FrancophonIA/ELRC3.0 huggingface dataset:
English: Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively.
Maltese: Tulathromycin għandha attività in vitro kontra Mannheimia haemolytica, Pasteurella multocida, Histophilus somni u Mycoplasma bovis, u Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis u Bordetella bronchiseptica il-mikrobi patoġeniċi li huma l-aktar assoċjati ma' mard respiratorju tal-baqar u tal-majjali, rispettivament.
English: In addition to its antimicrobial properties, tulathromycin demonstrates immune-modulating and antiinflammatory actions in experimental studies.
Maltese: Flimkien mal-kwalitajiet anitmikrobiċi tulathromycin kellha azzjonijiet ta' tibdil immunoloġiku u anti-imfjammatorju fi studji sperimentali.
English: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin.
Maltese: Trattament u metafilassi tal-marda respiratorja tal-majjali (SRD) assoċjata ma' Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis u
English: Subcutaneous administration of Draxxin to cattle causes very commonly transient pain reactions and local swellings at the injection site that can persist for up to 30 days.
Maltese: Amministrazzjoni ta' Draxxin taħt il-ġilda fil-baqar ta' spiss twassal għal reazzjonijiet ta' wġigħ li jgħaddi u nefħiet lokalizzati fil-post tal-injezzjoni li jistgħu jibqgħu sa 30 ġurnata.
English: Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis and Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively.
Maltese: Tulathromycin għandha attività in vitro kontra Mannheimia haemolytica, Pasteurella multocida, Histophilus somni u Mycoplasma bovis, u Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae u Haemophilus parasuis u Bordetella bronchiseptica il-mikrobi patoġeniċi li huma l-aktar assoċjati ma' mard respiratorju tal-baqar u tal-majjali, rispettivament.
English: In both bovine and porcine polymorphonuclear cells (PMNs; neutrophils), tulathromycin promotes apoptosis (programmed cell death) and the clearance of apoptotic cells by macrophages.
Maltese: F'polymorphonuclear cells (PMNs; neutrophils) kemm tal baqar kif ukoll tal-majjali, tulathromycin ħeġġet l-apoptożi (mewt ipprogrammat taċ-ċelloli) u ttneħħija taċ-ċelloli apoptotiċi permezz tal-makrofaġi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (50 ml / 100 ml / 250 ml)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun (50 ml / 100 ml / 250 ml)
English: Intramuscular use.
Maltese: Tessuti mmirati
English: Draxxin 25 mg/ml: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM
Maltese: 4.7 Użu fit-tqala, fit-treddigħ u fi żmien il-bidien
English: Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of approximately 91 hours in plasma.
Maltese: Wara li ntlaħqu l-ogħla livelli kien hemm tnaqqis bil-mod ta' Tulathromycin fis-sistema, b'half life ta' eliminazzjoni (t1/2) mil-plażma li jidher li hu ta' 91 siegħa.
English: Treatment and metaphylaxis of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin.
Maltese: Pasteurella multocida, Histophilus somni u Mycoplasma bovis sensittivi għal tulathromycin.
English: The volume of distribution at steady-state (Vss) determined after intravenous administration was 11 l/kg.
Maltese: Il-volum ta' distribuzzjoni fi stat stabbli (Vss) iddeterminat wara amministrazzjoni fil-vina kien ta' 11 l/kg.
English: In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous dose of 2.5 mg/kg bodyweight, was characterised by rapid and extensive absorption followed by high distribution and slow elimination.
Maltese: Fil-baqar, il-profil farmakokinetiku ta' tulathromycin meta tingħata f'doża waħda taħt il-ġilda ta' 2.5 mg/kg piż, kien ikkaratterizzat minn assorbiment estensiv u ta' malajr segwit minn distribuzzjoni għolja u eliminazzjoni bil-mod.
English: Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are very common for approximately 30 days after injection in cattle and pigs.
Maltese: Reazzjonijiet patomorfoloġiċi (li jinkludu bidliet riversibbli ta' konġestjoni, edema, fibrożi u emmoraġija) huma komuni ħafna fil-post tal-injezzjoni bejn wieħed u ieħor għal 30 ġurnata wara linjezzjoni fil-baqar u majjali.
