FrancophonIA/ELRC3.0 huggingface dataset:
English: In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Maltese: Fi studju fit-tul, kontrollat bi plaċebo (PRAISE-2) b'amlodipine f'pazjenti b'NYHA (Klassifikazzjoni ta' l-Assoċjazzjoni tal-Qalb Ta' New York) III u IV, insuffiċjenza tal-qalb b'etjoloġija mhux iskemika, amlodipine kien assoċjat ma' numru akbar ta' rapporti ta' edima fil-pulmun minkejja li ma kienx hemm differenza sinifikanti fin-numru ta' pazjenti li l-insuffiċjenza tal-qalb marret għall-agħar meta mqabbla mal-plaċebo.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan..
Maltese: Żiediet riversibbli tal-konċentrazzjonijiet ta' lithium fis-serum u tossiċità kienu rappurtati waqt li lithium kien qiegħed jingħata flimkien mal-inibituri tal-enzima li tibdel angiotensin jew antagonisti tar-riċettur ta' anġjotensin II, inkluż valsartan.
English: EU/1/06/371/009 7 film-coated tablets EU/1/06/371/010 14 film-coated tablets EU/1/06/371/011 28 film-coated tablets EU/1/06/371/012 30 film-coated tablets EU/1/06/371/013 56 film-coated tablets EU/1/06/371/014 90 film-coated tablets EU/1/06/371/015 98 film-coated tablets EU/1/06/371/016 280 film-coated tablets EU/1/06/371/028 56x1 film-coated tablet (unit dose) EU/1/06/371/029 98x1 film-coated tablet (unit dose) EU/1/06/371/030 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/371/009 7 pilloli miksija b'rita EU/1/06/371/010 14-il pillola miksija b'rita EU/1/06/371/011 28 pillola miksija b'rita EU/1/06/371/012 30 pillola miksija b'rita EU/1/06/371/013 56 pillola miksija b'rita EU/1/06/371/014 90 pillola miksija b'rita EU/1/06/371/015 98 pillola miksija b'rita EU/1/06/371/016 280 pillola miksija b'rita EU/1/06/371/028 56xpillola 1 miksija b'rita (doża waħda)
English: In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalaemia after administration of verapamil and intravenous dantrolene.
Maltese: F'annimali, fibrillazzjoni ventrikulari letali u kollass kardjovaskulari ġew osservati f'assoċjazzjoni ma' iperkalemija, wara l-għoti ta' verapamil u dantrolene ġol-vini.
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 80 mg valsartan.
Maltese: Kull pillola fiha 5 mg amlodipine (bħala amlodipine besylate) u 80 mg valsartan.
English: if you have a condition affecting the renal glands called “primary hyperaldosteronism”.
Maltese: - Jekk għandek problema tal-glandoli renali li tissejjaħ “iperaldosteroniżmu primarja”.
English: There are no available clinical data in severely renally impaired patients.
Maltese: M'hemmx dejta klinika disponibbli f'pazjenti b'indeboliment renali qawwi.
English: Very rare (may affect up to 1 in 10,000 people): Decreased number of white blood cells, decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage); excess sugar in blood (hyperglycaemia); swelling of the gums, abdominal bloating (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, sensitivity to light; disorders combining rigidity, tremor and/or movement disorders.
Maltese: Tnaqqis fin-numru ta' ċelloli bojod tad-demm, tnaqqis fin-numru ta' plejtlits fid-demm li jista' jwassal għal tbenġil mhux tas-soltu jew fsada malajr (ħsara fiċ-ċelloli ħomor tad-demm); zokkor żejjed fid-demm (ipergliċemija); nefħa filħanek, nefħa addominali (gastrite); funzjoni abnormali tal-fwied, infjammazzjoni tal-fwied (epatite), sfura fil-ġilda (suffejra), żieda fl-enzimi tal-fwied li jista' jkolIha effett fuq xi testijiet mediċi; żieda fit-tensjoni tal-muskoli; infjammazzjoni fil-vini u l-arterji, ħafna drabi b'raxx fil-ġilda, sensittività għad-dawl; disturbi li jikkombinaw riġidità, rogħda, u/jew disturbi fil-moviment.
