Примери за използване на Each indication на Английски и техните преводи на Български
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Different dosing schedules exist for each indication.
For each indication, the posology is presented as starting dose, titration schedule, maintenance dose and maximum dose.
Efficacy and safety have to be justified in each indication.
Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied.
The justification should be provided separately for each indication applied for.
Metrics on each indication(i.e. the number of patients who have been diagnosed with either IGHD, TS and small for gestational age and with whom iGRO has been used).
This section contains general parts as well as separate sub-sections for each indication.
The recommended infusion duration for patients with each indication is described below under the respective indication. .
Based on the submitted data the CHMP agreed on the dosing recommendations for each indication.
As the dosage for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions, the dosage in children is not considered to be different to that of adults.
Efficacy results of the largest studies in each indication are summarised below.
The application frequency andduration of treatment with imiquimod cream is different for each indication.
While this information may suggestan increase in dose, doses of etoricoxib greater than those listed for each indication have not been studied in combination with rifampicin and are therefore not recommended(see section 4.2).
Table 12 below shows the edoxaban anti-Factor Xa activity by CrCL category for each indication.
The posology in children and adolescents(2- 18 years)is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
Table 3 below shows the predictedsteady state exposure and anti-Factor Xa activity for each indication.
The posology in children and adolescents(0-18 years)is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned condition.
Anti-FXa activity by CrCL category Table 12 below shows the edoxaban anti-Factor Xa activity by CrCL category for each indication.
The posology in children and adolescents(0-18 years)is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome in replacement therapy indications. .
Overall, the CHMP harmonised this section,providing particular attention to the available information on resistance to ciprofloxacin for each indication.
Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to tedizolid in vitro.
The table below displays the adverse reactions reported in patients with soft tissue sarcoma andovarian cancer that were treated with Yondelis recommended regimen in each indication.
Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to ceftaroline in vitro.
SPC Section 4.1 Therapeutic Indications Overall, the CHMP harmonised this section,providing particular attention to the available information on resistance to ciprofloxacin for each indication.
Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to Zerbaxa in vitro.
If the mode of action of the active substance is complex and involves multiple receptors or binding sites(as is often the case with monoclonal antibodies), it may be difficult to establish the contribution of each receptor orbinding site to each indication.
As regards the posology, section 4.2 of the SmPC, the initial andmaximum doses were clarified and listed for each indication, for all patient populations- adult, elderly and paediatric.
The data referred to by the MAH is not considered sufficient to address what a potential difference in exposure,compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted bibliography, could mean for efficacy and safety for each indication.
The posology in children and adolescents(0-18 years)is not different from that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
Therefore the CHMP considered the provided clinical data to be very limited and not strong enough to address what a potential difference in exposure,compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted bibliography, could mean for efficacy and safety for each indication.