FrancophonIA/ELRC3.0 huggingface dataset:
English: 5.2 Pharmacokinetic particulars
Maltese: GĦAMLA FARMAĊEWTIKA
English: Mirataz 20 mg/g transdermal ointment for cats
Maltese: Mirataz 20 mg/g ingwent transdermali għall-qtates
English: The efficacy and safety of the veterinary medicinal product has not been established in cats weighing less than 2.1 kg or more than 7.0 kg (see “Dosage for each species, route(s) and method of administration”).
Maltese: L-effikaċja u s-sigurtà tal prodott mediċinali veterinarju ma ġewx stabbiliti fi qtates li jiżnu inqas minn 2.1 kg jew aktar minn 7.0 kg (ara “Doża għal kull speċi, mod(i) u metodu ta' amministrazzjoni”).
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Maltese: L-effikaċja tal-prodott mediċinali veterinarju ma ġietx stabbilita fi qtates ta' inqas minn 3 snin.
English: If contact with your skin occurs wash with soap and water.
Maltese: F'każ ta' kuntatt mal-ġilda aħsel bis-sapun u bl-ilma.
English: Manufacturer responsible for batch release: Klifovet AG
Maltese: Isem u indirizz tal-manifattur(i) responsabbli mill-ħruġ tal-lott Klifovet AG
English: In a crossover study conducted with the product at 0.5 mg/kg in eight cats to determine the relative bioavailability of oral and transdermal 2% mirtazapine, the mean terminal half-life (25.6 ± 5.5 hours) with topical administration was over 2X longer than the mean terminal half-life (8.63 ±3.9 hours) with oral administration.
Maltese: .2 Tagħrif farmakokinetiku Fi studju inkroċjat li sar bil-prodott f'doża ta' 0.5 mg/kg fuq tmien qtates biex tiġi determinata l bijodisponibilità relattiva ta' 2 % mirtazapine orali u transdermali, in-nofs ħajja terminali medja (25.6 ±
English: Do not use in cats treated with cyproheptadine, tramadol or monoamine oxidase inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the veterinary medicinal product as there may be an increased risk of serotonin syndrome (see “Contraindications”).
Maltese: Tużax fuq qtates li jkunu qed jingħataw kura b'inibituri tal-monoamina ossidażi (MAOIs) jew li jkunu ngħataw kura b'MAOI fl-14-il jum qabel il-kura bil-prodott mediċinali veterinarju minħabba li jista' jkun hemm riskju akbar tas-sindrome tas-serotonina (ara wkoll “twissijiet speċjali”).
English: The effects of mirtazapine on glucose regulation have not been evaluated.
Maltese: L-effetti ta' mirtazapine fuq ir-regolament tal-glukożju ma ġewx ivvalutati.
English: PACKAGE LEAFLET: Mirataz 20 mg/g transdermal ointment for cats
Maltese: VETERINARJU Mirataz 20 mg/g ingwent transdermali għall-qtates
English: Aniserve GmbH Geyerspergerstr.
Maltese: Dawn il-miżuri għandhom jgħinu sabiex jipproteġu l-ambjent.
English: Do not use in cats treated with cyproheptadine, tramadol or monoamine oxidase inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the veterinary medicinal product as there may be an increased risk of serotonin syndrome (see section 4.8).
Maltese: Tużax fuq qtates li jkunu qed jingħataw kura b'cyproheptadine, bi tramdol jew b'inibituri tal-monoamina ossidażi (MAOIs) jew li jkunu ngħataw kura b'MAOI fi żmien 14-il jum qabel il-kura bil-prodott mediċinali veterinarju minħabba li jista' jkun hemm riskju akbar tas-sindromu tas-serotonina (ara s-sezzjoni 4.8).
English: This line coincides with the appropriate length of ointment to be applied:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Step 2: Twist cap on tube counter clockwise to open.
Maltese: Pass 2: Dawwar l għatu tal-istoċċ fid-direzzjoni kontra l-arloġġ biex tiftħu.
English: The veterinary medicinal product should not be applied on damaged skin.
