FrancophonIA/ELRC3.0 huggingface dataset:
English: People with known hypersensitivity (allergy) to similar antibiotics (macrolide class) should avoid contact with Zactran.
Maltese: Persuni li jkunu jafu li huma sensittivi ħafna (allerġiċi) għal antibijotiċi simili (klassi tal-makrolidi) għandhom jevitaw il-kuntatt ma' Zactran.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zactran on 24 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Zactran valida fl-UE kollha fl24 ta' Lulju 2008.
English: How does Zactran work?
Maltese: Informazzjoni oħra dwar Zactran?
English: In the treatment of BRD, Zactran was shown to be as effective as tulathromycin.
Maltese: Fil-kura tal-BRD, Zactran intwera li kien effettiv daqs tulatromiċin.
English: As Zactran is an antibiotic, it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Maltese: Minħabba li Zacran huwa antibijotiku, huwa essenzjali li ssegwi mill-qrib l-istruzzjonijiet fil-fuljett ta' tagħrif biex jiġi minimizzat l-iżvilupp ta' reżistenza antibijotika.
English: Zactran must not be given to animals hypersensitive (allergic) to any macrolide, and must not be used at the same time as other macrolides or another type of antibiotic called lincosamides.
Maltese: Zactran m'għandux jingħata lil annimali sensittivi ħafna (allerġiċi) għal kwalunkwe makrolid, u m'għandux jintuża fl-istess ħin bħal makrolidi oħrajn jew tip ieħor ta' antibijotiċi msejħa linkosamidi.
English: A second field study in pigs with SRD compared Zactran to tulathromycin, however, in this study Zactran was not as effective as tulathromycin.
Maltese: Studju ieħor fil-ħnieżer b'SRD qabbel Zactran ma' tulatromiċin, madankollu, f'dan l-istudju Zactran ma kienx effettiv daqs tulatromiċin.
English: Zactran can also be used metaphylactically, which means to treat at the same time both diseased cattle and healthy cattle in close contact with them, in order to prevent healthy animals from developing infection and so prevent further spread of the disease.
Maltese: Zactran jista' jintuża wkoll b'mod metafilaktiku, li jfisser li jiġu kkurati fl-istess ħin kemm bhejjem tal-ifrat morda kif ukoll dawk il-bhejjem tal-ifrat b'saħħithom li għandhom kuntatt mill-qrib magħhom, sabiex b'hekk jiġi evitat li l-annimali b'saħħithom jiżviluppaw infezzjoni u li jkun hemm firxa akbar tal-marda.
English: Other information about Zactran
Maltese: Kif jintuża Zactran?
English: The withdrawal period is 64 days for meat from cattle, 16 days for meat from pigs and 29 days for meat from sheep treated with Zactran.
Maltese: Il-perjodu ta' tiżmim huwa 64 jum għal-laħam mill-bhejjem tal-ifrat, 16-il jum għal-laħam millħnieżer u 29 jum għal-laħam min-nagħaġ ikkurati b'Zactran.
English: As the efficacy of antimicrobial treatment of foot rot might be reduced by others factors, such as wet environmental conditions or inappropriate farm management, treatment of foot rot should therefore be undertaken along with other flock management tools.
Maltese: Peress li l-effikaċja tal-kura antimikrobjali ta' necrobacillosis tista' titnaqqas permezz ta' fatturi oħrajn, bħal kundizzjonijiet ambjentali mxarrba jew ġestjoni mhux xierqa tar-razzett, il-kura ta' necrobacillosis għaldaqstant għandha ssir flimkien ma' għodod oħrajn ta' ġestjoni tal-merħla.
English: The active substance in Activyl, indoxacarb, is an ectoparasiticide.
Maltese: Is-sustanza attiva f'Activyl, l-indoxacarb, hija mediċina ektoparasitiċida.
English: In the main field study, dogs and cats of various breeds, age groups, gender and different weights were treated either with Activyl or fipronil, another spot-on medicine which is authorised in the European Union for this indication.
Maltese: Fl-istudju prinċipali fuq il-post, klieb u qtates ta' diversi razez, gruppi ta' età, sess u piżijiet differenti ġew ittrattati jew b'Activyl jew fipronil, mediċina oħra ta' użu lokalizzat li hija awtorizzata fl-Unjoni Ewropea għal din l-indikazzjoni.
