FrancophonIA/ELRC3.0 huggingface dataset:
English: A main measure of effectiveness was a reduction of at least 90% in PASI scores.
Maltese: Kejl ewlieni tal-effikaċja kien tnaqqis ta' mill-inqas 90 % fil-punteġġi PASI.
English: Other information about Tremfya
Maltese: Informazzjoni oħra dwar Tremfya
English: The active substance in Tremfya, guselkumab, is a monoclonal antibody (a type of protein) which is designed to attach to interleukin 23 and block its activity.
Maltese: Is-sustanza attiva f'Tremfya, il-guselkumab, hija antikorp monoklonali (tip ta' proteina) mfassla biex teħel ma' interleukin 23 u timblokka l-attività tiegħu.
English: The recommended dose is 100 mg as a single dose, followed by a further dose after 4 weeks and then 100 mg every 8 weeks.
Maltese: Id-doża rakkomandata hija ta' 100 mg bħala doża waħda, segwita minn doża oħra wara 4 ġimgħat imbagħad 100 mg kull 8 ġimgħat.
English: The third study involved 871 patients who were treated with ustekinumab (another medicine used for treating psoriasis).
Maltese: It-tielet studju involva 871 pazjent li ġew ikkurati b'ustekinumab (mediċina oħra li tintuża biex tikkura l-psorjażi).
English: What are the risks associated with Tremfya?
Maltese: X'inhuma r-riskji assoċjati ma' Tremfya?
English: It has few side effects.
Maltese: Dan għandu ftit effetti sekondarji.
English: Three main studies involving 2,700 adults found Tremfya effective for treating moderate to severe plaque psoriasis in patients for whom treatments applied to the skin did not work well enough.
Maltese: Tliet studji ewlenin li involvew 2,700 adult sabu li Tremfya huwa effettiv biex jikkura psorjażi bil-qoxra moderata sa severa f'pazjenti li għalihom kuri li jiġu applikati fuq il-ġilda ma ħadmux tajjeb biżżejjed.
English: The first two studies compared Tremfya with adalimumab (another medicine used for treating psoriasis) and placebo (a dummy treatment).
Maltese: L-ewwel żewġ studji qabblu Tremfya ma' adalimumab (mediċina oħra li tintuża biex tikkura l-psorjażi) u ma' plaċebo (kura finta).
English: As for all medicines, data on the use of Tremfya are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Tremfya hija ssorveljata kontinwament.
English: Tremfya is a medicine that acts on the immune system and is used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Maltese: Tremfya huwa mediċina li taġixxi fuq is-sistema immunitarja u li tintuża biex tikkura psorjażi bil-qoxra, marda li tikkawża rqajja' ħomor bil-qxur fuq il-ġilda.
English: An overview of Tremfya and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Tremfya u għalfejn huwa awtorizzat fl-UE
English: The Agency considered that Tremfya is effective and longer-term studies have shown that it remains effective with continued use.
Maltese: L-Aġenzija kkunsidrat li Tremfya huwa effettiv u studji ta' perjodu itwal urew li dan jibqa' effettiv b'użu kontinwu.
English: The European Medicines Agency decided that Tremfya's benefits are greater than its risks in the treatment of moderate and severe plaque psoriasis, and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Tremfya huma akbar mir-riskji tiegħu filkura ta' psorjażi bil-qoxra moderata sa severa, u jista' jiġi awtorizzat għall-użu fl-UE.
English: How does Tremfya work?
Maltese: Kif jintuża Tremfya?
English: What measures are being taken to ensure the safe and effective use of Tremfya?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Tremfya?
English: By blocking the action of interleukin 23, guselkumab reduces inflammation and symptoms associated with the disease.
Maltese: Dan jintuża f'adulti b'marda moderata sa severa, li għaliha l-kuri applikati fuq il-ġilda mhumiex xierqa.
English: The most common side effects with Tremfya (which may affect more than 1 in 10 people) are infections in the nose and throat.
