FrancophonIA/ELRC3.0 huggingface dataset:
English: − Pack with 5 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Maltese: − Pakkett b'5 pakketti singoli, kull wieħed fih kunjett bit-trab, siringa mimlija għal-lest bis solvent, adattatur tal-kunjett b'labra, 2 imsielaħ ta' l-alkoħol jew
English: However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when pregnancy was detected and/or confirmed.
Maltese: Madankollu, kemm dam l-esponiment waqt l-ewwel trimestru mhuwiex ċar, peress li d-data kienet miġbura meta l-użu ta' interferon beta kien kontraindikat waqt it-tqala, u t-trattament aktarx twaqqaf meta ġiet osservata u/jew ikkonfermata t-tqala.
English: EDSS progression (confirmed increase in EDSS of at least one point compared to baseline) was lower in the immediate treatment group (Table 3, significant effect after 3 years, no significant effect after 5 years).
Maltese: Il-progressjoni fl-EDSS (żieda kkonfermata f'EDSS b'tal-inqas punt wieħed meta mqabbel mal-linja bażi) kienet aktar baxxa fil-grupp ta' kura immedjata (Tabella 3, effett sinifikanti wara 3 snin, l-ebda effett sinifikanti wara 5 snin).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING TITRATION PACK WITH 4x1 TRIPLE PACK (3 VIALS/3 PRE-FILLED SYRINGES), FOR FIRST 12 INJECTIONS/TREATMENT DAYS (INCLUDING BLUE BOX)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA PAKKETT TA' TITRAZZJONI B'4x1 PAKKETTI TRIPLI (3 KUNJETTI/3 SIRINGI MIMLIJA GĦAL-LEST), GĦALL-EWWEL 12-IL INJEZZJONI/ĠRANET TA' KURA (INKLUŻA L-KAXXA BLU)
English: After reconstitution, 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b*.
Maltese: Wara r-rikostituzzjoni 1 ml fih 250 mikrogramma (8.0 miljun IU) ta' interferon beta-1b*.
English: A number of these products have been measured in the serum and cellular fractions of blood collected from patients treated with interferon beta-1b.
Maltese: Numru minn dawn il-prodotti ġew imkejla fis-serum u fi frazzjonijiet ċellulari ta' demm, miġbura minn pazjenti kkurati b'interferon beta-1b.
English: Abdominal pain °
Maltese: Pressjoni għolja °
English: Flu-like symptoms may also be reduced by administration of non-steroidal anti-inflammatory drugs.
Maltese: Sintomi jixbħu lill-influwenza jistgħu jitnaqqsu wkoll bl-għoti ta' mediċini anti-infjammatorji mhux sterojdi.
English: Limited information available on the transfer of interferon beta-1b into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1b excreted in human milk are negligible.
Maltese: Informazzjoni limitata disponibbli dwar it-trasferiment ta' interferon beta-1b fil-ħalib tas-sider,
English: To easily increase the dosage during the first 12 injections, you may be given a special titration pack, containing four differently coloured triple packs with special marked syringes and with detailed instructions on the separate introductory leaflet for titration pack.
Maltese: Jekk inti għandek pakkett ta' titrazzjoni ta' Betaferon se ssib 4 pakketti tripli ta' kulur u b'numru differenti li kull wieħed fih:
English: Rotation Schedule:
Maltese: Tabella:
English: Triple pack 2 is designed to help you prepare the next 3 injections (days 7, 9 and 11).
Maltese: 2 huwa maħsub biex jgħinek tipprepara t-3 injezzjonijiet li jmiss (ġranet 7, 9 u 11).
English: − Pack with 15 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Maltese: − Pakkett bi 15-il pakkett singolu, kull wieħed fih kunjett bit-trab, siringa mimlija għal-lest bis solvent, adattatur tal-kunjett b'labra, 2 imsielaħ ta' l-alkoħol jew
English: Pulmonary arterial hypertension4
Maltese: Pressjoni għolja fl-arterja tal pulmun4
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer AG
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Bayer AG
English: This effect continued over the observation period of up to 33 months.
