FrancophonIA/ELRC3.0 huggingface dataset:
English: As a result the CHMP endorsed the MAH's proposal for this indication with the addition of the related population (i.e. adults only).
Maltese: B'riżultat ta' dan is-CHMP approva l-proposta tal-MAH għal din l-indikazzjoni iżda biż-żieda talpopolazzjoni relatata (jiġifieri, adulti biss).
English: The wording in section 5.3 is based on the MAH's CDS expect for a change from “mutagenic” to “genotoxic” and the addition of fertility data.
Maltese: Il-kliem fis-sezzjoni 5.3 huwa bbażat fuq is-CDS tal-MAH ħlief għal bidla minn “mutaġeniku” għal “ġenotossiku” u ż-żieda ta' dejta dwar il-fertilità.
English: Finally, the CHMP was of the view that the non-recommendation for the use of EMLA on genital skin for children should be introduced in section 4.4 as well in accordance with the wording in 4.2.
Maltese: Fl-aħħar nett, is-CHMP kien tal-fehma li n-nuqqas ta' rakkomandazzjoni għall-użu ta' EMLA fuq il-ġilda ġenitali għat-tfal għandu jkun introdott fis-sezzjoni 4.4 kif ukoll skont il-kliem f'4.2.
English: An additional subheading section on repeated application to leg ulcers was proposed compared to the CDS; this was discussed during the PSUR work sharing procedure and agreed to be included in this section.
Maltese: Kienet proposta sezzjoni addizzjonali b'sottointestatura dwar l-applikazzjoni ripetuta fuq l-ulċeri fir-riġlejn li ma tidhirx fis-CDS; dan kien diskuss waqt il-proċedura ta' ħidma kondiviża dwar il-PSUR u kien hemm qbil li tiġi inkluża f'din is-sezzjoni.
English: Section 4.7 - Effects on ability to drive and use machines The MAH proposed the following harmonised SmPC text in line with the agreed CSP.
Maltese: Il-MAH ippropona dan it-test armonizzat li ġej għall-SmPC skont is-CSP li sar qbil dwaru.
English: The CHMP requested the inclusion of a warning for the paediatric population as regards the maximum number of doses in 24 hours.
Maltese: Is-CHMP talab l-inklużjoni ta' twissija għall-popolazzjoni pedjatrika rigward in-numru massimu ta'dożi f'24 siegħa.
English: The CHMP was of the view that efficacy in genital mucosa indications such as application prior to superficial surgical procedures or infiltration anaesthesia when used in adults has been demonstrated in a number of clinical studies.
Maltese: L-effikaċja f'indikazzjonijiet tal-ġilda intatta bħal “inserzjoni bil-labra” u “proċeduri kirurġiċi superfiċjali” intweriet f'għadd ta' studji kliniċi u hija kkunsidrata aċċettabbli.
English: The CHMP addressed a list of questions to the MAH, pointing out the sections of the products SmPC where divergences existed.
Maltese: Is-CHMP indirizza lista ta' mistoqsijiet lid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fuq is-Suq (MAH), fejn indika s-sezzjonijiet tal-SmPC tal-prodott fejn jeżistu diverġenzi.
English: Regarding the posology and the application time for paediatric patients the information was presented by the MAH per age group and per related procedure in a tabular format.
Maltese: L-informazzjoni rigward il-pożoloġija u l-ħin ta' applikazzjoni għall-pazjenti pedjatriċi kienet ippreżentata mill-MAH għal kull grupp ta' età u skont il-proċedura relatata f'forma ta' tabella.
English: The CHMP commented that in the CSP and in the German SmPC “allergic reactions (in the most severe cases anaphylactic shock)” is listed instead.
Maltese: Is-CHMP ikkumenta li fis-CSP u fl-SmPC tal-Ġermanja hemm elenkat minflok “ reazzjonijiet allerġiċi (fil-każijiet l-aktar severi xokk anafilattiku)”.
English: The clinical justification for the dosage in adolescents referring to the similarity of the thickness of the stratum corneum (the ratelimiting barrier for percutaneous absorption) in adults and adolescents was considered acceptable by the CHMP.
