FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Improvac can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This summary was last updated in September 2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Settembru 2017.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku
English: The most common side effects with Improvac (which may affect more than 1 in 10 pigs) are injection site swelling, which gradually resolves but in 20 to 30% of animals will last for more than 6 weeks, and a short-lived increase in body temperature of around 0.5 ˚C within 24 hours of vaccination.
Maltese: L-effetti sekondarji l-aktar komuni b'Improvac (li jistgħu jaffettwaw aktar minn 1 minn kull 10 ħnieżer) huma nefħa fis-sit tal-injezzjoni, li titlaq gradwalment iżda f'20 sa 30 % tal-annimali ddum għal aktar minn 6 ġimgħat, u żieda fit-temperatura tal-ġisem li ma ddumx ta' madwar 0.5 ˚C fi żmien 24 siegħa mit-tilqim.
English: The European Commission granted a marketing authorisation valid throughout the EU for Improvac on 11 May 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Improvac fil-11 ta' Mejju 2009.
English: Other information about Improvac?
Maltese: Informazzjoni oħra dwar Improvac?
English: This is a summary of the European public assessment report (EPAR) for Improvac.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Improvac.
English: What are the risks associated with Improvac?
Maltese: X'inhuma r-riskji assoċjati ma' Improvac?
English: The first injection is from 8 weeks of age and the second 4 to 6 weeks before slaughter.
Maltese: L-ewwel injezzjoni hija mill-età ta' 8 ġimgħat u t-tieni 4 sa 6 ġimgħat qabel il-qtil.
English: The active substance in Improvac is an analogue of (similar to) gonatadotropin releasing factor (GnRF) linked to a carrier protein obtained from the bacterium Corynebacterium diphtheriae.
Maltese: Is-sustanza attiva f'Improvac hija analogu ta' (simili għal) fattur li jirrilaxxa l-gonatadotropin (GnRF) marbut ma' proteina ġarriera miksuba mill-batterju Corynebacterium diphtheriae.
English: This temporarily inhibits release of steroids from the testicles, including androstenone, one of the two causes of boar taint.
Maltese: Dan jinibixxi b'mod temporanju r-rilaxx ta' sterojdi mit-testikoli, inkluż androstenone, wieħed miż-żewġ kawżi ta' riħa jew togħma tal-ħanżir.
English: Androstenone and skatole levels are reduced from 4 to 6 weeks after the second injection and reduction of aggression and sexual behaviour is seen from 1 to 2 weeks after the second injection.
Maltese: Il-livelli ta' androstenone u skatole jitnaqqsu minn 4 sa 6 ġimgħat wara t-tieni injezzjoni u t-tnaqqis fl-aggressjoni u fl-imġiba sesswali jidher minn ġimgħa sa ġimagħtejn wara t-tieni injezzjoni.
English: Boar taint is caused by the production and build-up of the natural compounds androstenone and skatole in the flesh of these animals.
Maltese: Ir-riħa jew it-togħma tal-ħanżir tiġi kkawżata mill-produzzjoni u l-akkumulazzjoni tal-komposti naturali androstenone u skatole fil-laħam ta' dawn l-annimali.
English: Improvac works by stimulating the pig's immune system to produce antibodies against gonadotropin-releasing hormone (GnRH), part of the system that controls sexual development.
Maltese: Improvac jaħdem billi jistimula s-sistema immuni tal-ħanżir biex tipproduċi antikorpi kontra ormon li jirrilaxxa l-gonatadotropin (GnRH), parti mis-sistema li tikkontrolla l-iżvilupp sesswali.
English: Improvac contains the active substance gonadotropin releasing factor (GnRF) analogue-protein conjugate.
Maltese: Improvac fih is-sustanza attiva konjugat ta' analogu ta' proteina ta' fattur li jirrilaxxa gonadotropin (GnRF).
English: Improvac gonadotropin releasing factor (GnRF) analogue-protein conjugate
Maltese: Improvac konjugat ta' analogu ta' proteina ta' fattur li jirrilaxxa l-gonadotropin (GnRF, gonadotropin releasing factor)
English: The first injection had a limited effect, but the second injection is followed by production of antibodies against GnRF.
Maltese: L-ewwel injezzjoni kellha effett limitat, iżda t-tieni injezzjoni tiġi segwita mill-produzzjoni ta' antikorpi kontra
English: Why is Improvac approved?
Maltese: Għaliex ġie approvat Improvac?
English: For the full list of restrictions and all side effects reported with Improvac, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet u tal-effetti sekondarji kollha rrappurtati b'Improvac, ara l-fuljett ta' tagħrif.
