Gastro intestinal disorders

Pulmonary infiltrates , pneumonitis , interstitial pneumonitis 35

Pulmonary infiltrates , pneumonitis , interstitial pneumonitis

Dyspnoea, epistaxis, pleural effusion, pneumonia Pulmonary hypertension, pulmonary infiltrates Allergic alveolitis

Pulmonary infiltrates , pneumonitis

Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed

Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed lp

During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dosage adjusted if necessary.

Pulmonary changes As with other alpha interferons, pulmonary symptoms, including dyspnoea, pulmonary infiltrates, pneumonia, and pneumonitis have been reported during therapy with Pegasys.

Stomatitis ulcerative, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools

Confusion, sleep disorder, libido decreased Suicide ideation Suicide, suicide attempts, aggressive behaviour (sometimes directed against others), psychosis including hallucinations

Dyspnoea , coughing Epistaxis, respiratory disorder, nasal congestion, rhinorrhea,

Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive

Dyspnoea , coughing Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive lon

If pneumonitis or lung infiltrates are diagnosed, Vectibix should be discontinued and the patient should be treated appropriately.

In case of persistent or unexplained pulmonary infiltrates or pulmonary function impairment, treatment should be discontinued.

Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients.

Pulmonary disorders There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving VELCADE (see section 4.8).

Very

Respiratory, thoracic and mediastinal disorders very common cough common dyspnea uncommon rhinorrhea, sore throat and hoarseness, bronchospasm asthma rare pulmonary infiltrates, rhinitis, allergic alveolitis eosinophilic pneumonia

6 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.

Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.

27 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.

48 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.

69 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.

90 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.

111 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.

195 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.

216 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.

If the chest X ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.

rarely in interferon alpha treated patients, including those treated with Viraferon.

Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with Viraferon.

Ocular corneal infiltrates

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.

If the chest X ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.

Serious and sometimes fatal reactions, including bronchospasm, hypoxia, syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, myocardial infarction, arrhythmias, acute cardiac insufficiency and cardiac arrest have been observed.

During TRISENOX treatment, 13 of the 52 patients in the APL studies had one or more symptoms of APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis (see Section 4.4).

While this has been reported more often in patients with chronic i dic

While this has been reported more often in patients with chronic na

While this has been reported more often in patients with chronic i dic

Ocular corneal infiltrates were reported in conjunction with the use of EMADINE.

Unknown

Pulmonary changes

Pulmonary complications

Patients have experienced oedema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, increase in transaminases and weight decrease.