FrancophonIA/ELRC3.0 huggingface dataset:
English: - Depression, inability to sleep, poor quality sleep, fainting, fainting sensation, fall, hangover, weakness, inability to get legs comfortable, increased sensitivity to touch, headache following injury, burning sensation, abnormal taste sensation
Maltese: - Depressjoni, inabbiltà li persuna torqod, kwalità ħażina tal-irqad, ħass ħażin, sensazzjoni ta' ħass ħażin, waqgħat, sensazzjoni ta' sakra, dgħjufija, inabbiltà li persuna żżomm saqajha rilassati, sensittività eċċessiva għall-ħass (touch), uġigħ ta' ras wara li tweġġa', sensazzjoni ta' ħruq, sensazzjoni ta' togħma mhux normali
English: Implant site hypertrophy Implant site pruritus Device expulsion Application site discolouration Hangover
Maltese: It-tabib sejjer jiddeċiedu miegħek dwar liema huwa l-aktar żmien adegwat u liema huwa s-sit l-aktar adegwat għall-inserzjoni tal-impjant.
English: Implant site oedema Pyrexia
Maltese: Studju fil-firien Sprague
English: This effect was observed only at exposure levels approximately 8 times higher than human exposure.
Maltese: Dan l-effett ġie osservat biss f'livelli ta' espożizzjoni ta' madwar 8 darbiet ogħla mill-espożizzjoni umana.
English: Implant site hypersensitivity Implant site reaction Implant site pain Implant site haematoma Implant site erythema Implant site irritation Asthenia
Maltese: Sensittività eċċessiva fis-sit tal-impjant Reazzjoni fis-sit talimpjant
English: The MAH shall also agree the details of the controlled access programme to ensure distribution of SCENESSE only to centres where the physicians received the educational materials and have been trained.
Maltese: Dan ifisser li minħabba li l marda hija rari ma kienx possibbli li tinkiseb informazzjoni sħiħa dwar dan il-prodott mediċinali.
English: Myalgia
Maltese: Menorraġja
English: Eyelid oedema Ocular hyperaemia Dry eye
Maltese: Uġigħ fl-estremitajiet talġisem
English: - Confirm insertion of the implant by palpating the skin with subcutis cranial to/overlying the suprailiac crest until the implant is located.
Maltese: - Ikkonferma l-inserzjoni tal-impjant billi tagħfas il-ġilda b'subcutis cranial sa/biex tiġi fuq is suprailiac crest sakemm issib l-impjant.
English: Restless leg syndrome Hyperaesthesia Presyncope
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Retrospective chart review study The MAH shall conduct a retrospective study comparing long term safety data and outcome endpoints in patients receiving and not receiving SCENESSE, or having discontinued SCENESSE use.
Maltese: Il-MAH għandu jwettaq studju retrospettiv li jqabbel id-data tas sigurtà fuq perjodu ta' żmien twil u l-punti finali tal-effett f'pazjenti li jkunu qed jirċievu SCENESSE u f'dawk li ma jkunux qed jirċievu
English: Since available data in treatment of the elderly are limited, afamelanotide should not be used in patients over 70 years of age.
Maltese: Peress li d-data disponibbli fil-kura tal-anzjani hija limitata, afamelanotide m'għandux jintuża f'pazjenti li għandhom aktar minn 70 sena.
English: - Inflamed lips, lip swelling, colouration on lip, gum pain, toothache, discoloured gums, reduced sense of touch in mouth, lip discolouration, tongue discolouration
Maltese: - Tertir ta' bard, deni, influwenza, marda simili għall-influwenza, imnieħer imblokkat, sinusijiet imblokkati, imnieħer u griżmejn infjammati, infjammazzjoni tal-imnieħer
English: Pigmentation lip Post inflammatory pigmentation change Seborrhoea
Maltese: Dismenorrea Sensibilita' tas-sider Mestrwazzjoni irregolari Tnixxija mill-vaġina Tnaqqis fil-libido
English: The safety profile is based on pooled data from clinical studies in 425 patients.
