FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who had received 2 to 3 prior therapeutic regimens had a response rate of 32% (10/32) and patients who received greater than 7 prior therapeutic regimens had a response rate of 31% (21/67).
Maltese: Pazjenti li kienu ħadu minn 2 sa 3 korsijiet terapewtiċi qabel kellhom rata ta' rispons ta' 32% (10/32) u pazjenti li rċivew iktar minn 7 korsijiet terapewtiċi qabel kellhom rata ta' rispons ta' 31% (21/67).
English: If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive Bortezomib SUN intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment: - When Bortezomib SUN is given together with dexamethasone, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle.
Maltese: Jekk qatt ma ġejt ittrattat fil-passat għal majeloma multipla, u inti adattat biex tirċievi trapjant b'ċelluli staminali tad-demm, inti ser tirċievi Bortezomib SUN ġol-vini jew taħt il-ġilda flimkien malmediċini dexamethasone, jew dexamethasone u thalidomide, bħala trattament ta' induzzjoni:
English: The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects.
Maltese: L-analiżi ta' tqabbil bejn pari huwa metodu statistiku li fiha l-pazjenti fil-grupp ta' trattament (eż. bortezomib f'kombinazzjoni ma' dexamethasone) u pazjenti fil-grupp tal-paragun (eż. bortezomib) isiru komparabbli fir-rigward ta' fatturi li jfixklu lil dak li jkun billi individwi jiġu studjati f'parijiet individwali.
English: Bortezomib subcutaneous arm
Maltese: Grad ta' indeboliment talfwied*
English: Bortezomib SUN reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml
Maltese: Is-soluzzjoni rikostitwita ta' bortezomib 3.5 mg tingħata bħala injezzjoni f'daqqa ġol-vini ta' 3-5 sekondi minn kateter periferali jew ċentrali ġol-vini segwita bi flaxx ta' soluzzjoni ta' 9 mg/ml (0.9%) għall-injezzjoni ta' sodium chloride.
English: Dose adjustments for combination therapy for patients with progressive multiple myeloma For Bortezomib SUN dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Maltese: Aġġustamenti fid-doża għal terapija kombinata għal pazjenti b'majeloma multipla progressiva
English: Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Maltese: Immaġini tal-moħħ preferibbilment Immaġini bir-Riżonanza Manjetika (MRI), tintuża biex tikkonferma ddijanjosi.
English: Overall, the literature results are suggestive of a possible causal association between bortezomib (and other proteasome inhibitors) and TMA.
Maltese: Globalment ir-riżultati mill-letteratura medika jissuġġerixxu l-possibiltà li bortezomib (u inibituri oħra ta' proteasome) jikkawża TMA.
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Maltese: Ikkunsidra żieda sa doża ta' 1.0 mg/m2 jew aktar tnaqqis sa doża ta' 0.5 mg/m2 f'ċikli sussegwenti skont it-tolleranza tal-pazjent.
English: Cochran Mantel-Haenszel test.
Maltese: Jista' jkollok bżonn terġa' taqrah.
English: If you have not been treated before for mantle cell lymphoma you will receive Bortezomib SUN intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Maltese: BzmbR-CAP=bortezomib, rituximab, cyclophosphamide, doxorubicin, u prednisone;
English: 1 pre-filled pen
Maltese: 10 pinen mimlija għallest
English: Pack size
Maltese: Mnejn jingħata
English: What is Cymevene?
Maltese: X'inhu Cymevene?
English: The company that markets these medicines is F. Hoffmann - La Roche Ltd. and associated companies.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija F. Hoffmann - La Roche Ltd. u kumpaniji assoċjati.
English: It is also available in the EU under the names Cymevan, Cymeven i.v.
Maltese: Dan huwa disponibbli wkoll fl-UE taħt l-ismijiet Cymevan, Cymeven i.v. u Citovirax.
English: The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.5 (interactions) and 4.8 (side effects).
