FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (more than 1 but less than 10 animals in 100 animals treated)
Maltese: Komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat)
English: The number of tablets given to your dog may be adjusted by your veterinarian to manage side effects.
Maltese: In-numru ta' pilloli mogħtija lill-kelb tiegħek jista' jiġi aġġustata mill-veterinarju tiegħek bie jiġu mmaniġjati effetti mhux mixtieqa.
English: Discontinue treatment and institute supportive care until resolution of all clinical signs of blood in stool, then decrease dose by 0.5 mg/kg
Maltese: Waqqaf it-trattament u ibda kura ta' appoġġ sakemm jieqfu ssinjali kliniċi ta' telf tad-demm fl-ippurgar, imbagħad naqqas id-doża b'0.5 mg/kg
English: Toceranib was well tolerated at 2 mg/kg dose level whereas adverse reactions were noted in some dogs treated with 4 mg/kg and thus a NOAEL could not be established.
Maltese: Toceranib kienet ittollerata tajjeb b'2 mg/kg filwaqt li effetti mhux mixtieqa kienu nnotati b'4 mg/kg u għalhekk NOAEL ma setatx tiġi stabbilita.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' ingredjenti Qalba tal-pillola
English: As angiogenesis is a critical component of embryonic and foetal development, inhibition of angiogenesis following administration of Palladia should be expected to result in adverse effects on the pregnancy in the bitch.
Maltese: Billi l-anġjoġenesi hija komponent kritiku fl-iżvilupp tal-embrijo u l-fetu, limblukkar tal-anġjoġenesi wara amministazzjoni ta' Palladia huwa mistenni li jwassal għal effetti mhux mixtieqa fuq it-tqala tal-kelba.
English: Palladia 15 mg tablets for dogs.
Maltese: Palladia pilloli ta' 15 mg għal klieb.
English: Also seen commonly but with less severe effects, were localised or general pain, nausea, flatulence, tachypnea, polydipsia, fever, urinary tract infection, increased bilirubin, increased creatinine.
Maltese: Dehru ukoll ta' spiss imma b'effetti anqas serji kienu uġigħ lokaliżżat jew ġeneraliżżat, nawseja, gass fl-imsaren, żieda fit-teħid tan-nifs, polydipsia, deni, infezzjoni fis-sistema urinarja, żieda fil-bilirubin, żieda fil-kreatinina.
English: • Two dogs developed epistaxis that was not associated with thrombocytopenia.
Maltese: • Żewgt iklieb żviluppaw epistaxis, kundizzjoni li ma kienitx assoċjata ma' thromboċitopenja.
English: EMA/698861/2010 EMEA/H/C/002032
Maltese: EMA/698861/2010
English: The full EPAR for Docetaxel Teva Pharma can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Docetaxel Teva Pharma jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Docetaxel Teva Pharma is a ‘generic medicine'.
Maltese: Docetaxel Teva Pharma huwa “mediċina ġenerika”.
English: • breast cancer.
Maltese: • kanċer tal-pulmun mhux b'ċelloli żgħar.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Teva Pharma to Teva Pharma B.V. on 21 January 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Docetaxel Teva Pharma lil Teva Pharma B.V. fil-21 ta' Jannar 2011.
English: Docetaxel Teva Pharma is a medicine that contains the active substance docetaxel.
Maltese: Docetaxel Teva Pharma huwa mediċina li fiha s-sustanza attiva docetaxel.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Teva Pharma.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Docetaxel Teva Pharma.
English: Docetaxel Teva Pharma is used with prednisone or prednisolone (anti-inflammatory medicines);
Maltese: Docetaxel Teva Pharma jintuża ma' prednisone jew prednisolone (mediċini anti-infjammatorji).
English: The active substance in Docetaxel Teva Pharma, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Maltese: Is-sustanza attiva f'Docetaxel Teva Pharma, docetaxel jagħmel parti mill-grupp ta' mediċini ta' kontra l-kanċer magħrufa bħala taxanes.
English: Other information about Docetaxel Teva Pharma
Maltese: Informazzjoni oħra dwar Docetaxel Teva Pharma:
English: This means that Docetaxel Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Maltese: li jfisser li Docetaxel Teva Pharma huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Taxotere.
