FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:19 April 2002
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 ta' April 2002
English: 14 tablets 28 tablets 30 x 1 tablets 56 tablets 90 x 1 tablets 98 tablets 28 x 1 tablets
Maltese: 14-il pillola 28 pillola 30 x 1 pillola 56 pillola 90 x 1 pillola 98 pillola 28 x 1 pillola
English: 14 tablets 28 tablets 30 x 1 tablets 56 tablets 84 tablets 90 x 1 tablets 98 tablets 28 x 1 tablets
Maltese: 14-il pillola 28 pillola 30 x 1 pillola 56 pillola 84 pillola 90 x 1 pillola 98 pillola 28 x 1 pillola
English: See also information under the heading “Do not take MicardisPlus”.
Maltese: Ara wkoll l-informazzjoni taħt t-titlu “Tiħux MicardisPlus”.
English: • Second and third trimesters of pregnancy (see section s 4.4 and 4.6).
Maltese: • It-tieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.4 u 4.6).
English: MicardisPlus is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: MicardisPlus hu taħlita ta' antagonist tar-riċettur ta' angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
English: 1: Based on post-marketing experience 2: For further description, please see sub-section “Description of selected adverse reactions”
Maltese: 1: Ibbażat fuq esperjenza ta' wara t-tqegħid fis-suq 2: Għal deskrizzjoni addizzjonali, ara sottosezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula"
English: Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti Tel: +40 21 3022800
Maltese: KG Viena - Sucursala Bucuresti Tel: +40 21 3022800
English: INFORMATION IN BRAILLE MicardisPlus 80 mg/25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE MicardisPlus 80 mg/25 mg
English: MicardisPlus contains milk sugar (lactose) and sorbitol.
Maltese: MicardisPlus fih zokkor tal-ħalib (lactose) u sorbitol.
English: Do not take MicardisPlus
Maltese: Tiħux MicardisPlus
English: The effect of MicardisPlus may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).
Maltese: L-effetti ta' MicardisPlus jistgħu jitnaqqsu meta tieħu NSAIDs (non-steroidal anti-inflammatory drugs, eż. aspirina jew ibuprofen).
English: The overall incidence of adverse reactions reported with MicardisPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Maltese: L-inċidenza totali ta' reazzjonijiet avversi rrappurtati b'MicardisPlus kienet komparabbli ma' dawk irrappurtati b'telmisartan waħdu fi provi kkontrollati u randomised li saru fuq 1471 pazjent li kienu randomised biex jirċievu telmisartan flimkien ma' hydrochlorothiazide (835) jew telmisartan biss (636).
English: MicardisPlus 40 mg/12.5 mg tablets
Maltese: MicardisPlus 40 mg/12.5 mg pilloli
English: INFORMATION IN BRAILLE MicardisPlus 40 mg/12.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE MicardisPlus 40 mg/12.5 mg
English: MicardisPlus 80 mg/12.5 mg tablets
Maltese: MicardisPlus 80 mg/12.5 mg pilloli
English: The concomitant use of MicardisPlus with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Maltese: L-użu fl-istess ħin ta' MicardisPlus flimkien ma' prodotti li fihom aliskiren huwa kontraindikat f'pazjenti b'dijabete mellitus jew b'indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: PC: {number} {product code}
Maltese: PC:
English: Metabolism and nutrition disorders Common:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni:
English: INFORMATION IN BRAILLE MicardisPlus 80 mg/12.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE MicardisPlus 80 mg/12.5 mg
English: MicardisPlus must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Maltese: MicardisPlus ma jistax jintuża f'pazjenti b'indeboliment renali sever (rata ta' tneħħija tal-krejatinina ta' < 30 ml/min) (ara sezzjoni 4.3).
English: Coadministration of lithium and MicardisPlus is not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' lithium u MicardisPlus mhuwiex rakkomandat (ara sezzjoni 4.4).
