FrancophonIA/ELRC3.0 huggingface dataset:
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Maltese: IgG diretti lejn l-attività prokoagulanti tal-fattur VIII, li jiġu kwantifikati f'Unitajiet Bethesda (BU) għal kull mL ta' plażma billi tintuża l-analiżi modifikata (modified assay).
English: Specific studies with long-term repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with Nuwiq due to the immune response to heterologous proteins in all non-human mammalian species.
Maltese: Studji speċifiċi b'għoti ripetut fuq perijodu ta' żmien twil għal tossiċità riproduttiva, tossiċità kronika, u karċinoġeniċità ma sarux b'Nuwiq minħabba r-rispons immuni għal proteini eterologi fi speċi mammiferi li mhumiex umani.
English: INFORMATION IN BRAILLE Nuwiq 250
Maltese: INFORMAZZJONI BIL-BRAILLE Nuwiq 250
English: INFORMATION IN BRAILLE Nuwiq 2000
Maltese: INFORMAZZJONI BIL-BRAILLE Nuwiq 2000
English: Each pack contains: - 1 powder vial with 250, 500, 1000, 2000, 2500, 3000 or 4000 IU simoctocog alfa in a type 1
Maltese: Kull pakkett ta' Nuwiq fih: - Kunjett 1 ta' trab b'250, 500, 1000, 2000, 2500, 3000 jew 4000 IU simoctocog alfa
English: INFORMATION IN BRAILLE Nuwiq 2500
Maltese: INFORMAZZJONI BIL-BRAILLE Nuwiq 2500
English: 1 powder vial, 1 pre-filled syringe with 2.5 mL water for injections, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs
Maltese: Kunjett 1 ta' trab, siringa 1 mimlija għal-lest b'2.5 mL ilma għall-injezzjonijiet, adapter 1 tal-kunjett, labra farfett 1, 2 msiħ tal-alkoħol
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 4000 IU simoctocog alfa (16000 IU/mL after reconstitution).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett 1 ta' trab fiha 4000 IU ta' simoctocog alfa (1600 IU/mL wara r-rikostituzzjoni)
English: Uncommon* Uncommon*
Maltese: Komuni* Mhux komuni*
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 3000 IU simoctocog alfa (1200 IU/mL after reconstitution).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett 1 ta' trab fiha 3000 unità IU ta' simoctocog alfa (1200 IU/mL wara r-rikostituzzjoni)
English: Weight-adjusted PK parameters for Nuwiq (Dose: 50 IU/kg) in adult previously treated patients (age 18-65 years) with severe haemophilia A (n = 20)
Maltese: IU/kg) f'pazjenti adulti trattati qabel (età 18-65 sena) b'emofilja A severa (n=20) Parametru PK
English: - The other ingredients are sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate and poloxamer 188.
Maltese: IU/mL ta' simoctocog alfa - Is-sustanzi l-oħra huma sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate and poloxamer 188.
English: INFORMATION IN BRAILLE Nuwiq 1000
Maltese: INFORMAZZJONI BIL-BRAILLE Nuwiq 1000
English: Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Maltese: Kategorija farmakoterapewtika, Mediċini kontra l-emorraġiji: fattur VIII ta' koagulazzjoni tad-demm,
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: INFORMATION IN BRAILLE Nuwiq 4000
Maltese: INFORMAZZJONI BIL-BRAILLE Nuwiq 4000
English: Each reconstituted solution contains approximately 100, 200, 400, 800, 1000, 1200 or 1600 IU/mL of simoctocog alfa.
Maltese: Kull soluzzjoni rikostitwita fiha madwar 100, 200, 400, 800, 1000, 1200 jew 1600
English: INFORMATION IN BRAILLE Nuwiq 500
Maltese: INFORMAZZJONI BIL-BRAILLE Nuwiq 500
English: A non-neutralizing anti-factor VIII antibody was detected in one adult patient (see Table 1).
Maltese: Antikorp kontra fattur VIII mhux newtralizzanti kien osservat f'pazjent adult wieħed (ara Tabella 1).
