FrancophonIA/ELRC3.0 huggingface dataset:
English: 9.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “7.5” on one side and “G” on the other side.
Maltese: Pilloli miksija b'rita ta' 9.0 mm, tondi, konvessi normali, ta' kulur abjad, imnaqqxin b'“OZ” fuq “7.5” fuq naħa waħda u “G” fuq in-naħa l-oħra.
English: Thrombocytopenia11
Maltese: Qalba tal-pillola
English: Hypersensitivity to the active substance, peanut or soya, or to any of the excipients listed in section
Maltese: Sensittività eċċessiva għas-sustanza attiva, karawett jew soja jew għal kwalunkwe wieћed milleċċipjenti elenkati fis-sezzjoni 6.1.
English: PHARMACEUTICAL FORM Film-coated tablet (tablet).
Maltese: Pillola miksija b'rita (pillola).
English: EU/1/08/475/018 EU/1/08/475/019 EU/1/08/475/020 EU/1/08/475/021 EU/1/08/475/022 EU/1/08/475/041 EU/1/08/475/042 EU/1/08/475/058 EU/1/08/475/063
Maltese: EU/1/08/475/021 EU/1/08/475/022 EU/1/08/475/023 EU/1/08/475/024
English: Age >75 years and vascular/mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
Maltese: L-età ta' > 75 sena u d-demenzja tat-tip vaskulari jew imħallta kienu identifikati bħala fatturi ta' riskju għal CVAE f'assoċjazzjoni ma' trattament b'olanzapine.
English: 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
Maltese: 2 Iż-żidiet medji fil-livelli tax-xaħmijiet waqt is-sawm (kolesterol totali, LDL kolesterol, u trigliċeridi) kienu ogħla f'pazjent li fil-linja bażi ma wrewx evidenza ta' problemi fil-kontroll tax-xaħmijiet.
English: Amenorrhea Breast enlargement Galactorrhea in females Gynaecomastia/breast enlargement in males
Maltese: Ginekomastija/tkabbir żejjed tas-sider fl-irġiel
English: INFORMATION IN BRAILLE Olanzapine 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE OLANZAPINE 10 mg
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija fiha 20 mg olanzapine
English: 35 film-coated tablets
Maltese: 35 pilloli miksijin b'rita
English: A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
Maltese: Għandha tiġi kkunsidrata tnaqqis fid-doża ta' olanzapine jekk jinbeda xi trattament b'inibitur ta' CYP1A2.
English: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Maltese: Doża anqas tal-bidu (5 mg/ġurnata) mhux indikata normalment imma għandha tiġi kkunsidrata għal dawk li għandhom 65 jew fuqhom meta fatturi kliniċi jindikaw hekk (ara sezzjoni 4.4).
English: Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.
Maltese: Id-doża tal-bidu rakkomandata għal olanzapine hija 10 mg/ġurnata.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 7.5 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija fiha 7.5 mg olanzapine
English: • Diabetes
Maltese: • Dijabete
English: Olanzapine Mylan 10 mg is available in packs containing 100 and 500 film-coated tablets.
Maltese: L-Olanzapine Mylan ta' l-10 mg jinbiegħu f'pakketti ta' 100 u ta' 500 pillola miksija b'rita.
English: EU/1/08/475/013 EU/1/08/475/014 EU/1/08/475/015 EU/1/08/475/016 EU/1/08/475/039 EU/1/08/475/040 EU/1/08/475/054 EU/1/08/475/055 EU/1/08/475/057 EU/1/08/475/062
Maltese: EU/1/08/475/036 EU/1/08/475/037 EU/1/08/475/038 EU/1/08/475/039 EU/1/08/475/040
English: Olanzapine Mylan 15 mg are oval-shaped, white film-coated tablets with sides that curve outwards, marked with “OZ 15” on one side and “G” on the other side.
Maltese: L-Olanzapine Mylan 5 mg huma 8.0 mm, tondi, mżaqqa normali, bojod miksijin b'rita imnaqqxa b' “OZ 5” fuq naħa waħda u b' “G” fuq in-naħa l-oħra.
