FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Kexxtone, monensin, is an antibiotic produced by natural fermentation.
Maltese: Is-sustanza attiva f'Kexxtone, il-monesin, hija antibiotiku prodott permezz ta' fermentazzjoni naturali.
English: Kexxtone must not be used in animals weighing less than 300 kg.
Maltese: Kexxtone ma għandux jintuża f'annimali li jiżnu inqas minn 300 kg.
English: Kexxtone has been studied in one main study involving 1,312 commercial dairy cows.
Maltese: Kexxtone ġie studjat fi studju wieħed ewlieni li involva 1,312-il baqra tal-ħalib kummerċjali.
English: Kexxtone is a veterinary medicine that contains the active substance monensin.
Maltese: Kexxtone huwa prodott mediċinali li fih is-sustanza attiva monensin.
English: It is mainly active against Gram-positive bacteria.
Maltese: Huwa prinċipalment attiv kontra batterji Gram-pożittivi.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ tal-benefiċċju/riskju jista' jinstab fil-modulu taddiskussjoni xjentifika ta' dan l-EPAR.
English: This summary was last updated on 28 January 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal Kexxtone fi 28/01/2013.
English: Ketosis is a metabolic disturbance in which blood glucose levels are low and substances called ketones (such as acetoacetatic acid and β-hydroxybutyrate) accumulate in the blood.
Maltese: Ketożi hija disturb metaboliku li fih, il-livelli talglukożju fid-demm huma baxxi u sustanzi msejħin ketoni (bħal acetoacetatic acid u βhydroxybutyrate) jakkumulaw fid-demm.
English: Accidental administration of more than one intraruminal device could result in side effects typical of monensin overdose, including decreased appetite, scouring (diarrhoea) and lethargy.
Maltese: Għoti aċċidentali ta' aktar minn strument intraruminali wieħed jista' jirriżulta f'effetti sekondarji tipiċi ta' doża eċċessiva tal-monensin, inkluż tnaqqis fl-aptit, ippurgar (dijarrea) u letarġija.
English: What is Kexxtone?
Maltese: X'inhu Kexxtone?
English: Why has Kexxtone been approved?
Maltese: Għaliex ġie approvat Kexxtone?
English: What is the risk associated with Kexxtone?
Maltese: X'inhu r-riskju assoċjat ma' Kexxtone?
English: Dogs, horses, other equines or guinea fowl must not be allowed access to Kexxtone as consumption of intraruminal device contents can be fatal in these species.
Maltese: Klieb, żwiemel, ekwini oħrajn jew tajr tal-guinea ma għandhomx jitħallew jersqu ħdejn Kexxtone minħabba li l-konsum tal-kontenut tal-istrument intraruminali jista' jkun fatali f'dawn l-ispeċi.
English: Other information about Kexxtone:
Maltese: Aktar tagħrif dwar Kexxtone:
English: The person administering Kexxtone should wear gloves when handling the product, including when retrieving a regurgitated intraruminal device.
Maltese: Il-persuna li tagħti Kexxtone għandha tilbes ingwanti meta tmiss ilprodott, inkluż meta tislet apparat intraruminali regugurġitat.
English: The main measure of effectiveness was the cumulative rate of clinical ketosis in the cows over the 15 to 16 weeks after calving.
Maltese: Il-kejl ewlieni tal-effikaċja kien ir-rata kumulattiva ta' ketożi klinika fil-baqar fuq 15 sa 16-il ġimgħa wara t-twelid.
English: A single intraruminal device is given to a dairy cow or heifer three to four weeks before the expected calving, using an appropriate administration tool.
Maltese: Strument intraruminali waħdieni jingħata lil baqra tal-ħalib jew heifer tlieta jew erba' ġimgħat qabel iddata mistennija tat-twelid, permezz ta' strument ta' amministrazzjoni apposta.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Kexxtone exceed the risks for the approved indication and recommended that Kexxtone be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Kexxtone huma akbar mir-riskji tiegħu għall-indikazzjoni approvata u rrakkomanda li Kexxtone jingħata
English: Clinical ketosis was defined based on a minimum level of the substance ß-hydroxybutyrate in the blood in combination with one or more clinical signs of ketosis.