English: Docetaxel Teva Pharma is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Maltese: Docetaxel Teva Pharma jintuża biss meta n-numru ta' neutrophil (tip ta' ċelloli bojod fid-demm) ikun normali (minn tal-inqas 1,500 ċellola/mm
English: Docetaxel Teva Pharma should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Maltese: Docetaxel Teva Pharma għandu jintuża f'taqsimiet tal-kura speċjalizzati fl-għoti ta' kemoterapija (l-użu ta' mediċina għall-kura tal-kanċer) taħt superviżjoni ta' tabib ikkwalifikat fl-għoti ta' kimoterapija.
English: The CHMP concluded that, in accordance with EU requirements, Docetaxel Teva Pharma has been shown to be comparable to Taxotere.
Maltese: Is-CHMP ikkonkluda li skont ir-rekwiżiti tal-UE, Docetaxel Teva Pharma wera li jista' jiġi mqabbel ma' Taxotere.
English: The company has provided data from the published literature on docetaxel.
Maltese: Il-kumpannija pprovdiet dejta minn kitbiet ippubblikati dwar docetaxel.
English: Because Docetaxel Teva Pharma is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Billi Docetaxel Teva Pharma huwa mediċina ġenerika, il-benefiċċju u r-riskju tiegħu huma meqjusa listess bħal dawk tal-mediċina ta' referenza.
English: What is Docetaxel Teva Pharma?
Maltese: X'inhu Docetaxel Teva Pharma?
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Taxotere, il-benefiċċji huwa akbar mir-riskji identifikati.
English: • prostate cancer, when the cancer does not respond to hormonal treatment.
Maltese: • kanċer tal-prostata, meta l-kanċer ma jirrispondix għall-kura bl-ormoni.
English: It is available as a concentrate and a solvent that are made up into a solution for infusion (drip into a vein).
Maltese: Huwa disponibbli bħala trab u solvent, kif ukoll konċentrat, li jitħalltu biex isiru soluzzjoni għal infużjoni (dripp fil-vina).
English: No additional studies were needed as Docetaxel Teva Pharma is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali billi Docetaxel Teva Pharma huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Taxotere.
English: Docetaxel Teva Pharma is used to treat the following types of cancer:
Maltese: Docetaxel Teva Pharma jintuża fit-trattament ta' dawn it-tipi ta' kanċer li ġejjin:
English: Not relevant.
Maltese: Mhux relevanti.
English: Creatinine value [mg/l (mol/l)]
Maltese: Valur ta' kreatinina [mg/l (mol/l)]
English: Very common (>1/10); Common (>1/100, <1/10); Uncommon (>1/1,000 <1/100); Rare (>1/10,000 <1/1,000); Very Rare (<1/10,000)
Maltese: Komuni Ħafna (>1/10); Komuni (>1/100, <1/10); Mhux Komuni (>1/1,000 <1/100); Rari (>1/10,000 <1/1,000); Rari Ħafna (<1/10,000)
English: below 15*
Maltese: taħt 15*
English: Adjusted infusion rate [% of original dose]
Maltese: Rata ta' infużjoni aġġustata [% tad-doża oriġinali]
English: Age alone causes a 7 % reduction in clearance from the age of 30 to 70 years.
Maltese: L-età waħedha tikkawża tnaqqis ta' 7 % fit-tneħħija minn età ta' 30 sa 70 sena.
English: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Germany
Maltese: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Ġermanja
English: above 60 (530)*
Maltese: 'l fuq minn 60 (530)*
English: Also contains: mannitol, sodium hydroxide.
Maltese: Fih ukoll: mannitol, sodium hydroxide.
English: Date of first authorisation: 13-03-1997 Date of last renewal: 05-03-2007
Maltese: Data ta' l-aħħar tiġdid: 05-03-2007
English: Additional aPTT monitoring is mandatory.
Maltese: Sorveljanza addizzjonali ta' aPTT hija obligatorja.
English: Manufacturer CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Germany.
Maltese: CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Ġermanja.
English: This is valid up to a body weight of 110 kg.
Maltese: Dan huwa validu sa piż tal-ġisem ta' 110 kg.
English: Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom
Maltese: Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, Renju Unit
English: The specific activity of lepirudin is approximately 16,000 ATU/mg.
Maltese: L-attività speċifika ta' lepirudin hija ta' madwar 16,000 ATU/mg.
English: One anti-thrombin unit (ATU) is the amount of hirudin that neutralises one unit of WHO preparation 89/588 of thrombin.