Maltese: Il-Kumitat armonizza wkoll sezzjonijiet oħrajn tas-SmPC inklużi s-sezzjonijiet 4.4 (twissijiet speċjali u prekawzjonijiet għall-użu), 4.5 (interazzjonijiet) u 4.8 (effetti sekondarji).
English: The medicine can be used in adults and adolescents from 12 years of age.
Maltese: Din il-mediċina tista' tintuża fl-adulti u l-adolexxenti mill-età ta' 12-il sena 'l fuq.
English: On 25 February 2016, the European Medicines Agency completed a review of Cymevene.
Maltese: Fil-25 ta' Frar 2016, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Cymevene.
English: CMV is a common virus that belongs to the herpes virus family.
Maltese: Is-CMV huwa virus komuni li jappartjeni għall-familja tal-virus tal-ħerpes.
English: Cymevene must not be used in patients allergic to its active substance ganciclovir, to a related antiviral medicine, valganciclovir, or to any other ingredients of the medicine.
Maltese: Cymevene m'għandux jintuża f'pazjenti allerġiċi għas-sustanza attiva tiegħu ganciclovir, għal mediċina antivirali relatata, valganciclovir, jew għal kwalunkwe ingredjent ieħor tal-mediċina.
English: Information on the safety and efficacy of Cymevene in children under 12 years of age is limited.
Maltese: Informazzjoni dwar is-sigurtà u l-effikaċja ta' Cymevene fi tfal li għandhom inqas minn 12-il sena hija limitata.
English: and Citovirax.
Maltese: Bidliet oħra
English: Cymevene is an antiviral medicine that is used to treat or prevent infection with cytomegalovirus (CMV) in immunocompromised individuals (people with a weakened immune system).
Maltese: Cymevene huwa mediċina antivirali li tintuża għall-kura jew għall-prevenzjoni tal-infezzjoni biċċitomegaolvirus (CMV) f'individwi immunokompromessi (persuni b'sistema immunitarja mdgħajfa).
English: Questions and answers on Cymevene and associated names (ganciclovir, 500 mg powder for concentrate for solution for infusion, intravenous)
Maltese: Mistoqsijiet u tweġibiet dwar Cymevene u ismijiet assoċjati (ganciclovir, 500 mg trabgħal konċentrat għal soluzzjoni għall-infużjoni, minn ġol-vina)
English: Ganciclovir has the potential to cause birth defects in humans.
Maltese: Ganciclovir għandu l-potenzjal li jikkawża disturbi konġenitali fil-bniedem.
English: The European Commission issued an EU-wide legally binding decision on this opinion on 28 April 2016.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti madwar l-UE kollha dwar din l-opinjoni fit-28 ta' April 2016.
English: Cymevene is marketed in all EU member states with the exception of Latvia, Malta and Slovenia.
Maltese: Cymevene jitqiegħed fis-suq fl-Istati Membri kollha tal-UE ħlief fil-Latvja, f'Malta u fis-Slovenja.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Cymevene in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bnedmin (CHMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal Cymevene fl-Unjoni Ewropea (UE).
English: Cymevene contains the active substance ganciclovir and is available as a powder to be made into a solution for infusion (drip) into a vein.
Maltese: Cymevene fih is-sustanza attiva ganciclovir u huwa disponibbli bħala trab li jitħallat f'soluzzjoni għallinfużjoni (dripp) ġol-vina.
English: On 15 September 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Cymevene in the EU.
Maltese: Fil-15 ta' Settembru 2014, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Cymevene fl-UE.
English: The CHMP agreed that Cymevene can be used for the treatment of diseases caused by CMV in immunocompromised patients.
Maltese: Is-CHMP qabel li Cymevene jista' jintuża għall-kura tal-mard ikkawżat mis-CMV f'pazjenti immunokompromessi.
English: Cymevene was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Cymevene ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċeduri tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh).
