FrancophonIA/ELRC3.0 huggingface dataset:
English: It contains the active substances fluticasone furoate, umeclidinium bromide and vilanterol.
Maltese: Dan fih is-sustanzi attivi flutikason furoate, bromur tal-umeklidinju u vilanterol.
English: Other information about Elebrato Ellipta
Maltese: Informazzjoni oħra dwar Elebrato Ellipta
English: Elebrato Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Maltese: Elebrato Ellipta hija mediċina użata biex ittaffi s-sintomi tal-mard pulmonari ostruttiv kroniku (COPD, chronic obstructive pulmonary disease) minn moderat sa sever.
English: In this study, Elebrato Ellipta reduced the rate of moderate and severe exacerbations over one year by 15% compared with treatment with vilanterol and fluticasone furoate, and by 25% compared with treatment with vilanterol and umeclidinium bromide.
Maltese: F'dan l-istudju, Elebrato Ellipta naqqas ir-rata ta' aggravar moderat u sever fuq sena bi 15 % meta mqabbel mal-kura b'vilanterol u flutikason furoate, u b'25 % meta mqabbel mal-kura b'vilanterol u lbromur tal-umeklidinju.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom infjammazzjoni, bħall-istamina, b'hekk tnaqqas l-infjammazzjoni u tgħin biex iżżomm il-passaġġi talarja miftuħin u tippermetti li l-pazjent jieħu n-nifs b'mod aktar faċli.
English: A study compared Elebrato Ellipta with either vilanterol given with fluticasone furoate or vilanterol with umeclidinium bromide, in 10,355 patients with advanced COPD who were at risk of exacerbations and whose disease was not satisfactorily controlled with a daily maintenance treatment.
Maltese: Studju qabbel Elebrato Ellipta jew ma' vilanterol mogħtija ma' flutikason furoate jew vilanterol malbromur tal-umeklidinju, f'10,355 pazjent b'COPD avvanzata li kienu f'riskju ta' aggravar u li l-marda tagħhom ma kinitx ikkontrollata b'mod sodisfaċenti b'kura ta' manutenzjoni ta' kuljum.
English: Another study involving 1,810 patients whose COPD was not satisfactorily controlled with a daily maintenance treatment for their COPD found Elebrato Ellipta more effective at improving patients' breathing than an inhaled combination of budesonide, a corticosteroid, and formoterol, a long-acting beta-2 agonist.
Maltese: Studju ieħor li involva 1,810 pazjenti li s-COPD tagħhom ma kinitx ikkontrollata b'mod sodisfaċenti bilkura ta' manutenzjoni ta' kuljum għas-COPD tagħhom sab li Elebrato Ellipta huwa aktar effettiv biex itejjeb it-teħid tan-nifs tal-pazjenti milli kieku tittieħed man-nifs taħlita ta' budesonide, kortikosterojde u formoterol li huwa agonista beta-2 li jaġixxi fit-tul.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors (targets) in various types of immune cells.
Maltese: Din taħdem b'mod simili għal ormoni kortikosterojdi li jseħħu b'mod naturali, tnaqqas l-attività tas-sistema immunitarja billi teħel ma' riċetturi (miri) f'diversi tipi ta' ċelloli immunitarji.
English: How is Elebrato Ellipta used?
Maltese: Kif jaħdem Elebrato Ellipta?
English: Elebrato Ellipta is used for maintenance (regular) treatment on a daily basis.
Maltese: Elebrato Ellipta jintuża bħala kura ta' manutenzjoni (regolari) kuljum.
English: The most common side effects with Elebrato Ellipta (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), headache and upper respiratory tract infection (nose and throat infection).
Maltese: L-effetti sekondarji l-aktar komuni b' Elebrato Ellipta (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma n-nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn), l-ugigħ ta' ras u l-infezzjoni talapparat respiratorju ta' fuq (infezzjoni tal-imnieħer u tal-griżmejn).
English: Regarding the safety profile of the medicine, the most frequent side effects reported with Elebrato Ellipta were similar to those with the individual active substances of the medicine and are well known.
Maltese: Fir-rigward tal-profil tas-sigurtà tal-mediċina, l-effetti sekondarji l-aktar frekwenti li ġew irrapportati b'Elebrato Ellipta kienu simili għal dawk tas-sustanzi attivi individwali tal-mediċini u huma magħrufin tajjeb.
English: What are the risks associated with Elebrato Ellipta?
Maltese: X'inhuma r-riskji assoċjati ma' Elebrato Ellipta?
English: As for all medicines, data on the use of Elebrato Ellipta are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Elebrato Ellipta hija ssorveljata kontinwament.