English: Two studies showed reduction of aggression and mounting from 1 to 2 weeks after the second injection of Improvac, while the third studied the long term effect on aggression and mounting after 4 weeks only.
Maltese: Żewġ studji wrew tnaqqis ta' aggressjoni u rkib minn ġimgħa sa ġimagħtejn wara t-tieni injezzjoni ta' Improvac, filwaqt li t-tielet wieħed studja l-effett fit-tul fuq l-aggressjoni u l-irkib wara biss 4 ġimgħat.
English: These may include a temporary reduction in sex hormone levels and reduced ability to reproduce in men and in women, including problems with pregnancy.
Maltese: Dawn jistgħu jinkludu tnaqqis temporanju fil-livelli tal-ormon sesswali u abbiltà mnaqqsa għar-riproduzzjoni fl-irġiel u fin-nisa, inkluż problemi fit-tqala.
English: Improvac also reduces aggressive and sexual (mounting) behaviour in pigs.
Maltese: Improvac itejjeb ukoll l-imġiba aggressiva u sesswali (irkib) fil-ħnieżer.
English: In a number of field studies pigs treated with Improvac were comparable to surgically castrated pigs in terms of levels of androstenone and skatole at slaughter.
Maltese: F'numru ta' studji fuq il-post, il-ħnieżer ikkurati b'Improvac kienu komparabbli għal ħnieżer kastrati b'kirurġija f'termini ta' livelli ta' androstenone u skatole mal-qtil.
English: Three field studies investigated the effectiveness of Improvac in reducing aggression and sexual behaviour in pigs.
Maltese: Tliet studji fuq il-post investigaw l-effettività ta' Improvac fit-tnaqqis tal-aggressjoni u l-imġiba sesswali fil-ħnieżer.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Improvac's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Improvac huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Improvac also contains a compound derived from the sugar dextran as an adjuvant (ingredient that strengthens the immune response).
Maltese: Improvac fih ukoll kompost derivat mid-dextran taz-zokkor bħala addittiv (ingredjent li jsaħħaħ ir-rispons immuni).
English: The full EPAR for Preotact 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 05-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 05-2012.
English: Preotact significantly reduced the risk of having a vertebral fracture, in comparison with placebo: after 18 months, there were 42 vertebral fractures in the placebo group (3.37) and 17 in the Preotact group (1.32).
Maltese: Preotact naqqas drastikament ir-riskju li jkun hemm ksur vertebrali, meta mqabbel ma' plaċebo: wara 18-il xahar, kien hemm 42 ksur vertebrali fil-grupp tal-plaċebo (3.37) u 17 fil-grupp ta' Preotact (1.32).
English: Preotact was compared with placebo (a dummy treatment).
Maltese: Preotact tqabbel ma' plaċebo (trattament finta).
English: Preotact has been studied in one main study involving 2,532 women with postmenopausal osteoporosis.
Maltese: Preotact ġie studjat fi studju li involva 2,532 mara li jbatu minn osteoporożi ta' wara l-menopawża.
English: Preotact parathyroid hormone
Maltese: Preotact ormon paratirojdu
English: This is a summary of the European public assessment report (EPAR) for Preotact.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Preotact.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a bacterium that has received a gene (DNA) that makes it able to produce it.
Maltese: Dan huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': l-ormon huwa magħmul minn batterju li jkun irċieva ġene (DNA) li jagħmilha possibbli li jipproduċih.
English: The most common side effects with Preotact (seen in more than 1 patient in 10) are hypercalcaemia (high blood calcium levels), hypercalciuria (high calcium levels in the urine) and nausea (feeling sick).
Maltese: L-aktar effetti sekondarji komuni b'Preotact (li dehru f'aktar minn pazjent 1 minn kull 10) huma liperkalsemija (livelli għolja ta' kalċju fid-demm), iperkalsjurja (livelli għolja ta' kalċju fl-awrina) u nawżja (tħossok ma tiflaħx).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Preotact on 24 April 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Preotact valida fl-Unjoni Ewropea kollha fl-24 ta' April 2006.
English: The recommended dose of Preotact is 100 micrograms, given once a day as an injection under the skin into the abdomen.
Maltese: Id-doża rakkomandata ta' Preotact hija ta' 100 mikrogramma, darba kuljum bħala injezzjoni taħt ilġilda fl-addome.
English: What is Preotact?
Maltese: X'inhu Preotact?
English: Preotact is a medicine that contains the active substance parathyroid hormone.
Maltese: Preotact huwa mediċina li fih is-sustanza attiva ormon paratirojdu.
English: • with unexplained high levels of alkaline phosphatase (an enzyme),
Maltese: • persuni li jbatu minn disturbi li jaffettwa l-bilanċ tal-kalċju u l-fosfat fil-ġisem,
English: Preotact contains parathyroid hormone, which stimulates bone formation by acting on osteoblasts (bone forming cells).
Maltese: Preotact taħdem bħall-ormon biex tistimula l-formazzjoni tal-għadam billi taġixxi fuq osteoblasts (ċelloli li jiffurmaw l-għadam).
English: The parathyroid hormone in Preotact is identical to the human parathyroid hormone.
Maltese: L-ormon paratirojdu f'Preotact huwa l-istess bħall-ormon paratirojdu uman.
English: Patients may also need to take calcium and vitamin D supplements if they do not have enough from their diet. Preotact can be used for up to 24 months, after which patients can be treated with a bisphosphonate (a medicine that reduces bone loss).
Maltese: Preotact jista' jibqa' jittieħed sa mhux aktar minn 24 xahar, imbagħad ilpazjenti jisgħu jkomplu jiġu kkurati bil-bisfosfonat (mediċina li tnaqqas it-telf tal-għadam).
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.
Maltese: Finnisa, l-osteoporożi hija aktar komuni wara l-menopawża, meta l-livelli tal-ormon tan-nisa, l-estroġenu, jaqgħu.
English: When the cartridge is inserted in the special injection pen and the pen screwed together, or when the pre-filled pen is prepared for use, the powder and solvent mix to make up the solution for injection.
Maltese: It-tnaqqis tar-riskju kien inqas fin-nisa li diġà kellhom vertebra miksura fil-passat, u fin-nisa li diġà kellhom skor baxx tad-densità tal-għadam meta beda l-istudju, u dan jindika li kellhom spina aktar fraġli.
English: Why has Preotact been approved?
Maltese: Għaliex ġie approvat Preotact?
English: What is the risk associated with Preotact?
Maltese: X'inhu r-riskju assoċjat ma' Preotact?
English: Preotact is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women who are at high risk of fractures.
Maltese: Preotact wera li jnaqqas b'mod sinifikanti l-ksur vertebrali (tas-sinsla tad-dahar), iżda mhux il-ksur fil-ġenbejn.
English: • who have a bone disease that is not osteoporosis,
Maltese: • persuni li għandhom marda fl-għadam li mhix l-osteoporożi,
English: The bone density was also the main measure in another study, which looked at the use of Preotact with or without alendronate (a bisphosphonate).
Maltese: Id-densità tal-għadam kien ukoll il-kejl ewlieni fi studju ieħor, li ffoka fuq l-użu ta' Preotact flimkien jew mingħajr l-alendronat (bisfosfonat).
English: How has Preotact been studied?
Maltese: Kif ġie studjat Preotact?
English: EMA/619580/2012 EMEA/H/C/002568
Maltese: EMEA/H/C/002568
English: The full EPAR for Capecitabine Medac 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 tablets (150, 300 and 500 mg).
Maltese: Jiġi f'pilloli (150, 300 u 500 mg).
English: 5-FU is an analogue of pyrimidine.
Maltese: 5-FU hu analogu tal-pirimidina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Medac on 19 November 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Capecitabine Medac fid-19 ta' Novembru 2012.
English: Capecitabine Medac capecitabine
Maltese: Aktar tagħrif dwar Capecitabine Medac
English: It is used to treat:
Maltese: Jintuża għat-trattament ta':
English: Capecitabine Medac is a ‘generic' and a ‘hybrid' medicine.
Maltese: Capecitabine Medac huwa mediċina ‘ġenerika' u ‘ibrida'.
English: It is taken as tablets, while 5-FU normally needs to be injected.
Maltese: Tittieħed bħala pilloli, waqt li 5-FU normalment tkun trid tiġi injettata.
English: Pyrimidine is part of the genetic material of cells (DNA and RNA).
Maltese: Il-pirimidina hi parti mill-materjal ġenetiku taċ-ċelloli (DNA u RNA).
English: This is a summary of the European public assessment report (EPAR) for Capecitabine Medac.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Capecitabine Medac.
English: Treatment is continued for six months after colon surgery.
Maltese: It-trattament jitkompla għal sitt xhur wara l-intervent kirurġiku fil-kolon.
English: • advanced gastric (stomach) cancer.
Maltese: • kanċer gastriku (fl-istonku) fi stadju avvanzat.
English: Capecitabine Medac is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Maltese: Capecitabine Medac jittieħed darbtejn kuljum b'dożi ta' bejn 625 u 1,250 mg għal kull metru kwadru tas-superfiċje tal-ġisem (li jiġi kkalkulat permezz tat-tul u l-piż tal-pazjent).