Maltese: Dan l-effett kompla tul il-perijodu ta' osservazzjoni sa' 33 xahar.
English: 3 Pre-filled syringes with solvent for reconstitution, each containing 1.2 ml sodium chloride solution, 5.4 mg/ml.
Maltese: II. 3 siringi mimlija għal-lest b'solvent għar-rikostituzzjoni, kull waħda fiha 1.2 ml ta' soluzzjoni ta' sodium chloride, 5.4 mg/ml.
English: Each triple pack contains the syringes you will require for preparing each dose.
Maltese: Kull pakkett triplu fih is-siringi li se jkollok bżonn għall-preparazzjoni ta' kull doża.
English: The binding of interferon beta-1b to these receptors induces the expression of a number of gene products that are believed to be the mediators of the biological actions of interferon beta-1b.
Maltese: L-irbit ta' interferon beta-1b ma' dawn ir-riċevituri jwassal għall ħelisen ta' numru ta' prodotti ġenetiċi li huma meqjusa bħala medjaturi tal-azzjonijiet bijoloġiċi ta' interferon beta-1b.
English: NAME OF THE MEDICINAL PRODUCT Betaferon 250 microgram/ml, powder and solvent for solution for injection
Maltese: Betaferon 250 mikrogramma/ml, trab u solvent għas-soluzzjoni għall-injezzjoni
English: − Pack with 12 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Maltese: − Pakkett bi 12-il pakkett singolu, kull wieħed fih kunjett bit-trab, siringa mimlija għal-lest bis solvent, adattatur tal-kunjett b'labra, 2 imsielaħ ta' l-alkoħol jew
English: Betaferon prolonged the time to CDMS by 363 days, from 255 days in the placebo group to 618 days in the Betaferon group (based on the 25th percentiles)
Maltese: ġurnata fil-grupp tal plaċebo għal 618 ġurnata fil-grupp ta' Betaferon (ibbażat fuq il-25 perċentili)
English: Metrorrhagia
Maltese: Pożoloġija
English: Symptoms include redness, swelling, change in the skin colour, inflammation, pain and hypersensitivity.
Maltese: Is-sintomi jinkludu ħmura, nefħa, bidla fil-kulur tal-ġilda, infjammazzjoni, uġigħ u sensittività eċċessiva.
English: Time to confirmed EDSS progression Kaplan-Meier estimates
Maltese: Żmien sa progressjoni kkonfermata fl-EDSS
English: Patients receiving Betaferon showed a reduction in frequency (30%) and severity of clinical relapses, as well as the number of hospitalisations due to disease.
Maltese: Pazjenti li ħadu Betaferon kellhom tnaqqis fil frekwenza (30%) u fis-severità tal-irkadar kliniku, kif ukoll tnaqqis fin-numru ta' drabi li kellhom jittieħdu l-isptar minħabba l-marda.
English: 1 vial adapter with needle + 2 alcohol wipes *Betaferon is formulated to contain a calculated overfill of 20 %.
Maltese: III. 3 adattaturi tal-kunjett b'labar + 6 imsielaħ ta' l-alkoħol *Betaferon huwa magħmul biex ikun fih ammont ikkalkulat żejjed ta' 20 %.
English: Injection site necrosis * °
Maltese: Uġigħ fil-muskoli * °
English: ► Checking the content of the pack
Maltese: ► Iċċekkja l-kontenut tal-pakkett
English: − 2-month pack with 2x14 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or
Maltese: − Pakkett għal xaharejn bi 2x14-il pakkett singolu, kull wieħed fih kunjett 1 bit-trab, siringa mimlija għal-lest bis-solvent, adattatur tal-kunjett b'labra, 2 imsielaħ ta' l-alkoħol jew
English: Patients exhibiting depression should be monitored closely during therapy with Betaferon and treated appropriately.
Maltese: Pazjenti li għandhom depressjoni għandhom jiġu sorveljati mill-qrib waqt it-terapija b'Betaferon u kkurati skont il-bżonn.
English: The absolute bioavailability of subcutaneously administered interferon beta-1b was approximately
Maltese: interferon beta-1b f'kull kunjett.
