FrancophonIA/ELRC3.0 huggingface dataset:
English: When Luxturna is injected into the eye the virus carries the RPE65 gene into the retinal cells and enables them to produce the missing enzyme.
Maltese: Meta Luxturna jiġi injettat fl-għajn il-virus iġorr il-ġene RPE65 fiċ-ċelloli retinali u jippermettilhom jipproduċu l-enzima nieqsa.
English: How does Luxturna work?
Maltese: Kif jaħdem Luxturna?
English: The most common side effects with Luxturna (which may affect more than 1 in 20 people) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye), cataract (clouding of the lens of the eye) and increased pressure inside the eye. For the full list of side effects of Luxturna, see the package leaflet.
Maltese: L-effetti sekondarji l-iktar komuni b'Luxturna (li jistgħu jaffetwaw iktar minn persuna 1 minn 20) huma iperimija konġunktivali (żieda ta' iktar demm fl-għajn, li jwassal għall-ħmura tal-għajn) katarretti (tiċpir tal-lenti tal-għajn) u żieda fil-pressjoni fuq ġewwa tal-għajn.
English: The safety of Luxturna was considered acceptable and side effects manageable.
Maltese: Is-sigurtà ta' Luxturna kienet ikkunsidrata aċċettabbli u l-effetti sekondarji kienu maniġġabbli.
English: The company that markets Luxturna will set up an educational programme and prepare educational material aimed at doctors and pharmacists expected to use and handle Luxturna, in order to ensure the correct use of the medicine and minimise the risks associated with the medicine and its administration.
Maltese: Il-kumpanija li tqiegħed Luxturna fis-suq ser tistabbilixxi programm edukattiv u ser tħejji materjal edukattiv li għandu fil-mira lit-tobba u lill-ispiżjari li huma mistenni li jużaw u jimmaniġġaw Luxturna, sabiex jiġi żgurat l-użu korrett tal-mediċina u jiġu minimizzati r-riskji assoċjati mal-mediċina u l-għoti tagħha.
English: SEE ALL CONTRAINDICATIONS IN THE SMPC.
Maltese: FL-SMPC.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott sussegwentement tista' tiġi aġġornata mill-awtoritajiet kompetenti talIstat Membru, b'kordinament mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stabbiliti fil-Kapitolu 4 ta' Titolu III tad-Direttiva 2001/83/EC.
English: [This statement below should be strongly emphasised (e.g. capitalized, bold letters or use of colours), the visual details of the warning on the outer and immediate packaging should be agreed with NCAs and be subject to a user test taking into account the "Guideline on the Readability of the labelling and package leaflet on medicinal products for human use" within 1 month from the Commission Decision.]
Maltese: [Din id-dikjarazzjoni ta' hawn taħt għandha tkun enfasizzata ħafna (eż. b'ittri kapitali, b'tipa grassa jew bl-użu ta' kuluri), id-dettalji viżivi tat-twissija fuq il-pakkett ta' barra u il-pakkett li jmiss mal-prodott għandhom jiġu miftiehma mal-NCAs u għandhom ikunu suġġetti għal test tal-utent b'konsiderazzjoni tal-"Linji gwida dwar il-Leġġibbiltà tat-tikkettjar u l-fuljett ta' tagħrif dwar prodotti mediċinali għall-użu mill-bniedem" fi żmien xahar mid-Deċiżjoni tal-Kummissjoni.]
English: Annex III Amendments to relevant sections of the Product Information
Maltese: Anness III Emendi fis-sezzjonijiet rilevanti tal-Informazzjoni dwar il-Prodott
English: Warning Do not use in sepsis (severe generalised infection), renal impairment, or critically ill patients.
Maltese: Twissija Tużax f'każ ta' sepsis (infezzjoni ġeneralizzata severa), indeboliment tal-kliewi jew f'pazjenti morda b'mod kritiku.
