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a = spacer tape (0,25 mm);
a = tejp ta' l-ispejser (0,25mm):
Last Update: 2014-11-21
Usage Frequency: 2
Quality:
height of spacer device for positioning of dummy
l-għoli tal-apparat tal-ispazjatur għall-ippożizzjonar tal-manikin
Last Update: 2014-11-21
Usage Frequency: 2
Quality:
11*tubular spacer*steel*40 by 40 by 2 by 50 mm*
11 spazjatur forma ta’ tubu azzar 40 x 40 x 2 x50 mm
Last Update: 2014-11-21
Usage Frequency: 3
Quality:
the chmp requested the applicant to provide data from a pk study with concomitant use of a spacer.
is- chmp talab lill- applikant biex jipprovdi dejta minn studju farmakokinetiku bl- użu konkomittanti ta ’ spejser.
Last Update: 2012-04-10
Usage Frequency: 2
Quality:
the pooling method used and the addition of the spacer is likely to mask differences in quality between the two products.
il- metodu ta ’ raggruppament użat u ż- żieda tal- ispejser x’ aktarx jgħatti d- differenzi fil- kwalità bejn iż- żewġ prodotti.
Last Update: 2012-04-10
Usage Frequency: 2
Quality:
examine the syringe and needle to ascertain that the implant has not remained within the syringe or needle, and that the spacer is visible.
eżamina s-siringa u l-labra biex tassigura li l-impjant ma baqax fis-siringa jew fil- labra, u li l-ispejser jidher.
Last Update: 2017-04-26
Usage Frequency: 6
Quality:
question 4 - raw data of the comparison with spacer have not been provided and neither the raw data nor results in humid conditions have been provided and discussed.
mistoqsija 4 - dejta mhux ipproċessata tat- tqabbil bi spejser ma ġietx provduta u la d- dejta mhux ipproċessata u lanqas ir- riżultati f’ kundizzjonijiet umdi ma ġew ipprovduti jew diskussi.
Last Update: 2012-04-10
Usage Frequency: 2
Quality:
spacer bars of adequate size shall be fitted to all walls, roofs and bases of containers to ensure that there is a free flow of air to the animals in the event of stacking or close storing of cargo.
vireġ spazjati ta’ daqs adekwat għandhom ikunu mwaħħla mal-ħitan kollha, is-soqfa u l-bażi tal-kontenituri biex ikun assigurat li jkun hemm kurrent ħieles ta’ l-arja għall-annimali fil-każ ta’ tagħbija fuq xulxin jew ħażna viċina tal-merkanzija.
the chmp noted the additional data but remained of the opinion that the pooling method masked the differences between the test products and that in addition, the used spacer decreased the amount of the larger particles and increased the amount of fine particles.
is- chmp innota d- dejta addizzjonali iżda baqa ’ tal- opinjoni li l- metodu raggruppat għatta d- differenzi bejn il- prodotti tat- test u li barra minn hekk, l- ispejser użat naqqas l - ammont ta ’ partiċelli ikbar u żied l- ammont ta ’ partiċelli fini.
although the claim of the applicant that the pk bioequivalence study demonstrated equivalence without spacer was endorsed, the chmp did not support the assumption that the data with the use of a spacer would provide the same evidence of equivalence and therefore considered that a pk study with a spacer is mandatory.
għalkemm il- klejm tal- applikant li l - ekwivalenza tal- istudju tal- bijoekwivalenza tal- farmakokinetika ntweriet mingħajr l- ispejser ġiet approvata, is- chmp ma appoġġjax is- suppożizzjoni li d- dejta bl- użu ta ’ spejser tipprovdi l- istess evidenza ta ’ ekwivalenza u għaldaqstant li studju farmakokinetiku bi spejser huwa obbligatorju.
the fine particle dose ratio was 1.01 and the corresponding confidence interval was 0.97 – 1.04 and the data therefore clearly demonstrate that the expected spacer effect is identical for test and reference product.
il- proporzjon ta ’ doża ta ’ partiċelli fini kien 1. 01 u l- intervall ta ’ kunfidenza korrispondenti kien 0. 97 – 1. 04 u għaldaqstant, id - dejta turi b’ mod ċar li l- effett mistenni tal- spejser huwa identiku għall- prodott tat- test u tar- referenza.
the pharmacokinetic bioequivalence data also confirmed that sabumalin and the reference product possess the same systemic safety profile since bioequivalence in systemic levels (auc and cmax) have been shown, when used with or without a spacer.
id- dejta ta ’ bijoekwivalenza farmakokinetika kkonfermat ukoll li salbumalin u l- prodott ta ’ referenza għandhom l- istess profil ta ’ sigurtà sistemika minħabba li ntweriet il- bijoekwivalenza f’ livelli sistemiċi (auc u cmax), meta użati bi jew mingħajr spejser.
the chain tensioner which enables the neck to be adjusted consists of a polyamide block (10) , a tubular spacer (11) and a tensioning component (12 and 13).
il-mezz tat-tensjoni f’katina li jippremetti li l-għonq jiġi aġġustat jikkonsisti minn blokk tal-polyamide (10), spazjatur forma ta’ tubu (11) u komponent tat-tensjoni (12 u 13).