English: While the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Capecitabine Accord is also available as 300 mg tablets.
Maltese: Filwaqt li l-mediċina ta' referenza, Xeloda, hija disponibbli f'pilloli ta' 150 u 500 mg, Capecitabine Medac huwa disponibbli wkoll f'pilloli ta' 300 mg.
English: Capecitabine Medac is a medicine that contains the active substance capecitabine.
Maltese: Capecitabine Medac huwa prodott mediċinali li fih is-sustanza attiva kapesitabina.
English: The CHMP concluded that, in accordance with EU requirements, Capecitabine Medac has been shown to have comparable quality and to be bioequivalent to Xeloda.
Maltese: Is-CHMP kkonkluda li, f'konformità mar-rekwiżiti tal-UE, Capecitabine Medac wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Xeloda.
English: The company provided data from the published literature on capecitabine.
Maltese: Il-kumpanija pprovdiet dejta minn letteratura ppubblikata dwar il-kapesitabina.
English: In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Maltese: Filġisem, 5-FU jissostitwixxi l-pirimidina u jinterferixxi mal-enzimi li jieħdu sehem fil-produzzjoni ta' DNA ġdid.
English: Capecitabine Medac is an anticancer medicine.
Maltese: Capecitabine Medac huwa mediċina kontra l-kanċer.
English: Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, but more is converted in tumour cells than in normal tissues.
Maltese: Il-kapesitabina hija ‘promediċina' li tiġi metabolizzata fil-ġisem bħala f'5-fluorouracil (5-FU), iżda fiċċelloli tat-tumuri din tiġi kkonvertita iktar f'ċelloli tal-kanċer milli f'tessuti b'saħħithom.
English: Other information about Capecitabine Medac
Maltese: Capecitabine Medac kapesitabina
English: The company carried out a ‘bioequivalence' study to show that 500 mg Capecitabine Medac produces the same levels of capecitabine in the blood as 500 mg Xeloda.
Maltese: Il-kumpanija wettqet studju ‘bijoekwivalenti' biex turi li 500 mg ta' Capecitabine Medac jipproduċi listess livelli ta' kapesitabina fid-demm bħat-teħid bħal 500 mg ta' Xeloda.
English: The active substance in Capecitabine Medac, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Maltese: Is-sustanza attiva f'Capecitabine Medac, il-kapesitabina, hija mediċina ċitotossika (mediċina li toqtol iċċelloli li jkunu qed jimmultiplikaw, bħaċ-ċelloli tal-kanċer) li jkunu parti mill-grupp tal-‘antimetaboliti'.
English: How has Capecitabine Medac been studied?
Maltese: Kif ġie studjat Capecitabine Medac?
English: What are the benefits and risks of Capecitabine Medac?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Capecitabine Medac?
English: Capecitabine Medac is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Maltese: Capecitabine Medac jintuża flimkien ma' medicini oħra kontra l-kanċer, inklużi mediċini kontra l-kanċer li jkun fihom il-platinu bħaċ-ċisplatina;
English: Capecitabine Medac tablets should be swallowed with water within 30 minutes after a meal.
Maltese: Il-pilloli ta' Capecitabine Medac għandhom jittieħdu flimkien mal-ilma sa 30 minuta wara l-ikel.
English: Why has Capecitabine Medac been approved?
Maltese: Għaliex ġie approvat Capecitabine Medac?
English: • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Maltese: • kanċer kolorettali metastatiku (kanċer tal-musrana l-għamja li jkun infirex għal partijiet oħra talġisem).
English: Capecitabine Medac is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Maltese: • kanċer tal-kolon (tal-musrana l-għamja). Capecitabine Medac jintuża waħdu jew ma' mediċini oħra kontra l-kanċer f'pazjenti li kienu sottoposti għal intervent kirurġiku għal kanċer tal-kolon tal-‘fażi III' jew ‘fażi C ta' Dukes';
English: For more information on generic and hybrid medicines, see the questionand-answer document here.
Maltese: Għal aktar tagħrif dwar il-mediċini ġeneriċi u ibridi, ara d-dokument mistoqsijiet-utweġibiet hawnhekk.
English: What is Capecitabine Medac?
Maltese: Għal xiex jintuża Capecitabine Medac?
