FrancophonIA/ELRC3.0 huggingface dataset:
English: This bar code is the doctor's reference number used at the analysing laboratory as a patient identifier; the two spare bar code labels are for the doctor's use on the patient notes/files etc.
Maltese: Din il-bar kowd hija n-numru ta' referenza tat-tabib li jintuża fil-laboratorju fejn issir l-analiżi biex ikun identifikat il-pazjent; iż-żewġ tikketti tal-bar kowd żejda huma għall-użu tat-tabib fuq in-noti/il-fajls tal-pazjent eċċ.
English: A further 3 samples of your breath will then be taken 30 minutes later.
Maltese: Wara 30 minuta, jittieħdu 3 kampjuni oħra tan-nifs tiegħek.
English: Pylobactell is not recommended for use in children below the age of 18 years due to insufficient data on efficacy.
Maltese: Pylobactell mhux irrakkomandat għall-użu fit-tfal u adoloxxenti taħt 18-il sena peress li m'hemmx biżżejjed informazzjoni dwar l-effikaċja.
English: Excess 
Maltese: EFFETTI
English: Soluble tablet A white, biconvex tablet.
Maltese: Inti ser tintalab biex tixrob “ikla tat-test”.
English: C-Urea breath test, for one of the following reasons:
Maltese: L-ikla tat-test:
English: ANNEX I
Maltese: ANNESS II A.
English: This is not included in this kit but may have been supplied separately.
Maltese: Din mhix inkluża f'dan is-sett iżda tista' tkun ingħatat separatament.
English: Six glass tubes, with caps and bar code labels.
Maltese: Sitt tubi tal-ħġieġ, bit-tappijiet u tikketti tal-bar kowd.
English: • 30 ml glass mixing tube with cap.
Maltese: • Tubu tal-ħġieġ b'tapp biex tħallat ta' 30 ml.
English: 20 Holles Street Dublin 2
Maltese: Holles Street, Dublin 2, L-Irlanda.
English: Security Label and three additional bar code labels.
Maltese: Tikketta tas-Sigurtà u tliet tikketti oħra bil-bar kowd.
English: Mins Test Check List
Maltese: Tagħmilx it-test jekk:
English: H. pylori status:
Maltese: Pazjenti pedjatriċi:
English: • you have long term stomach problems (atrophic gastritis) as the breath test may give the wrong result and other tests may be required to confirm the presence of H. pylori.
Maltese: • inti għandek problemi fl-istonku fit-tul (gastrite atrofika) minħabba li t-test tan-nifs jista' jagħti riżultat ħażin u jistgħu jkunu meħtieġa testijiet oħra biex tkun ikkonfermata l-preżenza ta' H. pylori.
English: It is recommended that the breath test is performed while you are in a seated position.
Maltese: Huwa rrakkomandat li t-test tan-nifs isir waqt li l-pazjent ikun bilqiegħda
English: Reference gases must be standardised against an appropriate international standard to allow inter-laboratory comparison of results.
Maltese: Il-gass ta' referenza għandu jkun standardizzat skond stàndard internazzjonali xieraq biex jippermetti l-paragun ta' riżultati bejn il-laboratorji.
English: Alternatively, any other suitably-validated method may be used, carried out by any objectively qualified laboratory.
Maltese: Alternattivament, kwalunkwe metodu ieħor li huwa pruvat b'mod xieraq jista' jintuża, u applikat minn kull laboratorju ikkwalifikat b'mod oġġettiv.
English: C-urea
Maltese: OĦRAJN
English: How to store Pylobactell
Maltese: X'INHU PYLOBACTELL
English: ANALYSIS REQUEST FORM:
Maltese: Spjegazzjoni tar-riżultati :
English: It is important to follow the instructions for use described in Section 6.6 adequately, otherwise the validity of the test result will be questionable.
Maltese: Huwa importanti li ssegwi kif suppost l-istruzzjonijiet għall-użu deskritti f'sezzjoni 6.6, inkella lvalidità tat-test tkun dubjuża.
