Usted buscó: sabumalin (Inglés - Maltés)

sabumalin
suspensión para inhalación en envase a presción efg

what is sabumalin?
x’ inhu sabumalin?

why was sabumalin reviewed?
għaliex ġie rivedut sabumalin?

sabumalin is a ‘ generic medicine’.
sabumalin huwa ‘ mediċina ġenerika ’.

sabumalin is a medicine in a pressurised inhaler that contains salbutamol as active substance.
sabumalin huwa mediċina f’ inalatur taħt pressjoni li fih salbutamol bħala sustanza attiva.

overall summary of the scientific evaluation of sabumalin and associated names (see annex i)
sommarju Ġenerali tal- evalwazzjoni xjentifika ta ’ sabumalin u ismijiet assoĊjati (ara l- anness i)

hexal ag submitted sabumalin to the swedish medicines regulatory agency for a decentralised procedure on 5 december 2006.
hexal ag issottomettiet sabumalin lill- aġenzija regolatorja tal- mediċini Żvediża għal proċedura deċentralizzata fil- 5 ta ’ diċembru 2006.

questions and answers on the referral for sabumalin salbutamol, metered dose aerosol inhaler, 100 μ g/ dose
mistoqsija u tweġiba dwar ir- referenza għal sabumalin salbutamol, inalatur ajrosol b’ doża mkejla, 100 μg/ doża

when given by inhalation as in sabumalin, salbutamol directly activates the beta2-receptors in the respiratory system.
meta mogħti b’ inalazzjoni bħal f’ sabumalin, salbutamol jattiva direttament ir- riċetturi- beta2 fis- sistema respiratorja.

sabumalin is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (copd).
sabumalin jintuża biex jittratta d- diffikultajiet fit- teħid tan- nifs ikkawżati mill- ażżma u minn mard pulmonari ostruttiv kroniku (copd).

sabumalin is a metered dose aerosol inhaler containing a suspension formulation of salbutamol sulphate 100 µg/ spray, with hfa 134a as propellant.
sabumalin huwa inalatur aerosol ta ’ doża mkejla li fih formulazzjoni ta ’ sospensjoni ta ’ salbutamol sulfat 100 µg/ sprej, b’ hfa 134a bħala propellent.

the european medicines agency (emea) has completed a referral procedure following a disagreement among member states of the european union regarding the authorisation of the medicine sabumalin.
l- aġenzija ewropea dwar il- mediċini (emea) temmet proċedura ta ’ referenza wara nuqqas ta ’ qbil fost l- istati membri tal- unjoni ewropea fir- rigward tal- awtorizzazzjoni tal- mediċina sabumalin.

this means that sabumalin is similar to a ‘ reference medicine’ already authorised in the european union (eu) called sultanol inhaler.
dan ifisser li sabumalin huwa simili għal ‘ mediċina ta ’ referenza ’ li hija diġà awtorizzata fl- unjoni ewropea (ue) imsejħa sultanol inalatur.

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 chmp has recommended the granting of the marketing authorisations for which the valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the coordination group procedure are set out in annex iii for sabumalin and associated names (see annex i).
is- chmp irrakkomanda l- għoti ta ’ awtorizzazzjonijiet għat- tqegħid fis- suq li s- sommarju tal - karatteristiċi tal- prodott, tikketta u fuljett ta ’ tagħrif għalihom validi huma l- verżjonijiet finali miksubin waqt il- proċedura tal- grupp ta ’ koordinament kif stabbiliti fl- anness iii għal sabumalin u ismijiet assoċjati (ara l- anness i).