English: Because Capecitabine Medac contains the same active substance as its reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Capecitabine Medac fih l-istess sustanza attiva bħall-mediċina ta' referenza, il-benefiċċji u rriskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Capecitabine Medac is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Maltese: • kanċer tas-sider lokalment avvanzat jew metastatiku (kanċer tas-sider li beda jinfirex ma' partijiet oħra tal-ġisem). Capecitabine Medac jintuża ma' docetaxel (mediċina oħra kontra lkanċer) wara li jkun falla trattament bl-antraċiklini (tip ieħor ta' mediċini kontra l-kanċer).
English: This means that it is similar to a ‘reference medicine', but it contains capecitabine at a new strength in addition to existing strengths.
Maltese: Dan ifisser li hija simili għal ‘mediċina ta' referenza' iżda fiha l-kapesitabina f'qawwa ġdida minbarra l-qawwiet eżistenti.
English: 6.2 Incompatibilities
Maltese: .2 Inkompatibilitajiet
English: gastric irritation
Maltese: irritazzjoni gastrika
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: • Adults:
Maltese: • Adulti:
English: INFORMATION ON BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Hard capsule.
Maltese: Kapsula iebsa.
English: Gastrointestinal disorders common:
Maltese: Disturbi gastrointestinali komuni:
English: Belgique/België/Belgien Recordati
Maltese: Belgique/België/Belgien
English: 4.3 Contraindications
Maltese: 4.3 Kontra-indikazzjonijiet
English: Recordati Rare Diseases Spain S.L.U.
Maltese: Recordati Rare Diseases Spain S.
English: Reporting of side effects
Maltese: Rappurtar tal-effetti sekondarji
English: System organ class
Maltese: Sistema tal-klassifika tal-organi
English: The active substance is zinc.
Maltese: Is-sustanza attiva hi zinc.
English: blood amylase, lipase and alkaline phosphatase increased
Maltese: blood amylase, lipase u alkaline phosphatase għoljin
English: 6.1 List of excipients Capsule content maize starch magnesium stearate
Maltese: 6.1 Lista ta' sustanzi mhux attivi Kontenut tal-kapsulamaize starch magnesium stearate
English: 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Oral use.
Maltese: Użu orali.
English: Recordati Rare Diseases Eco River Parc 30, rue des Peupliers F-92000 Nanterre France
Maltese: Recordati Rare Diseases Eco River Parc 30, rue des Peupliers F-92000
English: ANNEX I
Maltese: ANNESS I
English: Recordati Rare Diseases Italy Srl Tel: +39 02 487 87 173
Maltese: Recordati Rare Diseases ItalySrl Tel: +39 02 487 87 173
English: Contains E110.
Maltese: A16AX05.
English: Common:
Maltese: Komuni:
English: Capsule shell gelatin titanium dioxide (E171) sunset yellow FCF (E110)
Maltese: Il-qoxra tal-kapsula ġelatin titanium dioxide (E171) sunset yellow FCF (E110)
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: The capsule shell contains gelatin, titanium dioxide (E171) and either brilliant blue FCF (E133) for Wilzin 25 mg, or sunset yellow FCF (E110) for Wilzin 50 mg.
Maltese: Il-qoxra tal-kapsula tikkonsisti minn ġelatina, titanium dioxide (E171) u jew brilliant blue FCF (E133) għal Wilzin 25 mg jew sunset yellow FCF (E110) għal Wilzin 50 mg.
English: Investigations common:
Maltese: Investigazzjonijiet komuni:
English: Pharmacodynamic studies were conducted in Wilson's disease patients on the combination of Wilzin (50 mg three times daily) with ascorbic acid (1 g once daily), penicillamine (250 mg four times daily), and trientine (250 mg four times daily).
Maltese: Studji farmakodinamiċi saru f'pazjenti bil-marda ta'Wilson b'terapija kombinata ta' Wilzin (50 mg tliet darbiet kuljum) ma' ascorbic acid (1g darba kuljum), penicillamine (250 mg erba' darbiet kuljum) u trientine (250 mg erba' darbiet kuljum).
English: EU/1/04/286/002
Maltese: FIS-SUQ EU/1/04/286/002
English: ANNEX III
Maltese: ANNESS III
English: • common:
Maltese: • komuni:
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra bħala: komuni ħafna (≥1/10), komuni (≥1/100 sa < 1/10) u mhux komuni (≥1/1,000 sa <1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Reporting of suspected adverse reactions
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: Wilzin 50 mg is an orange opaque hard capsule imprinted “93-377”.
Maltese: Wilzin 50 mg hija kapsula iebsa ta' lewn oranġjo opaka li fuqha hemm stampat “93-377”.
English: Date of latest renewal: 13 October 2009
Maltese: Data tal-aħħar reviżjoni: 13 t'Ottubru 2009
English: Each bottle contains 250 capsules.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 250 kapsuli iebsin.