Examples of using Safety data in English and their translations into Finnish
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Medicine
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Colloquial
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Official
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Financial
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Ecclesiastic
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Official/political
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Computer
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Programming
Efficacy and safety data in the age group 2 months to<
Given the limited long- term safety data available and the uncertainties around the potential risk for carcinogenicity,
In this context the clinical trial safety data demonstrate that ropinirole has an acceptable tolerability
Should non-clinical product-specific safety data be submitted for this product, in line with point 5.3 the Core SPC for human Immunoglobulin for IV administration?
The possibility that Gadograf may cause torsade de pointes arrhythmias in an individual patient cannot be excluded see section 5.3 Preclinical safety data.
Wider provision of safety data sheets(SDS) for all dangerous preparations, giving detailed information for professional users on the chemical composition of preparations, their hazardous properties
No clinically significant differences were seen when the safety data were analysed by age,
However, safety data are limited and do not allow a meaningful comparison between adult and paediatric patients to
section 5.3(Preclinical safety data) have been corrected
Therefore, the CHMP agreed that the safety data did not show any evidence that the safety profile of ciprofloxacin is affected by a longer treatment duration up to 3 months.
However, a paediatric retrospective cohort study collected safety data with Rebif from medical records in children(n=52)
Support the adoption of universally recognised Chemicals Abstract Service registry numbers and Material Safety Data Sheets for nanomaterials.
In animal studies, reproductive toxicity has been observed with the nomegestrol acetate/ estradiol combination see preclinical safety data in section 5.3.
The CHMP also considers that the safety data do not show any evidence that the safety profile of ciprofloxacin is affected by a longer treatment duration up to 3 months.
The exposure to the metabolite doripenem-M-1 in patients on continuous renal replacement therapy may be increased to levels where no in vivo safety data are presently available.
Studies in pregnant rabbits have shown effects on reproduction at maternally toxic doses see section 5.3“ Preclinical safety data”.
labelling and safety data sheets SDS.
Divergent action by the Member States would prevent the full sharing of safety data and would increase the administrative burden on competent authorities and industry.
serious side effects are uncommon, but further long-term safety data are to be collected.
postnatal development see section 5.3 Preclinical safety data.