English: Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Maltese: Riżultati tal-laboratorju li jissuġġerixxu TMA jinkludu tnaqqis flgħadd tal-plejtlits, żieda fil-livell ta' lactate dehydrogenase (LDH) fis-serum minħabba l-emolisi u xistoċiti (frammentazzjoni ta' eritroċiti) fuq film tad-demm.
English: METHOD AND ROUTE OF ADMINISTRATION For subcutaneous injection after reconstitution with 1.2 ml of solvent.
Maltese: Għall-injezzjoni minn taħt il-ġilda wara rikostituzzjoni b'1.2 ml ta' solvent.
English: Patients with monofocal or multifocal onset of the disease were included (i.e. patients with clinical evidence for a single or at least two lesions, respectively, of the central nervous system).
Maltese: Kienu inklużi pazjenti li kellhom bidu monofokali jew multifokali talmarda (i.e. pazjenti b'evidenza klinika ta' leżjoni waħda jew mill-inqas żewġ leżjonijiet, rispettivament, tas-sistema nervuża ċentrali).
English: SN
Maltese: KG
English: Thyroid function tests are recommended regularly in patients with a history of thyroid dysfunction or as clinically indicated.
Maltese: Madankollu dan ma kienx investigat in vivo u s-sinifikanza klinika tiegħu għadha mhux aċċertata.
English: Part of a pack containing 14 single packs in a 2-month pack of 2x14 single packs.
Maltese: Parti minn pakkett li fih 14-il pakkett singolu f'pakkett għal xaharejn ta' 2x14-il pakkett singolu.
English: When starting treatment with Betaferon, it is tolerated best by gradually increasing the dose, i.e. starting with just 0.25 ml of the medication and then increasing, after every 3rd injection, first to 0.5 ml, then to 0.75 ml and then finally to the full dose (1 ml) of Betaferon.
Maltese: Meta tinbeda l-kurab'Betaferon huwa ttollerat l-aħjar meta d-doża tiżdied b'mod gradwali , i.e. tibda biss b'0.25 ml tal-medikazzjoni u wara żżid, wara kull tliet injezzjonijiet, l-ewwel għal 0.5 ml, imbagħad għal 0.75 ml u fl-aħħar għad-doża sħiħa (1 ml) ta' Betaferon.
English: During the post-marketing period very rare reports have been received of worsening of cardiac status in patients with pre-existing significant cardiac disease temporarily associated with the initiation of Betaferon therapy.
Maltese: Waqt il-perijodu ta' wara t-tqegħid fis-suq waslu rapporti rari ħafna ta' aggravar fl-istat kardijaku ta' pazjenti b'mard tal-qalb sinifikanti li kien jeżisti minn qabel, temporanjament assoċjat ma' bidu ta' terapija b'Betaferon.
English: Problems with your small blood vessels (capillaries) may develop when using medicines like Betaferon (systemic capillary leak syndrome).
Maltese: Jistgħu jiżviluppaw problemi fil-kanali ż-żgħar taddemm (kapillari) tiegħek meta jintużaw mediċini bħal Betaferon (sindrome sistemika ta' tnixxija kapillari).
English: Continue with the green triple pack 3 containing 3 syringes with a 0.75-ml marking, for treatment days 13, 15 and 17.
Maltese: Dan it-tielet pakkett triplu għandu jintuża għal ġranet ta' kura 13, 15 u 17.
English: To reduce the risk of getting injection site reactions you must:
Maltese: ► Għid lit-tabib tiegħek minnufih u waqqaf l-użu ta' Betaferon:
English: You will find that within a few weeks your treatment will become a natural part of your routine.
Maltese: Se ssib li wara ftit ġimgħat, il-kura tiegħek se ssir parti naturali mir-rutina tiegħek.
English: Betaferon can reduce the number and severity of the attacks, and slow the progression of disability.
Maltese: Betaferon jista' jnaqqas in-numru u s-severità tal-attakki, u jittardja l-progressjoni tad diżabilità.
English: Caution should be exercised when Betaferon is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. anti-epileptics.