English: Elebrato Ellipta improves lung function as well as the quality of life of patients with moderate to severe COPD.
Maltese: L-Aġenzija kkonkludiet li Elebrato Ellipta jtejjeb il-funzjoni tal-pulmun kif ukoll il-kwalità tal-ħajja talpazjenti b'COPD minn moderata sa severa.
English: Elebrato Ellipta is used in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a longacting muscarinic antagonist.
Maltese: Elebrato Ellipta jintuża f'adulti li l-marda tagħhom mhijiex ikkontrollata tajjeb biżżejjed b'taħlita ta' mediċini li jittieħdu man-nifs li tikkonsisti minn agonist beta-2 li jaġixxi fit-tul flimkien ma' jew kortikosterojde jew antagonist muskariniku li jaġixxi fit-tul.
English: For the full list of side effects and restrictions with Elebrato Ellipta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Elebrato Ellipta, ara l-fuljett ta' tagħrif.
English: Further information on Senstend can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/senstend.
Maltese: ema.europa.eu/medicines/human/EPAR/senstend.
English: Other information about Senstend
Maltese: Informazzjoni oħra dwar Senstend
English: average ejaculation time in patients using the medicine was 3.8 minutes compared with 1.1 minute in the placebo group.
Maltese: ħin medju għall-eġakulazzjoni f'pazjenti li użaw il-mediċina kien 3.8 minuti meta mqabbel ma' 1.1 minuta fil-grupp tal-plaċebo.
English: Senstend can only be obtained with a prescription and is available as a spray-on solution that supplies 7.5 mg of lidocaine and 2.5 mg of prilocaine per spray.
Maltese: Senstend jista' jinkiseb biss b'riċetta ta' tabib u jiġi bħala soluzzjoni fi sprej li jissupplixxi 7.5 mg ta' lidokajina u 2.5 mg ta' prilokajina għal kull sprej.
English: Senstend (lidocaine / prilocaine) EMA/519240/2019
Maltese: EMA/519240/2019
English: The effectiveness of Senstend has been shown in two main studies involving 256 and 300 heterosexual adult men with premature ejaculation, respectively; both studies compared the medicine with a placebo (dummy) spray over 12 weeks.
Maltese: L-effikaċja ta' Senstend intweriet f'żewġ studji ewlenin li fihom ħadu sehem 256 u 300 raġel adult eterosesswali b'eġakulazzjoni prematura, rispettivament; iż-żewġ studji qabblu l-mediċina ma' sprej plaċebo (fint) fuq perjodu ta' 12-il ġimgħa.
English: Senstend is a medicine containing the active substances lidocaine and prilocaine.
Maltese: Senstend huwa mediċina li fiha s-sustanzi attivi lidokajina u prilokajina.
English: The most common side effects with Senstend (which may affect up to 1 in 10 people) are hypoaesthesia (reduced sensation) and a burning sensation in the genital area in both men and their female sexual partners, and erectile dysfunction (inability to maintain a normal erection) in men.
Maltese: L-effetti sekondarji l-aktar komuni b'Senstend (li jistgħu jaffettwaw sa persuna waħda minn kull 10) huma ipoestesija (sens imnaqqas) u sensazzjoni ta' ħruq fil-parti ġenitali f'kemm l-irġiel kif ukoll fissħab nisa tagħhom, u disfunzjoni erettili (nuqqas ta' abbiltà li tinżamm erezzjoni normali) fl-irġiel.
English: How is Senstend used?
Maltese: Kif jaħdem Senstend?
English: There were also positive psychological benefits to patients and their partners, and side effects were local and generally manageable.
Maltese: Kien hemm ukoll benefiċċji psikoloġiċi pożittivi għall-pazjenti u għas-sħab tagħhom, u l-effetti sekondarji kienu maniġġabbli lokalment u ġeneralment.
English: As for all medicines, data on the use of Senstend are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Senstend hija ssorveljata kontinwament.
English: What are the risks associated with Senstend?
Maltese: X'inhuma r-riskji assoċjati ma' Senstend?
English: The active substances in the medicine, lidocaine and prilocaine, are local anaesthetics that temporarily numb the contact area by reversibly blocking the transmission of signals in the nerves.
Maltese: Is-sustanzi attivi fil-mediċina, il-lidokajina u l-prilokajina, huma anestetiċi lokali li b'mod temporanju jraqqdu l-parti ta' kuntatt billi jimblukkaw b'mod riversibbli t-trażmissjoni tas-sinjali fin-nervituri.