Maltese: Il-prodott mediċinali veterinarju ma għandux jiġi applikat fuq ġilda maqsuma.
English: The only effect tested under field practice was on bodyweight: clientowned cats presented with a weight loss ≥ 5%, deemed clinically significant by the investigator, gained a statistically significant (p<0.0001) amount of weight, after 14 days of product administration (3.39% weight gain or average of 130 grams) compared to those cats administered placebo (0.09% weight gain or average of 10 grams).
Maltese: wara 14-il jum ta' għoti tal-prodott (żieda fil-piż ta' 3.39 % jew medja ta' 130 gramma) meta mqabbla ma' dawk il-qtates li ngħataw plaċebo (żieda fil-piż ta' 0.09 % jew medja ta' 10 grammi).
English: Step 3: Apply even pressure on tube and squeeze a 3.8 cm line of ointment onto your index finger using the measured line on the bottle or in this leaflet as a guide.
Maltese: Pass 3: Applika pressjoni uniformi fuq l-istoċċ u għafas linja ta' ingwent ta' 3.8 cm fuq is-saba' l werrej billi tuża l linja gradata fuq ilflixkun jew f'dan il fuljett bħala gwida.
English: Do not use in cats treated with cyproheptadine, tramadol or monoamine oxidase inhibitors (MAOIs) or treated with an MAOI within 14 days prior to treatment with the veterinary medicinal product as there may be an increased risk of serotonin syndrome (see section 4.3).
Maltese: Tużax fuq qtates li jkunu qed jingħataw kura b'cyproheptadine, bi tramdol jew b'inibituri tal-monoamina ossidażi (MAOIs) jew li jkunu ngħataw kura b'MAOI fi żmien 14-il jum qabel il-kura bil-prodott mediċinali veterinarju minħabba li jista' jkun hemm riskju akbar tas-sindromu tas-serotonina (ara s-sezzjoni 4.3).
English: In these special cases, biochemical hepatic and renal parameters regularly monitored during the treatment.
Maltese: F'dawn il-każijiet speċjali, għandu jsir monitoraġġ regolari tal-parametri epatiċi u renali bijokimiċi waqt il-kura.
English: The efficacy and safety of the veterinary medicinal product has not been established in cats with severe renal disease and/or neoplasia.
Maltese: Dan il-prodott mediċinali veterinarju jista' jikkawża irritazzjoni fl-għajnejn u fil-ġilda.
English: Each plastic bottle with a child resistant cap contains 1 tube (5 g).
Maltese: Kull flixkun tal-plastik b'tapp reżistenti għat-tfal fih stoċċ 1 (5 g).
English: Mirtazapine has been identified as potentially reprotoxic in rats and rabbits.
Maltese: Mirtazapine ġie identifikat bħala potenzjalment reprotossiku fil-firien u fil-fniek.
English: Impermeable disposable protective gloves should be provided at the point of sale with the product and must be worn when handling and administering the veterinary medicinal product.
Maltese: Ma għandekx tiekol, tixrob jew tpejjep meta tkun qed timmaniġġja l-prodott mediċinali veterinarju.
English: BATCH NUMBER
Maltese: DAQS TAL-PAKKETT
English: Transient increased hepatic alanine transferase can be observed uncommonly.
Maltese: Żieda transjenti fl-alanina transferażi fil-fwied tista' tiġi osservata b'mod mhux komuni.
English: B. PACKAGE LEAFLET
Maltese: Daqs tal-pakkett
English: Mirtazapine may increase sedative properties of benzodiazepines and of other substances with sedative properties (antihistamines H1, opiates).
Maltese: Mirtazapine jista' jżid il-karatteristiċi sedattivi ta' benżodijażepini u ta' sustanzi oħra b'karatteristiċi sedattivi (antistamini
English: Further information on Remsima can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/remsima.
Maltese: Aktar informazzjoni dwar Remsima tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/remsima.
English: This overview was last updated in 11/2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'11/2019.
English: Remsima received a marketing authorisation valid throughout the EU on 10 September 2013.