Maltese: Il-profil tas-sigurtà huwa bbażat fuq data miġbura minn studji kliniċi f'425 pazjent.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with SCENESSE in one or more subsets of the paediatric population in erythropoietic protoporphyria (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Abdominal discomfort Toothache
Maltese: Ematoma fis-sit tal-injezzjoni
English: Women who could become pregnant should use adequate contraception such as oral contraceptives, diaphragm plus spermicide, intrauterine device (also known as a coil) during treatment and for three months after the last SCENESSE implantation.
Maltese: Nisa li jistgħu jinqabdu tqal għandhom jużaw kontraċezzjoni adegwata bħal kontraċettivi orali, dijaframma u spermiċida, apparat intrauterin (intrauterine device) (magħruf ukoll bħala kolja- coil)
English: Haematoma Diastolic hypertension Hypertension
Maltese: Ipoesteżija orali
English: The implant may be removed by a simple surgical procedure if needed.
Maltese: L-impjant jista' jitneħħa bi proċedura kirurġika sempliċi jekk ikun hemm bżonn.
English: • Registry information sheet.
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Dysphonia Sinus congestion Rhinitis
Maltese: Irritazzjoni fis-sit talimpjant
English: This results in part from afamelanotide's resistance to immediate degradation by serum or proteolytic enzymes (see section
Maltese: Dan jirriżulta parzjalment minħabba r-reżistenza ta' afamelanotide għal degradazzjoni immedjata minn enzimi tasserum jew dawk proteolitiċi (ara sezzjoni 5.2).
English: This means that because of the rarity of this disease, for scientific reasons, and for ethical reasons it has been impossible to get complete information on this medicine.
Maltese: Tqala M'hemmx data, jew hemm data limitata, dwar l-użu ta' afamelanotide f'nisa tqal.
English: - General changes to the skin including freckles and skin darkening; - migraine (a severe headache); - back pain; - abdominal (tummy) pain, - diarrhoea and vomiting,
Maltese: - epilessija (jew qalulek li għandek riskju li jkollok puplesiji); - anemija (għedud baxxi ta' ċelloli tad-demm ħomor f'demmek);
English: BindRen colestilan
Maltese: BindRen kolestilan
English: The full EPAR for BindRen 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: It is available as tablets (1 g) and as granules (sachets containing 2 or 3 g).
Maltese: Jiġi f'pilloli (1 g) u fi granuli (qratas ta' 2 jew 3 g).
English: The third study also showed that BindRen was more effective than placebo when used at doses of 6, 9, 12 and 15 g/day: compared with placebo, the reduction in blood phosphate levels seen with BindRen was 0.16, 0.21, 0.19 and 0.37 mmol/l respectively.
Maltese: It-tielet studju wera li BindRen kien iżjed effikaċi mill-plaċebo meta ntuża f'dożi ta' 6, 9, 12 u 15 kuljum: apparagun mal-plaċebo, it-tnaqqis fil-livelli tal-fosfat fid-demm li ġie rreġistrat bl-użu ta' BindRen kien 0.16, 0.21, 0.19 and 0.37 mmol/l rispettivament.
English: The active substance in BindRen, colestilan, is a phosphate binder.
Maltese: Is-sustanza attiva f'BindRen, il-kolestilan, hija sustanza li teħel mal-fosfat.
English: This is a summary of the European public assessment report (EPAR) for BindRen.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal BindRen.
English: BindRen is a medicine that contains the active substance colestilan.
Maltese: BindRen huwa mediċina li fih is-sustanza attiva kolestilan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BindRen on 21 January 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal BindRen valida fl-Unjoni Ewropea kollha fil-21 ta' Jannar 2013.
English: BindRen was investigated in two main studies involving 273 adults with long-term kidney disease and hyperphosphataemia.
Maltese: BindRen ġie studjat f'żewġ studji ewlenin fuq 273 adult bi storja medika twila ta' mard renali u iperfosfatemija.