English: Efficacy against flea infestations of more than 95% was achieved in dogs by 14 days post treatment and in cats by 42 days post treatment in the study.
Maltese: Intlaħqet effikaċja ta' aktar minn 95% kontra infestazzjonijiet mill-briegħed fil-klieb sa 14-il jum wara l-kura u fil-qtates sa 42 jum wara l-kura fl-istudju.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Activyl to Intervet International BV on 18/02/2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea għal Activyl lil Intervet International BV fi 18/02/2011 L-informazzjoni dwar l-istatus tal-preskrizzjoni ta' dan ilprodott tinsab fuq it-tikketta/fuq il-pakkett ta' barra.
English: Activyl is used to treat and prevent flea infestations in dogs and cats and to treat flea allergy dermatitis (an allergic reaction to flea bites).
Maltese: Activyl jintuża għall-kura u l-prevenzjoni ta' infestazzjonijiet mill-briegħed fil-klieb u l-qtates u għallkura tad-dermatite allerġika mill-briegħed (reazzjoni allerġika għall-gdim tal-briegħed).
English: What is Activyl?
Maltese: X'inhu Activyl?
English: Activyl is a medicine that contains the active substance indoxacarb.
Maltese: Activyl huwa mediċina li fih is-sustanza attiva indoxacarb.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CVMP, aqra dDiskussjoni Xjentifika (hija parti wkoll mill-EPAR).
English: Activyl is given as a single treatment.
Maltese: Activyl jingħata bħala trattament wieħed.
English: It is available as a clear, colourless to yellow solution presented as a ‘spot-on' in pipettes already filled with the correct amount of Activyl needed to treat one cat or dog depending on its weight (5 sizes of pipettes for different dog weights and 2 sizes of pipettes for different cat weights).
Maltese: Huwa disponibbli bħala soluzzjoni ċara, mingħajr kulur li tagħti fl-isfar ippreżentat bħala ‘spot-on' (użu lokalizzat) f'pipetti diġà mimlijin blammont eżatt ta' Activyl meħtieġ għall-kura ta' qattus jew kelb wieħed skont il-piż tiegħu (5 daqsijiet ta' pipetti għal piżijiet differenti ta' kelb u 2 daqsijiet ta' pipetti għal piżijiet differenti ta' qattus).
English: Why has Activyl been approved?
Maltese: Għaliex ġie approvat Activyl?
English: What is the risk associated with Activyl?
Maltese: X'inhu r-riskju assoċjat ma' Activyl?
English: Other information about Activyl:
Maltese: Aktar tagħrif dwar Activyl:
English: This active compound interferes with the parasites' nervous system and causes paralysis and death.
Maltese: Dan il-kompost attiv jinterferixxi massistema nervuża tal-parassiti u jikkawża l-paraliżi u l-mewt.
English: Furthermore, the CVMP concluded that the product is effective as part of a treatment strategy for flea allergy dermatitis and recommended that Activyl be given a marketing authorisation.
Maltese: Barra minn hekk, is-CVMP ikkonkluda li l-prodott huwa effettiv bħala parti minn strateġija ta' kura għad-dermatite allerġika mill-briegħed u rrakkomanda li Activyl jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The CVMP concluded that the benefits of Activyl exceed the risks for the treatment and prevention of flea infestations in dogs and cats.
Maltese: Is-CVMP ikkonkouda li l-benefiċċji ta' Activyl huma akbar mir-riskji għall-kura u l-prevenzjoni ta' infestazzjonijiet mill-briegħed fil-klieb u l-qtates.
English: How has Activyl been studied?
Maltese: Kif ġie studjat Activyl?
English: How does Activyl work?
Maltese: Għal xiex jintuża Activyl?
English: The contents of one full Activyl pipette (appropriate to the animal and its weight) is applied directly to the skin, after parting the animals fur, onto the back of the cat's neck at the base of its head, or between the shoulder blades and along the back of dogs.
