Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The adverse reactions within this section represent those that are thought to have an association with Dianeal PD4 or in conjunction with performing the peritoneal dialysis procedure.

Undesirables effects which occurred in patients treated with Dianeal PD4 from clinical trials and post marketing are listed below.

The adverse drug reactions listed in this section are given following the recommended frequency convention: very common: 10%; common: 1% and <10%; uncommon: 0.1% and <1%; very rare: <0.01%, not known (cannot be estimated from available data).
System Organ Class             Preferred term                                 Frequency METABOLISM AND                  • Hypokalaemia                                Not known NUTRITIONAL                     • Fluid retention
DISORDERS                       • Hypervolaemia
• Hypovolaemia
• Hyponatraemia
• Dehydration
• Hypochloraemia
VASCULAR                        • Hypertension                                Not known DISORDERS                       • Hypotension
RESPIRATORY,                    • Dyspnoea                                    Not known THORACIC, AND
MEDIASTINAL
DISORDERS
GASTROINTESTINAL                •   Sclerosing encapsulating peritonitis      Not known DISORDERS                       •   Peritonitis
•   Peritoneal cloudy effluent
•   Vomiting
•   Diarrhoea
•   Nausea
•   Constipation
•   Abdominal pain
•   Abdominal distension
•   Abdominal discomfort
SKIN AND                        • Stevens-Johnson syndrome                    Not known SUBCUTANEOUS                    • Urticaria
DISORDERS                       • Rash (including pruritic,
erythematous and generalised)
• Pruritus


MUSCULOSKELETAL,                •   Myalgia                                   Not known CONNECTIVE      TISSUE          •   Muscle spasms
DISORDERS                       •   Musculoskeletal pain
GENERAL DISORDERS               •   Generalised oedema                        Not known AND ADMINISTRATIVE              •   Pyrexia
SITE CONDITIONS                 •   Malaise
•   Infusion site pain


Other undesirable effects of peritoneal dialysis related to the procedure: Fungal peritonitis, bacterial peritonitis, catheter related infection, catheter related complication.
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