Maltese: Fir-rigward tal-adolexxenti ta' 12-il sena jew aktar, l-ebda kliem ma ġie implimentat qabel fl-SmPCs bl-eċċezzjoni ta' żewġ pajjiżi.
English: The MAH provided an updated text for pregnancy taking into consideration the comments of CHMP and the new wording was endorsed by the Committee.
Maltese: Dawn l-emendi kollha kienu kkunsidrati rilevanti mis-CHMP u ġew approvati.
English: The full EPAR for Firazyr 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: Firazyr contains the active substance icatibant.
Maltese: Firazyr fih is-sustanza attiva ikatibant.
English: This is a summary of the European public assessment report (EPAR) for Firazyr.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Firazyr.
English: Other information about Firazyr
Maltese: Informazzjoni oħra dwar Firazyr
English: Firazyr is used in patients whose angioedema is linked to naturally low levels of a protein called ‘C1 esterase inhibitor'.
Maltese: Firazyr jintuża f'pazjenti li l-enġjoedema hija marbuta ma' livelli baxxi naturali ta' proteina msejħa ‘inibitur esterażi C1'.
English: Because the number of patients with angioedema is low, the disease is considered ‘rare', and Firazyr was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 February 2003.
Maltese: Peress li n-numru ta' pazjenti li jbatu bl-anġjoedema huwa baxx, il-marda hija kkunsidrata “rari” u Firazyr ġie kklassifikat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) fis-17 ta' Frar 2003.
English: Patients' symptoms were relieved on average 2 to 2.5 hours after receiving Firazyr, compared with 12 hours for tranexamic acid in one study and 4.6 hours for placebo in the other study.
Maltese: Is-sintomi tal-pazjenti ttaffew fuq medja ta' 2 sa 2.5 sigħat wara li ngħataw Firazyr, meta mqabbla ma' 12-il siegħa għall-aċidu traneksemiku u 4.6 sigħat għall-plaċebo fl-istudju l-ieħor.
English: Why is Firazyr approved?
Maltese: Għal xiex ġiet approvat Firazyr?
English: Each pre-filled syringe of Firazyr contains 30 mg icatibant in 3 ml.
Maltese: Kull siringa mimlija minn qabel ta' Firazyr fiha 30mg ikatibant fi 3ml.
English: What are the risks associated with Firazyr?
Maltese: X'inhuma r-riskji assoċjati ma' Firazyr?
English: The recommended dose of Firazyr in adults is one injection (3 ml).
Maltese: Id-doża rakkomandata ta' Firazyr fl-adulti hija injezzjoni waħda (3ml).
English: The active substance in Firazyr, icatibant, blocks the receptors that bradykinin normally attaches to.
Maltese: Is-sustanza attiva f'Firazyr, l-ikatibant, timblokka rriċetturi li bradikinin normalment jeħel magħhom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Firazyr on 11 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Firazyr fil-11 ta' Lulju 2008.
English: The most common side effects with Firazyr (seen in more than 1 patient in 10) are injection site reactions including erythema (redness), swelling, burning, itching and pain at injection sites.
Maltese: L-effetti sekondarji l-aktar komuni b'Firazyr (li dehru f'aktar minn pazjent wieħed minn 10) huma reazzjonijiet fis-sit tal- injezzjoni inkluż eritema (ħmura), nefħiet, ħruq, ħakk u wġigħ fis-siti talinjezzjoni.
English: The first study compared Firazyr with tranexamic acid (another medicine for hereditary angioedema) in 74 patients, and the second study compared Firazyr with placebo (a dummy treatment) in 56 patients.
Maltese: L-ewwel studju qabbel Firazyr mal-aċidu traneksamiku (mediċina oħra użata għal anġjoedema li tintiret) f'74 pazjent, u t-tieni studju qabbel Firazyr ma' plaċebo (kura finta) f'56 pazjent.
English: In another study involving 22 adolescents and children aged over 2 years with hereditary angioedema, symptoms improved on average 1 hour after the patients received Firazyr.