Maltese: Unita waħda anti-thrombin (ATU) hija l-ammont ta' hirudin li tinnewtralizza unita waħda ta' preparazzjoni 89/588 ta' WHO ta' thrombin.
English: The parenteral agent can be discontinued when the International Normalised Ratio (INR) stabilises within the desired target range.
Maltese: L-aġent parenterali jista' jitwaqqaf meta l-International Normalised Ratio (INR) jistabilizza fil-firxa mmirata mixtieqa.
English: Infusion speed [ml/h]
Maltese: Veloċità ta' infużjoni [ml/h]
English: Angio-oedema (including: face oedema, tongue oedema, larynx oedema)
Maltese: Angjo-edema (inkluż: edema filwiċċ, edema fl-ilsien, edema fillarinġi)
English: Dosage 0.15 mg / kg body weight / h Dosage 0.1 mg / kg body weight / h
Maltese: Dożaġġ 0.15 mg / kg piż tal-ġisem / h Dożaġġ 0.1 mg / kg piż tal-ġisem / h
English: - Mannitol - Sodium hydroxide for adjustment to pH 7
Maltese: - Mannitol - Sodium hydroxide għall-aġġustament sa pH 7 6.2 Inkompatibilitajiet
English: Initial intravenous bolus:
Maltese: Bolus tal-bidu ġol-vina:
English: Rare (less than 1 in 1,000 people affected) - Allergic skin reactions (including rash), itching, hot flushes, fever, chills.
Maltese: Rari (anqas minn 1 kull 1,000 persuna affettwati) - Reazzjonijiet allerġiċi tal-ġilda (inkluż raxx), ħakk, fwawar, deni, tertir.
English: Marketing Authorisation Holder Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom.
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, Renju Unit.
English: The polypeptide composed of 65 amino acids has a molecular weight of 6979.5 Dalton.
Maltese: Ilpolypeptide huwa kompost minn 65 aċidi amminiċi u għandu piż molekolari ta' 6979.5
English: Pharmacotherapeutic group: Antithrombotic agent - direct thrombin inhibitor, ATC Code: B01AE02
Maltese: Aġent antitrombotiku - inibitur dirett ta' thrombin, Kodiċi ATC:
English: The diagnosis should be confirmed by the HIPAA (heparin induced platelet activation assay) or an equivalent test.
Maltese: Id-dijanjożi trid tiġi kkonfermata minn HIPAA (heparin induced platelet activation assay) jew test ekwivalenti.
English: In the indication HIT type II with thromboembolic disease (125 patients) the overall mortality during the study period was approximately 9 % while amputations and new thromboembolic complications were recorded in 6 % and 10 %, respectively.
Maltese: Fl-indikazzjoni ta' HIT tat-tip II b'mard tromboembolitiku (125 pazjent) il-mortalità globali waqt il-perjodu ta' studju kienet ta' madwar 9 % waqt li amputazzjonijiet u kumplikazzjonijiet tromboembolitiċi ġodda kienu rreġistrati f'6 % u 10 %, rispettivament.
English: Immune System Disorders
Maltese: Mard tas-Sistema Immuni
English: In this leaflet:
Maltese: Sorveljanza:
English: Anaphylactic/oid reactions
Maltese: Reazzjonijiet anafilattiċi/ojdi
English: - To obtain specific and exact aPTT limits, the laboratory equipment / test reagent used may be calibrated by spiking standardised human plasma with 0.15 g/ml lepirudin (lower limit) and 1.5 g/ml lepirudin (upper limit).
Maltese: - Sabiex jinkiżbu limiti speċifiċi u eżatti ta' aPTT, l-apparat tal-laboratorju / reaġent tat-test użati jistgħu jiġu kkalibrati billi tintuża plażma uman standardizzata miżjuda ma' 0.15 g/ml lepirudin (limitu baxx) u 1.5 g/ml lepirudin (limitu għoli).
English: Natural hirudin is produced in trace amounts as a family of highly homologous iso-polypeptides by the leech Hirudo medicinalis.
Maltese: Hirudin naturali huwa prodott f'ammonti żgħar ħafna bħala familja ta' iso-polipetids omologa ħafna minn sangisuga Hirudo medicinalis.
English: Distribution is essentially confined to extra-cellular fluids and is characterised by an initial half-life of approximately 10 minutes.
