FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/554/001 - Cartons of 14 film-coated tablets in all aluminium blisters EU/1/09/554/002 - Cartons of 28 film-coated tablets in all aluminium blisters EU/1/09/554/003 - Cartons of 30 film-coated tablets in all aluminium blisters EU/1/09/554/004 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/1/09/554/005 - Cartons of 84 film-coated tablets in all aluminium blisters EU/1/09/554/006 - Cartons of 90 film-coated tablets in all aluminium blisters EU/1/09/554/007 - Cartons of 100 film-coated tablets in all aluminium blisters EU/1/09/554/008 - Cartons of 7 film-coated tablets in all aluminium blisters
Maltese: - Kaxex ta' 50x1 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/09/554/005 - Kaxex ta' 84 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/09/554/006 - Kaxex ta' 90 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/09/554/007 - Kaxex ta' 100 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/09/554/008 - Kaxex ta' 7 pilloli miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum
English: It also contains hydrogenated castor oil.
Maltese: Castor oil, hydrogenated
English: The other ingredients are (see section 2 ‘Clopidogrel ratiopharm contains hydrogenated castor oil'):
Maltese: Is-sustanzi l-oħra huma (ara sezzjoni 2 ‘Clopidogrel ratiopharm fih il-castor oil idroġenat'):
English: EU/1/09/554/001 - 14 film-coated tablets EU/1/09/554/002 - 28 film-coated tablets EU/1/09/554/003 - 30 film-coated tablets EU/1/09/554/004 - 50 film-coated tablets EU/1/09/554/005 - 84 film-coated tablets EU/1/09/554/006 - 90 film-coated tablets EU/1/09/554/007 - 100 film-coated tablets EU/1/09/554/008 - 7 film-coated tablets
Maltese: EU/1/09/554/001 - Kaxex ta' 14-il pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/09/554/002 - Kaxex ta' 28 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/09/554/003 - Kaxex ta' 30 pillola miksija b'rita fil-folji kollha kemm huma ta' l-aluminjum EU/1/09/554/004
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin,
Maltese: Kategorija farmakoterapewtika: inibituri ta' l-aggregazzjoni tal-plejtlets eskl. heparin, Kodiċi ATC:
English: -Very rare side effects (may affect up to 1 in 10,000 people):
Maltese: -Effetti sekondarji rari ħafna: (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna)
English: Alu/Alu blisters containing 7, 14, 28, 30, 50, 84, 90 and 100 film-coated tablets packed in cardboard
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folji Alu/Alu li fihom 7, 14, 28, 30, 50, 84, 90 u 100 pillola miksija b'rita, ippakkjati f'kaxxi tal
English: PHARMACOLOGICAL PROPERTIES
Maltese: Farmakoġenetika
English: UAB "Sicor Biotech" Eesti filiaal Tel: +372 661 0801
Maltese: UAB "Sicor Biotech" filiāle Latvijā Tel: +371 677 849 80
English: They are supplied in cardboard cartons containing 7, 14, 28, 30, 50, 84, 90 and 100 tablets in aluminium blisters.
Maltese: Huma fornuti f'kaxex tal-kartun li fihom 7, 14, 28, 30, 50, 84, 90 u 100 pillola ġo folji talaluminju.
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis Acute liver failure, hepatitis, abnormal liver function test Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous, urticaria, eczema, lichen planus Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: Dermatite bulloża (nekroliżi tossika ta' lepidermide, Sindromu ta' Stevens Johnson, eritema multiforme), anġjoedima, sindromu ta' sensittività eċċessiva kkawżat millmediċina, raxx kkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS), raxx eritematika, urtikarja, ekżema, lichen planus
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Archie Samuel s.r.o.
Maltese: FIS-SUQ Archie Samuel s.r.o.
English: Tests are available to determine a patient's CYP2C19 genotype.
Maltese: Jeżistu testijiet li jidentifikaw il-ġenotip CYP2C19 ta' pazjent.
