Adverse reactions : תופעות לוואי

Adverse Reactions
Post-Marketing Adverse Reactions
The following adverse reactions have been reported with PLASMA-LYTE products without Dextrose. Adverse reactions are listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible.

- Immune System Disorders: Hypersensitivity/infusion reactions, including Anaphylactoid reaction, and the following manifestations: Tachycardia, Palpitations, Chest pain, Chest discomfort, Dyspnea, Respiratory rate increased, Flushing, Hyperemia, Asthenia, Feeling abnormal, Piloerection, Edema peripheral, Pyrexia 
- General Disorders and Administration Site Conditions: Infusion site reactions (e.g., Infusion site pain, Burning sensation)

Other adverse reactions reported with PLASMA-LYTE products with Dextrose are: - Other manifestations of hypersensitivity/infusion reactions: Hypotension, Wheezing, Urticaria, Cold sweat, Chills
- - Hyperkalemia

Overdose
Excessive administration of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may lead to metabolic alkalosis. Metabolic alkalosis may be accompanied by hypokalemia as well as a decrease in ionized serum calcium and magnesium.

An excessive volume of PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) may lead to fluid and sodium overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired.

Excessive administration of potassium may lead to the development of hyperkalemia, especially in patients with severe renal impairment.

Excessive administration of magnesium may lead to hypermagnesemia.

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.


Plama-Lyte A Injection       5.   10. 2014, RH