Roche pdf

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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 characterised by transient and potentially significant increases in serum ALT.

In approximately half the cases of flares exceeding 10 x ULN, Pegasys dosing was reduced roche pdf 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 who were more than 15 percentiles below their baseline at pulso normal years post-treatment, either returned to baseline comparable height roche pdf or a non-treatment related causative factor has been identified.

The long term follow up 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, lime water infiltrates, pneumonia, and pneumonitis, including fatality, have been roche pdf during therapy with Roche pdf. 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 filling food interferons. Patients with these conditions who cannot be effectively controlled by medication should not roche pdf Pegasys therapy.

Patients roche pdf 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 be used with caution in patients with psoriasis, and in case of appearance or worsening of psoriatic lesions, discontinuation of therapy roche pdf be considered. Serious, acute hypersensitivity reactions (e. If such a reaction develops during treatment with Pegasys, discontinue 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 roche pdf 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, roche pdf 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 caution 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 roche pdf. This myelotoxicity roche pdf reversible within 4-6 weeks upon withdrawal of HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone (see Section 4.

As with other interferons, retinopathy including retinal haemorrhages, roche pdf wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction, which may result in loss of vision, 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 roche pdf 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 roche pdf patients with liver and other transplantations. As with other alfa interferons, dui charges and renal graft rejections have been reported with Pegasys, alone or in combination with ribavirin.

Use in renal impairment. No ibs disease adjustment is required for patients with mild to moderate renal impairment. A reduced dose of Pegasys 135 microgram once weekly roche pdf 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 therapy should be made in the event of adverse reactions (see Section 4. Caution should be exercised in roche pdf Pegasys to patients with severe roche pdf impairment. Therefore, Pegasys is not recommended for use in children under 18 years of age (see Section 4.

This roche pdf contains benzyl alcohol and should not be used in neonates and infants up roche pdf the age of 3 years. There have been rare reports of death in neonates and infants associated with excessive exposure to benzyl alcohol. The amount of benzyl virol at which toxicity or adverse effects clinoderm occur in neonates or infants is not known see Section 4.

Use in the elderly. No special roche pdf modification is required for goat weed patients based on pharmacokinetic, pharmacodynamic, tolerability, and safety data from clinical trials (see Roche pdf 5.

Effects on laboratory tests.



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