English: In addition, clinical tolerance was good in
Maltese: Effikaċja klinika u sigurtà
English: Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)* Hallucinations, confusion
Maltese: Reazzjoni ta' sensittività eċċessiva li hija komuni għat-tipi differenti ta' thienopyridines (bħal ticlopidine, prasugrel) (ara sezzjoni 4.4)*
English: While you are taking Clopidogrel ratiopharm:
Maltese: Tiħux Clopidogrel ratiopharm:
English: Vertigo
Maltese: Ematurja
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel ratiopharm 75 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Clopidogrel ratiopharm 75 mg pilloli miksija b'rita
English: However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents and GPIIb/IIIa antagonists without evidence of clinically
Maltese: Madankollu, pazjenti li daħlu fi studji kliniċi bi clopidogrel ngħataw varjeta` ta' prodotti mediċinali fl-istess ħin u dawn kienu jinkludu dijuretiċi, beta blockers ACEI, antagonisti tal-kalċju, sustanzi li jbaxxu l-kolesterol, vasodilataturi koronarji, sustanzi kontra d-dijabete (inkluża l-insulina), sustanzi antiepilettiċi, u antagonisti GPIIb/IIIa mingħajr ma kien hemm evidenza ta' interazzjonijiet avversi klinikament sinifikanti.
English: Clopidogrel ratiopharm 75 mg film-coated tablets Clopidogrel
Maltese: Clopidogrel ratiopharm 75 mg pilloli miksija b'rita Clopidogrel
English: Excipients with known effect: Each film-coated tablet contains 3.80 mg of hydrogenated castor oil.
Maltese: Kull pillola miksija b'rita fiha 3.80 mg ta' castor oil idroġenat.
English: Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Maltese: Eliminazzjoni Wara doża orali ta' clopidogrel 14C-tikkettat fil-bniedem, bejn wieħed u ieħor 50% kien mneħħi fl urina u bejn wieħed u ieħor 46% ħareġ fl-ippurgar fl-intervall ta' 120 siegħa wara d-dożaġġ.
English: In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR = 23.7%; CI: 8.9 to
Maltese: F'analiżi tas-sottogrupp permezz ta' kondizzjoni qwalifikanti (infart mijokardijaku, puplesija iskemika, u PAD) il-benefiċċju jidher li kien l-ikbar (b'relevanza statistika ta' p=0.003) f'pazjenti li ddaħħlu minħabba PAD (speċjalment dawk li kellhom ukoll storja medika ta' infart mijokardijaku) (RRR = 23.7 %; CI: minn 8.9 sa 36.2) u inqas (mhux differenti b'mod sinifikanti minn ASA) f'pazjenti b'puplesija (RRR = 7.3 %; CI: minn -5.7 sa 18.7 [p=0.258]).
English: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain;
Maltese: Suffejra; uġigħ addominali qawwi flimkien ma' jew mingħajr uġigħ fid-dahar; deni, diffikultajiet finnifs kultant assoċjati mas-sogħla; reazzjonijiet allerġiċi ġeneralizzati ( per eżempju, sensazzjoni ta' sħana ma' ġismek kollu b'skonfort ġenerali f'daqqa sakemm tħossok ħażin); nefħa fil-ħalq; infafet filġilda; reazzjoni allerġika fil-ġilda; uġigħ fil-ħalq (stomatite); tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ fil-ġogi; uġigħ muskolari; tibdil fit-togħma ta' l-ikel.
English: Tests are available to identify a patient's CYP2C19 genotype (see section 5.2).
Maltese: Testijiet li jidentifikaw il-ġenotip ta' CYP2C19 f'pazjent huma disponibbli.
English: Patients should be evaluated for history of hypersensitivity to another thienopyridine (such as ticlopidine, prasugrel) since allergic cross-reactivity among thienopyridines has been reported (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu evalwati għal passat mediku ta' sensittività eċċessiva għal thienopyridine ieħor (bħal ticlopidine, prasugrel) peress li ġiet irrapportata reazzjoni allerġika li hija komuni għat-tipi differenti ta' thienopyridines (ara sezzjoni 4.8).