Maltese: Għandu jkun hemm attenzjoni meta Betaferon jingħata flimkien ma' prodotti mediċinali li għandhom indiċi terapewtiċi dojoq u li huma dipendenti ħafna fuq is-sistema taċċitokromju P450 tal-fwied għat-tneħħija, eż. anti-epilettiċi.
English: Norge
Maltese: Rimi
English: Skin discolouration
Maltese: Disturbi filqalb
English: Renal and urinary disorders Urinary retention Urinary protein positive
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija
English: 1 vial adapter with needle + 2 alcohol wipes
Maltese: Adattatur tal-kunjett wieħed b'labra + 2 imsielaħ ta' l-alkoħol
English: - the number of red cells in the blood may fall (anaemia) - the thyroid gland does not work properly (too little hormone is produced) (hypothyroidism) - weight increase or decrease - confusion - abnormally rapid heartbeat (tachycardia) - a reddish yellow pigment (bilirubin), which is produced by your liver, may rise (this will show up in blood tests) - swollen and usually itchy patches of skin or mucous membranes (urticaria) - itching (pruritus) - loss of scalp hair (alopecia) - menstrual disorders (menorrhagia)
Maltese: Lista 2: Effetti sekondarji rrappurtati dwar il-prodott wara t-tqegħid fis-suq (minn rappurtar spontanju, il-frekwenzi - fejn magħrufa - ibbażati fuq provi kliniċi) ► Komuni ħafna (jistgħu jaffettwaw aktar minn utent wieħed minn kull 10): - ġogi juġgħu (artralġja)
English: i.e. the following terms: injection site haemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site oedema, and injection site atrophy & “Flu-like symptom complex” denotes flu syndrome and/or a combination of at least two AEs from fever, chills, myalgia, malaise, sweating.
Maltese: (majastenja), uġigħ fid-dahar, uġigħ fl-estremitajiet bħal swaba' tal-idejn u tas-saqajn diffikultà biex tgħaddi l-awrina (żamma tal-awrina), proteina fl-awrina (osservati fit-testijiet tal-awrina), tgħaddi l-awrina ta' spiss, inabbiltà li żżomm l-awrina (inkontinenza tal-awrina), tgħaddi l-awrina b'urġenza uġigħ waqt il-menstrwazzjoni (dismenorea), disturbi menstrwali, tnixxija qawwija ta' demm mill-utru (metroraġja) speċjalment bejn menstrwazzjoni u oħra, impotenza reazzjoni fil-lok tal-injezzjoni (inkluż ħmura, nefħa, bidla fil-kulur, infjammazzjoni, uġigħ, reazzjoni allerġika (sensittività eċċessiva), problemi fil-ġilda u ħsara fit-tessuti (nekrosi) fis-sit tal-injezzjoni (ara sezzjoni 2 ‘Twissijiet u prekawzjonijiet'),
English: Altargo is an antibiotic medicine.
Maltese: Altargo hu mediċina antibijotika.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Altargo to Glaxo Group Ltd on 24 May 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-UE kollha għal Altargo lil Glaxo Group Ltd fit-24 ta' Mejju 2007.
English: This summary was last updated in 07-2007.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi 07-2007.
English: The active substance in Altargo, retapamulin, is an antibiotic belonging to the ‘pleuromutilin' class.
Maltese: Is-sustanza attiva f'Altargo, retapamulin, hija antibijotiku fil-klassi tal-‘pleuromutilin'.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ALTARGO EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) ALTARGO
English: Altargo is an ointment that contains the active substance retapamulin.
Maltese: Altargo hu ingwent li fih is-sustanza attiva retapamulin.
English: Altargo was at least as effective as fusidic acid, with 314 (99.1%) of 317 and 141 (94.0%) of 150 patients, respectively, responding to treatment.
Maltese: Altrago kien effettiv daqs il-fusidic acid ukoll, b'314 (99.1%) mit-317-il pazjent u 141 (94.0%) mill-150 pazjent, rispettivament, jirrispondu għat-trattament.
English: In patients with impetigo, Altargo was more effective than placebo, with 119 (85.6%) of the 139 patients using Altargo and 37 (52.1%) of the 71 using placebo responding to treatment.