English: In the first study, the average time to ejaculation in patients treated with Senstend was 2.6 minutes, compared with 0.8 minutes in those using placebo; in the second study,
Maltese: Fl-ewwel studju, il-ħin medju għall-eġakulazzjoni f'pazjenti kkurati b'Senstend kien 2.6 minuti, meta mqabbel ma' 0.8 minuti f'dawk li użaw il-plaċebo; fit-tieni studju, il
English: Senstend must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other local anaesthetics with a structure related to the active ingredients (amidetype local anaesthetics).
Maltese: Senstend ma għandux jintuża f'pazjenti li huma ipersensittivi (allerġiċi) għal kwalunkwe ingredjent talmediċina jew għall-anestetiċi lokali l-oħra bi struttura relatata mal-ingredjenti attivi (anestetiċi lokali tat-tip ammid).
English: The company that makes Fortacin has agreed that its scientific data can be used for Senstend (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Fortacin qablet li d-data xjentifika tagħha tista' tintuża għal Senstend (“kunsens infurmat”).
English: The European Medicines Agency considered that the active ingredients are a well-known local anaesthetic combination, and the use of a local spray minimises the amount of active substance absorbed and hence the risk of side effects affecting the body as a whole.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkunsidrat li l-ingredjenti attivi huma kombinazzjoni ta' anestetiku lokali magħruf sew, u l-użu ta' sprej lokali jnaqqas l-ammont tas-sustanza attiva assorbita u għaldaqstant ir-riskju tal-effetti sekondarji li jaffettwaw lill-ġisem kollu kemm hu.
English: Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.
Maltese: Xi pazjenti kienu mmonitorjati sa perjodu ta' mhux aktar minn disa' xhur f'estensjoni talistudji inizjali u komplew juru benefiċċju simili.
English: What measures are being taken to ensure the safe and effective use of Senstend?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Senstend?
English: For the full list of side effects reported with Senstend, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Senstend, ara l-fuljett ta' tagħrif.
English: In both studies, patients given the medicine reported substantially greater improvements in reported control, sexual satisfaction and distress than patients given the placebo.
Maltese: Fiż-żewġ studji, il-pazjenti li ngħataw il-mediċina rrapportaw titjib sostanzjalment akbar fil-kontroll, is-sodisfazzjon sesswali u t-tbatija rapportati mill-pazjenti li ngħataw il-plaċebo.
English: Further information on Isentress 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: The medicine is available as tablets to be swallowed (400 and 600 mg), chewable tablets (25 and 100 mg) and sachets containing granules for an oral suspension (each sachet containing 100 mg).
Maltese: Il-mediċina tiġi bħala pilloli li għandhom jinbelgħu (400 u 600 mg), pilloli li jintmagħdu (25 u 100 mg) u qratas li fihom granuli għal sospensjoni orali (kull qartas fih 100 mg).
English: Other information about Isentress:
Maltese: Aktar informazzjoni dwar Isentress:
English: The active substance in Isentress, raltegravir, is an integrase inhibitor.
Maltese: Is-sustanza attiva f'Isentress, ir-raltegravir, hija inibitur tal-integrażi.
English: Isentress received a conditional marketing authorisation valid throughout the European Union for Isentress on 20 December 2007.
Maltese: Isentress irċieva awtorizzazzjoni kkundizzjonata għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fl20 ta' Diċembru 2007.
English: Isentress is an HIV medicine that is used in combination with other HIV medicines to treat patients who are infected with human immunodeficiency virus (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Isentress huwa mediċina kontra l-HIV li tintuża f'kombinazzjoni ma' mediċini oħra kontra l-HIV fil-kura ta' pazjenti infettati bil-virus tal-immunodefiċjenza umana (HIV-1), virus li jikkawża s-sindromu talimmunodefiċjenza akkwiżita (AIDS).
English: After 48 weeks, 89% (472 of 531) of those on the once daily dose and 88% (235 of 266) of those taking Isentress twice daily had viral loads less than 40 copies/ml;
Maltese: Wara 48 ġimgħa, 89 % (472 minn 531) ta' dawk li kienu fuq id-doża ta' darba kuljum u 88 % (235 minn 266) ta' dawk li ngħataw Isentress darbtejn kuljum kellhom tagħbijiet virali inqas minn 40 kopja/ml;
English: • A sixth study included 26 children aged 4 weeks to 2 years who were given Isentress oral granules made into a suspension.
Maltese: • Is-sitt studju involva 26 tifel u tifla ta' età minn 4 ġimgħat sa sentejn li ngħataw granuli orali Isentress magħmula f'sospensjoni.
English: This study looked at viral loads after 24 and 48 weeks.
Maltese: Dan l-istudju ħares lejn tagħbijiet virali wara 24 u 48 ġimgħa.
English: After 48 weeks, 86% of the patients taking Isentress had viral loads below 50 copies/ml (241 out of 281), compared with 82% of those taking efavirenz (230 out of 282);
Maltese: Wara 48 ġimgħa, 86 % tal-pazjenti li kienu qed jingħataw Isentress kellhom tagħbijiet virali taħt il-50 kopja/ml (241 minn 281) meta mqabbla ma' 82 % ta' dawk li kienu qed jingħataw efavirenz (230 minn 282);
English: • A fourth study in 802 patients who had not taken HIV treatment before showed that giving Isentress as a single dose of 1,200 mg once daily was as effective as giving 400 mg twice daily.
Maltese: • Ir-raba' studju fuq 802 pazjenti li ma kinux ingħataw kura għall-HIV qabel wera li l-għoti ta' Isentress bħala doża unika ta' 1,200 mg darba kuljum kien effettiv daqs l-għoti ta' 400 mg darbtejn kuljum.
English: Patients also received the medicine Truvada (emtricitabine with tenofovir disoproxil).
Maltese: Il-pazjenti rċevew ukoll il-mediċina Truvada (emtricitabine b'tenofovir disoproxil).
English: • Two studies involved a total of 699 ‘treatment-experienced' patients who were already receiving treatment for HIV infection that was not working.
Maltese: • Żewġ studji li involvew total ta' 699 pazjent “imdorrijin bil-kura” li kienu diġà qegħdin jingħataw kura għall-infezzjoni tal-HIV liema kura ma kinitx qed taħdem.
English: It blocks an enzyme called integrase, which is involved in a step in the reproduction of HIV.
Maltese: Din timblokka enzima msejħa integrażi, li hija involuta f'pass fir-riproduzzjoni tal-HIV.
English: • A third study involved 566 patients who had not taken HIV treatment before and compared Isentress with efavirenz (another HIV medicine).
Maltese: • It-tielet studju involva 566 pazjent li qatt ma ngħataw kura għall-HIV qabel u qabbel lil Isentress ma' efavirenz (mediċina oħra kontra l-HIV).
English: What are the risks associated with Isentress?
Maltese: X'inhuma r-riskji assoċjati ma' Isentress?
English: • Isentress has also been studied in a fifth study involving 126 HIV-1 infected children between 2 and 18 years whose existing treatment for HIV infection was not working.
Maltese: • Isentress ġie studjat ukoll fil-ħames studju li involva 126 tifel u tifla ta' bejn is-sentejn u t-18-il sena infettati bl-HIV-1 li l-kura eżistenti tagħhom għall-infezzjoni tal-HIV ma kinitx qed taħdem.
English: The most common serious side effects are immune reconstitution syndrome (symptoms of infection caused by a recovering immune system) and rash.
Maltese: L-effetti sekondarji serji l-aktar komuni huma sindromu ta' rikostituzzjoni immunitarja (sintomi ta' infezzjoni kkawżati minn sistema immunitarja li qed tirkupra) u raxx.
English: There have also been uncommon reports of rhabdomyolysis (breakdown of muscle fibres).
Maltese: Kien hemm ukoll rapporti mhux komuni ta' rabdomijoliżi (il-qsim tal-fibri tal-muskoli).
English: • Additional supportive studies established doses that provide similar effective levels of Isentress in newborn infants as in young children.
Maltese: • Studji ta' sostenn addizzjonali stabbilixxew dożi li jipprovdu livelli effettivi ta' Isentress fi trabi ta' twelid li huma simili għal dawk fi tfal żgħar.
English: Isentress was as effective as efavirenz.
Maltese: Isentress kien effettiv daqs efavirenz.
English: The granules are to make a mixture for babies and children to drink, the chewable tablets are for bigger children, and the 400- and 600-mg tablets are for different dose regimens in older children and adults, as recommended by the doctor.
Maltese: Il-granuli huma għal taħlita għal trabi u tfal biex jixorbuha, il-pilloli li jintmagħdu huma għal tfal akbar, u l-pilloli ta' 400- u ta' 600mg huma għal skemi ta' dożi differenti fi tfal akbar fl-età u f'adulti, skont kif rakkomandat mit-tabib.
English: Isentress has been shown to be effective in helping control HIV when used with other HIV medicines.
Maltese: Isentress wera li kien effettiv biex jgħin jikkontrolla l-HIV meta jintuża ma' mediċini oħra kontra l-HIV.
English: The studies compared Isentress with placebo (a dummy treatment), which were added to ‘optimised background therapy' (a combination of other HIV medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood).
