Adverse reactions : תופעות לוואי

4.8. Undesirable effects

The following adverse reactions (listed by MedDRA System Organ Class) have been reported spontaneously during the post-market experience.

Immune System Disorders                         Hypersensitivity/Infusion reactions including Anaphylactic/Anaphylactoid reaction, possibly manifested by one or more of the following symptoms: Angioedema, Chest pain, Chest discomfort, Decreased heart rate, Tachycardia,
Blood pressure decreased, Respiratory distress,
Bronchospasm, Dyspnea, Cough, Urticaria,
Rash, Pruritus, Erythema, Flushing, Throat irritation, Paresthesias, Hypoesthesia oral,
Dysgeusia, Nausea, Anxiety, Pyrexia, Headache

Metabolism and Nutrition Disorders              Hyperkalaemia
Hospital acquired hyponatraemia*

Nervous System Disorders                        Acute hyponatraemic encephalopathy* General Disorders and Administration Site       Infusion site reactions manifested by one or Conditions                                      more of the following symptoms: Phlebitis, Infusion site inflammation, Infusion site swelling, Infusion site rash, Infusion site pruritus, Infusion site erythema, Infusion site pain, Infusion site burning

*Hospital acquired hyponatraemia may cause irreversible brain injury and death, due to development of acute hyponatraemic encephalopathy, frequency unknown (see sections 4.4 and      4.5).

The following adverse reactions have been reported spontaneously during the use of other sodium-lactate containing solutions:
• Hypersensitivity: Laryngeal oedema (Quincke’s oedema), skin swelling, Nasal congestion, Sneezing
• Electrolyte disturbances
•    Hypervolaemia
•    Panic attack
•    Other infusion site reactions: Infection at the site of injection, Extravasation, Infusion site anesthesia (numbness)

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: https://sideeffects.health.gov.il and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com