FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections with a virus called cytomegalovirus have been reported in patients treated with LEMTRADA.
Maltese: Infezzjonijiet b'virus imsejjaħ cytomegalovirus ġew irrappurtati f'pazjenti ttrattati b'LEMTRADA.
English: Clinical presentation may include diarrhoea, increased frequency of bowel movements, abdominal pain, or haematochezia, with or without fever.
Maltese: Il-preżentazzjoni klinika tista' tinkludi ddijarea, frekwenza akbar ta' ċaqliq fl-imsaren, uġigħ addominali, jew haematochezia, bid-deni u mingħajr deni.
English: Infliximab must not be used if gastrointestinal perforation or sepsis is suspected (see the Summary of Product Characteristics for infliximab).
Maltese: Infliximab m'għandux jintuża jekk ikun hemm suspett ta' tiċrita jew sepsis gastrointestinali (ara s-Sommarju talKaratteristiċi tal-Prodott għal infliximab).
English: Duloxetine - Interstitial lung disease (EPITT no 19175)
Maltese: 3. Duloxetine - Mard tal-interstizju tal-pulmun (EPITT nru
English: The experience from clinical trials on the management of corticosteroid-refractory diarrhoea or colitis is limited.
Maltese: It-test il-ġdid li għandu jiżdied mal-informazzjoni dwar il-prodott huwa sottolineat.
English: Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC.
Maltese: L-azzjonijiet ta' fotosensittività ta' HCTZ jistgħu jaġixxu bħala mekkaniżmu possibbli għal NMSC.
English: A clear cumulative dose response relationship was observed for both BCC and SCC.
Maltese: Ġiet osservata relazzjoni għar-rispons tad-doża kumulattiva kemm għall-BCC kif ukoll għall-SCC.
English: Non-melanoma skin cancer
Maltese: Kanċer tal-ġilda mhux melanoma
English: Before initiation of therapy, evaluation of immune serostatus could be considered according to local guidelines.
Maltese: Qabel tinbeda t-terapija, tista' tiġi kkunsidrata l-evalwazzjoni tas-serostatus immuni skont il-linji gwida lokali.
English: Stool infections work-up should be performed upon presentation of diarrhoea or colitis to exclude infectious or other alternate etiologies.
Maltese: Għandha ssir eżaminazzjoni tal-infezzjonijiet tal-ippurgar wara li tiġi ppreżentata d-dijarea jew kolite biex jiġu esklużi etjoloġiji infettużi jew etjoloġiji alternati oħrajn.
English: ANNEX II[Not applicable for MRP/DCP]
Maltese: ANNESS II[Not applicable for MRP/DCP]
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/000/000
Maltese: EU/2/00/000/000
English: ** This statement should be used only when critical.
Maltese: The statement should only be used in exceptional cases. ** This statement should be used only when critical.
English: <Official control authority batch release is required for this product.> [only for those immunological veterinary medicinal products which are listed for Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
Maltese: <Hemm bżonn ta' ħrug tal-lott minn awtorità ta' kontroll uffiċjali għal dan il-prodott.> [only for those immunological veterinary medicinal products which are listed for Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
English: Formatted: Highlight
Maltese: Highlight
English: ***** Depending on the pharmaceutical form and the properties of the product, there may be a risk of deterioration due to physical changes if subjected to low temperatures.
Maltese: **** The actual name of the container should be used (e.g. bottle, blister, etc.)] *****Depending on the pharmaceutical form and the properties of the product, there may be a risk of deterioration due to physical changes if subjected to low temperatures.
English: <6 months.><…><1 year.><18 months.><2 years.><30 months.><3 years.><use immediately.>
Maltese: <6 xhur.> <...> <Sena.> <18- il- xahar.> <Sentejn.> <30 xahar.> <3 snin.> <użau immedjatament.>
English: Pharmaco-logically active substance
Maltese: Sustanza farmakoloġikament attiva
English: <Batch><Lot> {number}
Maltese: <Lott> <Lott> {numru}
English: <5.1 Pharmacodynamic properties> <5.2 Pharmacokinetic particulars> <Environmental properties>
Maltese: <5.1 Kwalitajiet farmakodinamiċi > <5.
