FrancophonIA/ELRC3.0 huggingface dataset:
English: At low oxygen saturation, nitric oxide can combine with deoxyhaemoglobin to transiently form nitrosylhaemoglobin, which is converted to nitrogen oxides and methaemoglobin upon exposure to oxygen.
Maltese: F'saturazzjoni tal-ossiġnu baxxa, nitric oxide jista' jingħaqad ma' deoxyhaemoglobin biex momentarjament jifforma nitrosylhaemoglobin, li jinbidel f'nitrogen oxides u methaemoglobin meta jkun espost għall-ossiġnu.
English: If oxygenation falls >20 %, INOmax therapy should be resumed at 5 ppm and discontinuation of INOmax therapy should be reconsidered after 12 to 24 hours.
Maltese: Jekk l-għoti tal-ossiġnu jaqa' > 20%, it-terapija b'INOmax għandha titkompla b'5 ppm u l-waqfien tat-terapija b'INOmax għandu jerġa' jiġi kkunsidrat wara 12 sa 24 siegħa.
English: These include prilocaine (a local anaesthetic used for pain relief in association to minor painful procedures e.g. suturing, and minor surgical or diagnostic procedures) or glyceryl trinitrate (used to treat chest pain).
Maltese: Dawn jinkludu prilocaine (anestetiku lokali) jew glyceryl trinitrate (użat għall-kura tal-anġina).
English: Storage in the pharmacy department
Maltese: Ħażna fid-dipartiment tal-farmaċija
English: Persistent Pulmonary Hypertension in the Newborn (PPHN) The maximum recommended dose of INOmax is 20 ppm and this dose should not be exceeded.
Maltese: Pressjoni għolja Pulmonari Persistenti fi Trabi tat-Twelid (PPHN) Id-doża massima rakkomandata ta' INOmax hija ta' 20 ppm u din id-doża m'għandhiex tinqabeż.
English: Side effects that are commonly seen (affects more than 1 user in 100) in association with INOmax therapy include:
Maltese: Effetti sekondarji li jidhru b'mod komuni ħafna (jaffettwaw aktar minn utent 1 minn kull 100) f'assoċjazzjoni ma' terapija ta' INOmax jinkludu:
English: The power supply for the monitoring equipment should be independent of the delivery device function.
Maltese: L-apparat li jipprovdi l kurrent għall-apparat ta' monitoraġġ għandu jkun indipendenti mill-funzjoni tal-apparat li jforni.
English: No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 h/day for up to two years.
Maltese: Ebda evidenza ta' effett karċinoġeniku ma kienet apparenti, f'espożizzjonijiet ta' inalazzjoni sad-doża rakkomandata (20 ppm), f'firien għal 20 siegħa/jum għal massimu ta' sentejn.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Maltese: L-effetti fi studji mhux kliniċi kienu osservati biss f'esponimenti meqjusin suffiċjentement ogħla millesponiment massimu fil-bniedem li ftit jindika rilevanza għall-użu kliniku.
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch of the new indication, all Healthcare Professionals who are expected to use and/or prescribe INOmax as part of the treatment of peri- or post- operative pulmonary hypertension in adults and children in conjunction to heart surgery are provided with an Educational pack.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jiżgura li, mat-tnedija tal indikazzjoni l-ġdida, il-Professjonisti tal-Kura tas-Saħħa kollha li huma mistennija li jużaw u/jew li jippreskrivu INOmax bħala parti mill-kura ta' pressjoni pulmonari għolja qabel jew wara operazzjoni f'adulti u tfal flimkien ma' kirurġija tal-qalb, jiġu pprovduti b'pakkett Edukattiv.
English: A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
Maltese: Ċilindru tal-gass tal-aluminju ta' 10 litri (identifikazzjoni bi spalla akkwamarina u qafas ewlieni bajdani) mimli taħt pressjoni ta' 155 bar, mgħammar b'valv tal-pressjoni (residwa) pożittiva tal istainless steel b'konnessjoni speċifika għall-iżbokk u rota tal-idejn tal-valv standard.
English: Methaemoglobin concentrations increase during the first 8 hours of nitric oxide exposure.