English: Restless legs syndrome
Maltese: Sindromu ta' saqajn irrikwieti
English: INFORMATION IN BRAILLE Olanzapine 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Olanzapine 5 mg
English: Changes in fasting glucose from borderline at baseline (≥ 5.56-< 7 mmol/l) to high (≥ 7 mmol/l) were very common.
Maltese: Tibdil fil-livelli taz-zokkor waqt is-sawm mil-limitu tan-normal fil-linja bażi (≥ 5.56< 7 mmol/l) għal għoljin (≥ 7m mol/l) kienu komuni ħafna.
English: 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Maltese: 7 Ġew irrapportati sintomi akuti bħal għaraq, insomnja, rogħda, ansjetà, tqalligħ u rimettar meta olanzapine jitwaqqaf f'daqqa.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 2.5 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija fiha 2.5 mg olanzapine
English: How to store Olanzapine Mylan Contents of the pack and other information
Maltese: Id-Dehra ta' OLANZAPINE MYLAN u l-kontenuti tal-pakkett:
English: EMA/327117/2014 EMEA/H/C/002659
Maltese: EMEA/H/C/002659
English: uncontrollably.
Maltese: waqfien.
English: It was to be available as tablets.
Maltese: Kellu jiġi bħala pilloli.
English: Masitinib was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2009 for the treatment of pancreatic cancer.
Maltese: Masitinib ġie kklassifikat bħala 'mediċina orfni' (mediċina li għandha tintuża f'mard rari) fit-28 ta' Ottubru 2009 għall-kura ta' kanċer tal-frixa.
English: What is Masiviera?
Maltese: X'inhu Masiviera?
English: The active substance in Masiviera, masitinib, is a tyrosine-kinase inhibitor.
Maltese: Is-sustanza attiva f'Masiviera, il-masitinib, hija inibitur tat-tirosina kinażi.
English: The company that applied for authorisation is AB Science.
Maltese: Ilkumpanija li applikat għal awtorizzazzjoni hija AB Science.
English: Masiviera is an anticancer medicine that contains the active substance masitinib.
Maltese: Masiviera hija mediċina kontra l-kanċer li fiha s-sustanza attiva masitinib.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.
Maltese: Wara li qies ir-raġunijiet għal din it-talba, isCHMP eżamina mill-ġdid l-opinjoni inizjali, u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq fit-22 ta' Mejju 2014.
English: Masiviera was expected to be used to treat adults with cancer of the pancreas (an organ of the digestive system) that is locally advanced or metastatic (has spread to other parts of the body), nonresectable (unsuitable for surgery) and is accompanied by at least moderate pain.
Maltese: Masiviera kien mistenni li jintuża biex jikkura adulti b'kanċer tal-frixa (organu tas-sistema diġestiva) li huwa lokalment avvanzat jew metastatiku (ikun infirex għal partijiet oħrajn tal-ġisem), inoperabbli (mhux xieraq biex jitneħħa b'kirurġija) u huwa akkumpanjat minn tal-inqas uġigħ moderat.
English: On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masiviera, intended for the treatment of advanced inoperable pancreatic cancer.
Maltese: Fit-23 ta' Jannar 2014, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Masiviera, maħsub għall-kura ta' kanċer tal-frixa inoperabbli fi stadju avvanzat.
English: This means that it blocks certain enzymes known as tyrosine kinases.
Maltese: Dan ifisser li timblokka ċerti enzimi magħrufin bħala tirosina kinażi.
English: How is Masiviera expected to work?
Maltese: Għal xiex kien mistenni li jintuża Masiviera?
English: For more information, see here.
Maltese: Għal aktar informazzjoni, ara hawn.
English: The company presented results of one main study involving 353 patients with advanced or metastatic pancreatic cancer.
Maltese: Il-kumpanija ppreżentat riżultati ta' studju prinċipali wieħed li kien jinvolvi 353 pazjent b'kanċer talfrixa avvanzat jew metastatiku.
English: In addition, Masiviera was associated with significant toxicity.