Maltese: Distribuzzjoni hija essenzjalment ristretta għall-fluwidi extra-ċellolari u hija kkaratterizzata minn half-life inizjali ta' madwar 10 minuti.
English: - With other reagents, the upper limit of the therapeutic aPTT window should be reduced to 2.5 fold prolongation of the normal control value.
Maltese: - B'reaġents oħra, il-limitu ta' fuq tat-tieqa terapewtika ta' aPTT għandha titnaqqas għal titwil ta' 2.5 drabi aktar mill-valur normali ta' kontroll.
English: The other ingredients are mannitol (E421) and sodium hydroxide for pH adjustment.
Maltese: Is-sustanzi l-oħra huma mannitol (E421) u sodium hydroxide għall-aġġustament tal-PH.
English: Concomitant use with - antiplatelet agents other than acetylsalicylic acid, such as ticlopidine or clopidogrel, - GpIIb/IIIa receptor antagonists such as eptifibatide, tirofiban, or abciximab, - other thrombin inhibitors such as low molecular weight heparins has not been assessed.
Maltese: L-użu flimkien ma' - aġenti antiplejtlet minbarra acetylsalicylic acid, bħal ticlopidine jew clopidogrel, - antagonisti tar-riċetturi GpIIb/IIIa bħal eptifibatide, tirofiban, jew abciximab, - inibituri ta' thrombin oħra bħall-eparins ta' piż molekolari baxx Ma ġiex studjat.
English: Injection site reactions including pain.
Maltese: Reazzjonijiet fil-post ta' linjezzjoni inkluż uġigħ.
English: - Target range (therapeutic window) for the aPTT: - Using "Actin FS" or "Neothromtin" on automated coagulometers the target range for the aPTT is 1.5 fold to 3 fold prolongation of the normal control value.
Maltese: - Firxa mmirata (tieqa terapewtika) għal aPTT: - Bl-użu ta' "Actin FS" jew "Neothromtin" f'koagulometri awtomati il-firxa mmirata għal aPTT hija titwil ta' 1.5 drabi sa 3 darbiet aktar mill-valur normali ta' kontroll.
English: Allergic Skin Reactions (including rash) Pruritus
Maltese: Reazzjonijiet Allerġiċi tal-Ġilda (inkluż raxx)
English: This may result in an enhanced anticoagulant effect of lepirudin, possibly due to delayed renal elimination of active lepirudin-antihirudin complexes.
Maltese: Dan jista' jwassal għalleffetti antikoagulanti msaħħa ta' lepirudin, possibilment minħabba dewmien fl-eliminazzjoni millkliewi ta' kumplessi attivi ta' lepirudin-antihirudin.
English: VIAL LABEL: 20 mg
Maltese: TIKKETTA TAL-KUNJETT: 20 mg
English: One molecule of hirudin binds to one molecule of thrombin and thereby blocks the thrombogenic activity of thrombin.
Maltese: Molekola waħda ta' hirudin teħel ma' molekola waħda ta' thrombin u b'hekk iwaqqaf l-attività tromboġenika ta' thrombin.
English: Refludan is an antithrombotic medicine.
Maltese: U GĦALXIEX JINTUŻA Refludan huwa mediċina antitrombolitika.
English: * In haemodialysis patients or in case of acute renal failure (creatinine clearance below 15 ml/min or creatinine value above 60 mg/l [530 mol/l]), infusion of Refludan is to be avoided or stopped.
Maltese: * F'pazjenti b'emodijalisi jew f'każ ta' insuffiċjenza akuta tal-kliewi (tneħħija ta' kreatinina taħt 15 ml/min jew valur ta' kreatinina l'fuq minn 60 mg/l [530 mol/l]), infużjoni ta' Refludan għandha tiġi evitata jew titwaqqaf.
English: This particularly includes the following situations with increased bleeding risk: - Recent puncture of large vessels or organ biopsy - Anomaly of vessels or organs - Recent cerebrovascular accident, stroke, or intracerebral surgery - Severe uncontrolled hypertension - Bacterial endocarditis - Advanced renal impairment - Haemorrhagic diathesis - Recent major surgery - Recent bleeding (e.g. intracranial, gastrointestinal, intraocular, pulmonary) - Overt signs of bleeding - Recent active peptic ulcer - Age > 65 years.
