FrancophonIA/ELRC3.0 huggingface dataset:
English: SPECIAL STORAGE CONDITIONS Store at 2 - 8°C.
Maltese: Aħżen f'temperatura ta' 2
English: Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica is extremely low, it is advised that cats, which are in close contact with immunocompromised humans are not vaccinated with this vaccine.
Maltese: Għalkemm ir-riskju li nies b'immunita dgħajfa, jiġu nfettati bil-Bordetella bronchiseptica huwa estremament baxx, dawn l-individwi għandhom ikunu jafu li qtates imlaqqma jistgħu ixerrdu lmikrobu sa sena wara t-tilqima.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Solvent for Nobivac Bb
Maltese: VETERINARJU Solvent għal Nobivac Bb għal qtates
English: CFU of live Bordetella bronchiseptica bacteria strain B-C2.
Maltese: ta' PJK tal-Bordatella bronchiseptica.
English: b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Maltese: b) il-marda li għaliha l-prodott mediċinali veterinarju huwa intiż li jagħti immunità hija ġeneralment assenti mit-territorju.
English: Any person intending to import, sell, supply and/or use Nobivac Bb for cats must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Maltese: Kull persuna li turi l-intenzjoni li timporta, tbiegħ, tipprovdi u/jew tuża Nobivac Bb għal qtates għandha tikkonsulta ma' l-Awtorità Kompetenti ta' l-Istat Membru dwar il-programmi ta' tilqim kurrenti qabel timporta, tbiegħ, tipprovdi u/jew tuża.
English: TARGET SPECIES Cats
Maltese: Tikketta tal-kaxxa
English: Vaccination scheme: One dose, of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.
Maltese: 2ml tal-vaċċin rikostitwit tal-anqas 72 siegħa qabel il-perjodu li fih huwa maħsub li jkun hemm riskju.
English: From literature it is considered that this type of intranasal vaccine is able to induce an immune response without interference from maternally derived antibodies.
Maltese: Fil-letteratura huwa kkunsidrat li dan it-tilqim intranasali kapaċi jinduċi rispons ta' immunizzazzjoni mingħajr interferenza minn antikorpi ġejjin mill-omm. 4.3 Kontra indikazzjonijiet
English: Allow the solvent to reach room temperature.
Maltese: Ħalli s-solvent jilħaq it-temperatura tal-kamra .
English: For active immunisation of cats, of 1 month of age or older, to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
Maltese: Għal immunizzazzjoni attiva fi qtates ta' xahar jew aktar, sabiex jitnaqqsu s-sinjali kliniċi ta' mard filparti ta' fuq tas-sistema respiratorja assoċjat ma Bordetella bronchiseptica.
English: SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children Store at 2 - 8C.
Maltese: KONDIZZJONIJIET SPEĊJALI DWAR KIF GĦANDU JINĦAŻEN 2C - 8C.
English: Box label:
Maltese: 2ml fiha:
English: Water for injections.
Maltese: Ilma għal injezzjoni
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: 3. DIKJARAZZJONI TAS-SUSTANZA ATTIVA U INGREDJENTI
English: Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Maltese: B'mod asettiku ħallat il-vaċċin imnixxef u ffriżat ma 0.3ml tas-solvent sterili pprovdut.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Each dose (0.2 ml) of reconstituted suspension contains:
Maltese: Kull doża (0.2ml) tas-suspensjoni rikostitwita fiha:
English: 16 March 2015
Maltese: 16 ta' Marzu 2015
English: EMEA/V/A/106
Maltese: EMEA/V/C/106
English: International non-proprietary name (INN): colistin
Maltese: Isem Komuni Internazzjonali (INN): colistin
English: Colistin sulfate belongs to the polymyxin group of antibiotics.
Maltese: Colistin sulfate jagħmel parti mill-grupp ta' antibijotiċi polimiksini.
English: The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Maltese: Holzhauser-Alberti bħala ko-rapporteur.
English: This group of antibiotics has a polypeptide structure, with mainly bactericidal activity and a medium antibacterial spectrum, which covers Gram-negative microorganisms only.
Maltese: Dan il-grupp ta' antibijotiċi għandu struttura polipeptida, b'attività prinċipalment batteriċida u bi spettru antibatteriku medju, li jkopri biss mikroorganiżmi Gram-negattivi.
