FrancophonIA/ELRC3.0 huggingface dataset:
English: Abundant data supports treating patients with oesophageal GERD syndromes with antisecretory drugs and there is ample evidence that, as a drug class, PPIs are more effective in these patients than H2 receptor antagonist.
Maltese: Dejta abbundanti tappoġġa ttrattament ta' pazjenti li għandhom sindromi esopagali GERD b'mediċini kontra t-tnixxija u hemm ħafna evidenza li, bħala klassi ta' mediċina, il-PPIs huma aktar effikaċi f'dawn il-pazjenti milli lantagonist tar-riċettur H2.
English: For gastric ulcer, data from two clinical trials and one meta-analysis was provided.
Maltese: Għall-ulċera gastrika, id-dejta minn żewġ provi kliniċi u meta-analiżi waħda ġiet ipprovduta.
English: The CHMP noted the MAH proposal and adopted a harmonised text for this section, applicable to all Protium formulations.
Maltese: Is-CHMP ħa nota tal-proposta tal-MAH u adotta test armonizzat għal din is-sezzjoni, li japplika għallformulazzjonijiet ta' Protium kollha.
English: A randomized, dose-finding study showed statistically significant differences between 20 mg and 40 mg, thus indicating that pantoprazole at a daily dose of 40 mg is the recommended efficacious and safe dosage.
Maltese: Studju fortuwitu għas-sejbien tad-doża wera differenzi statistikament sinifikanti bejn 20 mg u 40 mg, u b'hekk jindika li pantoprazole b'doża ta' kuljum ta' 40 mg huwa d-dożaġġ rakkomandat effikaċi u sigur.
English: The general text of frequencies classification, and the adverse reaction obtained from postmarketing experience were clarified, and the frequency of a number of events was revised.
Maltese: It-test ġenerali ta' klassifikazzjoni tal-frekwenzi, u r-reazzjoni avversa miksuba mill-esperjenza ta' wara t-tqegħid fis-suq ġew iċċarati, u l-frekwenza ta' għadd ta' avvenimenti ġiet riveduta.
English: The statement on a possible increase in gastrointestinal infections is supported by a case-control study comparing 6,414 patients with an episode of gastroenteritis (GE) with a healthy control group of 50,000 and showing that the use of PPIs is associated with an increased risk of bacterial GE, regardless of the treatment duration.
Maltese: Id-dikjarazzjoni dwar żieda possibbli flinfezzjonijiet gastrointestinali hija appoġġata minn studju b'każ ikkontrollat li jqabbel 6,414 pazjent b'episodju ta' gastroenterite (GE) ma' grupp ta' kontroll b'saħħtu ta' 50,000 u li juri li l-użu tal-PPIs huwa assoċjat ma' riskju miżjud ta' GE batterjali, ikun xi jkun it-tul tat-trattament. l-irdoppjar taddoża tal-PPI żiedet aktar ir-riskju ta' GE, bi Campylobacter u Salmonella l-aktar ta' spiss responsabbli.
English: The CHMP considered that the proven clinical efficacy of pantoprazole 40 mg p.o. and the documented equivalence of pantoprazole 40 mg p.o. and pantoprazole 40 mg i.v.
Maltese: Is-CHMP ikkunsidra li l-effikaċja klinika ppruvata ta' pantoprazole 40 mg p.o. u l-ekwivalenza dokumentata ta' pantoprazole 40 mg p.o. u pantoprazole 40 mg i.v. jiġġustifikaw l-użu fit-trattament ta' esofaġite tarrifluss moderata u severa, ulċera duwodenali, ulċera gastrika u ZES u kundizzjonijiet patoloġiċi ta' tnixxija żejda oħra.
English: The CHMP noted the submitted randomized clinical trials results demonstrating that pantoprazole is therapeutically superior to placebo and to ranitidine in patients with moderate and severe reflux oesophagitis and equivalent in healing rates after 4/8 weeks and/or symptom relief after 2/4 weeks of treatment with omeprazole, esomeprazole and lansoprazole.
Maltese: Indikazzjonijiet proposti għal pilloli gastro-reżistenti ta' pantoprazole ta' 40 mg: Is-CHMP ħa nota tar-riżultati tal-provi kliniċi fortuwiti ssottomessi li juru li pantoprazole huwa terapewtikament superjuri għal plaċebo u għal ranitidine f'pazjenti li għandhom esofaġite tar-rifluss moderata u severa u ekwivalenti fir-rati ta' fejqan wara 4/8 ġimgħat u/jew solliev tas-sintomi wara 2/4 ġimgħat ta' trattament b'omeprazole, esomeprazole u lansoprazole.
English: Regarding duodenal ulcer, data from several randomized trials was provided, comparing pantoprazole with ranitidine.
Maltese: Rigward l-ulċera duwodenali, id-dejta minn bosta provi fortuwiti ġiet pprovduta, li tqabbel pantoprazole ma' ranitidine.
English: In conclusion, the harmonisation procedure led to the adoption by the CHMP of a harmonised set of Product Informations for the three Protium formulations included in the scope and the CHMP was of the opinion that the benefit/risk ratio of Protium and associated names is considered to be favourable.
Maltese: Bħala konklużjoni, il-proċedura ta' armonizzazzjoni wasslet għall-adozzjoni mis-CHMP ta' sett armonizzat ta' Informazzjoni dwar il-Prodott għat-tliet formulazzjonijiet ta' Protium inklużi fl-iskop u s-CHMP kien tal-opinjoni li l-proporzjoni tal-benefiċċji/riskji ta' Protium u ismijiet assoċjati huwa kkunsidrat bħala wieħed favorevoli.
English: In line with the assessment of the 20 mg gastro-resistant tablets, Protium is not recommended in children below 12 years.
Maltese: B'mod konformi mal-valutazzjoni tal-pilloli gastro-reżistenti ta' 20 mg, Protium mhuwiex rakkomandat fittfal ta' taħt it-12-il sena.
English: Clarithromycin, metronidazole, tinidazole and amoxicillin are widely used in Europe for eradication of H. Pylori, however the prevalence of antimicrobial resistance in H. pylori shows regional variability and alternative antibiotics based on local resistance rates may improve eradication rates.
Maltese: Irreżistenza antibijotika hija kawża ewlenija tal-falliment tat-trattament u peress li l-prevalenza tarreżistenza f'H. pylori turi varjazzjoni reġjonali, antibijotiċi alternattivi bbażati fuq ir-rati ta' reżistenza lokali jistgħu jtejbu r-rati tal-eradikazzjoni.
English: Tablet characterisation, excipient compliance with the requirements of the Ph. Eur, specifications for dissolution, tests on colorants, stress and impurities, certificates of analysis of the reference substances and packaging and containers are considered generally acceptable.
Maltese: Eur, lispeċifikazzjonijiet għal dissoluzzjoni, it-testijiet fuq koloranti, stress u impuritajiet, iċ-ċertifikati ta' analiżi tas-sustanzi ta' referenza u l-imballaġġ u l-kontenituri huma kkunsidrati aċċettabbli b'mod ġenerali.
English: Finally, for the Zollinger-Ellison syndrome (ZES) and other pathological hypersecretory conditions, data from two studies comparing the efficacy of pantoprazole in reducing gastric acid secretion in 11 ZES patients who previously had received omeprazole and lansoprazole was provided.
Maltese: Fl-aħħar nett, għas-sindrome ta' Zollinger-Ellison (ZES) u kundizzjonijiet patoloġiċi ta' tnixxija żejda oħra, id-dejta minn żewġ studji li qabblu l-effikaċja ta' pantoprazole fit-tnaqqis tat-tnixxija tal-aċidu gastriku fi 11-il pazjent b'ZES li qabel kienu ħadu omeprazole u lansoprazole ġiet ipprovduta.
English: In order to reduce the risk in this population, the statement was moved to Section 4.2.
Maltese: Sabiex jitnaqqas ir-riskju f'din il-popolazzjoni, id-dikjarazzjoni tressqet għas-Sezzjoni 4.2.
English: The pharmaceutical development, the description of the manufacturers and their activities, the packaging and containers, the excipients used, the release specifications, the lower assay limit in drug product shelf-life specifications, the inclusion of related substances, the peak purity test, the reference standards of the drug substance and related substances and the stability of the drug product are considered generally acceptable.
Maltese: L-iżvilupp farmaċewtiku, id-deskrizzjoni tal-manifatturi u l-attivitajiet tagħhom, limballaġġ u l-kontenituri, l-eċċipjenti wżati, l-ispeċifikazzjonijiet tar-rilaxx, il-limitu analitiku l-aktar baxx fl-ispeċifikazzjonijiet tat-tul ta' skadenza ta' prodott mediċinali, l-inklużjoni ta' sustanzi relatati, it-test tal-purezza l-aktar għolja, l-istandards ta' referenza tas-sustanza mediċinali u tas-sustanzi relatati u l-istabbiltà tal-prodott mediċinali huma kkunsidrati aċċettabbli b'mod ġenerali.
English: For the prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs, a summary of three clinical trials was provided, showing superiority of pantoprazole versus placebo and misoprostol and similar effectiveness to omeprazole.
Maltese: Għall-prevenzjoni ta' ulċeri gastroduwodenali kkawżati minn mediċini mhux selettivi u mhux sterojdali kontra l-infjammazzjoni, sommarju ta' tliet provi kliniċi ġie pprovdut, li juri s-superjorità ta' pantoprazole kontra plaċebo u misoprostol u effikaċja simili ma' omeprazole.
English: In conclusion, based on the data provided by the MAH and the existing clinical evidence, the proposed indications are considered appropriate; however, the CHMP proposed a new wording for the moderate and severe reflux oesophagitis, taking into account the current classification of gastroesophageal reflux disease.
Maltese: Bħala konklużjoni, fuq il-bażi tad-dejta pprovduta mill-MAH u l-evidenza klinika eżistenti, l-indikazzjonijiet proposti huma kkunsidrati approprjati; madankollu s-CHMP ippropona kliem ieħor għall-esofaġite tar-rifluss moderata u severa, filwaqt li kkunsidra l-klassifikazzjoni attwali tal-marda tar-rifluss gastro-esofagali.
English: Co-administration of atazanavir with proton pump inhibitors is not recommended and if the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended while high doses of proton pump inhibitors should be avoided.
Maltese: Il-ko-amministrazzjoni ta' atazanavir ma' inibituri proton pump mhijiex rakkomandata u jekk it-taħlita ta' atazanavir ma' inibitur proton pump tiġi meqjusa li ma tistax tiġi evitata, il-monitoraġġ kliniku mill-qrib huwa rakkomandat filwaqt li dożi għoljin ta' inibituri proton pump għandhom jiġu evitati.
English: The relapse of erosive oesophagitis in subjects with GERD was shown to be dramatically decreased by PPI treatment and reflux symptoms were also better controlled with maintenance-dose PPI therapy than with placebo.
Maltese: Ir-rikaduta ta' esofaġite erożiva f'suġġetti li għandhom GERD uriet li titnaqqas b'mod drammatiku bit-trattament PPI u s-sintomi tar-rifluss kienu wkoll ikkontrollati aħjar bit-terapija PPI b'doża ta' manutenzjoni milli bi plaċebo.
English: Pantoprazole 40 mg gastro-resistant tablets
Maltese: Pilloli gastro-reżistenti ta' pantoprazole ta' 40 mg
English: For the long-term management and prevention of relapse in reflux oesophagitis the MAH summarised 7 studies in long term treatment (between 6-12 months) showing that pantoprazole is superior in maintaining the healing and relapse rates compared to placebo and ranitidine.
Maltese: Għallġestjoni fuq żmien twil u l-prevenzjoni tar-rikaduta fl-esofaġite tar-rifluss il-MAH ġabar fil-qosor 7 studji fit-trattament fuq żmien twil (bejn 6-12-il xahar) li juru li pantoprazole huwa superjuri fiżżamma tar-rati tal-fejqan u tar-rikaduta meta mqabbel ma' plaċebo u ranitidine.
English: It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome.
Maltese: Jintuża wkoll għat-trattament ta' kundizzjonijiet fejn l-istonku jipproduċi wisq aċidu, bħas-sindrome ta' Zollinger-Ellison.
English: For Module 1, the submitted current manufacturing authorisations for all manufacturers of the drug products in EU countries and GMP certificates of EU inspectorates for manufacturers of the drug products in non-EU countries, together with the declaration of the QP of the manufacturer for drug product release in the EU were considered acceptable.
Maltese: Għall-Modulu 1, l-awtorizzazzjonijiet ta' manifattura attwali ssottomessi għall-manifatturi kollha talprodotti mediċinali fil-pajjiżi tal-UE u ċ-ċertifikati GMP tal-ispettorati tal-UE għall-manifatturi talprodotti mediċinali fil-pajjiżi mhux tal-UE, flimkien mad-dikjarazzjoni tal-QP tal-manifattur għarrilaxx tal-prodott mediċinali fl-UE kienu kkunsidrati aċċettabbli.
English: It was noted that concomitant intake of food had no influence on AUC and maximum serum concentration but that the variability of the lag-time will be increased.
Maltese: Kien innotat li tteħid konkomitanti ta' ikel ma kellu l-ebda influwenza fuq AUC u l-konċentrazzjoni massima tas serum iżda li l-varjabbiltà tal-ħin tal-intervall jiżdied.
English: The method and the statistical approach together with the data provided were reviewed and the CHMP considered the estimated frequency to be appropriate.
Maltese: Il-metodu u l-approċċ statistiku flimkien mad-dejta pprovduta ġew riveduti u s-CHMP ikkunsidra li l-frekwenza stmata kienet approprjata.
English: The CHMP agreed that on demand treatment is an appropriate option for symptomatic gastro-oesophageal reflux disease.
Maltese: Is-CHMP qabel li ittrattament fuq talba huwa għażla approprjata għall-marda tar-rifluss gastro-esofegali sintomatika.
English: Regarding hypersensitivity and concomitant use with atazanavir, the comments provided for the 20 mg tablet dose apply.
Maltese: Rigward is-sensittività żejda u l-użu konkomitanti ma' atazanavir, il-kummenti pprovduti għad-doża tal-pillola ta' 20 mg japplikaw.
English: In summary, the CHMP adopted the following sets of indications for Protium and associated names:
Maltese: Fil-qosor, is-CHMP adotta s-settijiet ta' indikazzjonijiet li ġejjin għal Protium u ismijiet assoċjati:
English: The CHMP adopted a harmonised text for all sections under Section 5.
Maltese: Is-CHMP adotta test armonizzat għas-sezzjonijiet kollha taħt is-Sezzjoni 5.
English: Section 4.5 states that co-administration of atazanavir and other HIV medications whose absorption is pH-dependent with proton-pump inhibitors might result in a substantial reduction in the bioavailability of these HIV medications and might impact efficacy.
Maltese: Is-Sezzzjoni 4.5 tiddikjara li l-ko-amministrazzjoni ta' atazanavir u mediċini tal-HIV oħra li l-assorbiment tagħhom jiddependi fuq il-pH ma' inibituri proton-pump tista' tirriżulta fi tnaqqis sostanzjali fil-bijodisponibbiltà ta' dawn il-mediċini tal-HIV u jista' jkollha impatt fuq l-effikaċja.
English: The association between NSAIDs and the presence of upper gastrointestinal (GI) complications is considered well established and evidence that acid aggravates NSAID-induced injury provides a rationale for minimizing such damage by acid suppression.
Maltese: It-test li jirreferi għal “gwida lokali uffiċjali” huwa miftiehem għaliex jippermetti l-inklużjoni ta' antibijotiċi alternattivi mingħajr ma jiġu msemmija l-alternattivi kollha li jintużaw fuq livell nazzjonali.
English: Section 4.7 - Effects on ability to drive and use machines
Maltese: Sezzjoni 4.7 - Effetti fuq l-abbiltà li wieħed isuq u juża l-magni
English: PRILACTONE tablets contain the active substance spironolactone (10 mg, 40 mg or 80 mg).
Maltese: Il-pilloli PRILACTONE fihom is-sustanza attiva spironolactone (10 mg, 40 mg jew 80 mg).
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ ta' riskju-benefiċċju jista' jinstab f'modulu 6 ta' dan l-EPAR.
English: The dose to use is 2 mg per kilogram of the dog's body weight.
Maltese: Id-doża wżata hija 2 mg kull kilogramm tal-piż korporju tal-kelb.
English: What is PRILACTONE?
Maltese: X'inhu PRILACTONE?
English: Why has PRILACTONE been approved?
Maltese: Għaliex ġie approvat PRILACTONE?
English: The appropriate number of tablets, half tablets or quarter tablets to give according to the dog's size is given in the Package Leaflet.
Maltese: In-numru addattat ta' pilloli, nofs pilloli jew kwart ta' pilloli li għandhom jingħataw skond id-daqs tal-kelb huwa mogħti filFuljett ta' Tagħrif.
English: PRILACTONE tablets should not be given to dogs with poor kidney function that are being given medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Pilloli PRILACTONE m'għandhomx jingħataw lill-klieb b'funzjoni tal-kliewi bagħtuta li qed jingħataw mediċini magħrufa bħala mediċini anti-infjammatorji mhux sterojdi (NSAIDs).
English: The active substance in PRILACTONE, spironolactone, blocks the actions of a hormone called aldosterone in the kidneys, heart and blood vessels.
Maltese: Is-sustanza attiva f'PRILACTONE, spironolactone, timblokka l-azzjonijiet ta' l-ormon imsejjaħ aldosterone fil-kliewi, il- qalb u l-arterji.
English: PRILACTONE is used in combination with ‘standard therapy' (other heart medicines, including diuretic support where necessary).
Maltese: PRILACTONE jintuża f'kumbinazzjoni ma' ‘terapija standard' (mediċini oħra tal-qalb, inkluż appoġġ dijuretiku fejn ikun hemm bżonn).
English: What is the risk associated with PRILACTONE?
Maltese: X'inhu r-riskju assoċjat ma' PRILACTONE?
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni fuq il-bażi tarrakkomandazzjonijiet tal-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of PRILACTONE outweigh its risks for use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs, and recommended that PRILACTONE be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' PRILACTONE jisbqu r-riskji tiegħu għal użu f'kumbinazzjoni ma' terapija standard (inkluż appoġġ dijuretiku, fejn ikun hemm bżonn) għat-trattament ta' falliment konġestiv tal-qalb ikkaġunat minn regurġitazzjoni valvulari fil-klieb, u rrakkomanda li PRILACTONE jingħata awtorizzazzjoni għattqegħid fis-suq.
English: The results of the studies showed that dogs with congestive heart failure caused by faulty heart valves that were given PRILACTONE tablets in addition to another heart medicine (‘standard therapy'), had a longer survival time than the dogs that received the standard therapy plus placebo tablets.
Maltese: Ir-riżultati ta' l-istudji wrew li klieb b'falliment konġestiv tal-qalb ikkaġunat minn valvi tal-qalb difettużi li ngħataw pilloli PRILACTONE flimkien ma' mediċina oħra tal-qalb (‘terapija standard') kellhom żmien ta' sopravivenza itwal milli klieb li rċevew terapija standard flimkien ma' pilloli plaċebo.
English: In these clinical studies, the animal owners gave either PRILACTONE tablets or placebo (dummy tablets without any active ingredient) to their dogs, once daily, at a dose of 2 mg/kg with food.
Maltese: F'dawn listudji kliniċi, is-sidien ta' l-annimali taw jew pilloli PRILACTONE jew plaċebo (pilloli finta mingħajr sustanza attiva) lill-klieb tagħhom, darba kuljum, f'doża ta' 2 mg/kg ma' l-ikel.
English: PRILACTONE may cause skin sensitisation, so people who know that they are allergic to spironolactone should not handle the product.
Maltese: PRILACTONE jista' jikkaġuna sensitizzazzjoni tal-ġilda, għalhekk nies li jafu li huma allerġiċi għal spironolactone m'għandhomx imissu dan il-prodott.
English: Other information about PRILACTONE:
Maltese: Tagħrif ieħor dwar PRILACTONE:
English: They should also not be given to animals with high blood potassium levels (hyperkalaemia) or low blood sodium levels (hyponatraemia), or to animals with hypoadrenocorticism (a disease that results from the reduction in corticosteroid secretion from the adrenal gland).
Maltese: Dawn m'għandhomx jingħataw ukoll lill-annimali b'livelli għolja ta' potassju fid-demm (iperkalimja) jew b'livelli baxxi ta' sodju (iponatrimja), jew lill-annimali b'iperadrenokortiċiżmu (marda li tirriżulta mittnaqqis fit-tnixxija kortikosterojde mill-glandola adrenali).
English: As spironolactone can reduce the levels of some male hormones, male dogs which have not been neutered may show a shrinking of the prostate gland.
Maltese: Minħabba li spironolactone jista' jnaqqas il-livelli ta' l-ormoni ta' l-irġiel, klieb irġiel li ma ġewx ikkastrati tista' tinxtorbilhom il-glandola tal-prostata.
English: For a full list of all side effects reported with PRILACTONE, and for a list of all interactions with other medicines, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati bi PRILACTONE, u għal-lista ta' l-interazzjonijiet kollha ma' mediċini oħra, ara l-Fuljett ta' Tagħrif.
English: By blocking aldosterone, spironolactone causes the kidneys to excrete salt and fluids, but retain potassium, and hence it improves heart function.
Maltese: Spironolactone iġiegħel lill-kliewi jeliminaw melħ u fluwidi, iżda jżommu l-potassju, billi jimblokkaw aldosterone, u b'hekk itejjeb il-funzjoni tal-qalb.
English: PRILACTONE was generally well tolerated when administered daily at the recommended dose for up to 15 months in dogs with heart failure.
Maltese: Ġeneralment PRILACTONE kien ittollerat sew meta amministrat ta' kuljum fid-doża irrakkomandata sa 15-il xahar fi klieb b'falliment tal-qalb.
English: PRILACTONE has been studied in the laboratory, as well as in three studies in dogs with heart valve diseases, which were treated in various veterinary practices or clinics across Europe (‘clinical studies‘).
Maltese: PRILACTONE ġie studjat fil-laboratorju, kif ukoll fi tliet studji fi klieb b'mard tal-valvi tal-qalb, li kienu ttrattati f'diversi prattiċi jew kliniċi veterinarjari madwar l-Ewropa (‘studji kliniċi').
English: Total VTE
Maltese: Total ta' VTE
English: 00-725 Warsaw
Maltese: 00-725 Varsavja
English: ATC code: B01A B05
Maltese: B01A B05
English: Techdow Europe AB Kåbovägen 32, 75236 Uppsala Sweden
Maltese: Techdow Europe AB Kåbovägen 32, 75236 Uppsala
English: 518057, People's Republic of China
Maltese: 518057, Repubblika taċ-Ċina
English: Mitvertrieb: Techdow Pharma Germany GmbH Potsdamer Platz 1, 10785 Berlin
Maltese: Techdow Pharma Germany GmbH Potsdamer Platz 1, 10785
English: Health-Med spółka z ograniczoną odpowiedzialnością sp.k.
Maltese: Health-Med spółka z ograniczoną odpowiedzialnością sp.k. Chełmska 30/34
English: Shenzhen Techdow Pharmaceutical Co., Ltd. No. 19, Gaoxinzhongyi Road, Hi-tech Industrial Park, Nanshan District,
Maltese: No. 19, Gaoxinzhongyi Road, Hi-tech Industrial Park, Nanshan District,
English: • Proximal DVT
Maltese: • DVT Prossimali
English: • Traceability
Maltese: • Traċċabilità
English: - Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac,
Maltese: - Salicylates sistemiċi, acetylsalicylic acid bid-dożi antiinfjammatorji, u NSAIDs inkluż ketorolac,
English: - enoxaparin sodium once a day versus heparin (-3.0 to 3.5)
Maltese: - enoxaparin sodium darba kuljum versus heparin (-3.0 sa 3.5)
English: - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2).
Maltese: - Trombolitiċi (eż. alteplase, reteplase, streptokinase, tenecteplase, urokinase) u antikoagulanti oħra (ara sezzjoni 4.2).
English: Important information about some of the ingredients of Inhixa Inhixa contains benzyl alcohol (45 mg/3 mL; 75 mg/5 mL; 150 mg/10 mL).
Maltese: Informazzjoni importanti dwar xi wħud mill-ingredjenti ta' Inhixa Inxiha fih alkoħol benżiliku (45 mg/3 mL; 75 mg/5 mL; 150 mg/10 mL).
English: • Proximal DVT (%) *p value versus placebo =0.008 #p value versus placebo =0.537
Maltese: • DVT Prossimali (%) *valur p versus plaċebo =0.008 #valur p versus plaċebo =0.537
English: Acute infective endocarditis
Maltese: Endokardite infettiva akuta
English: Total VTE (%)
Maltese: Total ta' VTE (%)
English: This difference persisted at three months [13.8% vs. 5.5% (n = 23 vs 9), p = 0.01].
Maltese: Din id-differenza ippersistiet sa tliet xhur [13.8% vs. 5.5% (n = 23 vs 9), p = 0.01].
English: - enoxaparin sodium every 12 hours versus heparin (-4.2 to 1.7).
Maltese: - enoxaparin sodium kull 12-il siegħa versus heparin (-4.2 sa 1.7).
English: History of HIT (>100 days)
Maltese: Storja ta' HIT (>100 jum)
English: Tel: +34 91 123 21 16
Maltese: TECHDOW PHARMA SPAIN, S.L. Tel: +34 91 123 21 16
English: • History of HIT (>100 days)
Maltese: • Storja ta' HIT (>100 jum)
English: 30 IU/kg (0.3 mg/kg) enoxaparin sodium should be administered.
Maltese: UI/kg (0.3 mg/kg) enoxaparin sodium.
English: What Inhixa contains - The active substance is enoxaparin sodium.
Maltese: X'fih Inhixa - Is-sustanza attiva hija enoxaparin sodium.