English: INFORMATION IN BRAILLE Nuwiq 3000
Maltese: INFORMAZZJONI BIL-BRAILLE Nuwiq 3000
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in adult previously treated patients (age 1865 years) with severe haemophilia A (n = 20)
Maltese: IU/kg) f'pazjenti adulti trattati qabel (età 18-il sena-65 sena) b'emofilja A severa (n=20) Parametru PK Kollha (n=20)
English: If severe, sudden allergic reactions (anaphylactic) occur (very rare: may affect up to 1 in 10,000 people), the injection must be stopped immediately.
Maltese: Jekk ikun hemm reazzjonijiet allerġiċi severi, u f'daqqa (anafilattiċi), (rari ħafna, jistgħu jaffettwaw sa persuna 1 minn kull 10,000), l-injezzjoni għandha titwaqqaf minnufih.
English: IVR (%/IU/kg) 2.5 ± 0.4 CL (mL/hr/kg) 3.0 ± 1.2
Maltese: AUC (hr*IU/mL) T1/2 (hr) IVR (%/IU/kg) CL (mL/hr/kg) AUC = (Area under the curve)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 July 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Lulju 2014
English: Uncommon side effects may affect up to 1 in 100 people Tingling or numbness (paraesthesia), headache, injection site inflammation, injection site pain, back pain, vertigo, dry mouth, dizziness, a vague feeling of bodily discomfort, shortness of breath, haemorrhagic anaemia, non-neutralising antibody positive (in PTPs).
Maltese: Tnemnim jew tirżiħ (paraesteżija), uġigħ ta' ras, infjammazzjoni fis-sit tal-injezzjoni, uġigħ fis-sit tal-injezzjoni, uġigħ fid-dahar, vertiġni, ħalq xott, sturdament, tħoss skumdità fil-ġisem, qtugħ ta' nifs, anemija emorraġika, antikorpi mhux newtralizzanti pożittivi (f'PTPs).
English: What Nuwiq contains Powder: - The active substance is recombinant human coagulation factor VIII (simoctocog alfa).
Maltese: X'fih Nuwiq Trab - Is-sustaza attiva hi fattur VIII ta' koagulazzjoni rikombinanti umana (simoctocog alfa).
English: Each pack of Nuwiq contains: - 1 powder vial with 250, 500, 1000, 2000, 2500, 3000 or 4000 IU simoctocog alfa - 1 pre-filled syringe with 2.5 mL water for injections - 1 vial adapter - 1 butterfly needle - 2 alcohol swabs
Maltese: Kull pakkett fih: - Kunjett 1 ta' trab b'250, 500, 1000, 2000, 2500, 3000 jew 4000 IU simoctocog alfa f' kunjett tal-ħġieġ ta' tip 1, magħluq b'tapp miksi bil-bromobutyl u ssiġillat b'għatu tal-aluminju li jinqala' b'saba'.
English: Paraesthesia Headache
Maltese: Reazzjonijiet allerġiċi
English: Patients developing factor VIII inhibitors
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI 5
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tal-kartuna u tal-kunjett wara EXP.
English: How to store Nuwiq
Maltese: Mediċini oħra u Nuwiq
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: One International Unit (IU) of factor VIII activity is equivalent to the quantity of factor VIII in one mL of normal human plasma.
Maltese: Unità Internazzjonali wieħed (IU) ta' fattur VIII hu ekwivalenti għall-kwantità ta' fattur VIII f'mL wieħed ta' plażma umana normali.
English: Haemorrhagic anaemia Factor VIII inhibition
Maltese: Emartrosi bikrija, emorraġija muskolari jew emorraġija orali
English: Teл.
Maltese: mid-dawl.
English: Nuwiq 3000 IU contains approximately 1200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Maltese: Nuwiq 3000 IU fih madwar 1200 IU/mL ta' fattur VIII ta' koagulazzjoni (rDNA) uman, simoctocog alfa wara r-rikostituzzjoni.