Maltese: Remsima ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-10 ta' Settembru 2013.
English: Remsima is a ‘biosimilar' medicine.
Maltese: Remsima huwa mediċina “bijosimili”.
English: Remsima is an anti-inflammatory medicine that contains the active substance infliximab.
Maltese: Remsima huwa mediċina antiinfjammatorja li fiha s-sustanza attiva infliksimab.
English: Other information about Remsima
Maltese: Informazzjoni oħra dwar Remsima
English: A study was also carried out in 250 patients with ankylosing spondylitis to show that Remsima given by infusion into a vein produces levels of the active substance in the body that are comparable to the reference medicine, Remicade.
Maltese: Sar ukoll studju f'250 pazjent bi spondilite ankilosanti li juri li Remsima mogħti b'infużjoni fil-vina jipproduċi livelli tas-sustanza attiva fil-ġisem li huma komparabbli mal-mediċina ta' referenza, Remicade.
English: Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Maltese: Infliksimab tfasslet biex teħel ma' messaġġier kimiku fil-ġisem magħruf bħala l-fattur alfa ta' nekrożi tat-tumur (TNF-alpha).
English: Remsima is used with methotrexate (another medicine that acts on the immune system);
Maltese: Remsima jintuża ma' methotrexate (mediċina oħra li taħdem fuq is-sistema immunitarja);
English: The most common side effects with Remsima (which may affect more than 1 in 10 people) are viral infections (such as flu or cold sores), headache, upper respiratory-tract infection (nose and throat infections), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Remsima (li dehru f'aktar minn pazjent wieħed minn kull 10) huma infezzjonijiet virali (bħallinfluwenza jew ponot tal-irjiħat), uġigħ ta' ras, infezzjoni fin-naħa ta' fuq tal-apparat respiratorju (infezzjoni fl-imnieħer u fil-gerżuma), sinusite (infjammazzjoni tas-sinus), nawżja (tħossok ma tiflaħx),
English: The reference medicine for Remsima is Remicade.
Maltese: Il-mediċina ta' referenza għal Remsima hija Remicade.
English: Laboratory studies comparing Remsima with Remicade have shown that the active substance in Remsima is highly similar to that in Remicade in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Remsima ma' Remicade wrew li s-sustanza attiva f'Remsima hija simili ħafna għal dik f'Remicade f'termini ta' struttura, purità u attività bijoloġika.
English: What are the risks associated with Remsima?
Maltese: X'inhuma r-riskji assoċjati ma' Remsima?
English: For more information on biosimilar medicines, see here.
Maltese: Għal aktar informazzjoni dwar mediċini bijosimili, ara hawn.
English: In addition, Remsima and Remicade given by infusion into a vein were compared in one main study involving 606 adults with rheumatoid arthritis.
Maltese: Barra minn hekk, Remsima u Remicade mogħtija b'infużjoni f'vina ġew imqabbla fi studju ewlieni wieħed li kien jinvolvi 606 adulti bl-artrite rewmatojde.
English: • Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulas, abnormal passageways between the gut and other organs);
Maltese: • il-marda ta' Crohn (marda li tikkawża infjammazzjoni tal-passaġġ diġestiv), meta l-marda tkun moderata sa severa jew fistulanti (bil-formazzjoni ta' fistuli, passaġġi anormali bejn l-imsaren u organi oħrajn);
English: The active substance in Remsima, infliximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Maltese: Is-sustanza attiva f'Remsima, infliksimab, hija antikorp monoklonali, tip ta' proteina li tfasslet sabiex tagħraf u teħel ma' struttura fil-mira speċifika (imsejħa antiġene) fil-ġisem.
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
Maltese: • spondilite ankilotika (marda li tikkawża infjammazzjoni u wġigħ fil-ġogi tas-sinsla tad-dahar);
English: This means that Remsima is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Remsima huwa simili ħafna għal mediċina bijoloġika oħra (il-“mediċina ta' referenza”) li diġà hija awtorizzata fl-UE.
