FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/08/445/005 1 pre-filled syringe EU/1/08/445/006 5 pre-filled syringes EU/1/08/445/008 10 pre-filled syringes
Maltese: EU/1/08/445/005 1 siringa mimlija għal-lest EU/1/08/445/006 5 siringi mimlija għal-lest EU/1/08/445/008 10 siringi mimlija għal-lest
English: 0.5 MIU (5 μg)/kg/day from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Maltese: MIU (5 μg)/kg/jum mill-ewwel ġurnata wara t-tmiem tal-kimoterapija sakemm in-nadir mistenni jkun għadda u l-għadd ta' newtrofili jkun reġa' lura għan-normal.
English: It is important to contact your doctor immediately - if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
Maltese: Huwa importanti li tikkuntattja lit-tabib tiegħek minnufih - jekk ikollok reazzjoni allerġika inkluż dgħufija, tnaqqis fil-pressjoni, diffikultà sabiex tieħu nifs, nefħa tal-wiċċ (anafilassi), raxx tal-ġilda, raxx bil-ħakk (urtikarja), nefħa tal-wiċċ, tax-xufftejn, tal-ħalq, tal-ilsien jew tal-gerżuma (anġjoedima) u qtugħ ta' nifs (dispnea). - jekk ikollok sogħla, deni jew diffikultà sabiex tieħu nifs (dispnea) minħabba li dan jista' jkun sinjal ta' Sindrome ta' Diffikultà Respiratorja Akuta (ARDS - Acute Respiratory Distress Syndrome). - jekk ikollok ħsara fil-kliewi (glomerulonefrite).
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome [MDS]).
Maltese: Jekk inti pazjent b'newtropenija kronika severa, tista' tkun f'riskju li tiżviluppa kanċer tad-demm (lewkimja, sindrome mijelodisplastiku [MDS - myelodysplastic syndrome]).
English: Diseaseb
Maltese: TEVA GmbH
English: Prior to allogeneic PBPC transplantation, use of filgrastim for the mobilisation of PBPC in normal donors allows a collection of >4 x 106 CD34+ cells/kg recipient body weight in the majority of the donors after two leukaphereses.
Maltese: Qabel trapjant alloġenejiku ta' ċelluli proġenitriċi tad-demm periferali, l-użu ta'filgrastim għall-mobilizzazzjoni ta' ċelluli proġenitriċi tad-demm periferali f'donaturi normali jippermetti li jinġabru ≥ 4 x 106 CD34+ celluli għal kull kg ta' piż tal-ġisem tar-riċevitur, fil-maġġoranza ta' donaturi, wara żewġ proċeduri ta' lewkafereżi.
English: The volume of distribution in blood is approximately 150 mL/kg.
Maltese: Ilvolum ta' distribuzzjoni fid-demm hu madwar 150 mL/kg.
English: Solution for injection/infusion 1 pre-filled syringe with 0.8 mL 5 pre-filled syringes with 0.8 mL 10 pre-filled syringes with 0.8 mL
Maltese: 1 siringa mimlija għal-lest b'0.8 mL 5 siringa mimlija għal-lest b'0.8 mL 10 siringa mimlija għal-lest b'0.8 mL
English: Chest paina Paina
Maltese: Għadd taċ-ċelluli tad-demm
English: For the mobilisation of PBPC in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Maltese: Għall-mobilizzazzjoni ta' PBPCs f'pazjenti taħt kura majelosoppressiva jew majeloablativa segwit bit-trapjant awtolgu ta' PBPC
English: Haemoglobi n decreasede
Maltese: Trapjant kontra lOspitub
English: Blood glucose decreased Pseudogouta (Chondrocal cinosis Pyrophosph ate)
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: How do I prepare my Tevagrastim injection?
Maltese: Kif nipprepara l-injezzjoni ta' Tevagrastim?
English: • Inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2
Maltese: • infjammazzjoni tal-aorta (l-arterja l-kbira tad-demm li tittrasporta d-demm mill-qalb għallġisem), ara sezzjoni 2
English: Discontinue filgrastim
Maltese: filgrastim.