English: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf
Maltese: 2 CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf
English: Committee for Medicinal Products for Veterinary Use (CVMP)
Maltese: Kumitat għal prodotti mediċinali għall-użu veterinarju (CVMP)
English: Oral colistin formulations including powder, solution, premix, tablets and paste have been authorised, mainly for group and flock treatment for the treatment and prevention of different specified gastrointestinal diseases caused by sensitive Enterobacteriacea species (e.g. Salmonella and Escherichia coli), but marketing authorisations without more specific indications do also exist.
Maltese: Prodotti mediċinali veterinarji li fihom colistin bħala l-unika sustanza attiva għall-għoti orali f'annimali li jipproduċu l-ikel, jintużaw b'mod estensiv fi kważi l-Istati Membri kollha tal-UE. Formulazzjonijiet orali ta' colistin, fosthom trab, soluzzjoni, taħlitiet lesti minn qabel, pilloli u pejst ġew awtorizzati, prinċipalment għall-kura ta' gruppi u ta' qatgħat għall-kura u l-prevenzjoni ta' mard gastrointestinali speċifikat differenti kkawżat minn speċi sensittivi għal Enterobacteriacea (eż. Salmonella u Escherichia coli), iżda jeżistu wkoll awtorizzazzjonijiet għat-tqegħid fis-suq mingħajr indikazzjonijiet aktar speċifiċi.
English: On 12 May 2014, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing colistin to be administered orally.
Maltese: Fit-12 ta' Mejju 2014, il-Kummissjoni Ewropea ppreżentat notifika ta' riferiment lill-Aġenzija skont lArtikolu 35 tad-Direttiva 2011/82/KE, fir-rigward tal-prodotti mediċinali veterinarji li fihom colistin biex jingħataw oralment.
English: Opinion following an Article 350F referral for veterinary medicinal products containing colistin to be administered orally
Maltese: Opinjoni wara riferiment tal-Artikolu 35 għall-prodotti mediċinali veterinarji li fihom colistin li għandu jingħata oralment
English: The referral started on 4 June 2014.
Maltese: Ir-riferiment inbeda fl-4 ta' Ġunju 2014.
English: Opinion following an Article 351 referral for veterinary medicinal products containing colistin to be administered orally
Maltese: Opinjoni wara riferiment tal-Artikolu 35 1għall-prodotti mediċinali veterinarji li fihom colistin li għandu jingħata oralment
English: The final opinion was converted into a Decision by the European Commission on 16 March 2015.
Maltese: L-opinjoni finali nbidlet f'Deċiżjoni mill-Kummissjoni Ewropea fis-16 ta' Marzu 2015.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom ristretti għall-prodotti identifikati filwaqt li titqies il-linja gwida rieżaminata tas-CVMP dwar l-SPC għal prodotti antimikrobiċi (EMEA/CVMP/SAGAM/383441/2005) 2.
English: The CVMP was requested to give its opinion on the measures that need to be taken in order to ensure the prudent use of colistin in food-producing animals across the EU and to minimise potential risks with the use of the identified products; inter alia whether there is a need to include adequate indications and warnings on prudent use in the product information and/or restrict indications for the identified products taking into account the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005) 2.
Maltese: Is-CVMP intalab jagħti l-opinjoni tiegħu dwar il-miżuri li jeħtieġ jittieħdu sabiex jiġi żgurat l-użu prudenti ta' colistin f'annimali li jipproduċu l-ikel fl-UE kollha u biex jiġu minimizzati r-riskji potenzjali bl-użu tal-prodotti identifikati; inter alia jekk hemmx il-ħtieġa li fl-informazzjoni dwar ilprodott jiġu inklużi indikazzjonijiet u twissijiet adegwati dwar l-użu prudenti u/jew l-indikazzjonijiet jiġu
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Maltese: Skont evalwazzjoni tad-data disponibbli attwalment, is-CVMP ikkunsidra li l-profil benefiċċju-riskju ġenerali għal dawn il-prodotti jibqa' pożittiv soġġett għal emendi fl-informazzjoni dwar il-prodott.
English: Therefore, on 11 December 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing colistin to be administered orally.
Maltese: Għalhekk, fil-11 ta' Diċembru 2014, il-Kumitat adotta b'kunsens opinjoni pożittiva, fejn irrakkomanda varjazzjonijiet għat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali veterinarji li fihom colistin sabiex jingħataw oralment.
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Numru talproċedura ta' l-EMA (EU)
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Maltese: Stimulant AS03 magħmul minn squalene (10.69 milligrammi), DL-α-tocopherol (11.86 milligrammi) u polysorbate 80 (4.86 milligrammi)
English: 2 x 25 vials (emulsion)
Maltese: 2 x 25 kunjett(emulsjo ni)
English: Split influenza virus inactivated, containing antigen* equivalent to:
Maltese: Virus maqsum, mhux attivat ta' l-influwenza li jkun fih antiġen* ekwivalenti għal:
English: Intramuscular use suspension (H1N1): vial (glass); emulsion (adjuvant): vial (glass)
Maltese: Użu għal ġol-muskoli suspensjoni (H1N1): kunjett (ħġieġ); emulsjoni (stimulant): kunjett (ħġieġ)
English: Packaging Content (concentration) Package size
Maltese: Kontenut (konċentrazzjoni)
English: A/California/7/2009 (H1N1)v like strain (X-179A) 3.75 micrograms** * propagated in eggs ** haemagglutinin
Maltese: Razza (X-179A) tixbaħ lil A/California/7/2009 (H1N1)v
English: l t o r d
Maltese: Mnejn jingħata Il-pakkett
English: Further information on Cufence can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/cufence
Maltese: Aktar informazzjoni dwar Cufence tinstab fis-sit web tal-Aġenzija: www.ema.europa.eu/medicines/human/EPAR/cufence
English: Cufence is available as 200 mg capsules.
Maltese: Cufence jiġi bħala kapsuli ta' 200 mg.
English: Cufence (trientine dihydrochloride) EMA/410631/2019
Maltese: Cufence (diidroklorur trientina) EMA/325626/2019
English: Cufence (trientine dihydrochloride)
Maltese: Cufence (diidroklorur trientina)
English: Other information about Cufence
Maltese: Informazzjoni oħra dwar Cufence
English: The recommended daily dose is 4 to 8 capsules in adults, and 2 to 5 capsules in children.
Maltese: Id-doża rakkomandata ta' kuljum hija bejn 4 u 8 kapsuli fladulti, u bejn 2 u 5 kapsuli fit-tfal.
English: Skin rash may affect up to 1 in 100 people.
Maltese: Raxx tal-ġilda jista' jaffettwa sa persuna 1 minn kull 100.
English: Cufence contains the active substance trientine dihydrochloride.
Maltese: Cufence fih is-sustanza attiva diidroklorur trientina.
English: The active substance in Cufence, trientine, is a chelating agent.
Maltese: Is-sustanza attiva f'Cufence, it-trientina, hija aġent kelanti.
English: In a study of medical records of 77 patients treated with trientine for at least six months, symptoms of liver disease improved in almost half (49%) of the patients treated, and neurological symptoms
Maltese: Fi studju tar-rekords mediċi ta' 77 pazjent ikkurati bit-trientina għal mill-inqas sitt xhur, is-sintomi talmarda fil-fwied tjiebu fi kważi nofs (49 %) tal-pazjenti kkurati, u s-sintomi newroloġiċi tjiebu f'14 %
English: The safety of Cufence has been shown to be similar to that of other trientine medicines.
Maltese: Is-sigurtà ta' Cufence ntweriet li hija simili għal dik ta' mediċini oħra ta' trientina.
English: A small proportion of patients had deteriorating symptoms: 5% with worsening liver symptoms and 3% with worsening neurological symptoms.
Maltese: Proporzjon żgħir ta' pazjenti kellhom sintomi li ddeterjoraw: 5 % b'sintomi fil-fwied li marru għall-agħar u 3 % b'sintomi newroloġiċi li marru għall-agħar.
English: As for all medicines, data on the use of Cufence are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Cufence hija ssorveljata kontinwament.
English: Duodenitis (inflammation of the duodenum, the part of the gut leading out of the stomach) and severe colitis (inflammation in the large bowel causing pain and diarrhoea) have also been reported.