English: Nuwiq 250 IU powder and solvent for solution for injection Nuwiq 500 IU powder and solvent for solution for injection Nuwiq 1000 IU powder and solvent for solution for injection Nuwiq 2000 IU powder and solvent for solution for injection Nuwiq 2500 IU powder and solvent for solution for injection Nuwiq 3000 IU powder and solvent for solution for injection Nuwiq 4000 IU powder and solvent for solution for injection
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Nuwiq 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni Nuwiq 4000 IU trab u solvent għal soluzzjoni għall-injezzjoni
English: Nuwiq 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Maltese: Nuwiq 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
English: Nuwiq 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Maltese: Nuwiq 4000 IU trab u solvent għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
English: The sample was tested by the central laboratory at eight dilutions.
Maltese: Il-kampjun kien ittestjat fil-laboratorju ċentrali fi tmien dilwazzjonijiet.
English: Nuwiq 500 IU powder and solvent for solution for injection Nuwiq 1000 IU powder and solvent for solution for injection Nuwiq 2000 IU powder and solvent for solution for injection Nuwiq 2500 IU powder and solvent for solution for injection Nuwiq 3000 IU powder and solvent for solution for injection Nuwiq 4000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Maltese: IU, trab u solvent għal soluzzjoni għall-injezzjoni Nuwiq 3000 IU, trab u solvent għal soluzzjoni għall-injezzjoni Nuwiq 4000
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2% of normal activity or 2 IU/dL.
Maltese: Il-kalkulazzjoni tad-doża meħtieġa ta' fattur VIII hi bażata fuq ir-riżultat empiriku li Unità Internazzjonali 1 (IU) ta' fattur VIII għal kull kg ta' piż tal-ġisem jgħolli l-attività ta' fattur VIII filplażma b'madwar 2% tal-attività normali jew 2 IU/dL.
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in previously treated children aged 6 to 12 years with severe haemophilia A (n = 12)
Maltese: IU/kg) f'pazjenti tfal trattati qabel ta' età bejn 6 snin sa 12-il sena b'emofilja A severa (n=12) Parametru PK
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/007
Maltese: EU/1/14/936/007
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).
Maltese: Irrepeti l-infużjoni kull 8 - 24 siegħa sakemm il-ġerħa tfieq b'mod xieraq, imbagħad terapija għal tal-anqas 7 ijiem sabiex tinżamm attività għal fattur VIII ta' 30% sa 60% (IU/dL).
English: Paediatric population The listed warnings and precautions apply both to adults and children and adolescents.
Maltese: It-twissijiet u l-prekawzjonijiet elenkati japplikaw kemm għal adulti u għal tfal u adolexxenti.
English: For children and adolescents not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients).
Maltese: Għal tfal u adolexxenti li ma kinux ikkurati qabel b'mediċini li fihom Fattur VIII, antikorpi inibituri (ara sezzjoni 2) jistgħu jiffurmaw b'mod komuni ħafna (aktar minn pazjent 1 minn kull 10).
English: Tel: +48 22 2082734
Maltese: Tél/Tel: +32 2 3730890
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Nuwiq
Maltese: Parametri farmakokinetiċi (pharmacokinetic properties, PK) għal Nuwiq (Doża:
English: As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Maltese: Bħal fil-każ ta' kwalunkwe prodott ta' proteina li jingħata ġol-vina, reazzjonijiet allerġiċi ta' sensittività eċċessiva huma possibbli.
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Maltese: in vitro għad-determinazzjoni tal-attività ta' fattur VIII fil-kampjuni tad-demm tal-pazjenti, ir-riżultati tal-attività ta' fattur VIII fil-plażma jistgħu jiġu affettwati b'mod sinifikanti minn kemm it-tip ta' ‘reagent' ta' aPTT kif ukoll mill-istandard ta' referenza li jintuża fl-‘assay'.
English: When infused into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient's circulation.
Maltese: Dan hu partikularment importanti jekk ser ikollok intervent kirurġiku maġġuri.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 4000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Maltese: Nuwiq 4000 IU trab għal soluzzjoni għall-injezzjoni simoctocog alfa (fattur VIII ta' koagulazzjoni umana rikombinanti)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/005
Maltese: EU/1/14/936/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/004
Maltese: EU/1/14/936/004
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in previously treated children aged 2 to 5 years with severe haemophilia A (n = 13)
Maltese: IU/kg) f'pazjenti tfal trattati qabel ta' età bejn 2 snin sa 5 snin b'emofilja A severa (n=13)
English: A CVAD is an external connector that allows access to the bloodstream through a catheter without injection through the skin.
Maltese: Ġeneralment, it-trattament għal emofilja A huwa għal tul ħajtek kollha.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/003
Maltese: EU/1/14/936/003
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/006
Maltese: EU/1/14/936/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/002
Maltese: EU/1/14/936/002
English: No interaction studies have been performed with Nuwiq.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni b'Nuwiq.
English: 16 November 2018 EMA/799169/2018
Maltese: 16 ta' Novembru 2018
English: The company that applied for the change to the authorisation is Bristol-Myers Squibb Pharma EEIG.
Maltese: Il-kumpanija li applikat għall-bidla fl-awtorizzazzjoni hija Bristol-Myers Squibb Pharma EEIG.
English: Opdivo has been authorised since June 2015.
Maltese: Opdivo ilu awtorizzat minn Ġunju 2015.
English: What were the CHMP's main concerns that led to the initial negative opinion?
Maltese: X'kien it-tħassib ewlieni tas-CHMP li wassal għall-opinjoni negattiva inizjali?
English: It is used to treat adults with advanced melanoma.
Maltese: Jintuża biex jikkura adulti b'melanoma avvanzata.
English: The company presented the results of a main study involving 1,096 patients with previously untreated advanced renal cell carcinoma.
Maltese: Il- kumpanija ppreżentat ir-riżultati ta' studju ewlieni li involva 1,096 pazjent b'karċinoma avvanzata taċ-ċelloli renali li ma kinitx ikkurata qabel.
English: On 26 July 2018, the CHMP had originally adopted a negative opinion for the use of Opdivo and Yervoy for the treatment of renal cell carcinoma.
Maltese: Fis-26 ta' Lulju 2018, is-CHMP kien oriġinarjament adotta opinjoni negattiva għall-użu ta' Opdivo u Yervoy għall-kura tal-karċinoma taċ-ċelloli renali.
English: What were the conclusions of the CHMP following the re-examination?
Maltese: X'kienu l-konklużjonijiet tas-CHMP wara r-rieżaminazzjoni?
English: It is also used to treat the following other cancers: melanoma (a skin cancer), non-small cell lung cancer, classical Hodgkin lymphoma (a blood cancer), squamous cell cancer of the head and neck, and urothelial (bladder) cancer.
Maltese: Jintuża wkoll biex jikkura lkanċers li ġejjin: melanoma (kanċer tal-ġilda), kanċer tal-pulmun ta' ċelloli mhux żgħar, linfoma ta' Hodgkin klassika (kanċer tad-demm), kanċer taċ-ċellola skwamuża tar-ras u tal-għonq, u kanċer uroteljali (bużżieqa tal-awrina).
English: How do Opdivo and Yervoy work?
Maltese: Għalxiex għandhom jintużaw Opdivo u Yervoy?
English: Yervoy has been authorised since July 2011.
Maltese: Yervoy ilu awtorizzat minn Lulju 2011.
English: On 15 November 2018, the Committee for Medicinal Products for Human Use (CHMP) recommended that a change to the marketing authorisation for the medicinal products Opdivo (nivolumab) and Yervoy (ipilimumab) be granted.
Maltese: Fil-15 ta' Novembru 2018, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) irrakkomanda li jkun hemm bidla fl-awtorizzazzjoni għat-tqegħid fis-suq għall-prodotti ta' Opdivo (nivolumab) u Yervoy (ipilimumab).
