FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have had any allergic reaction to other antibiotics such as penicillin, you may also be allergic to Zinacef.
Maltese: Jekk inti qatt kellek xi reazzjoni allerġika għal antibijotiċi oħrajn bħal penicillin, inti tista' tkun allerġiku/a wkoll għal Zinacef.
English: • inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus,
Maltese: • infjammazzjoni tal-kolon (il-musrana l-ħoxna), li tikkawża dijarea, ġeneralment bid-demm u l-mukus,
English: Zinacef 750 mg and 1.5 g powder for solution for infusion (Monovial presentation) IV
Maltese: Zinacef 750 mg u 1.5 g trab għal soluzzjoni għall-infużjoni (ippreżentat bħala Monovial)
English: In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents.
Maltese: Fil-kura u l-prevenzjoni ta' infezzjonijiet fejn wisq probabbli jkun hemm organiżmi anerobiċi, cefuroxime għandu jingħata flimkien ma' sustanzi antibatteriċi addizzjonali xierqa.
English: Gram-positive aerobes:
Maltese: Aerobi pożittivi għal Gram:
English: (other than P. vulgaris) Providencia spp.
Maltese: L-ispeċijiet Proteus (ħlief P. vulgaris) L-ispeċijiet Providencia
English: Zinacef and associated names (see Annex I) 250 mg powder for solution for injection Zinacef and associated names (see Annex I) 750 mg powder for solution for injection Zinacef and associated names (see Annex I) 1.5 g powder for solution for injection Zinacef and associated names (see Annex I) 250 mg powder and solvent for solution for injection Zinacef and associated names (see Annex I) 500 mg powder and solvent for solution for injection Zinacef and associated names (see Annex I) 750 mg powder and solvent for solution for injection Zinacef and associated names (see Annex I) 1 g powder and solvent for solution for injection Zinacef and associated names (see Annex I) 750 mg powder for solution for infusion Zinacef and associated names (see Annex I) 1.5 g powder for solution for infusion Zinacef and associated names (see Annex I) 2 g powder for solution for infusion Zinacef and associated names (see Annex I) 250 mg powder for solution for injection or infusion Zinacef and associated names (see Annex I) 750 mg powder for solution for injection or infusion Zinacef and associated names (see Annex I) 1.5 g powder for solution for injection or infusion Zinacef and associated names (see Annex I) 750 mg powder for solution for infusion (Monovial presentation) Zinacef and associated names (see Annex I) 1.5 g powder for solution for infusion (Monovial presentation)
Maltese: Zinacef u ismijiet assoċjati (ara Anness I) 250 mg trab għal soluzzjoni għall-injezzjoni Zinacef u ismijiet assoċjati (ara Anness I) 750 mg trab għal soluzzjoni għall-injezzjoni Zinacef u ismijiet assoċjati (ara Anness I) 1.5 g trab għal soluzzjoni għall-injezzjoni Zinacef u ismijiet assoċjati (ara Anness I) 250 mg trab u solvent għal soluzzjoni għall-injezzjoni Zinacef u ismijiet assoċjati (ara Anness I) 500 mg trab u solvent għal soluzzjoni għall-injezzjoni Zinacef u ismijiet assoċjati (ara Anness I) 750 mg trab u solvent għal soluzzjoni għall-injezzjoni Zinacef u ismijiet assoċjati (ara Anness I) 1 g trab u solvent għal soluzzjoni għall-injezzjoni Zinacef u ismijiet assoċjati (ara Anness I) 750 mg trab għal soluzzjoni għall-infużjoni Zinacef u ismijiet assoċjati (ara Anness I) 1.5 g trab għal soluzzjoni għall-infużjoni Zinacef u ismijiet assoċjati (ara Anness I)
English: Gram-negative anaerobes:
Maltese: Anerobi negattivi għal Gram:
English: There is an almost complete recovery (85 to 90%) of unchanged cefuroxime in urine within 24 hours of administration.
Maltese: Hemm kważi rkupru totali (85 sa 90%) ta' cefuroxime mhux mibdul fl-awrina fi żmien 24 siegħa mill-għoti.
English: Use of cefuroxime may result in the overgrowth of Candida.
Maltese: L-użu ta' cefuroxime jista' jwassal għal tkabbir żejjed ta' Candida.
