Adverse Reactions

Adverse reactions

Undesirable effects

Other adverse reactions

3.9 The uniform approach to the management of undesirable effects and serious undesirable effects has been established.

Table 1 Undesirable Effects in Clinical Studies

Adverse events at least possibly causally related to adalimumab for pivotal studies, both clinical and laboratory, are displayed by system organ class and frequency (very common 1 10 common

Undesirable effects in clinical studies in adult patients Infections and infestations

Serious expected and unexpected adverse drug reactions

Table 1 Undesirable Effects in Clinical Studies

Table 1 Undesirable Effects in Clinical Studies

Table 1 Undesirable Effects in Clinical Studies t

Table 1 Undesirable Effects in Clinical Studies t

Table 1 Undesirable Effects in Clinical Studies t

Undesirable Effects in Clinical Studies

Tell your doctor if you notice any unwanted effects.

73 Undesirable effects in clinical studies in adult patients Infections and infestations

Clinical response and undesirable effects may also be used as guidance for dose titration.

Overdosage is unlikely to have any untoward effect.

Reported side effects following the use of OPTISON

the lack of an overall survival benefit versus adverse events in locally advanced prostate cancer

Adverse reactions are listed below, by system organ class and frequency.

Rare

The titration period may be adjusted, if any significant adverse reaction occurs.

The titration period may be adjusted, if any significant adverse reaction occurs.

The titration period may be adjusted if any significant adverse reaction occurs.

53 Undesirable effects in clinical studies in adult patients Infections and infestations

Adverse reactions are listed below, by system organ class and frequency.

No case of neurological AE was reported after introduction of STAMARIL.

Adverse reactions with at least 2 difference over placebo are marked in italics.

Adverse reactions with at least 2 difference over placebo are in italics.

Undesirable effects in clinical studies in paediatric patients Infections and infestations

33 Undesirable effects in clinical studies in adult patients Infections and infestations

Undesirable effects in clinical studies in paediatric patients Infections and infestations

Relevant adverse reactions obtained from post marketing surveillance have been tabulated in Table 2.

The following undesirable effects were commonly ( 1 100, 1 10) reported in clinical trials erythema, tenderness, swelling over the implant site, and heterotopic ossification myositis ossificans.

Rarely severe adverse reactions have been reported in preterm and full term newborns.

Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.

Non haematological adverse reactions are generally mild to moderate in severity.

Additional reactions include nausea, urticaria, vomiting, fatigue, dyspnoea, headache, pruritus, diarrhoea and bronchospasm.

3 Cognitive and neuropsychiatric adverse reactions, particularly confusion, are common in patients treated with ziconotide.

Cognitive and neuropsychiatric adverse reactions, particularly confusion, are common in patients treated with ziconotide.

Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.

The product was administered at 10 times the recommended dose, and no undesirable effects were observed.

Clinical response and undesirable effects may also be used as guidance for dose titration.