FrancophonIA/ELRC3.0 huggingface dataset:
English: Cytopoint was as effective as ciclosporin in treating itchy skin; after 28 days the pruritus score (measurement of itchiness) was reduced by 52% in dogs given Cytopoint and 44% in those given ciclosporin.
Maltese: Cytopoint kien effettiv daqs iċ-ċiklosporina fil-kura tal-irritazzjoni tal-ġilda; wara 28 jum l-iskor tal-prurite (il-kejl tal-irritazzjoni) tnaqqas bi 52% fil-klieb li ngħataw Cytopoint u b'44% f'dawk li ngħataw iċ-ċiklosporina.
English: This is a summary of the European public assessment report (EPAR) for Cytopoint.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta᾽ valutazzjoni (EPAR) għal Cytopoint.
English: This summary was last updated in February 2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi Frar 2017.
English: Repeated accidental self-injection may cause an allergic reaction to the medicine.
Maltese: Awtoinjezzjoni aċċidentali ripetittiva tista' tikkawża reazzjoni allerġika għall-mediċina.
English: Cytopoint is a veterinary medicine used to treat atopic dermatitis in dogs.
Maltese: Cytopoint huwa mediċina veterinarja użata għall-kura u ta' dermatite atopika fil-klieb.
English: Cytopoint contains the active substance lokivetmab.
Maltese: Cytopoint fih is-sustanza attiva lokivetmab.
English: Lokivetmab is a monoclonal antibody (a type of protein) that recognises and attaches to interleukin-31, a protein that plays an important role in triggering atopic dermatitits in dogs.
Maltese: Lokivetmab huwa antikorp monoklonali (tip ta' proteina) li jagħraf u jeħel mal-interleukin-31, proteina li għandha rwol importanti fl-iskattar tad-dermatite atopika fil-klieb.
English: Other information about Cytopoint
Maltese: Informazzjoni oħra dwar Cytopoint
English: Why is Cytopoint approved?
Maltese: Għal xiex ġie approvat Cytopoint?
English: What are the risks associated with Cytopoint?
Maltese: X'inhuma r-riskji assoċjati ma' Cytopoint?
English: In a field study involving dogs with atopic dermatitis, 142 dogs received Cytopoint monthly for 3 months whilst 132 were treated with ciclosporin, another medicine approved for treating atopic dermatitis.
Maltese: Fi studju li sar fuq il-post li involva klieb b'dermatite atopika, 142 kelb ingħataw Cytopoint kull xahar għal 3 xhur filwaqt li 132 ġew ikkurati b'ċikolsporina, mediċina oħra approvata għall-kura tad-dermatite atopika.
English: The most common side effects with Cytopoint (which may affect up to 1 in 1,000 animals) are allergic reactions with swelling of the face and itchy rash.
Maltese: L-effetti sekondarji l-aktar komuni b'Cytopoint (li jistgħu jaffettwaw sa 1 minn kull 1,000 annimal) huma reazzjonijiet allerġiċi b'nefħa fuq il-wiċċ u raxx irritanti.
English: By blocking interleukin 31, lokivetmab reduces itchy skin and inflammation.
Maltese: Bl-imblukkar tal-interleukin 31, lokivetmab inaqqas l-irritazzjoni tal-ġilda u l-infjammazzjoni.
English: Atopic dermatitis is inflammation of the skin that is linked to allergy, often to things in the environment such as house dust mites and pollens.
Maltese: Dermatite atopika hija infjammazzjoni tal-ġilda relatata ma' allerġija, ħafna drabi għal affarjiet fl-ambjent bħal insetti parassiti domestiċi u polline.
English: In a follow up study, 81 dogs of the dogs continued Cytopoint treatment for a further six months and the itchy skin score went down further to 14.
Maltese: Fi studju ta' segwitu, 81 kelb komplew il-kura b'Cytopoint għal sitt xhur oħra u l-iskor tal-irritazzjoni tal-ġilda niżel aktar għal 14.
English: Cytopoint must not be given to dogs weighing less than 3 kg. For the full list of restrictions and all side effects reported with Cytopoint, see the package leaflet.
Maltese: Cytopoint ma għandux jintuża fi klieb li jiżnu inqas minn 3 kg.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Cytopoint, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà għal Cytopoint, inklużi l-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti fil-qasam tal-kura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: The full EPAR for Fosavance 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: Fosavance alendronic acid and colecalciferol
Maltese: Aċidu alendroniku u kolekalċiferol
English: This is a summary of the European public assessment report (EPAR) for Fosavance.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Fosavance.