Maltese: Il-konċentrazzjonijiet ta' methaemoglobin jiżdiedu matul l-ewwel 8 sigħat ta' esponiment għal nitric oxide.
English: A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
Maltese: Ċilindru tal-gass tal-aluminju ta' 2 litri (identifikazzjoni bi spalla akkwamarina u qafas ewlieni bajdani) mimli taħt pressjoni ta' 155 bar, mgħammar b'valv tal-pressjoni (residwa) pożittiva tal istainless steel b'konnessjoni speċifika għall-iżbokk u rota tal-idejn tal-valv standard.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Endotracheopulmonary use
Maltese: Pressjoni għolja Pulmonari Persistenti fi Trabi tat-Twelid (PPHN)
English: Nitric oxide is absorbed systemically after inhalation.
Maltese: Nitric oxide huwa assorbit sistematikament wara li jittieħed man-nifs.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 2 litres gas cylinder
Maltese: Ċilindru tal-gass ta' 2 litri
English: If the fraction of methaemoglobin rises to a level that potentially compromises adequate oxygen delivery, the INOmax dose should be decreased and the administration of reducing medicinal products such as methylene blue may be considered.
Maltese: Jekk il-frazzjon ta' methaemoglobin jogħla f'livell li jista' jikkomprometti t-twassil adegwat tal-ossiġnu, id-doża ta' INOmax għandha titnaqqas u jista' jiġi kkunsidrat l-għoti ta' prodotti mediċinali ta' tnaqqis bħal methylene blue.
English: Pack sizes:
Maltese: Fax:
English: In these states, pulmonary vascular resistance (PVR) is high, which results in hypoxemia secondary to right-to-left shunting of blood through the patent ductus arteriosus and foramen ovale.
Maltese: F'dawn l-istati, r-reżistenza vaskulari pulmonari (PVR) hija għolja, li tirriżulta f'hypoxemia sekondarja għal shunting mil-lemin għax-xellug tad-demm permezz tal-patent ductus arteriosus u l-foramen ovale.
English: A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
Maltese: Ċilindru tal-gass tal-aluminju ta' 10 litri (identifikazzjoni bi spalla akkwamarina u qafas ewlieni bajdani) mimli taħt pressjoni ta' 155 bar, mgħammar b'valv tal-pressjoni (residwa) pożittiva talistainless steel b'konnessjoni speċifika għall-iżbokk u rota tal-idejn tal-valv standard.
English: The duration of therapy is variable, but typically less than four days.
Maltese: It-tul tat-terapija jvarja, iżda, normalment dan ikun inqas minn erbat ijiem.
English: Inhaled nitric oxide has been shown to selectively reduce pulmonary vascular resistance and reduce the increased pulmonary artery pressure.
Maltese: Nitric oxide li jittieħed man-nifs intwera li jnaqqas b'mod selettiv ir-reżistenza vaskulari pulmonari u jnaqqas il-pressjoni arterjali pulmonari.
English: A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
Maltese: Ċilindru tal-gass tal-aluminju ta' 2 litri (identifikazzjoni bi spalla akkwamarina u qafas ewlieni bajdani) mimli taħt pressjoni ta' 155 bar, mgħammar b'valv tal-pressjoni (residwa) pożittiva talistainless steel b'konnessjoni speċifika għall-iżbokk u rota tal-idejn tal-valv standard.
English: INOmax should be used only after respiratory support has been optimised.
Maltese: INOmax għandu jintuża biss wara li l-għajnuna respiratorja tkun ġiet ottimizzata.
English: Effects on platelets
Maltese: Disturbi filqalb
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 January 2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 ta' Jannar 2018 EMA/43037/2018
English: EMA/43037/2018
Maltese: Mylan (rotigotina) EMA/43037/2018
English: What is Rotigotine Mylan?
Maltese: X'inhu Rotigotina Mylan?
English: Rotigotine Mylan was expected to be used to treat adults with Parkinson's disease and adults with restless-leg syndrome (a disorder where the patient has uncontrollable urges to move the legs to stop uncomfortable, painful or odd sensations in the body, usually at night).