English: Protein binding has been stated as 33 to 50%, depending on the methodology used.
Maltese: L-irbit mal-proteini ġie ddikjarat bħala 33 sa 50%, skont il-metodoloġija wżata.
English: Adverse reactions at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded.
Maltese: Bid-dożi terapewtiċi mhumiex mistennija reazzjonijiet avversi, għalkemm ma jistgħux jiġu esklużi riskju ta' dijarea u infezzjoni bil-moffa fir-riti mukużi.
English: Renal function should be monitored in the elderly and those with known pre-existing renal impairment (see section 4.2).
Maltese: Il-funzjoni tal-kliewi għandha tiġi mmonitorjata fl-anzjani u f'dawk li diġà huma magħrufa li għandhom indeboliment tal-kliewi (ara sezzjoni 4.2).
English: Reproductive studies in animals have shown no effects on fertility.
Maltese: Studji fuq irriproduzzjoni fl-annimali ma wrew l-ebda effetti fuq il-fertilità.
English: 250 mg, 750 mg, 1.5 g powder for solution for injection Powder for solution for injection [To be completed nationally]
Maltese: 250 mg, 750 mg, 1.5 g trab għal soluzzjoni għall-injezzjoni Trab għal soluzzjoni għall-injezzjoni [Biex timtela mill-pajjiż partikolari]
English: Preparation of solution for intravenous infusion The contents of the Monovial are added to small volume infusion bags containing 0.9% Sodium Chloride Injection, or 5% Dextrose Injection, or another compatible fluid.
Maltese: Il-kontenut tal-Monovial jiżdied ma' boroż ta' infużjoni b'volum żgħir li jkun fihom Injezzjoni ta' 0.9% Sodium Chloride, jew Injezzjoni ta' 5% Dextrose, jew fluwidu kumpatibbli ieħor.
English: 750 mg, 1.5 g, 2 g powder for solution for infusion Powder for solution for infusion [To be completed nationally]
Maltese: 750 mg, 1.5 g, 2 g trab għal soluzzjoni għall-infużjoni Trab għal soluzzjoni għall-infużjoni [Biex timtela mill-pajjiż partikolari]
English: 750 mg powder for solution for injection or infusion 750 mg intramuscular intravenous bolus intravenous infusion
Maltese: 750 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni 750 mg intramuskolari doża f'daqqa għal ġol-vini infużjoni ġol-vini
English: $ All methicillin-resistant S. aureus are resistant to cefuroxime.
Maltese: L-ispeċijiet Legionella $ L-S. aureus kollha li huma reżistenti għall-methicillin huma reżistenti għal cefuroxime.
English: See (‘Conditions you need to look out for') in section 4.
Maltese: Ara ‘Kundizzjonijiet li inti għandek toqogħod attent għalihom' f'sezzjoni 4.
English: 1 g powder for solution for injection or infusion Italy - Curoxim
Maltese: 1 g trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni L-Italja - Curoxim
English: • if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems).
Maltese: antibijotiku betalactam (penicillins, monobactams u carbapenems).
English: AUC and Cmax appear to increase linearly with increase in dose over the single dose range of 250 to 1000 mg following IM and IV administration.
Maltese: L-AUC u s-Cmax jidhru li jiżdiedu b'mod lineari ma' żieda fid-doża fuq medda ta' doża singola ta' bejn 250 u 1000 mg wara għoti fil-muskolu u fil-vina.
English: It will retain potency for up to 24 hours at room temperature in:
Maltese: Huwa jżomm il-qawwa tiegħu sa 24 siegħa f'temperatura tal-kamra f':
English: • if you are allergic (hypersensitive) to any cephalosporin antibiotics or any of the other ingredients of Zinacef .
Maltese: • jekk inti allerġiku/a (tbati minn sensittivtià eċċessiva) għal kwalunkwe wieħed mill-antibijotiċi cephalosporin jew għal xi sustanza oħra ta' Zinacef.
English: Patients on haemodialysis
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Fusobacterium spp.
Maltese: L-ispeċijiet Fusobacterium
English: 1 g powder for solution for injection 1 g intramuscular intravenous bolus
Maltese: 1 g trab għal soluzzjoni għall-injezzjoni 1 g intramuskolari doża f'daqqa għal ġol-vini
English: This may be supplemented with two 750 mg doses (intramuscularly) after 8 hours and 16 hours.
Maltese: Dan jista' jiġi ssupplimentat b'żewġ dożi ta' 750 mg (intramuskolari) wara 8 sigħat u 16-il siegħa.
English: Zinacef and associated names (see Annex I) 250 mg powder for solution for injection Zinacef and associated names (see Annex I) 750 mg powder for solution for injection Zinacef and associated names (see Annex I) 1.5 g powder for solution for injection Zinacef and associated names (see Annex I) 250 mg powder and solvent for solution for injection Zinacef and associated names (see Annex I) 500 mg powder and solvent for solution for injection Zinacef and associated names (see Annex I) 750 mg powder and solvent for solution for injection Zinacef and associated names (see Annex I) 1 g powder and solvent for solution for injection Zinacef and associated names (see Annex I) 750 mg powder for solution for infusion Zinacef and associated names (see Annex I) 1.5 g powder for solution for infusion Zinacef and associated names (see Annex I) 2 g powder for solution for infusion Zinacef and associated names (see Annex I) 250 mg powder for solution for injection or infusion Zinacef and associated names (see Annex I) 750 mg powder for solution for injection or infusion Zinacef and associated names (see Annex I) 1.5 g powder for solution for injection or infusion Zinacef and associated names (see Annex I) 750 mg powder for solution for infusion (Monovial presentation)
Maltese: 2 g trab għal soluzzjoni għall-infużjoni Zinacef u ismijiet assoċjati (ara Anness I) 250 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Zinacef u ismijiet assoċjati (ara Anness I) 750 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Zinacef u ismijiet assoċjati (ara Anness I) 1.5 g trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Zinacef u ismijiet assoċjati (ara Anness I) 750 mg trab għal soluzzjoni għall-infużjoni (ippreżentat bħala kunjett għal użu wieħed Zinacef u ismijiet assoċjati (ara Anness I) 1.5 g trab għal soluzzjoni għall-infużjoni (ippreżentat bħala kunjett għal użu wieħed)
English: Chlamydia spp.
Maltese: L-ispeċijiet Chlamydia
English: Some strains that produce beta-lactamases are susceptible or intermediate to 3rd or 4th generation cephalosporins with these breakpoints and should be reported as found, i.e. the presence or absence of an ESBL does not in itself influence the categorization of susceptibility.
Maltese: Pulmonite li tittieħed mill-komunità u aggravament akut ta' bronkite kronika Infezzjonijiet fit-tessuti rotob: ċellulite, irsipla u infezzjonijiet fil-ġrieħi.
English: • low levels of white blood cells (leucopenia) • increase in bilirubin (a substance produced by the liver)
Maltese: • żieda fil-bilirubin (sustanza li jipproduċiha l-fwied)
English: Treatment related adverse reactions, all grades, are listed below by MedDRA body system organ class, frequency and grade of severity.
Maltese: Reazzjonijiet avversi marbuta mal-kura, fil-gradi kollha, huma elenkati hawn taħt skont il-klassi tas-sistemi u tal-organi tal-ġisem MedDRA, il-frekwenza u l-grad ta' qawwa.
English: • diarrhoea, nausea, stomach pain
Maltese: • dijarea, tqalligħ, uġigħ fl-istonku
English: 750 mg, 1.5 g powder for solution for infusion (Monovial presentation).
Maltese: 750 mg, 1.5 g trab għal soluzzjoni għall-infużjoni (ippreżentat bħala kunjett għal użu wieħed).
English: Transient rises in serum liver enzymes or bilirubin have been observed which are usually reversible.
Maltese: Ġew osservati żidiet temporanji fil-livelli tal-enzimi tal-fwied jew fil-bilirubin fis-serum li ġeneralment ikunu riversibbli.
English: The development of a positive Coomb's Test associated with the use of cefuroxime may interfere with cross matching of blood (see section 4.8).
Maltese: Din id-dijanjosi għandha titqies f'pazjenti li jkollhom dijarea waqt jew wara l-għoti ta' cefuroxime (ara sezzjoni 4.8).