English: MAHs of HES solution for infusion should amend the product information (insertion, replacement or deletion of the text, as appropriate) to reflect the wording as provided below, and in conjunction to the Scientific conclusions:
Maltese: L-MAHs tas-soluzzjoni għall-infużjoni HES għandhom jemendaw l-informazzjoni dwar il-prodott (inserzjoni, sostituzzjoni jew tħassir tat-test, kif xieraq) biex tirrifletti l-kliem kif ipprovdut hawn taħt, u flimkien mal-Konklużjonijiet xjentifiċi:
English: OTHER SPECIAL WARNING(S):
Maltese: TWISSIJA(IET) SPEĊJALI
English: • fusariosis (fungal infection caused by Fusarium),
Maltese: • fusarjożi (infezzjoni fungali kkawżata minn Fusarium),
English: Further information on Poxaconazole AHCL can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/posaconazole-ahcl.
Maltese: ema.europa.eu/medicines/human/EPAR/posaconazole-ahcl.
English: Posaconazole AHCL is an antifungal medicine used to treat adults with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed:
Maltese: Posaconazole AHCL huwa mediċina antifungali li tintuża biex tikkura adulti bil-mard fungali li ġej, meta kuri b'mediċini antifungali oħra (amphotericin B, itraconazole jew fluconazole) ma jistgħux jiġu ttollerati jew ma jkunux irnexxew:
English: • chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters),
Maltese: • kromoblastomijakosi u majċetoma (infezzjonijiet fungali fit-tul tal-ġilda jew tat-tessut eżatt taħt il ġilda, normalment ikkawżati minn spori fungali li jinfettaw il-ġrieħi minħabba spini jew skaldi).
English: The active substance in Posaconazole AHCL, posaconazole, is an antifungal medicine that belongs to the triazole group.
Maltese: Is-sustanza attiva f'Posaconazole AHCL, il-posakonażol, hija mediċina antifungali li tappartjeni lillgrupp tat-triażol.
English: For thrush, Posaconazole AHCL is taken as 200 mg (5 ml) on the first day followed by 100 mg (2.5 ml) once a day for the following 13 days.
Maltese: Għat-thrush, Posaconazole AHCL jittieħed bħala 200 mg (5 ml) fl-ewwel ġurnata segwit minn 100 mg (2.5 ml) darba kuljum għat-13-il jum ta' wara.
English: For the prevention of invasive fungal infections, Posaconazole AHCL is taken at a dose of 200 mg (5 ml) three times a day.
Maltese: Għall-prevenzjoni ta' infezzjonijiet fungali invażivi, Posaconazole AHCL jittieħed bħala doża ta' 200 mg (5 ml) tliet darbiet kuljum.
English: Posaconazole AHCL is available as an oral suspension (40 mg/ml) which is taken with a meal or nutritional supplement.
Maltese: Posaconazole AHCL jiġi bħala sospensjoni orali (40 mg/ml) li tittieħed ma' ikla jew ma' suppliment nutrizzjonali.
English: Posaconazole AHCL contains the active substance posaconazole and is a ‘generic medicine'.
Maltese: Posaconazole AHCL fih is-sustanza attiva posakonażol u huwa ‘mediċina ġenerika'.
English: Other information about Posaconazole AHCL
Maltese: Informazzjoni oħra dwar Posaconazole AHCL
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Noxafil, and do not need to be repeated for Posaconazole AHCL.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użijiet awtorizzati bil-mediċina ta' referenza, Noxafil, u ma għandhomx għalfejn jiġu ripetuti għal Posaconazole AHCL.
English: For the treatment of fungal infections, with the exception of thrush, Posaconazole AHCL is taken at a dose of 400 mg (10 ml) twice a day, or 200 mg (5 ml) four times a day in patients who are not eating.
Maltese: Għall-kura ta' infezzjonijiet fungali, bl-eċċezzjoni ta' thrush, Posaconazole AHCL jittieħed f'doża ta' 400 mg (10 ml) darbtejn kuljum, jew 200 mg (5 ml) erba' darbiet kuljum f'pazjenti li ma jkunux qed jieklu.
English: Posaconazole AHCL is also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow).
Maltese: Posaconazole AHCL jintuża wkoll biex jipprevjeni infezzjonijiet fungali f'pazjenti li s-sistema immunitarja tagħhom tiddgħajjef minħabba kuri li jkunu qed jirċievu għal kanċers fid-demm jew filmudullun jew mediċini li jintużaw fi trapjant ta' ċelloli staminali ematopojetiċi (proċedura fejn ilmudullun tal-pazjent jiġi sostitut minn ċelloli staminali minn donatur biex jiġi ffurmat mudullun ġdid).
English: Because Posaconazole AHCL is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Posaconazole AHCL huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: • coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).
Maltese: • koċċidijoidomikożi (infezzjoni fungali tal-pulmun ikkawżata mit-teħid tan-nifs fl-ispori).
English: How has Posaconazole AHCL been studied?
Maltese: Kif ġie studjat Posaconazole AHCL?
English: Posaconazole AHCL is also used as a first-line treatment for ‘thrush', a fungal infection of the mouth and throat due to Candida.
Maltese: Posaconazole AHCL jintuża wkoll bħala kura tal-ewwel linja għal ‘thrush', infezzjoni fungali tal-ħalq u tal-griżmejn minħabba Candida.
English: Side effects reported with Posaconazole AHCL are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Posaconazole AHCL huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex il-pazjenti jiġu protetti.
English: As for all medicines, data on the use of Posaconazole AHCL are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Posaconazole AHCL hija ssorveljata kontinwament.
English: Posaconazole AHCL (posaconazole)
Maltese: Kif jaħdem Posaconazole AHCL?
English: Posaconazole AHCL can only be obtained with a prescription and treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections.
Maltese: Posaconazole AHCL jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda minn tabib li għandu esperjenza fil-ġestjoni ta' infezzjonijiet fungali jew fil-kura ta' pazjenti b'riskju għoli ta' infezzjonijiet fungali invażivi.
English: What are the benefits and risks of Posaconazole AHCL?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Posaconazole AHCL?
English: This means that Posaconazole AHCL contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Noxafil.
Maltese: Dan ifisser li Posaconazole AHCL fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-UE li jisimha Noxafil.
English: Therefore, the Agency's view was that, as for Noxafil, the benefit of Posaconazole AHCL outweighs the identified risk and it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-opinjoni tal-Aġenzija kienet li, bħal fil-każ ta' Noxafil, il-benefiċċju ta' Posaconazole AHCL huwa ikbar mir-riskju identifikat u jista' jiġi awtorizzat għall-użu fl-UE.
English: Date of last renewal: 13 November 2007
Maltese: Data tal-aħħar tiġdid: 13 Novembru 2007
English: BATCH NUMBER Lot: {number}
Maltese: NUMRU TAL-LOTT Lot {numru}
English: Vedaprofen is highly bound to plasma proteins and extensively metabolised.
Maltese: Vedaprofen laktar li ssibu huwa mwaħħal mal-proteini fil-plasma u jiġi metabolizzat estensivament.
English: Purna Pharmaceuticals N.V. Rijksweg 17
Maltese: Purna Pharmaceuticals N.V.
English: Propylene glycol:
Maltese: Propilin glajkol:
English: Both enantiomers are equipotent PGF2α antagonists.
Maltese: Iż-żewġ enantiomers huma qawwija ndaqs bhala antagonisti ta' PGF2α.
English: BELGIUM
Maltese: IN-NETHERLANDS
English: Otto Hahnweg 24 3542 AX Utrecht NETHERLANDS
Maltese: 3542 AX
English: Vedaprofen contains an asymmetric carbon atom and, therefore, is a racemic mixture of a (+) enantiomer and a (-) enantiomer.
Maltese: Vedaprofen għandu atoma tal-karbonju asimmetrika i għaldaqstant huwa taħlita raċemika ta' (+) enantiomer u (-) enantiomer.
English: EXPIRY DATE EXP: {Month/year}
Maltese: EXP {xahar / sena}
English: The advised dosage is an initial dose of 2 mg/kg (2.0 ml/100 kg) followed by a maintenance dose of 1 mg/kg (1.0 ml/100 kg) given every 12 hours.
Maltese: Id-doża rakkomandata hija doża inizjali ta' 2 mg/kilogramm (2.0 ml/100kilogramm), u doża ta' manteniment ta' 1 mg/kilogramm (1.0 ml/100kilogramma) kull 12 il- siegħa.
English: Water (minimum purified grade), Propylene glycol, Hydroxyethylcellulose, Potassium hydroxide (E525), Hydrochloric acid, Chocolate flavour.
Maltese: Hydroxymethylcellulose Potassium hydroxide (E525)
English: Vedaprofen is a non-steroidal anti-inflammatory drug (NSAID) belonging to the propionic acid derivate group.
Maltese: Vedaprofen huwa sustanza anti-inflammatorja u mhux sterojde (NSAID) derivativ tal-aċidu arilpropjoniku.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta emergenza, antidot), jekk ikun hemm bżonn
English: Adjustable dose syringe, containing 30 ml gel 3 adjustable dose syringes, each containing 30 ml gel
Maltese: Siringa ikkalibrata li fiha 30 ml ġell 3 siringi ikkalibrati li fihom 30ml ġell
English: Horse.
Maltese: Żiemel.
English: The terminal half-life following oral administration is 350-500 minutes and no accumulation occurs following repeated oral dosing.
Maltese: It-Terminal half life meta jiġi amministrat mill-ħalq hija ta' 350 - 500 minuta u il- prodott ma jakkumulax meta jingħata repetutament.
English: Vedaprofen inhibits the prostaglandin synthesis enzyme system (cyclo-oxygenase enzyme) and thus possesses anti-inflammatory, antipyretic and analgesic properties.
Maltese: Vedaprofen iwaqqaf l-enżima li tagħmel il-prostaglandin (cyclo-oxygenase) u jippossedi kwalitajiet anti inflammatorji, anti piretiċi u analġesiċi.
English: Meat and offal: 12 days.
Maltese: Laħam u interjur:12-il ġurnata.
English: A 30 ml adjustable multidose syringe consisting of high density polyethylene (white) and low density polyethylene (white and natural).
Maltese: In-natura u l-għamla tal ippakkjar li jmiss mall-prodott Siringa multidose ta' 30 ml magħmula minn high density polyethylene(abjad) u low density polyethylene (abjad u naturali).
English: Kidney Liver Muscle Fat
Maltese: Kliewi Fwied Muskoli Xaħam
English: Studies in the horse have demonstrated potent inhibition of prostaglandin E2 (PG E2) synthesis in exudate and thromboxane B2 synthesis in serum and exudate.
Maltese: Studji fiż-żwiemel urew twaqqif qawwi fissintesi ta' prostaglandin E2 (PG E2) fit-tnixxija u tas-sintesi ta' tromboksejn B2 fis-sirum u t-tnixxija.
English: In case of doubt, it is advisable to test the urine.
Maltese: Jekk ikun hemm dubju, hu rakkomandat li tagħmel test tal-urina.
English: If side effects occur, treatment should be discontinued.
Maltese: Jekk ikun hemm xi effetti mhux mixtieqa, it-trattament għandu jitwaqqaf.
