FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects and restrictions with trastuzumab, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati bi trastuzumab, ara l-fuljett ta' tagħrif.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Herzuma has been shown to have a comparable quality, safety and effectiveness to Herceptin.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Herzuma wera li għandu kwalità, sigurtà u effettività komparabbli għal Herceptin.
English: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Maltese: • kanċer tas-sider li jkun għadu fil-bidu (meta l-kanċer ikun infirex fis-sider jew fil-glandoli taħt iddriegħ iżda mhux f'partijiet oħrajn tal-ġisem) wara kirurġija, kimoterapija (mediċini li jikkuraw ilkanċer), u radjoterapija (kura bir-radjazzjoni) jekk applikabbli.
English: Studies have also shown that giving Herzuma produces similar levels of the active substance in the body to giving Herceptin.
Maltese: L-istudji wrew ukoll li lgħoti ta' Herzuma jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Herceptin.
English: In addition, one main study involving 549 patients with early breast cancer that overexpressed HER2 showed that Herzuma was as effective as Herceptin.
Maltese: Barra minn hekk, studju ewlieni li inolva 549 pazjent b'kanċer tas-sider li kien għadu fil-bidu li kellu espressjoni żejda ta' HER2 wera li Herzuma kien effettiv daqs Herceptin.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Maltese: Billi jeħel mal-HER2, trastuzumab jattiva ċ-ċelloli tas-sistema immuni, li mbagħad joqtlu ċ-ċelloli tat-tumur.
English: 170 mg Nebuliser solution Inhalation use ampoule (PE)
Maltese: Għal biex jinġibed man-nifs ampulla (PE)
English: 56 ampoules x 1 administration device
Maltese: 56 ampulla x strument għallgħoti wieħed
English: References:
Maltese: Referenzi:
English: 20 September 2013 EMA/564255/2013
Maltese: 20 ta' Settembru 2013 EMA/564255/2013
English: Canada T, Crill C, Guenter P. A.S.P.E.N.
Maltese: Canada T, Crill C, Guenter P.
English: Koletzko B, Goulet O, Hunt J, Krohn K, Shamir R. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), and the European Society for Clinical Nutrition and Metabolism (ESPEN), Supported by the European Society of Paediatric Research (ESPR).
Maltese: 3. Koletzko B, Goulet O, Hunt J, Krohn K, Shamir R. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), and the European Society for Clinical Nutrition and Metabolism (ESPEN), Supported by the
English: Numeta G13%E and Numeta G16%E have been authorised since 2011 via national procedures in the following Member States: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom.
Maltese: Numeta G13%E u Numeta G16%E ilhom awtorizzati sa mill-2011 permezz ta' proċeduri nazzjonali flIstati Membri li ġejjin: l-Awstrija, il-Belġju, ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, Franza, ilĠermanja, il-Greċja, l-Irlanda, l-Italja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, il-Portugall, Spanja, l-Isvezja, ir-Renju Unit.
English: However, widelyrecognised guidelines 1,2 recommend a parenteral magnesium intake of 0.15 - 0.25 mmol/kg/day.
Maltese: Madankollu, linji gwida rikonoxxuti sew 1,2 jirrakkomandaw teħid ta' manjesju parenterali ta' 0.150.25 mmol/kg/kuljum.
English: They contain nutrients such as glucose (sugar), lipids (fats), aminoacids and other important substances including magnesium.
Maltese: Fihom nutrijenti bħal glukosju (zokkor), lipidi (xaħmijiet), aminoaċidi u sustanzi importanti oħra fosthom il-manjesju.
English: The review of Numeta G13%E and Numeta G16%E was initiated on 13 June 2013 at the request of Sweden, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Maltese: Ir-reviżjoni ta' Numeta G13%E u Numeta G16%E inbdiet fit-13 ta' Ġunju 2013 fuq talba tal-Isvezja, skont l-Artikolu 107i tad-Direttiva 2001/83/KE, magħruf ukoll bħala l-proċedura urġenti tal-Unjoni.
