Примери за използване на Paediatric populations на Английски и техните преводи на Български
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Paediatric populations.
Available data in paediatric populations.
The CHMP agreed with the following wording proposed by the MAH for the elderly and paediatric populations.
Data in paediatric populations.
The following phrase was recommended regarding the paediatric populations.
Studies in paediatric populations have not been performed.
Efficacy has not been established in the paediatric populations studied(see below).
Use in children and adolescents under 18 years of age No clinical trials have been conducted with duloxetine in paediatric populations.
Efficacy has not been established in the paediatric populations studied(see below).
Table 1 Undesirable effects in prophylactic clinical studies with premature and bronchopulmonary dysplasia paediatric populations.
Information about the pharmacokinetics of somatropin in elderly and paediatric populations, in different races or genders and in patients with renal or hepatic impairment is incomplete.
Pharmacokinetic properties are similar in CAPS, TRAPS, HIDS/MKD, FMF and SJIA paediatric populations.
Information about the pharmacokinetics of somatropin in elderly and paediatric populations, in different races or genders and in patients with renal or hepatic impairment is incomplete.
Off-label use- The CHMP considers that Qsiva is expected to have a high probability of off-label use, particularly in patients with some nutritional disorders(e.g. bulimia, Binge Eating Disorder)as well as in psychiatric patients, paediatric populations, adults with high CV risk, and elderly patients.
Having reviewed the appropriateness of the formulations andpharmaceutical forms for use in the authorised paediatric populations up to 5 years of age, the CHMP considered that acceptability studies in children below the age of 5 years should be performed for Respivax, Buccalin, Ismigen, Polyvaccinum suspension for injection.
Recommendations for dose modifications of Pegasys for toxicities in the CHB and CHC paediatric populations are presented in Table 6.
While acknowledging that uncertainties remain regarding the identification of particular paediatric populations at higher risk and the impact of age on codeine metabolism, the PRAC was of the opinion that neonates, toddlers and young children may be more vulnerable to opioid toxicity and therefore at special risk of life-threatening respiratory depression.
The European medicines Agency has deferred the obligation to submit the results of studies with Foclivia in one or more subsets of the paediatric populations in active immunisation against H5N1 subtype of Influenza A virus.
In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.
The European Medicines Agency has deferred the obligation to submit the results of studies with Viekirax in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C(see section 4.2 for information on paediatric use).
In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.
The European medicines Agency has deferred the obligation to submit the results of studies with Foclivia in one or more subsets of the paediatric populations in active immunisation against H5N1 subtype of Influenza A virus. See section 4.2 for information on paediatric use.
In prophylactic studies in premature and bronchopulmonary dysplasia paediatric populations, the mean half-life of palivizumab was 20 days and monthly intramuscular doses of 15 mg/ kg achieved mean 30 day trough serum active substance concentrations of approximately 40 μ g/ ml after the first injection, approximately 60 μ g/ ml after the second injection, approximately 70 μ g/ ml after the third injection and fourth injection.
The European Medicines Agency has deferred the obligation to submit the results of studies with ZINPLAVA in one or more subsets of the paediatric populations for the prevention of recurrence of Clostridium difficile infection(see section 4.2 for information on paediatric use).
No medically important differences were observed during the prophylactic studies carried out in the premature andbronchopulmonary dysplasia paediatric populations in ADRs by body system or when evaluated in subgroups of children by clinical category, gender, age, gestational age, country, race/ ethnicity or quartile serum palivizumab concentration.
In the paediatric population.
Paediatric population(DVT/PE).
The paediatric population was not sized to test for non-inferiority.
Paediatric population(under 2 years of age).
Other paediatric population.