Maltese: Rotigotina Mylan kien mistenni li jintuża fit-trattament ta' adulti bil-marda ta' Parkinson u adulti li jbatu mis-sindromu ta' riġlejn irrikweti (disturb fejn il-pazjent ikollu urġenzi inkontrollabbli biex iċaqlaq irriġlejn biex iwaqqaf sensazzjonijiet fil-ġisem skomdi, ta' uġigħ jew mhux normali, li normalment jagħtu bi-lejl).
English: Rotigotine Mylan is a medicine that contains the active substance rotigotine.
Maltese: Rotigotina Mylan huwa mediċina li fiha s-sustanza attiva rotigotina.
English: On 22 December 2017, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Rotigotine Mylan, for the treatment of Parkinson's disease and restless-leg syndrome.
Maltese: Fit-22 ta' Diċembru 2017, Mylan S.A.S. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) bl-intenzjoni li tixtieq tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Rotigotina Mylan, għall-kura tal-marda ta' Parkinson u s-sindromu ta' riġlejn irrekweti.
English: Rotigotine Mylan was developed as a ‘generic medicine'.
Maltese: Rotigotina Mylan ġie żviluppat bħala ‘mediċina ġenerika'.
English: The active substance in Rotigotine Mylan, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Maltese: Is-sustanza attiva f'Rotigotina Mylan, rotigotina, hija agonista tad-dopamina, li jfisser li timita l-azzjoni tad-dopamina.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Neupro, and did not need to be repeated for Rotigotine Mylan.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Neupro, u ma kellhomx għalfejn jiġu ripetuti għal Rotigotina Mylan.
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.
Maltese: Huwa maħsub li s-sindromu huwa kkawżat minn problemi fil-mod kif id-dopamina taħdem fil-moħħ, li jista' jitjieb permezz tar-rotigotina.
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 bil-mistoqsijiet-u-tweġibiet hawnhekk.
English: Withdrawal of the marketing authorisation application for Rotigotine Mylan (rotigotine)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Rotigotina Mylan (rotigotina)
English: The CHMP was concerned that insufficient data had been provided on the quality of the medicine and its manufacturing process.
Maltese: Is-CHMP kien imħasseb li ma ġietx provduta informazzjoni biżżejjed dwar il-kwalità tal-mediċina u lproċess ta' manifattura tagħha.
English: Dopamine is a messenger substance in the parts of the brain that control movement and coordination.
Maltese: Id-dopamina hija sustanza messaġġiera li taħdem fil-partijiet tal-moħħ li jikkontrollaw il-moviment u l-koordinazzjoni.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Rotigotine Mylan could not have been approved for the treatment Parkinson's disease and restless-leg syndrome.
Maltese: Fuq il-bażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Rotigotina Mylan ma setax jiġi approvat għall-kura tal-marda ta' Parkinson u tassindromu ta' riġlejn irrekweti.
English: The company also carried out studies to investigate whether Rotigotine Mylan is ‘bioequivalent' to the reference medicine.
Maltese: Il-kumpanija għamlet studji biex tinvestiga jekk ir-Rotigotina Mylan hijiex ‘bijoekwivalenti' għall-mediċina ta' referenza.
English: What was Rotigotine Mylan expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Rotigotina Mylan?
English: It was to be available as transdermal patches (patches that deliver a medicine across the skin).
Maltese: Kellha tkun disponibbli permezz ta' rqajja' transdermali (rqajja' li jwasslu l-mediċina minn ġol-ġilda).
English: This means that Rotigotine Mylan contains the same active substance and was intended to work in the same way as a ‘reference medicine' already authorised in the European Union called Neupro.
Maltese: Dan ifisser li Rotigotina Mylan fih l-istess sustanza attiva u kien maħsub li jaħdem bl-istess mod bħal “mediċina ta' referenza” li diġà hija awtorizzata fl-Unjoni Ewropea imsejħa Neupro.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would be unable to provide the required additional data in the time available.
Maltese: Fl-ittra li bagħtet lill-Aġenzija biex tgħarrafha bl-irtirar tal-applikazzjoni, il-kumpanija sostniet li ma kinitx se tkun kapaċi tipprovdi d-data addizzjonali fil-perjodu disponibbli.
English: Secondary endpoint
Maltese: Endpoint sekondarju
English: No. at risk Neparvis
Maltese: Nru. f'riskju Neparvis
English: KM estimate of cumulative failure rate (%)
Maltese: KM tar-rata ta' falliment kumulattiv (%)
English: PDE5 inhibitors including sildenafil
Maltese: Inibituri ta' PDE5, inkluż sildenafil
English: Do not take Neparvis:
Maltese: Tiħux Neparvis:
English: OATP and MRP2 transporters
Maltese: Trasportaturi ta' OATP u MRP2
English: Table 1 List of adverse reactions
Maltese: Tabella 1 Lista ta' reazzjonijiet avversi
English: Hazard ratio (95% CI)
Maltese: Proporzjon ta' periklu (95% CI)
English: Nitrates, e.g. nitroglycerine
Maltese: Nitrati eż. nitrogliċerina
English: Sacubitril is further metabolised to the active metabolite LBQ657.
Maltese: Sacubitril ikompli jiġi metabolizzat fil-metabolita attiva LBQ657.
English: CYP 450 interactions
Maltese: Interazzjonijiet b'CYP450
English: Symptomatic treatment should be provided.
Maltese: Għandu jiġi pprovdut trattament sintomatiku.
English: P<0.0001 HR (95%CI):
Maltese: HR (95%CI):
English: Prior to study participation, patients were well treated with standard of care therapy which included ACE inhibitors/ARBs (>99%), beta blockers (94%), mineralocorticoid antagonists (58%) and diuretics (82%).
Maltese: Qabel il-parteċipazzjoni fl-istudju, il-pazjenti kienu kkurati tajjeb bi standard ta' terapija ta' kura, inklużi inibituri ta' ACE/ARBs (>99%), imblokkaturi tar-riċetturi beta (94%), antagonisti mineralokortikojdi (58%) u dijuretiċi (82%).
English: Neparvis improved survival with a significant reduction in all-cause mortality of 2.8% (Neparvis, 17%, enalapril, 19.8%).
Maltese: Neparvis tejjeb is-sopravivenza bi tnaqqis sinjifikanti fil-mortalità minn kull kawża ta' 2.8% (Neparvis, 17%, enalapril, 19.8%).
English: Approximate tablet dimensions 15.1 mm x 6.0 mm.
Maltese: Id-dimensjonijiet approssimattivi tal-pillola huma ta' 15.1 mm x 6.0 mm.
English: B-type natriuretic peptide (BNP)
Maltese: Natriuretic peptide tat-tip B (BNP - B-type natriuretic peptide)
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Maltese: Imblukkar doppju tas-sistema ta' renin-anġjotensina-aldosterone (RAAS)
English: Non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors
Maltese: Aġenti anti-infjammatorji nonsterojdali (NSAIDs - Non-steroidal anti-inflammatory agents), inklużi inibituri selettivi ta' cyclooxygenase-2 (COX-2)
English: The relative risk reduction was 20% versus enalapril (see Table 2).
Maltese: It-tnaqqis tar-riskju relattiv kien ta' 20% versus enalapril (ara Tabella 2).
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists, other combinations, ATC code: C09DX04
Maltese: Sustanzi li jaġixxu fuq is-sistema ta' renin-angiotensin; antagonisti ta' angiotensin II, kombinazzjonijiet oħra, Kodiċi ATC: C09DX04
English: Hyperkalaemia and serum potassium
Maltese: Iperkalimja u potassju fis-serum
English: OATP1B1 and OATP1B3 substrates, e.g. statins
Maltese: Sottostrati ta' OATP1B1 u OATP1B3 eż. statins
English: The pharmacokinetics of Neparvis (sacubitril, LBQ657 and valsartan) are similar between male and female subjects.
Maltese: Il-farmakokinetiċi ta' Neparvis (sacubitril, LBQ657 u valsartan) huma simili bejn individwi maskili u femminili.
English: Sacubitril, LBQ657 and valsartan are highly bound to plasma proteins (94-97%).
Maltese: Sacubitril, LBQ657 u valsartan huma marbutin ħafna mal-proteini fil-plażma (94-97%).
English: The average apparent volume of distribution of valsartan and sacubitril were 75 litres to 103 litres, respectively.
Maltese: Il-volum medju ta' distribuzzjoni evidenti ta' valsartan u sacubitril kien minn 75 litru sa 103 litri, rispettivament.
English: The mean LVEF was 29% and there were 963 (11.4%) patients with a baseline LVEF >35% and ≤40%.
Maltese: L-LVEF medja kienet ta' 29% u kien hemm 963 (11.4%) pazjent b'LVEF fil linja bażi >35% u ≤40%.
English: Sacubitril is readily converted to LBQ657 by carboxylesterases 1b and 1c; LBQ657 is not further metabolised to a significant extent.
Maltese: Sacubitril huwa faċilment konvertit għal LBQ657 permezz ta' carboxylesterases 1b u 1ċ; LBQ657 ma jkomplix jiġi metabolizzat sa punt sinjifikanti.
English: Relative risk reduction p-value ***
Maltese: Tnaqqis tar-riskju relattiv valur p ***
English: Valsartan is minimally metabolised, as only about 20% of the dose is recovered as metabolites.
Maltese: Valsartan huwa metabolizzat minimament, hekk kif 20% biss tad-doża tiġi rkuprata bħala metaboliti.
English: Microcrystalline cellulose Low-substituted hydroxypropylcellulose Crospovidone, type A Magnesium stearate
Maltese: Microcrystalline cellulose Hydroxypropylcellulose b'sostituzzjoni baxxa Crospovidone, tat-tip A Stearate tal-manjeżju
English: No. at risk
Maltese: Nru. f'riskju
English: No clinically meaningful drug-drug interaction was observed when Neparvis was co-administered with digoxin, warfarin, hydrochlorothiazide, amlodipine, omeprazole, carvedilol or a combination of levonorgestrel/ethinyl estradiol.
Maltese: Ma ġiet osservata ebda interazzjoni klinikament sinjifikanti bejn mediċina u oħra meta Neparvis ngħata flimkien ma' digoxin, warfarin, hydrochlorothiazide, amlodipine, omeprazole, carvedilol jew kombinazzjoni ta' levonorgestrel/ethinyl estradiol.
English: A hydroxyl metabolite of valsartan has been identified in plasma at low concentrations (<10%).
Maltese: Ġiet identifikata metabolita ta' hydroxyl ta' valsartan fi plażma f'konċentrazzjonijiet baxxi (<10%).
English: Whilst there is no controlled epidemiological data on the risk with ARBs, similar risks may exist for this class of medicinal product.
Maltese: Filwaqt li m'hemm l-ebda dejta epidemjoloġika kkontrollata dwar ir-riskju b'ARBs, jistgħu jeżistu riskji simili għal din il-klassi ta' prodotti mediċinali.
English: Approximate tablet dimensions 13.1 mm x 5.2 mm.
Maltese: Id-dimensjonijiet approssimattivi tal-pillola huma ta' 13.1 mm x 5.2 mm.
English: • decreased renal function (renal impairment)
Maltese: • funzjoni renali mnaqqsa (indeboliment tal-kliewi)
English: The active metabolite of sacubitril (LBQ657) and valsartan are OATP1B1, OATP1B3, OAT1 and OAT3 substrates; valsartan is also a MRP2 substrate.
Maltese: Il-metabolita attiva ta' sacubitril (LBQ657) u valsartan huma s-sottostrati OATP1B1, OATP1B3, OAT1 u OAT3; valsartan huwa wkoll sottostrat ta' MRP2.
English: • (acute) renal failure (severe kidney disorder)
Maltese: • indeboliment renali (akut) (disturb tal-kliewi gravi)
English: Individual components of the primary composite endpoint CV death**
Maltese: Komponenti individwali tal-endpoint kompost primarju Mewt CV**
English: Preferred term
Maltese: Terminu ppreferut
English: 26 May 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 26 Mejju 2016
English: Sacubitril, LBQ657 and valsartan are eliminated from plasma with a mean elimination half-life (T½) of approximately 1.43 hours, 11.48 hours, and 9.90 hours, respectively.
Maltese: Sacubitril, LBQ657 u valsartan jiġu eliminati mill-plażma b'nofs ħajja medja ta' eliminazzjoni (T½) ta' madwar 1.43 siegħa, 11.48 siegħa u 9.90 siegħa, rispettivament.
English: Angioedema*
Maltese: Anġjoedima*
English: A higher incidence of angioedema was observed in Black patients treated with Neparvis (2.4%) and enalapril (0.5%) (see section 4.4).
Maltese: Ġiet osservata inċidenza ogħla ta' anġjoedima f'pazjenti suwed ikkurati b' Neparvis (2.4%) u b'enalapril (0.5%) (ara sezzjoni 4.4).
English: Interactions between Neparvis and lithium have not been investigated.
Maltese: L-interazzjonijiet bejn Neparvis u lithium ma ġewx investigati.
English: The tablets are supplied in PVC/PVDC/Aluminium blister packs of 14, 20, 28 tablets or 56 tablets and in multipacks of 196 tablets (7 packs of 28 tablets).
Maltese: Il-pilloli jiġu f'pakketti ta' folji tal-PVC/PVDC/Aluminju ta' 14, 20, 28 jew 56 pillola u f'pakketti b'ħafna ta' 196 (7 pakketti ta' 28 pillola).
English: There are no available data on the effect of Neparvis on human fertility.
Maltese: Ma hemm ebda dejta disponibbli dwar l-effett ta' Neparvis fuq il-fertilità umana.
English: They were then randomised to the double-blind period of the study, during which they received either Neparvis 200 mg or enalapril 10 mg twice daily [Neparvis (n=4,209); enalapril (n=4,233)].
Maltese: Imbagħad huma ġew randomizzati fil-perjodu double-blind tal-istudju, li matulu rċevew Neparvis 200 mg jew enalapril 10 mg darbtejn kuljum [Neparvis (n=4,209); enalapril (n=4,233)].
English: The valsartan contained within Neparvis is more bioavailable than the valsartan in other marketed tablet formulations; 26 mg, 51 mg, and 103 mg of valsartan in Neparvis is equivalent to 40 mg, 80 mg and 160 mg of valsartan in other marketed tablet formulations, respectively.
Maltese: Il-valsartan li hemm f' Neparvis huwa aktar bijodisponibbli mill-valsartan f'formulazzjonijiet ta' pilloli kummerċjalizzati oħrajn; 26 mg, 51 mg u 103 mg ta' valsartan f' Neparvis huwa ekwivalenti għal 40 mg, 80 mg u 160 mg ta' valsartan f'formulazzjonijiet ta' pilloli kummerċjalizzati oħrajn, rispettivament.
English: • Hereditary or idiopathic angioedema (see section 4.4).
Maltese: • Anġjoedima ereditarja jew idjopatika (ara sezzjoni 4.4).
English: • if you are taking another type of medicine called an angiotensin converting enzyme (ACE) inhibitor (for example enalapril, lisinopril or ramipril).
Maltese: • jekk qed tieħu xi tip ieħor ta' mediċina msejħa inibitur ta' enzima ta' konverżjoni talanġjotensina (ACE) (pereżempju enalapril, lisinopril jew ramipril).
English: • if you have ever had angioedema (see “Do not take Neparvis” and section 4 “Possible side effects”).
Maltese: • jekk qatt xi darba kellek anġjoedima (ara “Tiħux Neparvis” u sezzjoni 4 “Effetti sekondarji possibbli”).
English: The exposure of LBQ657 in patients with moderate (30 ml/min/1.73 m
Maltese: L-esponiment għal LBQ657 f'pazjenti b'indeboliment renali moderat (30 ml/min/1.73 m
English: Figure 1 Kaplan-Meier curves for the primary composite endpoint and the CV death component
Maltese: Kaplan-Meier għall-endpoint kompost primarju u għall-komponent ta' mewt CV
English: Patients with SBP <100 mmHg were not studied (see section 5.1).
Maltese: Pazjenti b'SBP <100 mmHg ma kinux studjati (ara sezzjoni 5.1).