English: In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 (valsartan) and 10 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Maltese: Fi studju dwar l-iżvilupp ta' l-embriju-fetu tal-far, kien hemm numru akbar ta' uretri mwessa', sternebre malformati, u l-falanġi tas-sieq bid-dwiefer ta' quddiem mingħajr għadam kienu nnutati b'esponimenti ta' madwar 12-il darba (valsartan) u 10 darbiet (amlodipine) id-dożi kliniċi ta' 160 mg valsartan u 10 mg amlodipine.
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Maltese: Kull pillola fiha 5 mg amlodipine (bħala amlodipine besylate) u 160 mg valsartan.
English: The safety and efficacy of Dafiro in children aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Dafiro fit-tfal ta' taħt it-18-il sena ma ġewx determinati s'issa.
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Maltese: Kull pillola fiha 10 mg amlodipine (bħala amlodipine besylate) u 160 mg valsartan.
English: When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to amlodipine or Dafiro, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Maltese: Meta pazjenti eliġibbli bi pressjoni għolja (ara sezzjoni 4.1) li għandhom indeboliment epatiku jinqalbu għal amlodipine jew Dafiro, għandha tintuża l-inqas doża disponibbli ta' amlodipine bħala monoterapija jew tal-komponent ta' amlodipine, rispettivament.
English: EU/1/06/371/001 7 film-coated tablets EU/1/06/371/002 14 film-coated tablets EU/1/06/371/003 28 film-coated tablets EU/1/06/371/004 30 film-coated tablets EU/1/06/371/005 56 film-coated tablets EU/1/06/371/006 90 film-coated tablets EU/1/06/371/007 98 film-coated tablets EU/1/06/371/008 280 film-coated tablets EU/1/06/371/025 56x1 film-coated tablet (unit dose) EU/1/06/371/026 98x1 film-coated tablet (unit dose) EU/1/06/371/027 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/371/001 7 pilloli miksija b'rita EU/1/06/371/002 14-il pillola miksija b'rita EU/1/06/371/003 28 pillola miksija b'rita EU/1/06/371/004 30 pillola miksija b'rita EU/1/06/371/005 56 pillola miksija b'rita EU/1/06/371/006 90 pillola miksija b'rita EU/1/06/371/007 98 pillola miksija b'rita EU/1/06/371/008 280 pillola miksija b'rita EU/1/06/371/025 56xpillola 1 miksija b'rita (doża waħda)
English: Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Maltese: Mewt kardjovaskulari u puplesija t-tnejn kienu numerikament iktar frekwenti fil-grupp ta' aliskiren milli filgrupp tal-plaċebo, u avvenimenti avversi u avvenimenti avversi serji ta' interess (iperkalimja, pressjoni baxxa u disfunzjoni tal-kliewi) ġew irrappurtati b'mod iktar frekwenti fil-grupp ta' aliskiren milli fil-grupp tal-plaċebo.
English: In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death.
Maltese: F'pazjenti b'insuffiċjenza severa tal-qalb li jkollhom funzjoni renali li tiddependi mill-attività tas-sistema renin-angiotensin-aldosterone, kura b' inibituri ta' ACE u antagonisti tar-riċettur ta' angiotensin kienet assoċjata ma' oligurja u/jew ażotemja li tavvanza u (rarament) insuffiċjenza akuta renali u/jew mewt.
English: As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Maltese: Bħala konsegwenza ta' l-inibizzjoni tas-sistema renin-angiotensin-aldosterone, tibdil fil-funzjoni renali tista' tkun mistennija f'indvidwi li huma suxxettibli.
English: Pruritus
Maltese: Iperkalimja
English: Gingival hyperplasia
Maltese: Disturbi psikjatriċi
English: EU/1/06/371/017 EU/1/06/371/018 EU/1/06/371/019 EU/1/06/371/020 EU/1/06/371/021 EU/1/06/371/022 EU/1/06/371/023 EU/1/06/371/024 EU/1/06/371/031 EU/1/06/371/032 EU/1/06/371/033 EU/1/06/371/036 EU/1/06/371/039
Maltese: EU/1/06/371/031 EU/1/06/371/032 EU/1/06/371/033 EU/1/06/371/036 EU/1/06/371/039
English: Uncommon (may affect up to 1 in 100 people): Mood changes, anxiety, depression, sleeplessness, trembling, taste abnormalities, fainting, loss of pain sensation; visual disturbances, visual impairment, ringing in the ears; low blood pressure; sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis); indigestion, vomiting (being sick); hair loss, increased sweating, itchy skin, skin discolouration; disorder in passing urine, increased need to urinate at night, increased number of times of passing urine; inability to obtain an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight increase or decrease.
Maltese: Bidliet fil-burdata, ansjetà, dipressjoni, nuqqas ta' rqad, rogħda, togħma abnormali, ħass ħażin, telf tas-sensazzjoni tal-uġigħ; disturbi viżwali, nuqqas ta' vista, żanżin fil-widnejn; pressjoni baxxa tad-demm; għatis/imnieħer iqattar ikkawżati minn infjammazzjoni fir-rita tal-imnieħer (rinite); indiġestjoni, rimettar (tkun imdardar); twaqqigħ tax-xagħar, żieda fl-għaraq, ġilda tieklok, tidnis tal-ġilda; disturb biex tagħmel lawrina, żieda fil-bżonn li tagħmel l-awrina billejl, żieda fin-numru ta' drabi li tagħmel l-awrina; nuqqas ta' kapaċità li jkollok erezzjoni, skonfort jew tkabbir tas-sider fl-irġiel, uġigħ, tħossok ma tiflaħx, uġigħ fil-muskoli, bugħawwieġ fil-muskoli; żieda jew tnaqqis fil-piż.
English: Urticaria and other forms of rash
Maltese: Urtikarja u forom oħrajn ta' raxx
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Maltese: KARTUNA TAN-NOFS TAL-PAKKETT B'ĦAFNA (BIL-KAXXA ĊELESTI)
English: VA NEPHROND was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.
Maltese: VA NEPHRON-D kien studju li twettaq f'pazjenti b'dijabete mellitus tip 2 u nefropatija dijabetika.
English: Dark yellow, oval film-coated tablet, imprinted with “NVR” on one side and “ECE” on the other side.
Maltese: Pillola safra skura, ovali miksija b'rita, ittimbrata “NVR” fuq naħa u “ECE” fuq l-oħra.
English: Micturition disorder
Maltese: Disfunzjoni tal-erezzjoni
English: Dafiro 10 mg/160 mg film-coated tablets
Maltese: Dafiro 10 mg/160 mg pilloli miksija b'rita
English: When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Dafiro, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Maltese: Meta pazjenti eliġibbli anzjani bi pressjoni għolja (ara sezzjoni 4.1) jinqalbu għal amlodipine jew Dafiro, għandha tintuża linqas doża disponibbli ta' amlodipine bħala monoterapija jew tal-komponent ta' amlodipine, rispettivament.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Maltese: Trabi li ommhom ħadet AIIRAs għandhom jkunu taħt osservazzjoni mill-qrib għal pressjoni baxxa (ara wkoll sezzjonijiet 4.3 u 4.4).
English: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
Maltese: L-użu ta Antagonisti tar-Riċetturi ta' Angiotensin II (AIIRAs) mhuwhiex rakkomandat fl-ewwel trimestru tat-tqala (ara sezzjoni 4.4).
English: Dafiro 5 mg/160 mg film-coated tablets
Maltese: Dafiro 5 mg/160 mg pilloli miksija b'rita
English: Distribution: The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.
Maltese: Il-volum ta' distribuzzjoni ta' valsartan fi stat fiss wara li jingħata ġol-vina huwa madwar 17-il litru, li jindika li valsartan ma jinfirixx b'mod estensiv fit-tessuti.
English: Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin.
Maltese: Valsartan ma jaħdimx bħala impeditur ta' ACE, magħruf ukoll bħala kininase II, li jaqleb angiotensin I f'angiotensin II u jkisser bradykinin.
English: Uncommon (may affect up to 1 in 100 people): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Maltese: Mhux komuni (jistgħu jaffettwaw mhux aktar minn persuna 1 f'100): Sturdament; tqallih u uġigħ addominali; ħalq xott; tħeddil, tingiż jew jorqdulek idejk jew saqajk; vertigo; qalb tħabbat mgħaġġla bil-palpitazzjonijiet; sturdament meta tqum bil-wieqfa; sogħla; dijarea; stitikezza; raxx tal-ġilda, ħmura tal-ġilda; nefħa tal-ġogi, uġigħ fid-dahar; uġigħ fil-ġogi.
English: What Dafiro looks like and contents of the pack Dafiro 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Maltese: Dafiro 5 mg/80 mg pilloli huma tondi u sofor skuri b' “NVR” fuq naħa u “NV” fuq in-naħa l-oħra.
English: Nasopharyngitis
Maltese: angiotensin
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Dafiro containing the same component doses.
Maltese: Għall-konvenjenza, pazjenti li qed jieħdu amlodipine u valsartan minn pilloli/kapsuli separati jistgħu jinqalbu għal Dafiro li fihom l-istess dożi tal-komponenti.
English: In haemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and humans, even when co-administered with beta blockers to humans.
Maltese: Fi studji imodinamiċi, amlodipine ma kienx assoċjat ma' effett inotropiku negattiv meta ingħata fil-medda ta' dożi terapewtiċi lill-annimali u bnedmin b'saħħithom, anki meta ingħata ma' beta blockers filbnedmin.
English: Sensation of heaviness
Maltese: Sensazzjoni ta' toqol
English: Light yellow, oval film-coated tablet, imprinted with “NVR” on one side and “UIC” on the other side.
Maltese: Pillola safra ċara, ovali miksija b'rita, ittimbrata “NVR” fuq naħa u “UIC” fuq l-oħra.
English: Dafiro combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Maltese: Dafiro jikkombina żewġ sustanzi kontra l-pressjoni għolja ma' mekkaniżmi kumplimentari sabiex tkun kontrollata l-pressjoni tad-demm f'pazjenti b'pressjoni għolja naturali: amlodipine huwa membru ta' klassi li huma antagonisti ta' calcium u valsartan ta' klassi ta' mediċini li huma antagonisti ta angiotensin II. Il-kombinazzjoni ta' dawn iż-żewġ sustanzi twassal għal effett kontra l-pressjoni għolja adittiv, b'mod li l-pressjoni titbaxxa aktar milli kieku jingħataw il-mediċini waħidhom.
English: Hypoesthesia
Maltese: Iponatrimija
English: Dysgeusia
Maltese: Sogħla
English: Discomfort, malaise
Maltese: Disturbi vaskulari
English: The amlodipine component of Dafiro inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Maltese: Il-komponent amlodipine f'Dafiro jinibixxi id-dħul mill-membrana ta' joni ta' calcium fil-muskoli talqalb u tal-muskoli lixxi tal-vini.
English: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Dafiro in placebo-controlled studies.
Maltese: Pressjoni baxxa eċċessiva dehret f'0.4% tal-pazjenti b'pressjoni għolja mingħajr kumplikazzjonijiet li kienet kurata b'Dafiro fi studji kontrollati bi plaċebo.
English: Amlodipine is excreted in human milk .
Maltese: Amlodipine jiġi eliminat fil-ħalib uman.
English: Plasma concentrations correlate with effect in both young and elderly patients.
Maltese: Kienu rrappurtati l-effetti sekondarji li ġejjin.
English: EU/1/06/371/009 EU/1/06/371/010 EU/1/06/371/011 EU/1/06/371/012 EU/1/06/371/013 EU/1/06/371/014 EU/1/06/371/015 EU/1/06/371/016 EU/1/06/371/028 EU/1/06/371/029 EU/1/06/371/030 EU/1/06/371/035 EU/1/06/371/038
Maltese: EU/1/06/371/016 EU/1/06/371/028 EU/1/06/371/029 EU/1/06/371/030
English: The addition of amlodipine 10 mg and 5 mg produced an additional reduction in systolic/diastolic blood pressure of 6.0/4.8 mmHg and 3.9/2.9 mmHg, respectively, compared to patients who remained on valsartan 160 mg only.
Maltese: 8 mmHg u 3.9/2.9 mmHg, rispettivament imqabbla ma' pazjenti li baqgħu fuq valsartan 160 mg waħdu.