English: ulcers in the oesophagus, dysphagia (difficulty swallowing), abdominal distension (swollen tummy), acid regurgitation and musculoskeletal pain (pain in the muscles, bones and joints).
Maltese: dijarrea, flatulenza (gass), ulċeri fl-esofagu, disfaġija (diffikultà meta tibla'), distensjoni addominali (żaqq minfuħa), tlugħ ta' aċidu mill-istonku u wġigħ muskoloskelettriku (uġigħ fil-muskoli, l-għadam u l-ġogi).
English: Fosavance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels.
Maltese: Fosavance (li fih 2,800 jew 5,600 IU kolekalċiferol) jintuża fit-trattament tal-osteoporożi (marda li tagħmel l-għadam fraġli) fin-nisa wara l-menopawża u li huma f'riskju ta' livelli baxxi ta' vitamina D.
English: It is available as tablets (70 mg alendronic acid and 2,800 international units [IU] colecalciferol; 70 mg alendronic acid and 5,600 IU colecalciferol).
Maltese: [IU] kolekalċiferol; 70 mg aċidu alendroniku u 5,600 IU kolekalċiferol).
English: The most common side effects with Fosavance (seen between 1 and 10 patients in 100) are headache, abdominal pain (stomach ache), dyspepsia (heartburn), constipation, diarrhoea, flatulence (gas),
Maltese: L-effetti sekondarji l-aktar komuni b'Fosavance (li dehru f'bejn pazjent wieħed u 10 minn kull 100) huma wġigħ ta' ras, uġigħ addominali (uġigħ fl-istonku), dispepsija (qrusa tal-istonku), stitikezza,
English: Why has Fosavance been approved?
Maltese: Għaliex ġie approvat Fosavance?
English: A risk management plan has been developed to ensure that Fosavance is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Fosavance jintuża bl-aktar mod sigur possibbli.
English: The European Commission granted a marketing authorisation valid throughout the EU for Fosavance on 24 August 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Fosavance valida fl-Unjoni Ewropea kollha fl-24 ta' Awwissu 2005.
English: In the extension study, similar numbers of patients taking Fosavance 70 mg/2,800 IU and Fosavance 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Fosavance 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
Maltese: IU u b'Fosavance 70 g/5,600 IU ġew osservati livelli baxxi ta' vitamina D, iżda fil-pazjenti ttrattati b'Fosavance 70 mg/5,600 IU ġew osservati żidiet ogħla fil-vitamina D fuq il-perjodu ta' 24 ġimgħa li kopra l-istudju.
English: What is Fosavance?
Maltese: X'inhu Fosavance?
English: Fosavance contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Maltese: Fosavance fih żewġ sustanzi attivi: l-aċidu alendroniku u l-kolekalċiferol (vitamina D3). Aċidu alendroniku huwa bisfosfonat li ilu jintuża għall-osteoporożi sa min-nofs id-disgħinijiet.
English: for the full list of restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation.
Maltese: Il-vitamina D3, flimkien ma' forom oħra tal-vitamina D, hija neċessarja għall-assorbiment talkalċju u għall-formazzjoni normali tal-għadam.
English: This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Fosavance 70 mg/2,800 IU on its own or adding another 2,800 IU vitamin D3 (equivalent to using Fosavance 70 mg/5,600 IU).
Maltese: IU waħdu jew b'żieda ta' 2,800 IU vitamina D3 (li huwa ekwivalenti għal kura b'Fosavance 70 mg/5,600 IU).
English: The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins).
Maltese: Il-pazjent għandu jibla' l-pillolla b'tazza mimlija ilma (iżda mhux ilma minerali), tal-anqas 30 minuta qabel kwalunkwe ikel, xorb, jew mediċina oħra (fosthom antiaċidi, supplimenti tal-kalċju u vitamini).
English: How has Fosavance been studied?
Maltese: Kif ġie studjat Fosavance?
English: Fosavance must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes.
Maltese: Fosavance m'għandux jintuża minn pazjenti li jkollhom anomaliji fl-esofagu, li jkollhom ipokalċemija (livelli baxxi ta' kalċju fid-demm), jew li ma jkunux jistgħu jqumu bilwieqfa jew ipoġġu dritti għal millanqas 30 minuta.
English: What benefit has Fosavance shown during the studies?
Maltese: X'benefiċċji wera Fosavance waqt l-istudji mwettqa?
English: To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Fosavance's ability to increase vitamin D levels.
