FrancophonIA/ELRC3.0 huggingface dataset:
English: In the main study, 67% of the women who received the approved dose of Luveris (75 International Units) together with FSH produced functional follicles (6 out of 9).
Maltese: Fl-istudju prinċipali, 67% tan-nisa li ngħataw id-doża approvata ta' Luveris (75
English: This is a summary of the European public assessment report (EPAR) for Luveris.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Luveris.
English: Luveris, given together with FSH, has been studied in one main study involving 38 women with severe LH and FSH deficiency.
Maltese: Luveris, flimkien ma' FSH, ġie studjat fi studju ewlieni li kien jinvolvi 38 mara b'nuqqas gravi ta' LH u FSH.
English: It is used with follicle stimulating hormone (FSH) to stimulate the development of eggs in the ovaries of adult women who have severe deficiency (very low levels) of luteinising hormone (LH) and FSH.
Maltese: Dan jintuża flimkien mal-ormon li jistimula l-follikulu (FSH) sabiex jistimula l-iżvilupp ta' bajd fl-ovarji ta' nisa adulti li jkollhom nuqqas gravi (livelli baxxi ħafna) talormon luteinizzanti (LH - luteinising hormone) u FSH.
English: Why has Luveris been approved?
Maltese: Għaliex ġie approvat Luveris?
English: FSH, which is used together with Luveris, also stimulates ovulation.
Maltese: FSH, li jintuża flimkien ma' Luveris, jistimula wkoll l-ovulazzjoni.
English: Treatment with Luveris should be carried out by a doctor who has experience in the treatment of fertility problems.
Maltese: It-trattament b'Luveris għandu jsir minn tabib li għandu esperjenza fit-trattament ta' problemi ta' fertilità.
English: What is Luveris?
Maltese: X'inhu Luveris?
English: How has Luveris been studied?
Maltese: Kif ġie studjat Luveris?
English: It must not be used in women who have tumours of the pituitary gland, hypothalamus (a region of the brain), breast, womb or ovary.
Maltese: M'għandux jintuża f'nisa b'tumuri fil-glandola pitwitarja, fl-ipotalama (parti mill-moħħ), fis-sider, fil-ġuf, jew fl-ovarji.
English: What is the risk associated with Luveris?
Maltese: X'inhu r-riskju assoċjat ma' Luveris?
English: The marketing authorisation is valid for an unlimited period.
Maltese: L-awtorizzazzjoni għat-tqegħid fissuq hija valida għal perjodu mhux limitat.
English: Ovarian hyperstimulation syndrome occurs when the ovaries over respond to treatment, especially when medicines to trigger ovulation have been used, and can cause nausea, weight gain and diarrhoea.
Maltese: Is-sindromu tal-iperstimulazzjoni tal-ovarji jseħħ meta l-ovarji jirrispondu aktar milli suppost għat-trattament, speċjalment meta jkunu ntużaw mediċini li jqanqlu l-ovulazzjoni, u jista' jikkawża nawzja, żieda fil-piż u dijarrea.
English: The CHMP decided that Luveris's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Luveris huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Adempas is available as tablets (0.5, 1, 1.5, 2 and 2.5 mg).
Maltese: Adempas jiġi bħala pilloli (0.5, 1, 1.5, 2 u 2.5 mg).
English: Adempas (riociguat)
Maltese: Adempas (riokigwat)
English: Other information about Adempas
Maltese: Informazzjoni oħra dwar Adempas
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/en/medicines/human/orphan-designations/eu307518.
English: The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity while ‘class III' involves marked limitation of physical activity.
Maltese: Il-“klassi” tirrifletti l-gravità tal-marda: “klassi II” tinvolvi limitazzjoni żgħira tal-attività fiżika filwaqt li “klassi III” tinvolvi limitazzjoni evidenti tal-attività fiżika.
English: Further information on Adempas can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/adempas.
Maltese: ema.europa.eu/en/medicines/human/EPAR/adempas.
