FrancophonIA/ELRC3.0 huggingface dataset:
English: • For renal function with GFR levels approaching moderate renal impairment and in elderly patients, at least 2 to 4 times per year.
Maltese: • Għal funzjoni renali b'livelli tal-GFR li jqarrbu dawk ta' indeboliment renali moderat u f'pazjenti anzjani, tal-anqas darbtejn sa erba' darbiet fis-sena.
English: In March 2016 the EMA was informed by the Marketing authorization holder (MAH) of canagliflozin about an approximately 2-fold increase of lower limb amputations in canagliflozin-treated subjects compared to placebo in the MAH sponsored ongoing cardiovascular (CV) event study CANVAS.
Maltese: F'Marzu 2016, l-EMA ġiet infurmata mid-Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) ta' canagliflozin dwar żieda ta' madwar darbtejn aktar fin-numru ta' amputazzjonijiet tan-naħa ta' isfel tarriġlejn f'individwi kkurati b'canagliflozin meta mqabbel mal-plaċebo fl-istudju ta' avveniment kardjovaskulari (CV) CANVAS li għadu għaddej sponsorjat mill-MAH.
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo c
Maltese: HbA1c < 7 % Aġġustat għallinja bażi
English: These infections were more frequent in females (8.4 % and 1.2 % for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection.
Maltese: Dawn l-infezzjonijiet kienu aktar frekwenti fin-nisa (8.4 % u 1.2 % għal dapagliflozin u plaċebo, rispettivament), u individwi b'passat mediku ta' mard kellhom iktar ċans ta' infezzjoni li tirrepeti ruħha.
English: The efficacy of dapagliflozin, a component of this medicinal product, is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment.Therefore, this medicinal product is not recommended for use in patients with moderate to severe renal impairment (patients with GFR < 60 mL/min) (see section 4.2).
Maltese: Għaldaqstant, dan il-prodott mediċinali mhuwiex rrakkomandat għall-użu f'pazjenti b'indeboliment renali moderat sa sever (pazjenti b'GFR < 60 mL/min) (ara sezzjoni
English: Therapeutic experience in patients 75 years and older is limited.
Maltese: L-esperjenza terapewtika f'pazjenti ta' 75 sena jew ikbar hija limitat.
English: Urinary tract infections were more frequently reported for dapagliflozin compared to placebo in a pooled analysis up to 24 weeks (see section 4.8).
Maltese: Infezzjonijiet fil-passaġġ urinarju kienu rrapportati b'mod aktar frekwenti għal dapagliflozin meta mqabbel ma' plaċebo f'analiżi miġbura sa 24 ġimgħa (ara sezzjoni 4.8).
English: After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg or 850 mg metformin tablet is approximately 50-60 % in healthy subjects.
Maltese: Il-bijodisponibbiltà assoluta ta' pillola ta' metformin ta' 500 mg jew ta' 850 mg hija bejn wieħed u ieħor 50-60 % f'individwi b'saħħithom.
English: In subjects ≥ 65 years of age, a higher proportion of subjects treated with dapagliflozin had adverse reactions related to volume depletion (see section 4.8).
Maltese: F'pazjenti ta' ≥ 65 sena, proporzjon ikbar ta' individwi kkurati b'dapagliflozin kellhom reazzjonijiet avversi relatati ma' tnaqqis fil-volum (ara sezzjoni 4.8).
English: Very rare (may affect up to 1 in 10,000 people)
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000)
English: Fifty percent of subjects were on insulin monotherapy at baseline; 50 % were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80 % were on metformin alone, 12 % were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Maltese: Minn dan il-grupp tal-aħħar, 80 % kienu fuq metformin waħdu, 12 % kienu fuq terapija ta' metformin flimkien ma' sulphonylurea, u l-bqija kienu fuq prodotti mediċinali orali oħrajn li jbaxxu l-glukożju.