English: Remsima injection to be given under the skin was shown to be as effective as Remsima given by infusion into a vein in a study involving 343 patients with rheumatoid arthritis.
Maltese: L-injezzjoni ta' Remsima li għandha tingħata taħt il-ġilda ntweriet li hija effettiva daqs Remsima mogħtija permezz ta' infużjoni f'vina fi studju li fih ħadu sehem 343 pazjent bl-artrite rewmatojde.
English: Some side effects, including infections, may be more common in children than in adults.
Maltese: Xi effetti sekondarji, inklużi infezzjonijiet, jistgħu jkunu aktar komuni fit-tfal milli fl-adulti.
English: • rheumatoid arthritis (a disease causing inflammation of the joints).
Maltese: • artrite rewmatojde (marda li tikkawża infjammazzjoni tal-ġogi).
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Maltese: • kolite ulċerattiva (marda li tikkawża infjammazzjoni u ulċeri fir-rita tal-imsaren);
English: By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Maltese: Bl-imblukkar ta' TNF-alpha, l-infliksimab ittaffi l-infjammazzjoni u s-sintomi loħrajn tal-mard.
English: Remsima is also used in patients aged between 6 and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Maltese: Remsima jintuża wkoll f'pazjenti ta' bejn is-6 snin u s-17-il sena bil-marda ta' Crohn severa u attiva jew b'kolite ulċerattiva attiva b'mod sever, meta ma jkunux irrispondew għal jew ma jkunux jistgħu jieħdu mediċini jew kuri oħrajn.
English: After 30 weeks of treatment, Remsima was as effective as Remicade with around 60% of patients responding to treatment with either medicine.
Maltese: Wara 30 ġimgħa ta' kura, Remsima kien effettiv daqs Remicade b'madwar 60 % tal-pazjenti li rrispondew għall-kura b'Remsima jew b'Remicade.
English: Remsima must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remsima.
Maltese: Remsima ma għandux jintuża f'pazjenti li, fil-passat, esperjenzaw sensittività eċċessiva (allerġija) għal -infliksimab, jew li huma ipersensittivi (allerġiċi) għall-proteini tal-ġrieden jew għal kwalunkwe sustanza oħra ta' Remsima.
English: Remsima given by injection under the skin for rheumatoid arthritis is as effective as Remsima given by infusion and the safety profile is acceptable.
Maltese: Remsima mogħti permezz ta' injezzjoni taħt il-ġilda għall-artrite rewmatojde huwa effettiv daqs Remsima mogħti permezz ta' infużjoni u l-profil tas-sigurtà huwa aċċettabbli.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Remsima has a highly similar structure, purity and biological activity to Remicade and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, f'konformità mar-rekwiżiti tal-UE għal mediċini bijosimili, Remsima għandu struttura, purità u attività bijoloġika simili ħafna għal Remicade u jiġi distribwit fil-ġisem bl-istess mod.
English: Because Remsima is a biosimilar medicine, the studies on effectiveness and safety of infliximab carried out with Remicade do not all need to be repeated for Remsima.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Remsima hija ssorveljata kontinwament.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Maltese: • artrite psorijatika (marda li tikkawża rqajja' ħomor bil-qxur fuq il-ġilda u infjammazzjoni tal-ġogi);
English: In addition, studies in rheumatoid arthritis and ankylosing spondylitis have shown that the safety and effectiveness of Remsima are equivalent to those of Remicade in the conditions.
Maltese: Barra minn hekk, studji fl-artrite rewmatojde u fl-ispondilite ankilosanti wrew li s-sigurtà u l-effikaċja ta' Remsima huma ekwivalenti għal dawk ta' Remicade filkundizzjonijiet.
English: The safety of Remsima has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Remicade.
Maltese: Is-sigurtà ta' Remsima ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza Remicade.
English: Remsima is available as a powder to be made up into a solution for infusion (drip) into a vein.
Maltese: Remsima jiġi bħala trab li jiġi magħmul f'soluzzjoni għall-infużjoni (dripp) ġol-vina.
English: How does Remsima work?
Maltese: Kif jintuża Remsima?
English: Remsima can only be obtained with a prescription and treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remsima can be used to treat.
Maltese: Il-kumpanija li tqiegħed Remsima fis-suq se tipprovdi kard lill-pazjenti li tinkludi informazzjoni dwar ilmediċina u li tista' tintuża biex jiġu rreġistrati t-testijiet li jkunu ħadu.
English: All these data were considered sufficient to conclude that Remsima will behave in the same way as Remicade in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Remsima se jaġixxi bl-istess mod bħal Remicade f'termini ta' effikaċja u sigurtà fl-użi approvati tiegħu.
English: What measures are being taken to ensure the safe and effective use of Remsima?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Remsima?
English: This is normal.
Maltese: Dan normali.
English: 1316 BN Almere The Netherlands
Maltese: 1316 BN Almere L-Olanda
English: Haemoglobin (g/L)
Maltese: Emoglobina (g/L)
English: Date of first authorisation: 18 December 2007 Date of latest renewal: 15 November 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Diċembru 2007 Data tal-aħħar tiġdid: 15 ta' Novembru 2012
English: 17.UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: The apparent molecular weight of erythropoietin is 32 000 to 40 000 dalton.
Maltese: Il-massa molekulari apparenti taleritropoetina hija ta' 32,000 sa 40,000 dalton.
English: 4.3 Contraindications
Maltese: 4.3 Kontraindikazzjonjiet
English: Screening sEPO <200 mU/ml (N)
Maltese: Total (N) sEPO fl-iskrinjar <200 mU/ml (N)
English: • porphyria (a rare blood disorder)
Maltese: • porfirja (disturb tad-demm rari)
English: Retacrit contains phenylalanine
Maltese: Retacrit fih phenylalanine
English: Do not use Retacrit:
Maltese: Tużax Retacrit:
English: The solution contains 3 333 IU epoetin zeta per ml.
Maltese: Is-soluzzjoni fiha 3,333 IU epoetin zeta kull ml.
English: INTERMEDIATE CARTON (WITHOUT BLUE BOX) COMPONENT OF MULTIPACK
Maltese: KARTUNA INTERMEDJA (MINGĦAJR KAXXA BLU) KOMPONENT TA' PAKKETT MULTIPLU
English: A less defined profile was observed for RBCs and haemoglobin.
Maltese: Ġie osservat profil inqas definit għar-RBCs u l-emoglobina.
English: Frequency estimate: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1 000 to <1/100); rare (>1/10 000 to <1/1 000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (>1/10); komuni (>1/100 sa <1/10); mhux komuni (>1/1,000 sa <1/100); rari (>1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli).
English: Epoetin zeta is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way.
Maltese: Epojetin zeta hija kopja tal-proteina umana eritropojetin (e-rit-ro-po-ee-tin) u taġixxi bl-istess mod.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13 933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10 441 patients).
Maltese: Meta-analiżi tat-tagħrif tas-sopravivenza globali rriżultat fi stima ta' punt ta' proporzjon ta' riskju relattiv ta' 1.06 favur il-kontrolli (95% CI: 1.00, 1.12; 53 prova u 13,933 pazjent) u għal pazjenti bil-kanċer li jirċievu kimoterapija, il-proporzjon ta' riskju ta' sopravivenza globali kien ta' 1.04 (95% CI: 0.97, 1.11; 38 prova u 10,441 pazjent).
English: At the final analysis, 1 653 deaths were reported.
Maltese: Flanaliżi finali, ġew irrappurtati 1,653 mewta.
English: Contains phenylalanine, see leaflet for further information.
Maltese: Fih phenylalanine, ara l-fuljett ta' tagħrif għal aktar informazzjoni.
English: Significantly fewer patients received RBC transfusions in the epoetin alfa plus SOC arm (5.8% versus 11.4%); however, significantly more patients had thrombotic vascular events in the epoetin alfa plus SOC arm (2.8% versus 1.4%).
Maltese: B'mod sinifikanti, inqas pazjenti rċivew trasfużjonijiet ta' RBC filfergħa ta' epoetin alfa u SOC (5.8% kontra 11.4%); madankollu, b'mod sinifikanti aktar pazjenti kellhom avvenimenti vaskulari trombotiċi fil-fergħa ta' epoetin alfa u SOC (2.8% kontra 1.4%).
English: Sixteen percent of epoetin alfa 300 IU/kg, 23% of epoetin alfa 100 IU/kg and 45% of placebo-treated patients required transfusion.
Maltese: Sittax fil-mija ta' epoetin alfa 300 IU/kg, 23% ta' epoetin alfa 100 IU/kg u 45% tal-pazjenti kkurati bil-plaċebo kienu jeħtieġu trasfużjoni.
English: Following intravenous administration of erythropoietin in subjects with chronic renal failure, the volume of distribution ranged from 57-107 mL/kg after single dosing (12 IU/kg) to 42-64 mL/kg after multiple dosing (48-192 IU/kg), respectively.
Maltese: Wara għoti ġol-vini ta' eritropoetina f'individwi b'falliment kroniku tal-kliewi, il-volum ta' distribuzzjoni varja minn 57-107 mL/kg wara dożaġġ wieħed (12 IU/kg) sa 42-64 mL/kg wara dożaġġ multiplu (48-192 IU/kg), rispettivament.
English: • have severe disorders of the veins and arteries
Maltese: • għandek disturbi gravi tal-vini u l-arterji
English: Pharmacotherapeutic group: Other antianaemic preparations, erythropoietin ATC code: B03XA01
Maltese: Kategorija farmakoterapewtika: Preparazzjonijiet antianemiċi oħra, eritropojetin Kodiċi ATC:
English: Patients were stratified according to their baseline haemoglobin (≤ 10 g/dL, >10 to ≤ 13 g/dL and >13 g/dL).
Maltese: Il-pazjenti ġew stratifikati skont l-emoglobina tagħhom fil-linja bażi (≤ 10 g/dL, >10 sa ≤ 13 g/dL u >13 g/dL).
English: After single doses (20 000 to 160 000 IU subcutaneously) of epoetin alfa, a dose-dependent response was observed for the pharmacodynamic markers investigated including: reticulocytes, RBCs, and haemoglobin.
Maltese: Wara dożi waħdanin (20 000 sa 160 000 IU taħt il-ġilda) ta' epoetin alfa, ġie osservat rispons dipendenti fuq id-doża għall-markaturi farmakodinamiċi li ġew investigati li jinkludu: retikuloċiti, RBCs, u emoglobina.
English: • an observed 9% increase in risk for PD or death in the epoetin zeta plus SOC group from a primary analysis and a 15% increased risk that cannot be statistically ruled out in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 10 to 12 g/dL (6.2 to 7.5 mmol/L).
Maltese: • żieda osservata ta' 9% fir-riskju għal PD jew mewt fil-grupp ta' epoetin zeta u SOC minn analiżi primarja u riskju miżjud ta' 15% li ma jistax jiġi statistikament eskluż f'pazjenti b'kanċer tassider metastatiku li jirċievu kimoterapija mta tingħata biex tinkiseb medda tal-konċentrazzjoni talemoglobina ta' 10 sa 12 g/dL (6.2 sa 7.5 mmol/L).
English: The median age of patients enrolled in the study was 11.6 years (range 0.5 to 20.1 years).
Maltese: L-età medjana tal-pazjenti rreġistrati flistudju kienet ta' 11.6 snin (medda 0.5 sa 20.1 snin).
English: The solution contains 40 000 IU epoetin zeta per ml.
Maltese: Is-soluzzjoni fiha 40,000 IU epoetin zeta kull ml.
English: Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects.
Maltese: Minn total ta' 3,417-il individwu f'25 studju każwali bi plaċebo jew kura standard bħala kontroll, double-blinded, il-profil tas-sikurezza globali ta' epoetin alfa kien valutat f'2094 individwu anemiku.