English: Adempas received a marketing authorisation valid throughout the European Union on 27 March 2014.
Maltese: Adempas irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fis27 ta' Marzu 2014.
English: Adempas contains the active substance riociguat.
Maltese: Adempas fih is-sustanza attiva riokigwat.
English: The maximum dose should not exceed 2.5 mg three times a day.
Maltese: Id-doża massima ma għandhiex taqbeż 2.5 mg kuljum.
English: CTEPH and PAH are rare, and Adempas was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 December 2007.
Maltese: CTEPH u PAH huma rari, u Adempas ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl-20 ta' Diċembru 2007.
English: • The medicine was also compared with placebo in another main study in 445 patients with PAH.
Maltese: • Il-mediċina tqabblet ukoll ma' plaċebo fi studju ewlieni ieħor f'445 pazjent b'PAH.
English: Why is Adempas approved?
Maltese: Għaliex ġie approvat Adempas?
English: • Chronic thromboembolic pulmonary hypertension (CTEPH, where the blood vessels of the lungs are blocked or narrowed with blood clots).
Maltese: • Ipertensjoni pulmonari tromboembolika kronika (CTEPH, fejn il-vażijiet tal-pulmun huma mblokkati jew imdejqa b'emboli tad-demm).
English: The active substance in Adempas, riociguat, stimulates an enzyme called ‘soluble guanylate cyclase' in the blood vessels of the lungs, which causes the blood vessels to relax and widen.
Maltese: Is-sustanza attiva f'Adempas, ir-riociguat, tistimula enzima msejħa ‘gwanilat ċiklasi solubbli' fil-vażijiet tal-pulmun, li tikkawża lill-vażijiet biex jirrilassaw u jitwessgħu.
English: It must also not be used together with medicines called ‘PDE 5 inhibitors' (a class of medicines used for PAH or erectile dysfunction) or with nitrates or nitric oxide donors (often used to treat high blood pressure, chest pain and heart disease, or as recreational drugs).
Maltese: Lanqas ma għandu jintuża flimkien ma' mediċini msejħa “inibituri PDE 5” (klassi ta' mediċini użati għal PAH jew disfunzjoni erettili) jew b'nitrati jew donaturi ta' ossidu nitriku (spiss użati għall-kura ta' pressjoni tad-demm għolja, uġigħ fis-sider u mard tal-qalb, jew bħala mediċini rikreattivi).
English: Serious side effects include haemoptysis (coughing up blood) and pulmonary haemorrhage (bleeding in the lungs).
Maltese: Effetti sekondarji serji jinkludu emottiżi (sogħla tad-demm) u emorraġija pulmonari (tnixxija ta' demm fil-pulmun).
English: The most common side effects with Adempas (which may affect more than 1 in 10 people) are headache, dizziness, dyspepsia (heartburn), peripheral oedema (swelling, especially of the ankles and feet), nausea (feeling sick), diarrhoea and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Adempas (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma wġigħ ta' ras, sturdament, dispepsija (ħruq ta' stonku), edema periferali (nefħa, speċjalment fl-għekiesi u fis-saqajn), nawżja (tħossok ma tiflaħx), dijarea u rimettar.
English: • Adempas was compared with placebo (a dummy treatment) in one main study in 262 patients with CTEPH who could not be operated, or in whom CTEPH remained or returned after surgery.
Maltese: • Adempas tqabbel ma' plaċebo (kura finta) fi studju ewlieni wieħed f'262 pazjent bi CTEPH li ma setax jiġi operat, jew jibqgħu jsofru jew jerġgħu jibdew isofru minn CTEPH wara l-kirurġija.
English: The usual recommended starting dose is 1 mg three times a day (approximately 6 to 8 hours apart) for two weeks.
Maltese: Normalment id-doża rakkomandata tal-bidu hija ta' 1 mg tliet darbiet kuljum (bejn wieħed u ieħor b'intervalli ta' 6 sa 8 sigħat) għal ġimagħtejn.