English: How long will I have to take Tevagrastim?
Maltese: Għal kemm żmien għandi nieħu Tevagrastim?
English: Dizziness Hypoaesthe sia
Maltese: glucose fiddemm Psewdogott aa
English: • rejection of transplanted bone marrow (graft versus host disease)
Maltese: • rifjut tal-mudullun trapjantat (marda tat-trapjant kontra l-ospitu)
English: In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Maltese: sseħħ il-Marda tat-trapjant kontra l-ospitu (GvHD - Graft versus host disease) - din hija reazzjoni taċċelluli donaturi kontra l-pazjent li jirċievi t-trapjant; is-sinjali u s-sintomi jistgħu jinkludu raxx fuq ilpali ta' jdejk jew il-qiegħ ta' saqajk u ulċera u feriti f'ħalqek, fl-imsaren, fil-fwied, fil-ġilda, jew f'għajnejk, fil-pulmun, fil-vaġina u fil-ġogi.
English: There were no relevant differences between Tevagrastim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Maltese: Ma kienx hemm differenzi rilevanti bejn Tevagrastim u l-prodott ta' referenza fir-rigward ta' dewmien ta' newtropenja qawwija u l-inċidenza ta' newtropenja bid-deni.
English: If leukocyte counts exceed 50 x 109/L after the expected nadir, filgrastim should be discontinued immediately.
Maltese: Jekk l-għadd ta' lewkoċiti jaqbeż 50 x 109/L wara li jkun għadda in-nadir mistenni, filgrastim għandu jitwaqqaf minnufih.
English: Vascular disorders
Maltese: Studju retrospettiv
English: the CHMP was of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Maltese: Is-CHMP kien tal-opinjoni li d-dettalji sottomessi b'appoġġ għall-applikazzjoni ma jikkonformawx malArtikolu 10 tad-Direttiva 2001/83/KE kif emendata.
English: • the rapporteur's and co-rapporteur's assessment reports;
Maltese: • ir-rapporti ta' valutazzjoni tar-rapporteur u tal-korapporteur;
English: Key pharmaceutical parameters of the drug product, manufacturing process and control are established .
Maltese: Għandhom jiġu stabbiliti parametri farmaċewtiċi fundamentali tal-mediċina, tal-proċessi ta' manifattura u tal-kontroll.
English: • and scientific discussion within the Committee,
Maltese: • u d-diskussjoni xjentifika fil-Kumitat,
English: • the description of the pharmaceutical development was considered to be unsatisfactory and the deficiencies resulting from this, including the absence of skin permeation or similar in vitro studies, were considered to be critical;
Maltese: • id-deskrizzjoni tal-iżvilupp fawmaċewtiku ma kinitx meqjusa sodisfaċenti u n-nuqqasijiet bħala riżultat ta' dan, inkluż in-nuqqas ta' permeazzjoni fil-ġilda jew studji simili in vitro, tqiesu li kienu kritiċi;
English: • the results from the studies provided by the MAH;
Maltese: • ir-riżultati mill-istudji pprovduti mill-MAH;
English: Grounds for refusal
Maltese: Raġuni għar-rifjut
English: Conditions for the lifting of the marketing authorisation suspension
Maltese: Kundizzjonijiet għat-tneħħija tas-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq
English: Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Maltese: Qabel it-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq, l-awtoritajiet kompetenti nazzjonali, ikkoordinati mill-Istat Membru ta' referenza, għandhom jiżguraw li d-detentur talawtorizzazzjoni għat-tqegħid fis-suq jissodisfa l-kundizzjonijijiet li ġejjin:
English: • the data provided by the company was considered to be neither robust nor extensive enough to warrant waiving a clinical study, or other validated model, to show therapeutic equivalence.
Maltese: • id-dejta pprovduta mill-kumpanija tqieset li la kienet robusta u lanqas estensiva biżżejjed biex tiġġustifika t-tneħħija ta' studju kliniku, jew ta' mudell validat ieħor, biex tintwera l-ekwivalenza terapewtika.
