Examples of using Class effect in English and their translations into Bulgarian
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Computer
Class effect.
It is unknown whether this constitutes a class effect.
Class effects.
Not known** Osteonecrosis of the jaw(see sections 4.4 and 4.8 Class effects).
Class effects Renal impairment.
These changes are known from other VEGFR-2 inhibitors andcan be considered class effects.
Impaired wound healing is a class effect of rapamycin derivatives, including Votubia.
Extrapyramidal symptoms(including acute dystonia)are known class effects for antipsychotics.
The potential for hepatotoxicity is a class effect of azole antifungals and has been long reported for ketoconazole in numerous nonclinical and clinical references.
Non-lethal thyroid C-cell tumours observed in rodents are a class effect for GLP-1 receptor agonists.
The risk of malignancy, particularly lymphoproliferative disorders,is increased with use of some other agents that affect the immune system(class effect).
Non-infectious pneumonitis is a class effect of rapamycin derivatives, including everolimus.
Hence, it is currently not possible to establish whether the increased amputation risk is a class effect or not.
The safety profile is characterised by anticholinergic and β2-adrenergic class effects related to the individual components of the combination.
Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsades de pointes have been reported with theuse of neuroleptics and are considered class effects.
Overall, although hepatotoxicity is a class effect of azoles, the quantitative and qualitative aspects of the hepatotoxicity of ketoconazole are of particular concern.
All the other formulations only state in section 4.8 that dystonia is a class effect of this medication.
Additional class effects that may be observed following administration of fentanyl include dysphoria and urinary retention, therefore appropriate precautionary measures should be in place.
Adverse reactions associated with pancreas powder obtained from clinical studies,post-marketing surveillance and some additional class effects are tabulated below.
Due to heterogeneity across products,there is considerable uncertainty in extrapolating the findings of studies that have evaluated only class effects to individual products; and particularly to products(including more recently authorised products) which are not included in such studies.
In April 2010, the PhVWP noted that further data from both the published literature andpostmarketing reports were now available that suggested that atypical stress fractures of the femur may be a class effect.
Due to the heterogeneity across products,there is considerable uncertainty in extrapolating the findings of studies evaluating only class effects to individual products; and particularly to the products that are not included in such studies.
Furthermore, the PRAC considered that a class effect could not be excluded, as all SGLT2 inhibitors share the same mechanism of action, as the potential mechanism leading to an increased amputation risk is not known, and as an underlying cause specific to canagliflozin containing medicines only cannot be identified at the moment.
This resulted in exaggerated pharmacological effects considered related to the compound's inhibition of skeletal calcium mobilisation,resulting in periparturient hypocalcaemia, a bisphosphonate class effect, dystocia and early termination of the study.
Based on a number of angioedema cases reported in relation to carfilzomib monotherapy or combination therapy, 5 of which with positive dechallenge, andthe plausible mechanism considering possible class effect(bortezomib has angioedema included in section 4.8 of SmPC), as well as presented cases which suggest causal role of carfilzomib, the PRAC considers that the product information(PI) should be updated to include this adverse reaction.
The proposal of the applicant/ MAH to include five pharmacovigilance safety concerns in the Risk Management Plan is endorsed(two relate specifically to the unique Vantas formulation while the other three are classified as class effects: expulsions, cellulitis, flare, osteoporosis and QT prolongation).
Further to the PhVWP discussions and the emerging data from published literature andpost-marketing reports that suggest that atypical stress fractures may be a class effect of bisphosphonates, the UK asked the CHMP in September 2010, to provide an opinion under Article 31 of directive 2001/83 EEC, as amended on whether the Marketing Authorisations for medicinal products containing bisphosphonates should be maintained, varied, suspended or withdrawn.
Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, ordehydration in the post infusion period(see sections 4.4 and 4.8 Class effects).
The PRAC considered that the overall available data strongly suggests that the concerns identified with regard to safety andthe lack of efficacy are a class effect and therefore considered that the conclusions of the review apply to all the active substances involved in the procedure.
The PRAC was of the opinion that the concerns identified with regard to safety andthe lack of additional efficacy of dual RAS blockade therapy are a class effect and that the conclusions of the review therefore apply to all the active substances involved in this procedure;