Maltese: L-effetti sekondarji l-aktar komuni bi Tremfya (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet fl-imnieħer u fil-griżmejn.
English: [≥ 1/1,000 to < 1/100]).
Maltese: (≥ 1/100 sa < 1/10) (≥ 1/1,000 sa < 1/100)
English: 3P BIOPHARMACEUTICALS SL C/ Mocholi 2, Poligono Industrial Mocholi 31110 Noain Spain
Maltese: 3P BIOPHARMACEUTICALS SL C/ Mocholi 2, Poligono Industrial Mocholi 31110 Noain
English: MedDRA system organ class
Maltese: Sistema talklassifika tal organi MedDRA
English: Calle García Ximénez, nº3-1º 31002 Pamplona (Navarra) Spain
Maltese: Mundipharma Biologics S.L. Calle García Ximénez, nº3-1º 31002 Pamplona (Navarra) Spanja
English: Sími: + 354 540 8000 icepharma@icepharma.is
Maltese: + 354 540 8000 icepharma@icepharma.is
English: “SNAP”
Maltese: “TFAQQIHA”
English: Pulmonary hemorrhage
Maltese: Emorraġija pulmonari
English: Pulmonary adverse events
Maltese: Avvenimenti avversi pulmonaril
English: Tel.: +36 1 803 5555 mailbox@egis.hu
Maltese: +36 1 803 5555 mailbox@egis.hu
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13
Maltese: Kategorija farmakoterapewtika: immunostimulanti, fattur li jistimola l-kolonji, Kodiċi ATC:
English: Tel:
Maltese: Sími:
English: Sweet's syndrome (acute febrile dermatosis)1,2;
Maltese: (dermatożi akuta biddeni)1,2;
English: - breathing problems.
Maltese: Disturbi respiratorji,
English: Musculoskeleta l and connective tissue disorders
Maltese: Disturbi muskoluskeletrali u tat-tessut konnettiv
English: Gastrointestina l disorders
Maltese: Disturbi gastrointestinali
English: Österreich Mundipharma Gesellschaft m.b.H.
Maltese: Mundipharma Gesellschaft m.b.H.
English: White blood cell (WBC) counts of 100 × 109/L or greater have been observed in less than 1 % of patients receiving pegfilgrastim therapy.
Maltese: Għadd ta' ċelluli bojod tad-demm (white blood cell, WBC) ta' 100 x 109 /L jew aktar ġew osservati f'inqas minn 1 % tal-pazjenti li ngħataw pegfilgrastim.
English: Sodium acetate* Sorbitol (E 420)
Maltese: Sorbitol (E 420)
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 × 109/L) have been reported (see section 4.4).
Maltese: Kienu rrappurtati każijiet komuni ta' lewkoċitosi (Għadd ta' Ċelluli Bojod tad-Demm [WBC] > 100 x 109/L) (ara sezzjoni 4.4).
English: D-79539 Lörrach
Maltese: 8 79539 Loerrach Il-Ġermanja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1409/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1409/001
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pegfilgrastim Mundipharma.
Maltese: Reazzjonijiet severi tal-ġilda (sindrome ta' Stevens-Johnson) ġew irrappurtati bl-użu ta' Pegfilgrastim Mundipharma.
English: Polysorbate 20 Water for injections
Maltese: Polysorbate 20
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l­identifikatur uniku inkluż.
English: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults.
Maltese: Data limitata tindika li l-farmakokinetika ta' pegfilgrastim fl-anzjani (> 65 sena) hija simili għal dik fl-adulti.
English: Splenomegaly2; Splenic rupture2
Maltese: Tkabbir tal-milsa2; Milza mifqugħha2
English: The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1 % versus 14 %, p < 0.001; and 2 % versus 10 %, p < 0.001).
Maltese: IV assoċjati ma' dijanjożi klinika ta' newtropenija bid-deni kienet aktar baxxa fil-grupp ta' pegfilgrastim meta mqabbla mal-grupp tal-plaċebo (1 % versus 14 %, p < 0.001; u 2 % versus 10 %, p < 001).