Maltese: Fi studju ieħor li involva 22 adoloxxent u tfal li għandhom minn sentejn 'il fuq b'anġjoedema li tintiret, is-sintomi tjiebu fuq medja ta' siegħa wara li l-pazjenti ngħataw Firazyr.
English: Firazyr icatibant
Maltese: Dan mhux intiż biex jipprov
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Firazyr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designations Dan is-sommarju ġie aġġornat l-aħħar f'10-2017.
English: Patients with hereditary angioedema have high levels of a substance called ‘bradykinin', which is involved in causing inflammation and swelling.
Maltese: Pazjenti li jbatu bl-anġjoedema li tintiret ikollhom livelli għoljin ta' sustanza msejħa ‘bradikinin', li hija involuta fl-ikkawżar ta' infjammazzjoni u nefħa.
English: The medicine is given by injecting it slowly under the skin, preferably in the abdomen (belly).
Maltese: Il-mediċina tingħata billi tinjettaha bil-mod taħt il-ġilda, preferibbilment fl-addome (fiż-żaqq).
English: Firazyr is a medicine used to treat the symptoms of attacks of hereditary angioedema in adults, adolescents and children aged over 2 years.
Maltese: Firazyr huwa mediċina li tintuża biex jikkura s-sintomi ta' attakki ta' anġjoedema li tintiret fl-adulti, ladoloxxenti u t-tfal minn sentejn 'il fuq.
English: For the list of all side effects and restrictions with Firazyr, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Firazyr, ara l-fuljett ta' tagħrif.
English: No more than three injections should be given in any 24-hour period.
Maltese: Ma għandhomx jingħataw aktar minn tliet injezzjonijiet f'perjodu ta' 24 siegħa.
English: Firazyr was also found effective among patients included in the two studies who had attacks of angioedema that affected the throat.
Maltese: Firazyr instab li kien effettiv ukoll fost pazjenti inklużi fiż-żewġ studji li kellhom attakki ta' anġjoedema li affettwaw ilgerżuma.
English: What measures are being taken to ensure the safe and effective use of Firazyr?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Firazyr?
English: How is Firazyr used?
Maltese: Kif jaħdem Firazyr?
English: The full EPAR for Vitekta 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 is a summary of the European public assessment report (EPAR) for Vitekta.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vitekta.
English: Vitekta is an antiviral medicine that contains the active substance elvitegravir.
Maltese: Vitekta huwa mediċina antivirali li fiha s-sustanza attiva elvitegravir.
English: It is used to treat adults with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Maltese: Tintuża fil-kura tal-adulti bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu mill-immunodefiċjenza akkwiżita (AIDS).
English: The active substance in Vitekta, elvitegravir, is a type of antiviral agent called an ‘integrase inhibitor'.
Maltese: Is-sustanza attiva f'Vitekta, l-elvitegravir, hija tip ta' aġent antivirali msejjaħ “inibitur tal-integrasi”.
English: After 48 weeks, around 59% of patients treated with Vitekta (207 out of 351) responded to treatment compared with around 58% of patients treated with
Maltese: Wara 48 ġimgħa, madwar 59 % tal-pazjenti kkurati b'Vitekta (207 minn 351) irrispondew għall-kura meta mqabbla ma' madwar 58 % tal-pazjenti kkurati
English: The most common side effects with Vitekta (which may affect up to 1 in 10 people) are headache, abdominal pain (stomach ache), diarrhoea, vomiting, nausea (feeling sick), rash, fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Vitekta (li jistgħu jaffettwaw sa 1 minn kull 10) huma uġigħ ta' ras, uġigħ fl-addome (uġigħ fl-istonku), dijarrea, remettar, nawżja (tħossok ma tiflaħx), raxx, għeja.
English: Vitekta is available as tablets (85 and 150 mg); the recommended dose is one tablet a day, taken with food.
Maltese: Vitekta jiġi bħala pilloli (85 u 150 mg); id-doża rakkomandata hija ta' pillola waħda kuljum, li għandha tittieħed mal-ikel.
English: Vitekta has been investigated in one main study involving 712 patients with HIV-1 who had not been treated before with an integrase inhibitor.
