FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary was last updated in 04-2013.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f' 04-2013.
English: In 2012 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1 Ovis to convert to normal.
Maltese: Fl-2012 is-CVMP qies li d-dejta mressqa kienet adegwata biex l-awtorizzazzjoni ta' Zulvac 1 Ovis issir normali.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zulvac 1 Ovis exceed the risks in the prevention of viraemia caused by Bluetongue Virus, serotype 1 in sheep from one and a half months of age.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) kkonkluda li l-benefiċċji tal-użu ta' Zulvac 1 Ovis jisbqu lir-riskji fil-prevenzjoni tal-viremija kkawżata mis-serotip 1 tal-Vajrus talLingwablu f'nagħaġ minn xahar u nofs 'l fuq.
English: Inactivated vaccine against Bluetongue disease virus, serotype 1
Maltese: Vaċċin inattivat kontra l-marda tal-vajrus tal-Lingwablu, serotip 1
English: The animals were challenged with bluetongue virus serotype 1, after receiving Zulvac 1 Bovis vaccine containing different amounts of virus.
Maltese: Lannimali ngħataw bi sfida sperimentali s-serotip 1 tal-vajrus tal-lingwablu wara li kienu ngħataw ilvaċċin Zulvac 1 Bovis b'diversi dożi tal-vajrus.
English: Zulvac 1 Ovis is a vaccine.
Maltese: Zulvac 1 Ovis huwa vaċċin.
English: The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality and safety of the vaccine.
Maltese: Ewropea għall-Mediċini (EMA) rrevediet informazzjoni addizzjonali li tressqet skont skeda maqbula dwar il-kwalità, is-sigurtà u l-effikaċja tal-vaċċin.
English: Zulvac 1 Ovis is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Maltese: Zulvac 1 Ovis jintuża fin-nagħaġ biex jipproteġihom kontra l-marda tal-lingwablu, li hija infezzjoni kkawżata mill-vajrus tal-lingwablu li jiġi trażmess mill-insetti dipteri.
English: What is the risk associated with Zulvac 1 Ovis?
Maltese: X'riskji huma assoċjati ma' Zulvac 1 Ovis?
English: What is Zulvac 1 Ovis?
Maltese: X'inhu Zulvac 1 Ovis?
English: How has Zulvac 1 Ovis been studied?
Maltese: Kif ġie studjat Zulvac 1 Ovis?
English: When it is given to sheep, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf lill-vajrus bħala ‘barrani' u tipproduċi antikorpi kontrih.
English: Zulvac 1 Ovis is a vaccine that is available as a suspension for injection.
Maltese: Zulvac 1 Ovis huwa vaċċin li jiġi f'sospensjoni għal inezzjoni.
English: B.V. Kloosterstraat 6 5349 AB Oss The Netherlands
Maltese: Aspen Oss B.V. Kloosterstraat 6 5349 AB Oss Olanda
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/018/001
Maltese: EU/2/00/018/001
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidot),(jekk ikun hemm bżonn)
English: Date of last renewal: March 2010
Maltese: Marzu 2010
English: 4.6 Adverse reactions (frequency and seriousness)
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza u gravita)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Maltese: Intervet International B.V.
English: Amylopectin Potato starch Magnesium stearate Lactose
Maltese: Lamtu tal-patata Stirejt tal-magneżju
English: See also 4.3 Contraindications.
Maltese: Ara wkoll sezzjoni 4.3 kontra indikazzjonijiet
English: One blister contains 30 tablets.
Maltese: Kull strixxa fiha 30 pillola.
English: After oral administration Estriol is nearly completely absorbed from gastrointestinal tract.
Maltese: Wara amministrazzjoni mill-ħalq Estriol huwa kważi kompletament assorbit minn organu gastrointestinali.
English: 8 MARKETING AUTHORISATION NUMBER(S) EU/2/00/018/001
Maltese: Numru ta' Awtorizzazzjoni biex jitpoġġa fis-Suq EU/2/00/018/001
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: INTERVET INTERNATIONAL B.V WIM DE KORVERSTRAAT 35 5831 AN BOXMEER OLANDA
English: The minimum dose given should not be less than 0.5 mg per dog per day.
Maltese: L- inqas doża qatt ma għanda tkun inqas minn 0.5 milligrammi għal kull kelba kuljum.
English: Nearly the whole Estriol is bound to Albumin in Plasma.
Maltese: Kważi l-kwantita kollha ta' Estriol hija mwaħħla mal-albumina fil-plasma.
