FrancophonIA/ELRC3.0 huggingface dataset:
English: In an additional study Mekinist did not show any benefit when given to patients who did not respond to previous treatment with another cancer medicine that blocked BRAF.
Maltese: Fi studju addizzjonali, Mekinist ma wera l-ebda benefiċċju meta ngħata lil pazjenti li ma rrispondewx għal kura preċedenti b'mediċina oħra ta' kontra l-kanċer li mblukkat il-BRAF.
English: 1ere Avenue 2056 M Lid 06516 Carros Cedex France
Maltese: 1ere Avenue 2056 M Lid 06516 Carros Cedex Franza
English: Pharmacologically active substance
Maltese: Is-sustanza farmakoloġikament attiva
English: Injection volumes ranged from 2.88 to 5.52 ml.
Maltese: Il-volumi ta' l-injezzjoni varjaw bejn 2.88 u 5.52 ml.
English: 15 mg amoxicillin/kg bw (equivalent to 1ml/10 kg)
Maltese: 15 mg amoxicillin/kg toqol (ekwivalenti għal 1ml/10 kg)
English: Suramox 15% LA contains amoxicillin which is a beta lactam antibiotic belonging to the group of penicillins.
Maltese: Suramox 15% LA fih amoxicillin li huwa antibijotiku tat-tip beta lactam fil-kategorija tal-peniċillini.
English: Milk: 2.5 days
Maltese: 2.5 jiem
English: Meat and offal: Cattle: 58 days Pigs: 35 days
Maltese: Frat: 58 jum Majjali: 35 jum
English: Marker residue
Maltese: Ir-residwu markatur
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ANIMAL SPECIES, FREQUENCY AND ROUTES OF ADMINISTRATION, RECOMMENDED DOSES, WITHDRAWAL PERIODS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES CONCERNED BY THE REFERRAL
Maltese: LISTA TA' L-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA, SPEĊI TA' ANNIMAL, FREKWENZA U MNEJN JINGĦATA, DOŻI RAKKOMANDATI , PERJODI TA' RTIRAR U DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI
English: Benzylpenicillin was considered by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) at its 36th meeting in 1990.
Maltese: Benzylpenicillin kien ikkonsidrat fil-Kumitat Espert Konġunt tal-FAO/WHO dwar l-Addittivi ta' lIkel (JECFA) fis-36 laqgħa tiegħu fl-1990.
English: Sixteen cattle were slaughtered at 7, 14, 46 and 57 days after treatment with Suramox.
Maltese: Sittax-il fart inqatlu sebat ijiem, 14-il jum, 46 jum u 57 jum wara t-trattament b'Suramox.
English: Neither the statistical (large extrapolation) nor the alternative approach (values above the MRL at the last time point) could be applied to the data provided, and therefore a withdrawal period could not be set according to the “Note for guidance: Approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95-FINAL).
Maltese: Mad-data pprovduta, la seta' jiġi applikat il-metodu statistiku (estrapolazzjoni kbira) u lanqas dak alternattiv (valuri ogħla mill-MRL fl-aħħar punt ta' ħin il-qatla), u allura l-perjodu ta' rtirar ma setax jiġi stabbilit skond in-“Nota għall-gwida: Metodu lejn l-armonizzazzjoni tal-perjodi ta' rtirar” (EMEA/CVMP/036/95-FINAL).
English: In a complementary study, eight pigs were slaughtered at 30 and 36 days after treatment with Suramox.
Maltese: Fi studju kumplimentari, inqatlu tmien majjali 30 u 36 jum wara t-trattament b'Suramox.
English: In the injection sites, the amoxicillin concentrations were 14209 to 109535 µg/kg at day 1, 358 to 5429 µg/kg at day 7, 182 to 2816 µg/kg at day 14, below the limit of quantification to 211 µg/kg at day 21 and below the limit of quantification to 38 µg/kg at day 27.
Maltese: Fis-siti ta' l-injezzjoni, ilkonċentrazzjonijiet ta' amoxicillin kienu ta' bejn 14209 u 109535 µg/kg fl-ewwel jum, bejn 358 u 5429 fis-7 jum, bejn 182 u 2816 µg/kg fl-14-il jum, inqas mil-limitu ta' kwantifikazzjoni ta' 211 µg/kg fil-21 jum u inqas mil-limitu ta' kwantifikazzjoni ta' 38 µg/kg fis-27 jum.
English: Groups of 4 animals (2 male and 2 female) were slaughtered at 1, 7, 14, 21, and 36 days after the final injection.