English: After 16 weeks, patients treated with Adempas could walk on average 46 metres further in 6 minutes than patients taking placebo.
Maltese: Wara 16-il ġimgħa, il-pazjenti kkurati b'Adempas setgħu jimxu medja ta' 46 metru aktar f'6 minuti minn pazjenti li kienu qed jieħdu l-plaċebo.
English: How is Adempas used?
Maltese: Adempas?
English: After 12 weeks, patients treated with Adempas could walk 36 metres further in 6 minutes than patients taking placebo.
Maltese: Wara 12-il ġimgħa, il-pazjenti kkurati b'Adempas setgħu jimxu 36 metru aktar f'6 minuti minn pazjenti li kienu qed jieħdu l-plaċebo.
English: As for all medicines, data on the use of Adempas are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Adempas hija ssorveljata kontinwament.
English: Regarding safety it considered that side effects of concern, including haemoptysis and pulmonary haemorrhage, have been adequately reflected in the product information and risk management plan.
Maltese: Fir-rigward tas-sigurtà kkunsidrat li l-effetti sekondarji ta' tħassib, inklużi emottiżi u emorraġija pulmonari, ġew riflessi b'mod adegwat fl-informazzjoni dwar il-prodott u fil-pjan tal-ġestjoni tar-riskju.
English: Adempas has been shown to be effective at improving the distance patients with CTEPH or PAH could walk in 6 minutes (a way of measuring exercise capacity):
Maltese: Adempas wera li kien effettiv biex itejjeb id-distanza li l-pazenti bi CTEPH jew PAH setgħu jimxu f'6 minuti (mod ta' kif titkejjel il-kapaċità ta' eżerċizzju):
English: Adempas is a medicine that is used to increase the ability to carry out physical activity in adults with the following forms of pulmonary hypertension (high blood pressure in the blood vessels of the lungs):
Maltese: Adempas huwa mediċina li tintuża biex iżżid l-abbiltà li titwettaq attività fiżika fl-adulti bil-forom li ġejjin ta' ipertensjoni pulmonari (pressjoni tad-demm għolja fil-vażijiet tal-pulmun):
English: CTEPH and PAH are debilitating diseases where there is severe narrowing of the blood vessels of the lungs.
Maltese: CTEPH u PAH huma mard debilitanti fejn ikun hemm tidjiq serju tal-vażijiet tal-pulmun.
English: Adempas is used in patients with functional class II to III CTEPH or PAH.
Maltese: Adempas jintuża f'pazjenti bi CTEPH jew PAH tal-klassi funzjonali
English: • Pulmonary arterial hypertension (PAH, where the walls of the blood vessels of the lungs are thickened and the vessels become narrowed).
Maltese: • L-ipertensjoni arterjali pulmonari (PAH, fejn il-ħitan tal-vażijiet tal-pulmun jeħxienu u l-vażijiet jidjiequ).
English: What are the risks associated with Adempas?
Maltese: X'inhuma r-riskji assoċjati ma' Adempas?
English: Adempas can be used on its own or in combination with other medicines for PAH called ‘endothelin receptor antagonists'.
Maltese: Adempas jista' jintuża waħdu jew flimkien ma' mediċini oħra għal PAH imsejħa ‘antagonisti tar-riċettur ta' endothelin'.
English: The Agency therefore decided that Adempas's benefits are greater than its risks and that it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-Aġenzija ddeċidiet li l-benefiċċji ta' Adempas huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: For the full list of side effects with Adempas, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Adempas, ara l-fuljett ta' tagħrif.
English: Route of Administration Immediate Packaging Pack size
Maltese: Daqs tal-pakkett
English: EMA/787689/2015 EMEA/H/C/002616
Maltese: EMA/787689/2015 EMA/H/C/002616
English: Wakix is available as tablets (4.5 and 18 mg).
Maltese: Wakix jiġi bħala pilloli (4.5 u 18 mg).
English: Wakix contains the active substance pitolisant.
Maltese: Wakix fih is-sustanza attiva pitolisant.