Maltese: Vitekta ġie mistħarreġ fi studju ewlieni wieħed li involva 712-il pazjent b'HIV-1 li ma ġewx ikkurati qabel b'inibitur tal-integrasi.
English: It blocks an enzyme called integrase, which is involved in a step in the reproduction of HIV.
Maltese: Jimblokka enzima msejħa integrasi, li hija involuta fi stadju fir-riproduzzjoni tal-HIV.
English: It is used in combination with ‘protease inhibitor' medicines taken together with ritonavir, and with other anti-HIV medicines in patients whose disease is not expected to be resistant
Maltese: Jintuża flimkien ma' mediċini tal-“inibituri tal-proteażi” li jittieħdu flimkien ma' ritonavir, u ma' mediċini oħra kontra l-HIV f'pazjenti li l-marda tagħhom mhix mistennija li tkun
English: Patients who attained a viral load of less than 50 copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Maltese: Il-pazjenti li kisbu tagħbija virali ta' anqas minn 50 kopja/ml wara 48 ġimgħa ta' kura kienu kkunsidrati bħala li rrispondew għall-kura.
English: Regarding the safety profile of the medicine, this was not considered of concern, with side effects comparable to other similar medicines.
Maltese: Rigward il-profil tas-sigurtà tal-mediċina, dan ma kienx ikkunsidrat bħala ta' tħassib, b'effetti sekondarji komparabbli ma' mediċini oħra simili.
English: In this study, Vitekta was at least as effective as raltegravir (another integrase inhibitor) when taken in combination with other anti-HIV medicines.
Maltese: F'dan l-istudju, Vitekta kien tal-anqas effikaċji daqs raltegravir (inibitur ieħor tal-integrasi) meta ttieħed flimkien ma' mediċini oħra kontra l-HIV.
English: The CHMP concluded that the benefits of Vitekta in reducing the levels of HIV in the blood had been clearly shown in studies.
Maltese: Is-CHMP ikkonkluda li l-benefiċċji ta' Vitekta fit-tnaqqis tal-livelli ta' HIV fid-demm kienu ntwerew b'mod ċar flistudji.
English: When the enzyme is blocked, the virus cannot reproduce normally, slowing down the spread of infection.
Maltese: Meta l-enzima tiġi mblokkata, il-virus ma jistax jirriproduċi ruħu b'mod nornali, u dan inaqqas it-tifrix tal-infezzjoni.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vitekta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Vitekta huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: For the full list of all side effects reported with Vitekta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Vitekta, ara l-fuljett ta' tagħrif.
English: This summary was last updated in 11/2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 11/2013.
English: Vitekta does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Il-Kumitat innota wkoll li hemm potenzjal sinifikanti għal interazzjonijiet ma' mediċini oħra, u dan ġie rifless fl-informazzjoni dwar il-prodott.
English: A risk management plan has been developed to ensure that Vitekta is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Vitekta jintuża bl-aktar mod sigur possibbli.
English: Bartók Béla út 43-47 H-1114 Budapest
Maltese: Bartók Béla út 43-47 H-1114
English: Stella-Klein-Löw-Weg 17 A-1020 Wien
Maltese: Stella-Klein-Löw-Weg 17 A-1020
English: P-2710-444 Sintra
Maltese: P-2710-444
English: Kemistvägen 1B P.O.
Maltese: Kemistvägen 1B P.O. Box 1150
English: Lyngbyvej 172 DK-2100 København Ø
Maltese: Lyngbyvej 172 DK-2100
English: • The active substance is valsartan.
Maltese: • Is-sustanza attiva hija valsartan.
English: Pharmacotherapeutic group: Angiotensin II Antagonists, plain, ATC code: C09CA03
Maltese: Antagonisti ta' Angiotensin II, wa edhom, Kodi i ATC: C09CA03
English: Valsartan shows multiexponential decay kinetics (t½ <1 h and t½ß about 9 h).
Maltese: Valsartan juri kinetika ta' di integrazzjoni multiesponenzjali (t½ <1 h u t½ß madwar 9 h).
English: Valsartan dose
Maltese: Id-do a ta' valsartan
English: Mean absolute bioavailability is 23% and 39% with tablets and solution formulation, respectively.
Maltese: Ilbijodisponibiltà assoluta medja hija ta' 23% u 39% bil-pilloli u l-formulazzjoni tas-soluzzjoni rispettivament.
English: Artificial blueberry flavour (538926 C) Propylene glycol (E1520) Sodium hydroxide
Maltese: Tog ma artifi jali tal-blueberry (538926 C) Propylene glycol (E1520) Sodium hydroxide
English: Methyl parahydroxybenzoate (E218) Potassium sorbate
Maltese: Methyl parahydroxybenzaote (E218) Potassium sorbate
English: Adverse reactions are ranked by frequency, the most frequent first, using the following convention: very common ( 1/10); common ( 1/100 to <1/10); uncommon ( 1/1,000 to <1/100); rare ( 1/10,000 to <1/1,000) very rare (<1/10,000), including isolated reports.
Maltese: Ir-reazzjonijet avversi huma mni la skond il-frekwenza, bl-aktar frekwenti l-ewwel, bl-u u talkonvenzjoni li ejja: komuni afna ( 1/10); komuni ( 1/100 sa <1/10); mhux komuni ( 1/1,000 sa <1/100); rari ( 1/10,000 sa <1/1,000) rari afna (<1/10,000), inklu rapporti i olati.
English: Each ml solution contains 0.3 g sucrose, 1.62 mg methyl parahydroxybenzoate (E218) and 5 mg poloxamer (188)
Maltese: Kull ml ta' soluzzjoni fiha 0.3 g sucrose, 1.62 mg methyl parahydroxybenzaote (E218) u 5 mg poloxamer (188).
English: • angioedema (see section “Some symptoms need immediate medical attention”)
Maltese: • an jodema (ara s-sezzjoni “Xi sintomi je tie u attenzjoni medika immedjata”)
English: Nervous system disorders Common
Maltese: Disturbi fis-sistema nervu a Komuni
English: Valsartan is highly bound to serum proteins (94-97%), mainly serum albumin.
Maltese: Valsartan huwa mwa al afna mal-proteini fis-serum (94-97%), l-aktar ma' l-albumina fis-serum.
English: A press in bottle adapter:
Maltese: Adapter press in tal-flixkun:
English: A long term study in the younger age group (1 to 5 years old).
Maltese: Studju fit-tul fil-grupp tal-età i g ar (1 sa 5 snin).
English: • 1 ml oral solution contains 3 mg of valsartan.
Maltese: • 1 ml ta' soluzzjoni orali fiha 3 mg ta' valsartan.
English: For a full list of excipients, see section 6.1.
Maltese: G al-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan or any of the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Maltese: Fi studji dwar l-interazzjoni tal-medi ina b'valsartan, ma nstabet l-ebda interazzjoni ta' sinifikanza klinika b'valsartan jew b'xi wie ed mis-sustanzi li ejjin: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
English: Children and adolescents 6 to 18 years of age
Maltese: Tfal u adolexxenti f'età ta' bejn 6 u 18 -il sena
English: Available data are described in sections 4.8, 5.1 and 5.2.
Maltese: Id-dejta disponibbli tinsab deskritta f'sezzjoniet 4.8, 5.1 u 5
English: Norway
Maltese: In-Norveja
English: I-21040 Origgio (Tel: + 39-02-96542214)
Maltese: Origgio (Tel: + 39-02-96542214)
English: • if you suffer from aldosteronism.
Maltese: • jekk issofri minn aldosteroni mu.
English: Reductions in systolic blood pressure were comparable in patients receiving valsartan (15 mmHg) and enalapril (14 mm Hg) (non-inferiority p-value <0.0001).
Maltese: It-tbaxxijiet fil-pressjoni tad-demm g olja kienu paragunabbli ma' pazjenti li r evew valsartan (15 mm Hg) u enalapril (14 mm Hg) (non inferiority p-value <0.
English: This metabolite is pharmacologically inactive.
Maltese: Dan il-metabolit mhux attiv farmakolo ikament.