English: Although this is within the recommendations reported in the literature as a whole, it is slightly more than suggested by some recognised guidelines1,2,3 (0.15-0.25 mmol/kg/day and 0.2 mmol/kg/day for term infant to one year of age, 0.15-0.25 mmol/kg/day and 0.1 mmol/kg/day for children from one year to two years of age).
Maltese: Għalkemm dan huwa skont ir-rakkomandazzjonijiet irrapportati filletteratura inġenerali, huwa kemxejn aktar milli ssuġġerit minn xi linji gwida rikonoxxuti1,2,3 (0.150.25 mmol/kg/kuljum u 0.2 mmol/kg/kuljum għal trabi li jitwieldu wara 37 ġimgħa ta' ġestazzjoni sa sena, 0.15-0.25 mmol/kg/kuljum u 0.1 mmol/kg/kuljum għal tfal minn sena sa sentejn).
English: • The company marketing Numeta identified 14 case reports of hypermagnesaemia with Numeta G13%E.
Maltese: • Il-kumpanija li tqiegħed Numeta fis-suq identifikat 14-il rapport ta' każijiet ta' ipermagnesimja b'Numeta G13%E.
English: The PRAC assessed the available data on the risk of hypermagnesaemia with Numeta G13%E and Numeta G16%E preparations from clinical studies, post-marketing reports and the published literature and considered available treatment guidelines.
Maltese: Il-PRAC ivvaluta d-dejta disponibbli dwar ir-riskju ta' ipermagnesimja bil-preparazzjonijiet ta' Numeta G13%E u Numeta G16%E minn studji kliniċi, rapporti wara t-tqegħid fis-suq u l-letteratura ppubblikata u kkunsidra l-linji gwida ta' kura disponibbli.
English: Numeta G13%E, which is given into a vein to premature babies to provide nutritional support (intravenous nutrition or parenteral nutrition), will remain suspended until a re-formulated preparation is made available.
Maltese: Numeta G13%E, li jingħata ġol-vina lil trabi prematuri biex jipprovdi appoġġ nutrizzjonali (nutrizzjoni ġol-vina jew nutrizzjoni parenterali), se jibqa' sospiż sakemm issir disponibbli preparazzjoni riformulata.
English: • In case of hypermagnesaemia, the infusion of Numeta G16%E should be stopped or infusion rate reduced and alternative fluids, nutrition and electrolytes prescribed as deemed clinically appropriate.
Maltese: • Fil-każ ta' ipermagnesimja, l-infużjoni ta' Numeta G16%E għandha titwaqqaf jew titnaqqas ir-rata tal-infużjoni u jiġu preskritti fluwidi, nutrizzjoni u elettroliti alternattivi kif meqjus klinikament xieraq.
English: • The company identified one case of hypermagnesaemia associated with Numeta G16%E.
Maltese: • Il-kumpanija identifikat każ wieħed ta' ipermagnesimja marbut ma' Numeta G16%E.
English: Numeta G13%E and Numeta G16%E (glucose, lipids, aminoacids and electrolytes) are parenteral nutrition solutions.
Maltese: Numeta G13%E u Numeta G16%E (glukosju, lipidi, aminoaċidi u elettroliti) huma soluzzjonijiet għal nutrizzjoni parenterali. Nutrizzjoni parenterali hija l-provvista ta' nutrijenti u fluwidi ġol-vina f'pazjenti li ma jistgħux jintemgħu mill-ħalq jew permezz ta' nutrizzjoni enterali (l-użu ta' tubu tal-ikel li jgħaddi direttament fil-musrana).
English: • The maximum total amount of magnesium that can be delivered to term infants using Numeta G16%E according to its product information is 0.3 mmol/kg/day.
Maltese: • L-ammont totali massimu ta' manjesju li jista' jingħata lil trabi li jitwieldu wara 37 ġimgħa ta' ġestazzjoni permezz ta' Numeta G16%E skont l-informazzjoni dwar il-prodott tiegħu huwa ta' 0.3 mmol/kg/kuljum.
English: • Because of the risk of hypermagnesaemia (high blood levels of magnesium), the nutrition preparation Numeta G13%E has been suspended until a re-formulated preparation is made available.
Maltese: • Minħabba r-riskju ta' ipermagnesimja (livelli għoljin ta' manjesju fid-demm), il-preparazzjoni nutrizzjonali Numeta G13%E ġiet sospiża sakemm issir disponibbli preparazzjoni riformulata.
English: Magnesium levels mainly ranged from 1.025 mmol/L to > 1.5 mmol/L and no clinical signs or symptoms were reported for any of the cases.
Maltese: Il-livelli tal-manjesju kienu prinċipalment ivarjaw minn 1.025 mmol/L għal > 1.5 mmol/L u ma ġew irrapportati l-ebda sinjali jew sintomi kliniċi għall-ebda wieħed minn dawn il-każijiet.
English: • Following several reports of hypermagnesaemia in preterm infants, the nutrition preparation Numeta G13%E has been suspended until a re-formulated preparation is made available.
Maltese: • Wara bosta rapporti ta' ipermagnesimja fi trabi li twieldu qabel iż-żmien, il-preparazzjoni nutrizzjonali Numeta G13%E ġiet sospiża sakemm issir disponibbli preparazzjoni riformulata.
English: The review of Numeta G13%E and Numeta G16%E was carried out by the the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) following several reports of hypermagnesaemia (without clinical symptoms) in preterm infants.
Maltese: Ir-reviżjoni ta' Numeta G13%E u Numeta G16%E saret mill-Kumitat dwar il-Valutazzjoni tar-Riskji talFarmakoviġilanza (PRAC) tal-Aġenzija Ewropea għall-Mediċini wara bosta rapporti ta' ipermagnesimja (mingħajr sintomi kliniċi) fi trabi li twieldu qabel iż-żmien.
English: Doctors will monitor newborns and children who are receiving Numeta G16%E for symptoms of hypermagnesaemia such as weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).
Maltese: It-tobba se jimmonitorjaw it-trabi tat-twelid u t-tfal li qed jirċievu Numeta G16%E għal sintomi ta' ipermagnesimja bħal dgħjufija, dardir u rimettar, diffikultajiet fit-teħid tan-nifs, ipotensjoni (pressjoni tad-demm baxxa) u arritmiji (taħbit tal-qalb irregolari).
English: As a precautionary measure, the manufacturer decided to voluntarily recall Numeta G13%E in the EU.
Maltese: Bħala miżura ta' prekawzjoni, il-manifattur iddeċieda li b'mod volontarju jirtira lil Numeta G13%E fl-UE.
English: Hypermagnesaemia is a serious condition and symptoms may include weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).
Maltese: L-ipermagnesimja hija kundizzjoni serja u s-sintomi jistgħu jinkludu dgħjufija, dardir u rimettar, diffikultajiet fit-teħid tan-nifs, ipotensjoni (pressjoni tad-demm baxxa) u arritmiji (taħbit tal-qalb irregolari).
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), a medicines regulatory body representing the European Union (EU) Member States, has endorsed by consensus the recommendation to suspend the marketing authorisation of Numeta G13%E because of a risk of hypermagnesaemia (high blood levels of magnesium).
Maltese: Il-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u l-Proċeduri DeċentralizzatiUman (CMDh), korp regolatorju tal-mediċini li jirrappreżenta lill-Istati Membri tal-Unjoni Ewropea (UE), approva b'kunsens ir-rakkomandazzjoni biex l-awtorizzazzjoni għat-tqegħid fis-suq ta' Numeta G13%E tiġi sospiża minħabba riskju ta' ipermagnesimja (livelli għolja ta' manjesju fid-demm).