English: When dissolved, drink entire contents Refill with water to line, shake bottle and drink Discard this bottle after use Do not return with kit
Maltese: Meta tinħall, ixrob il-kontenut kollu Erġa' imla bl-ilma sas-sinjal, ħawwad il-flixkun u ixrob Armi dan il-flixkun wara li tużah Tirritornahx mas-sett
English: AFFIX BAR-CODE LABEL HERE PLEASE PLACE BAR-CODE LABEL ON PATIENT RECORDS, IF APPLICABLE
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: System Organ Class (SOC)
Maltese: Klassi tal-Organi tas-Sistema (SOC)
English: CZ-281 63 Kostelec nad Cernymi lesy Czech Republic
Maltese: CZ-281 63 Kostelec nad Cernymi lesy Ir-Rebupplika Ċeka
English: - The active substance is:
Maltese: - Is-sustanza attiva hi:
English: Preferred MedDRA Term
Maltese: Terminu Preferut minn MedDRA
English: PEEL OFF´S (1 PEEL OFF PER DOSIS)
Maltese: PEEL OFF´S (1 PEEL OFF KULL DOŻA)
English: Date of latest renewal: 04/01/2017
Maltese: Data tal-aħħar tiġdid: 04/01/2017
English: 4.8 Undesirable effects a) Summary of safety profile
Maltese: .8 Effetti mhux mixtieqa a) Sommarju tal-profil tas-sigurtà
English: Very Common (≥1/10) Common (≥1/100 - <1/10) Uncommon (≥1/1,000 - <1/100) Rare (≥1/10,000 - <1/1,000)
Maltese: Mhux komuni (≥1/1,000 - <1/100) Rari (≥1/10,000 - <1/1,000)
English: Clear to opalescent suspension.
Maltese: Ċara għal sospensjoni opalexxenti.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 17/02/2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17/02/2012
English: GASTROINTESTINAL DISORDERS
Maltese: DISTURBI GASTROINTESTINALI
English: Active immunisation against H5N1 subtype of influenza A virus.
Maltese: Immunizzazzjoni attiva kontra H5N1 sottotip ta' virus tal-influwenza A.
English: See section 6.6. for administration instructions.
Maltese: Ara sezzjoni 6.6 għall-istruzzjonijiet amministrattivi.
English: ACTIVE SUBSTANCE A/Vietnam/1203/2004 (H5N1)
Maltese: SUSTANZA ATTIVA A/Vjetnam/1203/2004 (H5N1)
English: A/Indonesia
Maltese: A/Indoneżja
English: 21 Days after 1st Dose 2nd Dose 1st Dose 2nd Dose 1st Dose 2nd Dose
Maltese: 21 Jum wara L-1 Doża It-2 Doża L-1 Doża It-2 Doża L-1 Doża It-2 Doża
English: Seroneutralization rate* 52.6% 85.4% 17.1% 72.9% 3.0% 68.8% Seroconversion rate** 9.1% 31.8% 16.4% 72.2% 9.1% 65.6% Seroconversion factor***
Maltese: Rata ta' serokonverżjoni** 9.1% 31.8% 16.4% 72.2% 9.1% 65.6% Fattur ta' serokonverżjoni*** * tajter MN ≥20 ** ≥żieda ta' 4 darbiet fit-tajter MN *** żieda medja ġeometrika
English: 60 years and above Strain A/Indonesia/05/2005 21 Days after 2nd Dose
Maltese: 60 sena u iżjed Razza A/Indoneżja/05/2005 21 jum wara tieni doża
English: PSUR submission when VEPACEL is used during an influenza pandemic:
Maltese: Sottomissjoni ta' PSUR meta VEPACEL jintuża waqt pandemija tal-influwenza:
English: Very Rare (<1/10,000)
Maltese: Rari ħafna (<1/10,000)
English: In such cases, the western blot method is negative.
Maltese: F'każijiet bħal dawn, il-metodu western blot ikun negattiv.
English: Immune system disorders: anaphylactic reaction, hypersensitivity Nervous system disorders: febrile convulsion Skin and subcutaneous tissue disorders: angioedema Muscoluskeletal and connective tissue disorders: pain in extremity
Maltese: Disturbi fis-sistema immuni: reazzjoni anafilattika, sensittività eċċessiva Disturbi fis-sistema nervuża: konvulżjoni bid-deni Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda: anġjoedema Disturbi muskolu-skeletriċi u tat-tessuti konnettivi: uġigħ fl-estremitajiet
English: Immunogenicity in immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123)
Maltese: Immunoġeniċità f'persuni immunokompromessi (N=122) u f'pazjenti b'kundizzjonijiet ta' mard kroniku (N=123)
English: A/Vietnam
Maltese: A/Vjetnam
English: A/Vietnam A/Indonesia
Maltese: A/Vjetnam A/Indoneżja
English: Adverse Reactions (infants, children and adolescents)
Maltese: Reazzjonijiet Avversi (trabi, tfal u adolexxenti)
English: HTLV-1.