Maltese: Gruppi ta' 4 annimali (2 irġiel u 2 nisa) inqatlu wara ġurnata, sebat ijiem, 14-il jum, 21 jum u 36 jum wara l-aħħar injezzjoni.
English: Sixteen pigs were slaughtered at 7, 14, 21 and 27 days after treatment with Suramox.
Maltese: Sittax-il majjal inqatlu sebat ijiem, 14-il jum, 21 jum u 27 jum wara t-trattament b'Suramox.
English: Marketing Authorisation pending 2 Reference Member State for the Mutual recognition Procedure
Maltese: Awtorizzazzjoni għat-Tqegħid fis-Suq pendenti 2 Stat Membru ta' Riferenza għall-Proċedura ta' Rikonoxximent Reċiproku
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SURAMOX 15% LA3
Maltese: TAL-VALUTAZZJONI XJENTIFIKA TA' SURAMOX 15% LA3
English: Groups of 4 animals (2 male, 2 female) were slaughtered at 1, 7, 14, 21, and 27 days after the final injection.
Maltese: Gruppi ta' 4 annimali (2 irġiel u 2 nisa) inqatlu wara ġurnata, sebat ijiem, 14-il jum, 21 jum u 27 jum wara l-aħħar injezzjoni.
English: In pigs ten male and ten female (bw 42 ± 7 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/kg bw (1 ml per 10 kg).
Maltese: Fil-majjali, għaxart irġiel u għaxar nisa (jiżnu 42 ± 7 kg) ingħataw żewġ injezzjonijiet ta' Suramox 15% LA fil-muskolu b'doża ta' 15 mg/kg toqol (millilitru għal kull 10 kg).
English: In kidney, amoxicillin concentrations were 5446 to 9896 µg/kg at day 1, 45 to 811 µg/kg at day 7, below the limit of quantification at day 14, below the limit of quantification to 180 µg/kg at day 21 and below the limit of quantification to 62 µg/kg at day 27.
Maltese: Fil-kliewi, ilkonċentrazzjonijiet ta' amoxicillin kienu bejn 5446 u 9896 µg/kg fl-ewwel jum, bejn 45 u 811 µg/kg fis-7 jum, inqas mil-limitu ta' kwantifikazzjoni fl-14-il jum, inqas mil-limitu ta' kwantifikazzjoni ta' 180 µg/kg fil-21 jum u inqas mil-limitu ta' kwantifikazzjoni ta' 62 µg/kg fis-27 jum.
English: For pigs of 40-50 kg, it was possible to derive a withdrawal period of 35 days based on injection site residues.
Maltese: Għall-majjali li jiżnu bejn 40 u 50 kg, seta' jiġi derivat perjodu ta' rtirar ta' 35 jum ibbażat fuq irresidwi fis-sît ta' l-injezzjoni.
English: Cattle, pigs
Maltese: Frat, majjali
English: 2.1 Calculation of withdrawal periods for Suramox 15% LA
Maltese: 2.1 Kalkoli tal-perjodi ta' rtirar għal Suramox 15% LA
English: On this basis MRLs for amoxicillin and other penicillins were proposed by the CVMP, and amoxicillin is currently entered in Annex I of Council Regulation (EEC) No 2377/90, in accordance with the following table:
Maltese: MRLs għal amoxicillin u peniċillini oħra, u amoxicillin iddaħħal fl-Anness I tar-Regolament tal-Kunsill (KEE) Nru 2377/90, skond it-tabella ta' hawn taħt:
English: In cattle ten male and ten female (body weight: 184 ± 24 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/kg bw (1 ml per 10 kg).
Maltese: Fl-ifrat, għaxart irġiel u għaxar nisa (jiżnu 184 ± 24 kg) ingħataw injezzjonijiet ta' Suramox 15% LA fil-muskolu b'doża ta' 15 mg/kg toqol (millilitru għal kull 10 kg).
English: Liver Kidney Milk
Maltese: Frekwenza u mnejn jingħata
English: France2
Maltese: Franza
English: Whereas: - the CVMP considered the referral made under Article 35 of Directive 2001/82/EC in the interest of the Community regarding consumer safety for national marketing authorisations for Suramox 15% LA or variations of that name as referred to in Annex I;
Maltese: - is-CVMP ikkonsidra r-riferenza magħmula skond l-Artikolu 35 tad-Direttiva 2001/82/KE flinteress tal-Komunità dwar is-sigurtà tal-konsumatur għal awtorizzazzjonijiet għat-tqegħid fis-suq għal Suramox 15% LA jew varjazzjonijiet ta' dak l-isem kif imsemmi fl-Anness I;
English: These samples were chilled, homogenised and stored at -80°C until analysis 4 to 6 months later (storage stability confirmed).