English: BindRen is used to control hyperphosphataemia (high blood phosphate levels) in adults with long-term kidney disease who are on dialysis (a blood clearance technique).
Maltese: BindRen jintuża għall-kontroll tal-iperfosfatemija (livelli għoljin ta' fosfat fid-demm) f'pazjenti adulti bi storja medika twila ta' insuffiċjenza renali li jkunu qed jingħataw it-trattament tad-dijaliżi (teknika tattisfija tad-demm).
English: What is BindRen?
Maltese: X'inhu BindRen?
English: Similarly in the second study, an average dose of 13.1 g of BindRen resulted in a reduction of the blood phosphate level by 0.50 mmol/l on average after three months.
Maltese: B'mod simili, fit-tieni studju, b'doża medja ta' 13.1 g ta' BindRen il-livell tal-fosfat fid-demm naqas b'medja ta' 0.50 mmol/l wara tliet xhur.
English: In the first study, an average dose of 11.5 g of BindRen reduced the blood phosphate level by 0.36 mmol/l on average after three months.
Maltese: Fl-ewwel studju, b'doża medja ta' 11.5 g ta' BindRen il-livell tal-fosfat fid-demm naqas b'medja ta' 0.36 mmol/l wara tliet xhur.
English: The most serious reported side effects with BindRen were gastrointestinal haemorrhage (bleeding in the stomach and gut) and constipation.
Maltese: Liżjed effetti sekondarji serji rrapurtati bl-użu ta' BindRen kienu emorraġija gastrointestinali (ħruġ ta' demm fl-istonku u fl-imsaren) u konstipazzjoni.
English: The CHMP noted that treatment with BindRen has a beneficial effect in lowering phosphate levels.
Maltese: Is-CHMP innota li t-trattament b'BindRen għandu effett pożittiv fit-tnaqqis tal-livelli ta' fosfat fiddemm.
English: Why has BindRen been approved?
Maltese: Għaliex ġie approvat BindRen?
English: What is the risk associated with BindRen?
Maltese: X'inhu r-riskju assoċjat ma' BindRen?
English: The effects of BindRen were first tested in experimental models before being studied in humans.
Maltese: Għall-ewwel l-effetti ta' BindRen ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: How is BindRen used?
Maltese: Għal xiex jintuża BindRen?
English: It is used in patients on haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Maltese: Jista' jintuża f'pazjenti li jkunu qed jingħataw it-trattament tal-emodijaliżi (bl-użu ta' magna li tiffiltra d-demm) jew tad-dijaliżi peritoneali (meta jiġi ppumpjat fluwidu fiż-żaqq u mbagħad membrana interna tiffiltra d-demm).
English: The CHMP decided that BindRen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' BindRen huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has BindRen been studied?
Maltese: Kif ġie studjat BindRen?
English: Further information on Biktarvy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Biktarvy tista' tinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Biktarvy
Maltese: Informazzjoni oħra dwar Biktarvy
English: Biktarvy 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: Biktarvy huwa mediċina antivirali li tintuża fil-kura ta' adulti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: Biktarvy is available as tablets, each containing 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide.
Maltese: Biktarvy huwa disponibbli bħala pilloli, li kull waħda minnhom fiha 50 mg ta' bictegravir, 200 mg ta' emtricitabine, u 25 mg ta' tenofovir alafenamide.
English: What are the risks associated with Biktarvy?
Maltese: X'inhuma r-riskji assoċjati ma' Biktarvy?
English: The second study compared Biktarvy with dolutegravir plus emtricitabine/tenofovir alafenamide in 645 patients: 89% (286 out of 320) of patients taking Biktarvy achieved satisfactory viral load reduction, compared with 93% (302 out of 325) of patients on the comparator.
Maltese: It-tieni studju qabbel lil Biktarvy ma' dolutegravir flimkien ma' emtricitabine/tenofovir alafenamide f'645 pazjent: 89 % (286 minn 320) tal-pazjenti li ħadu Biktarvy kisbu tnaqqis sodisfaċenti fil-kontenut virali, meta mqabbla ma' 93 % (302 minn 325) tal-pazjenti li ħadu l-komparatur.