English: EU/1/02/213/001 14 tablets EU/1/02/213/002 28 tablets EU/1/02/213/003 28 x 1 tablets EU/1/02/213/013 30 x 1 tablets EU/1/02/213/004 56 tablets EU/1/02/213/011 84 tablets EU/1/02/213/014 90 x 1 tablets EU/1/02/213/005 98 tablets
Maltese: EU/1/02/213/013 30 x 1 pillola EU/1/02/213/004 56 pillola EU/1/02/213/011 84 pillola EU/1/02/213/014 90 x 1 pillola EU/1/02/213/005 98 pillola
English: MicardisPlus fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Maltese: It-taħlita fissa tad-doża ta' MicardisPlus (40 mg telmisartan/12.5 mg ta' hydrochlorothiazide u 80 mg telmisartan/12.5 mg hydrochlorothiazide) hi indikata għal adulti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata sew b'telmisartan waħdu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/213/017-023
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/213/017-023
English: The use of MicardisPlus in children and adolescents up to the age of 18 years is not recommended.
Maltese: L-użu ta' MicardisPlus fit-tfal u fl-adolexxenti sa l-età ta' 18-il sena mhuwiex rakkomandat.
English: MicardisPlus fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on MicardisPlus 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Maltese: MicardisPlus taħlita fissa tad-doża (80 mg telmisartan/25 mg hydrochlorothiazide) hi indikata f'pazjenti adulti li pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat b'MicardisPlus 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) jew f'pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take MicardisPlus” and “Warnings and precautions”).
Maltese: - Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux MicardisPlus” u “Twissijiet u prekawzjonijiet”).
English: MicardisPlus 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Maltese: MicardisPlus 40 mg/12.5 mg pilloli Kull pillola fiha 40 mg ta' telmisartan u 12.5 mg ta' hydrochlorothiazide.
English: MicardisPlus 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Maltese: MicardisPlus 80 mg/12.5 mg pilloli Kull pillola fiha 80 mg ta' telmisartan u 12.5 mg ta' hydrochlorothiazide.
English: NAME OF THE MEDICINAL PRODUCT MicardisPlus 80 mg/25 mg tablets
Maltese: MicardisPlus 80 mg/25 mg pilloli
English: EU/1/02/213/017 14 tablets EU/1/02/213/018 28 tablets EU/1/02/213/019 28 x 1 tablets EU/1/02/213/020 30 x 1 tablets EU/1/02/213/021 56 tablets EU/1/02/213/022 90 x 1tablets EU/1/02/213/023 98 tablets
Maltese: EU/1/02/213/020 30 x 1 pillola EU/1/02/213/021 56 pillola EU/1/02/213/022 90 x 1 pillola EU/1/02/213/023 98 pillola
English: MicardisPlus 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: MicardisPlus 40 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: MicardisPlus 80 mg/25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the company logo and the code 'H9'.
Maltese: Il-pilloli MicardisPlus 80 mg/25 mg huma sofor u bojod, b'forma ovali, b'żewġ saffi, imnaqqxa billogo tal-kumpanija u l-kodiċi 'H9'.
English: Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include:
Maltese: Reazzjonijiet avversi ta' frekwenza mhux magħrufa rrappurtati bl-użu ta' hydrochlorothiazide waħdu jinkludu:
English: MicardisPlus is not indicated in patients with severe hepatic impairment.
Maltese: MicardisPlus mhuwiex indikat f'pazjenti b'indeboliment epatiku sever.
English: (It is also better to avoid MicardisPlus in early pregnancy - see pregnancy section.)
Maltese: MicardisPlus kmieni fit-tqala - ara ssezzjoni dwar it-tqala.)
English: MicardisPlus 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Maltese: MicardisPlus 80 mg/25 mg pilloli telmisartan/hydrochlorothiazide
English: MicardisPlus with food and alcohol
Maltese: MicardisPlus ma' ikel u alkoħol
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for MicardisPlus.