Maltese: L-istudji qabblu lil Isentress ma' plaċebo (kura finta), li żdied ma' “terapija ta' sfond ottimizzata” (kombinazzjoni ta' mediċini oħra kontra l-HIV magħżula għal kull pazjent minħabba li jkollha l-aħjar probabbiltà li tnaqqas il-livelli tal-HIV fid-demm).
English: For the full list of side effects and restrictions with Isentress, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'Isentress, ara l-fuljett ta' tagħrif.
English: How is Isentress used?
Maltese: Isentress?
English: As for all medicines, data on the use of Isentress are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Isentress hija ssorveljata kontinwament.
English: All of the patients also took tenofovir and emtricitabine (other HIV medicines).
Maltese: Il-pazjenti kollha ħadu wkoll tenofovir u emtricitabine (mediċini oħra kontra l-HIV).
English: The main measure of effectiveness was the reduction in the levels of HIV in the blood (viral load) after 16 weeks; 77% of the patients who took Isentress had viral loads below 400 copies/ml after 16 weeks, compared with 42% of those who took placebo.
Maltese: Il-kejl ewlieni tal-effikaċja kien it-tnaqqis fil-livelli tal-HIV fid-demm (tagħbija virali) wara 16-il ġimgħa; 77 % tal-pazjenti li ħadu Isentress kellhom tagħbijiet virali taħt l-400 kopja/ml wara 16-il ġimgħa, meta mqabbla ma' 42 % ta' dawk li ħadu l-plaċebo.
English: Isentress, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Isentress, meta jittieħed f'kombinazzjoni ma' mediċini oħra kontra l-HIV, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: The main measure of effectiveness was the number of patients who had ‘undetectable' viral loads (below 50 copies per millilitre of blood) after 48 weeks.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li kellhom tagħbijiet virali li “ma jistgħux jiġu osservati” (inqas minn 50 kopja għal kull millilitru demm) wara 48 ġimgħa.
English: Isentress treatment led to a reduction in viral load and after 48 weeks 53% of the children had viral loads below 50 copies/ml.
Maltese: Il-kura b'Isentress wasslet għal tnaqqis fit-tagħbija virali u wara 48 ġimgħa 53 % tat-tfal kellhom tagħbijiet virali taħt il-50 kopja/ml
English: This was switched to a full marketing authorisation on 14 July 2009.
Maltese: Din l-awtorizzazzjoni għat-tqegħid fis-suq saret sħiħa fl-14 ta' Lulju 2009.
English: The most common side effects with Isentress (seen in between 1 and 10 patients in 100) are headache, abdominal pain (stomach ache) and nausea (feeling sick).
Maltese: L-effetti sekondarji l-iktar komuni b'Isentress (li dehru f'bejn pazjent wieħed u 10 minn kull 100) huma wġigħ ta' ras, uġigħ addominali (uġigħ fl-istonku) u nawżja (tħossok ma tiflaħx).
English: Side effects in children were comparable to those in adults.
Maltese: L-effetti sekondarji fit-tfal kienu komparabbli ma' dawk fl-adulti.
English: Isentress does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Isentress ma jfejjaqx l-infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: When the enzyme is blocked, the virus cannot reproduce normally, slowing down the spread of infection.
Maltese: Meta l-enzima tiġi mblokkata, il-virus ma jistax jirriproduċi ruħu b'mod normali, b'hekk jitnaqqas it-tifrix tal-infezzjoni.
English: How does Isentress work?
Maltese: Kif jaħdem Isentress?
English: Date of last renewal: 09/08/2016
Maltese: Data tal-aħħar tiġdid: 09/08/2016
English: Cattle: SC, IV
Maltese: SC, IV
English: Bimeda Animal Health Limited, 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Ireland.
Maltese: Bimeda Animal Health Limited, 2, 3 & 4 Airton Close, Tallaght, Dublin 24, Irlanda.
English: EU/2/11/133/001 EU/2/11/133/002 EU/2/11/133/003
Maltese: EU/2/11/133/002 EU/2/11/133/003
English: LOT {number}
Maltese: Jiskadi {xahar/sena}
English: Ireland.
Maltese: Irlanda
English: Excipient: Ethanol 99.9% 150 mg
Maltese: Ethanol 99.9% 150 mg.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13/09/2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 13/09/2011
English: Pigs: IM
Maltese: Majjali: IM
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: 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: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Maltese: Meloxicam Meloxicam Frat, mogħoż, majjali, fniek,
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għal aġġustament pH) Hydrochloric acid (għal aġġustament pH)
English: Interactions with other medicinal products and other forms of interaction:
Maltese: Interazzjonijiet ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni: