FrancophonIA/ELRC3.0 huggingface dataset:
English: Vascular disorders flushing, hypotension
Maltese: Disturbi gastrointestinali tqalligħ, dispepsja, dijarea
English: Inject IL-2 as you have been instructed.
Maltese: Injetta IL-2 skont l-istruzzjonijiet li tawk.
English: Study AML-1 was exploratory, enrolling 39 AML patients in remission to determine the dose and feasibility of Ceplene administered together with IL-2.
Maltese: L-istudju AML-1 kien wieħed esploratorju, li daħħal 39 pazjenti b'AML f'remissjoni biex jiddetermina d-doża u jekk Ceplene jistax jingħata flimkien ma' IL-2.
English: Caution should be used for patients with any of the following: symptomatic peripheral arterial disease, past or present peptic or oesophageal ulcer disease with a history of bleeding, clinically significant renal disease and stroke within the last 12 months.
Maltese: Għandha tintuża l-kawtela għall-pazjenti b'xi waħda minn dawn li ġejjin: mard sintomatiku tal-arterji periferali, ulċera peptika jew tal-esofagu bi storja ta' fsada passata jew preżenti, nefropatija klinikament sinifikattiva jew puplesija fi żmien l-aħħar 12-il xahar.
English: Yearly, simultaneously with submission of Periodic Safety Update reports
Maltese: Kull sena, flimkien ma' sottomissjoni ta' rapporti dwar Aġġornamenti Perjodiċi tasSikurezza
English: - Tricyclic anti-depressants that may have H1 and H2 receptor blocking properties.
Maltese: - Antidepressivi triċikliċi li jista' jkollhom karatteristiċi li jimblokkaw riċetturi H1 u H2. - Inibituri ta' monoamine oxidase u aġenti kontra l-malarja u antitripanosomiċi.
English: Ceplene should not be injected into the same anatomic region as IL-2.
Maltese: Ceplene ma għandu jiġi injettat fl-istess żona anatomika bħalma jkun ġie injettat IL-2.
English: Patient monitoring on day 1 should include vital signs, including pulse, blood pressure and respiratory rate.
Maltese: Sorveljanza tal-pazjent fl-ewwel jum għandha tinkludi sinjali vitali, inklużi polz, pressjoni tad-demm u rata respiratorja.
English: While posology differs, when Ceplene is used in conjunction with IL-2, physicians should also refer to the Summary of Product Characteristics (SmPC) for IL-2 and observe the respective medicinal product interactions.
Maltese: Waqt li l-pożoloġija hija differenti, meta Ceplene jintuża flimkien ma' IL-2, it-tobba għandhom jirreferu wkoll għas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC - Summary of Product Characteristics) għal IL-2 u josservaw l-interazzjonijiet tal-prodott mediċinali rispettiv.
English: Ceplene should be administered in the clinic under supervision of the physician on day 1 of the initial treatment cycle.
Maltese: Ceplene għandu jingħata fi klinika taħt sorveljanza ta' tabib f'jum 1 taċ-ċiklu ta' trattament inizjali.
English: Very common injection site fibrosis, pain
Maltese: Komuni ħafna fibrożi fis-sit tal-injezzjoni, uġigħ
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: Effetti fi studji mhux kliniċi kienu osservati f'esponimenti kkunsidrati suffiċjentement f'eċċess tal-esponiment massimu tal-bniedem, li jindikaw ftit rilevanza għal użu kliniku.
English: You will start your treatment with Ceplene in the clinic under supervision of a doctor.
Maltese: Għandek tibda t-trattament tiegħek bi Ceplene fil-klinika taħt is-superviżjoni ta' tabib.
English: Where appropriate, consideration should be made to providing concomitant treatment with a proton pump inhibitor.
Maltese: Fejn approprjat, għandu jiġi kkunsidrat li tiġi pprovduta trattament konkomittanti b'inibitur tal-pompa protonika.
English: Thus, subjects with severe renal impairment may be more sensitive to the blood pressure lowering effects of exogenously administered histamine than subjects with normal renal function or subjects with mild or moderate renal impairment.
Maltese: Għalhekk, suġġetti b'insuffiċjenza renali gravi jistgħu jkunu iktar sensittivi għall-effetti ta' tnaqqis filpressjoni tad-demm tal-istamina mogħtija eżoġenament milli suġġetti b'funzjoni renali normali jew suġġetti b'insuffiċjenza renali minn ħafifa għal moderata.
English: Ceplene is used in adult patients, together with IL-2, to treat a particular type of leukaemia called acute myeloid leukaemia (AML) which is a cancer of blood forming cells in the bone marrow.
Maltese: Pazjenti li qegħdin jirċievu l-prodotti mediċinali li ġejjin għandhom jiġu ttrattati bil-kawtela (ara sezzjoni 4.5): - Imblokkaturi Beta jew mediċini antipertensivi oħrajn.
English: 2013 Jan 28;346:f360.
Maltese: BMJ. 2013 Jan 28;346:f360. doi: 10.
English: doi: 10.1136/bmj.f360.
Maltese: 1136/bmj.f360.
English: 3 ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial 4 Veterans Affairs Nephropathy in Diabetes 5 Aliskiren Trial in Type 2 Diabetes Using Cardiorenal Endpoints
Maltese: 3 ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial Veterans Affairs Nephropathy in Diabetes
English: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid=WC0b01ac058004d5c1
Maltese: 2 L-Aġenzija Ewropea għall-Mediċini tirrakkomanda kontradikazzjonijiet u twissijiet ġodda għal mediċini li fihom aliskiren, 17/02/2012, http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mi d=WC0b01ac058004d5c1
English: RAS-acting agents include angiotensin-converting enzyme inhibitors (ACEinhibitors) such as benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril), angiotensin receptor blockers (ARBs) such as candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan and azilsartan and direct renin inhibitors such as aliskiren.
Maltese: L-aġenti b'azzjoni RAS jinkludu inibituri tal-enzima li tikkonverti angiotensin (inibituri ACE) bħal benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril u zofenopril), imblokkaturi tar-riċettur ta' angiotensin (ARBs) bħal candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan u azilsartan u inibituri diretti ta' renin bħal aliskiren.
English: The renin-angiotensin system (RAS) is a hormone system that regulates blood pressure and fluid balance.
Maltese: Is-sistema ta' renin-angiotensin (RAS) hija sistema tal-ormoni li tirregola l-pressjoni tad-demm u lbilanċ tal-fluwidi.
English: 1 - Overall summary of the scientific evaluation by PRAC
Maltese: 1 - Sommarju ġenerali tal-evalwazzjoni xjentifika mill-PRAC
English: 1 Makani H, Bangalore S, Desouza KA, Shah A, Messerli FH.
Maltese: 1 Makani H, Bangalore S, Desouza KA, Shah A, Messerli FH. Efficacy and safety of dual blockade of the renin-angiotensin system: meta-analysis of randomized trials.
English: The PRAC was also of the opinion that the contraindication based on the ALTITUDE5 study data regarding the concomitant use of ACE-inhibitors or ARBs with aliskiren-containing products in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) was confirmed by the additional data reviewed and that it should also be implemented in the product information of ARBs and ACE-inhibitors.
Maltese: Il-PRAC kien ukoll tal-opinjoni li l-kontraindikazzjoni bbażata fuq id-dejta tal-istudju ALTITUDE5 dwar l-użu konkomitanti ta' inibituri-ACE jew ARBs bi prodotti li fihom aliskiren f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (rata ta' filtrazzjoni glomerulari (GFR) < 60 ml/min/1.73 m2) kienet ikkonfermata mid-dejta addizzjonali rriveduta u li għandha wkoll tkun implimentata fl-informazzjoni dwar il-prodott tal-ARBs u l-inibituri ACE.
English: • The PRAC was of the view that there is considerable evidence, in particular from the ONTARGET, ALTITUDE and VA NEPHRON-D trials which conclusively demonstrates that dual RAS blockade therapy through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and renal failure compared to monotherapy;
Maltese: • Il-PRAC kien tal-opinjoni li hemm evidenza konsiderevoli, b'mod partikolari mill-provi ONTARGET, ALTITUDE u VA NEPHRON-D li b'mod konklużiv turi li t-terapija ta' imblokk RAS doppja permezz tal-użu kkombinat ta' inibituri ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren hija assoċjata ma' riskju akbar ta' effetti avversi, inkluż pressjoni baxxa, iperkalemija u insuffiċjenza renali meta mqabbel ma' monoterapija;
English: The PRAC reviewed the totality of the available data, including clinical trials, meta-analysis and publications, the MAHs' responses as well as the report from the Scientific Advisory Group in Cardiovascular Issues (SAG CVS).
Maltese: Il-PRAC irreveda d-dejta disponibbli kollha, inkluż provi kliniċi, metaanaliżijiet u pubblikazzjonijiet, ir-risponsi tal-MAHs kif ukoll ir-rapport mill-Grupp Xjentifiku Konsulattiv fi Kwistjonijiet Kardjovaskulari (CVS tal-SAG).
English: • The PRAC reviewed the totality of the available data, including clinical trials, meta-analysis and publications, the MAHs' responses as well as the report from the Scientific Advisory Group in Cardiovascular Issues;
Maltese: • Il-PRAC irreveda d-dejta kollha disponibbli, inkluż il-provi kliniċi, metaanaliżijiet u pubblikazzjonijiet, ir-risponsi tal-MAHs kif ukoll ir-rapport mill-Grupp Xjentifiku Konsultattiv fi Kwistjonijiet Kardjovaskulari;
English: Changes were made to the heart failure indication in section 4.4 for candesartan-containing products and in sections 4.2 and 4.4 for valsartan-containing products, in order to further harmonise the wording for the two substances.
Maltese: Saru bidliet fl-indikazzjoni ta' insuffiċjenza tal-qalb fis-sezzjoni 4.4 għal prodotti li fihom candesartan u fis-sezzjonijiet 4.2 u 4.4 għal prodotti li fihom valsartan, sabiex tiġi armoizzata ulterjorment ilformulazzjoni għaż-żewġ sustanzi.
English: Having considered the new available evidence from the scientific literature and given the seriousness of the identified safety concerns, the Italian Medicines Agency (AIFA) decided to initiate a review under Article 31 of Council Directive 2001/83/EC on 17 April 2013, referring the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) and requesting the PRAC to issue a recommendation on the benefit-risk of dual RAS blockade therapy through the combined use of ACEinhibitors, ARBs or aliskiren and whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure.
Maltese: Wara li kkunsidrat l-provi l-ġodda disponibbli mid-dokumentazzjoni xjentifika u minħabba s-serjetà tal-problemi tas-sigurtà identifikati, l-Aġenzija tal-Mediċini Taljana (AIFA) iddeċidiet li tibda reviżjoni skont l-Artikolu 31 tad-Direttiva tal-Kunsill 2001/83/KE fis-17 ta' April 2013, u rriferiet il-kwistjoni lill-Kumitat tal-Evalwazzjoni tar-Riskju tal-Farmakoviġilanza (PRAC) u talbet lill-PRAC biex joħroġ rakkomandazzjoni dwar il-benefiċċju-riskju ta' terapija tal-imblokk RAS doppja permezz tal-użu kkombinat ta' inibituri ACE, ARBs jew aliskiren u jekk għandhomx jittieħdu xi miżuri regolatorji fuq lawtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti involuti f'din il-proċedura.
English: It was noted that the Committee for Medicinal Products for Human Use (CHMP) had already conducted a review2 under Article 20 of Regulation (EC) No 726/2004 for aliskiren-containing products, concluding that these products should be contraindicated in patients with diabetes mellitus or moderate to severe renal impairment who take ACE-inhibitors or ARBs.
Maltese: Ġie nnotat li l-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) diġà wettaq reviżjoni2 skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għal prodotti li fihom aliskiren, li kkonkludiet li dawn il-prodotti għandhom jiġu kontraindikati f'pazjenti b'dijabete mellitus jew b'indeboliment renali moderat sa sever li jieħdu inibituri ACE jew ARBs.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC initiated by Italy following the emergence of new evidence on the efficacy and safety of dual RAS blockade therapy through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren, to determine whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure;
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE li nbdiet mill-Italja wara li nħarġet evidenza ġdida dwar l-effikaċja u s-sigurtà ta' terapija ta' imblokk RAS doppja permezz tal-użu kkombinat ta' inibituri ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren, sabiex jiġi stabbilit jekk għandhomx jittieħdu xi miżuri regolatorji fuq id-detentur talawtorizzazzjoni għat-tqegħid fis-suq tal-prodotti involuti f'din il-proċedura;
English: BMJ.
Maltese: Anness IV
English: In particular, the publication of a meta-analysis by Makani et al1 involving over 68,000 patients raised concerns that combining several RAS-acting agents may be associated with an increased risk of hyperkalaemia, hypotension and kidney failure, compared with the single use of one RAS-acting agent.
Maltese: B'mod partikolari, il-pubblikazzjoni ta' metaanaliżi minn Makani et al1 li involviet aktar minn 68,000 pazjent qajmet tħassib li l-kombinazzjoni ta' diversi aġenti b'azzjoni RAS tista' tkun assoċjata ma' riskju akbar ta' iperkalemija, ipotensjoni u insuffiċjenza tal-kliewi, meta mqabbel mal-użu waħdieni ta' aġent wieħed b'azzjoni RAS.
English: In particular the contraindication statements recommended by the PRAC were deleted from sections 5.1 (where proposed) and from section 4.4 for aliskiren, as these were already proposed in section 4.3 and therefore considered redundant.
Maltese: B'mod partikolari, id-dikjarazzjonijiet ta' kontraindikazzjoni rrakkomandati mill-PRAC tħassru mis-sezzjonijiet 5.1 (fejn propost) u mis-sezzjoni 4.4 għal aliskiren, peress li dawn kienu proposti fis-sezzjoni 4.3 u għalhekk huma kkunsidrati żejda.
English: RAS-acting agents act by blocking different stages of the renin-angiotensin system, lowering blood pressure and their use in the treatment of hypertension and its complications (including acute myocardial infarction, congestive heart failure and chronic kidney disease) is recommended in many current clinical guidelines.
Maltese: L-aġenti b'azzjoni RAS jaġixxu billi jwaqqfu l-istadji differenti tas-sistema ta' renin-angiotensin, it-tnaqqis tal-pressjoni tad-demm u l-użu tagħhom fil-kura ta' ipertensjoni u lkumplikazzjonijiet tagħha (inkluż infart mijokardijaku akut, insuffiċjenza tal-qalb konġestiva u mard tal-kliewi kroniku) huwa rrakkomandat f'diversi linji gwida kliniċi attwali.
English: The PRAC was of the opinion that there is considerable evidence from large clinical trials and meta-analyses which conclusively demonstrates that dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and renal failure compared to monotherapy, in particular in patients with diabetic nephropathy.
Maltese: Il-PRAC kien tal-opinjoni li kien hemm evidenza konsiderevoli minn provi kliniċi u meta-analiżijiet kbar li b'mod konklużiv juru li t-terapija ta' imblokk RAS doppja permezz tal-użu kkombinat ta' inibituri ta' ACE, ARBs jew aliskiren hija assoċjata ma' riskju akbar ta' avvenimenti avversi, inkluż ipotensjoni, iperkalemija u insuffiċjenza tal-kliewi meta mqabbla ma' monoterapija, b'mod partikolari f'pazjenti b'nefropatija dijabetika.
English: • The PRAC considered that the available efficacy data indicates that dual RAS blockade therapy does not provide significant benefit in the general patient population although certain patient subpopulations may benefit from treatment, provided that it occurs only under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure;
Maltese: • Il-PRAC ikkunsidra li d-dejta disponibbli dwar l-effikaċja tindika li t-terapija ta' imblokk RAS doppja ma tipprovdix benefiċċju sinifikanti fil-popolazzjoni ġenerali tal-pazjenti, għalkemm ċerti sottopopolazzjonijiet ta' pazjenti jafu jibbenefikaw mill-kura, sakemm issir biss taħt superviżjoni ta' speċjalista u soġġett għal sorveljanza mill-qrib frekwenti tal-funzjoni renali, lelettroliti u l-pressjoni tad-demm;
English: 2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
Maltese: 2 - Spjegazzjoni ddettaljata tar-raġunijiet xjentifiċi għal differenzi mir rakkomandazzjoni tal-PRAC
English: The PRAC therefore concluded that dual RAS blockade therapy should not be routinely used in the treatment of heart failure and is not recommended in the general population although it may benefit certain patients who remain symptomatic while receiving monotherapy or who cannot otherwise use alternative therapies, including potentially patients with diabetic nephropathy.
Maltese: Għalhekk, il-PRAC ikkonkluda li tterapija ta' imblokk RAS doppja ma għandhiex tintuża bħala rutina fil-kura ta' insuffiċjenza tal-qalb u mhijiex irrakkomandata fil-popolazzjoni ġenerali għalkemm jaf tkun ta' benefiċċju għal ċerti pazjenti li jibqgħu sintomatiċi meta jkunu qegħdin jirċievu monoterapija jew li inkella ma jistgħux jużaw terapiji alternattivi, inkluż pazjenti b'potenzjal ta' newroterapija dijabetika.
English: For candesartan- and valsartan-containing products, which are also authorised in the treatment of heart failure, additional information was agreed upon to reflect the fact that dual RAS blockade therapy in combination with an ACE-inhibitor may be of benefit in certain patients who cannot use other heart failure treatments, provided that they are used under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Maltese: Għal prodotti li fihom candesartan u valsartan, li huma wkoll awtorizzati fil-kura ta' insuffiċjenza tal-qalb, intlaħaq ftehim biex jiġi rifless il-fatt li terapija ta' imblokk RAS doppja flimkien ma' inibitur ACE tista' tkun ta' benefiċċju f'ċerti pazjenti li ma jistgħux jużaw kuri għal insuffiċjenza tal-qalb, sakemm jintużaw taħt superviżjoni ta' speċjalista u soġġett għal sorveljanza mill-qrib frekwenti tal-funzjoni tal-kliewi, l-elettroliti u l-pressjoni tad-demm.
English: The PRAC however clearly specified, based on data from the ONTARGET3 and VA NEPHRON-D4 studies that ACE-inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy.
Maltese: Madankollu, ilPRAC speċifika b'mod ċar, abbażi tad-dejta mill-istudji ONTARGET3 u VA NEPHRON-D4 li l-inibituri ACE u l-ARBs ma għandhomx jintużaw flimkien f'pazjenti b'nefropatija dijabetika.
English: • The PRAC was of the opinion that the concerns identified with regard to the safety and the lack of additional efficacy of dual RAS blockade therapy can be adequately managed through changes to the product information, without the need for additional risk minimisation measures.
Maltese: • Il-PRAC kien tal-opinjoni li t-tħassib identifikat matul din il-proċedura fir-rigward tas-sigurtà u n-nuqqas ta' effikaċja addizzjonali tat-terapija ta' imblokk RAS doppja jistgħu jiġu ġestiti b'mod adegwat permezz ta' bidliet fl-informazzjoni dwar il-prodott mingħajr il-ħtieġa għal miżuri ta' minimizzazzjoni tar-riskju addizzjonali.
English: The PRAC concluded that the benefit-risk balance of RAS-acting agents remains favourable, including in the context of dual RAS blockade therapy, subject to the agreed revisions to the product information.
Maltese: Il-PRAC ikkonkluda li l-bilanċ tal-benefiċċju-riskju ta' aġenti b'azzjoni RAS jibqa' wieħed favorevoli, anke fil-kuntest ta' terapija ta' imblokk RAS doppja, soġġett għar-reviżjonijiet miftiehma flinformazzjoni dwar il-prodott.
English: The concept of dual RAS blockade through the combined use of several RAS-acting agents, emerged in the late 1990's based on an experimental model hypothesising that the combined use of an ARB, an ACE-inhibitor or aliskiren could provide a more complete blockade of the RAS which could translate into better control of blood pressure and nephroprotective and cardioprotective effects.
Maltese: Il-kunċett ta' imblokk RAS doppju permezz tal-użu kkombinat ta' diversi aġenti b'azzjoni RAS, ħareġ fl-aħħar tad-disgħinijiet abbażi ta' mudell esperimentali li jipotezza li l-użu kkombinat ta' ARB, inibitur ACE jew aliskiren jista' jipprovdi imblokk aktar sħiħ tal-RAS li jista' jissarraf f'kontroll aħjar tal-pressjoni tad-demm u l-effetti nefroprotettivi u kardjoprotettivi.
English: Important note
Maltese: Nota importanti
English: • Subcutaneous administration
Maltese: • Amministrazzjoni subkutanja
English: ATC code: B01AX05
Maltese: B01AX05
English: Odds Ratio1 (95%CI)
Maltese: Proporzjon ta' probabbiltà1 (95%CI)
English: Low Dose UFH N = 1024
Maltese: UFH N = 1024
English: Standard Dose UFH N = 1002
Maltese: UFH N = 1002
English: Aspen Notre Dame de Bondeville, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.
Maltese: Aspen Notre Dame de Bondeville, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, Franza.
English: Picture A
Maltese: Stampa A
English: Date of first authorisation: 21 March 2002 Date of latest renewal: 21 March 2007
Maltese: Data tal-aħħar tiġdid: 21 ta' Marzu 2007
English: Aspen Notre Dame de Bondeville 1, rue de l'Abbaye F-76960 Notre Dame de Bondeville France
Maltese: Aspen Notre Dame de Bondeville 1, rue de l'Abbaye F-76960 Notre Dame de Bondeville Franza
English: Picture B1
Maltese: B1
English: Treatment of Pulmonary Embolism
Maltese: Trattament ta' Emboliżmu Pulmonari
English: Secondary
Maltese: Sekondarji
English: The distribution volume of fondaparinux is limited (7-11 litres).
Maltese: Il-volum ta' distribuzzjoni ta' fondaparinux huwa limitat (7-11 litri).
English: 1: Odds ratio: Low Dose/Standard Dose Note: MI - myocardial infarction.
Maltese: Doża baxxa/Doża Standard Nota: MI - infart mijokardijaku.
English: Rare: post-operative wound infection
Maltese: Rari: infezzjonijiet tal-feriti wara l-operazzjoni
English: Spinal / Epidural anaesthesia
Maltese: Anestesija Spinali / Epidurali
English: Between 50 kg and 100 kg
Maltese: Bejn 50 kg u 100 kg
English: Types of safety syringe
Maltese: Tipi ta' siringa ta' sikurezza
English: Picture D
Maltese: Stampa D
English: Picture F
Maltese: Stampa F
English: • Store below 25°C.
Maltese: • Aħżen f'temperatura taħt 25oC.
English: Store below 25°C.
Maltese: Aħżen f'temperatura taħt 25oC.
English: Below 50 kg
Maltese: Taħt 50 kg
English: Adverse reactions in patients treated for VTE1
Maltese: Reazzjonijiet avversi f'pazjenti fuq trattament għal VTE1
English: (listed in section 6)
Maltese: (ara sezzjoni 4.4).
English: Rare: bilirubinaemia
Maltese: Rari: żieda fil-bilirubin
English: • allergic reaction (including itching, swelling, rash)
Maltese: • reazzjonijiet allerġiċi (inkluż ħakk, nefħa, raxx)
English: Sodium chloride Water for injections Hydrochloric acid Sodium hydroxide
Maltese: Hydrochloric acid Sodium hydroxide
English: System organ class MedDRA
Maltese: Sistema tal-klassifika tal-organi fiddatabase MedDRA
English: MI or TVR at Day 30
Maltese: TVR fil-Jum 30
English: Picture B2
Maltese: B2
English: Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Maltese: Fondaparinux ma jinibixxix CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1
English: Arixtra contains a synthetic substance called fondaparinux sodium.
Maltese: Arixtra fiha sustanza sintetika msemmija fondaparinux sodium.
English: Rare: allergic reaction (including very rare reports of angioedema, anaphylactoid/anaphylactic reaction)
Maltese: Rari: reazzjoni allerġika (inkluż rapporti rari ħafna ta' anġjoedima, reazzjoni anafilaktojd/anafilattika)