English: It is not known whether ganciclovir passes into breast milk; however this possibility cannot be excluded and therefore breastfeeding must be discontinued in women treated with Cymevene, to avoid potential serious side effects in breastfed infants.
Maltese: Mhuwiex magħruf jekk ganciclovir jgħaddix fil-ħalib tas-sider; madankollu din il-possibbiltà ma tistax tiġi eskluża u għaldaqstant it-treddigħ għandu jitwaqqaf f'nisa kkurati b'Cymevene, sabiex jiġu evitati effetti sekondarji serji potenzjali fi trabi ta' twelid li jkunu qegħdin jitreddgħu.
English: Since the use of highly active antiretroviral therapy (HAART) has reduced the risk of CMV disease in patients with HIV infection, preventive treatment with Cymevene is no longer considered necessary.
Maltese: Minħabba li l-użu ta' terapija antiretrovirali li għandha attività għolja (HAART) naqqas ir-riskju tal-marda tas-CMV f'pazjenti bl-infezzjoni tal-HIV, il-kura preventiva b'Cymevene m'għadhiex meqjusa aktar neċessarja.
English: It can infect almost anyone but usually remains dormant in healthy people, rarely causing symptoms.
Maltese: Dan jista' jinfetta kważi lil kulħadd iżda ġeneralment jibqa' inattiv f'nies b'saħħithom, fejn rarament jikkawża sintomi.
English: Men whose female partner could become pregnant must be advised to use barrier contraception methods during treatment with Cymevene, and for at least 90 days afterwards.
Maltese: L-irġiel fejn l-imsieħba nisa tagħhom jistgħu jinqabdu tqal għandhom jingħataw il-parir sabiex jużaw metodi ta' kontraċezzjoni tat-tip barriera waqt il-kura b'Cymevene, u mill-anqas 90 jum wara.
English: Different treatment schedules should be followed during initial and maintenance treatment, in accordance with treatment guidelines.
Maltese: Għandhom jiġu segwiti skedi differenti ta' kura waqt il-kura tal-bidu u ta' manteniment, skont il-linji gwida tal-kura.
English: Women who could become pregnant must be advised to use effective contraception during treatment with Cymevene and for at least 30 days after treatment has stopped.
Maltese: In-nisa li jistgħu jinqabdu tqal għandhom jingħataw il-parir sabiex jużaw kontraċezzjoni effettiva waqt il-kura b'Cymevene u mill-anqas 30 jum wara li l-kura waqfet.
English: The CHMP also agreed that Cymevene should no longer be indicated for the prevention of CMV disease in patients with AIDS.
Maltese: Is-CHMP qabel ukoll li Cymevene m'għandux ikun aktar indikat għall-prevenzjoni tal-marda tas-CMV f'pazjenti bl-AIDS.
English: Cymevene can also be used to prevent CMV disease in patients with drug-induced immunosuppression (for example after an organ transplant or chemotherapy).
Maltese: Cymevene jista' jintuża wkoll sabiex jipprevjeni l-marda tas-CMV f'pazjenti b'immunosuppressjoni kkaġunata mill-mediċina (pereżempju wara t-trapjant tal-organi jew kimoterapija).
English: In these patients, CMV can result in severe or life-threatening infections that attack various organs including the lungs, brain and eyes.
Maltese: F'dawn il-pazjenti, is-CMV jista' jirriżulta f'infezzjonijiet severi jew ta' theddida għall-ħajja li jattakkaw diversi organi inkluż ilpulmun, il-moħħ u l-għajnejn.
English: Patients with reduced kidney function should receive lower doses of Cymevene.
Maltese: Għaliex ġie rieżaminat Cymevene?
English: Cymevene has been authorised in the EU via national procedures.
Maltese: Cymevene huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: ATCvet code: QI02AD04.
Maltese: Kodiċi ATC veterinarja QI02AD04.
English: Solvent: Store below 25 °C.
Maltese: Aħżen f'temperaturi anqas minn 25°C.