Maltese: L-1 Doża
English: Sensory disturbance (paresthesia, dysesthesia, oral dysesthesia, hypoesthesia, dysgeusia, and burning sensation)
Maltese: Disturbi sensorjali (parastesija, disestesija, disestesija orali, ipoestesija, indeboliment fis-sens tat-togħma u sensazzjoni ta' ħruq)
English: Rare: neuralgia, transient thrombocytopenia.
Maltese: Rari: nevralġija, tromboċitopenija temporanja.
English: Side effects observed with a similar influenza vaccine (Celvapan) The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme:
Maltese: Effetti sekondarji osservati b'vaċċin simili tal-influwenza (Celvapan) L-effetti sekondarji elenkati hawn taħt seħħew b'vaċċin simili tal-influwenza (Celvapan) f'persuni adulti u t-tfal matul il-programm ta' tilqim kontra l-influwenza pandemika (H1N1):
English: One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Maltese: Pakkett wieħed ta' 20 kunjett b'ħafna dożi (ħġeġ ta' tip I) ta' 5 ml ta' suspensjoni (10 dożi x 0.5 ml) b'tapp (lastku bromobutyl).
English: OTHER Ology Bioservices Ireland Ltd Logo
Maltese: OĦRAJN Logo ta' Ology Bioservices Ireland Ltd
English: The following serious adverse reactions have been reported from post-marketing surveillance with egg-derived interpandemic trivalent vaccines:
Maltese: Ir-reazzjonijiet avversi serji li ġejjin ġew irrappurtati mis-sorveljanza ta' wara t-tqegħid fis-suq b'vaċċini trivalenti interpandemiċi derivati mill-bajd:
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (0.5 ml) contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Doża 1 (0.5 ml) fiha:
English: • neurological disorders such as encephalomyelitis (inflammation of the central nervous system),
Maltese: • disturbi newroloġiċi bħal enċefalomajelite (infjammazzjoni tas-sistema nervuża ċentrali), nevrite
English: Trivalent seasonal influenza vaccines
Maltese: Vaċċin trivalenti kontra influwenza staġjonali
English: Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus, and especially, HTLV-1.
Maltese: Wara t-tilqim kontra l-influwenza, riżultati pożittivi foloz għal testijiet seroloġiċi jistgħu jinkisbu permezz tal-metodu ELISA għal antikorpi kontra l-virus tal-immunodefiċjenza umana-1 (HIV-1), epatite Ċ, u speċjalment, HTLV-1.
English: 1 dose (0.5 ml) contains:
Maltese: Doża 1 (0.5 ml) fiha:
English: Sodium chloride Water for injections Polysorbate 80.
Maltese: Sodium chloride Ilma għall-injezzjonijiet Polysorbate 80.
English: neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome
Maltese: (infjammazzjoni tan-nervaturii) u tip ta' paralisi magħrufa bħala s-Sindrome ta' Guillain-Barré
English: History of anaphylactic reactions to the active substance, or to any of the excipients listed in section 6.1, or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein).
Maltese: Storja medika ta' reazzjonijiet anafilattiċi għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 jew għal residwi fi traċċa (formaldehyde, benzonase, sucrose, trypsin u proteina ta' ċelluli ospitu Vero).
English: • Adults, older people, and special risk groups
Maltese: • Adulti, persuni aktar anzjani u gruppi f'riskju speċjali
English: Trometamol Sodium chloride Water for injections Polysorbate 80
Maltese: Trometamol Sodium chloride Ilma għall-injezzjonijiet Polysorbate 80
English: The protective efficacy of VEPACEL against morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian influenza H5N1 virus was assessed non-clinically in a ferret challenge model.
Maltese: L-effikaċja protettiva ta' VEPACEL kontra morbożità u mortalità kkaġunati mill-infezzjoni b'dożi letali tal-virus patoġeniku ħafna tal-influwenza tat-tjur H5N1 ġiet evalwata mhux klinikament f'mudell ta' sfida fuq in-nemes.
English: MARKETING AUTHORISATION NUMBER EU/1/12/752/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/752/002
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature.
Maltese: Madankollu, l-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 3 sigħat fit-temperatura tal-kamra.