English: 100 x 1 tablets
Maltese: 100 x 1 pilloli
English: EU number
Maltese: Numru ta' l-EU
English: Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Għamla farmaċewtika
English: Package size
Maltese: Il-pakkett
English: Invented name
Maltese: Numru ta' l-EU Isem inventat
English: Packaging
Maltese: Qawwa
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Maltese: Tenofovir huwa inibitur nukleotidiku tat-transkrittażi inversa.
English: How does it work?
Maltese: Kif taħdem?
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka efavirenz / emtricitabine / tenofovir disoproxil
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka efavirenz / emtriċitabina / tenofovir disoprossil
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka huwa mediċina antivirali li tintuża fil-kura ta' adulti li jkunu infettati bil-virus tal-immunodefiċjenza umana 1 (HIV-1, human immunodeficiency virus-1), virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS, acquired immune deficiency syndrome).
English: The full EPAR for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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: This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Maltese: Din il-mediċina fiha tliet sustanzi attivi: efavirenz, li hija inibitur mhux nukleosidiku tat-traskriptażi inversa (NNRTI, non-nucleoside reverse transcriptase inhibitor); emtriċitabina, li hija inibitur nukleosidiku tat-traskriptażi inversa; u tenofovir disoprossil, li hija ‘prodroga' ta' tenofovir, jiġifieri li tinbidel fis-sustanza attiva tenofovir fil-ġisem.
English: This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: What are the benefits and risks of this medicine?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' din il-mediċina?
English: The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one.
Maltese: Il-kumpanija li tqiegħed il-mediċina fis-suq se tiżgura li t-tobba kollha li mistennija jippreskrivu lmediċina jiġu pprovduti b'pakkett edukattiv li jinkludi informazzjoni dwar ir-riskju miżjud ta' mard filkliewi b'mediċini li fihom tenofovir disoprossil bħal din.
English: The medicine contains the active substances efavirenz, emtricitabine and tenofovir disoproxil and is a ‘generic medicine'.
Maltese: Il-mediċina fiha s-sustanzi attivi efavirenz, emtriċitabina u tenofovir disoprossil u hija ‘mediċina ġenerika'.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument mistoqsijiet-u-tweġibiet hawnhekk.
English: Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
Maltese: Informazzjoni oħra dwar Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
English: Because Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Efavirenz/Emtricitabine/Tenofovir disoproxil Krka huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk talmediċina ta' referenza.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-mediċina ta' referenza, Atripla, u m'għandhomx għalfejn jiġu ripetuti għal Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.
Maltese: Il-pakkett edukattiv fih ukoll rakkomandazzjonijiet għall-monitoraġġ tal-funzjoni tal-kliewi f'pazjenti li jkunu qed jieħdu l-mediċina.
English: It is only used in patients whose levels of HIV in the blood (viral load) have been below 50 copies/ml for more than 3 months on their current HIV treatment combination.
Maltese: Jintuża biss f'pazjenti li l-livelli tagħhom ta' HIV fid-demm (tagħbija virali) huma taħt 50 kopja/ml għal aktar minn 3 xhur tal-kombinazzjoni tal-kura attwali tagħhom kontra l-HIV.
English: Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Maltese: Kemm inibituri nukleosidi kif ukoll nukleotidiċi tat-transkrittażi inversa huma magħrufin b'mod komuni bħala NRTIs.
English: How has the medicine been studied?
Maltese: Kif ġiet studjata l-mediċina?
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka keeps the amount of HIV in the blood at a low level.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka jżomm l-ammont ta' HIV fid-demm f'livell baxx.
English: All three active substances block the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Maltese: It-tliet sustanzi attivi kollha jimblukkaw l-attività tat-traskriptażi inversa, enzima prodotta mill-HIV li tħalliha tipproduċi lilha nnifisha fiċ-ċelluli li tkun infettat.
English: The full EPAR for Xiliarx can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Xiliarx jinsab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (50 mg).
Maltese: Jiġi bħala pilloli (50 mg).
English: The active substance in Xiliarx, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Maltese: Is-sustanza attiva f'Xiliarx, il-vildagliptin, hija inibitur tad-dipeptidil-peptidażi-4 (DPP-4).
English: This summary was last updated in 11-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'11-2012.