Maltese: F'pazjenti bl-impetiġini, Altargo kien iktar effettiv mill-plaċebo, b'119 (85.6%) mill-139 pazjent li użaw Altargo u 37 (52.1%) tal-71 pazjent li użaw il-plaċebo jirrispondu għat-trattament.
English: It is derived from a compound produced by certain types of fungus.
Maltese: Hija derivata minn kompost prodott minn ċerti tipi ta' fungi.
English: How has Altargo been studied?
Maltese: Kif ġie studjat Altargo?
English: compared the effects of five days' treatment with Altargo to those of cefalexin (an oral antibiotic medicine): two studies were carried out in a total of 1,918 patients with infected skin wounds, and the final study was carried out in 545 patients with infected dermatitis (skin inflammation).
Maltese: It-tliet studji loħra qabblu l-effetti ta' ħamest ijiem trattament b'Altargo ma' l-effetti ta' cefalexin (mediċina antibijotika orali): saru żewġ studji li fihom b'kollox ħadu sehem 1,918-il pazjent b'feriti infettati filġilda, u fl-istudju finali ħadu sehem 454 pazjent b'dermatite (infjammazzjoni fil-ġilda) infettata.
English: The first compared the effects of five days' treatment with Altargo to those of placebo (a dummy treatment) in 213 patients, and the second compared Altargo to fusidic acid (another antibiotic ointment) in 519 patients.
Maltese: ijiem trattament permezz ta' l-Altrago ma' dawk ta' plaċebo (trattament fint) fuq 213 pazjent, u t-tieni wieħed qabbel Altrago ma' fusidic acid (ingwent antibijotiku ieħor) f'519-il pazjent.
English: For the treatment of infected skin wounds, Altargo and cefalexin had similar response rates: when the results of both skin wound studies were taken together, around 90% of both groups of patients responded to treatment.
Maltese: Għat-trattament ta' feriti infettati fil-ġilda, Altargo u cefalexin kellhom rati simili ta' rispons: meta r-riżultati taż-żewġ studji tal-feriti fil-ġilda ttieħdu flimkien, madwar 90% taż-żewġ gruppi ta' pazjenti kellhom rispons għat-trattament.
English: Altargo has been studied in five main studies involving over 3,000 patients aged from 9 months upwards.
Maltese: Altargo ġie studjat f'ħames studji ewlenin li fihom ħadu sehem iktar minn 3,000 pazjent li kellhom 9 xhur jew iktar.
English: Altargo should not be used to treat infections known or thought likely to be due to methicillin-resistant Staphylococcus aureus (MRSA), as it may not work against this type of infection.
Maltese: Altargo m'għandux jintuża fit-trattament ta' infezzjonijiet li jkun magħruf jew maħsub li ġew ikkawżati minn methicillin-resistant Staphylococcus aureus (MRSA), għax jista' ma jaħdimx fuq din it-tip ta' infezzjoni.
English: The effects of Altargo were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Altargo ġew studjati f'mudelli esperimentali qabel ma ġew studjati fin-nies.
English: It is used for short-term treatment of superficial skin infections.
Maltese: Jintuża għat-trattament immedjat ta' infezzjonijiet superfiċjali talġilda.
English: • infected small lacerations, abrasions or sutured wounds.
Maltese: • laċerazzjonijiet, barxiet jew feriti meħjuta infettati.
English: However, it may be used to treat infections caused by other types of Staphylococcus aureus.
Maltese: Madankollu, Altargo jista' jintuża fit-trattament ta' infezzjonijiet ikkawżati minn tipi oħra ta' Staphylococcus aureus.
English: Altargo can be used in patients from the age of nine months, but in patients under 18 years of age, the area to be treated should not be more than 2% of the body's surface.
Maltese: Altargo jista' jintuża f'pazjenti li jkollhom iktar minn disa' xhur, iżda f'pazjenti li jkollhom inqas minn 18-il sena, il-parti ttrattata ma tridx tkun ikbar minn 2% tas-superfiċje tal-ġisem.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Altargo's benefits are greater than its risks for the short term treatment of the following superficial skin infections:
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Altargo huma ikbar mir-riskji meta wżat għat-trattament immedjat ta' dawn l-infezzjonijiet superfiċjali
English: It works by blocking the bacteria's ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria.
Maltese: Taħdem billi timblokka r-ribożomi tal-batterji (il-parti taċ-ċelloli li fihom jiġu manifatturati l-proteini), u b'hekk trażżan it-tkabbir tal-batterji.
English: The most common side effect with Altargo (seen in between 1 and 10 patients in 100) is irritation at the site of application.
Maltese: L-iktar effett sekondarju komuni ta' Altargo (li deher f'bejn wieħed u għaxar pazjenti minn kull 100) hu l-irritazzjoni fil-post ta' l-applikazzjoni.
English: Immediate Packaging Pack size
Maltese: Imballaġġ primarju Daqs tal-pakkett
English: Pharmaceutical Form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: It is available as tablets: 10 mg (blue), 15 mg (orange) and 50 mg (red).
Maltese: Hija disponibbli f'pilloli ta': 10 mg (blu), 15 mg (oranġjo) u 50 mg (ħomor).
English: The active substance in Palladia, toceranib, is a receptor tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Palladia, toceranib, hija inibitur tar-riċettur tiroxina kinażi.
English: Palladia contains toceranib, which belongs to a class of medicines with anticancer activity.
Maltese: Palladia fih toceranib, li jappartjeni għall-klassi tal-mediċini b'attività antikanċeroġena.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Palladia exceed the risks for the treatment of non-resectable Patnaik grade II (intermediate grade) or III (high grade), recurrent, cutaneous mast cell tumours in dogs and recommended that Palladia be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Palladia huma akbar mir-riskji għat-trattament b'Patnaik Grad II li ma jitneħħiex b'operazzjoni (grad intermedju) jew III (grad għoli), rikurrenti, tumuri tat-tip mast-cell tal-ġilda fi klieb u rrakkomanda li Palladia jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Palladia on 23.09.2009.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pallaida f'23.09.2009.
English: These reactions are usually mild to moderate and temporary.
Maltese: Dawn ir-reazzjonijiet normalment huma minn ħfief għal moderati u temporanji.
English: The most common side effects with Palladia are diarrhoea and vomiting, loss of appetite, lethargy (lack of energy), neutropenia (low white blood cell counts), difficulty moving (lameness) and weight loss.
Maltese: L-effetti l-aktar komuni b'Palladia huma dijarrea u remettar, telf tal-aptit, letarġija (nuqqas ta' enerġija), newtropenija (rata baxxa ta' ċelloli bojod fid-demm), diffikultà fil-mobilità (izappap) u telf ta' piż.
English: Why has Palladia been approved?
Maltese: Għaliex ġie approvat Palladia?
English: A complete response (disappearance of the tumour) was seen in around 8% and a partial response (shrinkage of the tumour) was seen in around 29% of the dogs treated with Palladia.
Maltese: Rispons sħiħ (it-tumur telaq) deher f'madwar 8% u rispons parzjali (it-tumur ċkien) deher f'29% tal-klieb ittrattati b'Palladia.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċji u r-riskji jista' jiġi kkonsultat fil-modulu 6 ta' dan l-EPAR.
English: The usual dose is 3.25 mg per kilogram bodyweight, and the number of tablets to use is carefully calculated for each dog.
Maltese: Id-doża normali hija ta' 3.25 mg għal kull kilo ta' piż tal-ġisem u n-numru ta' pilloli użat huwa kkalkulat b'mod kawt għal kull kelb.
English: What is Palladia?
Maltese: X'inhu Palladia?
English: Dogs treated with Palladia had greater objective response rates (37%) than dogs treated with placebo (8%) after six weeks of treatment.
Maltese: Klieb ittrattati b'Palladia kellhom rati ta' ripons oġġettivi u akbar (37%) minn klieb ittrattati b'plaċebo (8%) wara sitt ġimgħat tat-trattament.
English: In a first phase (up to six weeks), Palladia was compared with placebo (a dummy treatment).
Maltese: Palladia ġie mqabbel ma' plaċebo (trattament finta).