English: Infants, children, and adolescents Immune response against A/Vietnam/1203/2004 (H5N1)
Maltese: Rispons immuni kontra A/Vjetnam/1203/2004 (H5N1)
English: Seroneutralisation rate* Seroconversion rate** Seroconversion factor*** * MN titre ≥ 20 ** ≥ 4-fold increase in MN titre *** geometric mean increase
Maltese: Ir-rata ta' seronewtralizzazzjoni* Ir-rata ta' serokonverżjoni** Il-fattur ta' serokonverżjoni*** * Tajter MN ≥20 ** ≥żieda ta' 4 darbiet fit-tajter MN *** żieda medja ġeometrika
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu/.
English: 21 Days after 2nd Dose
Maltese: 21 jum wara tieni doża
English: Adults, older people, and special risk groups
Maltese: Adulti, persuni aktar anzjani u gruppi f'riskju speċjali
English: MARKETING AUTHORISATION NUMBER EU/1/12/752/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/752/001
English: B. PACKAGE LEAFLET
Maltese: b) Lista tabulata ta' reazzjonijiet avversi
English: The A/Vietnam/1203/2004 vaccine afforded protection against homologous challenge as evidenced by full survival, reduced weight loss, a less pronounced and shorter increase in temperature, a less marked reduction in lymphocyte counts and in reduction of inflammation and necrosis in brain and olfactory bulb in the vaccinated cohorts as compared to control animals.
Maltese: Il-vaċċin A/Vjetnam/1203/2004 offra protezzjoni kontra sfida omologa kif muri minn sopravivenza sħiħa, tnaqqis fit-telf tal-piż, żieda inqas evidenti u iqsar fit-temperatura, tnaqqis inqas notevoli fl-għadd ta' limfoċiti u fit-tnaqqis tal-infjammazzjoni u n-nekrożi fil-moħħ u fil-basla olfattorja fil-koorti mlaqqma meta mqabbel mal-annimali tal-kontroll.
English: • feeling cold c) The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years.
Maltese: • tħoss il-bard ċ) Ġew irrappurtati dawn l-effetti sekondarji fl-istudji kliniċi f'adolexxenti ta' età minn 9 sa 17-il sena.
English: In consequence, as soon as the pandemic is declared and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update.
Maltese: B'konsegwenza ta' dan, hekk kif tiġi ddikjarata l-pandemija u l-vaċċin ta' qabel il-pandemija jintuża, l-MAH għandu jisottometti b'mod aktar frekwenti r-rapporti perjodiċi ta' aġġornament dwar is-sigurtà simplifikati u f'intervalli definti fir-"Rakkomandazzjonijiet ta' CHMP għal Pjan ta' l-Immaniġġjar ta' Riskju Centrali għal Vaċċini ta' l-Influwenza preparati minn vajrus bil-potenzjal li jikkawżaw pandemiku u li huma intiżi għall-użu barra l-kuntest tad-dossier ċentali" (EMEA/49993/2008), u kwalunkwe aġġornament sussegwenti.
English: This vaccine may contain traces of formaldehyde, benzonase, sucrose, trypsin and Vero host cell protein, which are used during the manufacturing process.
Maltese: Dan il-vaċċin jista' jkun fih traċċi ta' formaldehyde, benzonase, sucrose, trypsin u proteina ta' ċelluli ospitu Vero, li jintużaw waqt il-proċess ta' manifattura.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (EMA): http://www.ema.europa.eu/
English: a) The following side effects have been reported in a clinical study in infants aged 6 to 35 months.
Maltese: a) Ġew irrappurtati dawn l-effetti sekondarji fi istudju kliniku fi trabi ta' età minn 6 sa 35 xahar.
English: Influenza virus (whole virion, inactivated), containing antigen of*strain: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** * produced in Vero cells ** haemagglutinin
Maltese: A/Vjetnam/1203/2004 (H5N1) 7.5 microgrammi** * prodott f'ċelluli Vero ** emagglutinin
English: Data obtained with the H5N1 vaccines will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with H5N1 vaccines are relevant for the pandemic and pre-pandemic vaccines.
Maltese: Dejta miksuba mill-vaċċini kontra l-H5N1 se jappoġġjaw strateġija ta' tilqim li x'aktarx li se tintuża għall-vaċċin kontra l-pandemija: immunoġeniċità klinika, sigurtà u r-reazzjoniġeneċità miksubin b'vaċċini kontra l-H5N1 huma rilevanti għat-tilqim pandemiku u prepandemiku.