English: Following the re-examination, the CHMP adopted a final positive opinion on 15 November 2018 recommending that the change to the marketing authorisation be granted for Opdivo and Yervoy, but requested the company to conduct a study to collect further data.
Maltese: Wara r-rieżaminazzjoni, is-CHMP adotta opinjoni pożittiva finali fil-15 ta' Novembru 2018 fejn irrakkomanda li jkun hemm bidla fl-awtorizzazzjoni għat-tqegħid fis-suq għal Opdivo u Yervoy, iżda talab lill-kumpanija biex twettaq studju biex tiġbor aktar data.
English: The CHMP considered that the results from the main study comparing Opdivo and Yervoy with sunitinib showed a clinically important increase in patients' survival with the combination, and side effects were considered acceptable.
Maltese: Is-CHMP kkunsidra li r-riżultati mill-istudju ewlieni li qabbel Opdivo u Yervoy ma' sunitinib urew żieda klinikament importanti fis-sopravivenza tal-pazjenti bil-kombinazzjoni, u l-effetti sekondarji tqiesu bħala aċċettabbli.
English: However, the company must conduct a study to determine the precise contribution of Yervoy in the combination and if the risks could be further minimised.
Maltese: Madanakollu, il-kumpanija għandha twettaq studju biex tiddetermina l-kontribuzzjoni preċiża ta' Yervoy fil-kombinazzjoni u jekk ir-riskji jistgħux ikomplu jiġu mnaqqsa.
English: What are Opdivo and Yervoy?
Maltese: X'inhuma Opdivo u Yervoy?
English: The study compared treatment with Opdivo and Yervoy versus treatment with another cancer medicine, sunitinib.
Maltese: L-istudju qabbel il-kura b'Opdivo u Yervoy kontra l-kura ma' mediċina oħra kontra l-kanċer, sunitinib.
English: The active substance in both medicines, nivolumab and ipilimumab, are monoclonal antibodies, a type of protein that has been designed to recognise and attach to a specific structure.
Maltese: Is-sustanza attiva fiż-żewġ mediċini, in-nivolumab u l-ipilimumab, huma antikorpi monoklonali, tip ta' proteina li tfasslet biex tagħraf u teħel ma' mira speċifika.
English: Although the precise contribution of Yervoy was not clear, the CHMP reassessed data from other non-clinical and clinical studies, including studies with the combination in relevant other cancer types, and considered that the benefit of Yervoy in the combination has been sufficiently demonstrated.
Maltese: Għakemm il-kontribuzzjoni preċiża ta' Yervoy ma kinitx ċara, is-CHMP ivvaluta millġdid id-data minn studji oħra kliniċi u mhux kliniċi, inkluż studji bil-kombinazzjoni f'tipi ta' kanċer relevanti oħra, u kkunsidra li l-benefiċċju ta' Yervoy fil-kombinazzjoni kien intwera biżżejjed.
English: By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Maltese: Billi teħel mar-riċettur, innivolumab tipprevjeni PD-L1 u PD-L2 milli jitfu ċ-ċelloli T, b'hekk tiżdied l-abilità tas-sistema immunitarja biex toqtol iċ-ċelloli tal-kanċer.
English: Therefore, at that point in time, the CHMP considered that the combination could not be approved because of the lack of knowledge of the contribution of Yervoy.
Maltese: Għaldaqstant, is-CHMP, f'dak il-mument ikkunsidra li l-kombinazzjoni ma setgħetx tiġi approvata minħabba n-nuqqas ta' għarfien dwar il-kontribuzzjoni ta' Yervoy.
English: During the re-examination, the CHMP looked again at all the data and consulted a group of cancer experts and patients with cancer.
Maltese: Matul ir-rieżaminazzjoni, is-CHMP reġa' ħares lejn id-data kollha u kkonsulta grupp ta' esperti talkanċer u pazjenti bil-kanċer.
English: Ipilimumab attaches to and blocks the activity of CTLA-4, a protein that controls the activity of T cells.