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lot {numru}
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/005/001 (1 x 30 ml)
Maltese: EU/2/97/005/001 (1 x 30ml)
English: PHARMACEUTICAL FORM Oral gel
Maltese: GĦAMLA FARMAĊEWTIKA Ġell orali
English: Meat and offal: 12 days
Maltese: Laħam u Interjur: 12-il ġurnata
English: The active substance in Quadrisol is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Quadrisol 5 mg/ml soluzzjoni intramammarja għal baqar hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f‘sezzjoni 6.1 tal-karatteristiċi tal-prodott fil-qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan liskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Quadrisol 100 mg/ml can be used during pregnancy.
Maltese: Quadrisol 100mg / ml jista' jintuża waqt it-tqala.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Quadrisol 100 mg/ml oral gel for horses
Maltese: VETERINARJU Quadrisol 100 mg /ml ġell orali għaż-żwiemel
English: Bioavailability after oral administration is 80-90%, but is reduced significantly if medication is administered with food.
Maltese: Il-bioavilibilita wara amministrazzjoni orali hija ta' 80 - 90%, iżda din tonqos sew jekk il-prodott jingħata mal-ikel.
English: Target tissues Other provisions vedaprofen vedaprofen Equidae 1000 µg/kg 100 µg/kg
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Vedaprofen: 100 mg/ml
English: An initial dose of 2 mg/kg (2.0 ml/100 kg) is followed by a maintenance dose of 1 mg/kg (1.0 ml/100 kg) given every 12 hours.
Maltese: U doża ta' manteniment ta' 1 mg/kilogramm (1.0 ml/100kilogramma) kull 12 il- siegħa.
English: The most abundant metabolite is a monohydroxylated derivative.
Maltese: Id-derivat monoidroksillat huwa l-metabolat l-aktar abbundanti.
English: PACKAGE LEAFLET: Quadrisol 100 mg/ml oral gel for horses
Maltese: Quadrisol 100 mg / ml ġell orali għaż-żwiemel
English: 130 mg For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara sezzjoni 6.1.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: non-steroidal anti-inflammatory drug ATCvet code: QM01AE90
Maltese: Sustanza anti-inflammatorja u mhux sterojde Kodiċi ATC veterinarja:
English: For oral use.
Maltese: M'hemm xejn magħruf.
English: 20 µg/kg
Maltese: 1000 µg/kg 100 µg/kg 50 µg/kg 20 µg/kg
English: Other NSAIDs, diuretics and substances with high protein binding may compete for binding and lead to toxic effects.
Maltese: NSAID s oħra, dijuretiċi, u sustanzi oħra li għandhom kapaċità qawwija li jeħlu mal-proteina filplasma jistgħu jikkompetu u joħolqu effetti tossiċi.
English: In case of prophylactic treatment, a maximum duration of treatment of 7 consecutive days is sufficient.
Maltese: F'każ ta' trattament profilattiku, trattament sa massimu ta' sebat' ijiem huwa biżżejjed.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Maltese: .8 Interazzjoni ma' prodotti mediċinali ohra jew forom ohra ta' interazzjoni
English: Excipients: Propylene glycol:
Maltese: Sustanzi mhux attivi:
English: Treatment can be continued for a maximum of 14 consecutive days.
Maltese: It-trattament jista' jdum sa massimu ta' erbatax il-ġurnata.
English: Animal species
Maltese: U LUŻU
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Vedaprofen:
Maltese: TAS-SUSTANZA(I) ATTIVA(I)
English: The (+) enantiomer is more potent in inhibiting prostaglandin synthesis.
Maltese: Il- (+) enantiomer huwa iktar qawwi sabiex iwaqqaf is-sintesi tal-prostaglandin.
English: Reduction of inflammation and relief of pain associated with musculo-skeletal disorders and soft tissue lesions (traumatic injuries and surgical trauma).
Maltese: Tnaqqis ta' infjammazjoni u uġiegħ assoċjati ma diżordnijiet tas-sistema tal-muskoli u għadam u taqtiegħ fil-laħam (trawma minħabba xi korriment jew intervent kirurġiku).
