FrancophonIA/ELRC3.0 huggingface dataset:
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Maltese: Reazzjonijiet avversi pulmonari, b'mod partikulari pnewmonja interstizjali, ġew irrappurtati wara lgħoti ta' G-CSF.
English: In clinical studies, more than 90% of patients responded at these doses, achieving a reversal of neutropenia in a median of 2 days.
Maltese: Fi studjikliniċi, aktar minn 90% tal-pazjenti rrispondub'dawn id-dożi, kisba ta 'taqlib ta' newtropenja f'medjan ta '2 ijiem.
English: Pyrophosphate) Fluid volume
Maltese: Pirofosfat) Disturbi filvolum talfluwidu
English: The no observed adverse effect level for embryo-fetal toxicity in this study was 10 µg/kg/day, which corresponded to a systemic exposure of approximately 3-5 times the exposures observed in patients treated with the clinical dose.
Maltese: Il-livell ta' ebda effett avvers osservat għal tossiċità embrijo-fetali f'dan l-istudju kien ta'10 µg/kg/kuljum, li kienet tikkorrispondi għal espożizzjoni sistemika ta' madwar 3-5 darbiet l-espożizzjonijiet osservati f'pazjenti kkurati bid-doża klinika.
English: • severe pain in the bones, chest, gut or joints (sickle cell anaemia with crisis)
Maltese: • uġigħ sever fl-għadam, fis-sider, fl-imsaren jew fil-ġogi (anemija taċ-ċelloli sickle bi kriżi)
English: Blood alkaline phosphatase increased Hepatomegaly
Maltese: Żieda f'alkaline phosphatase Epatomegali ja
English: Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use.
Maltese: Każijiet tas-sindrome ta' tnixxija kapillari ġew irrapportati fl-ambjent ta' wara t-tqegħid fis-suq blużu ta' fattur li jistimula l-kolonja granuloċita.
English: musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting with filgrastim in patients undergoing bone marrow transplant or PBPC mobilization e Adverse events with higher incidence in Filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy
Maltese: Inċidenza akbar ta' telf tal-embriju ġiet osservata fil-fniek f'multipli għoljin tal-espożizzjoni klinika u fil-preżenza ta' tossiċità fl-omm (ara sezzjoni 5.3). Kien hemm rapporti fid-dokumentazzjoni fejn intwera l-passaġġ transplaċentali ta' filgrastim f'nisa tqal.
English: Special precautions in patients undergoing PBPC mobilization
Maltese: Prekawzjonijiet speċjali f'pazjenti li jkunu qed jirċievu mobilizzazzjoni tal-PBPC
English: The needle cover of the pre-filled syringe contains dry natural rubber (see section 4.4).
Maltese: L-għatu tal-labra tas-siringa mimlija għal-lest fih lastku naturali xott (ara sezzjoni 4.4).
English: EU/1/14/946/011 - 1 prefilled syringe with a needle safety guard EU/1/14/946/014 - 5 prefilled syringes with a needle safety guard EU/1/14/946/013 - 3 prefilled syringe with a needle safety guard EU/1/14/946/016 - 10 prefilled syringe with a needle safety guard EU/1/14/946/018 - 7 prefilled syringe with a needle safety guard
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/946/011-1siringa mimlija għal-lest b'ilqugħ tas-sigurtà għal-labra EU/1/14/946/014 - 5 siringi mimlijin għal-lest b'ilqugħ tas-sigurtà għal-labra EU/1/14/946/013 - 3 siringi mimlijin għal-lest b'ilqugħ tas-sigurtà għal-labra
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Maltese: Ġeneralment, avvenimenti ta' glomerulonefrite għaddew wara tnaqqis fid-doża jew l-irtirar ta' filgrastim u pegfilgrastim.
English: In view of the possible risk of microbial contamination, Accofil syringes are for single use only.
Maltese: Minħabba r-riskju potenzjali ta' kontaminazzjoni bil-mikrobi, is-siringi ta' Accofil iridu jintużaw darba biss.
English: Not known: cannot be estimated from the available data.
Maltese: Mhuxmagħruf: ma tistax tittieħed stimamid-data disponibbli.
English: EU/1/14/946/003 - 1 prefilled syringe EU/1/14/946/004 - 5 prefilled syringes EU/1/14/946/012 - 3 prefilled syringe EU/1/14/946/015 - 10 prefilled syringe
Maltese: EU/1/14/946/012- 3 siringi mimlijin għal-lest EU/1/14/946/015 - 10 siringi mimlijin għal-lest
English: Current data indicate that immunological interactions between the allogeneic PBPC graft and the recipient may be associated with an increased risk of acute and chronic GvHD when compared with bone marrow transplantation.
Maltese: Id-dejta kurrenti tindika li interazzjonijiet immunoloġiċi bejn trapjant alloġeneiku tal-PBPC u rreċipjent jistgħu jiġu assoċjati ma' riskju miżjud ta' GvHD akut u kroniku meta mqabbel ma'
English: CLINCAL PARTICULARS
Maltese: Raxxa Eritema
English: Each pre-filled syringe contains 48 MU (equivalent to 480 micrograms of filgrastim in 0.5 ml solution for injection or infusion.
Maltese: Kull siringa mimlija għal-lest fiha 48 MU (ekwivalenti għal 480 mikrogramma ta' filgrastim f'0.5 ml ta' soluzzjoni għall-injezzjoni jew għall-infużjoni.
English: - chemotherapy - bone marrow transplantation - severe chronic neutropenia (low number of a type of white blood cells) - neutropenia (low number of a type of white blood cells) in patients with HIV infection - peripheral blood stem cell mobilisation (to stimulate stem cells to enter the blood stream to be collected and used in bone marrow transplantation).
Maltese: - trapjant alloġeneiku tal-mudullun - newtropenija kronika severa (numru baxx ta' tip ta' ċelluli tad-demm bojod - newtropenija (numru baxx ta' tip ta' ċelluli tad-demm bojod) f'pazjenti b'infezzjoni tal-HIV - mobilizzazzjoni taċ-ċelluli staminali tad-demm periferali (biex tistimola liċ-ċelluli staminali biex jidħlu fil-fluss tad-demm biex jinġabru u jintużaw fit-trapjant tal-mudullun).
English: Following subcutaneous administration of recommended doses, serum concentrations were maintained above10 ng/ml for 8 - 16 hours.
Maltese: Wara l-għoti taħt il-ġilda tad-dożi rakkomandati, il-konċentrazzjonijiet fis-serum inżammu fuq 10 ng/mL għal 8-16-il siegħa.
English: Wash your hands thoroughly.
Maltese: Vaskulite tal ġildaa
English: Do not shake.
Maltese: Reazzjoni ta'
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, il-perjodu u l-kundizzjonijiet tal-ħażna qabel l-użu huma rresponsabilità ta' min jużah u normalment ma jkunx ta' iktar minn 24 siegħa f'temperatura ta' bejn 2°C - 8°C, sa kemm rrikostituzzjoni ma sseħħx f'kundizzjonijiet kontrollati u validati asettiċitament.
English: Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Maltese: Il-frekwenza hija stmata bħala li mhijiex komuni mid-dejta tal-provi kliniċi.
English: • Experience puffiness in your face or ankles, blood in your urine or brown-coloured urine or you notice you urinate less than usual (glomerulonephritis).
Maltese: • Tesperjenza nefħa f'wiċċek jew fl-għekiesi, demm fl-awrina tiegħek jew awrina ta' kulur kannella jew tinnota li tgħaddi inqas awrina mis-soltu (glomerulonefrite).
English: Fluid volume disturbance s
Maltese: Mard okklużiv tal vinid
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/L prior to leukapheresis; in general apheresis should not be performed if platelets are < 75 x 109/L.
Maltese: Jekk iktar minn lewkaferesi waħda tkun meħtieġa, għandha tingħata attenzjoni partikulari għal donaturi b'għadd tal-plejtlits ta' < 100 x 109/L b'mod ġenerali l-aferesi m'għandhiex titwettaq jekk l-għadd tal-plejtlits ikun ta' < 75 x 109/L.
English: Thrombocytopenia has been reported commonly in patients receiving filgrastim.
Maltese: Tromboċitopenja ġiet irrapportata b'mod komuni f'pazjenti li jirċievu filgrastim.
English: A risk to the breastfeeding child cannot be excluded.
Maltese: Ir-riskju gћat-tarbija li titredda' mhux eskluż.
English: The only consistently reported adverse event was musculoskeletal pain which is no different from the experience in the adult population.
Maltese: uniku avveniment avvers irrappurtat b'mod konsistenti kien uġigħ muskoloskeletriku, li mhuwiex differenti mill-esperjenza fil-popolazzjoni adulta.
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy suggesting no age-related differences in the pharmacokinetics of filgrastim.
Maltese: li tissuġġerixxi li m'hemm l-ebda differenzi relatati mal-età fil-farmakokinetika ta' filgrastim.
English: Period of Study
Maltese: 3. LISTA
English: In clinical studies, dosing with 30 MU (300 µg )/day on 1 - 7 days per week was required to maintain the ANC > 2.0 x 109/L, with the median dose frequency being 3 days per week.