English: 5 doses 25 doses
Maltese: 5 dożi 25 doża
English: *Cell culture infectious dose 50%
Maltese: *Doża infettuża tal-kultura taċ-ċelloli 50%
English: 5 doses
Maltese: 5 dożi
English: 10 vials of solvent (100 ml) 10 vials of solvent (500 ml)
Maltese: 10 kunjetti ta' solvent (100 ml) 10 kunjetti ta' solvent (100 ml)
English: Date of first authorisation: 29/07/2019
Maltese: Data tal-ewwel awtorizzazzjoni: 29/07/2019
English: 10 vials of lyophilisate (50 doses) 10 vials of lyophilisate (250 doses)
Maltese: 10 kunjetti ta' lijofiliżat (50 doża) 10 kunjetti ta' lijofiliżat (250 doża)
English: Solvent for NASYM
Maltese: VETERINARJU Solvent għal NASYM
English: Live attenuated bovine respiratory syncytial virus, strain Lym-56.
Maltese: Virus sinktjali respiratorju bovin ħaj attenwat, razza Lym-56.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (1x5 doses and 1x25 doses)
Maltese: Kaxex tal-kartun (1x5 dożi u 1x25 dożi)
English: <{DD/MM/YYYY}>
Maltese: {JJ/XX/SSSS}
English: Pharmacotherapeutic group: Immunological for Bovidae, Cattle, Live viral vaccines, bovine respiratory syncytial virus (BRSV).
Maltese: Immunoloġiku għal Bovidae, Frat, Vaċċini virali ħajjin, virus sinktjali respiratorju bovin (BRSV).
English: Potassium chloride Water for injections
Maltese: Potassium chloride Ilma għall-injezzjonijiet
English: Solvent: Polyethylene (PET) vials of 10 ml or 50 ml, sealed with a bromobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-polyethylene (PET) ta' 10 mL jew 50 mL, issiġillati tapp tal-gomma bromobutyl u għatu tal-aluminju.
English: Lyophilisate:
Maltese: Lijofilisat:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for solvent (10 x 10 ml and 10 x 50 ml)
Maltese: Kaxex tal-kartun għal solvent (10x10 ml u 10x50 ml)
English: NZ amine
Maltese: Dextran Sucrose Gelatin NZ amine
English: Lyophilisate (vaccine): 10 ml type I glass vials of 5 or 25 doses, sealed with a bromobutyl rubber stopper and aluminium cap.
Maltese: Lijofiliżat (vaċċin): Kunjetti tal-ħġieġ ta' tip 1 ta' 10 mL ta' 5 jew 25 doża, issiġillati b'tapp talgomma bromobutyl u għatu tal-aluminju.
English: To stimulate active immunity against bovine respiratory syncytial virus.
Maltese: Biex jistimula l-immunità attiva kontra l-virus sinktjali respiratorju bovin.
English: Active immunisation of cattle to reduce virus shedding and respiratory clinical signs caused by bovine respiratory syncytial virus infection.
Maltese: Immunizzazzjoni attiva tal-frat biex jitnaqqsu t-tneħħija tal-virus u s-sinjali respiratorji kliniċi kkawżati minn infezzjoni tal-virus sinktjali respiratorju bovin.
English: Phosphate buffer solution
Maltese: Soluzzjoni buffer tal-fosfat
English: Calves may uncommonly display a peak in temperature of at least 1.7°C two days after vaccination that resolves the next day without treatment.
Maltese: L-għoġġiela jistgħu b'mod mhux komuni juru żieda fit-temperatura ta' mill-inqas 1.7°C jumejn wara ttilqima li tgħaddi sal-jum ta' wara mingħajr trattament.
English: Phosphate buffer solution Lyophilisate: Whitish freeze-dried lyophilisate.
Maltese: Soluzzjoni buffer tal-phosphate Lijofiliżat: Lijofiliżat bajdani mnixxef bl-iffriżar Solvent: Soluzzjoni omoġena-ċara.
English: Full immunity is established from 21 days after nasal vaccination.
Maltese: Immunità sħiħa hija stabbilita minn 21 jum wara t-tilqim nażali.
English: Shelf life of the solvent: 5 years
Maltese: Żmien kemm idum tajjeb solvent: 5 snin.
English: la Selva 135, 17170 Amer (Girona) Spain
Maltese: Laboratorios Hipra, S.A. Avda. la Selva 135, 17170 Amer (Girona) Spain
English: Nasal use or intramuscular use.
Maltese: Mhux applikabbli.
English: Each dose of 2 ml contains: Live attenuated bovine respiratory syncytial virus, strain Lym-56 ................... 104.7 - 6.5 CCID50
Maltese: Kull doża ta' 2 mL fiha: Virus sinktjali respiratorju bovin ħaj attenwat, razza Lym-56 ......................... 104.7 - 6.5 CCID50
English: Gelatin
Maltese: Lijofiliżat
English: Primary vaccination (nasal use): Spray 1 ml into each nostril (so the total volume administered is 2 ml).
Maltese: Tilqim primarju (użu għall-imnieħer): Sprejja 1 mL f'kull minfes (għalhekk il-volum totali li jingħata jkun ta' 2 mL).
English: Each dose of 2 ml contains: Lyophilisate:
Maltese: Tilqim mill-ġdid:
English: Vial of lyophilisate (5 doses and 25 doses) NAME OF THE VETERINARY MEDICINAL PRODUCT
Maltese: Kunjett ta' Lijofiliżat (5 dożi u 25 doża)
English: Cardboard box with 1 lyophilisate vial of 25 doses and 1 vial of 50 ml of solvent.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' lijofiliżat ta' 25 doża u kunjett wieħed ta' 50 mL ta' solvent.
English: 1 vial of lyophilisate and 1 vial of solvent (5 doses) 1 vial of lyophilisate and 1 vial of solvent (25 doses)
Maltese: Kunjett wieħed ta' lijofiliżat u kunjett wieħed ta' solvent (5 dożi) Kunjett wieħed ta' lijofiliżat u kunjett wieħed ta' solvent (25 doża)
English: Live attenuated bovine respiratory syncytial virus, strain Lym-56 ................... 104.7 - 6.5 CCID50* *Cell culture infectious dose 50%
Maltese: Virus sinktjali respiratorju bovin ħaj attenwat, razza Lym-56 ......................... 104.7 - 6.5 CCID50*
English: Revaccination: One intramuscular injection of 2 ml should be given 6 months after completion of the primary vaccination scheme and then every 6 months after the last revaccination.
Maltese: Injezzjoni waħda ġol-muskoli ta' 2 ml għandha tingħata 6 xhur wara li tintemm l iskema ta' tilqim primarju, imbagħad kull 6 xhur wara l-aħħar tilqima mill-ġdid.
English: Cardboard box with 10 lyophilisate vials of 25 doses.
Maltese: Kaxxa tal-kartun b'10 kunjetti ta' lijofiliżat ta' 25 doża.
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for lyophilisate (10 x 5 doses and 10 x 25 doses)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxex tal-kartun għal lijofiliżat (10x5 dożi u 10x25 dożi)
English: Cardboard box with 10 lyophilisate vials of 5 doses.
Maltese: Kaxxa tal-kartun b'10 kunjetti ta' lijofiliżat ta' 5 dożi.
English: Cardboard box with 10 vials of 10 ml of solvent.
Maltese: Kaxxa tal-kartun b'0 kunjetti ta' 10 mL ta' solvent.
English: Cardboard box with 1 lyophilisate vial of 5 doses and 1 vial of 10 ml of solvent.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' lijofiliżat ta' 5 dożi u kunjett wieħed ta' 10 mL ta' solvent.
English: Cardboard box with 10 vials of 50 ml of solvent.
Maltese: Kaxxa tal-kartun b'10 kunjetti ta' 50 mL ta' solvent.
English: Do not mix with any other veterinary medicinal product, except with the solvent supplied for use with the veterinary medicinal product .
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor, ħlief mas-solvent ipprovdut għal użu ma' dan il-prodott mediċinali veterinarju.
English: For nasal use, spray the required volume of the vaccine into the animal's nostrils (1 ml in each nostril) using an intranasal applicator (droplet size: 25-220 µm).
Maltese: Għall-użu għall-imnieħer, sprejja l-volum meħtieġ tal-vaċċin ġol-imnifsejn tal-annimal (1 mL ġewwa kull minfes) bl-użu ta' tagħmir għall-applikazzjoni ġewwa l-imnieħer (daqs tal-qtajra: 25-220 µm).
English: Reduction of respiratory clinical signs (but not a reduction of virus shedding) is observed 5 days after nasal vaccination.
Maltese: 5 ijiem wara t-tilqim nażali, ġie osservat tnaqqis tas-sinjali kliniċi respiratorji (iżda mhux tnaqqis tattixrid tal-virus).
English: Lyophilisate: Whitish freeze-dried lyophilisate.
Maltese: Numri ta' dożi fil kunjett tal-lijofiliżat
English: Do not use this veterinary medicinal product and the solvent after the expiry date which is stated on the carton and the label.
Maltese: Tużax dan il-prodott mediċinali veterinarju u s-solvent wara d-data ta' skadenza murija fuq il-kartuna u t-tikketta.
English: HIPRA UK AND IRELAND, Ltd. Tel. (+44) 0115 845 6486
Maltese: Tel: (+44) 0115 845 6486
English: NASYM lyophilisate and solvent for suspension for injection or nasal spray for cattle NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
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: NASYM lyophilisate and solvent for suspension for injection or nasal spray for cattle
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija
English: Solvent: Homogeneous-clear solution.
Maltese: Soluzzjoni omoġena-ċara.
English: Intravenous use vial (glass)
Maltese: Isem (ivvintat) Qawwa
English: Powder for concentrate for solution for infusion
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni
English: EMA/808930/2011 corr. EMEA/H/C/001225
Maltese: EMA/990701/2011 EMEA/H/C/001225
English: The full EPAR for Colobreathe can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: EPAR summary for the public colistimethate sodium
Maltese: Sommarju tal-EPAR għall-pubbliku colistimethate sodium
English: Colobreathe is a medicine that contains the active substance colistimethate sodium.
Maltese: Colobreathe huwa mediċina li fiha s-sustanza attiva colistimethate sodium.
English: Other information about Colobreathe
Maltese: Informazzjoni oħra dwar Colobreathe
English: The active substance in Colobreathe, colistimethate sodium, is an antibiotic from the polymyxin group.
Maltese: Is-sustanza attiva f'Colobreathe, colistimethate sodium, hija antibijotiku tal-grupp ta' polymyxin.
English: Among patients that completed the study, the improvement in FEV1 adjusted for age and height was 0.39% with Colobreathe compared with 0.78% with tobramycin.
Maltese: Fost il-pazjenti li temmew l-istudju, it-titjib fl-FEV1 aġġustat skont l-età u t-tul kien ta' 0.39% bi Colobreathe meta mqabbel ma' 0.78% bi tobramycin.
English: This is a summary of the European public assessment report (EPAR) for Colobreathe.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Colobreathe.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Colobreathe on 13 February 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Colobreathe fi 13 ta' Frar 2012.
English: Polymyxins target a group of bacteria called Gram-negative bacteria, which includes P. aeruginosa, because their cell membranes contain a high level of phospholipids.
Maltese: Polymyxins għandhom fil-mira lil grupp ta' batterji msejħa batterji Gram-negattivi, li jinkludi P. aeruginosa, għaliex il-membrani taċ-ċelloli tagħhom fihom livell għoli ta' fosfolipidi.