English: Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA.
Maltese: Il-makrolidi huma antibijotiċi batterjostatiċi u jimblokkaw il-biosintesi ta' proteini essenzjali billi b'mod selettiv jeħlu mar-ribosomal RNA tal-mikrobi.
English: Use only according to the benefit/risk assessment by the responsible veterinarian.
Maltese: Uża biss skont il-valutazzjoni tal-benefiċċju u r-riskju tal-veterinarju responsabbli.
English: It differs from many other macrolides in that it has a long duration of action that is, in part, due to its three amine groups; therefore it has been given the chemical subclass designation of triamilide.
Maltese: Hija differenti minn ħafna makrolidi oħra billi l-effett tagħha huwa twil, dan minħabba l-fatt li għandha tliet gruppi amini, u għalhekk ġiet imqiegħda fis-sotto-klassi ta' denominazzjoni kimika ta' triamilide.
English: Meat and offal: 13 days.
Maltese: Laħam u interjuri: 13-il ġurnata.
English: The volume of distribution at steady-state (VSS) determined after intravenous administration was 13.2 l/kg.
Maltese: Il-volum ta' distribuzzjoni fi stat stabbli (Vss) iddeterminat wara amministrazzjoni fil-vina, kien ta' 13.2 l/kg.
English: The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 L/kg.
Maltese: Il-volum ta' distribuzzjoni fi stat stabbli (Vss) iddeterminat wara amministrazzjoni fil-vina, kien ta' 13.2 L/kg.
English: Muscle Fat
Maltese: KONTENUT BĦALA
English: The bioavailability of tulathromycin after intramuscular administration in pigs was approximately 88%.
Maltese: Il-bijodisponibiltà ta' tulathromycin wara amministrazzjoni fil-muskolu fil-majjali kienet bejn wieħed u ieħor ta' 88%.
English: Draxxin showed limited efficacy in sheep with severe clinical signs or chronic foot rot and should therefore only be given at an early stage of foot rot.
Maltese: Draxxin wera effikaċja limitata f'nagħaġ b'sinjali kliniċi serji jew foot rot kronika u għalhekk għandu jintuża' biss fl-istadji bikrin tal-foot rot.
English: 14R)-2-ethyl tetrahydroxy hexamethyl trideoxy-3(dimethylamin o)-ß-Dxylohexopyranosyl]oxy]-1oxa-6azacyclopentde-can-15-one expressed as tulathromycin equivalents
Maltese: Tużax fl-istess ħin li jkunu qed jintużaw makrolidi oħrajn jew linkosamidi (ara sezzjoni 4.8).
English: Draxxin 25 mg/ml solution for injection for pigs tulathromycin
Maltese: Draxxin 25 mg/ml soluzzjoni għal injezzjoni għal majjali
English: Draxxin 100 mg/ml solution for injection for cattle tulathromycin
Maltese: VETERINARJU Draxxin 100 mg/ml soluzzjoni għal injezzjoni għal baqar tulathromycin
English: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep
Maltese: VETERINARJU Draxxin 100 mg/ml soluzzjoni għal injezzjoni għal baqar, majjali u nagħaġ.
English: Treatment and metaphylaxis of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin.
Maltese: Majjali Trattament u metafilassi tal-marda respiratorja tal-majjali assoċjata ma' Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae.
English: Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of 90 hours in plasma.
Maltese: Wara li ntlaħqu l-ogħla livelli kien hemm tnaqqis bil-mod ta' preżenza fis-sistema, b'half life ta' eliminazzjoni (t1/2) mill-plażma li jidher li hu ta' 90 siegħa.
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-eċċipjenti elenkati f'sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott 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 kunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, was also characterised by rapid and extensive absorption followed by high distribution and slow elimination.
Maltese: Fil-majjali, il-profil farmakokinetiku ta' tulathromycin meta tingħata f'doża waħda ta' 2.5 mg/kg piż, fil-muskolu, kien ukoll ikkaratterizzat minn assorbiment estensiv u ta' malajr segwit minn distribuzzjoni għolja u eliminazzjoni bil-mod.
English: Draxxin 25 mg/ml solution for injection for pigs
Maltese: VETERINARJU Draxxin 25 mg/ml soluzzjoni għal injezzjoni għal majjali.
English: Cattle (treatment and metaphylaxis) 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
Maltese: Injezzjoni waħda taħt il-ġilda ta' 2.5 mg tulathromycin/kg piż (ekwivalenti għal 1 ml/40 kg piż).
English: Sheep: 16 days.
Maltese: Nagħaġ : 16-il ġurnata.
English: For treatment of pigs over 40 kg bodyweight, divide the dose so that no more than 4 ml are injected at one site.
Maltese: Għal trattament ta' majjali 'l fuq minn 40 kg piż, aqsam id-doża biex f'kull post tal-injezzjoni ma jingħatawx aktar minn 4 ml.
English: Cross resistance occurs with other macrolides.
Maltese: Reżistenza inkroċjata sseħħ ma' makrolidi oħra.
English: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep Tulathromycin
Maltese: VETERINARJU Draxxin 100 mg/ml soluzzjoni għal injezzjoni għal baqar, majjali u nagħaġ tulathromycin
English: Pregnancy and lactation:
Maltese: Żmien ta' tiżmim:
English: Kidney
Maltese: Xejn
English: EU (MA) Number
Maltese: Numru tal-MA (EU)
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott tista' tiġi aġġornata sussegwentement mill-awtoritajiet kompetenti tal-Istat Membru, f'komunikazzjoni mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stipulati f'Kapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: 4.3 Contraindications [The following contraindication should be included]
Maltese: 4.3 Kontraindikazzjonijiet [Għandha tiddaħħal il-kontraindikazzjoni li ġejja]
English: Serious allergic reactions, including bronchospasm and anaphylaxis, were reported in patients allergic to cow's milk proteins who were treated for acute allergic conditions.
Maltese: Ġew irrappurtati reazzjonijiet allerġiċi serji, inkluż bronkospażmu u anafilassi, f'pazjenti allerġiċi għall-proteini tal-ħalib tal-baqar li ġew ikkurati għal kondizzjonijiet allerġiċi akuti.
English: Annex III Amendments to relevant sections of the Product Information
Maltese: Anness III Emendi għal sezzjonijiet rilevanti tal-Informazzjoni dwar il-Prodott
English: Allergic reactions to cow's milk proteins should be considered in patients receiving <invented name and strength(s)> for the treatment of acute allergic conditions in whom symptoms worsen or who are presenting new allergic symptoms (see section 4.3).
Maltese: Għandhom jiġu kkunsidrati r-reazzjonijiet allerġiċi għall-proteini tal-ħalib tal-baqar f'pazjenti li jirċievu <isem ivvintat u qawwa(iet)> għall-kura ta' kondizzjonijiet allerġiċi akuti li s-sintomi tagħhom jiggravaw jew li juru sintomi allerġiċi ġodda (ara sezzjoni 4.3).
English: 4.4 Special warnings and precautions for use [The following warning should be included] Immune System Effects
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu [Għandha tiddaħħal it-twissija li ġejja] Effetti fuq is-Sistema Immuni
English: Cow's milk allergy [The following clarification in brackets should be included in case of combined SmPC with strength(s) not included in Annex I] (the following paragraphs only apply to <invented name and strength(s)>)
Maltese: Allerġija għall-ħalib tal-baqar [Il-kjarifika li ġejja fil-parentesi għandha tiddaħħal f'każ ta' SmPC ikkombinat b'qawwa(iet) li mhijiex(mhumiex) inkluża(i) fl-Anness I] (il-paragrafi li ġejjin japplikaw biss għal <isem ivvintat u qawwa(iet)>)
English: <Invented name and strength(s)> is contraindicated in patients with a known or suspected allergy to cow's milk (see section 4.4).
Maltese: <Isem ivvintat u qawwa(iet)> huwa kontraindikat f'pazjenti b'allerġija magħrufa jew suspettata għall ħalib tal-baqar (ara sezzjoni 4.4).
English: <Invented name and strength(s)> contains lactose <monohydrate> produced from bovine origin as an excipient and may therefore contain trace amounts of cow's milk proteins (the allergens of cow's milk).
Maltese: <Isem ivvintat u qawwa(iet)> fih il-lattożju <monoidrat> prodott mill-oriġini bovina bħala eċċipjent u għalhekk jista' jkun fih ammonti żgħar ħafna ta' proteini tal-ħalib tal-baqar (l-allerġeni tal-ħalib tal-baqar).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-PAKKETTI
English: Summary of product characteristics
Maltese: TWISSIJA(IET) SPEĊJALI
English: EMA/612763/2014 EMEA/H/C/003956
Maltese: EMEA/H/C/003956
English: The full EPAR and risk management plan summary for Accofil 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: The active substance in Accofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Accofil, filgrastim, hi simili ħafna għal proteina umana msejħa fattur talistimulazzjoni tal-kolonji tal-granuloċiti (G-CSF).
English: Accofil, which contains the active substance filgrastim, is a ‘biosimilar medicine'.
Maltese: Accofil, li fih is-sustanza attiva filgrastim, huwa ‘mediċina bijoloġika simili'.
English: Severe neutropenia lasted on average for 1.4 days.
Maltese: Newtropenija severa damet medja ta' 1.4 ġranet.
English: Other information about Accofil
Maltese: Informazzjoni oħra dwar Accofil
English: This is comparable with 1.6 days and 1.8 days reported in other studies found in the literature using filgrastim.
Maltese: Dan hu komparabbli ma' 1.6 ġranet u 1.8 ġranet irrappurtati fi studji oħra misjuba fil-letteratura li jużaw filgrastim.
English: Why is Accofil approved?
Maltese: Għaliex ġie approvat Accofil?
English: The reference medicine for Accofil is Neupogen.
Maltese: Il-mediċina ta' referenza għal Accofil hi Neupogen.
English: This is a summary of the European public assessment report (EPAR) for Accofil.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Accofil.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Accofil on 18 September 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Accofil fit-18 ta' Settembru 2014.
English: Accofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy known to cause neutropenia.
Maltese: Accofil ġie studjat fi studju wieħed ewlieni li involva 120 pazjent adult mara bil-kanċer tas-sider ikkurati b'kimoterapija magħrufa li tikkawża newtropenija.
English: The filgrastim in Accofil is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce filgrastim.
Maltese: Filgrastim f'Accofil jiġi prodott b'metodu magħruf bħala ‘tekonoloġija tad-DNA rikombinanti': hi magħmula minn batterji li fihom ġie introdott ġene (DNA) li jagħmilhom kapaċi li jipproduċu filgrastim.
English: • to treat persistent neutropenia in patients with advanced Human-Immunodeficiency-Virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Maltese: • biex tikkura n-newtropenija persistenti f'pazjenti bl-infezzjoni tal-Vajrus tal-Immunodefiċjenza Umana (HIV), biex tnaqqas infezzjonijiet batterjali meta kuri oħrajn ma jkunux adatti.
English: What are the risks associated with Accofil?
Maltese: X'inhuma r-riskji assoċjati ma' Accofil?
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Maltese: • biex iżżid il-livelli ta' newtrofili u tnaqqas ir-riskju ta' infezzjoni f'pazjenti b'newtropenija li għandhom storja ta' infezzjonijiet severi u ripetuti;
English: Studies were carried out to show that Accofil produces similar levels of the active substance in the body to Neupogen and increases the numbers of neutrophils in a comparable way.
Maltese: Saru studji biex juru li Accofil jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħal Neupogen u jżid in-numru ta' newtrofili b'mod komparabbli.
English: The most common side effect with Accofil (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Maltese: L-iktar effett sekondarju komuni b'Accofil (innutat f'iktar minn pazjent 1 minn kull 10) hu l-uġigħ muskoloskeletali (uġigħ fil-muskoli u fl-għadam).
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving cytotoxic chemotherapy (medicines to treat cancer by killing cells);
Maltese: • biex tnaqqas it-tul ta' żmien ta' newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellula bajda taddemm) u l-okkorrenza ta' newtropenija bid-deni f'pazjenti li jkunu qed jirċievu kimoterapija ċitotossika (mediċini għall-kura tal-kanċer billi joqtlu ċ-ċelluli);
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Accofil has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li, skont irrekwiżiti tal-UE għal mediċini bijosimili, Accofil wera li għandu kwalità, sigurtà u profil ta' effikaċja komparabbli għal Neupogen.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijoloġiċi simili ara d-dokument ta' mistoqsija u tweġiba hawn.
English: This means that Accofil is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Accofil hu simili għal mediċina bijoloġika (magħrufa wkoll bħala ‘l-mediċina ta' referenza') li diġà hi awtorizzata flUnjoni Ewropea (UE).
English: Accofil is available as a solution for injection or infusion (drip) in pre-filled syringes.
Maltese: Accofil hu disponibbli bħala soluzzjoni għal injezzjoni jew infużjoni (dripp) f'siringi mimlijin għal-lest.
English: Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.
Maltese: Dejta minn studji ppubblikati tindika li l-benefiċċji u s-sigurtà ta' filgrastim huma simili kemm fl-adulti kif ukoll fit-tfal li jieħdu l-kimoterapija.
English: Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risks and recommended that it be approved for use in the EU.
Maltese: Għalhekk, l-opinjoni tas-CHMP kienet li, bħal fil-każ ta' Neupogen, ilbenefiċċju huwa ikbar mir-riskji identifikati u rrakkomanda li jkun approvat għall-użu fl-UE.
English: More information can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Aktar informazzjoni tista' tinstab fis-sommarju talkaratteristiċi tal-prodott (parti wkoll mill-EPAR).
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Accofil is being used for.
Maltese: Effetti sekondarji oħra jistgħu jiġu nnotati f'iktar minn pazjent 1 minn kull 10, skont il-kundizzjoni li għaliha jkun qed jintuża Accofil.
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
Maltese: • biex tnaqqas it-tul ta' żmien ta' newtropenija f'pazjenti li jkunu qed jirċievu kura biex joqtlu ċċelluli tal-mudullun qabel trapjant tal-mudullun tal-għadam (bħal f'xi pazjenti bil-lewkimja) jekk ikunu f'riskju ta' newtropenija severa għal żmien twil;
English: 10 (2 x 5) pre-filled pens (multipack)
Maltese: 10 (2 x 5) pinen mimlijin għal-lest (pakkett b'ħafna)
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla Farmaċewtika
English: Content (concentration) Package size
Maltese: Daqs tal-pakkett
English: Solvent: 10 ml (100 IU/ml)
Maltese: Mnejn jingħata Il-pakkett
English: Further information on Carmustine Obvius 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: Carmustine Obvius (carmustine) EMA/273425/2018
Maltese: EMA/273425/2018
English: Carmustine Obvius is a ‘generic medicine'.
Maltese: Carmustine Obvius huwa "mediċina ġenerika".
English: Carmustine Obvius is given by infusion (drip) into a vein.
Maltese: Carmustine Obvius jingħata permezz ta' infużjoni (dripp) ġol-vina.
English: Other information about Carmustine Obvius
Maltese: Informazzjoni oħra dwar Carmustine Obvius
English: Studies on the benefits and risks of the active substance carmustine in the authorised uses have already been carried out with the reference medicine, Carmubris, and do not need to be repeated for Carmustine Obvius.
Maltese: Studji fuq il-benefiċċji u r-riskji tas-sustanza attiva carmustine fl-użu approvat diġà twettqu bilmediċina ta' referenza, Carmubris, u m'għandhomx għalfejn jiġu ripetuti għal Carmustine Obvius.
English: Carmustine, the active substance in this medicine, is a type of cancer medicine known as an alkylating agent.
Maltese: Carmustine, is-sustanza attiva f'din il-mediċina, hija tip ta' mediċina kontra l-kanċer magħrufa bħala aġent alkilanti.
English: As for all medicines, data on the use of Carmustine Obvius are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Carmustine Obvius hija mmonitorjata kontinwament.
English: What are the benefits and risks of Carmustine Obvius?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Carmustine Obvius?