English: Results of (LOCF
Maltese: LOCF:
English: Primary episodes occurred at a rate of 1.62 % per patient-year in subjects treated with dapagliflozin and 2.06 % in comparator-treatment subjects, per patient-year.
Maltese: Lepisodji primarji seħħew bir-rata ta' 1.62 % kull sena ta' pazjent f'pazjenti ttrattati b'dapagliflozin u b'rata ta' 2.06 % f'pazjenti ttrattati bi prodott ta' paragun.
English: Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat
Maltese: - rimettar - uġigħ fl-istonku (uġigħ addominali) - bugħawwieġ fil-muskoli - sensazzjoni ġenerali li ma tiflaħx flimkien ma' għeja severa - diffikultà biex tieħu n-nifs - temperatura tal-ġisem u taħbit tal-qalb imnaqqsa
English: Treatment with dapagliflozin plus metformin at all doses produced clinically relevant and statistically significant improvements in HbA1c and fasting plasma glucose compared with placebo in combination with metformin.
Maltese: Il-kura b'dapagliflozin flimkien ma' metformin fid-dożi kollha pproduċiet titjib klinikament rilevanti u statistikament sinifikanti f'HbA1c u fil-glukożju fil-plażma waqt is-sawm meta mqabbla ma' plaċebo f'kombinazzjoni ma' metformin.
English: This is because you may be more prone to some side effects.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni bi Xigduo.
English: Hepatic impairment
Maltese: Mediċini oħra u Xigduo
English: • Dehydration: loss of too much fluid from your body, seen uncommonly (may affect up to 1 in 100 people).
Maltese: • Deidrazzjoni: telf eċċessiv ta' fluwidu mill-ġisem, ma jseħħx normalment (jista' jaffettwa sa persuna 1 minn kull 100).
English: Film-coating:
Maltese: • tnaqqis fil-piż
English: • The PRAC reviewed the totality of the data submitted by the marketing authorisation holders in relation to the risk of lower limb amputation in patients treated with Sodium-glucose co-transporter 2 (SGLT2) inhibitors for type 2 diabetes mellitus;
Maltese: • Il-PRAC irrieżamina t-totalità tad-data ppreżentata mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fir-rigward tar-riskju ta' amputazzjoni tan-naħa ta' isfel tar-riġlejn f'pazjenti kkurati b'inibituri tal-kotrasportatur 2 ta' sodju-glukożju (SGLT2) għad-dijabete mellitus tat-tip 2;
English: In a separate analysis of subjects on insulin plus metformin, similar reductions in HbA1C to those seen in the total study population were seen in subjects treated with dapagliflozin with insulin plus metformin.
Maltese: F'analiżi separata ta' individwi fuq l-insulina flimkien ma' metformin, deher tnaqqis simili fl-HbA1c għal dak li deher fil-popolazzjoni totali tal-istudju f'pazjenti ttrattati b'dapagliflozin mal-insulina flimkien ma' metformin.
English: This medicinal product may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Maltese: Dan il-prodott mediċinali jista' jkattar l-effett dijuretiku ta' thiazide u dijuretiċi loop u jista' jżid ir-riskju ta' deidratazzjoni u pressjoni tad-demm baxxa (ara sezzjoni 4.4).
English: Dapagliflozin and related metabolites are primarily eliminated via urinary excretion with less than 2 % as unchanged dapagliflozin.
Maltese: Dapagliflozin u metaboliti relatati jiġu eliminati primarjament permezz tat-tneħħija fl-awrina b'inqas minn 2 % bħala dapagliflozin mhux mibdul.
English: A 24-week study in 182 diabetic subjects using dual energy X-ray absorptiometry (DXA) to evaluate body composition demonstrated reductions with dapagliflozin 10 mg plus metformin compared with placebo plus metformin, respectively, in body weight and body fat mass as measured by DXA rather than lean tissue or fluid loss.