English: Further information about the EU-wide safety review:
Maltese: Aktar informazzjoni dwar ir-reviżjoni tas-sigurtà madwar l-UE:
English: The maximum total licensed amount of magnesium that can be delivered to preterm infants using Numeta G13%E is 0.55 mmol/kg/day which is above this recommended intake.
Maltese: L-ammont totali massimu liċenzjat ta' manjesju li jista' jingħata lil trabi li twieldu qabel iż-żmien permezz ta' Numeta G13%E huwa ta' 0.55 mmol/kg/kuljum li huwa ogħla minn dan it-teħid rakkomandat.
English: The review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: Ir-reviżjoni saret mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC).
English: Having considered available guidelines and relevant literature and considering the magnesium content of Numeta, the PRAC concluded that the administration of Numeta G13%E could lead to a higher risk of hypermagnesaemia.
Maltese: Wara li kkunsidra l-linji gwida disponibbli u l-letteratura rilevanti u meta wieħed iqis il-kontenut ta' manjesju ta' Numeta, il-PRAC ikkonkluda li l-għoti ta' Numeta G13%E jista' jwassal għal riskju ogħla ta' ipermagnesimja.
English: • Severe hypermagnesaemia is rare but can have adverse clinical consequences.
Maltese: • L-ipermagnesimja severa hija rari iżda jista' jkollha konsegwenzi kliniċi avversi.
English: For another nutrition preparation given into a vein, Numeta G16%E, used in full-term newborns and children up to 2 years, the CMDh agreed that the benefit-risk balance remains positive, provided that healthcare professionals monitor their patients' blood magnesium levels before giving the preparation and at appropriate intervals thereafter in accordance with routine clinical practice and the clinical needs of the individual patient.
Maltese: Għal preparazzjoni nutrizzjonali oħra li tingħata ġol-vina, Numeta G16%E, li tintuża fi trabi tat-twelid li jitwieldu wara 37 ġimgħa ta' ġestazzjoni u fi tfal sa sentejn, is-CMDh qabel li l-bilanċ tal-benefiċċjuriskju jibqa' pożittiv, sakemm il-professjonisti tal-kura tas-saħħa jimmonitorjaw il-livell ta' manjesju fid-demm tal-pazjenti tagħhom qabel ma jagħtu l-preparazzjoni u f'intervalli xierqa wara dan skont ilprattika klinika ta' rutina u l-ħtiġijiet kliniċi tal-pazjent individwali.
English: The product information should be revised accordingly and healthcare professionals should be informed in writing of the potential risk of hypermagnesaemia, which is increased in patients with impaired kidney function and those whose mothers were receiving supplemental magnesium before delivery, and of the measures to be taken to minimise this risk.
Maltese: L-informazzjoni dwar il-prodott għandha tiġi riveduta kif xieraq u lprofessjonisti tal-kura tas-saħħa għandhom jiġu infurmati bil-miktub dwar ir-riskju potenzjali ta' ipermagnesimja, li jiżdied f'pazjenti b'indeboliment fil-funzjoni tal-kliewi u dawk li ommhom kienet qed tirċievi manjesju supplementari qabel il-ħlas, u bil-miżuri li għandhom jittieħdu biex dan ir-riskju jiġi minimizzat.
English: Numeta G13%E is given into a vein to provide nutritional support in premature babies who cannot be fed by mouth or with a feeding tube.
Maltese: Numeta G13%E jingħata ġol-vina biex jipprovdi appoġġ nutrizzjonali fi trabi prematuri li ma jistgħux jintemgħu mill-ħalq jew permezz ta' tubu tal-ikel.
English: Stakeholders were also invited to submit any relevant information to support the assessment, and the Agency's Paediatric Committee (PDCO) was consulted for advice.