English: Based on:
Maltese: Anness
English: The CHMP considered that the data submitted in support of this application failed to show therapeutic equivalence between the test and the reference product:
Maltese: Is-CHMP ikkunsidra li d-dejta sottomessa b'appoġġ għal din l-applikazzjoni naqset milli turi ekwivalenza terapewtika bejn it-test u l-prodott ta' referenza:
English: Therapeutic equivalence to the reference product, through an appropriate clinical study or other validated model is demonstrated.
Maltese: Għandha tintwera l-ekwivalenza terapewtika għall-prodott ta' referenza, permezz ta' studju kliniku jew ta' model ivvalidat ieħor.
English: Therefore, the Committee adopted an opinion recommending the refusal of the marketing authorisation in the concerned member states and the suspension of the marketing authorisation in the reference member state, subject to the conditions outlined in annex III of the Opinion.
Maltese: Għalhekk, il-Kumitat adotta opinjoni li tirrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq flIstati Membri kkonċernati u s-sospensjoni tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istat Membru ta' referenza, soġġett għall-kundizzjonijiet elenkati fl-Anness
English: The full EPAR for Alli can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Alli jinsab fuq il-websajt tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as capsules (60 mg) and as chewable tablets (27 mg).
Maltese: Huwa disponibbli fl-għamla ta' kapsuli (60 mg) u ta' pilloli tal-magħad (27 mg).
English: Alli is a medicine that contains the active substance orlistat.
Maltese: Alli huwa mediċina li fiha s-sustanza attiva orlistat.
English: This is a summary of the European public assessment report (EPAR) for Alli.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Alli.
English: Orlistat blocks gastrointestinal lipases (enzymes that digest fat).
Maltese: L-orlistat jimblokka l-lipażi gastrointestinali (enzimi li jimmetabolizzaw ix-xaħam).
English: What is Alli?
Maltese: X'inhu Alli?
English: The European Commission granted a marketing authorisation valid throughout the EU for Orlistat GSK on 23 July 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Orlistat GSK fit-23 ta' Lulju 2007.
English: The active substance in Alli, orlistat, is an anti-obesity medicine, which does not affect appetite.
Maltese: Is-sustanza attiva f'Alli, l-orlistat, hija mediċina kontra l-obeżità li ma taffettwax l-aptit.
English: What is the risk associated with Alli?
Maltese: X'inhu r-riskju assoċjat ma' Alli?
English: The most common side effects with Alli (seen in more than 1 patient in 10) are oily spotting, flatus (gas) with discharge, faecal urgency (urgent need to open the bowels), fatty oily stool, oily evacuation (bowel movements of just oil, without stool), flatulence (gas) and soft stools.
Maltese: L-effetti sekondarji l-aktar komuni b'Alli (li dehru f'aktar minn pazjent 1 minn kull 10) huma ħruġ ta' qtar żejtni, flatulenza (gass) flimkien ma' tnixxija, urġenza biex jitbattlu l-imsaren (ħtieġa urġenti biex tiftaħ l-imsaren), feċi li jidhru xaħmin jew żejtnin, evakwazzjoni żejtnija (movimenti tal-imsaren ta' żejt biss, mingħajr feċi, flatulenza (gass) u feċi rotob.
English: The patient should be on a diet in which about 30% of the calories come from fat.
Maltese: Il-pazjent għandu jkun fuq dieta li 30% tal-kaloriji tagħha jkunu ġejjin mixxaħam.
English: Two of the studies involving a total of 1,353 overweight or obese patients with a BMI of 28 kg/m2 or more and lasted from one to two years, comparing Alli given at different doses with placebo (a dummy treatment), in combination with dieting.
Maltese: Żewġ studji minnhom involvew total ta' 1,353 pazjent li kellhom piż eċċessiv jew il-kundizzjoni tal-obeżità b'BMI ugwali għal 28 kg/m2 jew ogħla u damu minn sena sa sentejn iqabblu Alli mogħti f'dożi differenti mal-plaċebo (trattament finta), flimkien ma' dieta.