Maltese: Il-kontenut ta' pipett wieħed sħiħ ta' Activyl (adatt għall-annimal u l-piż tiegħu) jiġi applikat direttament fuq il-ġilda, wara li jitferraq il-pil tal-annimal, fuq wara tal-għonq tal-qattus fil-bażi ta' rasu, jew bejn il-ġewnaħ tad-dahar u tul id-daħar tal-klieb.
English: After application, indoxacarb is eaten by the insects and activated in their gut into an active compound.
Maltese: Wara li jiġi applikat, l-indoxacard jittiekel mill-insetti u jiġi attivat f'imsarinhom f'kompost attiv.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u rriskju jinsab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: Data were provided on the pharmaceutical quality, the tolerance of the products in cats and dogs, the safety in humans (people in contact with the product) and the safety to the environment.
Maltese: Ingħatat dejta dwar il-kwalità farmaċewtika, it-tolleranza tal-prodotti fil-qtates u l-klieb kif ukoll issigurtà fil-bnedmin (nies f'kuntatt mal-prodott) u s-sigurtà għall-ambjent.
English: The effectiveness was measured by counting of fleas, flea allergy dermatitis assessment, observations on local reactions at the application site after treatment.
Maltese: L-effikaċja tkejlet bl-għadd ta' briegħed, ilvalutzzjoni tad-dermatite allerġika mill-briegħed, l-osservazzjonijiet f'reazzjonijiet lokali fis-sit talapplikazzjoni wara l-kura.
English: For a full list of all side-effects reported with Activyl, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Activyl, ara l-Fuljett ta' Tagħrif.
English: Guarana seed EMA/HMPC/284498/2013
Maltese: Żerriegħa tal-Guarana EMA/HMPC/284498/2013
English: EMA/HMPC/284498/2013
Maltese: EMA/HMPC/284498/2013 Il-Kumitat għall-Prodotti Mediċinali Erbali (HPMC)
English: Paulinia cupana Kunth ex H.B.K.
Maltese: Paulinia cupana Kunth ex H.B.K. var. sorbilis (Mart.) Ducke, semen
English: Guarana seed
Maltese: Żerriegħa tal-Guarana
English: Further information on the HMPC assessment of guarana seed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini taż-żerriegħa tal-guarana, inklużi ddettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku talAġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Guarana seed is the common name for the seed of the plant Paulinia cupana Kunth ex H.B.K.
Maltese: Iż-żerriegħa tal-guarana huwa l-isem komuni għaż-żerriegħa tal-pjanta Paulinia cupana Kunth ex H.B.K. var. sorbilis (Mart.) Ducke.
English: The HMPC recommended that these medicines should not be used in patients with stomach and gut ulcers, hyperthyroidism (overactive thyroid gland) or cardiovascular problems, such as hypertension (high blood pressure) and arrhythmias (heart rhythm problems).
Maltese: L-HMPC rrakkomanda li dawn il-mediċini ma għandhomx jintużaw f'pazjenti b'ulċeri fl-istonku jew flimsaren, pazjenti b'ipertirojdiżmu (glandola tat-tirojde attiva żżejjed) jew bi problemi kardjovaskulari, bħal pressjoni għolja (pressjoni tad-demm għolja) u arrittmiji (problemi bir-rittmu tat-taħbit tal-qalb).
English: What are the risks associated with guarana seed medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini taż-żerriegħa tal-guarana?
English: What is guarana seed?
Maltese: X'inhi ż-żerriegħa tal-guarana?
English: Other information about guarana seed medicines
Maltese: Aktar informazzjoni dwar il-mediċini taż-żerriegħa tal-guarana
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm ma hemmx evidenza biżżejjed minn provi kliniċi, l-effikaċja ta' dawn il-mediċini erbali hija plawsibbli u hemm evidenza li dawn intużaw b'mod sikur b'dan il-mod għal mill-inqas 30 sena (inkluż għallinqas 15-il sena fi ħdan l-UE).
English: What evidence supports the use of guarana seed medicines?
Maltese: X'evidenza tappoġġa l-użu tal-mediċini taż-żerriegħa tal-guarana?
English: Herbal medicines containing guarana seed are usually available in solid forms to be taken by mouth.
Maltese: Mediċini erbali li fihom iż-żerriegħa tal-guarana normalment huma disponibbli f'forom solidi sabiex jittieħdu mill-ħalq.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of guarana seed.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali taż-żerriegħa tal-guarana.
English: Intravenous use vial (plastic)
Maltese: kunjett (plastik)
English: Intravenous use vial (glass)
Maltese: Daqs talpakkett kunjett (ħġieġ)
English: Pack size
Maltese: Kunejtt 1
English: --1 Cell-associated live recombinant turkey herpesvirus expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 103.3 - 104.6 PFU* * PFU: plaque forming units.
Maltese: --1 Cell-associated virus tal-herpes ħaj rikombinant tad-dundjani li jesorimi il-fużjoni tal-proteina tal-marda virali u il VP2 proteina tal-marda infettiva virali tal-bursal: 103.3 - 104.6
English: Packaging Content
Maltese: Daqs talpakett
English: Withdrawal period
Maltese: Suspensjoni:
English: E. Plater 53, 00-113 Warsaw Poland
Maltese: Plater 53, 00-113 Warsaw Poland
English: Swensweg 5, Postbus 552, 2003 RN Haarlem
Maltese: Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands
English: On 30 November 2006, the application has been referred and submitted for arbitration according to Article 29 of Directive 2001/83/EC, as amended.
Maltese: Fit-30 ta' Novembru 2006, l-applikazzjoni ġiet irreferuta u sottomessa għal arbitraġġ skond l-Artikolu 29 tad-Direttiva 2001/83/EC, kif emendat.
English: TEVA Sweden AB PO Box 1070, SE - 25110 Helsingborg
Maltese: TEVA Sweden AB PO Box 1070, SE - 25110
English: 1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12
Maltese: TEVA Classics S.A. 1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 France
English: United Kingdom TEVA UK Limited Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Maltese: Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
English: ANNEX II SCIENTIFIC CONCLUSIONS
Maltese: ANNESS II KONKLUZJONIJIET XJENTIFIĊI
English: 78-110%) were outside the conventional limits they comply with the wider 75-133% criterion.
Maltese: 78-110%) kienu barra mil-limiti konvenzjonali li jikkonformaw mal-kriterju usa' 75-133%.
English: In September 2006, a Mutual Recognition Procedure was started for Lansoprazole involving 16 CMS with the UK as Reference Member State (RMS).
Maltese: F'Settembru 2006, inbdiet Proċedura ta' Rikonoxximent Reċiproku għal Lansoprazole li nvolviet 16il CMS bir-Renju Unit bħala Stat Membru ta' Referenza (RMS).
English: Box 217, 3640 AE Mijdrecht The Netherlands
Maltese: Industrieweg 23, P.O. Box 217, 3640 AE Mijdrecht The Netherlands
English: Documentation presented to the CHMP shows that the test and reference products are essentially similar.
Maltese: Dokumentazzjoni ippreżentata lis-CHMP turi li t-test u l-prodotti ta' referenza huma essenzjalment simili.
English: SCIENTIFIC CONCLUSIONS
Maltese: KONKLUŻJONIJIET XJENTIFICI
English: The RMS approved the product on the basis of the results of the fasted study showed unequivocal equivalence as shown by the 90% confidence intervals (CI) for the AUC and Cmax which were within the conventional 80-125% bioequivalence range.
Maltese: L-RMS approva l-prodott fuq il-bażi tar-riżultati ta' studju sajjem li wrew ekwivalenza mhux ekwivoka kif muri mid-90% intervalli ta' kunfidenza (CI) għall-AUC u s- Cmax li kienu fi ħdan ilmedda konvenzjonali ta' bijoekwivalenza 80-125%.
English: Slovak Republic
Maltese: ls-Slovakkja
English: Box 217, 3640 AE Mijdrecht, The Netherlands,
Maltese: Teva Pharma B.V., Industrieweg 23, P.O. Box 217, 3640 AE Mijdrecht, The Netherlands,
English: This is supported by two similar fed studies using the same reference drug and the same test drug with the same batch number when entirely different results are obtained and which confidence intervals were within conventionally acceptable limits.
Maltese: Dan huwa imwieżen minn żewġ studji bl-ikel simili, bl-użu ta' l-istess mediċina ta' referenza u l-istess mediċina tat-test bl-istess numru tal-lott meta riżultati kompletament differenti huma miksuba u liema intervalli ta' kunfidenza kienu fi ħdan limiti konvenzjonalment aċċettabbli.
English: Lansoprazole has a wide therapeutic window regarding its clinical efficacy and safety.
Maltese: Lansoprazole għandu tieqa terapewtika wiesa' fir-rigward ta' l-effikaċja klinika u s-sigurtà klinika tiegħu.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPRAZOLE AND ASSOCIATED NAMES (see Annex I)
Maltese: SOMMARJU TOTALI TA' L-EVALWAZZJONI XJENTIFIKA TAL-LANSOPRAZOLE U ISMIJIET ASSOĊJATI (Ara Anness I)
English: Lansoprazole is a proton pump inhibitor that inhibits gastric acid secretion and is used for the treatment of duodenal and benign gastric ulcers, gastrooesophageal reflux disease and associated conditions.
Maltese: Lansoprazole 15 & 30 mg kapsuli gastro-reżistenti, iebsin (Teva UK Ltd) huma preparazzjonijiet ġeneriċi li jimpedixxu t-tnixxija ta' l-aċidu gastriku u huma wżati għat-trattament ta' ulċeri duwodenali u gastriċi beninni, mard ta' rifluss gastro-oesofaġiku u kondizzjonijiet assoċjati.
English: It was considered that this wider criterion can be applied in this case because of the extremely high intra-subject variability (70- 82%) under fed conditions shown in this study.
Maltese: Tqies li dan il-kriterju usa' jista' jiġi applikat f'dan il-każ minħabba l-varjabilità estremament għolja (70- 82%) fis-suġġetti nfushom taħt kondizzjonijiet bl-ikel murija f'dan l-istudju.
English: Lansoprazole 30 mg Gastro-resistant Capsules
Maltese: Lansoprazole 30 mg Gastroresistant Capsules
English: Lansoprazole 15 mg Gastro-resistant Capsules
Maltese: Lansoprazole 15 mg Gastroresistant Capsules
English: Strength Pharmaceutical Form
Maltese: FIL-PAKKETT
English: Lansoprazol - TEVA 15 mg 15 mg Gastro-resistant capsule, hard
Maltese: Lansoprazol - TEVA 15 mg 15 mg Kapsula gastroreżistenti, iebsa.
English: Lansoprazol - TEVA 30 mg 30 mg Gastro-resistant capsule, hard
Maltese: Lansoprazol - TEVA 30 mg 30 mg Kapsula gastroreżistenti, iebsa.
English: • a platelet count > 1000 x 10
Maltese: • għadd tal-plejtlets > 1000 x 10
English: They are marked with ‘S 063'.
Maltese: Huma mmarkati b'‘S 063'.
English: 9/l or
Maltese: 9/l.
English: Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous lactose (65.8 mg).
Maltese: Kull kapsula iebsa fiha lactose monohydrate (53.7 mg) u anhydrous lactose (65.8 mg).
English: Capsule contents: povidone (E1201); crospovidone; lactose, anhydrous; lactose monohydrate; cellulose, microcrystalline (E460) and magnesium stearate.
Maltese: Il-kontenut tal-kapsula: povidone (E1201); crospovidone; lactose, anhydrous; lactose monohydrate; cellulose, microcrystalline (E460) u magnesium stearate.
English: Nervousness
Maltese: Nervożiżmu
English: Capsule shell: gelatin and titanium dioxide (E171).
Maltese: Qoxra tal-kapsula: gelatin u titanium dioxide (E171).
English: • Inflammation of the kidneys (tubulointerstitial nephritis).
Maltese: • Infjammazzjoni tal-kliewi (Nefrite tubulointerstizjali).
English: Strong ammonium solution Potassium hydroxide (E525) Black iron oxide (E172)
Maltese: Soluzzjoni qawwija ta' ammonium Potassium hydroxide (E525) Black iron oxide (E172)
English: Printing ink: shellac; strong ammonium solution; potassium hydroxide (E525); black iron oxide (E172).