English: The incidence is about 59 %.
Maltese: L-inċidenza hija ta' madwar 5 - 9%.
English: STATEMENT OF ACTIVE AND OTHER SUBTANCES Active substance: estriol 1 mg/tablet
Maltese: Sustanza attiva :Estriol 1mg / pillola
English: 1 mg/tablet For a full list of excipients, see section 6.1
Maltese: Għall-lista sħiħa ta' sustanzi mhux attivi, ara sezzjoni 6.1
English: Animals should be re-examined every 6 months during treatment.
Maltese: Il- kelba għandha tiġi eżaminata kull 6 xhur waqt it-trattament.
English: Pharmacotherapeutic group: estrogens, ATCvet code: QG03CA04.
Maltese: F'każ ta' effetti estroġeniċi, id- doża għandha titnaqqas.
English: Dog.
Maltese: Xejn.
English: Dogs (bitches).
Maltese: Jiskadi {xahar / sena}
English: NAME OF THE VETERINARY MEDICINAL PRODUCT INCURIN 1 mg tablet
Maltese: VETERINARJU Incurin pilloli ta' milligramma
English: ANNEX II A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIOLOĠIKA(ĊI) ATTIVA(I) U> SID(/S-SIDIEN TA') L-AWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: 4.9 Amount(s) to be administered and administration route
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazjoni
English: 5.2 Pharmacokinetic particulars
Maltese: .2 KWALITAJIET FARMAKOKINETIĊI
English: This is probably due to the short-acting oestrogenic character of estriol.
Maltese: F'kazi ta' dożi eċċessivi se jkun hemm effetti tipiċi estroġeniċi.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Korverstraat 35 5831 AN Boxmeer The Netherlands
English: In ovarioectomised female dogs it has a beneficial effect on urinary incontinence.
Maltese: F'kelbat li tneħħewlhom l-ovarji għandu effett benefiku fuq il-inkontinenza urinarja.
English: Oestrogenic effects such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog.
Maltese: Effetti ħfief estroġeniċi, bħal vulva u sider minfuħ, namra żejda u remettar ġew osservati fl-ogħla doża ta 2 mg kull kelb.
English: BATCH NUMBER Batch number.
Maltese: Amministrazjoni mill-ħalq.
English: 6.5 Nature and composition of immediate packaging Blister package of clear PVC film backed by aluminium foil provided with heat seal coating (vinyl copolymer) on the side in contact with the tablets.
Maltese: In-natura tal-materjal tal-kontenitur u ta' dak li hemm ġo fih Strixxi ta' PVC ċar u minn wara b'folja tal-aluminjum b'kisja ssiġillata ta' (vinyl copolymer) fin-naħa ta' fejn imissu l-pinnoli.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Klassi farmakoterapewtika: estoġeni Kodici ATĊ veterinarja:
English: PACKAGE SIZE Carton box with 1 blister.
Maltese: Kaxxa tal-kartun bi strixxa waħda.
English: INDICATION
Maltese: PAKKETT
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza(i) bioloġika(ċi) attiva(i)
English: Treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs.
Maltese: Trattament ta' inkontinenza dipendenti fuq l-ormoni fi klieb femminili, minħabba sfinkter li m'għadux tajjeb.
English: PACKAGE LEAFLET INCURIN 1 mg tablet
Maltese: Incurin pillola ta'milligramma
English: 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Sustanzi mhux attivi Amilopektin
English: 4.2 Indications for use, specifying the target species The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches.
Maltese: Klieb li juru sintomi ta' għatx u urinar kontinwu m'għandhomx jiġu trattati bl-Incurin.
English: METHOD AND ROUTE OF ADMINISTRATION For oral administration.
Maltese: METODU U MOD TA' AMMINISTRAZZJONI Mill-ħalq
English: Aspen Oss.
Maltese: Twissijiet speċjali.
English: High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands).
Maltese: Dożi għolja ta' estroġeni, jistgħu jikkawżaw tumuri f'organi li jaħdmu fuqhom l-estroġeni (bħal fissider).
English: PHARMACEUTICAL FORM Tablet.
Maltese: VETERINARJU Pilloli
English: Estriol is a short-acting natural oestrogen.
Maltese: Estriol huwa estroġenu naturali li jaħdem għal żmien qasir.
English: 1 mg/tablet
Maltese: Incurin pilloli ta' milligramma
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Active substance: estriol
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Maltese: U L-INDIRIZZ TAS-SID TA' L- AWTORIZZAZJONI TAL-MANIFATTURA RESPONSABBLI, JEKK HUWA DIFFERENTI
English: EXPIRY DATE (Month / year)
Maltese: DATA TA' SKADENZA {xahar/sena}
English: A. LABELLING
Maltese: MANIFATTURA(I)
English: Infection, sepsis
Maltese: Infezzjoni, sepsis
English: Respiratory tract infection
Maltese: Infezzjoni tal-apparat respiratorju
English: The total body clearance of dexrazoxane in adults is estimated at 14.4 ± 1.6 l/h.
Maltese: It-tneħħija totali ta' dexrazoxane mill-ġisem fl-adulti jidher li hi ta' 14.4 ± 1.6 l/h.
English: Patients receiving chemotherapy alone (n=157)
Maltese: Pazjenti mogħtija l-kimoterapija biss (n=157)
English: There is limited data on pharmacokinetic interactions with chemotherapeutic agents other than doxorubicin, epirubicin, cyclophosphamide, 5-fluorouracil and paclitaxel.
Maltese: M'hemmx biżżejjed informazzjoni dwar l-interazzjonijiet farmakokinetiċi ma' aġenti kimoterapewtiċi ħlief doxorubicin, epirubicin, cyclophosphamide, 5-fluorouracil u paclitaxel.
English: Vertigo, ear infection
Maltese: Vertigo, infezzjoni tal-widna
English: Neutropenia, thrombocytopenia, febrile neutropenia, granulocytopenia
Maltese: Newtropenija, tromboċitopenija, newtropenija febrili, granuloċitopenija
English: Both dexrazoxane (ICRF-187) and ICRF-198 are capable of chelating metal ions.
Maltese: Kemm dexrazoxane (ICRF-187) u ICRF-198 għandhom effett kelanti fuq il-joni metalliċi.
English: The potential risk for humans is unknown.
Maltese: Ir-riskju li jista' jkun hemm għallbnedmin mhuwiex magħruf.
English: • {(Invented) Name} treatment: a mean dose of 1010 mg/m² (median: 1000 mg/m²) in combination with doxorubicin, and a mean dose of 941 mg/m² (median: 997 mg/m²) in combination with epirubicin.
Maltese: • Kura b'Cardioxane: doża medja ta' 1010 mg/m² (medja: 1000 mg/m²) flimkien ma' doxorubicin, u doża medja ta' 941 mg/m² (medja: 997 mg/m²) flimkien ma' epirubicin.
English: Data from adults treated in 8 controlled randomised clinical studies have been reviewed, 780 patients received dexrazoxane plus chemotherapy and 789 received chemotherapy alone.
Maltese: Saret reviżjoni tal-informazzjoni miġbura minn fost adulti kkurati waqt 8 studji kliniċi randomizzati kkontrollati, fejn 780 pazjent ingħataw dexrazoxane flimkien ma' kimoterapija u 789 ingħataw kimoterapija biss.
English: {(Invented) Name} 500 mg powder for solution for infusion Dexrazoxane
Maltese: {ISEM (IVVINTAT)} 500 mg trab għal soluzzjoni għall-infużjoni Dexrazoxane
English: Anaphylactic reaction, hypersensitivity Metabolism and nutrition disorders Common
Maltese: Reazzjoni anafilattika, sensittività eċċessiva Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: The plasma concentrations declined thereafter with an average half-life value of 2.2 ± 1.2 hours.
Maltese: Minn hemm 'il quddiem il-konċentrazzjonijiet fil-plażma niżlu bilvalur medju tal-half-live ta' 2.2 ± 1.2 sigħat.
English: • Chemotherapy treatment received: 43% single agent epirubicin 120 mg/m²; 33% combination therapy with 50 mg/m² doxorubicin (mainly with 5-fluorouracil and cyclophosphamide); 24% combination therapy with epirubicin at 60 or 90 mg/m² (mainly with 5-fluorouracil and cyclophosphamide).
Maltese: • Kura mogħtija b'kimoterapija: 43% 120 mg/m² epirubicin bħala aġent waħdieni; 33% terapija kkombinata b'50 mg/m² doxorubicin (prinċipalment b'5-fluorouracil u cyclophosphamide); 24% terapija kkombinata b'60 jew 90 mg/m² epirubicin (prinċipalment b'5-fluorouracil u cyclophosphamide).
English: In clinical trials, second primary malignancies, in particular acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS), have been reported in paediatric patients with Hodgkin's disease and acute lymphoblastic leukaemia receiving chemotherapy regimes including several cytotoxics (e.g. etoposide, doxorubicin, cyclophosphamide) (see section 4.8).
Maltese: Waqt provi kliniċi, kienu rrappurtati tumuri malinni sekondarji f'pazjenti pedjatriċi bil-marda ta' Hodgkin u b'lewkimija limfoblastika akuta kkurati bil-kimoterapija inkluż bosta ċitotossiċi (eż. etoposide, doxorubicin, cyclophosphamide) (ara sezzjoni 4.8).
English: Posology {(Invented) Name} is administered by a short intravenous infusion (15 minutes), approximately 30 minutes prior to anthracycline administration at a dose equal to 10 times the doxorubicin-equivalent dose and 10 times the epirubicin-equivalent dose.
Maltese: Pożoloġija {Isem (Ivvintat)} jingħata permezz ta' infużjoni qasira fil-vina (15-il minuta), madwar 30 minuta qabel ma tingħata doża ta' anthracycline li tammonta daqs 10 darbiet d-doża ekwivalenti ta' doxorubicin u 10 darbiet id-doża ekwivalenti ta' epirubicin.
English: Dexrazoxane-containing medicinal products (See Annex I) 500 mg powder for solution for infusion.
Maltese: Dexrazoxane-fih prodotti mediċinali (Ara Anness I) 500 mg trab għal soluzzjoni għall-infużjoni.
English: Dexrazoxane, an analogue of EDTA (ethylene diamine tetra-acetic acid), is hydrolysed in cardiac cells to the ring-opened product ICRF-198.
Maltese: Dexrazoxane, analogu ta' EDTA (ethylene diamine tetra-acetic acid), huwa idrolizzat f'ċelloli tal-qalb permezz tal-prodott ICRF-198 bil-ftuħ taċ-ċiklu.
English: Mucosal inflammation, pyrexia, fatigue, malaise, injection site reaction (including pain, swelling, burning sensation, erythema, pruritus, thrombosis)
Maltese: Infjammazzjoni tal-mukosi, piressija, għeja, telqa, reazzjoni fil-post fejn tingħata l-injezzjoni (inkluż uġigħ, nefħa, sensazzjoni ta' ħruq, eritema, ħakk, trombożi)
English: An increased risk of the development of second primary malignancies, particularly AML, has been reported.
Maltese: Kien irrappurtat riskju li jiżdiedu t-tumuri malinni primarji sekondarji, partikolarment l-AML.
English: Thus it is recommended that {(Invented) Name} is given at a dose of 500 mg/m2 when the commonly used dosage schedule for doxorubicin of 50 mg/m2 is employed or 600 mg/m2 when the commonly used dosage schedule for epirubicin of 60 mg/m2 is employed.
Maltese: Għaldaqstant huwa rrakkomandat li {Isem (Ivvintat)} jingħata f'doża ta' 500 mg/m2 meta tintuża liskeda tad-doża normali ta' 50 mg/m2 doxorubicin jew ta' 600 mg/m2 meta tintuża l-iskeda tad-doża komuni għal 60 mg/m2 epirubicin.
English: Effects on CYP450 enzymes or drug transporters have not been studied.
Maltese: L-effetti fuq l-enzimi CYP450 jew fuq ittrasportaturi tal-mediċina għadhom ma ġewx studjati.
English: The following side effects have been reported in very few patients during treatment with {(Invented) Name}:
Maltese: Uħud mill-effetti sekondarji jistgħu jkunu serji u jeħtieġu attenzjoni medika immedjata:
English: Children and adolescents up to 18 years of age (see sections 4.4 and 4.8) Patients who are hypersensitive to dexrazoxane Breast-feeding (see section 4.6)
Maltese: Tfal u żgħażagħ sa 18-il sena (ara sezzjonijiet 4.4 u 4.8) Pazjenti li għandhom sensittività eċċessiva għal dexrazoxane Treddigħ (ara sezzjoni 4.6)
English: The maximum plasma concentration observed after a 12-15 minute infusion of 1000 mg/m2 is around 80 μg/ml with area under the plasma concentration-time curve (AUC) of 130 ± 15 mg.h/l.
Maltese: L-ogħla konċentrazzjoni fil-plażma li dehret wara infużjoni ta' 1000 mg/m2 li damet 12-15-il minuta hi ta' madwar 80 μg/ml biż-żona ta' taħt il-kurva konċentrazzjoni-ħin (AUC) fil-plażma ta' 130 ± 15 mg.h/l.
English: In studies of dexrazoxane as a cytotoxic, its MTD is shown to be dependent on posology and dosing schedule, and varies from 3750 mg/m2 when short infusions are given in divided doses over 3 days to 7420 mg/m2 when given weekly for 4 weeks, with myelosuppression and abnormal liver function tests becoming dose-limiting.
Maltese: Waqt studji b'dexrazoxane bħala ċitotossiku, l-MTD tiegħu tidher li tiddependi fuq il-pożoloġija u l-iskeda tad-doża mogħtija, u tvarja minn 3750 mg/m2 meta jingħataw infużjonijiet qosra mqassma f'dożi fuq medda ta' 3 ijiem għal 7420 mg/m2 meta jingħataw kull ġimgħa mqassma fuq 4 ġimgħat, bil majelosuppressjoni u t-testijiet mhux normali tal-funzjoni tal-fwied iwasslu biex jillimitaw id-doża mogħtija.
English: Acute myeloid leukaemia Blood and lymphatic system disorders Very common Anaemia, leukopenia Common
Maltese: Lewkimija majelojdi akuta Disturbi tad-demm u tas-sistema limfatika Komuni ħafna Anemija, lewkopenija.
English: Embolism
Maltese: Emboliżmu
English: Animal studies showed embryotoxic and teratogenic effects (see section 5.3).
Maltese: Studji fuq l-annimali wrew tossiċità fuq l-embrijuni u effetti teratoġeniċi (ara sezzjoni 5.3).
English: There is no specific antidote and symptomatic treatment should be provided.
Maltese: M'hemmx antidotu speċifiku u għandha tingħata kura sintomatika.
English: • Chemotherapy treatment received by patients treated for breast cancer: 45% combination therapy with doxorubicin 50 mg/m² (mainly with 5-fluorouracil and cyclophosphamide): 17% with epirubicin alone; 14% combination therapy with epirubicin 60 or 90 mg/m² (mainly with 5fluorouracil and cyclophosphamide).
Maltese: • Kura b'kimoterapija mogħtija lil pazjenti kkurati minħabba kanċer tas-sider: 45% terapija kkombinata b'50 mg/m² doxorubicin (prinċipalment ma' 5-fluorouracil u cyclophosphamide): 17% b'epirubicin biss; 14% terapija kkombinata b'60 jew 90 mg/m² epirubicin (prinċipalment ma' 5-fluorouracil u cyclophosphamide).
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03AF02.
Maltese: Aġenti diżintossikanti f'każ ta' kura antineoplastika, Kodiċi ATC:
English: Secondary acute myeloid leukaemia (AML) / myelodysplastic syndrome (MDS) has been observed in paediatric patients with Hodgkin's disease or acute lymphoblastic leukaemia receiving dexrazoxane in combination with chemotherapy (see section 4.4).
Maltese: Kien hemm lewkimija majelojdi akuta (AML) sekondarja / sindromu majelojdisplastiku (MDS) f'pazjenti pedjatriċi bil-marda ta' Hodgkin jew b'lewkimija limfoblastika akuta mogħtija dexrazoxane flimkien mal-kimoterapija (ara sezzjoni 4.4).
English: Venous thrombosis, lymphoedema
Maltese: Trombożi venuża, limfoedema
English: • If you are allergic to dexrazoxane or razoxane.
Maltese: • Jekk int allerġiku għal dexrazoxane jew razoxane.
English: Infections and infestations Uncommon
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komuni
English: The rate of death on study was higher with the combination dexrazoxane plus chemotherapy (5.0%) compared to chemotherapy alone (3.4%).
Maltese: Ir-rata ta' mwiet studjata kienet ogħla meta ngħataw flimkien dexrazoxane u lkimoterapija (5.0%) mqabbla ma meta ngħatat il-kimoterapija biss (3.4%).
English: Second primary malignancies
Maltese: Tumuri malinni primarji sekondarji
English: INFORMATION FOR HEALTHCARE PROFESSIONALS {(Invented) Name} 500 mg powder for solution for infusion Dexrazoxane
Maltese: MEDIKU {ISEM (IVVINTAT)} 500 mg trab għal soluzzjoni għall-infużjoni Dexrazoxane
English: Gastrointestinal disorders Very common Nausea, vomiting, stomatitis Common
Maltese: Disturbi gastrointestinali Komuni ħafna Dardir, rimettar, stomatite Komuni
English: Plasma protein binding of dexrazoxane is low (2%) and it does not penetrate into the cerebrospinal fluid to a clinically significant extent.
Maltese: Il-plażma li teħel mal-proteini ta' dexrazoxane hi baxxa (2%) u ma tgħaddix fil-fluwidu ċerebrospinali f'ammont sinifikanti klinikament.
English: Other toxic effects were malaise, low grade fever, increased urinary clearance of iron and zinc, anaemia, abnormal blood clotting, transient elevation of serum triglyceride and amylase levels, and a transient decrease in serum calcium level.
Maltese: Effetti tossiċi oħrajn kienu telqa, deni ħafif, żieda fl-ammont ta' ħadid u zinku mgħoddija mal-awrina, anemija, emboli mhux normali, żieda tranżitorja fit-trigliċeridi tas-serum u fil-livelli tal-amilasi, u tnaqqis tranżitorju fil-livell tal-kalċju tas-serum.
English: Management should include prophylaxis and treatment of infections, fluid regulation, and maintenance of nutrition.
Maltese: Il-kura mogħtija għandha tinkludi l-profilassi u t-trattament tal-infezzjonijiet, ir-regolazzjoni talfluwidi, u ż-żamma tan-nutrizzjoni.
English: The most common adverse reactions are haematological and gastroenterological reactions, primarily anaemia, leukopenia, nausea, vomiting and stomatitis, as well as asthenia and alopecia.
Maltese: L-aktar reazzjonijiet avversi komuni huma reazzjonijiet ematoloġiċi u gastroenteroloġiċi, primarjament anemija, lewkopenija, dardir, rimettar u stomatite, kif ukoll astenja u alopeċja.
English: Combination of dexrazoxane with chemotherapy may lead to an increased risk of thromboembolism (see section 4.8).
Maltese: L-għoti flimkien ta' dexrazoxane mal-kimoterapija jista' jwassal biex jiżdied ir-riskju ta' tromboemboliżmu (ara sezzjoni 4.8).
English: Skin reaction such as swelling, redness, pain, burning sensation, itching at the site of injection Tingling or numbness of the hands or feet, dizziness, headache Discharge from the eye with itching, redness and swelling Tiredness, generally feeling unwell
Maltese: Reazzjoni fil-ġilda bħal nefħa, ħmura, uġigħ, sensazzjoni ta' ħruq, ħakk fil-post tal-injezzjoni Textix jew tnemnim fl-idejn jew fis-saqajn, sturdamenti, uġigħ ta' ras Tisfija mill-għajnejn flimkien ma' ħakk, ħmura u nefħa Dgħufija, normalment ma tħossokx f'siktek
English: If you are allergic (hypersensitive) to dexrazoxane.
Maltese: Jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal dexrazoxane.
English: It is generally thought that they can provide cardioprotection by scavenging metal ions thus preventing the Fe3+-anthracycline complex from redox cycling and forming reactive radicals.
Maltese: Normalment hu maħsub li dawn jistgħu jipprovdu kardjoprotezzjoni billi joqogħdu jfittxu l-joni metalliċi u għaldaqstant ma jħallux il-kumpless Fe3+-anthracycline milli joħloq ċiklu ta' ossidazzjoni u jifforma radikali reattivi.
English: Preclinical studies indicate that, with repeated dexrazoxane administration, the primary target organs are those of rapid cell division: bone marrow, lymphoid tissue, testes and gastrointestinal mucosa.
Maltese: Studji ta' qabel l-użu kliniku jindikaw li, meta dexrazoxane jingħata ripetutament, l-organi milquta primarjament huma dawk fejn id-diviżjoni taċ-ċelloli ssir b'ħeffa: il-mudullun tal-għadam, it-tessut limfatiku, it-testikoli u l-mukoża gastrointestinali.
English: The MTD is lower in patients who have been heavily pre-treated with chemotherapy, and those with pre-existing immunosuppression (e.g. AIDS).
Maltese: L-MTD hija anqas f'pazjenti li ngħataw minn qabel kura qawwija bil-kimoterapija, u f'dawk li diġà kellhom immunosuppressjoni (eż.AIDS).
English: Patients receiving chemotherapy and {(Invented) Name} (n=375):
Maltese: Pazjenti mogħtija l-kimoterapija u {Isem (Ivvintat)} (n=375):