Maltese: Ġiet osservata żieda flinċidenza b'telmisartan biss, biss din ma tistax tiġi eskluża għal MicardisPlus.
English: Hypokalaemia Hyperuricaemia, hyponatraemia
Maltese: Ipokalemija, Iperurikemija, ipernatremija
English: Rare cases have also been reported with angiotensin II receptor antagonists (including MicardisPlus).
Maltese: Każijiet rari kienu irrappurtati wkoll b'antagonisti ta' riċetturi ta' angiotensin II (li jinkludu MicardisPlus).
English: MicardisPlus 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: MicardisPlus 80 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: MicardisPlus is also available at the dose strengths 40 mg/12.5 mg and 80 mg/ 12.5 mg Renal impairment
Maltese: MicardisPlus hu disponibbli wkoll f'dożi b'qawwa ta' 40 mg/12.5 mg u 80 mg/ 12.5 mg Indeboliment tal-kliewi
English: Other medicines and MicardisPlus:
Maltese: Mediċini oħra u MicardisPlus
English: Inflammation of the lung (bronchitis), activation or worsening of systemic lupus erythematosus (a disease where the body's immune system attacks the body, which causes joint pain, skin rashes and fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick (vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience thise side effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Maltese: Infjammazzjoni tal-pulmun (bronkite), attivazzjoni jew aggravament ta' lupus erythematosus sistemiku (marda fejn is-sistema immuni tal-ġisem tattakka lill-ġisem, u tikkawża wġigħ fil-ġogi, raxx tal-ġilda u deni); uġigħ fil-griżmejn, sinuses infjammati, tħossok imdejjaq (dipressjoni), diffikultà biex torqod (insomnja), indeboliment fil-vista, diffikultà biex tieħu n-nifs, uġigħ addominali, stitikezza, gass żejjed (dispepsja), tħossok imdardar (rimettar), infjammazzjoni tal-istonku (gastrite), funzjoni anormali tal-fwied (hemm aktar ċans li pazjenti Ġappuniżi jkollhom dan l-effett sekondarju), ħmura tal-ġilda (eritema), reazzjonijiet allerġiċi bħal ħakk jew raxx, żieda fl-għaraq, ħorriqija (urtikarja), uġigħ fil-ġogi (artralġja) u uġigħ fl-estremitajiet, bugħawwieġ fil-muskoli, mard qisu influwenza, uġigħ, livelli baxxi ta' sodium, żieda fil-livelli tal-krejatinina, enzimi epatiċi jew creatine phosphokinase fid-demm.
English: Sepsis* (often called "blood poisoning"), is a severe infection with whole-body inflammatory response, rapid swelling of the skin and mucosa (angioedema), blistering and peeling of the top layer of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis)but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Maltese: Sepsis* (ta' spiss imsejħa “avvelenament tad-demm”, hi infezzjoni severa b'rispons infjammatorju talġisem kollu), nefħa mgħaġġla tal-ġilda u l-mukuża (anġjoedema), jitilgħu l-infafet u s-saff ta' fuq talġilda jitqaxxar (nekrolisi epidermali tossika); dawn l-effetti sekondarji huma rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000) jew ta' frekwenza mhux magħrufa (nekrolisi epidermali tossika) iżda huma estremament serji u l-pazjenti għandhom jieqfu jieħdu l-mediċina u jaraw lit-tabib tagħhom immedjatament.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 / 77 90 900
Maltese: KG Tel: +49 (0) 800 / 77 90 900
English: MicardisPlus is available in blisters packs containing 14, 28, 56, 84, or 98 tablets, or unit dose blister packs containing 28 x 1, 30 x 1 or 90 x 1 tablets.
Maltese: MicardisPlus hu disponibbli f'pakketti tal-folji li fihom 14, 28, 56, 84, jew 98 pillola, jew pakketti talfolji bid-doża ta' l-unità li fihom 28 x 1, 30 x 1 jew 90 x 1 pillola.
