FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee considered that harmonising the withdrawal periods of 49 of the products concerned within the scope of this referral procedure to a withdrawal period of 42 days for meat and offal from sheep, would be a conservative approach to ensure consumer safety (i.e., that residues from the injection site would be below the established MRL for tylosin meat (100 µg/kg)), as a withdrawal period of 42 days would accommodate for a decrease in release rate of more than 250% and ensure consumer safety if the injection volume was to be restricted to 2.5 ml per injection site.
Maltese: Il-Kumitat ikkunsidra li l-armonizzazzjoni talperjodi ta' tiżmim ta' 49 mill-prodotti kkonċernati fil-kamp ta' applikazzjoni ta' din il-proċedura ta' referenza għal perjodu ta' tiżmim ta' 42 jum għal-laħam u l-ġewwieni tan-nagħaġ, tkun approċċ konservattiv biex tiġi żgurata s-sigurtà tal-konsumatur (jiġifieri, li r-residwi mis-sit tal-injezzjoni jkunu inqas mill-MRL stabbilit għal-laħam tat-tilosina (100 µg/kg)), billi perjodu ta' tiżmim ta' 42 jum jakkomoda għal tnaqqis fir-rata ta' rilaxx ta' aktar minn 250 % u jiżgura s-sigurtà tal-konsumatur jekk il-volum tal-injezzjoni kellu jiġi ristrett għal 2.5 ml għal kull sit tal-injezzjoni.
English: The formulation of 49 of the concerned products is very similar.
Maltese: Il-formulazzjoni ta' 49 mill-prodotti kkonċernati hija simili ħafna.
English: Indeed, published data has shown that the rate of absorption from the injection site is inversely proportional to the viscosity of the product, i.e. the higher the viscosity, the slower the rate of absorption (Kakemi et al.,19723).
Maltese: Fil-fatt, data ppubblikata wriet li r-rata ta' assorbiment mis-sit tal-injezzjoni hija proporzjonali b'mod invers għall-viskożità tal-prodott, jiġifieri aktar ma tkun għolja l-viskożità, aktar tkun bil-mod ir-rata ta' assorbiment (Kakemi et al.,19723).
English: Macrolides are categorised as critically important antimicrobials both in human and veterinary medicine, however tylosin is not used in human medicine.
Maltese: Il-makrolidi huma kkategorizzati bħala antimikrobiċi kritikament importanti kemm fil-mediċina tal-bniedem kif ukoll f'dik veterinarja, madankollu t-tilosina ma tintużax fil-mediċina tal-bniedem.
English: Tylozyna Biovet JSC Tylosin base
Maltese: Tylozyna Biovet JSC Bażi tattilosina
English: However, to address certain deficiencies in the data set, an additional safety factor of 30% was considered necessary resulting in a withdrawal period of 28 days.
Maltese: Madankollu, sabiex jiġu indirizzati ċerti nuqqasijiet fis-sett ta' data, ġie kkunsidrat li hemm bżonn ta' fattur ta' sigurtà addizzjonali ta' 30 %, u dan irriżulta f'perjodu ta' tiżmim ta' 28 jum.
English: For one product (Tilocen), the solvent polyethylene glycol 400 was used instead of propylene glycol.
Maltese: Għal prodott wieħed (Tilocen), intuża s-solvent polietilenglikol 400 minflok il-glikol propileniku.
English: Although a number of shortcoming were identified from this study (more specifically that the number of treated animals (n=3) was below the number required in VICH GL 48, animals were very young (12 kg mean bw), and also the sampling of the injection site did not include an outer ring sample), the results showed that the injection site is the withdrawal period determining tissue and results from this residue study have been used for establishing the withdrawal periods for 49 out of the 50 products concerned.
Maltese: Għalkemm ġew identifikati għadd ta' nuqqasijiet minn dan l-istudju (b'mod aktar speċifiku li lgħadd ta' annimali kkurati (n=3) kien inqas min-numru meħtieġ f'VICH GL 48, l-annimali kienu żgħar ħafna (medja ta' 12 kg bw), u anke l-kampjunar tas-sit tal-injezzjoni ma kienx jinkludi kampjun taċċrieki ta' barra), ir-riżultati wrew li s-sit tal-injezzjoni huwa l-perjodu ta' tiżmim li jiddetermina t-tessut u r-riżultati minn dan l-istudju dwar ir-residwi ntużaw biex jiġu stabbiliti perjodi ta' tiżmim għal 49 mill50 prodott ikkonċernat.
English: • on the basis of the available data, the CVMP considered the withdrawal periods for meat and offal, and milk derived from treated sheep should be amended to provide assurance for consumer safety for all concerned veterinary medicinal products, as referred in Annex I, except for Tilocen (marketing authorisation holder: A. Nikolakopoulos S.A);
Maltese: • Abbażi tad-data disponibbli, is-CVMP ikkunsidra l-perjodi ta' tiżmim għal-laħam u l-ġewwieni, u ħalib derivati minn nagħaġ ikkurati għandhom jiġu emendati biex jipprovdi assigurazzjoni għassigurtà tal-konsumatur għall-prodotti mediċinali veterinarji kollha kkonċernati, kif imsemmi flAnness I, ħlief għal Tilocen (detentur tal-awtorizzazzjoni għat-tqegħid fis-suq: A.
English: The remaining product contains polyethylene glycol 400 instead of propylene glycol.
Maltese: Il-prodott li jifdal fih polietilenglikol 400 minflok glikol propileniku.
English: Having considered the grounds for referral and the data available, the CVMP concluded that for 49 out of 50 products, these being all those containing benzyl alcohol and propylene glycol as excipients, the withdrawal periods for meat and offal derived from treated sheep should be amended to 42 days, and the withdrawal periods for milk derived from treated sheep should be amended to 108 hours to provide assurance for consumer safety.
Maltese: Wara li kkunsidra r-raġunijiet għar-referenza u d-data disponibbli, is-CVMP ikkonkluda li għal 49 minn 50 prodott, dawn huma dawk kollha li fihom l-alkoħol benżiliku u l-glikolpropileniku bħala eċċipjenti, ilperjodi ta' tiżmim għal-laħam u l-ġewwieni derivati minn nagħaġ ikkurati għandhom jiġu emendati għal 42 jum, u l-perjodi ta' tiżmim għall-ħalib derivat minn nagħaġ ikkurati għandhom jiġu emendati għal 108 sigħat biex jipprovdu assigurazzjoni għas-sigurtà tal-konsumatur.
English: It has been noted that there are different approved withdrawal periods for sheep (milk, meat and offal) for veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep across the EU, e.g. sheep meat and offal from 8 days to 42 days; sheep milk from 4 days to 7 days.
Maltese: Ġie nnutat li hemm perjodi ta' tiżmim approvati differenti għan-nagħaġ (ħalib, laħam u ġewwieni) għal prodotti mediċinali veterinarji li fihom it-tilosina ppreżentati bħala soluzzjoni għall-injezzjoni li għandha tingħata lin-nagħaġ fl-UE kollha, eż. laħam u ġewwieni tan-nagħaġ minn 8 ijiem sa 42 jum; ħalib tan
English: Milk samples were analysed using a high-performance liquid chromatography method with solid phase extraction.
Maltese: Il-kampjuni tal-ħalib ġew analizzati permezz ta' metodu tal-kromatografija likwida bi prestazzjoni għolja b'fażi ta' estrazzjoni solida.
English: Hence, an option to overcome the lack of data in adult sheep would be to limit the injection volume, to the volume used in the residue study available with Tylosin/Anafasis (of 0.6 ml).
Maltese: Għalhekk, għażla biex jingħeleb in-nuqqas ta' data f'nagħaġ adulti tkun li jiġi limitat il-volum tal-injezzjoni, għall-volum użat fl-istudju dwar ir-residwi disponibbli b'Tylosin/Anafasis (ta' 0.6 ml).
