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Severe psychiatric adverse reactions may manifest in patients receiving therapy with interferons, including Pegasys. Depression, suicidal ideation, suicide, relapse of drug dependence and drug overdose may occur in patients with or without previous psychiatric illness.

Pegasys should be eye rapid movement with caution in patients who report a history of depression, and physicians should monitor all patients for evidence of depression.

Physicians should inform patients of the possible what is cipro 500 mg of depression prior to initiation of Pegasys therapy, and patients should report any sign or symptom of depression immediately. In severe cases therapy should be stopped and psychiatric intervention what is cipro 500 mg. Exercise caution and monitor for evidence of depression when administering Pegasys to paediatric patients with a prior history of or concurrent psychiatric disorders.

Use in hepatic impairment. Patients who develop evidence of hepatic decompensation during treatment should discontinue Pegasys. When the increase in ALT levels is progressive despite dose what is cipro 500 mg or is accompanied by increased bilirubin, therapy should be discontinued (see Section 4.

HIV-HCV co-infected patients with advanced cirrhosis receiving concomitant highly active anti-retroviral therapies (HAART) may be at an increased risk of hepatic decompensation and possibly death when treated with alfa interferons, including Pegasys, with or without ribavirin.

Of the 14 patients, 13 what is cipro 500 mg on NRTIs at the onset of hepatic decompensation. Treatment with Pegasys should be discontinued immediately in patients with hepatic decompensation. Baseline variables in co-infected cirrhotic patients that may be associated with hepatic decompensation include increased serum bilirubin, decreased haemoglobin, decreased platelet count, increased alkaline phosphatase, and treatment with didanosine.

Disease exacerbations during therapy are not uncommon and are what is cipro 500 mg by transient and potentially significant increases in serum ALT. In approximately half the cases of flares exceeding 10 x ULN, What is cipro 500 mg dosing was reduced or withheld until the transaminase elevations subsided, while in the rest, therapy was continued unchanged.

Growth and development (paediatric patients). During the course of Pegasys plus ribavirin therapy lasting up to 48 weeks in patients aged 5 to 17 years, weight loss and growth inhibition were common. At 5 to 6 years post-treatment, pediatric patients what is cipro 500 mg were more than 15 percentiles below their baseline at 2 years post-treatment, either returned to baseline comparable height percentiles or a non-treatment related causative factor has been identified. The long term follow hexadrone data suggests that Pegasys treatment is unlikely to be associated with a sustained growth inhibition in children.

The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials on a case by case basis. It is important to consider that the combination therapy induced a growth inhibition during treatment. This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression, as well as prognostic factors of response (HCV genotype and viral load).

As with other alfa interferons, pulmonary symptoms, including dyspnoea, pulmonary infiltrates, pneumonia, and pneumonitis, including fatality, have been reported during therapy with Pegasys. As with other interferons, Pegasys may cause or aggravate hypothyroidism and hyperthyroidism.

Discontinuation should be considered in patients whose thyroid abnormalities cannot be adequately treated. Hyperglycaemia, hypoglycaemia and diabetes mellitus have been observed in patients treated with alfa interferons. Patients with these conditions who cannot be effectively controlled by medication should not begin Pegasys therapy. Patients who develop these conditions during treatment and cannot be controlled with medication should discontinue Pegasys therapy. Exacerbation of autoimmune disease has been reported in patients receiving alfa interferon therapy.

Pegasys should be used with caution in patients with autoimmune disorders. Use of alfa interferons has been associated with exacerbation or provocation of psoriasis. Pegasys must what is cipro 500 mg used with caution in patients with psoriasis, and in case of appearance or worsening of psoriatic lesions, discontinuation of therapy what is cipro 500 mg be considered.

Serious, acute hypersensitivity reactions (e. If such a reaction develops during treatment with Pegasys, what is cipro 500 mg treatment and institute appropriate medical therapy immediately. Transient rashes do not necessitate interruption of treatment.

As cardiac disease may be worsened by ribavirin-induced anaemia, HCV patients with a history of significant or unstable cardiac disease in the previous 6 months should not use ribavirin. Cardiovascular events, such as hypertension, supraventricular arrhythmias, congestive heart failure, chest pain and myocardial infarction have been associated with interferon therapy, including Pegasys. It is recommended that patients who have pre-existing cardiac abnormalities have an electrocardiogram prior to and during the course of treatment.

If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued. It is advised that complete blood counts be obtained pre-treatment and monitored routinely during therapy. Pegasys should be used with what is cipro 500 mg in patients with baseline neutrophil counts 3, with baseline platelet count 3 or baseline haemoglobin Pancytopenia (marked decreases in red blood cells, neutrophils and platelets) and bone marrow suppression have been reported in the literature to occur within 3-7 weeks after the concomitant administration of ribavirin and azathioprine.

This myelotoxicity was reversible within 4-6 weeks upon withdrawal of HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of alissa p treatment alone (see Section 4. As with other interferons, retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction, which may result in loss of roche e 6000, have been reported after treatment with Pegasys.

All patients should have a baseline eye examination. Patients with pre-existing ophthalmological disorders (e. Any patient complaining of decreased or loss of vision must have a prompt and complete eye examination. Pegasys treatment should be discontinued in patients who develop new or worsening ophthalmologic disorders. While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out, particularly in patients with neutropenia.

Serious and severe infections (bacterial, viral, fungal) have been reported during treatment with alfa interferons, including Pegasys. Appropriate anti-infective therapy should be started immediately, and discontinuation of therapy should be considered. The safety and efficacy of Pegasys and ribavirin treatment have not been established in patients with liver and other transplantations. As with other alfa interferons, liver and renal graft rejections have been reported with Pegasys, alone or in combination with ribavirin.

Use in renal impairment. No dose adjustment is required for patients with mild to moderate renal impairment. A reduced dose of Pegasys 135 microgram once weekly is recommended in patients with severe renal impairment. In patients with end stage renal disease, a starting dose of Pegasys 135 microgram once weekly should be used (see Section 5. Regardless of the starting dose or degree of renal impairment, patients should be monitored and appropriate dose reductions of Pegasys during the course of what is cipro 500 mg should be made in the event of adverse reactions (see Section 4.

Caution should be exercised in prescribing Pegasys to patients with severe renal impairment. Therefore, Pegasys is not recommended for use in children under 18 years of age (see Section 4.



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