Maltese: Bħala appoġġ għall-kombinazzjoni tal-aċidu alendroniku u l-vitamina D3 fl-istess pillola, il-kumpanija wettqet ukoll studju f'717-il pazjent li kellhom l-osteoporożi, inklużi 682 mara li kienu għaddew millmenopawża, sabiex tintwera l-kapaċità ta' Fosavance biex iżid il-livelli tal-vitamina D. Lill-pazjenti ngħatalhom Fosavance 70 mg/2,800 IU jew l-aċidu alendroniku darba fil-ġimgħa biss.
English: What is the risk associated with Fosavance?
Maltese: Għal xiex jintuża Fosavance?
English: To avoid irritation of the oesophagus (the tube that leads from the mouth to the stomach), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet.
Maltese: Biex tiġi evitata l-irritazzjoni tal-esofagu (it-tubu li mill-ħalq iwassal għall-istonku), il-pazjent m'għandux jimtedd qabel ma jkun kiel l-ewwel ikel tal-ġurnata, li għandu jsir mill-anqas 30 minuta wara li tittieħed il-pillola.
English: Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Fosavance.
Maltese: Peress li jista' jkun li pazjenti bl-osteoporożi ma jiħdux biżżejjed vitamina D3 prodotta mill-esponiment għad-dawl tax-xemx, din il-vitamina hija inkluża f'Fosavance.
English: can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: k.s. jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Maltese: k.s. jiġi bħala kapsuli (25, 50, 75, 100, 150, 200, 225 u 300 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: The active substance in Pregabalin Zentiva k.s., pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Maltese: Is-sustanza attiva fi Pregabalin Zentiva k.s., il-pregabalin, hija simili fl-istruttura għall-aċidu butriku tal-gamma-amino (GABA) ‘newrotrażmettitur' tal-ġisem stess, iżda għandha effetti bijoloġiċi differenti ħafna.
English: has been shown to have comparable quality and to be bioequivalent to Lyrica.
Maltese: k.s. għandu kwalità komparabbli u huwa bijoekwivalenti għal Lyrica.
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with herpes zoster (shingles) or nerve disorders caused by diabetes,
Maltese: • uġigħ newropatiku (uġigħ minħabba ħsara fin-nervituri) inkluż uġigħ newropatiku periferiku, bħal uġigħ esperjenzat minn pazjenti li għandhom il-herpes zoster (ħruq ta' Sant'Antnin) jew distrbi fin nervituri minħabba d-dijabete, u wġigħ newropatiku ċentrali, bħalma huwa uġigħ esperjenzat minn pazjenti li kellhom korriment fis-sinsla tad-dahar;
English: pregabalin
Maltese: Pregabalin Zentiva
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Zentiva k.s.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Lyrica, u ma għandhomx għalfejn jiġu ripetuti għal Pregabalin Zentiva k.s. Bħal kull mediċina oħra, il-kumpanija pprovdiet studji dwar il-kwalità ta' Pregabalin Zentiva k.s.
English: Pregabalin Zentiva k.s.
Maltese: Informazzjoni oħra dwar Pregabalin Zentiva k.s.
English: This reduces the activity of nerve cells in the brain and spinal cord that are involved in pain, epilepsy and anxiety.
Maltese: Dan inaqqas l-attività taċ-ċelloli tan-nervituri fil-moħħ u fis-sinsla tad-dahar li huma involuti fl-uġigħ, l-epilessija u l-ansjetà.
English: is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: k.s. huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: contains the active substance pregabalin.
Maltese: Pregabalin Zentiva k.s. fih is-sustanza attiva pregabalin.
English: What is Pregabalin Zentiva k.s.
Maltese: Kif jintuża Pregabalin Zentiva k.s.?
English: Therefore, the CHMP's view was that, as for Lyrica, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Lyrica, il-benefiċċju huwa akbar mir-riskju identifikat.
English: The Committee recommended that Pregabalin Zentiva k.s.
Maltese: Għaliex ġie approvat Pregabalin Zentiva k.s.?
English: The full EPAR for Pregabalin Zentiva k.s.
Maltese: Sommarju tal-EPAR għall-pubbliku pregabalin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Zentiva k.s.
Maltese: Il-Kumitat irrakkomanda li Pregabalin Zentiva k.s. ikun approvat għall-użu fl-UE.
English: • epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures
Maltese: • epilessija, fejn jintuża bħala "żieda" flimkien ma' kura eżistenti f'pazjenti li jbatu minn aċċessjonijiet parzjali (aċċessjonijiet epileptiċi li jibdew f'parti speċifika tal-moħħ) li ma jistgħux jiġu kkontrollati bil-kura attwali;
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Ilkumpanija għamlet ukoll studji li wrew li hija 'bijoekwivalenti' għall-mediċina ta' referenza.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATIONS
Maltese: 49 pillola gastro-reżistenti
English: The MAH commits to respond to a number of unresolved quality related issues by presenting relevant and adequate documents and data as outlined in the Letter of Undertaking dated 9 December 2009.