English: Marketing authorisation holder:
Maltese: Detentur tal- awtorizzazzjoni għat-tqegħid fis-suq:
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there may be potential risk of increased renal toxicity.
Maltese: Evita li tuża f'annimali diżidrati, ipovolimiċi u bi pressjoni baxxa, minħabba li jista' jkun hemm riskju ikbar ta' tossiċita tal-kliewi.
English: Read the package leaflet before use.
Maltese: PROJBIZZJONI TA' BEJGĦ, PROVVISTA, U/JEW UŻU Mhux applikabli.
English: In cases of anticipated surgical trauma, Quadrisol can be given prophylactically at least 3 hours prior to elective surgery
Maltese: F'każi antiċipati ta' trawma minħabba kirurġija, Quadrisol jista' jingħata profilattikament tal-anqas tlett siegħat qabel l-intervent kirurġiku.
English: EMA/55700/2016 EMEA/H/C/000105
Maltese: EMA/55700/2016 EMA/H/C/000105
English: The full EPAR for Rapilysin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance reteplase.
Maltese: Fih is-sustanza attiva reteplażi.
English: Rapilysin reteplase
Maltese: Rapilysin reteplażi
English: This is a summary of the European public assessment report (EPAR) for Rapilysin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Rapilysin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rapilysin on 9 November 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rapilysin fid-9 ta' Novembru 1996.
English: The most common side effects with Rapilysin (seen in more than 1 patient in 10) are bleeding at the injection site, recurrent ischaemia (reduced blood supply to parts of the body) or angina (severe chest pain), hypotension (low blood pressure), heart failure or pulmonary oedema (build-up of fluid on the lungs), and reactions at the site of the injection, such as burning sensations.
Maltese: L-effetti sekondarji l-aktar komuni b'Rapilysin (li dehru f'aktar minn pazjent wieħed minn 10) huma fsada fis-sit tal-injezzjoni, iskemija rikorrenti, (tnaqqis fil-provvista tad-demm għal partijiet tal-ġisem) jew anġina (uġigħ qawwi fis-sider), ipotensjoni (pressjoni tad-demm baxxa), insuffiċjenza kardijaka jew edema pulmonarja (akkumulu ta' fluwidu fil-pulmun), u reazzjonijiet fis-sit tal-injezzjoni, bħal sensazzjonijiet ta' ħruq.
English: Rapilysin was more effective than streptokinase in reducing the number of patients with heart failure, and it was as effective as streptokinase in preventing death.
Maltese: Rapilysin kien aktar effettiv minn streptokinase fit-tnaqqis tal-għadd ta' pazjenti b'insuffiċjenza kardijaka, u kien effettiv daqs streptokinase fil-prevenzjoni ta' mewt.
English: Rapilysin is given as two injections, 30 minutes apart.
Maltese: Rapilysin jingħata bħala żewġ injezzjonijiet, 30 minuta 'l bogħod minn xulxin.
English: Other information about Rapilysin
Maltese: Informazzjoni oħra dwar Rapilysin
English: Rapilysin has been studied in more than 21,000 patients in four studies.
Maltese: Rapilysin ġie studjat f'aktar minn 21,000 pazjent f'erba' studji.
English: Rapilysin has been compared with other medicines used to dissolve blood clots: streptokinase in 6,000 patients and alteplase in about 15,000 patients.
Maltese: Rapilysin tqabbel ma' mediċini oħra li jintużaw biex iħollu l-emboli tad-demm: streptokinase f'6,000 pazjent u alteplase f'madwar 15,000 pazjent.
English: Why has Rapilysin been approved?
Maltese: Għaliex ġie approvat Rapilysin?
English: Rapilysin was also as effective as alteplase in preventing death and stroke.
Maltese: Rapilysin kien ukoll effettiv daqs alteplase fil-prevenzjoni ta' mewt u puplesija.
English: For the full list of all side effects reported with Rapilysin, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Rapilysin, ara l-fuljett ta' tagħrif.