esirable effects also occurred in the large randomised study, but they were not recorded because only serious and life-threatening adverse reactions were collected in that study.
Adverse reactions are classified according to system organ class and frequency. Frequency groupings are defined according to the following convention: Very common (1/10), common (1/100 to <1/10). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1. Adverse reactions associated with MEPACT in 1/100 patients
Infections and infestations
Common:
Sepsis, cellulitis, nasopharyngitis, catheter site infection, upper respiratory tract infection, urinary tract infection, pharyngitis, Herpes simplex infection
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Common:
Cancer pain
Blood and lymphatic system disorders
Very common:
Anaemia
Common:
Leukopenia, thrombocytopenia, granulocytopenia
Metabolism and nutrition disorders
Very common:
Anorexia
Common:
Dehydration, hypokalaemia, decreased appetite
Psychiatric disorders
Common:
Confusional state, depression, insomnia, anxiety
Nervous system disorders
Very common:
Headache, dizziness
Common:
Paraesthesia, hypoaesthesia, tremor, somnolence, lethargy
Eye disorders
Common:
Blurred vision
Ear and labyrinth disorders
Common:
Vertigo, tinnitus, hearing loss
Cardiac disorders
Very common:
Tachycardia
Common:
Cyanosis, palpitations
Vascular disorders
Very common:
Hypertension, hypotension
Common:
Phlebitis, flushing, pallor
Respiratory, thoracic and mediastinal disorders
Very common:
Dyspnoea, tachypnoea, cough
Common:
Pleural effusion, exacerbated dyspnoea, productive cough, haemoptysis, wheezing, epistaxis, exertional dyspnoea, sinus congestion, nasal congestion, pharyngolaryngeal pain
Gastrointestinal disorders
Very common:
Vomiting, diarrhoea, constipation, abdominal pain, nausea
Common:
Upper abdominal pain, dyspepsia, abdominal distension, lower abdominal pain
Hepatobiliary disorders
Common:
Hepatic pain
Skin and subcutaneous tissue disorders
Very common:
Hyperhidrosis
Common:
Rash, pruritis, erythema, alopecia, dry skin
Musculoskeletal and connective tissue disorders
Very common:
Myalgia, arthralgia, back pain, pain in extremity
Common:
Muscle spasms, neck pain, groin pain, bone pain, shoulder pain, chest wall pain, musculoskeletal stiffness
Renal and urinary disorders
Common:
Haematuria, dysuria, pollakiuria
Reproductive system and breast disorders
Common:
Dysmenorrhoea
General disorders and administration site conditions
Very common:
Fever, chills, fatigue, hypothermia, pain, malaise, asthenia, chest pain
Common:
Peripheral oedema, oedema, mucosal inflammation, infusion site erythema, infusion site reaction, catheter site pain, chest discomfort, feeling cold
Investigations
Common:
Weight decreased
Surgical and medical procedures
Common:
Post-procedural pain
Blood and lymphatic system disorders
Anaemia has most commonly been reported when MEPACT is used in conjunc |