Maltese: Dawn il-kampjuni tkessħu, ġew omoġenizzati u nħażnu f'temperatura ta' -80 °C sakemm ġew analizzati bejn 4 u 6 xhur wara (listabbilità tal-ħażna ġiet ikkonfermata).
English: In the detailed grounds for the re-examination of the opinion the MAH argued that the three out of eight kidney samples with amoxicillin concentrations higher than the MRL at 21 and 27 days after the last administration should be considered artefacts because of the abnormal kinetic depletion residue profile.
Maltese: Fir-raġunijiet dettaljati ta' l- istħarriġ mill-ġdid ta' l-opinjoni, il-MAH argumenta li tlieta mit-tmien kampjuni tal-kliewi b'konċentrazzjonijiet ta' amoxicillin ogħla mill-MRL fil-21 u fis-27 jum wara laħħar amministrazzjoni kellhom jiġu ikkunsidrati bħala artefatt minħabba l-profil mhux normali ta' leliminazzjoni kinetika tar-residwi.
English: Amoxicillin was previously evaluated by the CVMP together with other penicillins, in order to establish maximum residue limits (MRLs).
Maltese: Is-CVMP addotta l-istess metodu bħall-JEFCA biex jiffissa l-limiti massimi tar-residwi (MRLs) għallpeniċillini.
English: Injection volumes ranged from 15.0 to 25.9 ml.
Maltese: Il-volumi ta' l-injezzjoni varjaw bejn 15.0
English: Target tissue
Maltese: It-tessut studjat
English: Re-examination of the opinion
Maltese: BIR-RIFERIMENT
English: In the injection sites, the amoxicillin concentrations were 5822 to 149831 µg/kg at day 1, below the limit of quantification to 21724 µg/kg at day 7, below the limit of quantification to 1651 µg/kg at day 14, below the limit of quantification to 472 µg/kg at day 21 and below the limit of quantification to 162 µg/kg at day 36.
Maltese: Fis-siti ta' linjezzjoni, il-konċentrazzjonijiet ta' amoxicillin kienu ta' bejn 5822 u 149831 µg/kg fl-ewwel jum, inqas mil-limitu ta' kwantifikazzjoni ta' 21724 µg/kg fis-7 jum, inqas mil-limitu tal-kwantifikazzjoni
English: Two intramuscular injections at 48 hours interval
Maltese: Żewġ injezzjonijiet ġol-muskoli b'intervall ta' 48 siegħa bejniethom
English: - the CVMP assessed the information provided by the Marketing Authorisation Holder in response to the list of questions agreed by the CVMP, the argumentation provided by the Marketing Authorisation Holder in support of the request for the re-examination of the opinion and new residue data made available by the Marketing Authorisation Holder during the re-consideration of the opinion requested by the European Commission;
Maltese: - is-CVMP studja t-tagħrif mogħti mid-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq bi tweġiba għal-lista ta' mistoqsijiet maqbula mis-CVMP, l-argumentazzjoni pprovduta mid-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq b'appoġġ għat-talba għall-istħarriġ mill-ġdid ta' lopinjoni u ta' data ġdida dwar ir-residwi pprovduta mid-Detentur ta' l-Awtorizzazzjoni għatTqegħid fis-Suq matul il-konsiderazzjoni mill-ġdid ta' l-opinjoni mitluba mill-Kummissjoni Ewropea;
English: In addition, samples were taken from muscle (mixed sample of hindquarter/forequarter muscle), skin+fat in natural proportions, the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth).
Maltese: Barra minn hekk, ittieħdu kampjuni mill-muskolu (taħlita ta' muskolu min-naħa ta' quddiem u ta' wara), mixxaħam u l-ġilda fil-proporzjonijiet naturali, il-fwied sħiħ, iż-żewġt ikliewi u mis-sît tat-tieni injezzjoni (tan-naħa tal-lemin) (madwar 10 ċm dijametru u 6 ċm fond).
English: The MAH finally argued that the fluorimetric method used was capable of detecting residues of amoxicillin degradation products, and thus, the concentrations reported may have been overestimated.
Maltese: Barra minn hekk ilmetodu analitiku għad-determinazzjoni tar-residwi ma kienx validitat biżżejjed.
English: Muscle Fat
Maltese: KONKLUŻJONIJIET XJENTIFIĊI
English: With the submission of the new residue study for cattle the MAH proposed a withdrawal period of 96 days based on the statistical method.
Maltese: Bis-sottomissjoni ta' l-istudju l-ġdid tar-residwi għall-ifrat, il-MAH ippropona perjodu ta' rtirar ta' 96 jum ibbażat fuq il-metodu statistiku.
English: All samples were analysed for amoxicillin concentrations using an HPLC-UV method (HPLC-fluorescence for liver) with a claimed limit of quantification of 25 µg/kg for all tissues.
Maltese: Il-kampjuni kollha ġew analizzati biex tkun stabbilita lkonċentrazzjoni ta' amoxicillin bl-użu ta' l-HPLC-UV (bi fluworoxxenza-HPLC għall-fwied) b'limitu ta' kwantifikazzjoni ta' 25 µg/kg għat-tessuti kollha.
English: At slaughter, the left (first) injection site was taken for local tolerance assessment.
Maltese: Mal-qatla, is-sît ta' l-ewwel injezzjoni (tax-xellug) intuża għall-valutazzjoni tat-tolleranza lokali.
English: However an ADI for penicillins was not established.
Maltese: Madankollu ma ġiex stabbilit ADI għall-peniċillini.
English: However, the residue depletion profile in kidney indicated a non-regular profile.
Maltese: Madankollu l-profil ta' eliminazzjoni tar-residwi mill-kliewi kien irregolari.
English: In order to ensure a harmonised conclusion on the establishment of the withdrawal periods, it is highly recommended that any new residue depletion studies intended for the lifting of the suspensions of the marketing authorisations are submitted to the CVMP for assessment.
Maltese: Sabiex tkun żgurata konklużjoni armonizzata dwar l-iffissar ta' perjodi ta' rtirar, huwa rakkomandabbli ħafna li kwalunkwe studju ġdid dwar l-eliminazzjoni tar-residwi intiż għat-tneħħija tas-sospensjoni ta' l-awtorizzazzjonijiet għat-tqegħid fis-suq jiġi sottomess lis-CVMP għallvalutazzjoni.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: In addition, samples were taken from muscle (mixed sample of hindquarter/forequarter muscle), fat (mixed sample of perirenal/omental fat), the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth).
Maltese: Barra minn hekk, ittieħdu kampjuni mill-muskolu (taħlita ta' muskolu min-naħa ta' quddiem u ta' wara), mix-xaħam (taħlita ta' xaħam mill-kirxa u minn madwar il-kliewi), il-fwied sħiħ, iż-żewġt ikliewi u s-sît tat-tieni injezzjoni (tan-naħa tal-lemin) (madwar 10 ċm dijametru u 6 ċm fond).
English: Only residues at the injection sites were investigated.
Maltese: Ġew investigati biss residwi fis-siti ta' l-injezzjoni.
English: Residues in kidney ranged from below the limit of quantification to 150 µg/kg at 7 days and were below the limit of quantification at later time points.
Maltese: Ir-residwi fil-kliewi varjaw minn inqas mill-limitu tal-kwantifikazzjoni għal 150 µg/kg wara sebat ijiem u kienu inqas mill-limitu tal-kwantifikazzjoni fil-punti taż-żmien ta' wara.
English: Zero days
Maltese: Granet: 0
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RESPIPORC FLU3 EPAR summary for the public
Maltese: EMEA/V/C/153 RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) RESPIPORC FLU3 Sommarju tal-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the European Union, for RESPIPORC FLU3 to IDT Biologika GmbH on 14/01/2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal RESPIPORC FLU3 lil IDT Biologika GmbH fi 14/01/2010.
English: This summary was last updated on 14/01/2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 14/01/2010.
English: RESPIPORC FLU3 is a suspension for injection.
Maltese: RESPIPORC FLU3 huwa sospensjoni għall-injezzjoni.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of RESPIPORC FLU3 exceed the risks for the vaccination of pigs from the age of 56 days onwards inluding pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection and recommended that RESPIPORC FLU3 be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' RESPIPORC FLU3 jeċċedu r-riskji għall-vaċċinazzjoni tal-ħnieżer minn 56 jum ta' eta' ‘l quddiem inklużi ħnieżer ħobbla kontra l-influwenza tal-ħnieżer ikkawżata minn subtipi H1NI, H3N2 u H1N2 sabiex jitnaqqsu s-sinjali kliniċi u t-tagħbija virali tal-pulmun wara l-infezzjoni u rrakkommanda li RESPIPORC FLU3 jingħata awtorizzazzjoni għal tqegħid fuq is-suq.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Ilbilanċ bejn il-benefiċċji u r-riskji jista' jiġi kkonsultat fil-modulu 6 ta' dan l-EPAR.