Maltese: Linka ta' l-istampar: shellac; strong ammonium solution, potassium hydroxide (E525); black iron oxide (E172).
English: Date of first authorisation: 16 November 2004 Date of latest renewal: 18 July 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 ta' Novembru, 2004
English: 9/l and ideally at levels between 150 x 10 9/l and 400 x 10 9/l.
Maltese: 9/l u idejalment f'livelli bejn 150 x 10
English: Povidone (E1201) Lactose, anhydrous Lactose monohydrate Cellulose, microcrystalline (E460) Crospovidone
Maltese: X'fihom il-kapsuli Povidone (E1201) Lactose, anhydrous Lactose monohydrate Cellulose, microcrystalline (E460) Crospovidone
English: Following oral administration of anagrelide in man, at least 70% is absorbed from the gastrointestinal tract.
Maltese: Wara l-għoti orali ta' anagrelide fil-bniedem, ta' l-anqas 70% jiġi assorbit mill-passaġġ gastrointestinali.
English: Xagrid contains the active substance, anagrelide.
Maltese: Xagrid fih is-sustanza attiva, anagrelide.
English: The mean recovery of 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in urine is approximately 18-35% of the administered dose.
Maltese: L-irkupru medju ta' 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline fl-awrina huwa ta' bejn wieħed u ieħor 18%-35% tad-doża mogħtija.
English: Tubulointerstitial nephritis
Maltese: Nefrite tubuleinterstizjali
English: Name and address of the manufacturer(s) responsible for batch release Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower Dublin 2, Ireland
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower Dublin 2, L-Irlanda
English: Shire Pharmaceuticals Ireland Limited Dublin 2
Maltese: Shire Pharmaceuticals Ireland Ltd.
English: Linearity Dose proportionality has been found in the dose range 0.5 mg to 2 mg.
Maltese: Linearità Il-proporzjonalità fid-doża nstabet f'medda ta' doża li tvarja minn 0.5 mg sa 2 mg.
English: Currently available data are described in sections 4.4, 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjonijiet 4.4, 4.8, 5.1 u 5.2, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: • Anagrelide is an inhibitor of PDE III.
Maltese: • Anagrelide huwa impeditur ta' PDE III.
English: • Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives.
Maltese: • Anagrelide jista' jikkaġuna disturbi intestinali f' xi pazjenti u jikkomprometti l-assorbiment ta' kontraċettivi ormonali orali.
English: Pharmacokinetic data from fasting elderly patients with ET (age range 65 - 75 years) compared to fasting adult patients (age range 22 - 50 years) indicate that the Cmax and AUC of anagrelide were 36% and 61% higher respectively in elderly patients, but that the Cmax and AUC of the active metabolite, 3-hydroxy anagrelide, were 42% and 37% lower respectively in the elderly patients.
Maltese: Dejta farmakokinetika minn pazjenti anzjani fl-istat sajjem b'ET (età ta' bejn il-65 u l-75 sena) meta mqabbla ma' pazjenti adulti fl-istat sajjem (età ta' bejn it-22 u l-50 sena) tindika li s-Cmax u l-AUC ta' anagrelide kienu 36% u 61% ogħla rispettivament f'pazjenti anzjani, iżda li s-Cmax u l-AUC talmetabolit attiv, 3-hydroxy anagrelide, kienu 42% u 37% iktar baxxi fil-pazjenti anjani.
English: Xagrid 0.5 mg hard capsules anagrelide
Maltese: Xagrid 0.5 mg kapsuli ibsin anagrelide
English: It is not recommended in patients with elevated transaminases (> 5 times the upper limit of normal) (see sections 4.2 and 4.3).
Maltese: Mhux rrakkomandat f'pazjenti bi transaminases għoljin (> 5 darbiet mil-limitu ta' fuq tan-normal) (ara sezzjonijiet 4.2 u 4.3).
English: Patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min).
Maltese: Pazjenti b'indeboliment renali moderat jew serju (rata ta' eliminazzjoni tal-kreatinina < 50 ml/min).
English: Anaemia Pancytopenia Thrombocytopenia Haemorrhage
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Xagrid contains lactose.
Maltese: Xagrid fih lactose.