English: For the full list of excipients, see section 6.1.
Maltese: Għall-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: <Alternatively you can report via your national reporting system {national system details}.> [For MRP/DCP only]
Maltese: <Tista' wkoll tirrapporta permezz tas-sistema ta rapportaġġ nazzjonali {dettalji tas-sistema nazjonali}.> [For MRP/DCP only]
English: 4.2 Indications for use, specifying the target species <Onset of immunity: {x weeks}> <Duration of immunity: {x years}>
Maltese: <Bidu tal-immunità: {x ġimgħat}> <Perjodu tal-immunità: {x snin}> 4.3 Kontra indikazzjonijiet <Xejn>
English: <Lactation:> <Not applicable.>
Maltese: <Inkompatibilitajiet:>
English: <PHARMACOLOGICAL><IMMUNOLOGICAL> PROPERTIES Pharmacotherapeutic group: {group}.
Maltese: KWALITAJIET <FARMAKOLOĠIĊI> <IMMUNOLOĠIĊI>
English: <Do not store above <25 °C><30 °C>.> <Store below <25 °C><30 °C>.> <Store in a refrigerator (2 °C - 8 °C).> <Store and transport refrigerated (2 °C - 8 °C).>* <Store in a freezer {temperature range}.> <Store and transport frozen {temperature range}.>** <Do not <refrigerate> <or> <freeze>.> <Protect from frost.>*** <Store in the original <container><package>.>
Maltese: <Aħżen f'temperatura anqas minn <25oC> <30oC>.> <Aħżen fil-friġġ (2°C - 8°C).> <Aħżen u ttrasporta fil-friġġ (2°C - 8°C).>** <Aħżen fil-friża {firxa ta' temperatura}.> <Aħżen u ttrasporta ffriżat {firxa ta' temperatura}.>** <Tagħmlux fil-friġġ > <jew> <fiIl-friża>.> <Ipproteġi mill-ġlata>*** <Aħżen <fil-kontenitur> <pakkett> oriġinali>.>
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
: <Adjuvant
:> <Excipient
:>
Maltese: Sustanza<i> Attiva<i> : <Sustanza(<i>) mhux attiva(<i>):> <Ingredjent(<i>) ieħor/oħra:>
English: ATC vet code: {lowest available level (e.g. subgroup for chemical substance)}.
Maltese: ATĊC veterinarja {l-inqas livell disponibbli (e.ż. sottogrupp għas-sustanza kimika)}.
English: <The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).>
Maltese: <Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).>
English: <MANUFACTURER<S> OF THE BIOLOGICAL ACTIVE SUBSTANCE<S> AND>
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I) U>
English: Animal species MRLs Target tissues
Maltese: MRL Tessuti mmirati
English: <Pregnancy:> <and lactation:>
Maltese: <Fertilità:>
English: {Name and aAddress Country} <{Tel.}> <{Fax}> <{E-mail}>
Maltese: {Isem u Indirizz} <{Tel.}> <{Fax}> <{E-mail}>
English: ADVICE ON CORRECT ADMINISTRATION
Maltese: U METODU TA'' AMMINISTRAZZJONI
English: <Specific pharmacovigilance requirements:>
Maltese: <Ħtieġijiet ta' farmakoviġilanza:>
English: STATEMENT OF THE MRLs <Not applicable.> [For pharmaceutical products] The active substance
 in {name of the product} <is><are> <an> allowed substance
 as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: Pharmaco-logically active substance
Maltese: Is-sustanza(i) attiva(i) f'(isem tal-prodott) <hija> <huma> sustanza(i) ammissibbli kif deskritt fittabella numru 1 fl-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010:
English: <The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.The data lock point (DLP) for the next PSUR would be {add DLP}.>[Only applicable, if justified after authorisation.]
Maltese: Id-data lock point (DLP) għall-PSUR li jmiss tkun {daħħal iadd- DLP}> [Only applicable, if justified after authorisation.]
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA(iI) ATTIVA(I)
English: STATEMENT OF THE MRLs <D.
Maltese: DIKJARAZZJONI TA' L-MRLs
English: <Special precautions for use in animals:> <Special precautions to be taken by the person administering the veterinary medicinal product to animals:> <Pregnancy:> <Lactation:> <Pregnancy and lactation:> <Lay:> <Fertility:> <Interaction with other medicinal products and other forms of interaction:> <Overdose (symptoms, emergency procedures, antidotes):> <Incompatibilities:>
Maltese: <Interazzjoni ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni:> <Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti):>
English: <According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: <Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonal tiegħu, jipprojbixxi il-manifattura, l-importazzjoni, il pussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fitterritorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: <Date of first authorisation:> <{DD/MM/YYYY}><{DD month YYYY}.> <Date of last renewal:> <{DD/MM/YYYY}> <{DD month YYYY}.>
Maltese: <Data tal-ewwel awtorizzazzjoni:> <{JJDD/XXMM/SSSSYYYY}><{JJDD xahar month SSSSYYYY}> <Data tal-aħħar tiġdid:> <(JJ/DD/MMXX/YYYYSSSS)> <(DJJD xaharmonth SSSSYYYY).>
English: <MANUFACTURER<S> OF THE BIOLOGICAL ACTIVE SUBSTANCE<S> AND> MANUFACTURER<S> RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I) U> MANIFATTUR(I) RESPONSABBLI
English: {NATURE/TYPE}
Maltese: {GĦAMLA/TIP}
English: The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of {name of the active substance(s)} in {name of the product} in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Maltese: Il-Kumitat għal Prodotti Mediċinali Veterinarji rrakkomanda l-inkluzjoni ta' )(isem tas-sustanza(i) attiva(i)) f'(isem tal-prodott) f'tabella numru 1 (Sustanzi ammissibbli) fl-Anness tar-Regolament talKummissjoni (UE) Nru 37/2010 kif ġej:
English: <Keep the {container}**** tightly closed> <Keep the {container}**** in the outer carton> <in order to protect from <light> <and> <moisture>.>
Maltese: <Żomm {il-kontenitur}**** fil-pakkett ta' barra> <sabiex tipproteġi mid-<dawl> <u> <l-umdità>.>
English: A. LABELLING
Maltese: l-annimal
English: CLINICAL PARTICULARS 4.1 Target species
Maltese: <Xejn> 4.5 Prekawzjonijiet Speċjali għall-Użu
English: <People with known hypersensitivity to {INN} should <avoid contact with the veterinary medicinal product.><administer the veterinary medicinal product with caution.>>
Maltese: <Nies li huma sensittivi għal {INN} għandhom <jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: Marker residue
Maltese: Dispożizzjonijiet oħrajn
English: MANUFACTURER<S> RESPONSIBLE FOR BATCH RELEASE <Name and address of the manufacturer
 of the biological active substance
 {Name and address}>
Maltese: GĦALL-ĦRUĠ TAL-LOTT <Isem u indirizz tal-manufattur<i> tas-sustanza<i> bijoloġika<ċi> attiva<i> {Isem u indirizz }>
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Maltese: METODU U MOD(I) TA'' AMMINISTRAZZJONI
English: Any person intending to manufacture, import, possess, sell, supply and use <invented name> must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.> <Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.>
Maltese: <Il-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu tal-prodott mediċinali veterinarju huwa jew jista' jkuniġi ipprojibit fit-territorju kollu ta' f'xiċerti Stati Membriu jew f'parti minnu fit-territorju kollu tagħhom jew f'parti minnu, ara l-fuljett ta' tagħrif għal aktar informazzjoni.> <Għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-inkorporazzjoni ta' taħlita medikata ppreparata minn qabel, fl-għalf finali.>
English: Österreich {Name} <{Anschrift} A-00000 {Stadt}> Tel: + {Telefonnummer} <{E-mail}>
Maltese: A-00000 {Stadt}> Tel: + {Telefonnummer} <{E-mail}>
English: <Protect from light.> <Store in a dry place.> <Protect from direct sunlight.>
Maltese: <Ipproteġi mid-dawl.> <Aħżen f'post xott.> <Ipproteġi minn xemx diretta.>
English: <Not applicable.> <In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.> <Do not mix with any other veterinary medicinal product<, except <diluentsolvent or other component> <recommended><supplied> <for use with the veterinary medicinal product>.>
Maltese: <Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.> <Tħallatx ma' ebda prodott mediċinali veterinarju ieħor <ħlief mad-dilwent jew komponent ieħor <rakkomandat> <pprovdut> għal użu ma' dan il-prodott mediċinali veterinarju >.>
English: <Do not store above <25 °C><30 °C>.> <Store below <25 °C><30 °C>.> <Store in a refrigerator.> <Store and transport refrigerated.>* <Store in a freezer.> <Store and transport frozen.>** <Do not <refrigerate> <or> <freeze>.> <Protect from frost.>*** <Store in the original <container><package>.>
Maltese: <Aħżen fil-friġġ.> <Aħżen u ttrasporta ġo friġġ.>* <Aħżen fil-friża.> <Aħżen u ttrasporta ffriżat.>** <Tagħmlux fil-friġġ > <jew> <fil-friża>.> <Ipproteġi mill-ġlata.>*** <Aħżen <fil-kontenitur> <pakkett> oriġinali>.>
English: <Shelf life of the veterinary medicinal product as packaged for sale: > <Shelf life after first opening the immediate packaging: > <Shelf life after <dilution><reconstitution> according to directions: > <Shelf life after incorporation into meal or pelleted feed: >
Maltese: <qabel> <wara> l-amministrazzjoni ta' {deskrizzjoni tal-prodott(i) ittestjat(i).}> <M''hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' dan il-<vaċċin> <prodott mediċinali veterinarju immunoloġiku> meta jintuża flimkien ma' kwalunkwe prodott mediċinali veterinarju ħlief dawk il-prodotti msemmija aktar ‘'il fuq.
English: <The <veterinary medicinal product><vaccine><immunological veterinary medicinal product> should be given at different sites.>
Maltese: <Il-<prodott mediċinali veterinarju><vaċċin><prodott mediċinali veterinarju immunoloġiku> għandu jingħata f'postijiet differenti tal-ġisem.>
English: The active substance being a principle of biological origin intended to <produce> <active><passive><diagnose a state of> immunity is not within the scope of Regulation (EC) No
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġikua maħsuba sabiex <tipproduċi> <issir djanjosi ta' stat ta'> immunità <attiva> <passiva> ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru
English: NAME OF THE VETERINARY MEDICINAL PRODUCT {(Invented) name of veterinary medicinal product <strength> pharmaceutical form <target species>} {active substance(s)}
Maltese: VETERINARJU {L-isem (ivvintat) tal-prodott mediċinali veterinarju <qawwa> għamla farmaċewtika <speċi għal x'hiex huwa indikat >} {sustanza(i) attiva(i)}
English: BATCH NUMBER [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201 4/08/WC500170559.pdf] http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/20 09/10/WC500004426.pdf]
Maltese: NUMRU TAL-LOTT [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201 4/08/WC500170559.pdf] http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/20 09/10/WC500004426.pdf]
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.>
Maltese: b) il-marda li għaliha l-prodott huwa intiż li jagħti immunità hija ġeneralment assenti mit-territorju konċernat.>
English: <Not applicable.> <Zero days.> <<Meat and offal><Eggs><Milk> <Honey>: {X} <days><hours>.> <{X} degree days.>
Maltese: < Xejn.> <Twissijiet speċjali għhal kull speċci għal x'hiex huwa indikat:>
English: EXPIRY DATE [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201 4/08/WC500170559.pdf] http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/20 09/10/WC500004426.pdf]
Maltese: DATA TA'' SKADENZA [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201 4/08/WC500170559.pdf] http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/20 09/10/WC500004426.pdf]
English: NAME OF THE VETERINARY MEDICINAL PRODUCT {(Invented) name of veterinary medicinal product <strength> pharmaceutical form <target species>}
Maltese: VETERINARJU {L-isem (ivvintat) tal-prodott mediċinali veterinarju <qawwa> għamla farmaċewtika}
English: MANUFACTURER'S BATCH NUMBER [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201 4/08/WC500170559.pdf] http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/20 09/10/WC500004426.pdf]
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR [For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/201 4/08/WC500170559.pdf] http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/20 09/10/WC500004426.pdf]
English: Date of first authorisation: 23 September 2009 Date of latest renewal: 22 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Settembru 2009 Data tal-aħħar tiġdid: 22 ta' Mejju 2014
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, aquired haemophilia A, granulocytopenia, anaemia
Maltese: Purpura tromboċitopenikatrombotika (thrombotic thrombocytopenic purpura (TTP)) (ara sezzjoni 4.4), anemija aplastika, panċitopenija, agranuloċitosi, tromboċitopenija severa, emofilja A akwiżita, granuloċitopenija, anemija
English: Other medicines and Clopidogrel TAD
Maltese: Mediċini oħra u Clopidogrel TAD
English: - carbamazepine a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer, - anti-retroviral medicines (medicines to treat HIV infections).