English: Excipients: sodium acetate, sorbitol (E 420), polysorbate 20, and water for injections.
Maltese: Sustanzi mhux attivi: sodium acetate, sorbitol (E 420), polysorbate 20, u ilma għall-injezzjoni.
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Maltese: Pegfilgrastim huwa proteina magħmula mill-bijoteknoloġija fil-batterja msejħa E. coli.
English: Pegfilgrastim Mundipharma 6 mg pegfilgrastim
Maltese: Pegfilgrastim Mundipharma 6 mg injezzjoni pegfilgrastim
English: The concentration is 10 mg/mL based on protein only**.
Maltese: Ilkonċentrazzjoni hija ta' 10 mg/ml ibbażata fuq il-proteina biss**.
English: Tel.: + (48 22) 866 87 12 biuro@mundipharma.pl
Maltese: Mundipharma Polska Sp. z o.o. Tel.: + (48 22) 866 87 12 biuro@mundipharma.pl
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) *Sodium acetate is prepared by mixing sodium acetate trihydrate and acetic acid.
Maltese: * Sodium acetate huwa ppreparat bit-taħlit ta' sodium acetate trihydrate u acetic acid.
English: Pegfilgrastim Mundipharma may be exposed to room temperature (not above 30º C) for a maximum single period of up to 96 hours.
Maltese: Pegfilgrastim Mundipharma jista' jiġi espost għal temperatura ambjentali (mhux aktar minn 30 °C) għal perijodu wieħed ta' massimu ta' 96 siegħa.
English: (47.9 ± 22.5 μg·hr/mL) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 μg·hr/mL and 29.3 ± 23.2 μg·hr/mL, respectively) (see section 5.1).
Maltese: Il-grupp tal-iżgħar età (0-5 snin) kellu esponiment medju ogħla għal pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5μg hr/ml) minn tfal akbar b'età ta' 6-11-il sena u 12-21 sena (22.0 ± 13.1 μg hr/ml u 29.3 ± Konċ. Medjana ta' Pegfilgrastim fis-Serum (ng/ml) ANC 23.2 μg hr/ml, rispettivament) (ara sezzjoni 5.1).
English: Mundipharma Farmacêutica Lda Tel: +351 21 901 31 62 medinfo@mundipharma.pt
Maltese: Mundipharma Farmacêutica Lda Tel: +351 21 901 31 62 med.info@mundipharma.pt
English: The incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared with placebo (1 % versus 17 %, p < 0.001).
Maltese: L-inċidenza tan-newtropenija bid-deni kienet aktar baxxa f'pazjenti li rċevew pegfilgrastim meta mqabbla ma' dawk li reċevew il-plaċebo (1 % versus 17 %, p < 0.001).
English: A higher frequency of serious adverse reactions in younger children aged 0-5 years (92 %) has been observed compared to older children aged 6-11 and 12-21 years respectively (80 % and 67 %) and adults.
Maltese: Kienet osservata frekwenza ogħla ta' avvenimenti avversi serji fi tfal iżgħar b'età ta' 0-5 snin (92 %) meta mqabbla ma' tfal akbar b'età ta' 6-11 u 12-21 sena rispettivament (80 % u 67 %) u ma' adulti.
English: In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group
Maltese: Fi studju wieħed (n = 157), fejn intużat doża fissa ta' 6 mg ta' pegfilgrastim id-dewmien medju ta' newtropenija ta' grad 4 għall-grupp b'pegfilgrastim kien ta' 1.8 jiem meta mqabbel ma' 1.6 jiem tal-grupp b'filgrastim
English: Pegfilgrastim Mundipharma is for use in adults aged 18 and over.
Maltese: Pegfilgrastim Mundipharma huwa għall-użu f'adulti minn 18-il sena 'l fuq.
English: In two randomised, double-blind, pivotal studies in patients with high risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
Maltese: F'żewġ studji li fihom il-parteċipanti ntagħżlu b'mod każwali, double-blind, ta' importanza kbira, f'pazjenti b'kanċer tas-sider ta' riskju għoli ta' stadju II-IV li kienu qed jingħataw kimoterapija majelosopressiva li tikkonsisti f'doxorubicin u docetaxel, l-użu ta' pegfilgrastim, bħala doża waħda f'kull ċiklu, naqqset id-dewmien tannewtropenija u l-inċidenza ta' newtropenija bid-deni b'mod simili għal dak osservat bl-għoti ta' kuljum ta' filgrastim (medjan ta' 11-il għotja kuljum).
English: Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Maltese: Kienu rrappurtati reazzjonijiet avversi mhux komuni relatati malpulmun, fosthom pulmonite interstizjali, edima fil-pulmun, infiltrati fil-pulmun u fibrożi fil-pulmun.
English: Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported as uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of selected adverse reactions” below.
Maltese: Sindrome ta' tnixxija tal-kapillari, li tista' tkun ta' periklu għall-ħajja jekk it-trattament huwa ttardjat, ġie irrapportat b'mod mhux komuni (≥ 1/1000 sa < 1/100) f'pazjenti b'kanċer waqt il-kimoterapija wara l-għoti ta' fatturi li jistimulaw kolonji granuloċiti; ara sezzjoni 4.4 u sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” iktar 'l isfel.
English: This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol (23 mg) sodium f'kull doża ta' 6 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Pegfilgrastim Mundipharma is a biosimilar medicinal product.
Maltese: Pegfilgrastim Mundipharma huwa prodott mediċinali bijoloġiku simili.
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40 % incidence of febrile neutropenia.
Maltese: Fin-nuqqas ta' appoġġ ta' fattur tat-tkabbir, ġie rrappurtat li din l-iskema ta' dożaġġ tirriżulta f'newtropenija ta' grad 4 li ddum medja ta' 5 sa 7 ijiem, u inċidenza ta' 30-40 % ta' newtropenija bid-deni.
English: Bone pain Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Maltese: Uġigħ muskoluskeletrali (majalġja, artralġja, uġigħ flestremitajiet, uġigħ fid-dahar, uġigħ muskoluskeletrali, uġigħ fl-għonq)
English: The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Maltese: Id-data fit-tabella iktar 'l isfel tiddeskrivi reazzjonijiet avversi rrappurtati minn provi kliniċi u minn rappurtar spontanju.
English: This may be a sign of a problem with your spleen (splenomegaly) - if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration) - if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts, which reduces the ability of your blood to clot (thrombocytopenia).
Maltese: Dan jista' jkun sinjal ta' problema fil-milza tiegħek (splenomegalija) - jekk reċentement kellek infezzjoni serja tal-pulmun (pnewmonja), fluwidu fil-pulmuni (edema pulmonari), infjammazzjoni tal-pulmun (mard interstizjali tal-pulmun), jew bħala anormali tas-sider x-ray (infiltrazzjoni tal-pulmun) - jekk inti konxju ta' xi għadd taċ-ċelluli tad-demm mibdula (eż. żieda fiċ-ċelluli bojod tad-demm jew anemija) jew għadd ta' plejtlits fid-demm naqset, li jnaqqas l-abbiltà ta'demm tiegħek biex jagħqad (tromboċitopenija).
English: It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Maltese: Jappartjeni għal grupp ta' proteini msejħa ċitokini, u huwa simili ħafna għal proteina naturali (fattur li jistimola l-kolonji ta' granuloċiti) prodotta mill-ġisem tiegħek stess.
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Maltese: Ġeneralment, avvenimenti ta' glomerulonefrite solvuti wara tnaqqis fid-doża jew irtirar ta' filgrastim u pegfilgrastim.
English: Cutaneous vasculitis1,2
Maltese: Vaskulite fil-ġilda1,2
English: The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Maltese: Bidu ta' sinjali pulmonari bħal sogħla, deni u qtugħ ta' nifs flimkien ma' sinjali radjoloġiċi ta' infiltrati fil-pulmun, u deterjorazzjoni tal-funzjoni tal-pulmun flimkien ma' żieda fl-għadd ta' newtrofili jistgħu jkunu sinjali tal-bidu tas-sindrome ta' distress respiratorju akut (ARDS).
English: The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials.
Maltese: Il-kategorija ta' frekwenza kienet stmata minn kalkolu statistiku bbażat fuq 1,576 pazjent li kienu qed jirċievu pegfilgrastim f'disa' provi kliniċi li fih il-parteċipanti ntagħżlu b'mod każwali.
English: - The other ingredients are sodium acetate, sorbitol (E 420), polysorbate 20 and water for injections.
Maltese: - Is-sustanzi mhux attivi l-oħra huma sodium acetate, sorbitol (E 420), polysorbate 20 u ilma għall-injezzjoni.
English: Danmark Mundipharma A/S Tlf:
Maltese: Suomi/Finland Mundipharma Oy Puh/Tel:
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' pegfilgrastim f'0.6 ml (10 mg/ml) ta' soluzzjoni għallinjezzjoni.
English: Capillary leak syndrome1
Maltese: Sindrome ta' tnixxija tal-kapillari1
English: Finger grips Syringe label Syringe barrel
Maltese: KARTUNA TA' BARRA TAS-SIRINGA F'FOLJA
English: Sickle cell crisis2;
Maltese: Kriżi taċ-ċelluli forma ta' minġel2;
English: Sickle cell anaemia
Maltese: Anemija taċ-ċelluli b'forma ta' minġel (sickle cell anaemia)
English: BATCH NUMBER
Maltese: Tikketta tassiringa
English: Suomi/Finland Mundipharma Oy Puh/Tel: + 358 (0)9 8520 2065 info@mundipharma.fi
Maltese: + 358 (0)9 8520 2065 info@mundipharma.fi
English: Capillary leak síndrome
Maltese: Tikketta tas-siringa
English: The safety and efficacy of Pegfilgrastim Mundipharma administration in de novo AML patients aged < 55 years with cytogenetics t (15;17) have not been established.
Maltese: Is-sigurtà u l-effikaċja tal-għoti ta' Pegfilgrastim Mundipharma ma' ċitoġenetiċi t(15;17) f'pazjenti taħt il-55 sena li reġgħet qabdithom lewkimja majelojde akuta mill-ġdid, għadhom ma ġewx stabbiliti.
English: What Pegfilgrastim Mundipharma contains - The active substance is pegfilgrastim.
Maltese: X'fih Pegfilgrastim Mundipharma - Is-sustanza attiva hi pegfilgrastim.
English: Belly, except for a 5 cm (2-inch) area right around your belly button.
Maltese: Iż-żaqq, ħlief 5 cm (2 pulzieri) mad-dawra taż-żokra.
English: /kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95 % CI
Maltese: Fi studju ieħor (n = 310), fejn intużat doża maħduma skont il-piż (100 μg/kg), id-dewmien medju tan-newtropenija grad 4 għall-grupp b'pegfilgrastim kienet ta' 1.7 imqabbel ma' 1.8 ijiem talgrupp b'filgrastim (differenza ta' 0.03 ijiem, 95 % CI -0.36, 0.30).
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU -DATA LI TINQARA MILL-BNIEDEM
English: In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m2 every 3 weeks for 4 cycles).
Maltese: Fi studju double-blind, ikkontrollat bil-plaċebo, fuq pazjenti bil-kanċer tas-sider ġie evalwat l-effett ta' pegfilgrastim fuq l-inċidenza tan-newtropenija bid-deni wara l-għoti ta' ċiklu ta' kimoterapija assoċjat ma' rata ta' newtropenija bid-deni ta' 10-20 % (docetaxel 100 mg/m2 kull 3 ġimgħat għal 4 ċikli).
English: Reporting of suspected adverse reactions
Maltese: Reazzjonijiet avversi relatati mal-pulmun
English: Manufacturer PharmaKorell GmbH Marie-Curie-Strasse 8
Maltese: PharmaKorell GmbH Marie-Curie-Strasse 8 79539 Lörrach Il-Ġermanja
English: Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Maltese: Sindrome ta' tnixxija tal-kapillari (capillary leak syndrome) ġie rrappurtat wara għoti tal-fattur li jistimula l-kolonji ta' granuloċiti u huwa kkaratterizzat minn pressjoni baxxa, ipoalbuminemija, edema u emokonċentrazzjoni.
English: Pegfilgrastim Mundipharma
Maltese: Mediċini oħra u Pegfilgrastim Mundipharma
English: Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1).
Maltese: Data klinika limitata tissuġġerixxi li l-effett fuq il-ħin biex tirkupra minn newtropenija severa f'pazjenti li reġgħet qabdithom lewkimja majelojde akuta (acute myeloid leukaemia; AML) mill-ġdid, huwa komparabbli bejn dawk li ngħataw pegfilgrastim u dawk li ngħataw filgrastim (ara sezzjoni 5.1).
English: Additionally a higher incidence of febrile neutropenia was observed in younger children aged 0-5 years (75 %) compared to older children aged 6-11 years and 12-21 years (70 % and 33 %, respectively) and adults (see sections 4.8 and 5.2).
Maltese: Barra dan kienet osservata inċidenza ogħla ta' newtropenija bid-deni fi tfal iżgħar b'età ta' 0-5 snin (75 %) meta mqabbel ma' tfal akbar b'età ta' 6-11-il sena u 12-21 sena (70 % u 33 %, rispettivament) u ma' adulti (ara sezzjonijiet 4.8 u 5.2).
English: In an open label, single dose study (n = 31) various stages of renal impairment, including end-stage renal disease, had no impact on the pharmacokinetics of pegfilgrastim.
Maltese: (n = 31), varji stadji ta' indeboliment renali, inkluż mard renali tal-aħħar stadju, ma kellhom l-ebda impatt fuq il-farmakokinetika ta' pegfilgrastim.
English: Step 3: Inject A Hold the pinch.
Maltese: Pass 3: Injetta A Żomm il-qarsa.
English: Permanently discontinue Pegfilgrastim Mundipharma in patients with clinically significant hypersensitivity.
Maltese: Pegfilgrastim Mundipharma għandu jitwaqqaf għal kollox f'pazjenti li jkollhom ipersensitivita klinikament sinjifikanti.
English: Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4).
Maltese: B'mod mhux komuni, każijiet irriżultaw f'insuffiċjenza respiratorja jew Sindrome ta' Distress Respiratorju Akut (Acute respiratory distress syndrome, ARDS), li jistgħu jkunu fatali (ara sezzjoni 4.4).
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Maltese: Reazzjonijiet avversi relatati mal-pulmun, b'mod partikulari pulmonite interstizjali, ġew irrappurtati wara l-għoti ta' G-CSF.
English: Upper part of your thigh.
Maltese: Parti ta' fuq talkoxxa
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS) - if you have any of the following or combination of the following side effects: - swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Maltese: Dan jista' jkun sinjal ta' Sindrome ta' Distress Respiratorju Akut (ARDS) - jekk għandek xi wieħed minn dawn li ġejjin jew kombinazzjoni tal-effetti sekondarji li ġejjin: - nefħa jew tħossok minfuħ, li jistgħu jkunu assoċjati ma li tgħaddi l-awrina b'inqas frekwenza, diffikultà biex tieħu nifs, nefħa addominali u sensazzjoni ta' milja, u sensazzjoni ġenerali ta' għeja
English: B
Maltese: C
English: The injections should be given into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq l-immaniġġjar tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.