English: Because Alli is based on another medicine containing the same active substance already authorised in the EU (Xenical 120 mg capsules), some of the studies involved patients who took Xenical.
Maltese: Billi Alli huwa bbażat fuq mediċina oħra li fiha l-istess sustanza attiva diġà awtorizzata fl-UE (kapsuli ta' Xenical tal-120 mg), uħud mill-istudji involvew pazjenti ttrattati bi Xenical.
English: The name of the medicine was changed to Alli on 12 September 2008.
Maltese: Isem il-mediċina nbidel għal Alli fit-12 ta' Settembru 2008.
English: The third study compared Alli with placebo in 391 overweight patients with a BMI between 25 and 28 kg/m2.
Maltese: It-tielet studju qabbel Alli mal-plaċebo fi 391 pazjent li kellhom piż eċċessiv b'BMI ivarja bejn 25 u 28 kg/m2.
English: In the two studies of patients with a BMI of 28 kg/m2 or more, patients taking Alli 60 mg capsules had lost an average of 4.8 kg after a year, compared with 2.3 kg in those taking placebo.
Maltese: Fiż-żewġ studji ta' pazjenti li kellhom BMI ta' 28 kg/m2 jew ogħla, il-pazjenti ttrattati bil-kapsuli t'Alli tas-60 mg, wara sena, tilfu medja ta' 4.8 kg apparagun ma' medja ta' 2.3 kg f'dawk ittrattati bilplaċebo.
English: It is used in adults who are overweight with a body mass index (BMI) greater than or equal to 28 kg per square metre, in combination with a low calorie diet with reduced fat levels.
Maltese: Jintuża f'adulti li jkollhom piż eċċessiv b'indiċi tal-massa tal-ġisem (Body Mass Index - BMI) li jkun ugwali għal 28 kg jew ogħla għal kull metru kwadru, f'kombinazzjoni ma' dieta ipokalorika (bi ftit kaloriji) bi tnaqqis fil-livelli tax-xaħam.
English: The study of Alli in patients with a BMI between 25 and 28 kg/m2 failed to show a degree of weight loss that would be relevant for patients.
Maltese: L-istudju ta' Alli f'pazjenti li kellhom BMI li jvarja bejn 25 u 28 kg/m2 naqas milli juri livell ta' tnaqqis fil-piż rilevanti għall-pazjenti.
English: This authorisation was based on the authorisation already granted in 1998 to Xenical capsules.
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni diġà mogħtija fl-1998 lill-kapsuli ta' Xenical.
English: Alli was more effective than placebo in reducing weight in patients with a BMI of 28 kg/m2 or more.
Maltese: Alli kien iktar effikaċi mill-plaċebo fit-tnaqqis fil-piż f'pazjenti li kellhom BMIugwali għal 28 kg/m2 jew ogħla.
English: Why has Alli been approved?
Maltese: Għaliex ġie approvat Alli?
English: The company also carried out studies to show that Alli 27 mg chewable tablets have the same effect on fat absorption as Alli 60 mg capsules.
Maltese: Il-kumpanija għamlet ukoll studji biex turi li l-pilloli tal-magħad Alli tas-27 mg għandhom l-istess effett fuq l-assorbiment tax-xaħam daqs il-kapsuli Alli tas-60 mg.
English: When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to be passed out in the stools undigested.
Maltese: Meta dawn l-enzimi jiġu mblukkati ma jkunux jistgħu jiddiġerixxu xi wħud mix-xaħmijiet fid-dieta, u dan jippermetti li madwar kwart tax-xaħam li jkun ittiekel waqt l-ikel jgħaddi mill-imsaren bla ma jkun iddiġerit.
English: Alli capsules have been studied in three main studies.
Maltese: Il-kapsuli ta' Alli ġew studjati fi tliet studji ewlenin.
English: How has Alli been studied?
Maltese: Kif ġie studjat Alli?
English: How does Alli work?
Maltese: Għal xiex jintuża Alli?
English: For the full list of all side effects reported with Alli, see the package leaflet.
Maltese: Biex tara l-lista sħiħa tal-effetti sekondarji rrappurtati b'Alli, ara l-fuljett ta' tagħrif.
English: Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Alli.
Maltese: Din il-mediċina tista' tinkiseb mingħajr riċetta ta' tabib.
English: Osigraft eptotermin alfa
Maltese: Osigraft eptotermina alfa
English: The full EPAR for Osigraft 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: This summary was last updated in 03-2011.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'03-2011.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Osigraft to Howmedica International S. de R. L. on 17 May 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Osigraft lil Howmedica International S. de R. L. fis-17 ta' Mejju 2001.
English: Osigraft should be used by a qualified surgeon.
Maltese: Osigraft għandu jintuża minn kirurgu kkwalifikat.
English: The most common side effects with Osigraft (seen in between 1 and 10 patients in 100) are erythema (redness), tenderness, swelling over the implant site, heterotopic ossification (development of bone in abnormal areas) or myositis ossificans (abnormal bone growth in the muscle), and the formation of antibodies against eptotermin alfa.
Maltese: L-effetti sekondarji l-aktar komuni b'Osigraft (li dehru bejn 1 u 10 pazjenti minn kull 100) huma eritema (ħmura), sensittività, nefħa fis-sit tal-impjant, ossifikazzjoni eterotopika (żvilupp tal-għadam f'partijiet anomali) jew ossifikans mijosite (tkabbir tal-għadam anomalu fil-muskolu), u l-formazzjoni ta' antikorpi kontra l-eptotermina alfa.
English: This is a summary of the European public assessment report (EPAR) for Osigraft.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Osigraft.
English: • receiving chemotherapy, radiation treatment or immunosuppression.
Maltese: • li qed jieħdu l-kemoterapija, trattament ta' radjazzjoni jew immunosuppressjoni.
English: After nine months, 81% of the patients receiving Osigraft had responded to treatment (less pain and more weight bearing), compared with 77% of the patients treated with an autograft.
Maltese: Wara disa' xhur, 81% tal-pazjenti li ħadu Osigraft irrispondew għal-kura (inqas uġigħ u aktar żamma talpiż), meta mqabbla ma' 77% tal-pazjenti li ġew ikkurati bi trapjant awtoġenu.
English: • with an active infection at the surgery site or another serious infection;
Maltese: • b'infezzjoni attiva fis-sit tal-operazzjoni jew infezzjoni serja oħra;
English: It is a copy of a protein called osteogenic protein 1, also known as bone morphogenetic protein 7 (BMP-7), that is produced naturally by the body and which helps the formation of new bone tissue.
Maltese: Din hija kopja ta' proteina msejħa proteina 1 osteoġenika, magħrufa wkoll bħala proteina 7 morfoġenika tal-għadam (BMP-7), li hija prodotta b'mod naturali mill-ġisem u li tgħin il-formazzjoni ta' tessut tal-għadam ġdid.
English: The replacement eptotermin alfa acts in same way as naturally produced BMP-7.
Maltese: L-eptotemina alfa sostitwita taġixxi bl-istess mod bħal BMP-7 li jiġi prodott b'mod naturali.
English: Eptotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce it.
Maltese: L-epotermina alfa hija prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': hija magħmul minn ċelloli li jkunu rċevew ġene (DNA), li jagħmilhom possibbli biex jipproduċih.
English: It contains the active substance eptotermin alfa.
Maltese: Fih is-sustanza attiva eptotermina alfa.
English: The active substance in Osigraft, eptotermin alfa, acts on the bone structure.
Maltese: Is-sustanza attiva f'Osigraft, eptotermina alfa, taġixxi fuq l-istruttura tal-għadam.
English: • with an autoimmune disease (where the immune system attacks parts of the body);
Maltese: • b'mard awtoimmunoloġiku (fejn is-sistema immunitarja tattakka partijiet mill-ġisem);
English: How has Osigraft been studied?
Maltese: Kif ġie studjat Osigraft?
English: What is Osigraft?
Maltese: X'inhu Osigraft?
English: • skeletally immature (still growing);
Maltese: • dawk bl-għadam immatur (għadhom qed jikbru);
English: Osigraft was at least as effective as bone autograft, the standard treatment.
Maltese: Osigraft kien mill-anqas effikaċi daqs trapjant awtoġenu tal-għadam, it-trattament standard.
English: • where the fracture is disease-related (such as metabolic bone disease or cancer);
Maltese: • fejn il-ksur huwa relatat ma' mard (bħall-mard metaboliku tal-għadam jew il-kanċer);
English: Osigraft must also not be used by the following groups of patients:
Maltese: Osigraft m'għandu lanqas jintuża fil-gruppi ta' pazjenti li ġejjin:
English: The CHMP decided that Osigraft's benefits are greater than its risks and recommended that Osigraft be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Osigraft huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Why has Osigraft been approved?
Maltese: Għaliex ġie approvat Osigraft?
English: Immediately before use, Osigraft is mixed with 2 to 3 ml of sodium chloride solution to make up a suspension that has the consistency of wet sand.
Maltese: Preċiżament qabel l-użu, Osigraft jitħallat ma' 2 sa 3 ml ta' soluzzjoni tal-klorur tas-sodju biex isir sospensjoni li għandha l-konsistenza ta' ramel imxarrab.
English: • under 18 years old;
Maltese: • taħt it-18-il sena;
English: What is the risk associated with Osigraft?
Maltese: X'inhu r-riskju assoċjat ma' Osigraft?
English: Other information about Osigraft
Maltese: Kif jintuża Osigraft?
English: How does Osigraft work?
Maltese: Għal xiex jintuża Osigraft?
English: How is Osigraft used?
Maltese: Kif jaħdem Osigraft?
English: The main study of Osigraft was carried out in 122 patients with unhealed tibial fractures who were treated either with the medicine or with an autograft.
Maltese: L-istudju prinċipali ta' Osigraft sar f'122 pazjent bi ksur tibjali mhux imfejjaq li ġie kkurat jew bilmediċina jew bi trapjant awtoġenu.
English: Osigraft is a powder to be made up into a suspension for implantation.
Maltese: Osigraft huwa trab li għandu jsir f'sospensjoni għall-impjantazzjoni.
English: Bravecto Plus (fluralaner / moxidectin)
Maltese: Bravecto Plus (fluralaner / mossidektina)
English: Further information on Bravecto Plus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/bravecto-plus.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/bravecto-plus.
English: Bravecto Plus received a marketing authorisation valid throughout the EU on 8 May 2018.
Maltese: Bravecto Plus ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-8 ta' Mejju 2018.
English: Other information about Bravecto Plus
Maltese: Informazzjoni oħra dwar Bravecto Plus
English: Fluralaner acts as an ‘ectoparasiticide'.
Maltese: Il-fluralaner taġixxi bħala “ektoparassitiċida”.
English: In a field study of 167 cats infested with 5 or more ear mites, treatment with Bravecto Plus resulted in 94% of cats free from ear mites 14 days after treatment and 100% of cats free from ear mites 28 days after treatment.
Maltese: Fi studju fuq il-post ta' 167 qattus infestat b' 5 dud tal-widnejn jew aktar, il-kura bi Bravecto Plus irriżultat f' 94 % tal-qtates ħielsa mid-dud tal-widnejn 14-il jum wara l-kura u 100 % tal-qtates ħielsa mid-dud tal-widnejn 28 jum wara l-kura.
English: What are the risks associated with Bravecto Plus?
Maltese: X'inhuma r-riskji assoċjati ma' Bravecto Plus?
English: Bravecto Plus contains the active substances fluralaner and moxidectin.
Maltese: Bravecto Plus fih is-sustanzi attivi fluralaner u mossidektina.
English: For ear mite infestations, a veterinary check is necessary 28 days after treatment.
Maltese: Għallinfestazzjonijiet tad-dud tal-widnejn, huwa meħtieġ kontroll veterinarju 28 jum wara l-kura.