FrancophonIA/ELRC3.0 huggingface dataset:
English: a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: a) l-għotja tal-prodott lill-annimali tinterferixxi ma' l-implimentazzjoni ta' programmi nazzjonali għad-djanjosi, il-kontroll u l-eradikazzjoni tal-mard ta' l-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni ta' l-assenza tal-kontaminazzjoni f' annimali ħajjin jew fl-ikel jew prodotti oħrajn li jiġu minn annimali ttrattati;
English: The full EPAR for Icandra can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Icandra jinsab fuq is-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Vildagliptin / metformin hydrochloride
Maltese: Icandra vildagliptin/metformina kloridrat
English: This is a summary of the European public assessment report (EPAR) for Icandra.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Icandra.
English: Vildagliptin on its own was approved by the EU in September 2007 under the name Galvus, and metformin has been available in the EU since 1959.
Maltese: F'Settembru 2007, il-vildagliptin kienet ġiet approvata weħidha mill-UE bl-isem ta' Galvus, filwaqt li lmetformina ilha disponibbli fl-UE sa mill-1959.
English: Icandra is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
Maltese: Icandra huwa mediċina li fiha s-sustanzi attivi vildagliptin u metformina kloridrat (metformin hydrochloride).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vildagliptin/Metformin Hydrochloride on 1 December 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vildagliptin/Metformina Kloridrat fl-1 ta' Diċembru 2008.
English: Icandra contains two active substances, which each have a different mode of action.
Maltese: Icandra fih żewġ sustanzi attivi, fejn kull waħda għandha mezz differenti ta' azzjoni.
English: What is Icandra?
Maltese: X'inhu Icandra?
English: The most common side effects with Icandra (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Maltese: L-effetti sekondarji l-aktar komuni b'Icandra (li dehru f'aktar minn pazjent 1 minn kull 10) huma nawżja (dardir), remettar, dijarrea, uġigħ addominali (ta' żaqq) u telf tal-aptit.
English: Why has Icandra been approved?
Maltese: Għaliex ġie approvat Icandra?
English: Icandra is used to treat adults with type 2 diabetes.
Maltese: Icandra jintuża fil-kura ta' adulti li jbatu bid-dijabete tat-tip 2.
English: The company that makes Eucreas has agreed that its scientific data can be used for Icandra.
Maltese: Il-kumpanija li tipproduċi Eucreas qablet li d-dejta xjentifika tagħha tista' tintuża għal Icandra.
English: Vildagliptin has been shown to be more effective than placebo (a dummy treatment) at reducing HbA1c levels when it was added to metformin.
Maltese: Il-vildagliptin kienet aktar effikaċi mill-plaċebo (trattament finta) fit-tnaqqis tal-livelli ta' HbA1c meta din żdiedet mal-metformina.
English: The studies with Galvus as an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to support the use of Icandra in the same indications.
Maltese: L-istudji b'Galvus bħala terapija aġġuntiva għall-metformina, il-metformina u s-sulfonilurea, jew il-metformina u l-insulina ntużaw bħala sostenn għall-użu ta' Icandra fl-istess indikazzjonijiet.
English: • in combination with a sulphonylurea (another type of anti-diabetes medicine) together with diet and exercise, in patients whose diabetes is not satisfactorily controlled on metformin and a sulphonylurea.
Maltese: • flimkien mas-sulfonilurea (tip ieħor ta' mediċina antidijabetika) flimkien mad-dieta u l-eżerċizzju,
English: How has Icandra been studied?
Maltese: Kif ġie studjat Icandra?
English: What is the risk associated with Icandra?
Maltese: Għal xiex jintuża Icandra?
English: In other studies, vildagliptin in combination with metformin has been shown to be more effective than placebo when used with a sulphonylurea or insulin.
Maltese: Fi studji oħra, il-vildagliptin flimkien mal-metformina ntweriet li kien aktar effikaċi mill-plaċebo meta użat mas-sulfonilurea jew l-insulina.