Maltese: L-għoti flimkien ta' atazanavir u mediċini oħrajn kontra l-HIV li l-assorbiment tagħhom jiddependi mill-pH, ma' inibituri tal-pompa tal-proton jista' jirriżulta fi tnaqqis sostanzjali fil-bijodisponibilità ta' dawn il-mediċini kontra l-HIV u jista' jkollu impatt fuq l-effikaċja ta' dawn il-mediċini.
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: Investigazzjoni addizzjonali għandha tiġi kkunsidrata jekk is-sintomi jippersistu minkejja kura adegwata.
English: To reduce administrative work, all response documents should be submitted as a single data package one year after the issue of the EC decision.
Maltese: Protium hu trab ta' kulur minn abjad sa abjad jagħti fil-griż għal soluzzjoni għall-injezzjoni.
English: EMA/278771/2016 EMEA/V/C/002390
Maltese: EMEA/278771/2016 EMEA/V/C/002390
English: The full EPAR for Clynav 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: Other information about Clynav:
Maltese: Informazzjoni oħra dwar Clynav:
English: Protection lasts approximately three months after vaccination at average water temperature of 12 ±2 °C.
Maltese: Il-protezzjoni ddum madwar tliet xhur wara t-tilqima f'temperatura tal-ilma medja ta' 12 ±2°C.
English: Clynav is a DNA vaccine.
Maltese: Clynav huwa vaċċin tad-DNA.
English: Why is Clynav approved?
Maltese: Għaliex ġie approvat Clynav?
English: The time for protection to develop following vaccination depends on the water temperature: protection starts within 399 degree days, calculated as mean water temperature in °C multiplied by number of days, for example 40 days at a water temperature of 10 °C.
Maltese: Il-ħin biex il-protezzjoni tiżviluppa wara t-tilqima jiddependi fuq it-temperatura tal-ilma: il-protezzjoni tibda fi żmien 399 jum-grad, ikkalkulati bħala t-temperatura tal-ilma medja f' C immultiplikata b'numru ta' jiem, pereżempju 40 jum f'temperatura tal-ilma ta' 10 C.
English: Clynav is a veterinary vaccine used in Atlantic salmon to protect them against pancreas disease caused by salmonid alphavirus subtype 3 (SAV3).
Maltese: Clynav huwa vaċċin veterinarju li jintuża fis-salamun tal-Atlantiku biex jipproteġihom kontra marda tal-frixa kkawżata minn salmonid alphavirus sottotip 3 (SAV3, salmonid alphavirus subtype 3).
English: Following artificial infection by co-habitation with infected salmon 29 days and 3 months after vaccination, fish vaccinated with Clynav had improved weight gain, reduced heart, pancreas and skeletal muscle lesions and reduced risk of death compared to fish injected with the dummy saline injection.
Maltese: Wara injezzjoni artifiċjali minn koabitazzjoni ma' salamun infettat 29 jum u 3 xhur wara t-tilqima, il-ħut imlaqqam b'Clynax kellu titjib fiż-żieda fil-piż, leżjonijiet tal-qalb, tal-frixa u tal-muskoli skelettriċi mnaqqsa u riskju mnaqqas ta' mewt meta mqabbel ma' ħut injettat b'injezzjoni salina finta.
English: Clynav salmon pancreas disease vaccine (recombinant DNA plasmid)
Maltese: Clynav vaċċin tal-marda tal-frixa tas-salamun (plażmid tad-DNA rikombinanti)
English: Clynav contains as active substance a DNA plasmid (a small piece of DNA) containing the genetic code for making salmon pancreas disease virus proteins.
Maltese: Clynax fih bħala sustanza attiva plażmid tad-DNA (biċċa żgħira ta' DNA) li fiha l-kodiċi ġenetika biex tagħmel proteini tal-virus tal-marda tal-pankreas fis-salamun.
English: The most common side effects with Clynav (which may affect more than 1 in 10 fish) are short lived changes in swimming behaviour for up to two days, altered pigmentation (colouration) for up to seven days and lack of appetite for up to nine days.
Maltese: L-effetti sekondarji l-aktar komuni b'Clynav (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma tibdiliet li ma jdumux fl-imġiba tal-għawm sa jumejn, tibdil fil-pigmentazzjoni (kulur) sa sebat ijiem u nuqqas ta' aptit sa disat ijiem.