English: Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of MicardisPlus, hyperkalaemia might occur.
Maltese: Għal kuntrarju, minħabba l-antaġoniżmu tar-riċetturi ta' angiotensin II (AT1) mill-komponent ta' telmisartan ta' MicardisPlus, tista' sseħħ l-iperkalemija.
English: Pack sizes: - Blister with 14, 28, 56, 84, or 98 tablets or - Perforated unit dose blisters with 28 x 1, 30 x 1 or 90 x 1 tablets.
Maltese: - Folja b'14, 28, 56, 84 jew 98 pillola jew - Folji perforati bid-doża ta' l-unità bi 28 x 1, 30 x 1 jew 90 x 1 pillola.
English: Hepatobiliary disorders Not known:
Maltese: Imblokkaturi beta u diazoxide:
English: MicardisPlus is available in blister packs containing 14, 28, 56, or 98 tablets, or unit dose blister packs containing 28 x 1, 30 x 1 or 90 x 1 tablets
Maltese: MicardisPlus hu disponibbli f'pakketti tal-folji li fihom 14, 28, 56, jew 98 pillola, jew pakketti tal-folji bid-doża ta' l-unità li fihom 28 x 1, 30 x 1 jew 90 x 1 pillola.
English: Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia, ,
Maltese: Anoreksja, tnaqqis fl-aptit, żbilanċ fl-elettroliti, iperkolesterolemija, ipergliċemija, ipovolemija
English: NAME OF THE MEDICINAL PRODUCT MicardisPlus 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: IL-PRODOTT MEDIĊINALI MicardisPlus 40 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: MicardisPlus 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the company logo and the code 'H8'.
Maltese: Il-pilloli MicardisPlus 80 mg/12.5 mg huma ħomor u bojod, b'forma ovali, b'żewġ saffi, imnaqqxa bil-logo tal-kumpanija u l-kodiċi 'H8'.
English: Yellow and white oval shaped tablet of 6.2 mm engraved with the company logo and the code 'H9'.
Maltese: Pillola safra u bajda ta' 6.2 mm, b'forma ovali, imnaqqxa bil-logo tal-kumpanija u l-kodiċi 'H9'.
English: Hydrochlorothiazide: Following oral administration of MicardisPlus peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Maltese: Wara l-għoti ta' MicardisPlus mill-ħalq, il-konċentrazzjonijiet massimi ta' hydrochlorothiazide jintlaħqu wara madwar 1.0 - 3.0 sigħat wara d-dożaġġ.
English: Periodic monitoring of serum potassium and ECG is recommended when MicardisPlus is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Maltese: Monitoraġġ perjodiku tal-livell tal-potassium fis-serum u ECG huma rakkomandati meta MicardisPlus jingħata ma' prodotti mediċinali affettwati minn disturbi fil-livell tal-potassium fis-serum (eż. digitalis glycosides, u anti-arritimiċi) u mal-prodotti mediċinali li ġejjin li jinduċu torsades de pointes (li jinkludu xi anti-arritimici ), bl-ipokalemija, li hi fattur li jippredisponi t-torsades de pointes.
English: Cough Interstitial lung disease
Maltese: Disturbi gastro-intestinali
English: EU/1/02/213/006 14 tablets EU/1/02/213/007 28 tablets EU/1/02/213/008 28 x 1 tablets EU/1/02/213/015 30 x 1 tablets EU/1/02/213/009 56 tablets EU/1/02/213/012 84 tablets EU/1/02/213/016 90 x 1 tablets EU/1/02/213/010 98 tablets
Maltese: EU/1/02/213/006 14-il pillola EU/1/02/213/007 28 pillola EU/1/02/213/008 28 x 1 pillola
English: MicardisPlus may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Maltese: MicardisPlus jista' jżid l-effett li jbaxxi l-pressjoni tad-demm ta' mediċini oħrajn jew ta' mediċini b'potenzjal li jbaxxu l-pressjoni tad-demm (eż. baclofen, amifostine).