Maltese: Barra minn hekk, Masiviera kien assoċjat ma' tossiċità sinifikanti.
English: It was to be used in combination with another cancer medicine, gemcitabine.
Maltese: Kellu jintuża f'kombinazzjoni ma' mediċina oħra kontra l-kanċer, gemcitabine.
English: The company also presented various supporting analyses and information from a supportive study.
Maltese: Ilkumpanija ppreżentat ukoll analiżi ta' appoġġ varji u informazzjoni minn studju ta' appoġġ.
English: During the re-examination the CHMP looked again at the data from the company, including a proposal for a conditional authorisation in a restricted group of patients, and also consulted a group of experts in the treatment of pancreatic cancer.
Maltese: Matul l-eżaminazzjoni mill-ġdid, is-CHMP ħares mill-ġdid lejn id-dejta mill-kumpanija, inkluż proposta għal awtorizzazzjoni b'kundizzjoni fi grupp ristrett ta' pazjenti, u kkonsulta wkoll ma' grupp ta' esperti fil-kura ta' kanċer tal-frixa.
English: The effects of Masiviera were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Masiviera ġew ittestjati l-ewwel f'mudelli sperimentali qabel ma ġew studjati fil-bniedem.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Maltese: Jekk inti qed tieħu sehem fi prova klinika jew fi program ta' użu kompassjonali u teħtieġ aktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li jkun qed jagħtik il-kura.
English: At the time of the initial evaluation, the CHMP noted that the results of the main study with Masiviera did not show effectiveness in the overall group of patients with advanced or metastatic pancreatic cancer.
Maltese: Meta saret l-evalwazzjoni inizjali, is-CHMP innota li r-riżultati tal-istudju prinċipali b'Masiviera ma wrewx effikaċja fil-grupp ġenerali ta' pazjenti b'kanċer tal-frixa avvanzat jew metastatiku.
English: Although the company presented analyses suggesting that there was a benefit in a subgroup of patients with certain genetic changes associated with more aggressive disease, and in a subgroup of patients with pain, the study was not designed to show benefit in these smaller groups, and the Committee considered that further study would be needed to demonstrate such a benefit.
Maltese: Għalkemm il-kumpanija ppreżentat analiżi li tissuġġerixxi li kien hemm benefiċċju f'sottogrupp ta' pazjenti b'ċerti tibdiliet ġenetiċi assoċjati ma' marda aktar aggressiva, u f'sottogrupp ta' pazjenti b'uġigħ, l-istudju ma kienx imfassal sabiex juri benefiċċju f'dawn il-gruppi iżgħar, u l-Kumitat qies li hemm bżonn ta' aktar studju sabiex jintwera tali benefiċċju.
English: Pharmaceutical Form Route of administration Packaging
Maltese: Għamla Farmaċewtika Metodu ta' Amministrazzjoni
English: Strength
Maltese: Imballaġġ
English: EU number
Maltese: Numru tal-UE Isem maħsub Qawwa
English: (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: MA EU Number
Maltese: Mnejn għandu jingħata
English: Further information on Rxulti can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Rxulti tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Rxulti is available as tablets (0.25, 0.5, 1, 2, 3 and 4 mg) to be taken by mouth.
Maltese: Rxulti jiġi bħala kapsuli (0.25, 0.5, 1, 2, 3 u 4 mg) li għandhom jittieħdu mill-ħalq.
English: The safety profile of Rxulti is similar to other antipsychotic medicines.
Maltese: Il-profil tas-sigurtà ta' Rxulti huwa simili għal mediċini antipsikotiċi oħra.
English: Other information about Rxulti
Maltese: Informazzjoni oħra dwar Rxulti
English: The active substance in Rxulti, brexpiprazole, is thought to attach to receptors (targets) in the brain for several neurotransmitters (substances nerve cells use to communicate with neighbouring cells) including dopamine, serotonin and noradrenaline.
Maltese: Is-sustanza attiva f'Rxulti, il-brexpiprazole, hija maħsuba li teħel mar-reċetturi (miri) fil-moħħ għal diversi newrotrażmettituri (sustanzi li ċ-ċelloli tan-nervituri jużaw biex jikkomunikaw maċ-ċelloli ta' ħdejhom), inklużi d-dopamina, is-serotonina u n-noradrenalina.
English: Rxulti contains the active substance brexpiprazole.
Maltese: Rxulti fih is-sustanza attiva brexpiprazole.
English: In 4 of the studies, Rxulti was compared with placebo (a dummy treatment) and the main measure of effectiveness was reduction of symptoms on a standard rating scale called PANSS (positive and negative syndrome scale) which ranges from a minimum of 30 (no symptoms) to a maximum of 210 (severest symptoms) after 6 weeks of treatment.
Maltese: F'4 mill-istudji, Rxulti tqabbel ma' plaċebo (kura finta) u l-kejl ewlieni tal-effikaċja kien tnaqqis tassintomi fuq skala ta' klassifikazzjoni standard imsejħa PANSS (skala ta' sindrome pożittiv u negattiv) li tvarja minn minimu ta' 30 (l-ebda sintomu) għal massimu ta' 210 (is-sintomi l-aktar severi) wara 6 ġimgħat ta' kura.
English: Rxulti was effective at reducing symptoms of schizophrenia.
Maltese: Rxulti kien effettiv biex inaqqas is-sintomi tal-iskizofrenja.
English: The recommended dose is between 2 and 4 mg daily and 4 mg is the maximum recommended daily dose.
Maltese: Id-doża rakkomandata hija bejn 2 u 4 mg kuljum u 4 mg hija d-doża massima rakkomandata kuljum.
English: What are the risks associated with Rxulti?
Maltese: X'inhuma r-riskji assoċjati ma' Rxulti?
English: In the fourth study, doses of Rxulti ranging from 2 to 4 mg were compared with placebo and with another antipsychotic medicine, quetiapine.
Maltese: Fir-raba' studju, dożi ta' Rxulti li jvarjaw minn 2 sa 4 mg tqabblu mal-plaċebo u ma' mediċina antipsikotika oħra, quetiapine.
English: In the first study, the PANSS score fell by around 21 and 20 points with 2 mg and 4 mg Rxulti respectively compared with 12 points with placebo.
Maltese: Fl-ewwel studju, il-punteġġ PANSS niżel b'madwar 21 u 20 punt b'2 mg u 4 mg ta' Rxulti rispettivament meta mqabbel ma' 12-il punt bil-plaċebo.
English: Rxulti has been shown to be effective at reducing symptoms of schizophrenia in 5 main studies involving 2,404 adults with schizophrenia, although there were some inconsistent results.
Maltese: Rxulti ntwera li kien effettiv biex inaqqas is-sintomi tal-iskizofrenja f'5 studji ewlenin li involvew 2,404 adult bl-iskizofrenja, għalkemm kien hemm xi riżultati inkonsistenti.
English: Rxulti is an antipsychotic medicine used to treat schizophrenia in adults.
Maltese: Rxulti huwa mediċina antipsikotika li tintuża biex tikkura l-iskizofrenja fl-adulti.
English: The dose is then increased to 2 mg once daily taken on days 5, 6 and 7 and increased again if necessary to 4 mg once daily on day 8.
Maltese: Id-doża mbagħad tiżdied għal 2 mg darba kuljum li tittieħed fil-jiem 5, 6 u 7 u terġa' tiżdied jekk ikun meħtieġ għal 4 mg darba kuljum fil-jum 8.
English: Rxulti was more effective than placebo in preventing relapse: after a year, 14% of patients taking Rxulti had relapsed compared with 38% of patients taking placebo.
Maltese: Rxulti kien aktar effettiv mill-plaċebo biex jipprevjeni rrikaduti: wara sena, 14 % tal-pazjenti li kienu qed jieħdu Rxulti kellhom rikaduti meta mqabbel ma' 38 % tal-pazjenti li kienu qed jieħdu l-plaċebo.
English: The most common side effects with Rxulti are akathisia (a constant urge to move, which may affect around 6 in 100 people) and weight gain (which may affect around 4 in 100 people).
Maltese: L-effetti sekondarji l-aktar komuni b'Rxulti huma l-akatiżija (urġenza kostanti li tiċċaqlaq, li tista' taffettwa madwar 6 persuni minn 100) u żieda fil-piż (li tista' taffettwa madwar 4 persuni minn 100).
English: In patients with moderately or severely reduced kidney or liver function the dose should be limited to 3 mg once a day.
Maltese: F'pazjenti li l-funzjoni tal-kliewi jew tal-fwied tkun imnaqqsa b'mod moderat jew sever, id-doża għandha tkun limitata għal 3 mg darba kuljum.
English: For the full list of side effects and restrictions with Rxulti, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Rxulti, ara l-fuljett ta' tagħrif.
English: Although the reductions in symptoms were not consistent across the studies, this often occurs in studies with antipsychotic medicines and the European Medicines Agency considered that the effects were sufficient to conclude that Rxulti is beneficial to patients with schizophrenia.
Maltese: Għalkemm it-tnaqqis fis-sintomi ma kienx konsistenti fl-istudji, dan jiġri spiss fi studji b'mediċini antipsikotiċi u l-Aġenzija Ewropea għall-Mediċini qieset li l-effetti kienu biżżejjed biex tikkonkludi li Rxulti huwa ta' benefiċċju għall-pazjenti bliskizofrenja.
English: Quetiapine showed improvement in symptoms at 6 weeks compared with placebo.
Maltese: Quetiapine wera titjib fis-sintomi wara 6 ġimgħat meta mqabbel mal-plaċebo.
English: An overview of Rxulti and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Rxulti u għalfejn huwa awtorizzat fl-UE
English: Results at 2, 3 and 4 weeks showed improvement in symptoms with Rxulti compared with placebo.
Maltese: Ir-riżultati fit-2, it-3 u r-4 ġimgħa wrew titjib fis-sintomi b'Rxulti meta mqabbla mal-plaċebo.
English: In the third study, the PANSS score fell by around 15 points with 2 mg Rxulti compared with 8 points with placebo and there was not considered to be a difference between 4 mg Rxulti and placebo.
Maltese: Fit-tielet studju, il-punteġġ PANSS niżel b'madwar 15-il punt b'2 mg ta' Rxulti meta mqabbel ma' 8 punti bil-plaċebo u ma tqiesx li kien hemm differenza bejn 4 mg ta' Rxulti u plaċebo.
English: The recommended starting dose is 1 mg once daily for the first 4 days.
Maltese: Id-doża tal-bidu rakkomandata hija 1 mg darba kuljum għall-ewwel 4 ijiem.
English: Schizophrenia is a mental illness with symptoms such as delusions, disorganised thinking and speech, suspiciousness and hallucinations (seeing, hearing or feeling things that are not there).
Maltese: L-iskizofrenja hija marda mentali b'sintomi bħal delużjonijiet, diżorganizzazzjoni fil-ħsibijiet u l-kliem, suspetti u alluċinazzjonijiet (viżjoni, smigħ jew ħass ta' oġġetti li mhumiex hemm).
English: In the second study, the PANSS score fell by around 20 points with 4 mg Rxulti compared with 14 points with placebo.
Maltese: Fit-tieni studju, il-punteġġ PANSS niżel b'madwar 20 punt b'4 mg ta' Rxulti meta mqabbel ma' 14-il punt bil-plaċebo.
English: How does Rxulti work?
Maltese: Kif jintuża Rxulti?
English: As for all medicines, data on the use of Rxulti are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Rxulti hija ssorveljata kontinwament.
English: Why is Rxulti authorised in the EU?
Maltese: Għaliex Rxulti ġie awtorizzat fl-UE?
English: Via Giacomo Chiesi, 1, 43122 Parma Italy
Maltese: Via Giacomo Chiesi, 1, 43122 Parma L-Italja
English: Germany
Maltese: LISTA
English: Annex I List of medicinal products and presentations
Maltese: TA' PRODOTTI MEDIĊINALI AWTORIZZATI FUQ LIVELL
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Nobivac Piro is a vaccine that contains antigens (proteins) from the parasites Babesia canis and Babesia rossi.
Maltese: Nobivac Piro huwa vaċċin li fih antiġeni (proteini) mill-parassiti Babesia canis u Babesia rossi.
English: This helps to reduce the symptoms of babesiosis.
Maltese: Dan jgħin fit-tnaqqis tas-sintomi ta' babesiosis.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Piro to Intervet International B.V. on 2 September 2004.
Maltese: Ewropea kollha għal Nobivac Piro lil Intervet International B.V. fit-2 ta' Settembru 2004.
English: NOBIVAC PIRO
Maltese: X'inhu Nobivac Piro?
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 iktar informazzjoni abbażi tar rakkomandazzjonijiet tal-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Piro exceed the risks for active immunisation of dogs of six months or older against B. canis to reduce the severity of clinical signs associated with acute babesiosis (B. canis) and anaemia as measured by packed cell volume, and recommended that Nobivac Piro be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċju ta' Nobivac Piro huma ikbar mir-riskju tiegħu meta użat fit-tilqim attiv ta' klieb ta' sitt xhur jew iktar kontra B. canis fit-tnaqqis tas-severità tas-sinjali kliniċi assoċjati ma' babesiosis akuta (B. canis) u l-anemija kif imkejla mill-volum taċ-ċelloli ppakkjati, u rrakkomanda li
English: Other information about Nobivac Piro:
Maltese: Tagħrif ieħor dwar Nobivac Piro:
English: Nobivac Piro is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Maltese: Nobivac Piro hu lyophilisate (freeze-dried pellet) u solvent li jitħalltu biex jiffurmaw sospensjoni għall-injezzjoni.
English: What is Nobivac Piro?
Maltese: Kif jaħdem Nobivac Piro?
English: The vaccine can reduce the severity of symptoms caused by acute (short-lived) babesiosis (the disease caused by infection with B. canis, with weakness, fever and jaundice) and anaemia (low red blood cell counts).
Maltese: Il-vaċċin jista' jnaqqas is-severità tas-sintomi kkawżati minn babesiosis akuta (qasira) (il-marda kkawżata minn infezzjoni b'B. canis, bi dgħjufija, deni u suffejra) u anemija (tnaqqis fiċ-ċelloli tad-demm ħomor).
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r riskju jinsab fil-modulu 6 ta' dan l-EPAR.
English: In general, these disappear within four days, but in rare cases they can persist for up to 14 days after the second injection.
Maltese: B'mod ġenerali, dawn jgħibu fi żmien erbat ijiem, iżda f'każijiet rari jistgħu jippersistu sa 14-il jum wara t-tieni injezzjoni.
English: Because the antigens on B. canis are very variable, vaccines against B. canis only work effectively if they also include antigens from B. rossi.
Maltese: Billi l-antiġenti fuq B. canis huma varjabbli ħafna, it-tilqimiet kontra B. canis jaħdmu effettivament biss jekk jinkludu wkoll antiġeni minn B. rossi.
English: Why has Nobivac Piro been approved?
Maltese: Għaliex ġie aprovat Nobivac Piro?
English: Nobivac Piro contains small amounts of antigens (soluble parasite antigens) from B. canis and the related species B. rossi that have been extracted from cultures of the parasites in red blood cells.
Maltese: Nobivac Piro fih ammonti żgħar ta' antiġeni (antiġeni tal-parassit li jinħallu) minn B. canis u speċi B. rossi relatati li jkunu ġew estratti mill-parassiti kkultivati fiċ-ċelloli tad-demm ħomor.
English: Nobivac Piro was more effective than placebo at stimulating the production of antibodies: more dogs receiving the vaccine developed antibodies than those receiving placebo.
Maltese: Nobivac Piro kien iktar effettiv mill-plaċebo fl-istumulazzjoni tal-produzzjoni ta' antikorpi: