FrancophonIA/ELRC3.0 huggingface dataset:
English: * Significantly associated with Extavia treatment for RRMS, p <0.05 ° Significantly associated with Extavia treatment for SPMS, p <0.05 § Injection site reaction (various kinds) comprises all adverse events occurring at the injection site, i.e. the following terms: injection site haemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site oedema, and injection site atrophy & “Flu-like symptom complex” denotes flu syndrome and/or a combination of at least two adverse events from fever, chills, myalgia, malaise, sweating.
Maltese: Reazzjoni fil-lok ta' injezzjoni (diversi tipi) li tikkonsisti minn każijiet avversi li jseħħu fil-lok ta linjezzjoni, i.e. it-termini li ġejjin: emorraġija fil-lok ta' l-injezzjoni, sensittività eċċessiva fil-lok ta' linjezzjoni, massa fil-lok ta' l-injezzjoni, nekrosi fil-lok ta' l-injezzjoni, uġigħ fil-lok ta'l -injezzjoni, reazzjoni fil-lok ta' l-injezzjoni, edema fil-lok ta' l-injezzjoni, u atropija fil-lok ta' l-injezzjoni & “Kumpless tas-sintomi bħal ta' l-influwenza” jindika s-sindrome ta' l-influwenza u/jew kombinazzjoni ta' lanqas żewġ reazzjonijiet avversi minn deni, sirdat, mijalġija, telqa u ħruġ ta' għaraq.
English: Limited information available on the transfer of interferon beta-1b into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1b excreted in human milk are negligible.
Maltese: L-informazzjoni limitata dwar it-trasferiment ta' interferon beta-1b fil-ħalib tas-sider, flimkien malkaratteristiċi kimiċi / fiżjoloġiċi ta' interferon beta, jissuġġerixxu li l-livelli ta' interferon beta-1b li jgħaddi għall-ħalib tal-bniedem huma negliġibbli.
English: Vascular disorders Vasodilatation
Maltese: Disturbi vaskulari
English: ► Injection site reactions.
Maltese: ► Reazzjonijiet fis-sit ta' l-injezzjoni.
English: After 3 years, a pre-planned interim analysis showed EDSS progression (confirmed increase in EDSS of greater than or equal to 1.0 compared to baseline) occurred in 24% of the patients in the delayed treatment group compared to 16% in the immediate treatment group [Hazard Ratio = 0.6, 95% confidence interval (0.39, 0.92), p=0.022].
Maltese: Wara 3 snin, analiżi li kienet ippjanata minn qabel fl-intervall uriet li l-avvanz ta' l-EDSS (żieda konfermata fl-EDSS ta' aktar jew ugwali għall-1.0 meta mqabbla mal-linja bażi) seħħ f'24% talpazjenti fil-grupp li dam biex jibda l-kura meta mqabbel ma' 16% fil-grupp li ngħata l-kura immedjatament [Proporzjon tal-Periklu = 0.6, 95% confidence interval (0.39, 0.92), p=0.022].
English: 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.
Maltese: Wara r-rikostituzzjoni, kull ml fih 250 mikrogramma (8.0 miljun IU) ta' interferon beta-1b rikombinant.
English: The robustness of the treatment effect was also shown by the delay of progression to multiple sclerosis according to the McDonald criteria.
Maltese: Ir-robustezza ta' l-effett tat-trattament ġiet murija wkoll bid-dewmien fil-firxa ta' sklerożi multipla skond il-kriterji ta' McDonald.
English: Extavia should be used with caution with: - medicines which need a certain liver enzyme system (known as cytochrome P450 system) for their removal from the body, for example medicines used to treat epilepsy (such as phenytoin).
Maltese: Extavia għandu jintuża b'kawtela ma': - mediċini li jeħtieġu ċertu sistema ta' enzimi tal-fwied (magħrufa bħala s-sistema taċ ċitokromju P450) għat-tneħħija tagħhom mill-ġisem, pereżempju mediċini użati fil-kura ta' l epilessija (bħal phenytoin) - mediċini li jaffettwaw il-produzzjoni taċ-ċelluli tad-demm.
English: After reconstitution, each millilitre contains 250 microgram (8.0 million IU) interferon beta-1b.
Maltese: Wara r-rikostituzzjoni, kull millilitru jkun fih 250 mikrogramma (8.0 miljun IU) interferon beta-1b.
English: Abdominal pain °
Maltese: Uġigħ addominali
English: VIAL LABEL
Maltese: Koxxa taxXellug
English: Problems with your small blood vessels (capillaries) may develop (systemic capillary leak syndrome) when using medicines like Extavia.
Maltese: Tista' tiżviluppa problemi fil-kanali ż-żgħar tad-demm (kapillari) tiegħek (sindrome ta' tnixxija kapillari sistemika) meta tuża mediċini bħal Extavia.
English: Class label for interferon beta products (see section 4.4).
Maltese: Tikketta tal-klassi għall-prodotti beta interferon (ara sezzjoni 4.4). **Tikketta tal-klassi għall-prodotti interferon, ara taħt “Ipertensjoni arterjali tal-pulmun”.
English: D) Making the injection manually (to make an injection with the ExtaviPro 30G autoinjector, refer to the instructions for use provided with the auto-injector)
Maltese: D) Kif tagħmel l-injezzjoni manwalment (biex taghmel l-injezzjoni bl-ExtaviaPro 30G l-autoinjector, irreferi ghall-istruzzjonijiet ghal użu ipprovduti ma' l-auto-injector)
English: You will find that within a few weeks your treatment will become a natural part of your routine.
Maltese: Dan jista' jseħħ minn bosta ġimgħat sa bosta snin wara li tibda tieħu Extavia.
English: - the number of platelets (which help the blood to clot) may fall (thrombocytopenia), - a certain type of blood fats (triglycerides) may increase (will show up in blood tests), see section 2 “Warnings and precautions”, - suicide attempts, - mood swings, - convulsion, - a specific liver enzyme (gamma GT) which is produced by your liver, may rise (this will show up in blood tests), - inflammation of the liver (hepatitis), - skin discolouration.
Maltese: - l-għadd tal-plejtlits (li jgħinu lid-demm jagħqad) jista' jinżel (tromboċitopenija), - jistgħu jiżdiedu ċertu tipi ta' xaħmijiet fid-demm (trigliċeridi) (dawn joħorġu fit-testijiet tad demm), ara taqsima 2 “Twissijiet u prekawzjonijiet”, - attentati ta' suwiċidju, - tibdil fil-burdata, - konvulżjoni, - jista' jiżdied enzim speċifiku tal-fwied (Gamma GT) prodott mill-fwied, (dan joħroġ fit-testijiet tad-demm), - infjammazzjoni tal-fwied (epatite), - telf fil-kulur tal-ġilda.
English: Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Maltese: Pazjenti li bħalissa għandhom dipressjoni qawwija u/jew ħsibijiet ta' suwiċidju (ara sezzjonijiet 4.4 u 4.8).
English: Patients with monofocal or multifocal onset of the disease were included (i.e. patients with clinical evidence of a single or at least two lesions, respectively, of the central nervous system).
Maltese: Pazjenti bil-marda monofokali jew b'bidu monofokali ġew inklużi (i.e. pazjenti b'xhieda klinika ta' ferita waħda jew ta' lanqas tnejn, rispettivament tassistema nervuża ċentrali).
English: - If you have ever had seizures or if you are taking medicines to treat epilepsy (antiepileptics), you doctor will monitor your treatment carefully (see also “Other medicines and Extavia” and section 4, “Possible side effects”).
Maltese: - Jekk qatt kellek aċċessjonijiet jew jekk qed tieħu mediċini li jikkuraw l-epilessija (antiepilettiċi), it-tabib tiegħek ser jimmonitorja l-kura tiegħek b'attenzjoni (ara wkoll sezzjoni “Mediċini oħra u Extavia” u sezzjoni 4. “Effetti sekondarji possibbli”).
English: ► Flu-like symptoms such as fever, chills, painful joints, malaise, sweating, headache, or muscular pain.
Maltese: ► Sintomi li jixbħu lil dawk ta' l-influwenza bħal deni, tkexkix ta' bard, uġigħ fil-ġogi, telqa, għaraq, uġigħ ta' ras jew uġigħ fil-muskoli.
English: Hyperthyroidism, Thyroid disorders
Maltese: L-antikorpi newtralizzanti mhumiex prodotti filpazjenti kollha.
English: There have been reports of thrombocytopenia, with profound decreases in platelet count.
Maltese: Toħroġx l-adattur tal-kunjett mill-kontenitur.
English: 7 - Discard the syringe in the disposal unit.
Maltese: Extavia innifsu ma jaffettwax il-qalb direttament.
English: EMA/638722/2014 EMEA/H/C/001046
Maltese: EMEA/H/C/001046
English: The full EPAR for Tepadina 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 summary of the opinion of the Committee for Orphan Medicinal Products for Tepadina can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Tepadina jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In adults, the daily dose ranges from 120 to 481 mg per square metre (m2) given for up to five days before transplantation.
Maltese: Fl-adulti, id-doża ta' kuljum tvajra minn 120 sa 481 mg kull metru kwadru (m2) mogħtija għal mhux aktar minn ħamest ijiem qabel it-trapjant.
English: The most common side effects seen with Tepadina when used with other medicines are infections, cytopenia (low number of cells in the blood), graft-versus-host disease (when the transplanted cells attack the body), disorders of the gut, haemorrhagic cystitis (bleeding and inflammation in the bladder) and mucosal inflammation (inflammation of the moist body surfaces).
Maltese: L-effetti sekondarji l-aktar komuni li dehru b'Tepadina meta użat ma' mediċini oħrajn huma infezzjonijiet, ċitopenija (numru baxx ta' ċelloli fid-demm), mard graft-versus-host (meta ċ-ċelloli trapjantati jattakkaw lill-ġisem), disturbi tal-imsaren, ċistite emorraġika (nixxiegħa ta' demm u infjammazzjoni tal-bużżieqa tal-awrina) u infjammazzjoni mukożali (infjammazzjoni tas-superfiċje niedja tal-ġisem).
English: It contains the active substance thiotepa.
Maltese: Fih is-sustanza attiva tjotepa.
English: In children, the daily dose ranges from 125 to 350 mg/m2 given for up to three days before transplantation.
Maltese: Fittfal, id-doża ta' kuljum tvajra minn 125 sa 350 mg/m2 mogħtija għal mhux aktar minn tlett ijiem qabel it-trapjant.
English: This is a summary of the European Public Assessment Report (EPAR) for Tepadina.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tepadina.
English: The active substance in Tepadina, thiotepa, belongs to a group of medicines called ‘alkylating agents'.
Maltese: Is-sustanza attiva f'Tepadina, it-tjotepa, taħmel parti minn grupp ta' mediċini msejħin ‘sustanzi alkilanti'.
English: Tepadina thiotepa
Maltese: Kif jintuża Tepadina?
English: The CHMP noted that the active substance in Tepadina, thiotepa, has a well established used.
Maltese: Is-CHMP innota li s-sustanza attiva f'Tepadina, it-tjotepa, għandha użu stabbilit sew.
English: Because the number of patients in the European Union (EU) that undergo this type of conditioning and transplant is low, Tepadina was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 January 2007.
Maltese: Minħabba li n-numru ta' pazjenti fl-Unjoni Ewropea (UE) li jsirulhom dan it-tip ta' kondizzjonament u trapjant huwa baxx, Tepadina ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fid29 ta' Jannar 2007.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tepadina on 15 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Tepadina valida fl-Unjoni Ewropea kollha fil-15 ta' Marzu 2010.
English: Tepadina is a powder that is made up into a solution for infusion (drip into a vein).
Maltese: Tepadina huwa trab magħmul f'soluzzjoni għal infuzjoni (dripp ġo vina).
English: Tepadina is used in combination with chemotherapy (medicines to treat cancer) in two ways:
Maltese: Tepadina jintuża f'kombinazzjoni ma' kimoterapija (mediċini għall-kura tal-kanċer) f'żewġ modi:
English: What is the risk associated with Tepadina?
Maltese: X'inhu r-riskju assoċjat ma' Tepadina?
English: This included 109 studies involving around 6,000 adults and 900 children with blood diseases or solid tumours, who were having a transplant of blood-making cells.
Maltese: Dan kien jinkludi 109 studji li kienu jinvolvu madwar 6,000 adult u 900 tifel u tifla b'mard fid-demm jew tumuri solidi, li kienu sejrin jirċievu trapjant ta' ċelloli li jagħmlu d-demm.
English: Why has Tepadina been approved?
Maltese: Għaliex ġie approvat Tepadina?
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku tjotepa
English: The Committee decided that, based on available published information, Tepadina's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: IlKumitat iddeċieda li, abbażi tal-informazzjoni ppubblikata disponibbli, il-benefiċċji ta' Tepadina huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awotrizzazzjoni għat-tqegħid fis-suq.
English: Other information about Tepadina
Maltese: Informazzjoni oħra dwar Tepadina
English: The published studies showed that thiotepa used in combination with other chemotherapy medicines is beneficial to adults and children being treated for blood diseases and solid tumours.
Maltese: L-istudji ppubblikati wrew li t-tjotepa użata f'kombinazzjoni ma' mediċini ta' kimoterapija oħrajn hija ta' benefiċċju għall-adulti u t-tfal li jkunu qed jiġu kkurati għal mard tad-demm u tumuri solidi.
English: What is Tepadina?
Maltese: X'inhu Tepadina?
English: • during the treatment of solid tumours when high-dose chemotherapy followed by transplantation of haematopoietic progenitor cells is needed.
Maltese: • matul il-kura ta' tumuri solidi meta hija meħtieġa kimoterapija b'doża għolja segwita bi trapjant ta' ċelloli ematopojetiċi proġenitriċi.
English: EMA/729989/2014 EMEA/H/C/001128
Maltese: EMEA/H/C/001128
English: The full EPAR for Temozolomide Sandoz 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: Temozolomide Sandoz is a ‘generic medicine'.
Maltese: Temozolomide Sandoz huwa ‘mediċina ġenerika'.
English: The dose of Temozolomide Sandoz depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Maltese: Id-doża tat-Temozolomide Sandoz tiddependi mis-superfiċje tal-ġisem (ikkalkolati mit-tul u l-piż talpazjent) u tvarja minn 75 sa 200 mg għal kull metru kwadru, darba kuljum.
English: Temozolomide Sandoz temozolomide
Maltese: Temozolomide Sandoz temożolomur
English: This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Sandoz.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Temozolomide Sandoz.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Sandoz has been shown to have comparable quality and to be bioequivalent to Temodal.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Temozolomide Sandoz wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Temodal.
English: Other information about Temozolomide Sandoz
Maltese: Informazzjoni oħra dwar Temozolomide Sandoz
English: The active substance in Temozolomide Sandoz, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Maltese: Is-sustanza attiva f'Temozolomide Sandoz, it-temożolomur, tappartjeni għal grupp ta' mediċini ta' kontra l-kanċer li jissejħu aġenti alkilanti.
English: Temozolomide Sandoz is an anticancer medicine.
Maltese: Temozolomide Sandoz huwa mediċina kontra l-kanċer.
English: Because Temozolomide Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Maltese: Billi Temozolomide Sandoz huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Temodal.
English: Temozolomide Sandoz is a medicine that contains the active substance temozolomide.
Maltese: Temozolomide Sandoz huwa mediċina li fiha s-sustanza attiva t-temożolomur.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Sandoz on 15 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Temozolomide Sandoz valida madwar l-Unjoni Ewropea kollha fil-15 ta' Marzu 2010.
English: Because Temozolomide Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Temozolomide Sandoz huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: What is Temozolomide Sandoz?
Maltese: Għal xiex jintuża Temozolomide Sandoz?
English: What are the benefit and risk of Temozolomide Sandoz?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Temozolomide Sandoz?
English: Why has Temozolomide Sandoz been approved?
Maltese: Għaliex ġie approvat Temozolomide Sandoz?
English: This means that Temozolomide Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Maltese: Dan ifisser li Temozolomide Sandoz jixbah lill‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Temodal.
English: As a result, the cancer cells cannot divide, slowing down the growth of tumours.
Maltese: Għaldaqstant, iċ-ċelloli tal-kanċer ma jkunux jistgħu jinqasmu, u dan inaqqas ir-ritmu tat-tkabbir tattumuri.
English: How has Temozolomide Sandoz been studied?
Maltese: Kif ġie studjat Temozolomide Sandoz?
English: 37 Hollands Road Haverhill, Suffolk CB9 8PU United Kingdom
Maltese: 37 Hollands Road Haverhill, Suffolk CB9 8PU
English: Rescue patients
Maltese: Pazjenti Rescue
English: female (kg):
Maltese: nisa (kg):
English: What Mozobil contains - The active substance is plerixafor.
Maltese: X'fih Mozobil - Is-sustanza attiva hi plerixafor.
English: Fixed 20 mg (n=30) 0.24 mg/kg (n=31) Ratio (90% CI)
Maltese: Fiss 20 mg (n=30) 0.24 mg/kg (n=31) Proporzjon (90% CI)
English: Or Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Maltese: Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, L-Irlanda
English: 45.5 + 2.3 x ((Height (cm) x 0.394) - 60).
Maltese: 45.5 + 2.3 x ((Tul (ċm) x 0.394) - 60).
English: 50 + 2.3 x ((Height (cm) x 0.394) - 60);
Maltese: 50 + 2.3 x ((Tul (ċm) x 0.394) - 60);
English: Elderly patients (> 65 years old)
Maltese: Pazjenti anzjani (> 65 sena)
English: SDF-1α and CXCR4 play major roles in embryo-foetal development.
Maltese: SDF-1α u CXCR4 għandhom rwol importanti fl-iżvilupp embrijo-fetali.
English: Manufacturer Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.
Maltese: Manifattur Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Ir-Renju Unit.
English: The elimination half-life (t1/2) in plasma is 3-5 hours.
Maltese: Il-half-life tal-eliminazzjoni (t1/2) fil-plażma hi ta' 3-5 sigħat.
English: In in vitro studies with human hepatocytes, plerixafor does not induce CYP1A2, CYP2B6, and CYP3A4 enzymes.
Maltese: Fi studji in vitro b'epatoċiti umani, plerixafor ma jistimulax l-enzimi CYP1A2, CYP2B6, u CYP3A4.
English: The trial was conducted in patients weighing 70 kg or less (median: 63.7 kg , min: 34.2 kg, max: 70 kg).
Maltese: Il-prova saret f'pazjenti li jiżnu 70 kg jew inqas (medjan: 63.7 kg , min: 34.2 kg, max: 70 kg).
English: Magyarország SANOFI-AVENTIS Zrt.
Maltese: SANOFI-AVENTIS Zrt.
English: Plerixafor is moderately bound to human plasma proteins up to 58%.
Maltese: Plerixafor jeħel b'mod moderat mal-proteini fil-plażma tal-bniedem sa 58%.
English: Plerixafor is not metabolised in vitro using human liver microsomes or human primary hepatocytes and does not exhibit inhibitory activity in vitro towards the major drug-metabolising CYP450 enzymes (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5).
Maltese: In vitro, Plerixafor mhuwiex immetabolizzat permezz ta' mikrosomi mill-fwied uman jew epatoċiti primarji umani u ma jurix attività inibitorja in vitro lejn l-enzimi maġġuri CYP450 li jimmetabolizzaw il-mediċina (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, u 3A4/5).
English: A risk to the suckling child cannot be excluded.
Maltese: Riskju għat-tarbija li tkun qed terda' mhux eskluż.
English: Adult patients
Maltese: Pożoloġija Adulti
English: Thirty patients were treated with 0.24 mg/kg of Mozobil in an open label, multicenter, controlled study (DFI 12860) (see section 5.1).
Maltese: Tletin pazjent ġew ittrattati b'0.24 mg/kg ta' Mozobil f'studju kkontrollat,open-label u multiċentriku (DFI 12860) (see section 5.1).
English: Adult
Maltese: Pazjenti adulti
English: Efficacy endpoint b
Maltese: Endpoint tal-effikaċja b
English: Clear, colourless to pale yellow solution, with a pH of 6.0-7.5 and an osmolality of 260 - 320 mOsm/kg.
Maltese: Soluzzjoni ċara, bla kulur jew ta' kulur isfar ċar, b'pH ta' 6.0-7.5 u osmolalità ta' 260-320 mOsm/kg.
English: In the two placebo-controlled clinical studies of plerixafor, 24% of patients were ≥ 65 years old.
Maltese: Fiż-żewġ studji kliniċi ta' plerixafor, ikkontrollati bil-plaċebo, 24% tal-pazjenti kellhom ≥ 65 sena.
English: Geometric Mean AUC
Maltese: Medja Ġeometrika AUC
English: Rarely, gastrointestinal side effects may be severe (diarrhoea, vomiting, stomach pain and nausea).
Maltese: Rarament, l-effetti sekondarji gastrointestinali jistgħu jkunu severi (dijarea, rimettar, uġigħ fl-istonku u nawseja).
English: Mean (SD)
Maltese: Medjan Medja (SD)
English: Date of first authorisation: 31 July 2009 Date of latest renewal: 11 April 2014
Maltese: Data tal-aħħar tiġdid: 11 ta' April 2014
English: • In children age 1 to less than 18 years of age with lymphoma or solid tumours.
Maltese: • Fi tfal minn età ta' sena sa inqas minn 18-il sena b'limfoma jew tumuri solidi.
English: Patients achieving ≥ 5 x 10
Maltese: Pazjenti li kisbu ≥ 5 x 10
English: Uncommon Allergic reaction* Anaphylactic reactions, including anaphylactic shock (see section 4.4) **
Maltese: Mhux komuni Reazzjoni allerġika* Reazzjonijiet anafilattiċi li jinkludu xokk anafilattiku (ara sezzjoni 4.4)**
English: In the two Phase III studies in non-Hodgkin's lymphoma and multiple myeloma patients (AMD3100-3101 and AMD3100-3102, respectively), a total of 301 patients were treated in the Mozobil and G-CSF group and 292 patients were treated in the placebo and G-CSF group.
Maltese: III f'pazjenti b'limfoma mhux ta' Hodgkin u b'majeloma multipla (AMD3100-3101 u AMD3100-3102, rispettivament), total ta' 301 pazjenti kienu kkurati fil-grupp ta' G-CSF u Mozobil u 292 pazjent kienu kkurati fil-grupp tal- plaċebo u G-CSF.
English: * The frequency of allergic reactions presented is based on adverse reactions that occurred in the oncology studies (679 patients).
Maltese: * Il-frekwenza ta' reazzjonijiet allerġiċi ppreżentati hi bbażata fuq reazzjonijiet avversi li seħħew fl-istudji talonkoloġija (679 pazjent).
English: The efficacy and safety of Mozobil were evaluated in an open label, multi-center, controlled study in paediatric patients with solid tumors (including neuroblastoma, sarcoma, Ewing sarcoma) or lymphoma who were eligible for autologous hematopoietic stem cell transplantation (DFI12860).
Maltese: L-effikaċja u s-sigurtà ta' Mozobil ġew evalwati f'studju kkontrollat, open-label u multiċentriku f'pazjenti pedjatriċi b'tumuri solidi (inklużi newroblastoma, sarkoma, sarkoma ta' Ewing) jew limfoma li kienu eliġibbli għal trapjant ta' ċelluli staminali ematopojetiċi awtologi (DFI12860).
English: Each ml contains approximately 5 mg (0.2 mmol) of sodium.
Maltese: Kull ml fih madwar 5 mg (0.2 mmol) ta' sodium.