English: What are the risks associated with Clynav?
Maltese: X'inhuma r-riskji assoċjati ma' Clynav?
English: This is a summary of the European public assessment report (EPAR) for Clynav.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta
English: How does Clynav work?
Maltese: Kif jintuża Clynav?
English: A main laboratory model study looked at the signs of pancreas disease in fish given Clynav compared with a dummy saline injection.
Maltese: Studju mudell tal-laboratorju ewlieni ħares lejn is-sinjali tal-marda tal-frixa fil-ħut li ngħata Clynav meta mqabbel ma' injezzjoni salina finta.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Clynav'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' Clynav huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences)
Maltese: Il-vaċċini jaħdmu billi ‘jgħallmu' lis-sistema immuni (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra marda.
English: Pancreas disease in Atlantic salmon can lead to impaired daily weight gain, lesions of the heart, pancreas and skeletal muscle as well as death.
Maltese: Il-marda tal-frixa fis-salamun tal-Atlantiku tista' twassal għal indeboliment fiż-żieda fil-piż ta' kuljum, leżjonijiet tal-qalb, tal-frixa u tal-muskoli skelettriċi kif ukoll mewt.
English: For the full list of all side effects reported with Clynav, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Clynav, ara l-fuljett tat-tagħrif.
English: Needle injuries at the site of injection are common following vaccination and can persist for at least 90 days.
Maltese: Wara t-tilqima huma komuni korrimenti tal-labra fis-sit tal-injezzjoni u jistgħu jdumu għal tal-inqas 90 jum.
English: (myelosuppression).
Maltese: (majelosoppressjoni).
English: Carcinogenesis/mutagenesis
Maltese: Karċinoġenisi /mutaġenisi
English: Severe thrombocytopenias (< 50 x 10
Maltese: It-tromboċitopenji serji (< 50 x 10
English: Lipomed GmbH Hegenheimer Strasse 2 D-79576 Weil/Rhein Germany
Maltese: Lipomed GmbH Hegenheimer Strasse 2 D-79576
English: Very common adverse reactions observed during the three most relevant clinical trials with cladribine in 279 patients treated for various indications and in 62 patients with hairy cell leukaemia (HCL) were myelosuppression, especially severe neutropenia (41% (113/279), HCL 98% (61/62)), severe thrombocytopenia (21% (58/279), HCL 50% (31/62)) and severe anaemia (14% (21/150), HCL 55% (34/62)), as well as severe immunosuppression/lymphopenia (63% (176/279), HCL 95% (59/62)), infections (39% (110/279), HCL 58% (36/62)) and fever (up to 64%).
Maltese: Reazzjonijiet avversi komuni ħafna osservati waqt l-aktar tlett provi kliniċi rilevanti bi cladribine f'279 pazjent ittrattati għal indikazzjonijiet varji, u fi 62 pazjent b'lewkimja taċ-ċelluli ċiljati (HCL) kienu t-trażżin tal-funzjoni tal-mudullun, newtropenja serja ħafna (41% (113/279), HCL 98% (61/62)), tromboċitopenja serja (21% (58/279), HCL 50% (31/62)) u anemija serja (14% (21/150), HCL 55% (34/62)), kif ukoll immunosoppressjoni/limfopenja serja (63% (176/279), HCL 95% (59/62)), infezzjonijiet (39% (110/279), HCL 58% (36/62)) u deni (sa 64%).
English: Date of first authorisation: 14/04/2004 Date of last renewal: 27/03/2009
Maltese: Data tal-aħħar tiġdid: 27/03/2009
English: Secondary malignancies
Maltese: Malinni sekondarji
English: Prevention of tumour lysis syndrome
Maltese: Prevenzjoni tas-sindrome tal-lysis tat-tumur
English: Swelling of the eyelid.
Maltese: Insuffiċjenza tal-qalb.
English: Following cladribine, the incidence of second malignancies ranges from 0% to 9.5% after a median observation period of 2.8 to 8.5 years.
Maltese: Wara cladribine, l-inċidenza ta' malinni sekondarji tvarja minn 0% sa 9.5% wara perijodu medjan ta' osservazzjoni ta' 2.8 sa 8.5 snin.
English: Very common: infections * (e.g. pneumonia *, septicaemia *)
Maltese: Infezzjonijiet * (eż. pnewmonja*, settiċimja*)
English: Cladribine induces a severe and prolonged reduction of CD4+ and CD8+ T-lymphocytes.
Maltese: Clabridine jinduċi tnaqqis serju u prolongat tallimfoċiti T, CD4+ u CD8+.