Maltese: Ketożi klinika ġiet iddefinita abbażi ta' livell minimu tas-sustanza ßhydroxybutyrate fid-demm f'kombinazzjoni ma' sinjal kliniku wieħed jew aktar ta' ketożi.
English: It is available as a continuous-release intraruminal device (a device administered through the animal's mouth and placed within the rumen, or first stomach, of cattle).
Maltese: Jiġi bħala strument intraruminali b'rilaxx kontinwu (apparat mogħti permezz tal-ħalq tal-annimali u mpoġġi fi ħdan il-kirxa (rumen), jew l-ewwel stonku, ta' frat).
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Informazzjoni dwar l-istatus tal-preskrizzjoni ta' dan il-prodott tista' tinstab fuq it-tikketta/pakkett ta' barra.
English: What is the withdrawal period?
Maltese: Liema benefiċċju wera Kexxtone waqt l-istudji li twettqu?
English: How has Kexxtone been studied?
Maltese: Kif ġie studjat Kexxtone?
English: Cattle should be re-checked for up to four days after dosing in case the intraruminal device has not been fully swallowed and has lodged in the oesophagus (the gullet or tube leading from the mouth to the rumen).
Maltese: Il-frat għandhom jerġgħu jiġu ċċekkjati għal massimu ta' erbat ijiem wara d-dożaġġ fil-każ li l-istrument intraruminali ma jkunx inbela' għal kollox u jkun tressaq fl-esofagu (il-gullet jew it-tubu li jwassal millħalq għar-rumen).
English: Monensin changes the population of microbes in the rumen resulting in an increase of the bacteria that produce propionate, a substance used to make glucose.
Maltese: rumen u dan jirriżulta f'żieda tal-batterji li jipproduċu propionate, sustanza użata sabiex isir il-glukożju.
English: References: 1.
Maltese: Referenzi: 1.
English: 19 December 2013 EMA/809470/2013
Maltese: 19 ta' Diċembru 2013 EMA/809470/2013
English: Available on: http://clinicaltrials.gov/ct2/show/NCT00318942 5.
Maltese: Disponibbli fi: http://clinicaltrials.gov/ct2/show/NCT00318942
English: Available on ClinicalTrials.gov (NCT01122277) last updated on 07 July 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
Maltese: Disponibbli fi ClinicalTrials.gov (NCT01122277) aġġornat l-aħħar fir-7 ta' Lulju 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
English: Consequently, on 27 June 2013, the UK triggered an EU review of HES solutions under Article 107i of Directive 2001/83/EC.
Maltese: Konsegwentement, fis27 ta' Ġunju 2013, ir-Renju Unit ta bidu għal reviżjoni tal-UE ta' soluzzjonijiet HES skont l-Artikolu 107i tad-Direttiva 2001/83/KE.
English: Myburgh J, Finder S, Bellomo R et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care.
Maltese: Hydroxyethyl starch or saline for fluid resuscitation in intensive care.
English: Annane D. et al. CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial.
Maltese: CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial. NCT00318942.
English: A review of HES solutions for infusion was initiated on 29 November 2012 at the request of the German medicines agency, under Article 31 of Directive 2001/83/EC.
Maltese: Reviżjoni ta' soluzzjonijiet għall-infużjoni HES inbdiet fid-29 ta' Novembru 2012 fuq talba tal-aġenzija tal-mediċini Ġermaniża, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: * The CMDh is a medicines regulatory body representing the European Union (EU) Member States
Maltese: * Is-CMDh korp regolatorju mediċinali li jirrappreżenta lill-Istati Membri tal-Unjoni Ewropea (UE)
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Maltese: Ħtieġa akbar ta' terapija ta' sostituzzjoni renali ġiet irrapportata sa 90 jum wara l-għoti ta' HES.