Maltese: - repaglinide, mediċina għat-trattament tad-dijabete, - paclitaxel, mediċina għat-trattament tal-kanċer, - mediċini antiretrovirali (mediċini għall-kura ta' infezzjonijiet bl-HIV).
English: What Clopidogrel TAD contains - The active substance is clopidogrel.
Maltese: X'fih Clopidogrel TAD - Is-sustanza attiva hi clopidogrel.
English: In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
Maltese: Fi studju magħmul b'mod arbitrarju, b'grupp parallel u double-blind (CLARINET), 906 pazjenti pedjatriċi (trabi tat-twelid u tfal ċkejknin) b'mard tal-qalb konġenitali ċjanotiku u megħjuna b'devjazzjoni kirurġika ta' arterja sistemika għal dik pulmonarja, ġew mogħtija b'mod arbitrarju clopidogrel 0.2 mg/kg (n=467) jew plaċebo (n=439) flimkien ma' terapija konkomitanti ta' rutina sakemm kien hemm il-bżonn ta' kirurġija tattieni fażi.
English: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Maltese: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Il-Ġermanja
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Maltese: Dermatite bl-infafet (nekrolisi tossika talepidermide, Sindromu ta' Stevens Johnson, eritema multiforme), exanthematous pustulosis akuta u ġeneralizzata (AGEP), anġjoedema, Reazzjoni ta' sensittività eċċessiva li hija komuni għat-tipi differenti ta' thienopyridines (bħal ticlopidine, prasugrel) (ara sezzjoni 4.4)
English: Clopidogrel TAD 75 mg film-coated tablets clopidogrel
Maltese: Clopidogrel TAD 75 mg pilloli miksija b'rita clopidogrel
English: The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
Maltese: L-għamla ta' 2x2 factorial tal-prova COMMIT inkludiet 45,852 pazjent li daħlu fi żmien 24 siegħa mill-ħin li bdew is-sintomi suspettużi ta' MI b'abnormalitajiet fl-ECG suġġestivi t'hekk (iġifieri ST elevat, ST
English: Clopidogrel TAD 75 mg film-coated tablets
Maltese: Clopidogrel TAD 75 mg pilloli miksija b'rita
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel TAD (4 tablets of 75 mg) once at the start of treatment.
Maltese: Jekk kellek uġigħ sever f'sidrek (anġina instabbli jew attakk tal-qalb), it-tabib jista' jagħtik 300 mg ta' Clopidogrel TAD (4 pilloli ta' 75 mg) darba fil-bidu tal-kura.
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs) ), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Maltese: Bħal fil-każ ta' sustanzi oħra kontra l-plejtlets, clopidogrel għandu jintuża b'kawtela f'pazjenti li jista' jkollhom riskju ta' iktar dmija minn trawma, operazzjoni jew kundizzjonijiet patoloġiċi oħra u pazjenti li jkunu qed jirċievu l-kura b'ASA, heparin, inibituri ta' glycoprotein IIb/IIIa jew mediċini kontra l-infjammazzjoni li m'humiex sterojdi (NSAIDs) li jinkludu l-inibituri ta' Cox-2, jew inibituri selettivi tal-ġbir mill-ġdid ta' serotonin (SSRIs), jew prodotti mediċinali marbuta ma' riskju ta'fsada bħal pentoxifylline (ara sezzjoni 4.5).