English: If you forget to take Clopidogrel ratiopharm
Maltese: Mediċini oħra u Clopidogrel ratiopharm
English: Clopidogrel ratiopharm is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Maltese: Clopidogrel ratiopharm jittieħed mill-adulti biex inaqqas ir-riskju li emboli tad-demm (trombi) jifformaw fl-arterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista' jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: Clopidogrel ratiopharm contains hydrogenated castor oil which may cause stomach upset and
Maltese: Clopidogrel ratiopharm fih castor oil idroġenat Dan jista' jikkawża taqlib ta' l-istonku jew dijarrea
English: Retroperitoneal haemorrhage
Maltese: Puplesija iskemika reċenti
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Maltese: Għandek ukoll tgħid lit-tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika (magħrufa wkoll bħala Purpura Trombotika Tromboċitopenika jew TTP) li tinkludi deni u tbenġil taħt ilġilda li jidher bħal tikek ħomor irqaq, flimkien ma' jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal-ġilda jew ta' l-għajnejn (suffejra) (ara sezzjoni 4 'Effetti sekondarji possibbli').
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Maltese: Insuffiċjenza akuta talfwied, epatite, test talfunzjoni tal-fwied anormali
English: Absorption is at least 50%, based on urinary
Maltese: L-assorbiment huwa millinqas ta' 50%, skond l-eskrezzjoni fl-urina ta' metaboliti ta' clopidogrel.
English: 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]).
Maltese: (RRR = -4.0 %; CI: minn -22.5 sa 11.7 [p=0.639]).
English: Biotransformation
Maltese: Investigazzjonijiet
English: Pregnancy and breast-feeding It is preferable not to take this product during pregnancy.
Maltese: Tqala u treddigħ Huwa preferibbli li ma tiħuxdan il-prodott waqt it-tqala.
English: • Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial
Maltese: Pazjenti li għandhom infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard stabbilit ta' l-arterji periferali.
English: If you experience prolonged bleeding when taking Clopidogrel ratiopharm.
Maltese: Jekk tbati minn fsada għal perjodu twil waqt li qed tieħu Clopidogrel ratiopharm.
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Maltese: Ulċera gastrika u ulċera dwodenali, gastrite, rimettar, tqalligħ, stitikezza, gas flistonku retroperitonew gastrointestinali u tarretroperitonew b'eżitu fatali, pankreatite, kolite (inklużi kolite ulċerattiva jew limfoċitika), stomatite
English: Talk to your doctor or pharmacist before taking Clopidogrel ratiopharm: if you have a risk of bleeding such as a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Maltese: Twissijiet u prekawzjonijiet Kellem lit-tabib jew lill-ispiżjar tiegħek qabel tibda tieħu Clopidogrel ratiopharm: jekk tinsab f'riskju ta' fsada bħal: kundizzjoni medika li tpoġġik f'riskju ta' fsada interna (bħal ulċera fl-istonku) mard fid-demm li jwassal għal fsada interna (dmija f'xi tessuti, organi jew ġogi ta' ġismek); ferita serja riċenti; operazzjoni riċenti (anki tas-snien); operazzjoni li ser issirlek (anki tas-snien) fis-sebat ijiem li ġejjin.
English: In CAPRIE, in patients treated with either clopidogrel or ASA, the overall incidence of any bleeding was 9.3%.
Maltese: F'CAPRIE, f'pazjenti li ngħataw jew clopidogrel jew ASA, l-inċidenza totali ta' kull tip ta' fsada kienet ta' 9.3 %.
English: Clopidogrel ratiopharm with food and drink Clopidogrel ratiopharm may be taken with or without food.
Maltese: Meta tiehu Clopidogrel ratiopharm ma' ikel u xorb Clopidogrel ratiopharm jista' jittieħed ma' l-ikel jew mingħajru.
English: Method of administration For oral use
Maltese: MANIFATTUR RESPONSABBLI
English: Clopidogrel must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation.
Maltese: Sabiex jipproduċi l-metabolit attiv li jimpedixxi l-aggregazzjoni tal-plejtlits, clopidogrel irid jiġi mmetabolizzat mill-enzimi CYP450.
English: Clopidogrel ratiopharm contains hydrogenated castor oil This may cause stomach upset or diarrhoea.
Maltese: Ingħatajt Clopidogrel ratiopharm biex inaqqas ir-riskju ta' emboli tad-demm u l-konsegwenzi severi tagħhom għaliex:
English: In the long-term safety follow-up of this study, 26 patients with the shunt still in place at one year of age received clopidogrel up to 18 months of age.