Maltese: Fi studju ta' 24 ġimgħa fuq 182 pazjent dijabetiku bl-użu tal-assorbimetrika tal-X-ray dual energy (DXA) sabiex tiġi eżaminata l-kompożizzjoni tal-ġisem, deher tnaqqis b'10 mg dapagliflozin flimkien ma' metformin meta mqabbel ma' plaċebo flimkien ma' metformin, rispettivament, fil-piż tal-ġisem u filmassa tax-xaħam tal-ġisem kif imkejla mid-DXA aktar milli telf tat-tessut bla xaħam jew tal-fluwidi.
English: Ref. EMEA/614926/2008
Maltese: EMEA/421318/2009
English: London, 20 November 2008 Doc.
Maltese: Londra, 20 ta' Novembru 2008 Dok. ta' Ref.
English: It is usually fatal in adulthood.
Maltese: Normalment fl-adulti hija fatali.
English: International non-proprietary name (INN): idebenone
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): idebenone
English: It was to be available as tablets (150 mg).
Maltese: Hija disponibbli f'pilloli (150 mg).
English: The company that applied for authorisation is Santhera Pharmaceuticals (Deutschland) GmbH.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Santhera Pharmaceuticals (Deutschland)
English: What is Sovrima?
Maltese: X'inhu Sovrima?
English: Sovrima was designated as an orphan medicinal product on 8 March 2004 for Friedreich's ataxia.
Maltese: Sovrima ġie klassifikat bħala prodott mediċinali orfni fit-8 ta' Marzu 2004 għall-atassija ta' Friedreich.
English: Sovrima is a medicine that contains the active substance idebenone.
Maltese: Sovrima huwa mediċina li fiha s-sustanza attiva idebenone..
English: The active substance in Sovrima, idebenone, is an antioxidant agent.
Maltese: Is-sustanza attiva f'Sovrima, idebenone, hija aġent antiossidanti.
English: The study compared the effectiveness of three different doses of Sovrima (5, 15 and 40 mg per kilogram body weight) with that of placebo (a dummy treatment) over six months.
Maltese: L-istudju qabbel leffikaċja ta' tliet dożi differenti ta' Sovrima (5, 15 u 40 mg għal kull kilogramma tal-piż tal-ġisem)
English: On 24 July 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Sovrima 150 mg tablets, intended for the treatment of Friedreich's ataxia.
Maltese: Fl-24 ta' Lulju 2008, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, fejn irrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq tal-prodott mediċinali Sovrima pilloli ta' 150 mg, maħsub għat-trattament tal-atassija ta' Friedreich.
English: When frataxin is missing, the production of energy is severely impaired and highly reactive and toxic forms of oxygen are produced.
Maltese: In-nuqqas ta' frataxin jikkawża l-indeboliment gravi fil-produzzjoni tal-enerġija u jiġu prodotti forom tossiċi u reattivi ħafna ta' ossiġenu.
English: What is happening with idebenone for cognitive disorders and Alzheimer's disease?
Maltese: X'qiegħed jiġri b'idebenone għal disturbi konjittivi u l-marda ta' Alzheimer?
English: In November 2008, following the re-examination, the CHMP removed its concern over the intermediate dose of Sovrima.
Maltese: F'Novembru 2008, wara l-eżami mill-ġdid, is-CHMP irtira t-tħassib tiegħu dwar id-doża intermedja ta' Sovrima.
English: It has a range of symptoms that gradually get worse, including difficulty walking, an inability to co-ordinate movements, muscle weakness, speech problems, damage to the heart muscle, and diabetes.
Maltese: Għandha diversi sintomi li bil-mod jaggravaw, inkluż iddiffikultà fil-mixi, l-inkapaċità ta' koordinazzjoni ta' movimenti, dgħjufija tal-muskoli, problemi filkapaċità tad-diskors, ħsara fil-muskoli tal-qalb u d-dijabete.
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 November 2008.
Maltese: Wara li kkunsidra r-raġunijet għal din it-talba, isCHMP reġa' eżamina l-opinjoni inizjali u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq fl-20 ta' Novembru 2008.
English: Sovrima was expected to be used to treat Friedreich's ataxia.
