Special populations : אוכלוסיות מיוחדות

Geriatric use
When selecting the type of infusion and the volume/rate of infusion for a geriatric patient, consider that geriatric patients are generally more likely to have cardiac, renal, hepatic, and other diseases or concomitant drug therapy.


4.5 Interaction with other medicinal products and other forms of interaction

No studies have been conducted by Baxter.
Both the glycaemic and effects on water and electrolyte balance should be taken into account when administering Sodium Chloride 0.45 % and Glucose 5.0 % Solution for Infusion Baxter to patients treated with other substances that affect glycaemic control or fluid and/or electrolyte balance.
Drugs leading to an increased vasopressin effect
The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and increase the risk of hospital acquired hyponatraemia following inappropriately balanced treatment with i.v. fluids (see sections 4.2, 4.4 and 4.8).
• Drugs stimulating vasopressin release, e.g.: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N- methamphetamine, ifosfamide, antipsychotics, narcotics
• Drugs potentiating vasopressin action, e.g.: Chlorpropamide, NSAIDs, cyclophosphamide • Vasopressin analogues, e.g. : Desmopressin, oxytocin, terlipressin Other medicinal products increasing the risk of hyponatraemia also include diuretics in general and antiepileptics such as oxcarbazepine.

Caution is advised in patients treated with
• lithium. Renal sodium and lithium clearance may be increased during administration and can result in decreased lithium levels.
• corticosteroids, which are associated with the retention of sodium and water (with oedema and hypertension).
• diuretics, beta-2 agonist, or insulin, whom increase the risk of hypokalemia • certain antiepileptic and psychotropic medications that increase the risk of hyponatraemia.

4.6 Fertility, pregnancy and lactation

Pregnancy
Intrapartum maternal intravenous glucose infusion may result in foetal hyperglycaemia and metabolic acidosis as well as rebound neonatal hypoglycaemia due to foetal insulin production.
Sodium Chloride 0.45 % and Glucose 5.0 % Solution for Infusion Baxter should be administrated with special caution for pregnant women during labour particularly if administered in combination with oxytocin due to the risk of hyponatraemia (see sections 4.4, 4.5 and 4.8).

Fertility
There is no information on the effects of Sodium Chloride 0.45 % and Glucose 5.0 % Solution for Infusion Baxter on fertility.



Lactation
Sodium Chloride 0.45 % and Glucose 5.0 % Solution for Infusion Baxter can be used during breast-feeding. The potential risks and benefits for each specific patient should be carefully considered before administration.