Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use

WARNINGS
Electrolyte balance

Plasma-Lyte 148 (pH 7.4) is not indicated for the treatment of hypochloraemic hypokalaemic alkalosis.
Plasma-Lyte 148 (pH 7.4) is not indicated for the primary treatment of severe metabolic acidosis neither for the treatment of hypomagnesaemia.

Use in Patients with or at Risk for and from Hypermagnaesemia
Parenteral magnesium salts should be used with caution in less severe degrees of renal impairment and in patients with myasthenia gravis. Patients should be monitored for clinical signs of excess magnesium, particularly when being treated for eclampsia (See also section 4.5 – Interactions with other Medicinal Products and other forms of interaction).


Use in patients with Hypocalcaemia
Plasma-Lyte 148 (pH 7.4) contains no calcium, and an increase in plasma pH due to its alkalinizing effect may lower the concentration of ionized (not protein-bound) calcium.
Plasma-Lyte 148 (pH 7.4) should be administered with particular caution to patients with hypocalcaemia.

Use in Patients with or at Risk for Hyperkalaemia

Solutions containing potassium salts should be administered with caution to patients with cardiac disease or conditions predisposing to hyperkalaemia such as renal or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction as occurs with severe burns.
The plasma potassium level of the patient should be particularly closely monitored in patients at risk of hyperkalaemia.

The following combinations are not recommended; they increase the concentration of potassium in the plasma and may lead to potentially fatal hyperkalaemia notably in case of renal failure increasing the hyperkalaemic effects (see 4.5).
- Concomitant use with potassium-sparing diuretics (amiloride, potassium canreonate, spironolactone, triamterene)
- Angiotensin converting enzyme inhibitors (ACEi) and, by extrapolation, angiotensin II receptor antagonists: hyperkalaemia potentially lethal
-          Tacrolimus, cyclosporin
Use in patients with potassium deficiency
Although Plasma-Lyte 148 (pH 7.4) solution has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency and therefore it should not be used for this purpose.

Fluid balance/renal function

Risk of Fluid and/or Solute Overload and Electrolyte Disturbances
The patient’s clinical status and laboratory parameters (fluid balance, blood and urine electrolytes as well as acid-base balance) must be monitored during use of this solution.
Depending on the volume and rate of infusion, intravenous administration of Plasma-Lyte 148 (pH 7.4) can cause
− fluid and/or solute overload resulting in overhydration/hypervolaemia therefore high volume infusion must be used under specific monitoring in patients with cardiac, pulmonary or renal failure.
High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatraemia (see below).

Hyponatraemia
Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress, infections, burns, and CNS diseases), patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists (see section 4.5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids.
Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening brain injury.
Children, women in the fertile age and patients with reduced cerebral compliance (e.g.
meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

Use in Patients with Hypervolaemia or Overhydration, or Conditions that Cause Sodium Retention and Oedema
Plasma-Lyte 148 (pH 7.4) should be administered with particular caution to hypervolaemic or overhydrated patients.
Solutions containing sodium chloride should be carefully administered to patients with hypertension, heart failure, peripheral or pulmonary edema, impaired renal function, pre- eclampsia, aldosteronism, or other conditions associated with sodium retention (see also Section 4.5 – Interactions with other Medicinal Products and forms of interaction).

Use in Patients with Severe Renal Impairment
Plasma-Lyte 148 (pH 7.4) should be administered with particular caution to patients with severe renal impairment. In such patients administration of Plasma-Lyte 148 (pH 7.4) may result in sodium and/or potassium or magnesium retention.

Acid-base balance

Use in Patients with or at Risk for Alkalosis
Plasma-Lyte 148 (pH 7.4) should be administered with particular caution to patients with alkalosis or at risk for alkalosis. Excess administration of Plasma-Lyte 148 (pH 7.4) can result in metabolic alkalosis because of the presence of acetate and gluconate ions.

Other warnings

Hypersensitivity Reactions
Hypersensitivity/infusion reactions, including anaphylactoid reactions, have been reported with Plasma-Lyte 148 (pH 7.4).
The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Administration
Administration in the postoperative period shortly after recovery from neuromuscular block should be used with caution since magnesium salts can lead to recurarisation effect.
When used concomitantly with parenteral nutrition, electrolyte supply should be taken into account and adjusted accordingly.

PRECAUTIONS

Interference with laboratory tests for gluconate containing solutions There have been reports of false-positive test results using the Bio-Rad Laboratories Platelia 
Aspergillus EIA test in patients receiving Baxter gluconate containing Plasmalyte solutions.
These patients were subsequently found to be free of Aspergillus infection. Therefore, positive test results for this test in patients receiving Baxter gluconate containing Plasmalyte solutions should be interpreted cautiously and confirmed by other diagnostic methods.

Administration
Adding other medications or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately.
For information on incompatibilities and preparation of the product and additives, please see section 6.2 and 6.6.

Effects on Driving

4.7     Effects on ability to drive and use machines

There is no information of the effects of Plasma-Lyte 148 (pH 7.4) solution for infusion on the ability to drive and use machines.