Maltese: Sovrima kien mistenni jintuża għat-trattament tal-atassija ta' Friedreich.
English: The active substance in Sovrima, idebenone, has been available in some countries in Europe since the 1990s for cognitive disorders (problems with thinking, learning and memory) and for Alzheimer's disease.
Maltese: Is-sustanza attiva f'Sovrima, idebenone, ilha disponibbli f'xi pajjiżi Ewropej mid-disgħinijiet għal disturbi konjittivi (problemi fil-kapaċità tal-ħsieb, it-tagħlim u l-memorja) u għall-marda ta' Alzheimer.
English: Patients with Friedreich's ataxia do not have enough of a protein called frataxin.
Maltese: Pazjenti bl-atassija ta' Friedreich għandhom insuffiċjenza tal-proteina msejħa frataxin.
English: Frataxin plays a role in building the energy-producing parts of cells.
Maltese: Frataxin għandu rwol importanti fil-produzzjoni tal-partijiet taċ-ċelloli li jipproduċu l-enerġija.
English: What was Sovrima expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Sovrima?
English: The study looked also at the effectiveness of Sovrima in controlling movements, as measured on standard scales for ataxia symptoms, at its impact on daily activities as measured using a questionnaire, and at its effect on heart function.
Maltese: L-istudju eżamina wkoll l-effikaċja ta' Sovrima fil-kontroll ta' movimenti, kif imkejjel fuq skali standard għal sintomi tal-atassija, l-impatt tiegħu fuq l-attivitajiet ta' kuljum imkejjel peremzz ta' kwestjonarju, u l-effett tiegħu fuq il-funzjoni tal-qalb.
English: It is expected to work by enhancing the production of energy within cells and possibly by neutralising the highly reactive forms of oxygen.
Maltese: Huwa mistenni li jtejjeb ilproduzzjoni tal-enerġija fiċ-ċelloli u possibbilment jinnewtralizza l-forom reattivi ħafna tal-ossiġenu.
English: In addition, the supporting information from the scientific literature was weak and did not demonstrate a consistent clinical benefit of Sovrima for this disease.
Maltese: Barra minn hekk, it-tagħrif ta' sostenn mil-litteratura xjentifika kien dgħajjef u ma weriex benefiċċju kliniku konsistenti ta' Sovrima għal din il-marda.
English: This was expected to protect cells from damage and to reduce the symptoms of Friedreich's ataxia.
Maltese: Dan huwa mistenni li jipproteġi ċ-ċelloli mill-ħsara u li jnaqqas is-sintoma tal-atassija ta' Friedreich.
English: Friedreich's ataxia is an inherited disease.
Maltese: L-atassija ta' Friedreich hija marda li tintiret.
English: The effects of Sovrima were first tested in experimental models before being studied in humans.
Maltese: Għall-ewwel, l-effetti ta' Sovrima ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: In the initial application, it was intended for use in children and young adults, as well as in adults whose disease had been diagnosed within the past five years and in adults with cardiomyopathy (harm to the heart muscle).
Maltese: Fl-applikazzjoni inizjali, kien maħsub li jintuża fit-tfal u ż-żgħażagħ, kif ukoll fl-adulti li l-marda tagħhom kienet ġiet dijanjostikata fl-aħħar ħames snin u fl-adulti bil-kardjomjopatija (ħsara fil-muskoli tal-qalb).
English: What documentation did the company present to support its application to the CHMP?
Maltese: X'dokumentazzjoni ppreżentat il-kumpanija għas-sostenn tal-applikazzjoni tagħha lis-CHMP?
English: These highly reactive forms of oxygen damage cells in the brain, the spinal cord and nerves, as well as in the heart and pancreas, causing the symptoms of the disease.
Maltese: Dawn il-form reattivi ħafna tal-ossiġenu jagħmlu l-ħsara fil-moħħ, is-sinsla tad-dahar u n-nervituri, kif ukoll il-qalb u l-pankreas, biex b'hekk jikkawżaw is-sintomi tal-marda.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Sovrima in the treatment of Friedreich's ataxia did not outweigh its risks.
Maltese: Għalhekk, f'dak il-punt, is-CHMP kien tal-opinjoni li l-benefiċċji ta' Sovrima fit-trattament talatassija ta' Friedreich ma kinux ikbar mir-riskji.
English: How is Sovrima expected to work?
Maltese: Kif inhu mistenni li jaħdem Sovrima?
English: The company also informed the CHMP that there are no consequences for the named patient programmes or compassionate use programmes with Sovrima.
Maltese: Il-kumpanija infurmat lis-CHMP ukoll li ma kienx hemm konsegwenzi għallprogrammi msemmija tal-pazjent jew programma ta' użu b'kumpassjoni b'Sovrima.
English: The main measure of effectiveness was the change in the level of a substance in the blood called deoxyguanosine, which is a marker of cell damage caused by highly reactive forms of oxygen.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fil-livell ta' sustanza fid-demm imsejħa deossigwanosina (deoxyguanosine), li hija indikatur tal-ħsara fiċ-ċelloli kkawżata minn forom reattivi ħafna tal-ossiġenu.
English: EU/2/14/164/002
Maltese: EU/2/14/164/001 EU/2/14/164/002
English: Date of last renewal: 08/04/2019.
Maltese: Data tal-aħħar tiġdid: 08/04/2019.
English: Suspension:
Maltese: Sospensjoni:
English: ATC vet code: QI07AI02.
Maltese: QI07AI02.
English: Lyophilisate: Trometamol Edetic Acid Sucrose Dextran 70
Maltese: Trometamol Edetic Acid Sucrose Dextran 70
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Water for injection
Maltese: Potassium dihydrogen phosphate Disodium phosphate dodecahydrate
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/05/2014.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 07/05/2014.
English: VIAL (1 ML SUSPENSION)
Maltese: KUNJETT (SOSPENSJONI 1 ML) ISEM
English: Suspension: whitish colour with fine sediment.
Maltese: Sospensjoni: kulur bajdani b'sediment fin.
English: Canine parainfluenza virus Type 2
Maltese: Canine parainfluenza tip 2 virus
English: Suspension (inactivated): L. interrogans serovar Icterohaemorrhagiae
Maltese: L. interrogans serovar Icterohaemorrhagiae
English: 50 x 1 dose
Maltese: 25 x 1 doża 50 x 1 doża
English: At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus.
Maltese: Tal-anqas tliet snin wara l-kors primarju għall- canine distemper virus, canine adenovirus tip 1, canine adenovirus tip 2 u canine parvo virus.
English: Adjuvant: Aluminium hydroxide
Maltese: Idrossidu tal-aluminju
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral and inactivated bacterial vaccines.
Maltese: Immunoloġiċi għal canidae, vaċċini virali ħajjin u inattivati u vaċċini batteriċi inattivati.
English: First dose: Versican Plus DHPPi/L4 from 8-9 weeks of age.
Maltese: L-ewwel doża: Versican Plus DHPPi/L4 minn età ta' 8-9 ġimgħat.
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2, canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Maltese: It-tilqima hija intenzjonata għall-immunizzazzjoni attiva fi ġriewi f'saħħithom u klieb kontra mard ikkawżat mill-virus tal-canine distemper, mill-canine parvovirus, mill-canine adenovirus tip 1 u 2, millcanine parainfluenza virus, mill-Leptospira interrogens serogrupp Australis serovar Bratislava,
English: Sodium chloride
Maltese: Klorur tas-sodju Klorur tal-potassju
English: 103.6 TCID50* 105.3 TCID50 Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 10
Maltese: Canine parvovirus tip 2b, strejn CPV-2b-Bio 12/B
English: Type I glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-ħġieġ Tip I li fih 1 ml sospensjoni magħluq b'tapp tal-lastiku chlorobutyl u kappa tal-aluminju.
English: Re-vaccination scheme:
Maltese: Kodici ATC veterinarja:
English: − 4 weeks after the completion of primary course for Leptospira components.
Maltese: Tal-anqas sena wara l-kors primarju għall-CPiV u għall-komponenti tal-Leptospira.
English: 103.6 TCID50 105.3 TCID50
Maltese: 103.6 TCID50
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs
Maltese: VETERINARJU Versican Plus DHPPi/L4 lijofiliżat u sospensjoni għal sospensjoni għall-injezzjoni għall-klieb.
English: 1.8-2.2 mg. For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: However, in field studies 10% of sero-negative dogs did not show seroconversion (>0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies.
Maltese: Mandankollu, f'field studies 10% ta' klieb sero-negattivi ma wrewx serokonverżjoni (> 0.1
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 lyophilisate for dogs
Maltese: Żewġ dożi ta' Versican Plus DHPPi/L4
English: 10 3.1 TCID50 105.1 TCID50
Maltese: 105.1 TCID50
English: PACKAGE LEAFLET: Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs
Maltese: Versican Plus DHPPi/L4 sospensjoni għall-klieb
English: VIALS (1 DOSE LYOPHILISATE)
Maltese: VJALI (LIJOFILIŻAT DOŻA WAĦDA)
English: Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 103.1 TCID50* 105.1 TCID50 Suspension (inactivated):
Maltese: Canine parainfluenza virus tip 2, strejn CPiV-2-Bio 15
English: However, the vaccine has been proven to be protective against virulent challenge in the presence of maternally derived antibodies to CDV, CAV and CPV at levels equal or higher to those likely to be encountered under field conditions.
Maltese: Mandankollu, ġie ppruvat li t-tilqima toffri protezzjoni filpresenza ta' antikorpi derivati mill-omm kontra sfidi virali tal CDV, CAV u CPV f'livelli daqs jew ogħla minn dawk li x'aktarx jinstabu f'kundizzjonijiet reali.
English: 103.6 TCID50* 105.3 TCID50
Maltese: 105.3 TCID50
English: Second dose: Versican Plus DHPPi/L4R 3-4 weeks later but not before 12 weeks of age.
Maltese: It-tieni doża: Versican Plus DHPPi/L4R 3-4 ġimgħat wara imma mhux qabel l-età ta' 12-il ġimgħa.
English: 103.1 TCID50* 105.1 TCID50
Maltese: 103.1 TCID50* 105.
English: Annual re-vaccination is required for Parainfluenza and Leptospira components, therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
Maltese: Hemm bżonn ta' tilqima repetuta kull sena għall-parainfluenza u l-komponenti tal-Leptospira, għalhekk doża waħda tal-vaċċin kompatibbli Versican Plus Pi/L4 tista' tingħata kull sena skont il-bżonn.
English: Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089
Maltese: Tagħrif speċjali dwar kif għandu jinħażen
English: EMA/830607/2009
Maltese: 17 ta' Diċembru 2009 EMA/830607/2009
English: 17 December 2009 EMA/830607/2009 EMEA/H/C/1072
Maltese: EMEA/H/C/1072
English: The evaluation had finished and the CHMP had given a negative opinion.
Maltese: L-evalwazzjoni kienet intemmet u s-CHMP kien ta opinjoni negattiva.
English: Oncophage is a solution for injection that contains the active substance vitespen (20 micrograms).
Maltese: Oncophage huwa soluzzjoni li fiha s-sustanza attiva vitespen (20 mikrogramma).
English: What is Oncophage?
Maltese: X'inhu Oncophage?
English: Oncophage is an autologous immunotherapy product.
Maltese: Oncophage huwa prodott awtologu tal-immunoterapija.
English: Oncophage was designated as an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 April 2005 for renal cell carcinoma.
Maltese: Oncophage kien indikat bħala ‘mediċina orfni' (mediċina li għandha tintuża f'mard rari) fil-11 ta' April 2005 għall-karċinoma taċ-ċelloli renali.