Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Febrile response; infection at the injection site; tissue necrosis; venous thrombosis or phlebitis extending from the site of the injection; extravasation; hypovolemia, hypervolemia; dehydration; mental confusion or unconsciousness. These may occur because of the solution administration technique. Use the largest available peripheral vein and a well placed small bore needle. Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance.
Hypertonic solutions are more likely to cause irritation; administer into larger central veins.
Significant hyperglycemia, hyperosmolar syndrome and glycosuria may occur with too rapid administration of hypertonic solutions.
The physician should also be alert to the possibility of adverse reactions to drug additives.
Prescribing information for drug additives to be administered in this manner should be consulted.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form www.sideeffects.health.gov.il and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com