Maltese: L-ipilimumab teħel ma' u timblokka l-attività ta' CTLA-4, proteina li tikkontrolla l-attività taċ-ċelloli T. Billi timblokka s-CTLA-4, l-ipilimumab tikkawża l-attivazzjoni u ż-żieda taċ-ċelloli T, li jidħlu fit-tumuri u joqtlu ċ-ċelloli tat-tumur.
English: Opdivo and Yervoy are to be used together in patients with previously untreated advanced renal cell carcinoma that is considered to be of moderate or high risk of worsening.
Maltese: Opdivo u Yervoy huma mediċini kontra l-kanċer. Fihom is-sustanzi attivi nivolumab u ipilimumab rispettivament.
English: This means that the CHMP had no way to know if the addition of Yervoy to Opdivo treatment produced additional benefit.
Maltese: Dan ifisser li sCHMP ma kellux mod kif ikun jaf jekk iż-żieda ta' Yervoy ma' Opdivo pproduċietx benefiċċju addizzjonali.
English: At the same time it was clear that combination with Yervoy resulted in more side effects than are seen with Opdivo alone.
Maltese: Fl-istess ħin kien ċar li l-kombinazzjoni b'Yervoy irriżultat f'aktar effetti sekondarji minn dawk li dehru b'Opdivo waħdu.
English: Luxembourg Defiante Farmacêutica, S.A.
Maltese: Lussemburgu Defiante Farmacêutica, S.A.
English: CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule soft capsule
Maltese: CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule
English: Gastro-resistant tablet
Maltese: Pillola gastroreżistenti
English: 4.5 mg (1:1:1) film-coated tablet
Maltese: 4.5 mg (1:1:1) Pillola
English: Hydergin SRO 6 mg Kapseln modified-release capsule, hard
Maltese: Hydergin SRO 6 mg Kapseln
English: Verovskova 57, 1526 Ljubljana, Slovenia
Maltese: LEK PHARMACEUTICALS d.d. Verovskova 57, 1526 Ljubljana, Slovenia
English: Hydergin 3 mg/ml Tropfen 3 mg/ml (1:1:1) oral drops, solution oral use
Maltese: Hydergin 3 mg/ml Tropfen 3 mg/ml (1:1:1) Soluzzjoni qtar orali
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Maltese: Lista ta` l-ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali, mnejn jingħata, id-detenturi ta` l-awtorizzazzjoni għattqegħid fis-suq fl-istati membri
English: Belgium Defiante Farmacêutica S.A., Rua dos Ferreiros 260, 9000-082 Funchal, Portugal
Maltese: Defiante Farmacêutica S.A., Rua dos Ferreiros 260, 9000-082 Funchal, Portugal
English: Hydergin 1 mg/ml Tropfen 1 mg/ml (1:1:1) oral drops, solution oral use
Maltese: Hydergin 1 mg/ml Tropfen 1 mg/ml (1:1:1) Soluzzjoni qtar orali
English: Greece
Maltese: Portugall
English: 27 May 2019
Maltese: 27 ta' Mejju 2019
English: What is Septanest?
Maltese: X'inhu Septanest?
English: Septanest is also available in the EU under other trade names including Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest with Adrenaline, Septanestepi and Septocaine.
Maltese: Septanest huwa disponibbli wkoll fl-UE taħt ismijiet kummerċjali oħra inkluż Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest b'Adrenalina, Septanestepi u Septocaine.
English: It is given by injection.
Maltese: Jingħata permezz ta' injezzjoni.
English: Other harmonised sections of the SmPC include section 4.4 (special warnings and precautions for use), 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), 4.8 (side effects), and 4.9 (overdose).
Maltese: Sezzjonijiet armonizzati oħra tal-SmPC jinkludu s-sezzjonijiet 4.4 (twissijiet speċjali u prekawzjonijiet għall-użu), 4.5 (interazzjonijiet), 4.6 (fertilità, tqala u treddigħ), 4.7 (effetti fuq il-ħila biex issuq u tħaddem magni), 4.8 (effetti sekondarji), u 4.9 (doża eċċessiva).