English: This study was conducted with the product Tylosin/Anafasis, containing benzyl alcohol and propylene glycol as excipients.
Maltese: Dan l-istudju sar bil-prodott Tylosin/Anafasis, li fih l-alkoħol benżiliku u l-glikol propileniku bħala eċċipjenti.
English: In this study, however, additional shortcomings were identified, these being that the number of treated animals (n=3) was below the number required in VICH GL 484, animals were very young (12 kg mean bw), and also the sampling of the injection site did not include an outer ring sample.
Maltese: F'dan l-istudju, madankollu, ġew identifikati nuqqasijiet addizzjonali, u dawn kienu li l-għadd ta' annimali kkurati (n=3) kien taħt in-numru meħtieġ f'VICH GL 484, l-annimali kienu żgħar ħafna (12 kg bw medju), u anke t-teħid ta' kampjuni tas-sit tal-injezzjoni ma kienx jinkludi kampjun taċċrieki ta' barra.
English: • no suitable residue depletion study was made available the results from which could be extrapolated to the concerned product Tilocen (marketing authorisation holder: A. Nikolakopoulos S.A) containing tylosin presented as solution for injection for use in the target species sheep, and containing polyethylene glycol 400 as excipient.
Maltese: Minħabba li l-viskożitajiet tal-glikol propileniku u l-polietilenglikol 400 huma differenti, ma jistax jiġi eskluż impatt sinifikanti fuq l-assorbiment u t-tnaqqis tar-residwi mis-sit tal-injezzjonijiet, u konsegwentement fuq il-perjodi ta' tiżmim.
English: For the product Tilocen (marketing authorisation holder: A. Nikolakopoulos S.A) containing tylosin presented as solution for injection for use in target species sheep, and containing polyethylene glycol 400, there was no data available that could be used to determine adequate withdrawal periods that could assure that after 42 days after treatment, the residues are below the established MRLs for tylosin in sheep.
Maltese: Minħabba li l-viskożitajiet tal-glikol propileniku u l-polietilenglikol 400 huma differenti, ma jistax jiġi eskluż impatt sinifikanti fuq lassorbiment u t-tnaqqis tar-residwi, u konsegwentement fuq il-perjodi ta' tiżmim meħtieġa għal soluzzjonijiet tat-tilosina għall-injezzjonijiet b'dawn l-eċċipjenti differenti.
English: From the residue data available, the treatment of a 50 kg sheep would require an injection volume of 2.5 ml.
Maltese: Mid-data disponibbli dwar ir-residwi, il-kura ta' nagħaġ ta' 50 kg tkun teħtieġ volum tal-injezzjoni ta' 2.5 ml.
English: Therefore the Committee used the ‘alternative' method for determining the withdrawal period, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)5.
Maltese: Għalhekk il-Kumitat uża l-metodu “alternattiv” biex jiġi ddeterminat il-perjodu ta' tiżmim, f'konformità man-nota tas-CVMP għal gwida dwar l-approċċ lejn l-armonizzazzjoni tal-perjodi ta' tiżmim (EMEA/CVMP/036/95)5.
English: After analysis of the residue data for the injection site using the recommended EMA statistical software (WT 1.4), it was concluded that not all the statistical requirements (i.e., F-test) were met.
Maltese: Wara analiżi tad-data dwar ir-residwi għas-sit tal-injezzjoni permezz tas-softwer statistiku rakkomandat tal-EMA (WT 1.4), ġie konkluż li mhux ir-rekwiżiti statistiċi kollha (jiġifieri, it-test F) ġew issodisfati.
English: Therefore, the Committee considers that the benefit-risk balance for the veterinary medicinal product Tilocen (marketing authorisation holder: A. Nikolakopoulos S.A) containing tylosin presented as solution for injection for use in target species sheep, and containing polyethylene glycol 400 is not favourable in the absence of adequate residue depletion data in sheep to justify a withdrawal period of 42 days for sheep meat and offal, and 108 hours for sheep milk.
Maltese: Nikolakopoulos S.A) li fih ittilosina ppreżentata bħala soluzzjoni għall-injezzjoni għall-użu fl-ispeċi fil-mira n-nagħaġ, u li fih lpolietilenglikol 400 mhuwiex favorevoli fin-nuqqas ta' data adegwata dwar it-tnaqqis tar-residwi finnagħaġ biex jiġi ġġustifikat perjodu ta' tiżmim ta' 42 jum għal-laħam u l-ġewwieni tan-nagħaġ, u 108 sigħat għall-ħalib tan-nagħaġ.
English: PHARMASIN 200 mg/ml soluzione iniettabile per
Maltese: TILJET 200 mg/ml SOLUCION INYECTABLE
English: Tylosin and its phosphate and tartrate salts are used in veterinary medicines for the treatment of conditions caused by sensitive organisms.
Maltese: It-tilosina u l-imluħa fosfati u tartratiċi tiegħu jintużaw f'mediċini veterinarji għall-kura ta' kundizzjonijiet ikkawżati minn organiżmi sensittivi.
English: However, as the injection site is the withdrawal period determining tissue, for the product containing polyethylene glycol 400 (Tilocen, marketing authorisation holder: A. Nikolakopoulos S.A), and in view of the effect of this excipient on product viscosity, a different rate of absorption of residues from the injection site cannot be ruled out.
Maltese: Madankollu, ġie rrappurtat li r-rata ta' assorbiment mis-sit tal-injezzjoni tiddependi minn numru ta' fatturi (eż. volum tal-injezzjoni, eċċipjenti, lipofiliċità tas-sustanza attiva), u mingħajr data speċifika dwar irresidwi, huwa diffiċli li tiġi kkwantifikata l-influwenza taż-żieda fil-volum tal-injezzjoni/tas-sit talinjezzjoni fuq ir-rata ta' assorbiment.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration, applicants and marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali veterinarji, speċi ta' annimali, mnejn jingħata, lapplikanti u d-detenturi tal-awtorizzazzjoni għat-tqegħid fissuq fl-Istati Membri
English: For these 49 products, excipients listed are benzyl alcohol and propylene glycol (in concentrations that differ slightly between products), as well as small concentrations of different pH adjustors.
Maltese: Għal dawn id-49 prodott, l-eċċipjenti elenkati huma alkoħol benżiliku u glikol propileniku (f'konċentrazzjonijiet li huma kemxejn differenti bejn il-prodotti), kif ukoll konċentrazzjonijiet żgħar ta' regolaturi differenti tal-pH.
English: For these 49 products, excipients listed are benzyl alcohol and propylene glycol, as well as small concentrations of different pH adjustors.
Maltese: Għal dawn id-49 prodott, l-eċċipjenti elenkati huma l-alkoħol benżiliku u l-glikol propileniku, kif ukoll konċentrazzjonijiet żgħar ta' regolaturi differenti tal-pH.
English: Ref. EMA/CHMP/393579/2009 rev1 EMEA/H/A-29/1168
Maltese: EMA/CHMP/393579/2009 rev1 EMEA/H/A-29/1168
English: Dr. Concha Prieto Yerro (Spain)
Maltese: Dr. Concha Prieto Yerro (Spanja)
English: 29 May 2009
Maltese: 29 ta' Mejju 2008
English: Dr. Karl Broich (Germany)
Maltese: Dr. Karl Broich (Ġermanja)
English: London, 6 October 2009 Doc.
Maltese: Londra, 6 ta' Ottubru 2009 Dok. ta' Ref.
English: Fentrix is a ‘generic medicine'.
Maltese: Fentrix huwa ‘mediċina ġenerika'.
English: The review was carried out under an ‘Article 29' referral 1 .
Maltese: Ir-reviżjoni twettqet skont referenza tal-‘Artikolu 29' 1 .
English: • that Fentrix did not show a comparable local skin tolerability to the reference medicine, Durogesic;
Maltese: • Fentrix ma weriex tollerabbiltà tal-ġilda lokali komparabbli mal-mediċina ta' referenza, Durogesic;
English: What is Fentrix?
Maltese: X'inhu Fentrix?
English: Questions and answers on the referral for Fentrix and associated names 25, 50, 70 and 100 microgram/hour fentanyl transdermal patch
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Fentrix u ismijiet assoċjati roqgħa transdermali ta' fentanyl ta' 25, 50, 70 u 100 mikrogramma/siegħa
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Italy, the Netherlands, Portugal, Slovenia and Spain).
Maltese: Din hija proċedura meta Stat Membru (l-‘Istat Membru ta' referenza', f'dan il-każ ilĠermanja) jevalwa mediċina bil-għan li tingħata awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-‘Istati Membri konċernati', f'dan il-każ l-Awstrija, ilBelġju, l-Italja, l-Olanda, il-Portugall, is-Slovenja u Spanja).
English: 25 June 2009
Maltese: 6 ta' Ġunju 2009
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Maltese: L-Artikolu 29 tad-Direttiva 2001/83/KE kif emendat, referenza fuq il-bażi ta' riskju potenzjali serju għas-saħħa pubblika.
English: Helm Pharmaceuticals GmbH submitted Fentrix transdermal patch to Germany for a decentralised procedure.
Maltese: GmbH issottomettiet Fentrix roqgħa transdermali lill-Ġermanja għal proċedura deċentralizzata.
English: • the non-clinical local irritation and how sensitive the skin was to Fentrix were not investigated in accordance with current CHMP guidelines.
Maltese: • l-irritazzjoni lokali mhux klinika, u kemm il-ġilda kienet sensittiva għal Fentrix ma ġewx investigati skont il-linji gwida attwali tas-CHMP.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Fentrix outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU, Austria, Belgium, Italy, the Netherlands, Portugal, Slovenia and Spain.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-benefiċċji ta' Fentrix jisbqu r-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fil-Ġermanja u fl-Istati Membri tal-UE li ġejjin, l-Awstrija, il-Belġju, l-Italja, lOlanda, il-Portugall, is-Slovenja u Spanja.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Fentrix transdermal patch and associated names.
Maltese: L-Aġenzija Ewropea tal-Mediċini (EMEA) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost lIstati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni ta' Fentrix u ismijiet assoċjati roqgħa transdermali.
English: Fentrix is a transdermal patch (device that delivers the drug across the skin) that contains the active substance fentanyl.
Maltese: Fentrix huwa roqgħa transdermali (apparat li jagħti l-mediċina minn ġol-ġilda) li fih is-sustanza attiva fentanyl.
English: This means that Fentrix is similar to a ‘reference medicine' already authorised in the European Union (EU) called Durogesic.
Maltese: Dan ifisser li Fentrix huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea (UE) imsejħa Durogesic.
English: Why was Fentrix reviewed?
Maltese: Għaliex ġie rivedut Fentrix?
English: However, the Member States were not able to reach an agreement and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 4 May 2009.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija regolatorja tal-mediċini Spanjola rreferiet il-kwistjoni lis-CHMP għal arbitraġġ fl-4 ta' Mejju 2009.
English: It is used to treat severe long-term (chronic) pain which can only be adequately treated with opioid painkillers (medicines that are related to morphine).
Maltese: Jintuża biex jikkura uġigħ fit-tul (kroniku) li jkun jista' jiġi kkurat b'mod adegwat biss permezz ta' mewwieta tal-uġigħ b'opjojdi (mediċini li huma relatati mal-morfina).
English: The active substance in Fentrix, fentanyl, is an opioid that acts on receptors in the brain and spinal cord to prevent pain.
Maltese: Is-sustanza attiva f'Fentrix, fentanyl, hija opjojde li taġixxi fuq riċetturi fil-moħħ u fil-korda spinali biex timpedixxi l-uġigħ.
English: The full EPAR for Irbesartan Hydrochlorothiazide Zentiva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Irbesartan Hydrochlorothiazide Zentiva jinstab fuq il-websajt tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The most common side effects with Irbesartan Hydrochlorothiazide Zentiva (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles).
Maltese: L-effetti sekondarji l-aktar komuni b'Irbesartan Hydrochlorothiazide Zentiva (li dehru f'bejn pazjent 1 u 10 minn 100) huma sturdament, nawżea (dardir) jew remettar, disturbi urinarji, għeja kbira u żieda fillivelli tan-nitroġenu urejku tad-demm (blood urea nitrogen, BUN, prodott ta' skart mill-proteini), talkreatinina (prodott ta' skart mill-muskoli) u kreatina kinażi (creatine kinase, enzima li tinsab filmuskoli).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Hydrochlorothiazide Winthrop on 19 January 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Irbesartan Hydrochlorothiazide Winthrop fid-19 ta' Jannar 2007.
English: EPAR summary for the public irbesartan / hydrochlorothiazide
Maltese: Sommarju tal-EPAR għall-pubbliku irbesartan/idroklorotijażide (hydrochlorothiazide)
English: The name of the medicine was changed to Irbesartan Hydrochlorothiazide Zentiva on 6 February 2012.
Maltese: L-isem tal-mediċina nbidel u sar Irbesartan Hydrochlorothiazide Zentiva fis-6 ta' Frar 2012.
English: Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide.
Maltese: ogħla minn 300 mg irbesartan jew 25 mg idroklorotijażide darba kuljum.
English: This is a summary of the European public assessment report (EPAR) for Irbesartan Hydrochlorothiazide Zentiva.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Irbesartan Hydrochlorothiazide Zentiva.
English: Irbesartan Hydrochlorothiazide Zentiva contains two active substances, irbesartan and hydrochlorothiazide.
Maltese: Irbesartan Hydrochlorothiazide Zentiva fih żewġ sustanzi attivi, l-irbesartan u l-idroklorotijażide.
English: Previously known as Irbesartan Hydrochlorothiazide Winthrop.
Maltese: Dak li qabel kien magħruf bħala Irbesartan Hydrochlorothiazide Winthrop.
English: Irbesartan Hydrochlorothiazide Zentiva must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Maltese: Irbesartan Hydrochlorothiazide Zentiva ma għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal irbesartan, għall-idroklorotijażide, għas-sulfonamidi, jew għal kwalunkwe ingredjent ieħor.
English: Irbesartan Hydrochlorothiazide Zentiva in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Irbesartan Hydrochlorothiazide Zentiva ma għandux jintuża flimkien ma' mediċini li fihom l-aliskiren (użat fil-kura tal-ipertensjoni essenzjali) f'pazjenti bid-dijabete, jew insuffiċjenza moderata jew gravi fil-kliewi.
English: What is Irbesartan Hydrochlorothiazide Zentiva?
Maltese: Għal xiex jintuża Irbesartan Hydrochlorothiazide Zentiva?
English: For the full list of all side effects reported with Irbesartan Hydrochlorothiazide Zentiva, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Irbesartan Hydrochlorothiazide Zentiva, ara l-fuljett ta' tagħrif.
English: Irbesartan Hydrochlorothiazide Zentiva may be added to some other treatments for hypertension.
Maltese: Irbesartan Hydrochlorothiazide Zentiva jista' jintuża flimkien ma' trattamenti oħra għall-ipertensjoni.
English: The CHMP decided that Irbesartan Hydrochlorothiazide Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Irbesartan Hydrochlorothiazide Zentiva huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Other information about Irbesartan Hydrochlorothiazide Zentiva
Maltese: Kif jintuża Irbesartan Hydrochlorothiazide Zentiva?
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide Zentiva.
Maltese: Bħala appoġġ għall-użu ta' Irbesartan Hydrochlorothiazide Zentiva, intużaw l-istudji mwettqa b'Karvea/Aprovel flimkien mal-idroklorotijażide bħala pilloli separati.