Maltese: Fi studji kliniċi, dożaġġ bi 30 MU (300 µg)/jum fuq perjodu ta' 1-7 ijiem kull ġimgħa kien meħtieġ biex iżomm l-ANC f' > 2.0 x 109/L, bil-medjan tal-frekwenza tad-doża li jkun ta' 3 ijiem kull ġimgħa.
English: Capillary leak syndrome has been reported after granulocyte colony-stimulating factor administration, and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Maltese: Is-sindrome ta' tnixxija kapillari ġie rrapportat wara għoti ta' fattur li jistimulta l-kolonja granuloċita, u huwa kkaratterizzat minn pressjoni baxxa, ipoalbuminemija, edema u emokonċentrazzjoni.
English: Intravenous (80 µg/kg/day) administration of filgrastim to rabbits during the period of organogenesis was maternally toxic and increased spontaneous abortion, post-implantation loss, and decreased mean live litter size and fetal weight were observed.
Maltese: L-għoti ġolvina (80 µg/kg/kuljum) ta' filgrastim lill-fniek waqt il-perjodu ta' organoġenesi kien tossiku fl-omm u żied l-abort spontanju, it-telf wara l-impjantazzjoni, u naqas il-kwantita ta' frieħ ħajjin u l-piż talfetu.
English: Publication
Maltese: Pubblikazzjoni
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (>18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Maltese: L-ebda differenziglobali fis-sigurtàjewl-effikaċjama kienu osservatibejnl-fuq minn65 senameta mqabbla ma 'adulti iżgħar(>18-il sena) suġġettiqed jirċievu kimoterapija ċitotossikau l esperjenzaklinikama identifikatxdifferenzi fir-risponsi bejn il-pazjentiadultianzjaniu dawk iżgħar.
English: Not know n vasculitisa
Maltese: Infjammazzjo ni tal-mukużaa
English: For example, if you weigh 60 kilograms your daily dose will be 30 million units (300 micrograms).
Maltese: Pereżempju, jekk tiżen 60 kilogramm, id-doża tiegħek ta' kuljum se tkun ta' 30 miljun unità
English: Filgrastim for PBPC mobilisation when used alone Filgrastim may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection.
Maltese: Filgrastim jaġixxi primarjament fuq prekursuri tan-newtrofili biex jeżerċita l-effett tiegħu biex iżid l-għadd tan-newtrofili.
English: (Chondrocalcino sis
Maltese: (Kontrokalċi nożi
English: (Chondroca lcinosis Pyrophosp hate)
Maltese: Kif jingħata Accofil
English: Transformation to leukaemia or myelodysplastic syndrome Special care should be taken in the diagnosis of SCNs to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia and myeloid leukaemia.
Maltese: Attenzjoni specjali trid tingħata fid-dijanjosi ta' SCNs biex tiddistingwihom minn disturbi ematopojetiċi oħrajn bħal anemija aplastika, majelodisplasija, u lewkimja majelodje.
English: In patients treated with myeloablative therapy followed by bone marrow transplantation The recommended starting dose of filgrastim is 1.0 MU/kg/day (10 micrograms/kg/day).
Maltese: Accofil u newtropenija (numru baxx ta' tip ta' ċelluli tad-demm bojod) f'pazjenti b'infezzjoni tal-HIV Id-doża tal-bidu tas-soltu hi bejn 0.1 miljun unità (1 mikrogramma) u 0.4 miljun unità (4
English: The long-term safety of administration of filgrastim at doses above 24 µg/kg/day in patients with SCN has not been established.
Maltese: Is-sigurtà fit-tul tal-għoti ta' filgrastim f'dożi ta' iktar minn 24 µg/kg/jum f'pazjenti b'SCN ma ġietx stabbilita.
English: In patients with mobilisation of PBPC
Maltese: F'pazjenti b'mobilizzazzjoni tal-PBPC
English: • muscle spasm
Maltese: 4. GĦAMLA
English: Hypotension Hypertension
Maltese: Senisttività eċċessiva
English: Water for injections
Maltese: Infezzjonijiet u infestazzjoniji et
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Maltese: Il-lewkaferesi għandha tinbeda f'jum 5 u titkompla sa jum 6 jekk meħtieġ sabiex tiġbor 4x106 CD34+ ċellula/kg tal-piż tal-ġisem tar-reċipjent.
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 għallMediċini: http://www.ema.europa.eu
English: Rare side effects (seen in more than 1 in 10,000 people taking Accofil):
Maltese: Effetti sekondarji rari (osservati f'iktar minn persuna 1 minn kull 10,000 li jieħdu Accofil):
English: • high blood pressure (hypertension)
Maltese: • pressjoni tad-demm għolja (ipertensjoni)
English: Uncommon side effects (seen in more than 1 in 1000 people taking Accofil):
Maltese: Effetti sekondarji mhux komuni (osservati f'iktar minn persuna 1 minn kull 1,000 li jieħdu Accofil):
English: In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands and soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Maltese: F'pazjenti li jkun qed isirilhom trapjant ta' ċelluli staminali jew trapjant tal-mudullun, mard tattrapjant kontra l-ospitu (GvHD) jista' jseħħ-din hi reazzjoni taċ-ċelluli tad-donatur kontra l-pazjent li jkun qed jirċievi t-trapjant; sinjali u sintomi jinkludu raxx fuq il-pali ta' idejk u l-qiegħ ta' saqajk u ulċeri u feriti f'ħalqek, fl-imsaren, fil-fwied, fuq il-ġilda, jew f'għajnejk, fil-pulmun, fil-vaġina u filġogi.
English: Each pre-filled syringe contains 48 MU (480 micrograms) filgrastim in 0.5 ml, corresponding to 0.96 mg/ml.
Maltese: mikrogramma) ta' filgrastim f'0.5 ml, li jikkorrispondu għal 0.96 mg/ml.
English: Each pre-filled syringe contains 30 MU (equivalent to 300 micrograms of filgrastim in 0.5 ml solution for injection or infusion.
Maltese: Kull siringa mimlija għal-lest fiha 30 MU (ekwivalenti għal 300 mikrogramma ta' filgrastim f'0.5 ml ta' soluzzjoni għall-injezzjoni jew għall-infużjoni.
English: Filgrastim may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection.
Maltese: Filgrastim jista' jingħata bħala infużjoni kontinwa taħt il-ġilda fuq perjodu ta' 24 siegħa jew bħala injezzjoni taħt il-ġilda.
English: ATCvet code: QI06AH10.
Maltese: Q106AH10.
English: Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Maltese: Lijofiliżat (doża 10x1) + solvent (10x1 ml) Lijofiliżat (doża 50x1) + solvent ( 50x1 ml)
English: EU/2/04/048/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/048/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Maltese: EU/2/04/048/001 Lijofiliżat (10 fliexken ta' doża ) + solvent (10 fliexken ta' doża) EU/2/04/048/002 Lijofiliżat (50 flixkun ta' doża) + solvent (50 flixkun ta' doża)
English: FCV (431 and G1 strains) ............................................................................................... ≥ 2.0 ELISA U. FPV (PLI IV) ..................................................................................................................... ≥ 103.5 CCID50
Maltese: FHV (strejn F2).............................................................................................................. ≥ 104.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, - against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Maltese: Immunizzazzjoni attiva tal-qtates ta' 8 ġimgħat u akbar: - kontra r-rinotrakeite virali fil-qtates biex tnaqqas sinjali kliniċi, - kontra l-infezzjoni tal-kaliċivirus biex tnaqqas sinjali kliniċi - kontra l-panlewkopenja fil-qtates biex tipprevjeni mortalità u sinjali kliniċi - kontra l-lewkimja biex tipprevjeni viraemia persistenti u sinjali kliniċi tal-marda.
English: FeLV recombinant canarypox virus (vCP97) ................................................................. ≥ 10 7.2 CCID501 1 cell culture infective dose 50%.
Maltese: vajrus rikombinant tal-canarypox FeLV (vCP97) .......................................................... ≥ 107.2 CCID501 1: doża infettiva tas-cell culture 50%
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Maltese: Herpesvajrus attenwat tar-rinotrakeite fil-qtates (FHV strejn F2) .................................... ≥ 104.9 CCID501 kaliċivirus inattivat fil-qtates (strejn FCV 431 u G1) antiġeni ....................................... ≥ 2.0 ELISA U.
English: Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, feline panleucopenia virus and feline leukaemia virus.
Maltese: Tistimola immunità attiva kontra l-herpesvajrus tar-rhinotrakeite fil-qtates, kalċivirus fil-qtates, ilvajrus tal-panlewkopenja fil-qtates u l-vajrus tal-lewkemja fil-qtates.
English: FeLV recombinant canarypox virus (vCP97) ................................................................. ≥ 107.2 CCID501.
Maltese: Vajrus rikombinant tal-canarypox FeLV (vCP97) ......................................................... ≥ 107.2 CCID501
English: Purevax RCP FeLV Lyophilisate and solvent for suspension for injection.
Maltese: VETERINARJU Purevax RCP FeLV lijofiliżat u solvent għal suspensjoni għall-injezzjoni.
English: PACKAGE LEAFLET FOR: Purevax RCP FeLV lyophilisate and solvent for suspension for injection
Maltese: FIL-PAKKETT: Purevax RCP FeLV lijofiliżat u solvent għal suspensjoni għall-injezzjoni.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Maltese: kaliċivirus inattivat fil-qtates (strejn FCV 431 u G1) antiġeni ....................................... ≥ 2.0 ELISA U.
English: Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Maltese: FCV (strejn 431 u G1)..................................................................................................... ≥ 2.0 ELISA U. FPV (PLI IV).................................................. ................................................................ ≥ 103.5 CCID501 Vajrus rikombinant tal-canarypox FeLV (vCP97)............................................................ ≥ 107.2 CCID50
English: The feline leukaemia vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
Maltese: Kwalunkwe prodott mediċinali veterinarju li ma ġiex użat jew materjal għar-rimi li huwa derivat minn dan il-prodott mediċinali veterinarju għandhom jintremew skont kif jitolbu r-regolamenti tal-pajjiż.
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Maltese: F'kundizzjonijiet normali tal-użu, jista' jkun hemm apatija u anoressja li jgħaddu, u wkoll żieda fittemperatura tal-ġisem (li ddum normalment għal ġurnata jew tnejn).
English: Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the feline leukaemia component and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Maltese: - tilqim sussegwenti għandhom jingħataw kull sena għall-komponent tal-lewkimja fil-qtates, u f'intervalli sa tliet snin għall-komponenti tar-rinotrakeite, tal-kalċivirosi u tal-panlewkopenja.
English: Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Maltese: Flixkun tal-ħġieġ ta' Tip I li fih doża ta' lijofiliżat u flixkun tal-ħġieġ ta' Tip I li fih ml ta' solvent, ittnejn magħluqin b'tapp tal-butyl elastomer u ssiġillati b'tapp tal-aluminju.
English: 21 January 2011
Maltese: 21 ta' Jannar 2011
English: The company that markets these medicines is F. Hoffmann - La Roche Ltd.
Maltese: Il-kumpanija li tikkummerċjalizza dawn il-mediċini hija F. Hoffmann - La Roche Ltd.
English: Hydrochlorothiazide is a diuretic.
Maltese: Idroklorotijażide huwa dijuretiku.
English: What is Vascace Plus?
Maltese: X'inhu Vascace Plus?
English: Vascace Plus is also available in the EU under other trade names: Co-Inhibace, Dynorm Plus, Inhibace Plus and Inibace Plus.
Maltese: Fl-UE Vascace Plus huwa disponibbli wkoll b'ismijiet kummerċjali oħrajn: Co-Inhibace, Dynorm Plus, Inhibace Plus u Inibace Plus.
English: Questions and answers on Vascace Plus and associated names (cilazapril/hydrochlorothiazide tablets, 5/12.5 mg) EMA/652293/2010
Maltese: Mistoqsijiet u tweġibiet dwar Vascace Plus u ismijiet assoċjati (pilloli cilazapril/idroklorotijażide, 5/12.5 mg) EMA/652293/2010
English: Cilazapril is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Maltese: Cilazapril huwa ‘inibitur tal-enzima li tikkonverti l-anġjotensina (ACE)'.
English: 4.2 Posology and method of administration
Maltese: 4.2 Pożoloġija u Metodu kif jingħata
English: Vascace Plus is a medicine that contains the active substances cilazapril and hydrochlorothiazide.
Maltese: Vascace Plus huwa mediċina li fiha s-sustanzi attivi cilazapril u idroklorotijażide.
English: Vascace Plus is authorised in the EU via national procedures.
Maltese: Vascace Plus huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: Other sections
Maltese: Taqsimiet oħrajn
English: On 20 November 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vascace Plus in the EU.
Maltese: Fl-20 ta' Novembru 2009, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP biex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Vascace Plus fl-UE.
English: Questions and answers on Vascace Plus and associated names (cilazapril/hydrochlorothiazide tablets, 5/12.5 mg)
Maltese: Mistoqsijiet u tweġibiet dwar Vascace Plus u ismijiet assoċjati (pilloli cilazapril/idroklorotijażide, 5/12.5 mg)
English: The European Medicines Agency has completed a review of Vascace Plus.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Vascace Plus.
English: Vascace Plus was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Il-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproċi u Deċentralizzati fil-mediċini umani (CMD(h)) identifika l-ħtieġa li ssir armonizzazzjoni ta' Vascace Plus .