Maltese: Ġew irrappurtati wkoll duwodeniti (infjammazzjoni tad-duwodenu, il-parti tal-imsaren li twassal 'il barra mill-istonku) u kolite severa (infjammazzjoni fil-musrana l-kbira li tikkawża wġigħ u dijarea).
English: In some patients, neurological deterioration can occur at the start of the treatment, with symptoms such as dystonia (involuntary muscle contractions), stiffness, tremor (shaking) and dysarthria (difficulty speaking).
Maltese: F'xi pazjenti, id-deterjorazzjoni newroloġika tista' sseħħ fil-bidu tal-kura b'sintomi bħal distonja (kontrazzjonijiet involontarji tal-muskoli), riġidità, rogħda (tregħid) u disartrija (diffikultà biex titkellem).
English: Trientine has been used for over 30 years to treat patients with Wilson's disease.
Maltese: It-trientina ilha tintuża għal aktar minn 30 sena biex tikkura pazjenti bil-marda ta' Wilson.
English: Cufence must be stored in a refrigerator (between 2ºC and 8ºC).
Maltese: Cufence għandu jinħażen fi friġġ (bejn 2ºC u 8ºC).
English: What are the risks associated with Cufence?
Maltese: X'inhuma r-riskji assoċjati ma' Cufence?
English: The capsules are taken in 2 to 4 divided doses.
Maltese: Il-kapsuli jittieħdu f' bejn 2 u 4 dożi maqsuma.
English: The active substance in Cufence, trientine, has been shown to improve symptoms of liver and neurological disease in patients with Wilson's disease who could no longer take D-penicillamine.
Maltese: Is-sustanza attiva f'Cufence, it-trientina, uriet li ttejjeb is-sintomi tal-marda fil-fwied u dik newroloġika f'pazjenti bil-marda ta' Wilson li ma setgħux jibqgħu jieħdu D-penicillamine.
English: Side effects reported with Cufence are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Cufence huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: For the full list of side effects and restrictions of Cufence, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Cufence, ara l-fuljett ta' tagħrif.
English: Cufence is a medicine used to treat patients aged 5 years and older with Wilson's disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage.
Maltese: Cufence huwa mediċina li tintuża biex tikkura pazjenti ta' 5 snin jew iżjed li għandhom il-marda ta' Wilson, kundizzjoni ġenetika fejn ir-ram assorbit mill-ikel jakkumula fil-ġisem, b'mod partikolari filfwied u fil-moħħ, u jikkawża ħsara.
English: The company that markets Cufence will conduct a study to further characterise the effectiveness of trientine in the treatment of Wilson's disease, including its effect on the associated liver, neurological or psychiatric symptoms and what the dose should be during early treatment.
Maltese: Il-kumpanija li tqiegħed Cufence fis-suq se twettaq studju biex tkompli tikkaratterizza l-effettività tattrientina fil-kura tal-marda ta' Wilson, inkluż l-effett tagħha fuq is-sintomi fil-fwied, dawk newroloġiċi jew psikjatriċi assoċjati u x'għandha tkun id-doża fil-bidu tal-kura.
English: Cufence is used in patients who cannot take D-penicillamine, another medicine for this condition.
Maltese: Cufence jintuża f'pazjenti li ma jistgħux jieħdu D-penicillamine, mediċina oħra għal din il-kundizzjoni.
English: What measures are being taken to ensure the safe and effective use of Cufence?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Cufence?
English: Cufence can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson's disease.
Maltese: Cufence jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda minn speċjalist b'esperjenza filġestjoni tal-marda ta' Wilson.
English: Immunex Rhode Island Corporation (ARI) 40 Technology Way
Maltese: Immunex Rhode Island Corporation (ARI) 40
English: Date of latest renewal: 15 January 2015
Maltese: Data tal-aħħar tiġdid: 15 ta' Jannar 2015
English: KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) and NRAS (Neuroblastoma RAS viral oncogene homologue) are highly related members of the RAS oncogene family.
Maltese: KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) u NRAS (Neuroblastoma RAS viral oncogene homologue) huma membri relatati ħafna tal-familja ta' onkoġeni RAS.
English: Ulcerative keratitis1,4 Keratitis1
Maltese: Keratite ulċerattiva1, 4 Keratite1
English: Mutant RAS (n = 74)
Maltese: RAS mutant (n = 74)
English: Occurrence of skin symptom(s): ≥ grade 31
Maltese: sintomu(i) filġilda: ≥ grad 31
English: Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands
Maltese: Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, L-Olanda
English: • dehydration;
Maltese: • deidratazzjoni;
English: (mucosal inflammation);
Maltese: (infjammazzjoni tal-mukuża);
English: Improved (< grade 3)
Maltese: Titjib (< grad 3)
English: MedDRA system organ class
Maltese: Klassifika tas-sistemi u tal-organi MedDRA
English: The mean (± SD) AUC0-tau and CL were 1,306 ± 374 mcg•day/mL and 4.9 ± 1.4 mL/kg/day, respectively.
Maltese: L-AUC0-tau medja (± SD) u CL kienu 1,306 ± 374 mcg•jum/mL u 4.9 ± 1.4 mL/kg/jum, rispettivament.
English: EGFR is a transmembrane glycoprotein that is a member of a subfamily of type I receptor tyrosine kinases including EGFR (HER1/c-ErbB-1), HER2, HER3, and HER4.
Maltese: EGFR hija glikoproteina transmembranja li hija membru ta' sottofamilja ta' riċetturi tat-tip I tyrosine kinases inkluż EGFR (HER1/c-ErbB-1), HER2, HER3, u HER4.
English: See section 2 “Vectibix contains sodium”.
Maltese: Ara s-sezzjoni 2 “Vectibix fih sodium”.
English: The treatment will usually be given over a period of approximately 60 minutes.
Maltese: It-trattament normalment jingħata fuq perjodu ta' madwar 60 minuta.
English: Acetic acid, glacial (for pH-adjustment)
Maltese: Acetic acid, glacial (għall-aġġustament tal-pH)
English: The primary endpoint was PFS.
Maltese: Il-punt finali primarju kien PFS.
English: Patient tumour samples with wild-type KRAS exon 2 (codons 12/13) status were tested for additional RAS mutations in KRAS exon 3 (codons 61) and exon 4 (codons 117/146) and NRAS exon 2 (codons 12/13), exon 3 (codon 61), and exon 4 (codons 117/146) and BRAF exon 15 (codon 600).
Maltese: Kampjuni tat-tumur ta' pazjenti bi stat ta' KRAS tat-tip salvaġġ exon 2 (kodons 12/13) kienu ttestjati għall-mutazjonijiet addizzjonali ta' RAS fi KRAS exon 3 (kodons 61) u exon 4 (kodons 117/146) u NRAS exon 2 (kodons 12/13), exon 3 (kodon 61), u exon 4 (kodons 117/146) u BRAF exon 15 (kodon 600).
English: Stevens-Johnson syndrome4
Maltese: Sindrome ta' StevensJohnson4
English: The maximum frequency estimated from the upper limit of 95% confidence interval for the point estimate, i.e., 3/2,224 (or 0.13%).
Maltese: Il-frekwenza massima hija stmata mil-limitu ta' fuq tal-intervall ta' kunfidenza ta' 95% għall-istima tal-punt, jiġifieri, 3/2,224 (or 0.13%).
English: Angioedema1
Maltese: Anġjoedima1
English: Median PFS was 10.0 (95% CI: 8.9, 11.0) and 11.4 (95% CI: 10.5, 11.9) months in the panitumumab and the non-panitumumab arm, respectively.
Maltese: 0 xhur (CI ta' 95%: 8.9, 11.0) u 11.4 xhur (CI ta' 95%: 10.5, 11.9) fil-grupp ta' panitumumab u filgrupp mingħajr panitumumab, rispettivament.