English: RESPIPORC FLU3 is a vaccine that contains 3 different strains of swine influenza A virus which have been inactivated (killed).
Maltese: RESPIPORC FLU3 huwa vaċċin li fih 3 tipi differenti ta' vajrus tal-influwenza A li ġew diżattivati (maqtula).
English: RESPIPORC FLU3 is a vaccine.
Maltese: RESPIPORC FLU3 huwa vaċċin.
English: What is RESPIPORC FLU3?
Maltese: X'inhu RESPIPORC FLU3?
English: What is the risk associated with RESPIPORC FLU3?
Maltese: X'riskji huma assoċjati ma' RESPIPORC FLU3?
English: The vaccine also contains ‘adjuvants' to stimulate a better response.
Maltese: Il-vaċċin fih ukoll ‘aġġuvanti' sabiex jiġi stimulat rispons aħjar.
English: The effectiveness of RESPIPORC FLU3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza.
Maltese: L-effikaċja ta' RESPIPORC FLU3 ġiet studjata f'annimali ta' 56 jum u akbar u fi ħnieżer nisa qabel u wara t-tqala u dawn l-istudji jiddokumentaw li l-vaċċin jipproteġi kontra l-influwenza tal-ħnieżer.
English: RESPIPORC FLU3 is used to vaccinate pigs including pregnant sows over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs.
Maltese: RESPIPORC FLU3 jintuża bħala vaċċin għall-ħnieżer inklużi ħnieżer nisa ħobbla ta' 'l fuq minn 56 jum kontra l-influwenza tal-qżieqeż bħala għajnuna klinika iżda wkoll sabiex jitnaqqas l-ammont ta' vajrus preżenti fil-pulmuni.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi “jgħallmu” lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi lilha nfisha kontra marda.
English: Why has RESPIPORC FLU3 been approved?
Maltese: Għaliex ġie approvat RESPIPORC FLU3 ?
English: Use of the RESPIPORC FLU3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza A virus.
Maltese: L-użu ta' RESPIPORC FLU3 fil-ħnieżer inaqqas is-sinjali kliniċi u jnaqqas l-ammont ta' vajrus fil-pulmumi wara infezzjoni kkawżata mill-vajrus tal-influwenza tal-ħnieżer.
English: Other information about RESPIPORC FLU3:
Maltese: Tagħrif ieħor dwar RESPIPORC FLU3:
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: L-informazzjoni dwar l-istat tal-preskrizzjoni ta' dan il-prodott tista' tiġi kkonsultata fuq it-tikketta jew fuq ilqoxra tal-pakkett.
English: RESPIPORC FLU3 is also used to vaccinate pregnant sows following their first immunisation by giving them one dose 14 days prior to farrowing in order that the sows milk contains enough antibodies to help protect the piglets against swine influenza for at least 33 days after birth.
Maltese: RESPIPORC FLU3 jintuża wkoll sabiex jiġu vaċċinati ħnieżer nisa ħobbla wara l-ewwel immunizzazzjoni tagħhom billi tingħatalhom doża waħda 14 -il jum qabel it-tferriegħ sabiex il-ħalib tagħha jkun fih biżżejjed antikorpi sabiex jipproteġu l-qżieqeż kontra l-influwenza tal-ħnieżer għal mill-anqas 33 jum wara ttwelid.
English: • Information about Tracleer
Maltese: • Informazzjoni dwar Tracleer
English: The Member States shall ensure that the MAH shall set up a surveillance programme/registry to collect information on the demographics, safety and outcome data from patients prescribed Tracleer to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq għandu jorganizza programm/reġistru ta' sorveljanza biex jiġbor informazzjoni ta' demografija, siġurtà u tagħrif dwar ir-riżultat minn pazjenti li ġew preskritti Tracleer biex inaqqas in-numru ta' ulċeri fis-swaba ġodda f'pazjenti bi sklerosi sistemika u l-preżenza talmarda tal-ulċeri fis-swaba.
English: • That hormonal contraceptives on their own are not effective
Maltese: • Li kontraċettivi ormonali waħedhom m'humiex effettivi
English: The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all health care professionals who intend to prescribe and/or dispense Tracleer are provided with a Prescriber Kit containing the following:
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq għandu jiftieħem dwar id-dettalji ta' sistema ta' distribuzzjoni kkontrollata ma' l-Awtoritajiet Nazzjonali Kompetenti u għandu jimplimenta dan ilprogramm b'mod nazzjonali biex jiżgura li qabel jiġi preskrit il-professjonisti fil-qasam tas-saħħa kollha b'intenzjoni li jippreskrivu u/jew iqassamu Tracleer huma pprovduti b'Kit tat-Tabib li fiha li ġej:
English: • That Tracleer is teratogenic in animals
Maltese: • Li Tracleer huwa teratoġeniku fl-annimali
English: The MAH shall agree with each National Competent Authority the content of a "Reminder Letter" to all known prescribers of Tracleer, reminding them of the safety concerns with Tracleer in relation to pregnancy.
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq ser jiftiehem ma' kull Awtorità Kompetenti Nazzjonali dwar il-kontenut ta' “Ittra li Tfakkar” lil kull minn jippreskrivi Tracleer, li tfakkarhom dwar tħassib ta' sigurtà b'Tracleer b'konnessjoni mat-tqala.
English: • That Tracleer is hepatotoxic and the need for regular monitoring of liver function
Maltese: • Li Tracleer huwa epatotossiku u l-bżonn ta' sorveljanza regolari tal-funzjoni tal-fwied.
English: • Patient Information Booklet/Patient Reminder Card
Maltese: • Fuljett ta' Tagħrif għall-Pazjent/Kartuna biex Tfakkar tal-Pazjent
English: • That Tracleer causes a decrease in haemoglobin and the need for regular blood tests
Maltese: • Li Tracleer jikkawża tnaqqis fl-emoglobina u l-bżonn ta' testijiet tad-demm regolari
English: Details of the operation of the surveillance programme/registry shall be agreed with the National Competent Authorities in each Member State.
Maltese: Dettalji dwar kif jaħdem il-programm/reġistru ta' sorveljanza ser jiġu miftemha ma' l-Awtoritajiet Nazzjonali Kompetenti f'kull Stat Membru.
English: {Name and Address} {tel} {fax} {e-mail}
Maltese: {tel} {fax} {e-mail}
English: Operations and Anaesthetics
Maltese: Operazzjonijiet u Anestetiċi
English: *p value versus placebo =0.008 #p value versus placebo =0.537
Maltese: 008 #valur p versus plaċebo =0.537
English: DATE OF REVISION OF THE TEXT {MM/YYYY} {DD/MM/YYYY} {DD month YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST {XX/SSSS} {JJ/XX/SSSS} {JJ xahar SSSS}
English: - The active substance(s) is enoxaparin sodium
Maltese: Is-sustanza(i) attiva(i) hi enoxaparin sodium
English: Stop taking the vitamin-K antagonist.
Maltese: Waqqf l-antagonist tal-vitamina K.
English: INFORMATION IN BRAILLE LOVENOX 10 x 4,000 IU (10 x 40 mg) Pen
Maltese: INFORMAZZJONI BIL-BRAILLE LOVENOX 10 x 4,000 UI (10 x 40 mg) Pinna
English: Required dose 30 IU/kg (0.3 mg/kg)
Maltese: 30 UI/kg (0.3 mg/kg)
English: This is a preservative.
Maltese: Dan huwa preservattiv.
English: Excipient(s) with known effect: benzyl alcohol.
Maltese: Eċċipjent(i) b'effett magħruf: benzyl alcohol.
English: R
Maltese: Q
English: - Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants.
Maltese: - Trombolitiċi (eż. alteplase, reteplase, streptokinase, tenecteplase, urokinase) u antikoagulanti oħra.
English: Heparin aPTT Adjusted IV Therapy n (%)
Maltese: IV aġġustata għall aPTT n (%)
English: METHOD OF ADMINISTRATION SC / IV
Maltese: SC/ IV
English: METHOD OF ADMINISTRATION SC/ IV
Maltese: SC / IV
English: This reduction in the combined incidence was maintained after 30 days (from 23.3 to 19.8%; relative risk reduction of
Maltese: Dan it-tnaqqis fl-inċidenza kkombinata inżamm wara 30 jum (minn 23.3 għal 19.8%; tnaqqis relattiv fir-riskju ta' 15%).