English: • increase in levels of urea nitrogen and serum creatinine in the blood.
Maltese: • żieda fil-livelli tan-nitroġenu mill-urea fid-demm u tal-krejatinina tas-serum fid-demm.
English: ** The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/ml.
Maltese: ** Il-volum ta' soluzzjoni ta' cefuroxime li jinkiseb fis-sustanza tar-rikostituzzjoni jiżdied minħabba l-fattur ta' spostament tal-mediċina li jwassal għall-konċentrazzjonijiet elenkati f'mg/ml.
English: Breastfeeding
Maltese: TAL-PRODOTT
English: Legionella spp.
Maltese: Instruzzjonijiet għar-rikostituzzjoni
English: Renal impairment has been reported during use of these combinations.
Maltese: Indeboliment talkliewi kien irrappurtat waqt l-użu ta' dawn il-kombinazzjonijiet.
English: You must not be given Zinacef.
Maltese: Inti m'għadekx tingħata Zinacef.
English: For every 1 kg the baby or child weighs, they'll be given 30 to 100 mg of Zinacef per day divided in three or four doses.
Maltese: Għal kull kilogramma li tiżen it-tarbija, huma se jingħataw bejn 30 u 100 mg ta' Zinacef kuljum maqsuma f'żewġ jew fi tliet dożi.
English: - If you get any side effects, talk to your doctor or nurse.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, jew lill-infermier tiegħek.
English: Take special care with Zinacef
Maltese: Oqgħod attent ħafna b' Zinacef
English: Cefuroxime sodium has also been found compatible for 24 h at room temperature when admixed in i.v.
Maltese: Cefuroxime sodium instab ukoll li huwa kumpatibbli għal 24 siegħa f'temperatura tal-kamra meta jitħallat f'infużjoni għal ġol-vina ma':
English: Zinacef 750 mg, 1.5 g and 2 g powder for solution for infusion Intravenous use.
Maltese: Zinacef 750 mg, 1.5 g u 2 g trab għal soluzzjoni għall-infużjoni Użu għal ġol-vini.
English: Zinacef and associated names (see Annex I) 750 mg powder for solution for injection Zinacef and associated names (see Annex I) 1.5 g powder for solution for injection Zinacef and associated names (see Annex I) 250 mg powder and solvent for solution for injection Zinacef and associated names (see Annex I) 500 mg powder and solvent for solution for injection Zinacef and associated names (see Annex I) 750 mg powder and solvent for solution for injection Zinacef and associated names (see Annex I) 1 g powder and solvent for solution for injection Zinacef and associated names (see Annex I) 750 mg powder for solution for infusion Zinacef and associated names (see Annex I) 1.5 g powder for solution for infusion Zinacef and associated names (see Annex I) 2 g powder for solution for infusion Zinacef and associated names (see Annex I) 250 mg powder for solution for injection or infusion Zinacef and associated names (see Annex I) 750 mg powder for solution for injection or infusion Zinacef and associated names (see Annex I) 1.5 g powder for solution for injection or infusion Zinacef and associated names (see Annex I) 750 mg powder for solution for infusion (Monovial presentation)
Maltese: 2 g trab għal soluzzjoni għall-infużjoni Zinacef u ismijiet assoċjati (ara Anness I) 250 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Zinacef u ismijiet assoċjati (ara Anness I) 750 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Zinacef u ismijiet assoċjati (ara Anness I) 1.5 g trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Zinacef u ismijiet assoċjati (ara Anness I) 750 mg trab għal soluzzjoni għall-infużjoni (ippreżentat bħala kunjett għal użu wieħed)
English: Medical termination of developing intra-uterine pregnancy up to 63 days of amenorrhea.
Maltese: Terminazzjoni medika ta' żvilupp ta' tqala fl-utru sa 63 jum ta' amenorreja.
English: The method of administration is 200 mg of mifepristone (1 tablet) should be taken, followed 36 to 48 hours later by the administration of a prostaglandin analogue ( 1 pessary containing 1 mg of gemeprost placed in the vagina).
Maltese: Il-metodu ta' kif għandu jingħata huwa 200 mg ta' mifepristone (pillola waħda), segwit mill-għoti talanalogu ta' prostaglandin (pessarju wieħed li fih 1 mg ta' gemeprost imdaħħal fil-vaġina) 36 sa 48 siegħa wara.
English: The method of administration is 200 mg of mifepristone in a single oral dose, followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Maltese: Il-metodu ta' kif għandu jingħata huwa 200 mg ta' mifepristone f'doża waħda orali, segwita mill-għoti ta' 1 mg tal-analogu ta' prostaglandin, gemeprost mill-vaġina 36 sa 48 siegħa wara.
English: The dose of 200 mg should not be exceeded.
Maltese: Id-doża ta' 200 mg m'għandhiex tinqabeż.
English: The Mifepristone Linepharma tablet should be swallowed with some water in the presence of a doctor or a member of his/her medical staff.
Maltese: Il-pillola ta' Mifepristone Linepharma għandha tinbela' ma' ftit ilma fil-preżenza ta' tabib jew membru tat-tim mediku tiegħu.
English: The valid package leaflet is the final version achieved during the Coordination group procedure with the following amendments (highlighted below in bold underlined) in section 3:
Maltese: Is-sommarju tal-karatteristiċi tal-prodott validu huwa l-verżjoni finali miksuba waqt il-proċedura talgrupp ta' Koordinazzjoni bl-emendi li ġejjin (enfasizzati hawn taħt b'tipa grassa u ssottolinjati) fissezzjoni 4.2:
English: Amendments to be included in the relevant sections of the package leaflet
Maltese: Emendi li għandhom jiddaħħlu fis-sezzjonijiet rilevanti talfuljett ta' tagħrif
English: Mifepristone Linepharma is for oral use.
Maltese: 3. KIF GĦANDEK TUŻA MIFEPRISTONE LINEPHARMA Dejjem għandek tuża Mifepristone Linepharma skont il-parir eżatt tat-tabib tiegħek. Mifepristone Linepharma huwa għal użu orali.
English: It is available as capsules (20 mg).
Maltese: Jiġi bħala kapsuli (20 mg).
English: The full EPAR for Vyndaqel 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: The summary of the opinion of the Committee for Orphan Medicinal Products for Vyndaqel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Vyndaqel jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The active substance in Vyndaqel, tafamidis, is a transthyretin stabilizer.
Maltese: Is-sustanza attiva f'Vyndaqel, it-tafamidis, hija stabilizzatur tat-transtiretin.
English: Vyndaqel is a medicine that contains the active substance tafamidis.
Maltese: Vyndaqel huwa mediċina li fiha s-sustanza attiva tafamidis.
English: This is a summary of the European public assessment report (EPAR) for Vyndaqel.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vyndaqel.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vyndaqel on 16 November 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vyndaqel fis-16 ta' Novembru 2011.
English: Vyndaqel is used in adult patients with the early stage of nerve disease (stage 1).
Maltese: Vyndaqel jintuża f'pazjenti adulti li jbatu mill-istadju inizjali tal-marda fin-nervituri (stadju 1).
English: In 45% of patients taking Vyndaqel, nerve function either improved or stabilised, compared with 30% of patients taking placebo.
Maltese: F'45% tal-pazjenti li kienu qed jieħdu Vyndaqel, il-funzjoni tan-nervituri tjiebet jew inkella stabbilizzat ruħha, meta mqabbla ma' 30% tal-pazjenti li kienu qed jieħdu l-plaċebo.
English: The most common side effects with Vyndaqel (seen in more than 1 patient in 10) are urinary tract infection (infection of the structures that carry urine), vaginal infection, upper abdominal pain (stomach ache) and diarrhoea.
Maltese: L-effetti sekondarji l-aktar komuni b'Vyndaqel (li dehru f'aktar minn pazjent 1 minn kull 10) huma infezzjonijiet fl-apparat urinarju (infezzjonijiet fl-istrutturi li jġorru l-urina), infezzjoni fil-vaġina, uġigħ addominali fin-naħa ta' fuq (uġigħ ta' stonku), u dijarrea.
English: The broken protein forms a fibrous substance called amyloid that is deposited in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Maltese: Il-proteina mkissra tifforma sustanza fibruża li tissejjaħ amilojd li tiġi depożitata f'tessuti u organi madwar il-ġisem, inkluż in-nervituri, fejn tinterferixxi mal-funzjonijiet normali tagħhom.
English: What is Vyndaqel?
Maltese: Kif jintuża Vyndaqel?
English: Because the number of patients with transthyretin amyloidosis is low, the disease is considered ‘rare', and Vyndaqel was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 August
Maltese: Minħabba li n-numru ta' pazjenti bi transtiretin amilojdosi huwa wieħed baxx, il-marda hija meqjusa bħala ‘rari', u Vyndaqel ġie denominat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fit-28 ta' Awwissu 2006.
English: Why has Vyndaqel been approved?
Maltese: Għaliex ġie approvat Vyndaqel?
English: It attaches to transthyretin, which prevents the protein from breaking up, thereby stopping the formation of amyloid and slowing down the progression of the nerve disease.
Maltese: Din teħel ma' transtiretin, li tipprevjeni l-proteina milli tinkiser, u għalhekk twaqqaf il-formazzjoni ta' amilojd u tnaqqas ilprogressjoni tal-marda tan-nervituri.
English: Vyndaqel is used to delay nerve damage caused by transthyretin amyloidosis, a hereditary disease in which fibres called amyloid build up in tissues around the body including around the nerves.
Maltese: Vyndaqel jintuża sabiex jittardja l-ħsara fin-nervituri kkawżata minn transtiretin amilojdosi, marda ereditarja li fiha l-fibri msejħa amilojdi jinġemgħu fit-tessuti ta' madwar il-ġisem fosthom madwar innervituri.
English: What is the risk associated with Vyndaqel?
Maltese: X'inhu r-riskju assoċjat ma' Vyndaqel?
English: The company that makes Vyndaqel will carry out a study on the effects of the medicine in a subgroup of patients with certain genetic mutations.
Maltese: Il-kumpanija li timmanifattura Vyndaqel ser twettaq studju fuq l-effetti tal-mediċina f'sottogrupp ta' pazjenti b'ċerti mutazzjonijiet ġenetiċi.
English: Vyndaqel was compared with placebo (a dummy treatment) in 128 patients with transthyretin amyloidosis.
Maltese: Vyndaqel tqabbel ma' plaċebo (kura finta) f'128 pazjent li jbatu minn b'transtiretin amilojdosi.
English: In patients with transthyretin amyloidosis, a blood protein called transthyretin is defective and breaks easily.
Maltese: F'pazjenti bi transtiretin amilojdosi, il-proteina fid-demm li tissejjaħ transtiretin hija difettuża u titkisser malajr.
English: For the full list of all side effects and restrictions with Vyndaqel, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u rrestrizzjonijiet kollha b'Vyndaqel, ara l-fuljett ta' tagħrif.
English: What is Vyndaqel used for?
Maltese: Għal xiex jintuża Vyndaqel?
English: Treatment should be started and supervised by a doctor knowledgeable in the management of patients with this disease.
Maltese: Il-kumpanija li ser tpoġġi Vyndaqel fis-suq ser tipprovdi materjal edukattiv lit-tobba kollha li huma mistennija jippreskrivu Vyndaqel.
English: EU/1/09/537/001 Mozobil
Maltese: EU/1/09/537/001
English: 24 mg / 1.2 ml
Maltese: Kunjett (tal-ħġieġ) 24 mg/1,2 ml
English: 20 mg/ml Solution for injection
Maltese: 20 mg/ml soluzzjoni għallinjezzjoni
English: Subcutaneous use vial (glass)
Maltese: Isem (ivvintat)
English: rotavirus serotype* P1[8]
Maltese: rotavirus serotip* P1[8]
English: _*_One 2-ml dose contains: rotavirus serotype* G1
Maltese: _*_Doża waħda ta' 2 ml fiha: rotavirus serotip* G1
English: 2 As lower confidence limit (p = 0.95)
Maltese: Unitajiet infettużi Bħala limitu ta' kunfidenza l-baxx (p = 0.95)
English: not less than 2.3 x 106 IU1, 2 * human-bovine rotavirus reassortants (live), produced in Vero cells.
Maltese: IU * reassortanti ta' rotavirus uman-bovin (ħaj), prodotti f'ċelloli Vero.
English: 1 Infectious Units
Maltese: Għamla farmaċewtika