English: Very commonly reported adverse reactions occurring in ≥ 20% of patients were gastrointestinal disorders [diarrhoea (46%), nausea (39%), vomiting (26%), constipation (23%) and abdominal pain (23%)]; general disorders [fatigue (35%), pyrexia (21%)]; metabolism and nutrition disorders [decreased appetite (30%)]; infections and infestations [paronychia (20%)]; and skin and subcutaneous disorders [rash (47%), dermatitis acneiform (39%), pruritus (36%), erythema (33%) and dry skin
Maltese: Reazzjonijiet avversi rrappurtati b'mod komuni ħafna li seħħew f'≥ 20% tal-pazjenti kienu disturbi gastro-intestinali [dijarea (46%), tqalligħ (39%), rimettar (26%), stitikezza (23%) u uġigħ addominali (23%)]; disturbi ġenerali [għeja (35%), deni (21%)]; disturbi fil-metaboliżmu u n-nutrizzjoni [tnaqqis fl-aptit (30%)]; infezzjonijiet u infestazzjonijiet [paronikja (20%)]; u disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda [raxx (47%), dermatite li tixbaħ lill-akne (39%), ħakk (36%), eritema (33%) u ġilda xotta
English: Do not use Vectibix:
Maltese: Tużax Vectibix:
English: Sodium chloride, sodium acetate trihydrate, acetic acid (glacial), water for injections.
Maltese: Sodium chloride, sodium acetate trihydrate, acetic acid (glacial), ilma għall-injezzjonijiet.
English: Additional mutations in KRAS and NRAS at exon 3 (codon 59) were subsequently identified (n = 7).
Maltese: Imbagħad kienu identifikati mutazzjonijiet addizzjonali fi KRAS u NRAS f'exon 3 (kodon 59) (n = 7).
English: Vectibix contains sodium
Maltese: Vectibix fih sodium
English: The RAS/BRAF ascertainment was 85% (1,014 of 1,186 randomised patients).
Maltese: L-aċċertazzjoni ta' RAS/BRAF kienet ta' 85% (1,014 minn 1,186 pazjent randomised).
English: Vectibix in combination with irinotecan, bolus 5-fluorouracil, and leucovorin (IFL) chemotherapy
Maltese: Vectibix flimkien ma' kimoterapija ta' irinotecan, 5-fluorouracil bħala bolus, u leucovorin (IFL)
English: Mutant RAS population PFS
Maltese: Popolazzjoni b'RAS mutant PFS
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 December 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 3 ta' Diċembru 2007
English: x1 vial
Maltese: Kunjett x1
English: Pulmonary embolism Epistaxis
Maltese: Emboliżmu pulmonari Epistassi
English: The primary endpoint was OS.
Maltese: Il-punt finali primarju kien OS.
English: Patients with interstitial pneumonitis or pulmonary fibrosis (see section 4.4).
Maltese: Pazjenti b'pulmonite tal-interstizju jew fibrożi pulmonari (ara sezzjoni 4.4).
English: The hazard ratio for overall survival was 1.43 (95% CI: 1.11, 1.83).
Maltese: Il-proporzjon ta' periklu għas-sopravivenza globali kien ta' 1.43 (CI ta' 95%: 1.11, 1.83).
English: Diarrhoea1
Maltese: Dijarea1
English: Pulmonary complications
Maltese: Komplikazzjonijiet pulmonari
English: Hypersensitivity1
Maltese: Sensittività eċċessiva1
English: Secondary endpoints included PFS and objective response rate (ORR).
Maltese: Punti finali sekondarji kienu jinkludu PFS u r-rata ta' rispons oġġettiv (ORR - objective response rate).
English: In a randomised, open-label, controlled clinical trial, chemotherapy (oxaliplatin or irinotecan) and bevacizumab were given with and without panitumumab in the first-line treatment of patients with metastatic colorectal cancer (n = 1,053 [n = 823 oxaliplatin cohort, n = 230 irinotecan cohort]).
Maltese: Fi prova klinika, randomised, open-label u kkontrollata, kimoterapija (oxaliplatin jew irinotecan) u bevacizumab ingħataw ma' jew mingħajr panitumumab fit-trattament tal-ewwel għażla ta' pazjenti b'kanċer metastatiku tal-kolorektum (n = 1,053 [ko-orti ta' oxaliplatin n = 823, ko-orti ta' irinotecan n = 230]).
English: (asthenia); accumulation of fluid in the extremities (oedema peripheral);
Maltese: (astenja); akkumulazzjoni ta' fluwidu fl-estremitajiet (edima periferali);