English: • HES solutions are contraindicated in severe coagulopathy.
Maltese: • Soluzzjonijiet HES huma kontraindikati f'koagulopatija severa.
English: HES solutions should be discontinued at the first sign of coagulopathy.
Maltese: Soluzzjonijiet HES għandhom jitwaqqfu mal-ewwel sinjal ta' koagulopatija.
English: Siegemund M. Firstly presented at European Society of Anaesthesiology conference 2012.
Maltese: Firstly presented at European Society of Anaesthesiology conference 2012. Basel Study for Evaluation of Starch (130;0
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Is-CMDh, korp li jirrappreżenta lIstati Membri tal-UE, huwa responsabbli biex jiżgura standards ta' sikurezza armonizzati għall-mediċini awtorizzati permezz ta' proċeduri nazzjonali madwar l-UE.
English: The review of HES solutions was carried out by the PRAC following the publication of studies showing an increased risk of mortality in patients with sepsis1,2 and an increased risk of kidney injury requiring dialysis in critically ill patients1,2,3 following treatment with HES solutions.
Maltese: Ir-reviżjoni ta' soluzzjonijiet HES saret mill-PRAC wara l-pubblikazzjoni ta' studji li wrew żieda fir-riskju ta' mortalità f'pazjenti b'sepsis1,2 u żieda fir-riskju ta' ħsara lill-kliewi li kienet teħtieġ dijalisi f'pazjenti morda b'mod kritiku1,2,3 wara kura b'soluzzjonijiet HES.
English: Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients:BaSES (130;0.4) Trial, listed at http://clinicaltrials.gov/show/NCT00273728
Maltese: .4) Trial, elenkat f'http://clinicaltrials.gov/show/NCT00273728
English: On 23 October 2013, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)*, endorsed by majority the recommendations of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients because of an increased risk of kidney injury and mortality.
Maltese: Fit-23 ta' Ottubru 2013, il-Grupp ta ' Koordinazzjoni għall-Għarfien Reċiproku u l-Proċeduri Deċentralizzati - Uman (CMDh)*, approva b'maġġoranza r-rakkomandazzjonijiet tal-Kumitat ta' Valutazzjoni tar-Riskji ta' Farmakoviġilanza (PRAC) tal-Aġenzija Ewropea għall-Mediċini, li kkonkluda li s-soluzzjonijiet HES m'għandhomx jibqgħu jintużaw għall-kura ta' pazjenti b'sepsis (infezzjoni batterika fid-demm) jew b'feriti ta' ħruq jew fuq pazjenti morda b'mod kritiku minħabba riskju akbar ta' ħsara lill-kliewi u mortalità.
English: HES will be available in restricted patient populations
Maltese: HES se jkun disponibbli f'popolazzjonijiet ristretti ta' pazjenti
English: Additional studies will be performed with HES solutions in patients with trauma and in elective surgery.
Maltese: Studji addizzjonali sejrin jitwettqu b'soluzzjonijiet HES f'pazjenti bi trawma u f'kirurġija elettiva.
English: As the CMDh position was adopted by majority vote, it was sent sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision on 19 December 2013.
Maltese: Peress li l-pożizzjoni tas-CMDh ġiet adottata b'vot ta' maġġoranza, intbagħat lill-Kummissjoni Ewropea, li approvatha u adottat deċiżjoni legalment vinkolanti fl-UE kollha fid-19 ta' Diċembru 2013.
English: As HES-containing solutions for infusion are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Maltese: Peress li soluzzjonijiet għall-infużjoni li fihom HES huma kollha awtorizzati fuq livell nazzjonali, irrakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għall-Għarfien Reċiproku u lProċeduri Deċentralizzati - Uman (CMDh), li adotta pożizzjoni finali.
English: Colloids contain large molecules such as starch, whereas crystalloids, such as saline (salt) solutions or Ringer's acetate, contain smaller molecules.
Maltese: Kollojdi fihom molekuli kbar bħal-lamtu, filwaqt li kristallojdi, bħal soluzzjonijiet tas-salina (melħ) jew bl-aċetat ta' Ringer, fihom molekuli iżgħar.
English: • There is a lack of robust long-term safety data in patients undergoing surgical procedures and in patients with trauma.
Maltese: • Hemm nuqqas ta' dejta robusta fit-tul dwar is-sigurtà f'pazjenti li għaddejjin minn proċeduri kirurġiċi u f'pazjenti bi trawma.
English: This review procedure ran in parallel with the re-examination of the PRAC's June 2013 recommendation and both procedures were finalised on 10 October 2013.
Maltese: Din il-proċedura ta' reviżjoni twettqet simultanjament mal-eżami mill-ġdid tar-rakkomandazzjoni tal-PRAC ta' Ġunju 2013 u ż-żewġ proċeduri ġew finalizzati fl10 ta' Ottubru2013.
English: These recommendations are based on a review of all available safety and efficacy data, including recent data4,5,6, from clinical studies, meta-analyses and post-marketing experience.
Maltese: Dawn ir-rakkomandazzjonijiet huma bbażati fuq reviżjoni tad-dejta kollha disponibbli dwar is-sigurtà u l-effikaċja, inkluża dejta riċenti4,5,6, minn studji kliniċi, meta-analiżi u l-esperjenza wara t-tqegħid fissuq.
English: There are two main types of medicines used for volume replacement: crystalloids and colloids.
Maltese: Hemm żewġ tipi ewlenin ta' mediċini li jintużaw għassostituzzjoni tal-volum: kristallojdi u kollojdi.
English: N Engl J Med 2008; 358(2):125-39 3.
Maltese: 358(2):125-39 3. Myburgh J, Finder S, Bellomo R et al.
English: However, new evidence was considered in the parallel Article 107i procedure and this was the basis for the PRAC's final recommendation on the use of HES solutions.
Maltese: Madankollu, evidenza ġdida ġiet ikkunsidrata fil-proċedura parallela tal-Artikolu 107i u din kienet il-bażi għar-rakkomandazzjoni finali tal-PRAC dwar l-użu ta' soluzzjonijiet HES.
English: • HES solutions are now contraindicated in patients with renal impairment or renal replacement therapy.
Maltese: • Soluzzjonijiet HES issa huma kontraindikati f'pazjenti b'indeboliment renali jew fuq terapija ta' sostituzzjoni renali.
English: EU/1/13/896/001 GRANUPAS 4 g
Maltese: EU/1/13/896/001 GRANUPAS
English: Oral use sachet , , , , , , , , , , (Paper/LDPE/alu/ n n n LDPE)
Maltese: Użu Orali qartas (Paper/LDPE/alu/LDPE)
English: Gastro-resistant v granules
Maltese: Granuli gastroreżistenti
English: The full EPAR for Evicel 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: It is available as two solutions, one containing the active substance human clottable protein (50 to 90 mg/ml), and the other containing the active substance human thrombin (800 to 1200 international units per millilitre).
Maltese: Jiġi f'żewġ soluzzjonijiet: waħda fiha s-sustanza attiva proteina umana li tgħaqqad (50 sa 90 mg/ml), u l-oħra fiha s-sustanza attiva trombina umana (800 sa 1200 unità internazzjonali għal kull millilitru).
English: During abdominal surgery, 95% of the patients had no bleeding 10 minutes after treatment with Evicel (63 out of 66), compared with 81% of the patients treated with Surgicel (56 out of 69).
Maltese: Waqt l-interventi ta' kirurġija addominali, 95% talpazjenti ma kellhom l-ebda fsada 10 minuti wara li ngħataw trattament b'Evicel (63 min 66), apparagun ma' 81% tal-pazjenti li ngħataw trattament b'Surgicel (56 minn 69).
English: Evicel human clottable protein / human thrombin
Maltese: Evicel proteina umana li tgħaqqad / trombina umana
English: This is a summary of the European public assessment report (EPAR) for Evicel.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Evicel.
English: In vascular surgery, 85% of the patients had no bleeding four minutes after treatment with Evicel (64 out of 75), compared with 39% of the patients treated with manual compression (28 out of 72).
Maltese: Fl-interventi ta' kirurġija vaskulari, 85% tal-pazjenti ma kellhom l-ebda fsada għal erba' minuti wara li ngħataw trattament b'Evicel (64 minn 75), apparagun ma' 39% tal-pazjenti li ngħataw trattament bil-kompressjoni manwali (28 minn 72).
English: Evicel has been studied in two main studies involving a total of 282 patients.
Maltese: Evicel ġie studjat f'żewġ studji ewlenin fuq total ta' 282 pazjent.
English: The human clottable protein contains as its main component, fibrinogen, a protein involved in the natural clotting process.
Maltese: Il-komponent ewlieni fil-proteina umana li tgħaqqad, il-fibroġenu, hija proteina involuta fil-proċess naturali tal-koagulazzjoni tad-demm.
English: Why has Evicel been approved?
Maltese: Għaliex ġie approvat Evicel?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evicel on 6 October 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Evicel valida fl-Unjoni Ewropea kollha fis-6 ta' Ottubru 2008.
English: The active substances in Evicel, human clottable protein and thrombin, are natural substances obtained from human plasma (the liquid part of the blood).
Maltese: Is-sustanzi attivi f'Evicel, il-proteina umana li tgħaqqad u t-trombina, huma sustanzi naturali miksubin mill-plażma umana (il-parti likwida tad-demm).
English: The second study compared Evicel with Surgicel (a material used to help control bleeding) in reducing bleeding during abdominal surgery (surgery of organs in the tummy).
Maltese: It-tieni studju qabbel Evicel ma' Surgicel (materjal użat biex jgħin il-kontroll tal-fsada) fit-tnaqqis ta' fsada waqt interventi ta' kirurġija addominali (operazzjonijiet fuq l-organi tażżaqq).
English: Evicel is used by surgeons to help reduce local bleeding during operations when standard techniques are not sufficient.
Maltese: Evicel jintuża mill-kirurgi biex inaqqsu l-fsada lokali waqt l-operazzjonijiet meta t-tekniki standard ma jkunux biżżejjed.
English: What is Evicel?
Maltese: X'inhu Evicel?
English: In dura mater closure, 92% of patients treated with Evicel (82 out of 89) had a watertight closure compared with 38% of the patients who did not receive Evicel (19 out of 50).
Maltese: Fl-għeluq tad-dura mater, 92% tal-pazjenti kkurati b'Evicel (82 minn 89) kellhom għeluq komplut meta mqabbel ma' 38% tal-pazjenti li ma ngħatawx Evicel (19 minn 50).
English: Evicel has also been studied in one further main study involving 139 patients undergoing brain surgery and whose dura mater was leaking fluid following suturing of the dural incision.
Maltese: Evicel ġie studjat ukoll fi studju ieħor li involva 139 pazjent li kienu għaddejjin b'intervent kirurġiku f'moħħhom u li d-dura mater kienet qiegħda tnixxi l-fluwidi wara sutura tal-inċiżjoni durali.
English: Because the thrombin solution of Evicel is also used in another medicine, Quixil, the company used some data from Quixil to support the use of Evicel.
Maltese: Peress li s-soluzzjoni tat-trombina ta' Evicel tintuża wkoll f'mediċina oħra, Quixil, il-kumpanija użat xi dejta mill-istudji dwar Quixil biex tappoġġja l-użu ta' Evicel.
English: Cases of gas embolism (gas bubbles in the blood that affect the blood flow) have occurred when Evicel was applied as spray.
Maltese: Ġraw każi ta' embolija ta' gass (bżieżaq tal-gass li jaffettwaw il-fluss tad-demm) meta Evicel ġie applikat bi sprej.
English: The first study compared Evicel with manual compression (applying direct pressure) in reducing bleeding during vascular surgery.
Maltese: L-ewwel studju qabbel l-effikaċja ta' Evicel ma' dik tal-kompressjoni manwali (l-applikazzjoni ta' pressjoni diretta) fit-tnaqqis ta' fsada waqt l-interventi ta' kirurġija vaskulari.
English: Evicel is a medicine that is used as a sealant (glue).
Maltese: Evicel huwa mediċina li jintuża bħala siġillant (kolla).
English: For the full list of all side effects reported with Evicel, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rappurtati b'Evicel, ara l-fuljett ta' tagħrif.
English: In order to reduce the risk of gas embolism with spray application, the company will provide educational material and training to all surgeons who will use Evicel as a spray.
Maltese: Sabiex jitnaqqas ir-riskju ta' embolija tal-gass bl-użu tal-isprej, il-kumpanija ser tagħti materjal edukattiv u taħriġ lill-kirurgi li jużaw Evicel fl-għamla ta' sprej.
English: In addition, the company will ensure that Evicel is used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that the regulators contain labels stating the recommended pressure and distance for the spray application.
Maltese: Barra dan, il-kumpanija ser tiżgura li Evicel jintuża b'regolaturi tal-pressjoni li ma jaqbżux il-pressjoni massima meħtieġa biex jingħata ssiġillant tal-fibrina, u li r-regolaturi jkun fihom tikketti li jindikaw il-pressjoni u d-distanza rakkomandati għall-użu tal-isprej.
English: What is the risk associated with Evicel?
Maltese: Kif ġie studjat Evicel?
English: It can also be used in addition to sutures (stitching) during vascular surgery (surgery on the blood vessels).
Maltese: Evicel jista' jintuża wkoll mas-sutura (punti) waqt interventi tal-kirurġija vaskulari (kirurġija fuq il-vini u l-arterji).
English: As for other sealants, Evicel may cause an allergic reaction which can be severe especially when Evicel is used repeatedly.
Maltese: Għal dak li jirrigwarda siġillanti oħra, Evicel jista' jikkawża reazzjoni allerġika serja speċjalment meta jintuża ħafna drabi.
English: Other information about Evicel
Maltese: Kif jintuża Evicel?
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/230/001
Maltese: EU/2/18/230/001
English: ATC vet code: QD07AC16.
Maltese: QD07AC16.
English: Pharmacotherapeutic group: Corticosteroids, dermatological preparations.
Maltese: Grupp farmako-terapewtiku: kortikosterojdi, sustanzi dermatoloġiċi.
English: Flammable.
Maltese: Fjammabbli.
English: Marketing authorisation holder: Ecuphar NV
Maltese: ECUPHAR NV
English: This transformation is responsible for the potency of the therapeutic class.
Maltese: Din ittrasformazzjoni hi responsabbli għall-potenza tal-klassi terapewtika.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk meħtieġ
English: Ecuphar NV, Legeweg 157-i B-8020
Maltese: ECUPHAR NV Legeweg 157-I, B-8020, Oostkamp, Belgium
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cutaneous use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: Manufacturer responsible for batch release: Bioglan AB
Maltese: Manifattur responsabbli għall-ħrug tal-lott: Bioglan AB
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)) - 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: - komuni ħafna (aktar minn wieħed minn kull 10 annimali kkurati juru reazzjoni(jiet) avversa/avversi) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).>
English: Disposal: read package leaflet.
Maltese: Sprej kutanju, likwidu.
English: Interaction with other medicinal products and other forms of interaction:
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Legeweg 157-i
Maltese: Ecuphar NV Legeweg 157-i
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Eteru glikol metil propilin