Special populations : אוכלוסיות מיוחדות

Geriatric use

When selecting the type of infusion solution and the volume and rate of infusion for a geriatric patient, it must be taken into account that such patients are generally more likely to have cardiac, renal, hepatic and other diseases or concomitant therapies.


4.5 Interaction with other medicinal products and other forms of interaction
Baxter has not performed interaction studies.

Both the glycemic effects and the effects on water and electrolyte balance should be taken into account when using Sodium chloride 0.33% and Glucose 5% Baxter in patients treated with other substances that affect glycemic control or fluid and/or electrolyte balance.

Medicinal products leading to an increased vasopressin effect

The below-listed medicinal products increase the vasopressin effect, leading to reduced renal electrolyte-free water excretion and increased risk of hospital-acquired hyponatremia following inappropriately balanced treatment with solutions for intravenous infusion (see sections 4.2, 4.4 and 4.8).

• Medicinal products stimulating vasopressin release, e.g.: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N- methamphetamine, ifosfamide, antipsychotics, narcotics.
• Medicinal products potentiating vasopressin action, e.g.: Chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogues, e.g.: Desmopressin, oxytocin, terlipressin.

Other medicinal products known to increase the risk of hyponatremia 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 edema and hypertension).
• diuretics, beta-2 agonists or insulin, which increase the risk of hypopotassemia.
• certain antiepileptic and psychotropic medicinal products that increase the risk of hyponatremia.


4.6 Fertility, pregnancy and lactation

Pregnancy
Intrapartum intravenous glucose infusion may result in fetal insulin production, with an associated risk of fetal hyperglycemia and metabolic acidosis, as well as rebound neonatal hypoglycemia.

Sodium chloride 0.33% and Glucose 5% Baxter should be administered with special caution for pregnant women during labor particularly if administered in combination with oxytocin due to the risk of hyponatremia (see sections 4.4, 4.5 and 4.8).

Fertility
There is no information on the effects of Sodium chloride 0.33% and Glucose 5% Baxter on fertility.

Breastfeeding
Sodium chloride 0.33% and Glucose 5% Baxter can be used during breastfeeding.

The potential risks and benefits for each specific patient should be carefully considered before administration.