2-3 litres infusion fluid per day.
Maintelyte solution for infusion: 1000 ml administered intravenously during 4 -12 hours (based on a patient weighing 70 kg).
Infusion rate: 1.2-3.5 ml/kg/hour.
Buffering capacity: In order to increase pH of Maintelyte solution from 5 to 7, approximately 7 mmol NaOH will be needed. In order to decrease the pH of Maintelyte solution from 5 to 4, approximately 13 mmol HCl will be needed.
Infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia. For information, the maximum glucose oxidation capacities is 5mg/kg/min for adults.
Currently, there are no dosing recommendations for use in children (Please see section 4.4: Use in pediatric patients).
The solution should be administered by intravenous infusion (peripheral or central vein). Maintelyte solution for infusion must not be administered subcutaneously.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.
Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.
Because of the presence of glucose, this solution should NOT be administered through the same infusion equipment as whole blood, as haemolysis and clumping of the blood cells can occur.
Too fast infusion may lead to water and sodium overload with a risk of oaedema, particularly when there is a defective renal sodium excretion. In this case renal dialysis may be necessary.
Excessive administration or rapid infusion or prolonged administration of glucose may lead to hyperglycaemia.
Excessive administration of potassium may lead to the development of hyperkalaemia, especially in patients with renal impairment. Symptoms include paresthesia of the extremities, muscle weakness, paralysis, cardiac arrhythmias, heart block, cardiac arrest, and mental confusion. Treatment of hyperkalaemia involves the administration of calcium, insulin (with glucose) sodium bicarbonate, exchange resins or dialysis.
Excessive administration of magnesium may lead to hypermagnesemia,important signs of which are loss of deep tendon reflexes and respiratory depression, both due to neuromuscular blockade. Other symptoms of hypermagnesaemia may include nausea, vomiting, flushing of the skin, thirst, hypotension due to peripheral vasodilatation, drowsiness, confusion, muscle weakness, bradycardia, coma, and cardiac arrest.
Excessive administration of chloride salts may cause a loss of bicarbonate with an acidifying effect.
Excessive administration of compounds, such as sodium acetate, which are metabolized to form the bicarbonate anion may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Symptoms may include mood changes, tiredness, shortness of breath, muscle weakness, and irregular heartbeat. Muscle hypertonicity, twitching, and tetany may develop especially in hypocalcaemic patients. Treatment of metabolic alkalosis associated with bicarbonate overdose consists mainly of appropriate correction of fluid and electrolyte balance.
The infusion should be interrupted immediately. Administration of diuretics and continuous monitoring of serum electrolytes, correction of electrolyte balance and acid-base balance.
When assessing an overdose, any additives in the solution must also be considered.
The effects of an overdose may require immediate medical attention and treatment.
A patient with supralethal hypermagnesaemia was successfully treated using assisted ventilation, calcium chloride, administered intravenously, and forced diuresis with mannitol infusions.
Unopened: 3 years.
In-use shelf-life: Chemical and Physical stability of any additive at the pH of Maintelyte solution in the Viaflo container should be established prior to use.
From a microbiological point of view, the diluted product must be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution has taken place in controlled and validated aseptic conditions.
Do not store above 25°C.
The bags known as Viaflo are composed of polyolefin/polyamide co-extruded plastic (PL 2442).
The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene.
Bag size: 1000 ml.
Outer carton content: 10 bags of 1000 ml.
After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion.
The solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact.
Administer immediately following the insertion of infusion set.
Do not remove unit from overwrap until ready for use.
The inner bag maintains the sterility of the product.
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.
The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.
Additives may be introduced before infusion or during infusion through the medication port.
Adding other medication or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of adverse reaction, infusion must be stopped immediately.
Discard after single use.
Discard any unused solution.
Do not reconnect partially used bags.
a. Remove the Viaflo container from the overpouch just before use.
b. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility may be broken.
c. Check that the solution is clear and does not contain foreign matters. If so, discard the solution.
Use sterile material for preparation and administration.
a. Suspend container from eyelet support.
b. Remove plastic protector from outlet port at bottom of container:
c. Use an aseptic method to set up the infusion.
d. Attach administration set. Refer to complete directions accompanying set for connection, priming of the set and administration of the solution.
Note that some additives may be incompatible.
When additive is used, verify isotonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.
To add medication before administration
a. Disinfect medication site.
b. Use a syringe with 19 gauge (1,10 mm) to 22 gauge (0,70 mm) needle. Puncture resealable medication port and inject.
c. Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.
Caution: Do not store bags containing added medications.
To add medication during administration
a. Close clamp on the set.
b. Disinfect medication site.
c. Use a syringe with 19 gauge (1,10 mm) to 22 gauge (0,70 mm) needle. Puncture resealable medication port and inject.
d. Remove container from IV pole and/or turn to an upright position.
e. Evacuate both ports by tapping gently while the container is in an upright position.
f. Mix solution and medication thoroughly.
g. Return container to in use position, re-open the clamp and continue administration.
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