Maltese: Il-partijiet interessati ġew ukoll mistiedna jissottomettu informazzjoni rilevanti biex tappoġġa l-valutazzjoni, u l-Kumitat Pedjatriku tal-Aġenzija (PDCO) kien ikkonsultat għal parir.
English: • The nutrition preparation Numeta G16%E can continue to be used in full-term newborns and children up to 2 years, however the doctor will monitor the levels of magnesium in the child's blood before giving the preparation and at appropriate intervals thereafter.
Maltese: • Il-preparazzjoni nutrizzjonali Numeta G16%E tista' tkompli tintuża fi trabi tat-twelid li jitwieldu wara 37 ġimgħa ta' ġestazzjoni u fi tfal sa sentejn, madankollu t-tabib se jimmonitorja l-livelli ta' manjesju fid-demm tat-tifel/tifla qabel ma jagħti l-preparazzjoni u f'intervalli xierqa wara dan.
English: The PRAC also noted the difficulty in identifying symptoms of hypermagnesaemia in premature newborns, which means that hypermagnesaemia may not be detected until it causes serious complications.
Maltese: Il-PRAC innota wkoll id-diffikultà fl-identifikazzjoni ta' sintomi ta' ipermagnesimja fi trabi tat-twelid prematuri, li jfisser li l-ipermagnesimja tista' ma tkunx skoperta sakemm tikkawża komplikazzjonijiet serji.
English: • Doctors should also monitor patients for signs and symptoms of hypermagnesaemia such as nausea, vomiting and flushing, generalized weakness, respiratory failure, hypotension and arrhythmias.
Maltese: • It-tobba għandhom ukoll jimmonitorjaw il-pazjenti għal sinjali u sintomi ta' ipermagnesimja bħal dardir, rimettar u fwawar, dgħjufija ġeneralizzata, insuffiċjenza respiratorja, pressjoni baxxa u arritmija.
English: However, healthcare professionals should be aware of the potential risk for hypermagnesaemia.
Maltese: Madankollu, ilprofessjonisti tal-kura tas-saħħa għandhom ikunu konxji tar-riskju potenzjali għal ipermagnesimja.
English: The doctor will stop giving Numeta G16%E if magnesium levels are high, or will give Numeta at a slower rate.
Maltese: Numeta G13%E se jiġi sospiż u miżuri ġodda għall minimizzazzjoni tar-riskji se jiġu introdotti għal Numeta G16%E
English: Clinical signs may not be identifiable unless hypermagnesaemia is severe.
Maltese: Is-sinjali kliniċi jistgħu ma jkunux identifikabbli sakemm l-ipermagnesimja ma tkunx severa.
English: In patients whose blood magnesium levels are elevated or signs of hypermagnesaemia are identified Numeta G16%E should be stopped or the infusion rate reduced.
Maltese: F'pazjenti li l-livelli ta' manjesju fiddemm tagħhom ikunu elevati jew jiġu identifikati sinjali ta' ipermagnesimja Numeta G16%E għandu jitwaqqaf jew titnaqqas ir-rata tal-infużjoni.
English: • When giving Numeta G16%E, doctors should monitor serum magnesium levels, along with other electrolyte levels at baseline and at appropriate intervals thereafter.
Maltese: • Meta jagħtu Numeta G16%E, it-tobba għandhom jimmonitorjaw il-livelli ta' manjesju fis-serum, flimkien mal-livelli ta' elettroliti oħra fil-linja bażi u f'intervalli xierqa wara dan.
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicant in the Member States
Maltese: Lista ta` l-ismijiet, għamliet farmaċewtiċi, qawwa tal-prodott mediċinali, mnejn jingħata, l-applikant fl-istati membri
English: Poland
Maltese: Applikant
English: Sweden
Maltese: Hämeenlinna
English: 2745-663 Barcarena Portugal
Maltese: 2745-663 Barcarena Il-Portugall
English: Laboratorio Tau, S.A. C/ Serrano Galvache, 56 Edificio Roble 28033 Madrid Spain
Maltese: Laboratorio Tau, S.A. C/ Serrano Galvache, 56 Edificio Roble 28033 Madrid Spanja
English: Netherlands AstraZeneca BV Postbus 599
Maltese: L-Olanda AstraZeneca BV Postbus 599
English: AstraZeneca UK Ltd., Silk Road Business Park ,SK10 2NA Macclesfield, Cheshire, United Kingdom
Maltese: AstraZeneca UK Ltd., Silk Road Business Park ,SK10 2NA Macclesfield, Cheshire, Ir-Renju Unit
English: Via F. Sforza Palazzo Volta 20080 Basiglio (MI) Italy
Maltese: Via F. Sforza Palazzo Volta 20080
English: Via E. Folli 50 20134 Milano Italy
Maltese: Folli 50 20134
English: Germany AstraZeneca GmbH 22876 Wedel
Maltese: Il-Ġermanja AstraZeneca GmbH 22876 Wedel
English: Via Lungo l'Ema 7 50015 Bagno a Ripoli (FI) Italy
Maltese: 50015 Bagno a Ripoli (FI) L-Italja
English: 2700 AN, Zoetermeer The Netherlands
Maltese: AN, Zoetermeer L-Olanda
English: DK-2620 Albertslund Denmark
Maltese: DK-2620 Albertslund Id-Danimarka
English: Denmark AstraZeneca A/S Roskildevej 22
Maltese: Id-Danimarka AstraZeneca A/S Roskildevej 22
English: AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien
Maltese: Schwarzenbergplatz 7, A-1037 Wien
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi Athens Greece
Maltese: Theotokopoulou & Astronafton str 151 25
English: 2620 Albertslund Denmark
Maltese: 2620 Albertslund Id-Danimarka
English: AstraZeneca A/S Roskildevej 22
Maltese: L-Islanda AstraZeneca A/S Roskildevej 22
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels
Maltese: NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussels
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussel
Maltese: NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Brussel
English: AstraZeneca AB, 151 85 Södertälje Sweden
Maltese: AstraZeneca AB, 151 85 Södertälje, L-Isvezja
English: Sweden AstraZeneca AB S-151 85 Södertälje Sweden
Maltese: AstraZeneca AB, S-151 85 Södertälje L-Isvezja
English: Norway AstraZeneca AS, Postboks 200 Vinderen, 0319 OSLO
Maltese: In-Norveġja AstraZeneca AS, Postboks 200
English: 1, Place Renault 92844 RUEIL-MALMAISON Cedex
Maltese: AstraZeneca 1, Place Renault 92844
English: AstraZeneca Oy Luomanportti 3 FI-02200 Espoo Finland
Maltese: Il-Finlandja AstraZeneca Oy Luomanportti 3
English: Γαστροανθεκτικό καψάκιο σκληρό 20 mg/CAP
Maltese: Γαστροανθεκτικό δισκίο 20
English: Γαστροανθεκτικό καψάκιο σκληρό 40 mg/CAP
Maltese: Γαστροανθεκτικό δισκίο 40
English: Hungary AstraZeneca Kft. H-2045 Törökbálint, Park u. 3.
Maltese: Törökbálint, Park u.