English: The safety and efficacy of MicardisPlus in children and adolescents aged below 18 have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' MicardisPlus fit-tfal u l-adolexxenti li għandhom inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number} {product code}
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in MicardisPlus, minimal or no effects were reported.
Maltese: Żieda fil-livelli tal-kolesterol u tat-trigliċeridi kienet assoċjata ma' terapija dijuretika b'thiazide; madankollu, bid-doża ta' 12.5 mg li hemm f'MicardisPlus, effetti minimi kienu rrappurtati, jew l-ebda effett.
English: MicardisPlus is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Maltese: MicardisPlus hu taħlita ta' żewġ sustanzi attivi, telmisartan u hydrochlorothiazide f'pillola waħda.
English: Experience with MicardisPlus is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Maltese: L-esperjenza b'MicardisPlus hi modesta f'dawk il-pazjenti b'indeboliment renali minn ħafif sa moderat, u għalhekk, monitoraġġ pejodiku tal-livelli tal-potassium, tal-krejatinina u ta' l-uric acid serum hu rakkomandat.
English: Your doctor will normally advise you to stop taking MicardisPlus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of MicardisPlus.
Maltese: M'hemmx esperjenza dwar l-għoti ta' MicardisPlus f'pazjenti bi trapjant riċenti tal-kliewi.
English: Amantadine (medicine used to treat Parkinson's disease and also used to treat or prevent certain illnesses caused by viruses).
Maltese: - Amantadine (mediċina użata biex tikkura l-marda ta' Parkinson u tintuża wkoll bix tikkura jew tipprevjeni ċertu mard ikkawżat mill-viruses).
English: EU/1/16/1148/001 EU/1/16/1148/002
Maltese: EU/1/16/1148/002
English: • increased creatine kinase.
Maltese: • creatine kinase għolja.
English: Date of first authorisation: 9 November 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 9 Novembru 2016
English: 32 (9 to 55)
Maltese: 32 (9% sa 55)
English: • interleukin-2 (to treat cancer).
Maltese: • interleukin-2 (għat-trattament tal-kanċer).
English: Rare angioedema
Maltese: Rari anġjoedema
English: 41 (4 to 79)
Maltese: 41 (4% sa 79)
English: % difference (95% CI)
Maltese: Differenza (95%CI)
English: Importance of adherence
Maltese: L-importanza tal-aderenza
English: • amphotericin B (for fungal infection).
Maltese: • amphotericin B (għal infezzjoni fungali).
English: [outer packaging only]
Maltese: [għall-pakkett ta' barra]
English: Tablet core: microcrystalline cellulose, croscarmellose sodium, talc, hydrophobic colloidal silica, magnesium stearate.
Maltese: Qalba tal-pillola:microcrystalline cellulose, croscarmellose sodium, talc, hydrophobic colloidal silica, magnesium stearate.
English: Cmin: NC Ethinyl oestradiol:
Maltese: Ethinyl oestradiol:
English: • The active substances are emtricitabine and tenofovir disoproxil phosphate.
Maltese: • Is-sustanzi attivi huma emtricitabine u tenofovir disoproxil phosphate.
English: Contents of the pack:
Maltese: Kontenut tal-pakkett:
English: EU/1/16/1148/001 30 film-coated tablets EU/1/16/1148/002 90 (3x30) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1148/001 30 pillola miksija b'rita EU/1/16/1148/002 90 (3x30) pillola miksija b'rita
English: Age (Yrs), Median (Q1, Q3) Gender, N (%)
Maltese: Età (Snin), Medjana (Q1, Q3) Sess, N (%) Raġel Mara
English: Film coating: polyvinyl alcohol, titanium dioxide, macrogol, talc, indigo carmine aluminum lake (E 132).
Maltese: Kisja b'rita: polyvinyl alcohol, titanium dioxide, macrogol, talc, indigo carmine aluminum lake
English: Uncommon anaemia2
Maltese: Mhux komuni anemija2
English: Placebo (n = 1,584)
Maltese: Plaċebo (n = 1584)
English: Immune system disorders Common allergic reaction
Maltese: Disturbi fis-sistema immuni Komuni reazzjoni allerġika
English: The degree of renal impairment was defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 ml/min; mild impairment with CrCl = 50 - 79 ml/min; moderate impairment with CrCl = 30 - 49 ml/min and severe impairment with CrCl = 10 - 29 ml/min).
Maltese: Il-grad ta' indeboliment renali kien definit skont il-linja bażi tattneħħija tal-kreatinina (CrCl ) (funzjoni renali normali meta CrCl > 80 mL/min; indeboliment ħafif b'CrC = 50 - 79 mL/min; indeboliment moderat b'CrCl = 30 - 49 mL/min u indeboliment sever b'CrCl = 10 - 29 mL/min).
English: • Lactic acidosis (see Possible serious side effects)
Maltese: • Aċidożi lattika (ara Effetti sekondarji serji possibbli)
English: Uncommon pancreatitis
Maltese: Mhux komuni pankreatite
English: At baseline the randomised groups had similar median plasma HIV-1 RNA (5.02 and 5.00 log10 copies/ml) and CD4 counts (233 and 241 cells/mm3).
Maltese: Fil-linja bażi, il-gruppi randomised kellhom medjan simili ta' l-RNA talHIV 1 tal-plażma (5.02 u 5.00 log10 kopja/mlL u ta' l- għadd tas-CD4 (233 u 241 ċelluli/mm3).
English: • The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the emtricitabine/tenofovir disoproxil/efavirenz group and in 10/29 (34.5%) isolates analysed from the lamivudine/zidovudine/efavirenz group (p-value < 0.05, Fisher's Exact test comparing the emtricitabine/tenofovir disoproxil group to the lamivudine/zidovudine group among all patients).
Maltese: • Il-mutazzjoni M184V/I żviluppat fi 2/19 (10.5%) iżolati analizzati minn pazjenti fil-grupp ta' emtricitabine/tenofovir disoproxil /efavirenz u f'10/29 (34.5%) iżolati analizzati fil-grupp ta' lamivudine/zidovudine/efavirenz (valur p ta' < 0.05, it-Test 0ta' Fisher li qabbel il-grupp ta'emtricitabine+tenofovir disoproxil mal- grupp ta' lamivudine/zidovudine fost il-pazjenti kollha).
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 μg/ml.
Maltese: It-twaħħil in vitro ta' emtricitabine ma' proteini tal-plażma umana kienet ta' < 4% u indipendenti mill-konċentrazzjoni filmedda ta' 0.02 sa 200 μg/mL.
English: Number with Tenofovir Detected/Total Samples (%)
Maltese: Numru b'Tenofovir Skopert /Kampjuni Totali (%)
English: Excipient with known effect: each tablet contains a maximum of 9.53 mg sodium.
Maltese: Eċċipjent b'effett magħruf: kull pillola fiha massimu ta' 9.53 mg sodium.
English: Moderate renal impairment (CrCl 3049 ml/min)
Maltese: Indeboliment tal-kliewi moderat (CrCl 30-49 mL/min)
English: Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Maltese: Emtricitabine triphosphate u tenofovir diphosphate jinibixxu kompetittivament ir-reverse transcriptase ta' l-HIV 1 li jirriżulta fit-terminazzjoni tal-katina tad-DNA.
English: • cidofovir (for viral infection).
Maltese: • cidofovir (għal infezzjoni virali).
English: Uncommon angioedema3
Maltese: Mhux komuni anġjoedema3
English: Subjects were followed for 4,237 person-years.
Maltese: L-individwi kienu segwiti għal 4,237 sena ta' persuna.