Maltese: Bħala tkomplija tal-istudju biex tiġi studjata s-sigurtà fit-tul, 26 pazjent li kellhom età ta' sena u bid-devjazzjoni kirurġika għada f'postha, irċevew clopidogrel sa 18-il xahar ta' età.
English: Tel.: +48 22 345 93 00
Maltese: Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00
English: Hold down.
Maltese: Għatu ta'
English: Date of last renewal: 16 July 2007
Maltese: Data ta' l-aħħar tiġdid: 16 ta' Lulju 2007
English: Pharmacotherapeutic group: Cytokines, ATC Code: L03AA13
Maltese: Ċitokini, Kodiċi ATC: L03AA13
English: INFORMATION IN BRAILLE Neupopeg
Maltese: INFORMAZZJONI BIL-BRAILLE Neupopeg
English: Neupopeg contains sorbitol.
Maltese: Neupopeg fih sorbitol.
English: Manufacturer:
Maltese: Apparat:
English: The active substance is pegfilgrastim.
Maltese: Is-sustanza attiva hi pegfilgrastim.
English: At start, keep thumb clear of green button
Maltese: Fil-bidu, żżommx sebgħek At start, keep thumb clear of il-kbir fuq il-buttuna ħadra green button
English: You will hear a “click”.
Maltese: Għandek tisma' ħoss ta' “klik”.
English: The concentration is 10 mg/ml based on protein only**.
Maltese: Ilkonċentrazzjoni hija ta' 10 mg/ml bbażata fuq il-proteina biss**.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2002
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 22 ta' Awwissu 2002
English: Neupopeg contains the active substance pegfilgrastim.
Maltese: Neupopeg fih is-sustanza attiva pegfilgrastim.
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' newtropenja bid-deni kient aktar baxxa filgrupp ta' pegfilgrastim meta mqabbla mal-grupp tal-plaċebo (1% versus 14%, p<0.001; u 2% versus 10%, p<0.001).
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' polyethyleneglycol (PEG) ta' 20 kd.
English: For more information, see section 5.1.
Maltese: Għal aktar informazzjoni, are sezzjoni 5.1.
English: A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: A MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA' LAWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: Rare (≥ 1/10,000 to < 1/1,000) pulmonary adverse effects including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Maltese: Effeti mhux mixtieqa rari (≥ 1/10,000 u < 1/1,000) tal-pulmun fosthom pulmonite interstizjali, nefħa minn akkumulazzjoni ta' ilma fil-pulmun, infiltrati pulmonari, jew fibrożi pulmonari ġew rrappurtati.
English: Very rare (< 1/10,000) 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: Każijiet rari ħafna (< 1/10,000) ta' żjidiet f'ALT (alanine aminotransferase) jew f'AST (aspartate aminotransferase), fit-testijiet tal-funzjoni tal-fwied (LFTs) , ġew osservati f'pazjenti wara li ngħataw pegfilgrastim wara kimoterapija ċitotossika.
English: Excipients known to have a recognised action: sorbitol E420, sodium acetate (see section 4.4).
Maltese: Sustanzi mhux attivi li għandhom azzjoni magħrufa: sorbitol E-420, sodium acetate (ara sezzjoni 4.4).
English: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults.
Maltese: Tagħrif limitat jindika li l-farmakokinetika ta' pegfilgrastim fl-anzjani (> 65 sena) hija simili għal dik fl-adulti.
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of Neupopeg.
Maltese: Din iż-żjieda taċ-ċelluli bojod hija temporanja, tipikament osservata 24 sa 48 siegħa wara l-għoti u hija konsistenti ma' l-effetti farmakodinamiċi ta' Neupopeg.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U
English: Single use only.
Maltese: L-Istati Uniti
English: In a second study (n=310), which used a weight-adjusted dose (100 microgramsg/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 -0.36, 0.30).
Maltese: Fi studju ieħor (n=310), fejn intużat doża maħduma skond il-piż (100 mikrogrammi/kg), id-dewmien medju tan-newtropenja grad 4 għall-grupp b'pegfilgrastim kienet ta' 1.7 jiem, mqabbel ma' 1.8 jiem tal-grupp b'filgrastim (differenza ta' 0.03 jiem, 95% CI -0.36, 0.30).
English: • if you are hypersensitive (allergic) to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of Neupopeg.
Maltese: • jekk tbati minn sensittività eċċessiva (allerġija) għal pegfilgrastim, filgrastim, proteini ġejjin minn E.Coli, jew xi sustanza oħra ta' Neupopeg.
English: Pegfilgrastim Conc.
Maltese: Pegfilgrastim2.
English: Neupopeg is for use in adults aged 18 and over.
Maltese: Neupopeg huwa għall-użu f' adulti ta' 18-il sena ‘l fuq.
English: • a pre-filled syringe of Neupopeg; and
Maltese: ● pinna ġdida mimlija għal-lest b'Neupopeg; u
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-newtropenja 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: NAME OF THE MEDICINAL PRODUCT Neupopeg 6 mg injection Pegfilgrastim
Maltese: Neupopeg 6 mg Pegfilgrastim SC
English: Rare (≥ 1/10,000 to < 1/1,000) cases of thrombocytopenia and leukocytosis have been reported.
Maltese: Każijiet rari (≥ 1/10,000 u < 1/1,000) ta' tromboċitopenija u lewkoċitożi ġew rrappurtati.
English: Specific interaction or metabolism studies have not been performed, however, clinical studies have not indicated an interaction of Neupopeg with any other medicinal products.
Maltese: Ma sarux studji speċifiċi dwar l-interazzjonijiet u l-metaboliżmu, madanakollu, studji kliniċi ma indikawx interazzjoni ta' Neupopeg ma' prodotti mediċinali oħra.
English: Neupopeg contains less than 1 mmol (23 mg) sodium per 6 mg dose, i.e. essentially ‘sodium-free'.
Maltese: Neupopeg fih anqas minn 1 mmol (23 mg) sodium għal kull doża ta' 6 mg, għalhekk huwa essenzjalment ‘mingħajr sodium'.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pinna mimlija għal-lest fiha 6 mg pegfilgrastim f'0.6ml (10 mg/ml) soluzzjoni għall-injezzjoni.
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 Adult Respiratory Distress Syndrome (ARDS).
Maltese: Bidu ta' sinjali pulmonari bħal sogħla, deni u qtugħ ta' nifs flimkien ma' sinjali radjuloġiċi ta' infiltrati pulmonari, u deterjorazzjoni tal-funzjoni tal-pulmun flimkien ma' żjieda fl-għadd ta' newtrofili jistgħu jkunu sinjali tal-bidu tas-sindromu tat-tbatija respiratorja fl-adulti (ARDS).
English: Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were common (≥ 1/100 to < 1/10); reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were very common (≥ 1/10) in patients receiving Neupopeg following cytotoxic chemotherapy.
Maltese: Żjidiet ħfief għal moderati li jerġgħu għan-normal, u mingħajr effetti kliniċi assoċjati, f'uric acid u f' alkaline phosphatase kienu komuni (≥ 1/100 u < 1/10); żjidiet ħfief għal moderati li jerġgħu għannormal, u mingħajr effetti kliniċi assoċjati, f'lactate dehydrogenase, kienu komuni ħafna (≥ 1/10) f'pazjenti li ngħataw Neupopeg wara l-kimoterapija ċitotossika.
English: In a 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: Fi studju open label ta' doża waħda (n=31), varji stadji ta' indeboliment renali, inkluż mard renal ta' l-aħħar stadju, ma kellhom l-ebda impatt fuq il-farmakokinetika ta' pegfilgrastim.
English: 2 release
Maltese: .2 Inkompatibilitajiet
English: • if you have an allergy to latex.
Maltese: • jekk inti allerġiku għall-latex.
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Maltese: Pegfilgrastim huwa proteina magħmula millbijoteknoloġija f'batterji li jissejħu E.
English: White blood cell counts of 100 x 109/l or greater have been observed in less than 1% of patients receiving Neupopeg.
Maltese: Għadd taċ-ċelluli bojod ta' 100 x 109 /l jew aktar ġew osservati f'inqas minn 1% tal-pazjenti li ngħataw Neupopeg.
English: Marketing Authorisation Holder:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq: