FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali trattati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal trattati )
English: Metacam 40 mg/ml solution for injection for cattle and horses meloxicam
Maltese: Metacam 40 mg/ml soluzzjoni għall-injezzjoni għal baqar u żwiemel. meloxicam
English: Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
Maltese: Madwar 75% tad-doża li tingħata titneħħa flippurgar, u l-bqija fl-awrina.
English: 6 drops/kg body weight
Maltese: 6 qatriet/kg ta' piż tal-ġisem
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on day 1 (pre-surgery).
Maltese: Il-kura inizjali hija doża orali waħda ta' 0.2 mg meloxicam/kg piż tal-ġisem f'jum 1 (qabel ilkirurġija).
English: For animal treatment only.To be supplied only on veterinary prescription.
Maltese: Jekk jogħġbok segwi blattenzjoni l-istruzzjonijiet tal-veterinarju.
English: EMA/751270/2015 EMEA/H/C/000758
Maltese: EMA/636538/2015 EMA/H/C/000758
English: The full EPAR for Optaflu can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A/California/7/2009 (H1N1)pdm09-like strain; A/Switzerland/9715293/2013 (H3N2)-like strain; and
Maltese: Il-vaċċin fih ‘antiġen tas-superfiċje' minn tliet razez (tipi) differenti tal-virus tal-influenza (flu): tip simili għal A/California/7/2009 (H1N1)pdm09; tip simili għal A/Switzerland/9715293/2013 tip simili (H3N2); u tip
English: This is a summary of the European public assessment report (EPAR) for Optaflu.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Optaflu.
English: Optaflu is a vaccine.
Maltese: Optaflu hu vaċċin.
English: influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Maltese: vaċċin kontra l-influwenza (antiġen tas-superfiċje, inattivat, ikkultivat fiċ
English: Optaflu contains fragments from the surface of three different strains of flu virus.
Maltese: Optaflu fih frammenti mis-superfiċje ta' tliet razez differenti tal-virus tal-influwenza.
English: The ability of Optaflu to trigger the production of antibodies (immunogenicity) was first assessed using a formulation of the vaccine that included the virus strains expected to cause flu in the 2004/2005 season.
Maltese: L-abbiltà ta' Optaflu li jistimula l-produzzjoni ta' antikorpi (immunoġeneċità) ġiet ivvalutata l-ewwel darba bl-użu ta' formulazzjoni tal-vaċċin li inkludiet ir-razez tal-virusis li mistennija jikkawżaw linfluwenza fl-istaġun 2004/2005.
English: The two vaccines were similar in triggering the production of antibodies, both in adults 60 years of age and below, and in the elderly.
Maltese: Iż-żewġ vaċċini kellhom effikaċja simili flistimulazzjoni tal-produzzjoni tal-antikorpi, kemm f'adulti ta' 60 sena jew inqas u kemm fl-anzjani.
English: The most common side effects with Optaflu (seen in more than 1 patient in 10) are headache, reddening of the skin, muscle pain, pain at the site of injection, malaise (feeling unwell) and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Optaflu (li dehru f'pazjent 1 minn kull għaxra) huma wġigħ ta' ras, ħmura fil-ġilda, uġigħ fil-muskoli, uġigħ fis-sit tal-injezzjoni, telqa (ma tħossokx f'siktek) u eżawriment (għejja).
English: In the original main study, both Optaflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains, as defined in criteria laid down by the CHMP for flu vaccines.
Maltese: Fl-istudju ewlieni oriġinali, kemm Optaflu kif ukoll il-vaċċin li tqabbel miegħu pproduċew livelli adegwati ta' antikorpi għall-protezzjoni kontra kull waħda mit-tliet razez tal-influwenza, kif iddefinit mill-kriterji stabbiliti mis-CHMP għal vaċċini kontra l-influwenza.
English: Optaflu contains fragments (surface antigens) of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in Optaflu before the vaccine can be used.
Maltese: Jeħtieġ li frammenti (antiġen tas-superfiċje) tat-tipi tal-virus li huma mistennija jikkawżaw l-influwenza fl-istaġun ta' wara, skont ir-rakkomandazzjonijiet mid-WHO għall-emisferu tat-Tramuntana u mill-Unjoni Ewropea (UE), jiġu inklużi f'Optaflu qabel ma l-vaċċin ikun jista' jintuża.
English: Later seasonal formulations of Optaflu have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main study.
Maltese: Il-formulazzjonijiet staġunali ta' Optaflu li ġew wara wrew li pproduċew risponsi simili mill-antikorpi kontra t-tliet tipi tal-influwenza inklużi fil-vaċċin għal dawk osservati fl-istudju ewlieni.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi "jgħallmu" lis-sistema immunitarja (id-difiżi naturali talġisem) kif tiddefendi ruħha kontra l-mard.
English: A risk management plan has been developed to ensure that Optaflu is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Optaflu jintuża bl-aktar mod sigur possibbli.
English: The vaccine's effectiveness was assessed in one main study involving 2,654 adults, around half of whom were elderly (over 60 years of age).
Maltese: L-effikaċja tal-vaċċin ġiet ivvalutata fi studju ewlieni wieħed fuq 2,654 adult, li madwar nofshom kienu anzjani ('il fuq minn 60 sena).
English: Other information about Optaflu
Maltese: Tagħrif ieħor dwar Optaflu
English: The CHMP decided that Optaflu's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Optaflu huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The viruses used to obtain the surface antigen that are included in Optaflu are grown in mammalian cells, unlike those used for other flu vaccines, which are grown in hen's eggs.
Maltese: Il-virusis użati biex jinsiltu l-frammenti tas-superfiċje li jiġu inklużi f'Optaflu jitkabbru f'ċelluli talmammiferi, bil-kontra ta' dawk użati f'vaċċini tal-influwenza oħrajn li jitkabbru fil-bajd tat-tiġieġ.
English: The full EPAR for Glubrava can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Pioglitazone / metformin hydrochloride
Maltese: Pijoglitażonu / idroklorur tal-metformina
English: The studies lasted from four months to two years and involved 1,305 patients who took the combination.
Maltese: L-istudji damu bejn erba' xhur sa sentejn u involvew 1,305 pazjenti li ngħataw ilkombinazzjoni.
English: Glubrava is a medicine that is available as tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg).
Maltese: Glubrava huwa mediċina li tiġi bħala pilloli li jkun fihom żewġ sustanzi attivi, il-pijoglitażonu (15 mg) u l-idroklorur tal-metformina (850 mg).
English: This is a summary of the European public assessment report (EPAR) for Glubrava.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Glubrava.
English: Why has Glubrava been approved?
Maltese: Għaliex ġie approvat Glubrava?
English: In all studies, adding pioglitazone 30 mg to metformin led to an improvement in the control of blood glucose, with levels of HbA1c which further decreasing by 0.64 to 0.89% compared with the levels on metformin alone.
Maltese: Fl-istudji kollha, iż-żieda ta' 30 mg pijoglitażonu mal-metformina wasslet għal titjib fil-kontroll talglukożju fid-demm, bil-livelli tal-HbA1c ikomplu jitnaqqsu minn 0.64% għal 0.89% meta mqabbla mallivelli rreġistrati bil-metformina weħidha.
English: Other information about Glubrava
Maltese: Informazzjoni oħra dwar Glubrava
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Glubrava on 11 December 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Glubrava fil-11 ta' Diċembru 2007.
English: What is Glubrava?
Maltese: X'inhu Glubrava?
English: What is the risk associated with Glubrava?
Maltese: X'inhu r-riskju assoċjat ma' Glubrava?
English: The company that markets Glubrava will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Maltese: Il-kumpanija li tqiegħed Glubrava fis-suq se tipproduċi materjal edukattiv għat-tobba li jippreskrivu lmediċina, li se jkopri r-riskju possibbli ta' insuffiċjenza tal-qalb u kanċer fil-bużżieqa tal-urina bil-kuri li fihom il-pijoglitażonu, il-kriterji għall-għażla tal-pazjenti u l-ħtieġa ta' rieżami regolari tal-kura u li lkura titwaqqaf jekk il-pazjenti ma jibqgħux jibbenefikaw minnha.
English: Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Il-pijoglitażonu tagħmel iċ-ċelloli (ix-xaħam, il-muskoli u l-fwied) iktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi.
English: Glubrava must not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may affect the kidneys, and during breast-feeding.
Maltese: Glubrava m'għandux jintuża f'każi ta' intossikazzjoni alkoħolika, ketoaċidożi dijabetika (livell għoli ta' ketoni), kundizzjonijiet li jistgħu jaffettwaw il-kliewi u matul it-treddiegħ.
English: The CHMP concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Glubrava simplifies treatment and improves compliance when a combination of the active substances is required.
Maltese: Is-CHMP kkonkluda li l-effikaċja tal-pijoglitażonu u tal-metformina fid-dijabete tat-tip 2 ġiet ippruvata, u li Glubrava jissimplifika l-kura u jtejjeb il-possibbiltà ta' konformità meta tkun meħtieġa lkombinazzjoni tas-sustanzi attivi.
English: At the start of treatment, abdominal pain (stomach ache), diarrhoea, loss of appetite, nausea (feeling sick) and vomiting may occur.
Maltese: Fil-bidu tal-kura, jistgħu jseħħu wġigħ addominali (uġigħ fl-istonku), dijarrea, nuqqas ta' aptit, nawżja (tħossok ma tiflaħx) u remettar.
English: Pioglitazone on its own has been approved in the EU under the name Actos and can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Maltese: Il-pijoglitażonu waħdu ġie approvat fl-UE taħt l-isem Actos u jista' jintuża mal-metformina f'pazjenti bid-dijabete tat-tip 2 li ma jkunux ikkontrollati b'mod sodisfaċenti bil-metformina biss.
English: Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Maltese: Il-metformina taħdem prinċipalment billi tinibixxi l-produzzjoni ta' glukożju u tnaqqas l-assorbiment tiegħu fl-intestini.
English: Glubrava is used in adults (particularly those who are overweight) who have type 2 diabetes.
Maltese: Glubrava jintuża f'adulti (l-aktar dawk b'piż eċċessiv) li jkollhom id-dijabete tat-tip 2.
English: Glubrava is used in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own and at the maximum possible dose.
Maltese: Glubrava jintuża f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti bil-metformina (mediċina kontra d-dijabete) użata weħidha u mogħtija fl-ogħla doża possibbli.
English: This authorisation was based on the authorisation granted to Competat on 28 July 2006 (‘informed consent').
Maltese: Din l-awtorizzazzjoni hija bbażata fuq l-awtorizzazzjoni mogħtija lil Competact fit-28 ta' Lulju 2006 (‘kunsens infurmat').
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Glubrava.
Maltese: F'rieżamijiet sussegwenti, il-professjonisti li jippreskrivu din il-mediċina jenħtieġ li jikkonfermaw li l-pazjenti jkunu għadhom qegħdin jibbenefikaw.
English: Other side effects such as bone fracture, increased weight and oedema (swelling) may occur in less than 1 in 10 patients.
Maltese: Effetti sekondarji oħra bħal ksur fl-għadam, żieda fil-piż u oedema (nefħa) jistgħu jseħħu f'inqas minn pazjent wieħed minn kull 10.
English: For the full list of all side effects reported with Glubrava, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrapportati bi Glubrava, ara l-fuljett ta' tagħrif.
English: Elderly patients should have their kidney function monitored regularly.
Maltese: Il-pazjenti anzjani jenħtieġ li jkollhom il-funzjoni tal-kliewi tagħhom issorveljata b'mod regolari.
English: The Marketing Authorisation Holder (MAH) shall provide an educational pack covering the therapeutic indications RA and sJIA, targeting all physicians who are expected to prescribe/use RoActemra containing the following:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq (MAH) għandu jipprovdi pakkett edukattiv li jkopri l-indikazzjonijiet terapewtiċi ta' RA u sJIA immirat lejn it-tobba kollha li huma mistennija jippreskrivu/jużaw RoActemra li fih dan li ġej:
English: • Preparation of infusion
Maltese: • Preparazzjoni ta' l-infużjoni
English: • Diagnosis of Macrophage Activation Syndrome in sJIA patients
Maltese: • Dijanjożi ta' Sindrome ta' Attivazzjoni tal-Makrofagi f'pazjenti b'sJIA
English: • Physician Information Pack
Maltese: • Pakkett ta' Informazzjoni għat-Tabib
English: • Patient Alert Card - to address the risk of getting infections which can become serious if not treated.
Maltese: • Biljett ta' Twissija għall-Pazjent - biex jindirizza ir-riskju li jittieħdu infezzjonijiet li jistgħu jsiru serji jekk ma jiġux ikkurati.
English: • Infusion rate
Maltese: • Rata ta' l-infużjoni
English: The Member States shall discuss and agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational material.
Maltese: Qabel ma jitqassam il-materjal edukattiv, l-Istati Membri għandhom jiddiskutu u jiftiehmu dwar ilkontenut u d-disinn tal-materjal edukattiv , flimkien ma' pjan ta' komunikazzjoni mal-awtorità nazzjonali kompetenti Il-Pakkett ta' Informazzjoni għat-Tabib għandu jkun fih il-punti prinċipali li ġejjin:
English: • Nurse Information Pack
Maltese: • Pakkett ta' Informazzjoni għan-Ners
English: • Prevention of medical errors and infusion reactions
Maltese: • Prevenzjoni ta' żbalji mediċi u reazzjonijiet għall-infużjoni
English: • Dose calculation (RA and sJIA patients), preparation of infusion and infusion rate
Maltese: • Kalkulazzjoni tad-doża (pazjenti b'RA u sJIA), preparazzjoni ta' l-infużjoni u r-rata ta' linfużjoni
English: • The Patient Information Packs (to be given to patients by healthcare professionals)
Maltese: • Il-Pakketti ta' Informazzjoni għall-Pazjent (għandhom jingħataw lill-pazjenti minn professjonisti fil-qasam tas-saħħa)
English: • Patient Information Leaflet
Maltese: • Pakkett ta' Informazzjoni għall-Pazjent
English: The Physician Information Pack should contain the following key elements:
Maltese: Il-Pakkett ta' Informazzjoni għan-Ners għandu jkun fih il-punti prinċipali li ġejjin:
English: • Recommendations for dose interruptions in sJIA patients
Maltese: • Il-prodott jista' jnaqqas is-sinjali u s-sintomi ta' infezzjoni akuta u jittardja ddijanjosi
English: • Serious hypersensitivity reactions and their management
Maltese: • Reazzjonijiet ta' sensittività eċċessiva serji u l-immaniġjar tagħhom
English: The full EPAR for Kinzalkomb can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Kinzalkomb telmisartan / hydrochlorothiazide
Maltese: Kinzalkomb telmisartan / idroklorotijażide
English: This is a summary of the European public assessment report (EPAR) for Kinzalkomb.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Kinzalkomb.
English: It is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Maltese: Jiġi bħala pilloli (40 mg jew 80 mg telmisartan u 12.5 mg idroklorotijażide; 80 mg telmisartan u 25 mg idroklorotijażide).
English: Kinzalkomb has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Maltese: Kinzalkomb ġie studjat f'ħames studji ewlenin li involvew total ta' 2,985 pazjent li jbatu minn ipertensjoni minn ħafifa għal moderata.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kinzalkomb on 19 April 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Kinzalkomb fid-19 ta' April 2002.
English: The most common side effect with Kinzalkomb (seen in between 1 and 10 patients in 100) is dizziness.
Maltese: L-effett sekondarju l-aktar komuni b'Kinzalkomb (li deher f'bejn pazjent wieħed u 10 minn kull 100) huwa l-isturdament.
English: What is Kinzalkomb?
Maltese: Kif jintuża Kinzalkomb?
English: Why has Kinzalkomb been approved?
Maltese: Għaliex ġie approvat Kinzalkomb?
English: Kinzalkomb is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Maltese: Kinzalkomb huwa mediċina li fiha żewġ sustanzi attivi, it-telmisartan u l-idroklorotijażide.
English: Kinzalkomb contains two active substances, telmisartan and hydrochlorothiazide.
Maltese: Kinzalkomb fih żewġ sustanzi attivi, it-telmisartan u l-idroklorotijażide.
English: The CHMP decided that Kinzalkomb's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Maltese: Is-CHMP iddeċieda li Kinzalkomb għandu iktar benefiċċji milli riskji fil-kura tal-ipertensjoni essenzjali f'pazjenti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat bit-telmisartan waħidha.
English: For the full list of all side effects reported with Kinzalkomb, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Kinzalkomb, ara l-Fuljett ta' Tagħrif.
English: In four of these studies, Kinzalkomb was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
Maltese: F'erbgħa minn dawn l-istudji, Kinzalkomb tqabbel mal-plaċebo (kura finta) u mat-telmisartan meħuda waħidha f'total ta' 2,272 pazjent.
English: How has Kinzalkomb been studied?
Maltese: Kif ġie studjat Kinzalkomb?
English: The fifth study compared the effects of remaining on the 80/12.5 mg tablet with switching to the 80/25 mg tablet in 713 patients who had not responded to the 80/12.5 mg tablet.
Maltese: mg ma' dawk li ġew irreġistrati meta qaleb għall-pilloli ta' 80/25 mg fuq 713-il pazjent li ma rrispondewx għall-pillolli ta' 80/12.5 mg.
English: What is the risk associated with Kinzalkomb?
Maltese: X'inhu r-riskju assoċjat ma' Kinzalkomb?
English: The dose of Kinzalkomb to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Maltese: Id-doża ta' Kinzalkomb li għandha tintuża tiddependi mid-doża ta' telmisartan li l-pazjent kien qiegħed jieħu qabel: pazjenti li kienu qegħdin jieħdu 40mg telmisartan għandhom jieħdu l-pilloli ta' 40/12.5 mg, u pazjenti li kienu qed jingħataw 80 mg telmisartan għandhom jieħdu l-pilloli ta' 80/12.5
English: Other information about Kinzalkomb
Maltese: Tagħrif ieħor dwar Kinzalkomb
English: Kinzalkomb must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Maltese: Kinzalkomb ma għandux jintuża lanqas minn persuni li jkollhom problemi gravi fil-fwied, fil-kliewi jew problemi biljari, livelli baxxi wisq ta' potassju fid-demm, jew livelli għoljin wisq ta' kalċju fid-demm.
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Kinzalkomb must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Maltese: F'pazjenti bid-dijabete tat-tip 2 jew f'pazjenti b'indeboliment renali moderat jew sever, Kinzalkomb m'għandux jintuża wkoll flimkien ma' mediċini li fihom l-aliskiren (li jintużaw ukoll biex jikkuraw l-ipertensjoni essenzjali).
English: A risk management plan has been developed to ensure that Kinzalkomb is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Kinzalkomb jintuża bl-aktar mod sigur possibbli.
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to Kinzalkomb.
Maltese: Fil-pazjenti li ma kinux ikkontrollati bil-pilloli ta' 80/12.5 mg, il-fatt li qalbu għall-pilloli ta' 80/25 mg kien aktar effettiv fit-tnaqqis tal-pressjoni tad-demm dijastolika milli meta baqgħu jieħdu doża aktar baxxa.
English: The full list of these medicines is given in the package leaflet.
Maltese: Il-Kumitat irrakkomanda li Kinzalkomb jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: See section 4.10..
Maltese: Ara sezzjoni 4.10.
English: ATC vet code: QS02CA91
Maltese: QS02CA91
English: Posaconazole
Maltese: Posakonazol
English: Date of last renewal: 23/06/2013
Maltese: Data tal-aħħar tiġdid: 23/06/2013
English: Paraffin, Liquid
Maltese: Paraffin, Likwidu
English: packl sizes: 8.8 mL (7.5 g), 17.5 mL (15 g) and 35.1 mL (30 g)
Maltese: Daqsijiet tal-pakkett: 8.8 mL (7.5 g), 17.5 mL (15 g) and 35.1 mL (30 g).
English: Plasticised hydrocarbon gel (5% polyethylene in 95% mineral oil)
Maltese: Ġell plastiċizzat tal-ħidrokarbon (5% poli-etilin f'95% ta' żejt minerali).
English: N Min
Maltese: Min
English: No data available..
Maltese: M'hemmx data disponibbli.
English: Posaconazole is 40 - 100 times more potent in vitro against Malassezia pachydermatis than clotrimazole, miconazole and nystatin.
Maltese: Posakonażol hu 40-100 darba iktar potenti in vitro kontra Malassezia pachydermatis minn klotrimażol, mikonażol u nistatin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/06/2008
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23/06/2008