English: By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi żżid illivelli ta' ormoni inkretini fid-demm, il-vildagliptin tistimula l-frixa tipproduċi aktar insulina meta l-livelli tal-glukożju fid-demm ikunu għoljin.
English: The name of the medicine was changed to Icandra on 6 February 2009.
Maltese: L-isem tal-mediċina nbidel u sar Icandra fis-6 ta' Frar 2009.
English: INFORMATION IN BRAILLE Pelmeg
Maltese: INFORMAZZJONI BIL-BRAILLE Pelmeg
English: *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: QR code to be included <www.pelmeg.eu>
Maltese: [QR code www.pelmeg.eu]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1328/001
Maltese: EU/1/18/1328/001
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Novembru, 2018
English: 0.6 mL of solution.
Maltese: INDIVIDWALI 0.6 ml
English: Manufacturer PharmaKorell GmbH Marie-Curie-Strasse 8 D-79539 Lörrach Germany
Maltese: Manifattur PharmaKorell GmbH Marie-Curie-Strasse 8 79539 Lörrach
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: Barcode 2D li jkollu l­identifikatur uniku inkluż.
English: Tel.:+ 370 5 231 4658 info@egis.lt
Maltese: :+ 370 5 231 4658 info@egis.lt
English: Pelmeg is a biosimilar medicinal product.
Maltese: Pelmeg huwa prodott mediċinali bijoloġiku simili.
English: OTHER Mundipharma
Maltese: Mundipharma
English: Pelmeg contains sorbitol (E 420) and sodium acetate
Maltese: Pelmeg fih sorbitol (E 420) u sodium acetate.
English: Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Maltese: Sindrome ta' Distress Respiratorju Akut2; Reazzjonijiet avversi relatati mal-pulmun (pulmonite inters tizjali, edema fil-pulmun, infiltrati fil-pulmun u fibros i fil-pulmun) Emoptisi
English: Hypersensitivity reactions;
Maltese: sensittività eċċessiva;
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: IDENTIFIKATUR UNIKU -DATA LI TINQARA MILL-BNIEDEM PC:
English: Sweet's syndrome (acute febrile dermatosis)1,2; Cutaneous vasculitis1,2
Maltese: (dermatożi akuta bid deni)1,2; Vaskulite fil-ġilda1,2
English: • The active substance is pegfilgrastim.
Maltese: - Is-sustanza attiva hi pegfilgrastim.
English: ** The concentration is 20 mg/mL if the PEG moiety is included.
Maltese: ** Il-konċentrazzjoni hija ta' 20 mg/mL jekk jiġi inkluż l-porzjon ta' PEG.
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH)
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS)
Maltese: Dan jista' jkun sinjal ta' Sindrome ta' Distress Respiratorju Akut (ARDS)
English: Pelmeg contains the active substance pegfilgrastim.
Maltese: Pelmeg fih is-sustanza attiva pegfilgrastim.
English: *Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG).
Maltese: *Magħmul f'ċelluli ta' Escherichia coli permezz ta' teknoloġija rikombinanti tad-DNA segwita minn konjugazzjoni ma' polyethylene glycol (PEG).
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta f'sezzjonijiet 4.8, 5.1 u 5.2 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: Syringe label Syringe barrel
Maltese: KARTUNA TA' BARRA TAS-SIRINGA F'FOLJA
English: See section 4.8 for how to report adverse reactions.
Maltese: Ara sezzjoni 4.8 dw ar kif għandhom jiġu rappurtati reazzjonijiet avversi.
English: For more information, see section 5.1
Maltese: Għal aktar informazzjoni, are sezzjoni 5.1.
English: MedDRA system organ class
Maltese: S is tema talklas sifika talorgani MedDRA
English: • breathing problems.
Maltese: Disturbi respiratorji,
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 għall injezzjoni.
English: Pelmeg 6 mg solution for injection in pre-filled syringe pegfilgrastim
Maltese: Pelmeg 6 mg injezzjoni pegfilgrastim
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelmeg.
Maltese: Reazzjonijiet severi tal-ġilda (sindrome ta' Stevens-Johnson) ġew irrappurtati bl-użu ta' Pelmeg.
English: Grab here
Maltese: Reazzjonijiet ta'
English: Other medicines and Pelmeg
Maltese: Mediċini oħra u Pelmeg
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 × 109/L) have been reported (see section 4.4).
Maltese: > 100 x 109/L) (ara sezzjoni 4.4).
English: Figure 1: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Maltese: Figura 1: Profil tal-konċentrazzjoni medjana fis-serum ta' pegfilgrastim u l-għadd assolut ta' newtrofili (ANC) f'pazjenti kkurati b'kimoterapija wara injezzjoni waħda ta' 6 mg
English: • you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine.
Maltese:  jekk int allerġiku għal pegfilgrastim, filgrastim, proteini ġejjin minn E. coli, jew għal xi sustanza oħra ta' din il-mediċina.
English: In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 μg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 × 109) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
Maltese: kimoterapija ta' vincristine, doxorubicin u cyclophosphamide (VAdriaC/IE), kienet osservata tul itwal ta' newtropenija severa (newtrofili < 0.5 x 109) fi tfal iżgħar b'età ta' 0-5 snin (8.9 ijiem) meta mqabbel ma' tfal akbar b'età ta' 6-11-il sena u 12-21 sena (6 ijiem u 3.7 ijiem, rispettivament) u ma'
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: 4 li ddum medja ta' 5 sa 7 ijiem, u inċidenza ta' 30-40 % ta' newtropenija bid-deni.
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'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: Step 2: Get ready A Wash your hands thoroughly.
Maltese: Pass 1: Preparazjoni
English: Pelmeg may be exposed to room temperature (not above 30º C) for a maximum single period of up to 96 hours.
Maltese: Pelmeg jista' jiġi espost għal temperatura ambjentali (mhux aktar minn 30 °C) għal perijodu wieħed ta' massimu ta' 96 siegħa.
English: In a second study (n = 310), which used a weight-adjusted dose (100 μg /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: 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: 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: The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Maltese: Id-dejta fit-tabella iktar 'l isfel tiddeskrivi reazzjonijiet avversi rrappurtati minn provi kliniċi u minn rappurtar spontanju.
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (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: 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.
English: See package leaflet for further information.
Maltese: Kontenut tal-pakkett u informazzjoni oħra.
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffetwaw sa persuna waħda minn kull 1,000):
English: Syringe label
Maltese: Tikketta tas-siringa
English: Median Serum Pegfilgrastim Conc.
Maltese: Pelmeg 6 mg pegfilgrastim SC
English: Uncommon elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Maltese: Żidiet mhux komuni f'ALT (alanine aminotransferase) jew f'AST (aspartate aminotransferase),
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: 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: 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: 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: to < 1/100)
Maltese: (≥ 1/100 sa < 1/10) (≥ 1/1,000 sa < 1/100)
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.
Maltese: Pegfilgrastim huwa magħmul minn molekola ta' G-CSF umana rikombinanti (r-metHuG-CSF) marbuta b'rabta kovalenti ma' molekola waħda ta'
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Maltese: avvenimenti ta' glomerulonefrite solvuti wara tnaqqis fid-doża jew irtirar ta' filgrastim u pegfilgrastim.
English: Uncommonly, cases have resulted in respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see section 4.4).
Maltese: Respiratorju Akut (Acute respiratory distress syndrome, ARDS), li jistgħu jkunu fatali (ara sezzjoni 4.4).
English: Permanently discontinue Pelmeg in patients with clinically significant hypersensitivity.
Maltese: Pelmeg għandu jitwaqqaf għal kollox f'pazjenti li jkollhom ipersensitivita klinikament sinjifikanti.
English: In animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Maltese: Fi studji fl-annimali, lgħoti ta' pegfilgrastim ma' 5-fluorouracil (5-FU) jew anti-metaboliti oħra wera żieda filmajelosoppressjoni.
English: • 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)
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)
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 (difference 0.23 days, 95 % CI −0.15, 0.63).
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 (differenza ta' 0.23 jum, 95 % CI -0.15, 0.63). Matul l-istudju kollu, ir-rata ta' newtropenija bid-deni kienet ta' 13 % tal-pazjenti kkurati b'pegfilgrastim mqabbla ma' 20 % tal-pazjenti kkurati b'filgrastim (differenza ta' 7 %, 95 % CI ta' - 19 %, 5 %).
English: The overall rate of febrile neutropenia was 9 % of patients treated with pegfilgrastim and 18 % of patients treated with filgrastim (difference 9 %, 95 % CI of −16.8 %,−1.1 %).
Maltese: Ir-rata totali ta newtropenija biddeni kienet ta' 9 % tal-pazjenti kkurati b'pegfilgrastim u 18 % tal-pazjenti kkurati b'filgrastim (differenza ta' 9 %, 95 % CI ta' -16.
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥ 1/1,000 to < 1/100]).
Maltese:  reazzjonijiet allerġiċi serji, inkluż anafilassi (debbulizza, pressjoni titbaxxa, tbatija biex tieħu nnifs, nefħa fil-wiċċ).
English: Bone pain Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Maltese: (majalġja, artralġja, uġigħ fles tremitajiet, uġigħ fid-dahar, uġigħ muskoluskeletrali,
English: Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Maltese: Il-fattur uman li jistimola l-kolonji ta' granuloċiti (G-CSF) huwa glikoproteina li tirregola l produzzjoni u l-ħelsien ta' newtrofili mill-mudullun.
English: Non-cardiac chest pain 1
Maltese: Uġigħ fis-sider li mhux kardijaku 1
English: 1 See section “Description of selected adverse reactions” below.
Maltese: 1 Ara sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” ta' taħt.
English: Injection site reactions2
Maltese: Pass 3: Injetta
English: • Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Maltese:  Fsada fil-pulmun (emoraġija pulmonari)  Sindrome ta' Stevens-Johnson, li tista' tidher bħala rqajja' ċirkulari ħomor li jixbhu l-bersalli, ħafna drabi b'infafet ċentrali fuq it-torso, tqaxxir tal-ġilda, ulċeri fil-ħalq, il-griżmejn, limnieħer, il-ġenitali u l-għajnejn u li tista' tibda b'deni u sintomi li jixbhu l-influwenza.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' pegfilgrastim* f'0.6 ml ta' soluzzjoni għall-injezzjoni.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
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: Dejta 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: Thrombocytope nia1
Maltese:  problemi biex tieħu n-nifs.
English: PharmaKorell GmbH Marie-Curie-Str. 8 79539 Loerrach Germany
Maltese: 79539 Loerrach
English: Used syring barrel
Maltese: Bettija tassiringa użata
English: Remove and save the pre-filled syringe label
Maltese: Molla protettiva ta labra użata
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 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: Renal and urinary disorders
Maltese: Disturbi fil-kliewi jew sistema urinarja
English: The safety and efficacy of Pelmeg 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' Pelmeg ma' ċitoġenetiċi t(15;17) f'pazjenti taħt il-55 sena li reġgħet qabdithom lewkimja majelojde akuta mill-ġdid, għadhom ma ġewx stabbiliti.
English: Splenomegaly2; Splenic rupture2
Maltese: Għatu tal-labra imneħħi
English: What Pelmeg looks like and contents of the pack Pelmeg is a clear, colourless solution for injection in a pre-filled syringe (6 mg/0.6 mL).
Maltese: Pelmeg huwa soluzzjoni ċara u bla kulur għall-injezzjoni ġo siringa mimlija għal-lest (6 mg/0.6 ml).
English: NAME OF THE MEDICINAL PRODUCT Pelmeg 6 mg solution for injection pegfilgrastim NAME OF THE MARKETING AUTHORISATION HOLDER Mundipharma EXPIRY DATE
Maltese: Informazzjoni għall-utent Pelmeg 6 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest pegfilgrastim
English: (ng/ml)
Maltese: 50 mg / mL.
English: Pelmeg is for use in adults aged 18 and over.
Maltese: Pelmeg huwa għall-użu f'adulti minn 18-il sena 'l fuq.
English: • Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.