English: , Ενέσιμο λυόφιλο για ενδοφλέβια έγχυση 40 mg/VIAL
Maltese: Losec, Ενέσιμο λυόφιλο για ενδοφλέβια έγχυση 40
English: AstraZeneca
Maltese: L-Awstrija
English: Γαστροανθεκτικό καψάκιο σκληρό 10 mg/CAP
Maltese: Γαστροανθεκτικό δισκίο 10
English: , Ενέσιμο λυόφιλο 40 mg/VIAL
Maltese: mg/VIAL
English: 20 mg Gastroresistant tablets
Maltese: 20 mg Pillola gastroreżistenti
English: Losec-Mups 40mg 40 mg Gastroresistant tablets
Maltese: Losec MUPS 40 40 mg Pilloli gastroreżistenti
English: 40 mg Gastroresistant tablets
Maltese: 40 mg Pillola gastroreżistenti
English: Losec-Mups 10mg 10 mg Gastroresistant tablets
Maltese: Losec MUPS 10 10 mg Pilloli gastroreżistenti
English: 40 mg Gastroresistant capsules
Maltese: 40 mg Kapsuli gastrorezistenti
English: 10 mg Gastroresistant tablets
Maltese: 10 mg Pillola gastroreżistenti
English: 10 mg Capsules
Maltese: 10 mg Kapsuli
English: 20 mg Capsules
Maltese: 20 mg Kapsuli
English: Losec 10 mg kapszula 10 mg Capsule, hard
Maltese: Losec 10 mg kapszula
English: 20mg Capsules
Maltese: 20mg Kapsuli
English: 20 mg Gastroresistant capsules
Maltese: 20 mg Kapsuli gastrorezistenti
English: MUPS
Maltese: Lösungsmittel
English: ANNEX I
Maltese: Via E.
English: 10mg Capsules
Maltese: 10mg Kapsuli
English: Losec-Mups 20mg 20 mg Gastroresistant tablets
Maltese: Losec MUPS 20 20 mg Pilloli gastroreżistenti
English: Losec Capsules 10mg 10mg Hard gelatin capsules
Maltese: Losec Capsules 10mg
English: Losec 20 mg kapszulaz 20 mg Capsule, hard
Maltese: Losec 20 mg kapszulaz
English: 20mg Gastro-resistant, film-coated tablet
Maltese: 20mg Gastro-resistant, Pillola miksija b'Rita
English: LOSEC 20 mg
Maltese: LOSEC cápsulas 20 mg
English: Losec 40 MG
Maltese: Losec Infusion 40mg
English: Losec Capsules 20mg 20mg Hard gelatin capsules
Maltese: Losec Capsules 20mg
English: 10mg Gastro-resistant, film-coated tablet
Maltese: 10mg Gastro-resistant, Pillola miksija b'Rita
English: 20 m Gastro-resistant tablets
Maltese: 20 m Pilloli gastroreżistenti
English: Losec 40 mgTrockenstechampulle mit Lösungsmittel
Maltese: Losec 40 mg Trockenstechamp ulle mit
English: Losec MUPS 10
Maltese: Losec 10mgKapseln
English: Hungary
Maltese: Espoo
English: Antra MUPS 10 mg 10 mg Gastro-resistant tablets
Maltese: Antra MUPS 10 mg
English: Losec Capsules 40mg 40mg Hard gelatine capsules
Maltese: Losec Capsules 40mg
English: 40 mg Hard Gastroresistant capsules Oral use
Maltese: 40 mg Kapsuli gastroreżistenti ibsin Użu orali
English: Losec MUPS 20
Maltese: Losec 20mgKapseln
English: 10 mg Gstroresistant capsules
Maltese: 10 mg Kapsuli gastrorezistenti
English: 20mg
Maltese: Antra MUPS 20 mg
English: 20 mg Hard Gastroresistant capsules Oral use
Maltese: LOSEC 20 mg 20 mg Kapsula gastroreżistenti, iebsa Użu orali
English: 40 mg Hard gastroresis-tant capsules Oral use
Maltese: 40 mg Kapsuli gastroreżistenti, ibsin Użu orali
English: United Kingdom EX31 3UD
Maltese: Ir-Renju Unit EX31 3UD
English: Jenson R+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, United Kingdom EX31 3UD
Maltese: Jenson R+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, Ir-Renju Unit EX31 3UD
English: AV 2nd degree block, AV 3rd degree block
Maltese: Imblokk AV tat-2ni grad, imblokk AV tat3et grad
English: Angioedema Rash
Maltese: Anġjoedema Raxx