English: The most common side effects with Wakix (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), anxiety, irritability, dizziness, depression, tremor, sleep disorders, tiredness, vomiting, vertigo (a spinning sensation) and dyspepsia (heartburn).
Maltese: L-effetti sekondarji l-aktar komuni b'Wakix (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma insomnja (diffikultà biex torqod), uġigħ ta' ras, nawżja (tħossok imdardar), ansjetà, irritabbiltà, sturdament, dipressjoni, tregħid, disturbi tal-irqad, għejja, rimettar, vertigo (sensazzjoni ta' tidwir) u dispepsja (ħruq ta' stonku).
English: Serious but rare side effects are abnormal loss of weight and spontaneous abortion.
Maltese: Effetti sekondarji imma rari huma telf anormali tal-piż u abort spontanju.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Wakix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Wakix.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Wakix.
English: The full EPAR and risk management plan summary for Wakix 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: In patients with moderately reduced liver function or with kidney problems, the maximum dose should be 18 mg per day.
Maltese: F'pazjenti b'funzjoni moderament imnaqqsa tal-fwied jew bi problemi tal-kliewi, id-doża massima għandha tkun 18 mg kuljum.
English: Because the number of patients with narcolepsy is low, the disease is considered ‘rare', and Wakix was designated an ‘orphan medicine' (a medicine used in rare diseases) on 10 July 2007.
Maltese: Minħabba li n-numru ta' pazjenti bin-narkolessija huwa wieħed baxx, il-marda hija meqjusa bħala ‘rari', u Wakix ġie denominat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fl-10 ta' Lulju 2007.
English: Other information about Wakix
Maltese: Informazzjoni oħra dwar Wakix
English: During the second week of treatment, the dose can be increased to 18 mg per day or decreased to 4.5 mg per day.
Maltese: 18 mg kuljum jew titnaqqas għal 4.5 mg kuljum.
English: What are the risks associated with Wakix?
Maltese: X'inhuma r-riskji assoċjati ma' Wakix?
English: In a further study in 105 patients with narcolepsy and cataplexy, Wakix was also more effective than placebo at reducing the number of cataplexy attacks per week: the number of cataplexy attacks decreased from around 9 to around 3 per week in patients taking Wakix, while it remained at around 7 per week in patients taking placebo.
Maltese: Fi studju ieħor f'105 pazjenti bin-narkolessija u l-katalessija, Wakix kien ukoll aktar effettiv millplaċebo fit-tnaqqis tan-numru ta' attakki tal-katalessija kull ġimgħa: in-numru ta' attakki talkatalessija naqas minn madwar 9 għal madwar 3 fil-ġimgħa f'pazjenti li kienu qed jieħdu Wakix, filwaqt li baqa' madwar 7 kull ġimgħa f'pazjenti li kienu qed jieħdu l-plaċebo.
English: This is a standard scale used in patients with narcolepsy which ranges from 0 to 24.
Maltese: Din hija skala standard użata f'pazjenti binnarkolessija li tvarja bejn 0 u 24.
English: Why is Wakix approved?
Maltese: Għalxiex ġie approvat Wakix?
English: the dose may be further increased to the maximum dose of 36 mg per day.
Maltese: Waqt it-tielet ġimgħa, id-doża tista' tiżdied aktar saddoża massima ta' 36 mg kuljum.
English: Wakix has been investigated in 2 main studies involving a total of 261 adults with narcolepsy, the majority of whom also had cataplexy.
Maltese: Wakix ġie studjat f'2 studji ewlenin li kienu jinvolvu total ta' 261 adult bin-narkolessija, fejn ilmaġġoranza tagħhom kellhom ukoll il-katalessija.
English: Wakix is a medicine used to treat adults with narcolepsy.
Maltese: Wakix huwa mediċina li tintuża biex tikkura adulti li jbatu bin-narkolessija.
English: The active substance in Wakix, pitolisant, works by attaching to receptors in the brain called ‘histamine H3 receptors'.
Maltese: Is-sustanza attiva f'Wakix, il-pitolisant, taħdem billi teħel mar-riċetturi fil-moħħ li jissejħu "riċetturi H3 tal-istamina".
English: The first study showed that Wakix was more effective than placebo at reducing daytime sleepiness: patients taking Wakix had an average reduction of 3 points more in the ESS scale than those taking placebo after 8 weeks of treatment.
Maltese: L-ewwel studju wera li Wakix kien aktar effettiv mill-plaċebo fit-tnaqqis tan-ngħas ta' matul il-jum: ilpazjenti li ħadu Wakix kellhom tnaqqis medju ta' 3 punti aktar fl-iskala ESS minn dawk li ħadu lplaċebo wara 8 ġimgħat ta' kura.
English: During the first week of treatment, the recommended dose is 9 mg per day, taken in the morning during breakfast.
Maltese: Waqt l-ewwel ġimgħa ta' kura, id-doża rakkomandata hija 9 mg kuljum, meħuda filgħodu waqt il-kolazzjon.
English: How is Wakix used?
Maltese: Wakix?
English: The overall data available demonstrate that Wakix has a positive effect on the two major symptoms of narcolepsy, excessive daytime sleepiness and cataplexy.
Maltese: Id-data ġenerali disponibbli turi li Wakix għandu effett pożittiv fuq iż-żewġ sintomi kbar ta' narkolessija, ngħas eċċessiv matul il-jum u katalessija.
English: In addition, Wakix works differently from currently available treatments and therefore offers an alternative treatment option.
Maltese: Barra minn hekk, Wakix jaħdem b'mod differenti minn kuri disponibbli attwalment u għaldaqstant joffri għażla alternattiva ta' kura.
English: In addition, the company that markets Wakix will carry out an observational study to collect information on the safety of the medicine when used in medical practice.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Wakix fis-suq sejra twettaq studju ta' osservazzjoni sabiex tiġbor informazzjoni dwar is-sigurtà tal-mediċina meta tintuża fi prattika medika.
English: A risk management plan has been developed to ensure that Wakix is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Wakix jintuża bl-aktar mod sigur possibbli.
English: When looking at sleepiness with an objective test called Maintenance of Wakefulness Test or MWT, the results of the two studies together showed that Wakix significantly improved wakefulness compared with placebo.
Maltese: Dan iwassal għal sintomi bħal impuls irreżistibbli sabiex torqod, anke f'ħinijiet u f'postijiet mhux adatti, u disturb fl-irqad ta' bil-lejl.
English: Narcolepsy is a long-term sleep disorder which affects the brain's ability to regulate the normal sleep-wake cycle.
Maltese: In-narkolessija hija disturb tal-irqad fit-tul li taffettwa l-abilità tal-moħħ li jirregola ċ-ċiklu normali tal-irqad u l-qawmien.
English: For the full list of all side effects reported with Wakix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Wakix, ara l-fuljett ta' tagħrif.
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe
Maltese: 0.6 ml (10 mg/ml) siringa mimlija għal-lest 1
English: Subcutaneous use pre-filled syringe (glass)
Maltese: Użu għal taħt ilġilda siringa mimlija għal-lest (ħġieġ)
English: Article 35 of Directive 2001/82/EC, as amended
Maltese: Artiklu 35 tad-Direttiva 2001/82/KE, kif emendat
English: The referral started on 6 November 2013.
Maltese: Ir-riferiment beda fis-6 ta' Novembru 2013.
English: International non-proprietary name (INN): tylosin
Maltese: Isem mhux proprjetarju internazzjonali (INN): tylosin
English: Opinion following an Article 35
Maltese: Opinjoni wara riferiment tal-Artiklu 35
English: Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae.
Maltese: Tylosin huwa antibijotiku makrolidu prodott minn Streptomyces fradiae.
English: 31 July 2014
Maltese: 31 ta' Lulju 2014
English: The Committee appointed E. Persson as rapporteur and A. Wachnik-Święcicka as co-rapporteur.
Maltese: Wachnik-Święcicka bħala ko-rapporteur.
English: Committee for medicinal products for veterinary use (CVMP)
Maltese: Kumitat għal prodotti mediċinali għal użu veterinarju (CVMP)
English: On 30 October 2013, Sweden presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Maltese: Fit-30 ta' Ottubru 2013, l-Isvezja ppreżentat lill-Aġenzija notifika ta' riferiment skont l-Artiklu 35 tadDirettiva 2011/82/KE, fir-rigward tal-prodotti mediċinali veterinarji li fihom tylosin sabiex jingħataw oralment permezz ta' ikel jew ilma għax-xorb lill-majjali.
English: Tylosin is not used in human medicine.
Maltese: Tylosin mhuwiex użat f'mediċni għall-bnedmin.
English: The CVMP was requested to consider whether tylosin is still effective against swine dysentery (caused by Brachyspira hyodysenteriae) and whether the treatment durations beyond three weeks are justified.
Maltese: Is-CVMP intalab jikkunsidra jekk tylosin għadux effettiv kontra diżenterija tal-majjali (ikkawżata minn Brachyspira hyodysenteriae) u jekk it-tul ta' kura aktar minn tliet ġimgħat huwiex iġġustifikat.
English: It may be administered by oral or parenteral routes.
Maltese: Jista' jingħata minn rotot orali jew parenterali.
English: Written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders on 7 March 2014.
Maltese: Kummenti bil-miktub dwar ir-rakkomandazzjonijiet u lbidliet proposti fl-infomrazzjoni tal-prodott ġew ipprovduti mill-applikanti u d-detenturi talawtorizzazzjoni għat-tqegħid fis-suq fis-7 ta' Marzu 2014.
English: Tylosin and its phosphate and tartrate salts are used in food producing species for the treatment of conditions caused by sensitive organisms.
Maltese: Tylosin u l-imluħa fosfat u tartariċi jintużaw fi speċi li jipproduċu l-ikel għall-kura ta' kundizzjonijiet ikkawżati minn organiżmi sensittivi.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Maltese: Abbażi ta' evalwazzjoni tad-dejta disponibbli attwalment, is-CVMP ikkunsidra li l-profil ġenerali talbenefiċċju-riskju ta' dawn il-prodotti jibqa' pożittiv soġġett għal emendi fl-informazzjoni tal-prodott.
English: Opinion following an Article 35 referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs EMA/492247/2014
Maltese: Opinjoni wara riferiment tal-Artiklu 35 għal prodotti mediċinali veterinarji li fihom tylosin sabiex jiġu amministrati oralment permezz ta' ikel jew ilma għax-xorb lillmajjali
English: referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs
Maltese: 1 għal prodotti mediċinali veterinarji li fihom tylosin sabiex jiġu amministrati oralment permezz ta' ikel jew ilma għaxxorb lill-majjali
English: Therefore, on 8 May 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Maltese: Għalhekk, fit-8 ta' Mejju 2014 il-Kumitat adotta b'kunsens opinjoni pożittiva, u rrakkomanda varjazzjonijiet għat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali
English: Package size βlister (PVC/PE/PVDC/alu)
Maltese: Daqs tal-pakkett blister (PVC/PE/PVDC/alu) granet tal-ġimgħa
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Isem ivvintat Qawwa Għamla farmaċewtika
English: • Information about the following adverse reactions: o Infusion reactions o Hypersensitivity reactions o Antibody formation
Maltese: o Reazzjonijiet għall-infużjoni o Reazzjonijiet ta' sensittività eċċessiva o Formazzjoni ta' antikorpi
English: • Information on PML and IRIS including the risk of developing PML during Tysabri treatment stratified by prior treatment with immunosuppressants and JC virus infection.
Maltese: • Tagħrif dwar PML u IRIS inkluż ir-riskju ta' żvilupp ta' PML waqt kura b' TYSABRI stratifikat skont kura minn qabel b'immunosoppressanti u infezzjoni mill-virus JC.