English: • Bictegravir is a type of antiviral agent called an ‘integrase inhibitor'.
Maltese: • Bictegravir huwa tip ta' sustanza antivirali msejħa “inibitur ta' integrażi”.
English: Biktarvy was shown to be as effective as comparator antiviral medicines.
Maltese: Biktarvy intwera li huwa effettiv daqs mediċini antivirali komparaturi.
English: Side effects were similar to those of medicines of the same class.
Maltese: L-effetti sekondarji kienu simili għal dawk ta' mediċini tal-istess klassi.
English: • Emtricitabine is another type of NRTI (a nucleoside reverse transcriptase inhibitor) and it works in the same way as tenofovir.
Maltese: • Emtricitabine hija inibitur ta' NRTI (inibitur nukleosidiku tat-transkrittażi inversa) u dan jaħdem blistess mod bħal tenofovir.
English: Overall, 92% of patients taking Biktarvy (290 out of 314) achieved viral load reduction, compared with 93% (293 out of 315) of patients who achieved it with the comparator.
Maltese: B'mod ġenerali, 92 % tal-pazjenti li ħadu Biktarvy (290 minn 314) kisbu tnaqqis fit-tagħbija virali, meta mqabbla mat-93 % (293 minn 315) tal-pazjenti li kisbuh bil-komparatur.
English: Biktarvy contains three active substances which work in different ways against HIV:
Maltese: Biktarvy fih tliet sustanzi attivi li jaħdmu b'modi differenti kontra l-HIV:
English: Biktarvy contains the active substances bictegravir, emtricitabine and tenofovir alafenamide.
Maltese: Biktarvy fih is-sustanzi attivi bictegravir, emtricitabine u tenofovir alafenamide.
English: • Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Maltese: • Tenofovir alafenamide hija “promediċina” ta' tenofovir, li jfisser li tiġi kkonvertita fis-sustanza attiva tenofovir fil-ġisem.
English: In the first study, Biktarvy was compared with another antiviral medicine containing abacavir, dolutegravir and lamivudine in 629 patients.
Maltese: Fl-ewwel studju, Biktarvy tqabbel ma' mediċina antivirali oħra li fiha abacavir, dolutegravir u lamivudine f'629 pazjent.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI), which means that it blocks the activity of reverse transcriptase, another enzyme of the virus that allows it to reproduce itself.
Maltese: Tenofovir hija inibitur nukleosidiku tat-transkrittażi inversa (NRTI), li jfisser li dan jimblokka l-attività ta' transkrittażi inversa, enzima oħra tal-virus li tippermettilu jirriproduċi lilu nnifsu.
English: In the second study, the viral load went above the threshold in 2% (5 out of 290) of patients switched to Biktarvy, and in 2% (5 out of 287) of patients who stayed on their previous treatment (‘boosted' atazanavir or darunavir plus either emtricitabine/tenofovir or abacavir/lamivudine).
Maltese: Fit-tieni studju, il-kontenut virali qabeż il-limitu fi 2 % (5 minn 290) tal-pazjenti li qalbu għal Biktarvy, u fi 2 % (5 minn 287) tal-pazjenti li baqgħu fuq il-kura preċedenti tagħhom (atazanavir jew darunavir “imsaħħaħ” flimkien ma' emtricitabine/tenofovir jew abacavir/lamivudine).
English: Two studies involved adults infected with HIV-1 who had not been treated previously, and looked at the numbers whose viral load (the amount of HIV-1 in the blood) was reduced to less than 50 copies per ml after 48 weeks of treatment.
Maltese: Żewġ studji kienu jinvolvu adulti infettati bl-HIV-1 li ma kinux ġew ikkurati qabel, u ħarsu lejn innumru li l-kontenut virali tagħhom (l-ammont ta' HIV-1 fid-demm) tnaqqas għal anqas minn 50 kopja kull ml wara 48 ġimgħa ta' kura.
English: As for all medicines, data on the use of Biktarvy are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Biktarvy hija ssorveljata kontinwament.
English: In one study, the percentage of patients with viral load greater than or equal to 50 copies/ml was 1% (3 out of 282) of patients who switched to Biktarvy, compared with 0.5% (1 out of 281) of patients who stayed on their previous treatment (dolutegravir, abacavir, lamivudine).
Maltese: Fi studju minnhom, il-perċentwal ta' pazjenti b'kontenut virali akbar minn jew daqs 50 kopja/ml kien 1 % (3 minn 282) tal-pazjenti li qalbu għal Biktarvy, meta mqabbel ma' 0.5 % (1 minn 281) tal-pazjenti li baqgħu fuq il-kura preċedenti tagħhom(dolutegravir, abacavir, lamivudine).
English: How is Biktarvy used?
Maltese: Kif jintuża Biktarvy?
English: What measures are being taken to ensure the safe and effective use of Biktarvy?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Biktarvy?
English: The most common side effects with Biktarvy (which may affect around 1 in 20 people) are headache, diarrhoea and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni b'Biktarvy (li jistgħu jaffettwaw aktar minn 1 minn kull 20) huma wġigħ ta' ras, dijarea u nawsja (tħossok ma tiflaħx).
English: The benefits of Biktarvy in the treatment of HIV infection were investigated in four main studies.
Maltese: Il-benefiċċji ta' Biktarvy fil-kura tal-infezzjoni tal-HIV ġew investigati f'erba' studji ewlenin.
English: Side effects reported with Biktarvy are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Biktarvy huma evalwati bir-reqqa u tittieħed kull azzjoni meħtieġa għallprotezzjoni tal-pazjenti.
English: For the full list of side effects of Biktarvy, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Biktarvy, ara l-fuljett ta' tagħrif.
English: Table 2: Meta-analysis on studies of Creinin et al., 2006 and Glasier et al., 2010
Maltese: Tabella 2: Metanaliżi fuq studji ta' Creinen et al., 2006 u Glasier et al., 2010
English: Pregnancy rate 0.9% 1.3% 1.4% 6.4% 5.7%
Maltese: Ir-rata ta' tqala (95% CI) skont il-kategoriji ta' piż Piż (kg) N totali N tqal Rata ta' tqala 0,9 % 1,3 % 1,4 % 6,4 % 5,7 % Intervall ta' fiduċja
English: When should emergency contraception be used?
Maltese: Meta għandha tintuża kontraċezzjoni ta' emerġenza?
English: For Levonorgestrel-containing emergency contraceptive medicinal products A. Summary of product characteristics
Maltese: Għal prodotti mediċinali kontraċettivi ta' emerġenza li fihom Levonorgestrel A.
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010)
Maltese: Tabella 1: Metanaliżi fuq tliet studji tal-WHO (Von Hertzen et al., 1998 u 2002;
English: In three WHO studies no trend for a reduced efficacy with increasing body weight/BMI was observed (Table 1), whereas in the two other studies (Creinin et al., 2006 and Glasier et al., 2010) a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table 2).
Maltese: Fi tliet studji tal-WHO, ma ġiet osservata ebda tendenza għal effikaċja mnaqqsa b'żieda fil-piż tal-ġisem/BMI (Tabella 1), filwaqt li fiż-żewġ studji l-oħrajn (Creinin et al., 2006 u Glasier et al., 2010), ġiet osservata effikaċja kontraċettiva mnaqqsa b'żieda fil-piż tal-ġisem jew BMI (Tabella 2).
English: Both meta-analyses excluded intake later than 72 hours after unprotected intercourse (i.e. off-label use of levonorgestrel) and women who had further acts of unprotected intercourse.
Maltese: Iż-żewġ metanaliżi jeskludu t-teħid aktar tard minn 72 siegħa wara kopulazzjoni mhux protetta (jiġifieri użu ‘off-label' ta' levonorgestrel) u nisa li kellhom aktar atti ta' kopulazzjoni mhux protetta.
English: [The information below should be deleted together with the table] In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more and levonorgestrel was not effective in women who weighed more than 80 kg (see sections 4.2 and 4.4).
Maltese: [L-informazzjoni ta' hawn taħt għandha titħassar flimkien mat-tabella] Fi provi kliniċi, l-effikaċja kontraċettiva tnaqqset f'nisa li jiżnu 75 kg jew aktar, u levonorgestrel ma kienx effettiv f'nisa li jiżnu aktar minn 80 kg (ara sezzjonijiet 4.2 u 5.1).
English: Ask your doctor or pharmacist for advice on alternative methods of emergency contraception.
Maltese: Staqsi lit-tabib jew lill-ispiżjar tiegħek għal parir dwar metodi alternattivi ta' kontraċezzjoni ta' emerġenza.
English: There is limited and inconclusive data on the effect of high body weight/high BMI on the contraceptive efficacy.
Maltese: Hemm dejta limitata jew inkonklużiva dwar l-effett ta' piż kbir tal-ġisem/BMI għoli fuq l-effikaċja kontraċettiva.
English: Studies suggest that <invented name> is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg.
Maltese: Studji jissuġġerixxu li <isem ivvintat> huwa inqas effettiv f'nisa li jiżnu 75 kg jew aktar u mhuwiex effettiv f'nisa li jiżnu aktar minn 80 kg.
English: You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.
Maltese: Inti rrakkomandat/a li tkellem professjonista tal-kura tas-saħħa jekk inti mħassba dwar xi problema relatata mat-teħid ta' kontraċezzjoni ta' emerġenza.
English: Take special care with <invented name> <strength> tablet
Maltese: Oqgħod attent/a meta tuża <isem ivvintat> <qawwa> pillola
English: Limited and inconclusive data suggest that there may be reduced efficacy of <invented name> with increasing body weight or body mass index (BMI) (see section 5.1).
Maltese: Dejta limitata u inkonklużiva tissuġġerixxi li l-effikaċja ta' <isem ivvintat> tista' tonqos iktar ma jkun għoli l-piż tal-ġisem jew l-indiċi tal-massa tal-ġisem (BMI) (ara s-sezzjoni 5.1).
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Maltese: Anness III Emendi għas-sezzjonijiet relevanti tas-sommarju tal-karatteristiċi tal prodott u fuljett ta' tagħrif
English: Section 4.4 Special warnings and precautions for use
Maltese: Sezzjoni 4.4
English: B. Package leaflet
Maltese: Sezzjoni 5
English: [The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Maltese: [L-informazzjoni eżistenti dwar il-prodott għandha tiġi emendata (inserzjoni, sostituzzjoni jew tneħħija tat-test skont kif ikun meħtieġ) sabiex tirrifletti l-formolazzjoni tal-kliem maqbula kif ipprovdut hawn taħt]
English: There is some evidence that <invented name> may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.
Maltese: Hemm xi evidenza li <isem ivvintat> jista' jkun inqas effettiv hekk kif il-piż tal-ġisem jew l-indiċi tal-massa tal-ġisem (BMI) jiżdiedu, iżda din id-dejta hija limitata u inkonklużiva.
English: - if you weigh 75 kg or more (see “What <invented name> <strength> tablet is and what it is used for” for further details)
Maltese: - jekk tiżen 75 kg jew aktar (ara “X'inhu <isem ivvintat> <qawwa> pillola u għal xhiex jintuża” għal aktar dettalji)
English: Linearity/non-linearity
Maltese: Linearità/non-linearità
English: 250 tablets
Maltese: 30 pilloli 250 pilloli
English: Possible side effects of telmisartan:
Maltese: Effetti sekondarji possibli ta' telmisartan:
English: 14 tablets 28 tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets 100 tablets
Maltese: 14 pilloli 28 pilloli 30 pilloli 56 pilloli 84 pilloli 90 pilloli 98 pilloli 100 pilloli
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA07.
Maltese: Antagonisti ta' angiotensin II, sempliċi, kodiċi ATC: C09CA07.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS):
Maltese: Imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS)