Update of the Summary of Product Characteristics following the PRAC recommendation on the signal concerning IV fluids containing electrolytes and/or carbohydrates and the risk for hyponatremia(EPITT 18631)
Following a signal evaluation procedure concerning IV fluids containing electrolytes and/or carbohydrates and the risk for hyponatremia (EPITT 18631) the pharmacovigilance risk assessment committee (PRAC) recommended that the MAH(s) for the concerned products should submit a variation within 6 months to amend the product information. The wording provided with the recommendation was intended as guidance and was to be adapted at an individual product level. CMDh has confirmed that there should be flexibility for national competent authorities to adapt the texts.
Below are the key text elements that the Medical Products Agency in Sweden considers appropriate to add to the SmPC for concerned productsas a result of this PRAC recommendation. The SmPC adjustments may need to be adapted and merged into the actual SmPC for the particular product – such that the essence of the required adjustments is preserved.
Summary of Product Characteristics
4.2 Posology and Method of Administration
[for IV fluids containing glucose]
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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).
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[for IV fluids without glucose]
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Fluid balance and serum electrolytes should be monitored before and during administration(see sections 4.4, 4.5, 4.6 and 4.8).
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4.4 Special warnings and precautions for use
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Hyponatraemia
Treatment with intravenous fluidshaving a lower sodium concentration than the patient’s serum sodium may cause hyponatremia(see section 4.2). Children, patients with reduced cerebral compliance,patients with non-osmotic vasopressin release (e.g. in acute illness, trauma, post-operative stress, central nervous system diseases), and patients exposed to vasopressin agonists and other drugs that can lower serum sodium (see section 4.5) are at particular risk of acute hyponatraemia. Acute hyponatraemia can lead to acute brain oedema and life-threatening brain injury.
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4.5 Interactions with other medicinal products and other forms of interactions
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Drugs that can increase the risk for hyponatremia
Drugs that can lower serum sodium may increase the risk of acquired hyponatraemia following treatment with intravenous fluidsinappropriately balanced to the need of the patient in terms of fluid volume and sodium content (see sections 4.2, 4.4, 4.6 and 4.8). Examples are diuretics, non-steroid anti-inflammatory drugs (NSAIDs), antipsychotics, selective serotonin reuptake inhibitors, opioids,antiepileptics, oxytocin, and chemotherapy.
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4.6 Fertility, pregnancy and lactation
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When <Product name> is administrated to pregnant women during labour, particularly if administered in combination with oxytocin, there may be an increased risk for hyponatraemia (see section 4.4, 4.5 and 4.8).
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4.8 Undesirable effects
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[Add the two terms below to existing table of adverse reactions]
Tabulated list of adverse reactionsSystem Organ Class / Adverse reaction (MedDRA term) / Frequency
Metabolism and nutrition disorders / Hyponatraemia / Not known
Nervous system disorders / Hyponatraemic encephalopathy / Not known
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