Dyspnoea, epistaxis, cough Pleural effusion3, pharyngolaryngeal pain, pharyngitis Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage

Common dyspnoea, epistaxis Rare pleural effusion, lung fibrosis

interstitial lung disease, including pulmonary fibrosis

cutaneous vasculitis anaphylaxis

anaphylaxis

Interstitial lung disease (including pneumonitis and pulmonary fibrosis)

Patients with interstitial pneumonitis or pulmonary fibrosis (see Section 4.4).

Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis) Gastrointestinal disorders Common

Reported diagnoses in patients suspected of having ILD like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome (ARDS), alveolitis, and lung infiltration.

Reported diagnoses in patients suspected of having ILD like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome (ARDS), alveolitis, and lung infiltration.

In an animal model of pulmonary fibrosis, bosentan reduced collagen deposition in the lungs.

Multiple pulmonaryforeign body granulomas can lead to lung fibrosis and lethal pulmonary hypertension.

Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic drugs and or colony stimulating factors.

Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome, interstitial pneumonia and pulmonary fibrosis have rarely been reported.

2.5 above, involve a risk which, with regard to carcinogenesis and lung fibrosis, is likely to be lower.

It should also not be used in patients with interstitial pneumonitis or pulmonary fibrosis (lung diseases).

Patients with a history of, or evidence of, interstitial pneumonitis or pulmonary fibrosis were excluded from clinical studies.

Rare (1 10,000 to 1 1,000) pulmonary adverse effects including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.

or Rare ( 1 10,000 to 1 1,000) pulmonary adverse effects including interstitial pneumonia, pulmonary

Exposure to asbestos can cause serious illnesses, such as pleural and lung fibrosis and cancer of the lung, pleura or peritoneum.

Reported diagnoses in patients suspected of having ILD like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome (ARDS), alveolitis, and lung infiltration.

There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.

Cases of silicosis, silicatosis, silico tuberculosis, asbestosis malignant neoplasms of the lung or the pleura caused by asbestos pulmonary fibrosis caused by hard metal dust

143 Interstitial lung disease

Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n Viral load reduction (log10 copies ml)c HBV DNA undetectable ( 300 copies ml by PCR)c

n Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n

Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n

cellulitis, erysipelas hyperkalaemia myalgia paraneoplastic cerebellar degeneration membranous glomerulonephritis, glomerulonephropathy, renal failure bronchospasm, respiratory distress, acute pulmonary oedema, respiratory insufficiency, dyspnoea, hypoxia, laryngeal oedema, acute respiratory distress, acute respiratory distress syndrome, Cheyne Stokes breathing, pulmonary infiltrates, pneumonia, pneumonitis, pulmonary fibrosis.

4 METAVIR Fibrosis score

4

One patient experienced a fatal case of acute respiratory distress syndrome with subsequent respiratory failure associated with interstitial pulmonary fibrosis in the Busilvex studies.

have previously had or have evidence of interstitial pneumonitis (swelling of the lungs causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)

Pericardial effusion Pulmonary oedema Pulmonary hypertension Haemorrhage

Pericardial effusion Pulmonary oedema Ascites Pulmonary hypertension

Cases of abnormalities of the skin including thickening inflammation or fibrosis (NSF) have been reported.

Pulmonary embolism Interstitial lung disease Bronchopneumopathy Dyspnea

Cases of abnormalities of the skin including thickening inflammation or fibrosis (NSF) have been reported.

In patients with diffuse interstitial pulmonary fibrosis, the percent of dose recovered in expired air averaged 100 and the terminal half life was similar to that measured in healthy volunteers.

Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot derived dopaminergic agents.

Stomatitis

Hypophosphataemia Hypercholesterolaemia Hyperglycaemia Hypertriglyceridaemia

Pancreatitis

common arrhythmias (e. g.

It can result in very serious illnesses such as lung fibrosis, pleural fibrosis or mesothelioma. A number of doubts and unanswered questions still surround the use of this substance.

if you are allergic (hypersensitive) to perflutren or to any of the ingredients of OPTISON.