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 g al informazzjoni dwar l-u u pedjatriku.
English: Primary hyperaldosteronism
Maltese: Iperaldosteroni mu primarju
English: Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day), and non-selective NSAIDs When angiotensin II antagonists are administered simultaneously with NSAIDs, attenuation of the antihypertensive effect may occur.
Maltese: Medi ini anti-infjammatorji mhux sterojdi (NSAIDs), inklu inibituri selettivi ta' COX-2, acetylsalicylic acid >3 g/kuljum, u NSAIDs mhux selettivi Meta antagonisti ta' angiotensin II jing ataw flimkien ma' NSAIDs, jista' jkun hemm tnaqqis taleffett li jbaxxi l-pressjoni.
English: For example, if the prescribed dose is 13 ml, it will be necessary to measure out the solution in three separate stages: 5 ml + 5 ml + 3 ml.
Maltese: Per e empju jekk id-do a preskritta hija ta' 13 ml, ikun ne essarju li tkejjel is-soluzzjoni fi tliet stadji separati : 5 ml + 5 ml + 3 ml.
English: Novartis Farma S.p.A. Largo Umberto Boccioni 1
Maltese: Largo Umberto Boccioni 1
English: At 24 weeks, UAE was reduced (p<0.001) by 42% (-24.2 µg/min; 95% CI: -40.4 to -19.1) with valsartan and approximately 3% (-1.7 µg/min; 95% CI: -5.6 to 14.9) with amlodipine despite similar rates of blood pressure reduction in both groups.
Maltese: 001) b'42% (-24.2 µg/min; 95% CI: -40.4 sa -19.1) b'valsartan u b'madwar 3% (-1.7 µg/min; 95% CI: -5.6 sa 14.9) b'amlodipine minkejja rati simili ta' tnaqqis filpressjoni tad-demm fi - ew gruppi.
English: NO-0510 Oslo (Tel: +47-2305 20 00 )
Maltese: Oslo (Tel: +47-2305 20 00 )
English: • Diovan solution contains poloxamer (188).
Maltese: • Is-soluzzjoni Diovan fija poloxamer (188).
English: Diovan oral solution contains 0,3 g sucrose per mililiter.
Maltese: Diovan soluzzjoni orali fih 0.3 g ta' sucrose f'kull millilitru.
English: • decreased kidney function (signs of renal impairment)
Maltese: • funzjoni tal-kliewi mnaqqsa (sinjali ta' indeboliment tal-kliewi)
English: • Diovan solution contains methyl parahydroxybenzoate (E218).
Maltese: • Is-soluzzjoni Diovan fiha methyl parahydroxybenzoate (E218).
English: (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Maltese: (kalkulazzjonijet jassumu do a orali ta' 320 mg/kuljum u pazjent ta' 60-kg).
English: 5.2 Pharmacokinetic properties
Maltese: 5.2 Tag rif farmakokinetiku
English: Impaired renal function
Maltese: Indeboliment tal-funzjoni renali
English: At 30 weeks, the percentage change in UAE was significantly reduced by 36% from baseline with valsartan 160 mg (95%CI: 22 to 47%), and by 44% with valsartan 320 mg (95%CI: 31 to 54%).
Maltese: Wara 30 img a, il-persenta tal-bidla fil-UAE kien imnaqqas b'mod sinifikanti b'36% mil-linja ba i b'valsartan 160 mg (95%CI: 22 sa 47%), u b'44% b'valsartan 320 mg (95%CI: 31 sa 54%).
English: Some symptoms need immediate medical attention:
Maltese: Xi sintomi je tie u attenzjoni medika immedjata:
English: • lithium, a medicine used to treat some types of psychiatric illness.
Maltese: • lithium, medi ina w ata g all-kura ta' xi tipi ta' mard psikjatriku.
English: Renal artery stenosis
Maltese: Stenosi ta' l-arterja renali
English: 4.1 Therapeutic indications
Maltese: 4.1 Indikazzjonijiet terapewti i
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 3 mg of valsartan.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull ml fih 3 mg ta' valsartan
English: Thrombocytopenia
Maltese: Trombo itopenija