Maltese: - Titqib riċenti tal-kanali l-kbar tad-demm jew bijopsija ta' organu - Anomalija tal-kanali l-kbar tad-demm jew organi - Aċċident ċerebrovaskulari reċenti, puplesija, jew kirurġija intraċerebrali - Pressjoni għolja severa mhux ikkontrollata - Endokardite kkawżata minn batterja - Indeboliment avvanzat tal-kliewi - Dijateżi emorraġika - Kirurġija maġġuri reċenti - Fsada reċenti (e.ż. intrakranjali, gastro-intestinali, intraokulari, pulmonari) - Sinjali viżibbli ta' fsada - Ulċera peptika attiva reċenti - Età > 65 sena.
English: Anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease mandating parenteral antithrombotic therapy.
Maltese: Antikoagulazzjoni f'pazjenti adulti b'tromboċitopenija indotta mill-eparina (HIT) tat-tip II u mard tromboembolitiku li jeħtieġ terapija antitrombolitika parenterali.
English: VIAL LABEL: 50 mg
Maltese: TIKKETTA TAL-KUNJETT: 50 mg
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar il-mediċini (EMEA) http://www.emea.europa.eu
English: Cough Stridor Dyspnea
Maltese: STRUZZJONIJIET DWAR L-UŻU
English: Hot flushes Shock including fatal shock
Maltese: Fwawar Xokk inkluż xokk fatali
English: Respiratory, thoracic and mediastinal disorders
Maltese: Mard respiratorju, toraċiku u medjastinali
English: 9 mg/ml (0.9 %) or glucose 5 % solution.
Maltese: soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %) jew glucose 5 %.
English: - Known hypersensitivity to lepirudin, to hirudins or to any of the excipients - Pregnancy and lactation (see section 4.6)
Maltese: - Sensittività eċċessiva magħrufa għal lepirudin, hirudins jew xi wieħed mis-sustanżi l-oħra - Tqala u treddigħ (ara sezzjoni 4.6)
English: Colourless glass vial (glass type I) sealed with bromobutyl rubber infusion stopper, plastic flip-off cap and aluminium cap.
Maltese: Kunjett tal-ħġieġ bla kulur (ħġieġ tat-tip I) issiġillat b'tapp ta' l-infużjoni tal-lasktu bromobutyl, għatu flip-off tal-plastik u għatu ta' l-aluminju.
English: In female patients the systemic clearance is about 25 % lower as compared to male patients.
Maltese: F'pazjenti anzjani it-tneħħija sistemika ta' lepirudin hija madwar 25 % inqas meta mqabbla ma' dik f'pazjenti iżgħar.
English: Very common (at least 1 in 10 people) - Bleeding
Maltese: Komuni ħafna (mill-anqas 1 kull 10 persuni) - Fsada
English: Haematuria
Maltese: Ematuria
English: Currently, no specific antidote against lepirudin is available.
Maltese: Bħalissa, mhux disponibbli antidotu speċifiku kontra lepirudin.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA
English: Take special care with Refludan:
Maltese: X'fih Refludan:
English: Elimination follows a first order process and is characterised by a terminal half-life of about 1.3 hours in young healthy volunteers.
Maltese: Eliminazzjoni ssegwi proċess ta' lewwel ordni u hija kkaratterizzata minn half-life terminali ta' madwar 1.3 sigħat f'volontiera żagħżugħa b'saħħithom.
English: EU/1/97/035/001 REFLUDAN - 50 mg - Powder for solution for injection or infusion - 1 vial EU/1/97/035/002 REFLUDAN - 50 mg - Powder for solution for injection or infusion - 10 vials
Maltese: NUMRUI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/035/001 REFLUDAN - 50 mg - Trab għal soluzzjoni għall-injezzoni jew infużjoniEU/1/97/035/002 REFLUDAN - 50 mg - Trab għal soluzzjoni għall-injezzoni jew infużjoni - 10
English: - Anaphylactic/oid reactions including urticaria, difficulty in breathing (e.g. consisting of spasms), cough, sharp sound when breathing, build-up of water in the body and in the inner wall of a vessel (including: face oedema, tongue oedema, throat oedema).
Maltese: - Reazzjonijiet anafilattiċi/ojdi, inkluż urtikarja, diffikultà biex tieħu n-nifs (e.ż. li tikkonsisti fi spażmi), sogħla, ħoss qawwi man-nifs, akkumulazzjoni ta' ilma fil-ġisem u fil-ħajt ta' ġewwa ta' kanal (inkluż: edema fil-wiċċ, edema fl-ilsien, edema fil-griżmejn).
English: - The preparation should be warmed to room temperature before administration.
Maltese: - Il-preparazzjoni għandha tissaħħan sat-temperatura tal-kamra qabel l-amministrazzjoni.
English: Life-threatening bleeding events (including intracranial bleeding) were uncommonly reported (≥1/1,000 to <1/100) in patients with acute coronary syndrome included in clinical studies.
Maltese: Episodji ta' fsada li jistgħu jikkawżaw il-mewt (inkluż fsada intrakranjali) kienu irrappurtati b'mod mhux komuni (≥1/1,000 to <1/100) f'pazjenti bis-sindromu koronarju akut li kienu inkużi fl-istudji kliniċi.
English: EU/1/97/035/003 REFLUDAN - 20 mg - Powder for solution for injection or infusion - 1 vial EU/1/97/035/004 REFLUDAN - 20 mg - Powder for solution for injection or infusion - 10 vials
Maltese: NUMRUI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/035/003 REFLUDAN - 20 mg - Trab għal soluzzjoni għall-injezzoni jew infużjoniEU/1/97/035/004 REFLUDAN - 20 mg - Trab għal soluzzjoni għall-injezzoni jew infużjoni - 10
English: Vascular Disorders
Maltese: Mard Vaskulari
English: Lepirudin ([Leu1, Thr2]-63-desulfohirudin) is a recombinant hirudin derived from yeast cells.
Maltese: Lepirudin ([Leu1, Thr2]-63-desulfohirudin) huwa hirudin rikombinat derivat minn ċellolli tal-ħmira.
English: 10 x 1 vial of powder for solution for injection or infusion.
Maltese: 10 x 1 kunjetti ta' trab għal soluzzjoni għall-injezzjoni jew infużjoni.
English: HOW TO STORE REFLUDAN
Maltese: X'INHU REFLUDAN
English: Table 3: Examples for standard infusion speed according to body weight
Maltese: Tabella 3: Eżempji ta' veloċità ta' infużjoni standard skond il-piż tal-ġisem
English: - Injection site reactions, including pain.
Maltese: - Reazzjonijiet fil-lok ta' l-injezzjoni, inkluż uġigħ.
English: OUTER CARTON: 50 mg x 10 vials
Maltese: PAKKETT TA' BARRA: 50 mg x 10 KUNJETTI
English: Gastrointestinal bleeding
Maltese: Fsada gastro-intestinali
English: Mutagenicity Lepirudin was not mutagenic or clastogenic in standard assays for such effects.
Maltese: Lepirudin ma kienx mutaġeniku jew klastoġeniku f'analiżi stàndard għal dawn l-effetti.
English: In intensified post-marketing surveillance in HIT type II, fatal bleeding was reported in 1 % and intracranial bleeding in 0.2 % of patients.
Maltese: F'sorveljanza intensifikata ta' wara t-tqegħid fis-suq f'HIT ta' tip II, fsada fatali kienet irrappurtata f'1 % u fsada intrakranjali f'0.2 % tal-pazjenti.
English: The rate of infusion must be reduced in case of known or suspected renal insufficiency (see sections 4.2, and 5.2).
Maltese: Ir-rata ta' infużjoni għandha tiġi mnaqqsa f'każ ta' insuffiċjenza tal-kliewi magħrufa jew issuspettata (ara sezzjoni 4.2 u 5.2).
English: OUTER CARTON: 20 mg x 10 vials
Maltese: PAKKETT TA' BARRA: 20 mg x 10 Kunjetti
English: Results from studies in pigs showed that the application of von Willebrand Factor (vWF, 66 I.U./kg body weight) markedly reduced the bleeding time.
Maltese: Riżultati minn studji fil-ħnieżer urew li applikazzjoni tal-Fattur von Willebrand (vWF, 66
English: The clinical information on HIT type II in this SPC is based upon the data of two prospective trials comprising a total of 198 HIT type II patients treated with Refludan.
Maltese: L-informazzjoni klinika fuq HIT tat-tip II f'dan l-SPC huwa bbażat fuq it-tagħrif ta' żewġ provi prospettivi li għandhom total ta' 198 pazjent b'HIT tat-tip II kkurati b'Refludan.