FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding its safety, although more side effects were reported in patients treated with Vargatef plus docetaxel than in those treated with docetaxel alone, the side effects were considered manageable with dose reductions, supportive treatments and treatment interruptions.
Maltese: Fir-rigward tas-sigurtà, għalkemm aktar effetti sekondarji ġew rappurtati f'pazjenti kkurati b'Vargatef flimkien ma' docetaxel milli f'dawk ikkurati b'docetaxel waħdu, l-effetti sekondarji kienu kkunsidrati maniġġabbli bi tnaqqis fiddoża, kura ta' appoġġ u interruzzjonijiet tal-kura.
English: For the full list of all side effects and restrictions with Vargatef, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Vargatef, ara l-fuljett ta' tagħrif.
English: Vargatef is used to treat a type of non-small cell lung cancer called ‘adenocarcinoma', when the cancer is locally advanced, metastatic (when cancer cells have spread from the original site to other parts of the body) or locally recurrent (when the cancer has come back in the same area).
Maltese: Vargatef jintuża għall-kura ta' tip ta' kanċer tal-pulmun mhux taċ-ċelloli żgħar imsejjaħ ‘adenokarċinoma', fejn il-kanċer huwa lokalment avvanzat, metastatiku (meta ċ-ċelloli tal-kanċer ikunu nfirxu mis-sit ta' oriġini għal partijiet oħrajn tal-ġisem) jew lokalment rikorrenti (meta l-kanċer jerġa' jiġi lura fl-istess żona).
English: Vargatef is a cancer medicine used to treat adults with a type of lung cancer known as non-small cell lung cancer.
Maltese: Vargatef huwa mediċina tal-kanċer li tintuża għall-kura ta' adulti b'tip ta' kanċer tal-pulmun magħruf bħala kanċer tal-pulmun mhux taċ-ċelloli żgħar.
English: Vargatef must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients.
Maltese: Vargatef m'għandux jintuża minn pazjenti li għandhom sensittività eċċessiva (allerġiċi) għal nintedanib, karawett jew soja, jew sustanzi oħra.
English: The most common side effects with Vargatef (which may affect more than 1 in 10 people) include diarrhoea, vomiting and increased blood levels of certain liver enzymes (a sign of possible liver problems).
Maltese: L-effetti sekondarji l-aktar komuni b'Vargatef (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) jinkludu dijarrea, rimettar u żieda fil-livell ta' ċerti enzimi tal-fwied fid-demm (sinjal ta‘ problemi talfwied possibbli).
English: The recommended dose is 200 mg taken twice a day (around 12 hours apart).
Maltese: Id-doża rakkomandata hija 200 mg meħudin darbtejn kuljum (madwar 12-il siegħa ‘l bogħod
English: These enzymes can be found in certain receptors (such as VEGF, FGF and PDGF receptors) on the surface of cancer cells and on the cells of the surrounding tissue (e.g. blood vessel), where they activate several processes including cell division and the growth of new blood vessels.
Maltese: Dawn l-enzimi jistgħu jinstabu f'ċerti riċetturi (bħar-riċetturi VEGF, FGF u PDGF) fuq il-wiċċ taċ-ċelloli tal-kanċer u fuq iċ-ċelloli tat-tessut ta' madwarhom (eż. vażu), fejn jattivaw diversi proċessi inkluż diviżjoni taċ-ċelloli u t-tkabbir ta' vażi ġodda.
English: The CHMP noted that Vargatef was effective at slowing down disease progression and prolonging life in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type.
Maltese: Is-CHMP innota li Vargatef kien effettiv fit-tnaqqis tal-progressjoni tal-marda u fit-titwil tal-ħajja fis-sottogrupp ta' pazjenti b'kanċer tal-pulmun mhux taċ-ċelloli żgħar tat-tip adenokarċinoma.
English: What measures are being taken to ensure the safe and effective use of Vargatef?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Vargatef?
English: Treatment with Vargatef may continue after stopping docetaxel, for as long as the disease improves or remains stable and the side effects are tolerable.
Maltese: Kura b'Vargatef tista' titkompla wara t-twaqqif ta' docetaxel, sakemm il-marda titjieb jew tibqa' stabbli u l-effetti sekondarji jkunu tollerabbli.
English: EMA/381626/2014 EMEA/V/C/002802
Maltese: EMEA/V/C/002802
English: The period of protection is 8 weeks.
Maltese: Il-perjodu ta' kura hu ta' 8 ġimgħat.
English: Live avian infectious bronchitis virus strain D388
Maltese: Strejn tal-virus ħaj tal-Bronkite Infettiva tat-tjur D388
English: In the first field study 100% of the birds vaccinated with Nobilis IB Primo QX mixed with Nobilis IB Ma5 were protected from the QX strain and 90% were protected from M41, compared with none of the unvaccinated birds.
Maltese: Fl-ewwel studju fil-post, 100% tal-għasafar vaċċinati b'Nobilis IB Primo QX imħallta ma' Nobilis IBMa5 kienu protetti mill-istrejn QX u 90% kienu protetti minn M41, meta mqabbla mal-ebda wieħed millgħasafar mhux vaċċinati.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ tal-benefiċċju/riskju jista' jinstab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: Nobilis IB Primo QX is used to protect chickens against viral infectious bronchitis caused by strains of infectious bronchitis virus known as QX-like variants, such as strain D388.
Maltese: Nobilis IB Primo QX jintuża biex jipproteġi lit-tiġieġ kontra l-bronkite infettiva virali kkawżata minn strejns tal-vajrus tal-bronkite infettiva tat-tjur magħrufa bħala varjanti li jixbħu QX, bħall-istrejn D388.
English: In the first study broiler chickens (chickens bred for meat) were spray vaccinated with both Nobilis IB Primo QX and Nobilis IB Ma5, a vaccine against a Massachusetts strain of infectious bronchitis virus.
Maltese: Fl-ewwel studju, tiġieġ brojler (tiġieġ imrobbija għal-laħam) ġew vaċċinati permezz ta' sprej kemm b'Nobilis IB Primo QX kif ukoll b'Nobilis IB Ma5, vaċċin kontra strejn Massachusetts tal-vajrus ta' bronkite infettiva.
English: Two groups of 28 birds were challenged with the virus 3 weeks after vaccination, one group with a QX strain and the second group with another strain called M41.
Maltese: Żewġ gruppi ta' 28 għasfur ġew sfidati bil-vajrus 3 ġimgħat wara l-vaċċinazzjoni, grupp wieħed bi strejn QX u t-tieni grupp bi strejn imsejjaħ M41.
English: Nobilis IB Primo QX is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus strain D388.
Maltese: Nobilis IB Primo QX hu vaċċin veterinarju li fih strejn tal-virus ħaj attenwat (indebolit) tal-bronkite infettiva tat-tjur D388. Nobilis IB Primo QX hu disponibbli bħala lajofiliżejt (trab lijofilizzat) li jista' jkun fornut b'solvent.
English: Nobilis IB Primo QX is a vaccine.
Maltese: Nobilis IB Primo QX huwa vaċċin.
English: What is Nobilis IB Primo QX?
Maltese: X'inhu Nobilis IB Primo QX?
English: Why has Nobilis IB Primo QX been approved?
Maltese: Għaliex Nobilis IB Primo QX ġie approvat?
English: What is the risk associated with Nobilis IB Primo QX?
Maltese: X'riskji huma assoċjati ma' Nobilis IB Primo QX?
English: The effectiveness of Nobilis IB Primo QX was investigated in two field studies.
Maltese: L-effikaċja ta' Nobilis IB Primo QX ġiet investigata f'żewġ studji fil-post.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis IB Primo QX on 4 September 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Nobilis IB Primo QX fl-4 ta' Settembru 2014.
English: The second field study showed 93% of the Nobilis IB Primo QX vaccinated birds and none of the unvaccinated birds to be protected from the challenge.
Maltese: It-tieni studju fil-qasam, wera li 93% tal-għasafar vaċċinati b'Nobilis IB Primo QX u l-ebda wieħed millgħasafar mhux vaċċinati huma protetti mill-isfida.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobilis IB Primo QX exceed the risks for the approved indication and recommended that Nobilis IB Primo QX be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Nobilis IB Primo QX huma ikbar mir-riskji għall-indikazzjoni approvata u rrakkomanda li Nobilis IB Primo QX jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: These reactions are very rare (affecting less than 1 bird in 10,000).
Maltese: Dawn ir-reazzjonijiet huma rari ħafna (li jaffettwaw inqas minn għasfur 1 minn 1000).
English: Other information about Nobilis IB Primo QX:
Maltese: Tagħrif ieħor dwar Nobilis IB Primo QX:
English: prof. Michała Życzkowskiego 17
Maltese: Michała Życzkowskiego 17
English: 77772828 ή +357-22482330
Maltese: Τηλ. 77772828 ή +357-22482330
English: Not relevant.
Maltese: Mhux rilevanti.
English: I-20010 Arluno (MI) Tel : +39 02 903731/800 985 597
Maltese: Arluno (MI) Tel : +39 02 903731/800 985 597
English: Pharmacotherapeutic group: Other respiratory system products, ATC code R07AX01.
Maltese: Prodotti oħra tas-sistema respiratorja, Kodiċi ATC R07-AX01.
English: Hypoxia b,d
Maltese: Pressjoni baxxaa, b, d
English: Date of last renewal: 01/06/2006
Maltese: Data tal-aħħar tiġdid: 01/06/2006
English: ΛΙΝΤΕ ΕΛΛΑΣ ΜΟΝ ΕΠΕ Θέση Τρύπιο Λιθάρι GR-19600 Μάνδρα Αττικής Τηλ: 0030 211-1045500-510
Maltese: Μάνδρα Αττικής Τηλ: 0030 211-1045500-510
English: Nitrogen
Maltese: Nitric oxide
English: Limay-Porcheville 78440 Porcheville
Maltese: Z.I. Limay-Porcheville 78440
English: Butyl rubber, polyamide, and polyurethane should not be used.
Maltese: Butyl rubber, polyamide, u polyurethane ma għandhomx jintużaw.
English: Method of administration For endotracheopulmonary use.
Maltese: Użu endotrakeopulmonari.
English: Tested polymers which can be used in nitric oxide administration systems include polyethylene (PE) and polypropylene (PP).
Maltese: Polimers ittestjati li jistgħu jintużaw f'sistemi ta' forniment ta' nitric oxide jinkludu polyethylene (PE) u polypropylene (PP).
English: Tel. +385 47 609 200 tg.info@hr.linde-gas.com
Maltese: +385 47 609 200 tg.info@hr.linde-gas.com
English: Clinical data supporting the suggested dose in the age range 12-17 years is limited.
Maltese: Dejta klinika li tappoġġja d-doża rakkomandata fil-medda ta' etajiet bejn 12-17-il sena hija limitata.
English: The overall occurrence of intraventricular haemorrhage was 114 (28.9 %) among the iNO treated as compared to 91 (22.9 %) among the control neonates.
Maltese: emorraġija intraventrikolari kienet 114 (28.9%) fost dawk trattati bl-iNO meta mqabbla ma' 91 (22.9%) fost it-trabi tat-twelid ta' kontroll.
English: In case of insufficient response the dose may be titrated after a minimum of 10 minutes.
Maltese: F'każ ta' rispons insuffiċjenti, id-doża tista' tiġi titrata wara minimu ta' 10 minuti.
English: Prilocaine, whether administered as oral, parenteral, or topical formulations may cause methaemoglobinaemia.
Maltese: Prilocaine, kemm jekk mogħti bħala formulazzjoni orali, parenterali jew topika jista' jikkawża methaemoglobinaemia.
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Methaemoglobi naemiaa
Maltese: Metaemoglo binemijaa
English: Common Uncommon Rare Very rare
Maltese: Rari ħafna
English: Of the 97 patients treated with INOmax, 2(2 %) were withdrawn from study drug due to methaemoglobin levels >4 %.
Maltese: Mis-97 pazjent kollha ikkurati b'INOmax, 2(2 %) ġew irtirati mill-istudju minħabba livelli ta' methaemoglobin >4 %.
English: The combined incidence of death and/or initiation of ECMO (the prospectively defined primary endpoint) showed a significant advantage for the nitric oxide treated group (46 % vs. 64 %, p=0.006).
Maltese: L-inċidenza kombinata ta' mewt u/jew bidu ta' ECMO (il-punt ta' tmiem primarju definit prospettivament) uriet vantaġġ sinifikanti għall-grupp ikkurat b'nitric oxide (46% vs. 64%, p=0.006).
English: In the pivotal clinical trials, the starting dose was 20 ppm.
Maltese: Filprovi kliniċi pivotali, id-doża inizjali kienet ta' 20 ppm.
English: INOmax has been safely administered with tolazoline, dopamine, dobutamine, steroids, surfactant, and high-frequency ventilation.
Maltese: INOmax ingħata mingħajr periklu ma' tolazoline, dopamine, dobutamine, sterojdi, surfactant, u ventilazzjoni bi frekwenza għolja.
English: Limay Porcheville 3 avenue Ozanne 78440 Porcheville France
Maltese: Linde France Z.I. Limay-Porcheville 3 avenue Ozanne 78440
English: Elevated NO2 may cause acute lung injury.
Maltese: NO2 elevat jista' jikkawża ħsara akuta fil-pulmun.
English: There may be an additive effect with INOmax on the risk of developing methaemoglobinemia with nitric oxide donor substances, including sodium nitroprusside and nitroglycerin.
Maltese: Jista' jkun hemm effett addittiv b'INOmax fuq ir-riskju li tiġi żviluppata methaemoglobinemia bis-sustanzi donaturi tan-nitric oxide, inkluż sodium nitroprusside u nitroglycerin.
English: Fax: +43(0)50.4273-2260 healthcare@at.linde-gas.com
Maltese: +43(0)50.4273-2260 healthcare@at.linde-gas.com
English: Bradycardiab (following abrupt discontinuation of therapy)
Maltese: Bradikardijab (wara waqfien f'daqqa tal-kura)
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Inhaled NO has been given for time periods up to 7 days in the peri-operative setting, but common treatment times are 24 -48 hours.
Maltese: NO li jittieħed man-nifs ġie mogħti għal perjodi sa 7 ijiem fissitwazzjoni peri-operattiva, iżda l-ħinijiet komuni ta' trattament huma 24-48 siegħa.
English: (see section 6 ‘further information' where the full list of ingredients is provided).
Maltese: (ara sezzjoni 6 ‘aktar tagħrif' fejn hemm ipprovdut lista sħiħa tas-sustanzi).
English: INOmax is given in dose of 10 to 20 ppm, (maximal dose 20 ppm in children and 40 ppm in adults) part per million of the gas that you or your child inhale.
Maltese: INOmax jingħata f'doża ta' 10 sa 20 ppm, (doża massimali ta' 20 ppm fit-tfal u 40 ppm fl-adulti) parti minn kull miljun tal-gass li inti jew tifel/tifla tiegħek tieħdu man-nifs.
English: The displayed frequency categories use 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), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenza murija jużaw il-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari
English: ul.
Maltese: Av.
English: In cases of failure to respond to inhaled nitric oxide, see section 4.4.
Maltese: F'każijiet ta' nuqqas ta' rispons għan-nitric oxide li jkun ittieħed man-nifs, ara sezzjoni 4.4.
English: Tabulated list of adverse reactions
Maltese: Lista f'tabella ta' reazzjoni avversi
English: Nitric oxide has an unpaired electron, which makes the molecule reactive.
Maltese: Nitric oxide għandu elektron mhux imqabbad, li jagħmel il-molekula reattiva.
English: The INOmax group had significantly improved oxygenation as measured by PaO2, OI, and alveolar-arterial gradient (p<0.001 for all parameters).
Maltese: Il-grupp ta' INOmax kellu ossiġenazzjoni mtejba ferm kif imkejla b'PaO2, OI, u l-gradjent alveolari-arterjali (p<0.001 għall-parametri kollha).
English: Dizziness c a: Identified from the clinical trial b: Identified from Post-Marketing experience c: Identified from Post-Marketing experience, experienced by healthcare personnel following accidental exposure d: Post Marketing Safety Surveillance (PMSS) data, effects associated with acute withdrawal of the medicinal product, and /or delivery system failures.
Maltese: Sturdamentc a: Identifikat mill-prova klinika b: Identifikat mill-esperjenza ta' Wara t-Tqegħid fis-Suq. ċ: Identifikat mill-esperjenza ta' Wara t-Tqegħid fis-Suq, esperjenzata mill-persunal tal-kura tas-saħħa wara espożizzjoni aċċidentali d: Dejta ta' Sorveljanza tas-Sigurtà ta' Wara t-Tqegħid fis-Suq (PMSS), effetti assoċjati ma' rtirar akut tal prodott mediċinali, u/jew falliment tas-sistema tal-għoti.
English: The effects of inhaled nitric oxide are rapid, decrease in pulmonary artery pressure and improved oxygenation is seen within 5-20 minutes.
Maltese: L-effetti ta' nitric oxide meħud man-nifs huma tnaqqis rapidu fil-pressjoni tal-arterji pulmonari u jidher titjib fl-ossiġenazzjoni fi żmien 5-20 minuta.
English: The mean methaemoglobin levels remained below 1 % in the placebo group and in the 5 ppm and 20 ppm INOmax groups, but reached approximately 5 % in the 80 ppm INOmax group.
Maltese: Il-livelli medji ta' methaemoglobin baqgħu taħt 1% fil-grupp tal-plaċebo u fil-gruppi ta' INOmax ta' 5 ppm u 20 ppm, iżda laħqu madwar 5% fil-grupp ta' INOmax ta' 80 ppm.
English: INOmax is available in 2 litre and 10 litre aluminium gas cylinder.
Maltese: INOmax huwa disponibbli f'ċilindru tal-gass tal-aluminju ta' 2 litri u 10 litri.
English: Significantly fewer neonates in the INOmax group required ECMO compared to the control group (31 % vs. 57 %, p<0.001).
Maltese: Ferm inqas trabi tat-twelid fil-grupp ta' INOmax kienu jeħtieġu ECMO meta mqabbla mal-grupp ta' kontroll (31 % vs 57%, p<0.001).
English: Nitric oxide chemically reacts with oxygen to form nitrogen dioxide.
Maltese: Nitric oxide jirreaġixxi kimikament mal-ossiġnu biex jifforma nitrogen dioxide.
English: Monitoring formation of methaemoglobin (MetHb) Neonates and infants are known to have diminished MetHb reductase activity compared to adults.
Maltese: Monitoraġġ tal-formazzjoni ta' methaemoglobin (MetHB) It-trabi tat-twelid u t-trabi huma magħrufin li għandhom attività mnaqqsa ta' MetHb reductase meta mqabbla mal-adulti.
English: Linde Gaz România SRL str. Avram Imbroane nr. 9 Timisoara 300136 - RO Tel: +40 256 300 700 healthcare@ro.linde-gas.com
Maltese: Imbroane nr. 9 Timisoara 300136 - RO Tel: +40 256 300 700 healthcare@ro.linde-gas.com
English: Τηλ.
Maltese: INOmax.
English: See section 4.2 for information on monitoring for NO2.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar il-monitoraġġ ta' NO2.
English: Among metallic construction materials, only stainless steel can be recommended.
Maltese: Fost materjali tal-kostruzzjoni metalliċi, l-istainless steel biss jista' jiġi rrakkomandat.
English: The upper limit of exposure (mean exposure) to nitric oxide for personnel defined by worker's legislation is 25 ppm for 8 hours (30 mg/m3) in most countries and the corresponding limit for NO2 is 2-3 ppm (4-6 mg/m3).
Maltese: F'ħafna pajjiżi, l-ogħla limitu ta' esponiment (esponiment medja) għan-nitric oxide għall-ħaddiema definit bil-leġiżlazzjoni tal-ħaddiema huwa ta' 25 ppm għal 8 sigħat (30 mg/m3) u l-limitu korrispondenti għall-NO2 huwa 2-3 ppm (4-6 mg/m3).
English: Consideration should be given to discontinuation of treatment if no beneficial physiological effects are apparent after a 30-minute trial of therapy.
Maltese: Għandha tingħata kunsiderazzjoni għal waqfien tal-kura jekk ebda effett fiżjoloġiku ta' benefiċċju ma jkun apparenti wara prova ta' 30 minuta ta' terapija.
English: Av. Infante D. Henrique Lotes 21-24 P-1800-217 Lisboa Tel: + 351 218 310 420 linde.portugal@pt.linde-gas.com
Maltese: P-1800-217 Lisboa Tel: + 351 218 310 420 linde.portugal@pt.linde-gas.com
English: The concentrations of methaemoglobin in the blood should be monitored, see section 4.2.
Maltese: Ilkonċentrazzjonijiet ta' methaemoglobin fid-demm għandhom jiġu immonitorjati (ara sezzjoni 4.2).
English: In one clinical study (NINOS), treatment groups were similar with respect to the incidence and severity of intracranial haemorrhage, Grade IV haemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary haemorrhage, or gastrointestinal haemorrhage.
Maltese: Fi studju kliniku wieħed (NINOS), il-gruppi ta' kura kienu simili fir-rigward tal-inċidenza u s-severità ta' emorraġija fil-kranju, emorraġija tal-Grad IV, lewkomalasja periventrikulari, infart ċerebrali,
English: EXP
Maltese: Avram
English: For patient safety, appropriate alarms must be set for INOmax (± 2 ppm of the prescribed dose), NO2 (1 ppm), and FiO2 (± 0.05).
Maltese: Għas-sigurtà talpazjent, għandhom jiġu issettjati allarmi xierqa għal INOmax (± 2 ppm tad-doża preskritta), NO2 (1 ppm), u FiO2 (± 0.05).
English: In clinical trials INOmax has been given in addition to other standard treatment regimes in the peri-operative setting, including inotropic and vasoactive medicinal products.
Maltese: Fi provi kliniċi, INOmax ingħata flimkien ma' reġimi standard oħra ta' trattament fix-xenarju ta' madwar loperazzjoni (peri-operattiv), fosthom prodotti mediċinali inotropiċi u vażoattivi.
English: Formation of methaemoglobin
Maltese: Monitoraġġ tal-formazzjoni ta' methaemoglobin (MetHB)
English: The frequency and number of adverse events were similar in the two study groups.
Maltese: Il frekwenza u n-numru ta' avvenimenti avversi kienu simili fiż-żewġ gruppi ta' studju.
English: Formation of NO2
Maltese: NO2
English: Instructions for use/handling INOmax
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI
English: Follow-up exams at 18-24 months of age were similar between the two groups with respect to mental, motor, audiologic, and neurologic evaluations.
Maltese: Eżamijiet sussegwenti fi 18-24 xahar kienu simili bejn iż-żewġ gruppi fir-rigward ta' evalwazzjonijiet mentali, muturi, awdjoloġiċi, u newroloġiċi.
English: In children and adults with high blood pressure in the lungs, connected with heart surgery, INOmax is usually given for 24-48 hours.
Maltese: Fi tfal u adulti bi pressjoni tad-demm għolja fil-pulmuni, konnessa ma' kirurġija tal-qalb, INOmax normalment jingħata għal 24-48 siegħa.
English: The adverse events collected occurred at similar incidence rates in both groups.
Maltese: L-avvenimenti avversi miġbura seħħew f'rati ta' inċidenza simili fiż-żewġ gruppi.
English: Polytrifluorochloroethylene, hexafluoropropene-vinyliden copolymer and polytetraflourethylene have been used extensively with pure nitric oxide and other corrosive gases.
Maltese: Polytrifluorochloroethylene, hexafluoropropene-vinyliden copolymer u polytetraflourethylene ntużaw b'mod estensiv b'nitric oxide pur u gassijiet korrużivi oħrajn.
English: AS Eesti AGA Pärnu mnt. 141 EE - 11314 Tallinn Tel: +372 650 4500 aga@aga.ee
Maltese: Tallinn Tel: +372 650 4500 aga@aga.ee
English: During treatment with nitric oxide, the NO2 concentration should be < 0.5 ppm in the nitric oxide dose range < 20 ppm.
Maltese: għandha tkun < 0.5 ppm fil-gamma ta' doża ta' nitric oxide < 20 ppm.
English: In clinical studies treatment was often initiated before separation from Cardio Pulmonary Bypass.
Maltese: Fil-provi kliniċi, it-trattament ħafna drabi nbeda qabel separazzjoni minn Bypass Pulmonari Kardijaku.
English: The BALLR1 study, also evaluating the effects of iNO in preterm neonates, but initiating iNO at 7 days and in a dose of 20 ppm, found a significant increase in neonates alive without BPD at gestational week 36, 121 (45 % vs. 95 (35.4 %) p<0.028.
Maltese: L-istudju BALLR1, li wkoll evalwa l-effetti tal-iNO fi trabi li twieldu qabel iż-żmien, iżda li bdew l-iNO wara 7 ijiem u f'doża ta' 20 ppm, sab żieda sinifikanti fit-trabi tat-twelid li baqgħu ħajjin mingħajr BPD fis-36 ġimgħa ta' ġestazzjoni, 121 (45% vs 95 (35.4%) p<0.028.
English: The pharmacokinetics of nitric oxide has been studied in adults.
Maltese: Il-farmakokinetiċi ta' nitric oxide ġew studjati fl-adulti.
English: Thrombocytopeniaa
Maltese: Skumdità fissiderc
English: INOmax contains Nitrogen
Maltese: INOmax fih Nitroġenu
English: The prospectively defined primary endpoint was the receipt of ECMO.
Maltese: Il-punt ta' tmiem primarju definit prospettivament kien ir-riċeviment ta' ECMO.