FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreased milk production in nursing mothers has been reported with pseudoephedrine sulphate, a component of Aerinaze.
Maltese: Tnaqqis fil-produzzjoni tal-ħalib f'nisa li jreddgħu kien rappurtat bi pseudoephedrine sulphate, wieħed mill-komponenti ta' Aerinaze.
English: No clinically relevant interactions or changes in desloratadine plasma concentrations were observed in clinical trials with desloratadine in which erythromycin or ketoconazole were co-administered.
Maltese: Ma dehrux interazzjonijiet klinikament rilevanti jew bidliet tal-konċentrazzjonijiet ta' desloratadine fil-plażma fi provi kliniċi b'desloratadine mogħti ma' erythromycin jew ketoconazole flimkien.
English: Insomnia, somnolence, sleep disorder, nervousness
Maltese: Insomnja, ħedla ta' ngħas, disturb fl-irqad, nervi Aġitazzjoni, ansjetà, irritabilità
English: In controlled clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.
Maltese: Fi provi kliniċi kontrollati, bid-doża rakkomandata ta' 5 mg kuljum, ma kienx hemm aktar każijiet ta' ngħas meta mqabbel mal-plaċebo.
English: What Aerinaze is
Maltese: X'inhu Aerinaze
English: • stomach ache
Maltese: • vista mċajpra
English: It is advisable to limit treatment to about 10 days, as during chronic administration the activity of pseudoephedrine sulphate may diminish.
Maltese: Huwa rrakkomandat li tillimita l-kura għal madwar 10 ijiem, minħabba li waqt għoti kroniku l-attività ta' pseudoephedrine sulphate tista' tonqos.
English: One of the active ingredients in Aerinaze, pseudoephedrine sulphate, has the potential to be abused and large doses of pseudoephedrine sulphate can be toxic.
Maltese: Wieħed mis-sustanzi attivi f'Aerinaze, pseudoephedrine sulphate, jista' jiġi abbużat u dożi għoljin ta' pseudoephedrine sulphate jistgħu jkunu tossiċi.
English: This is especially important if you are taking: - digitalis, a medicine used to treat certain heart disorders - medicines for blood pressure (e.g. α-methyldopa, mecamylamine, reserpine, veratrum alkaloids and guanethidine) - decongestants by oral or nasal route (such as phenylpropanolamine, phenylephrine, ephedrine,
Maltese: Dan jgħodd l-aktar jekk qed tieħu: - diġitalis, mediċina li tintuża għal kura ta' ċerti tipi ta' mard tal-qalb - mediċini għall-pressjoni (eż. -methyldopa, mecamylamine, reserpine, veratrum alkaloids u guanethidine) - dekonġestjonanti mill-ħalq jew mill-imnieħer (bħal phenylpropanolamine, phenylephrine,
English: Pruritus
Maltese: Sentejn
English: The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot be fully excluded.
Maltese: L-enzima responsabbli għall-metaboliżmu ta' desloratadine s'issa għadha ma ġietx identifikata, u għalhekk, xi interazzjonijiet ma' prodotti mediċinali oħra ma jistgħux jiġu esklużi kompletament.
English: The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
Maltese: In-nuqqas ta' riskju ta' kanċer intwera bi studji li saru b'desloratadine u loratadine.
English: Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
Maltese: Stimulazzjoni tas-sistema nervuża ċentrali b'konvulżjonijiet jew kollass kardjovaskulari flimkien ma' pressjoni baxxa jistgħu jiġu kkawżati minn amines simpatomimetiċi.
English: Cases of severe skin reactions, including signs and symptoms such as fever, reddening of the skin, or many small pimples, have been reported with pseudoephedrine-containing products.
Maltese: Ġew irrappurtati każijiet ta' reazzjonijiet severi fil-ġilda, inklużi sinjali u sintomi bħal deni, ġilda tiħmar jew ħafna ponot żgħar bi prodotti li fihom pseudoephedrine.
English: Athletes should be informed that treatment with pseudoephedrine sulphate could lead to positive doping tests.
Maltese: L-atleti għandhom jiġu avżati li l-kura b'pseudephedrine sulphate tista' twassal għal testijiet ta' doping pożittivi.
English: • a history of haemorrhagic stroke or with risk factors which could increase the risk of haemorrhagic stroke.
Maltese: • b'storja medika ta' puplesija emorraġika jew b'fatturi ta' riskju li jistgħu jżidu r-riskju ta' puplesija emorraġika.
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 5204 201 msd.slovenia@merck.com
English: • blurry vision
Maltese: • grieżem xotti
English: Do not store above 30°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30ºC.
English: Therefore, if surgery is scheduled, it is preferable to discontinue treatment 24 hours before anaesthesia.
Maltese: Għalhekk jekk ikun hemm skedat li ssir operazzjoni, ikun aħjar jekk il-kura titwaqqaf 24 siegħa qabel il-loppju.
English: Risks of abuse
Maltese: Riskju ta' abbuż
English: Very rarely: the following other side effects reported during the marketing of desloratadine, may affect up to 1 in 10,000 people
Maltese: B'mod rari ħafna: l-effetti sekondarji oħra li ġejjin irrappurtati waqt li desloratadine tqiegħed fis-suq, jistgħu jaffettwaw sa persuna waħda minn kull 10,000
English: • Patients receiving digitalis (see section 4.5)
Maltese: • Pazjenti li jkunu qed jirċievu diġitalis (ara sezzjoni 4.5)
English: • severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling)
Maltese: • reazzjonijiet allerġiċi severi (tbatija biex tieħu n-nifs, tħarħir, ħakk, ħorriqija u nefħa)
English: Aerinaze is indicated in adults and adolescents 12 years and older for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Maltese: Aerinaze huwa indikat f'adulti u adoloxxenti minn 12-il sena 'l fuq għall-kura tas-sintomi ta' rajnajtis allerġiku ta' l-istaġun meta jkun hemm ukoll imnieħer imblukkat.
English: There were no significant differences in the efficacy of Aerinaze tablets across subgroups of patients defined by gender, age, or race.
Maltese: Ma kienx hemm differenzi sinifikanti fl-effikaċja tal-pilloli Aerinaze fis-sottogruppi ta' pazjenti imqassma skond is-sess, età jew razza.
English: Alcohol use should be avoided during Aerinaze treatment.
Maltese: Użu ta' alkoħol għandu jiġi evitat waqt kura b'Aerinaze.
English: • stomach flu
Maltese: • infjammazzjoni tal-fwied
English: • inflammation of the sinus
Maltese: • infjammazzjoni tas-sinus
English: Aerinaze is also contraindicated in patients with:
Maltese: Il-kombinazzjonijiet li ġejjin mhumiex irrakkomandati:
English: MA (EU) number
Maltese: Numru tal-UE
English: Content (concentration)
Maltese: Kontenut (konċentr azzjoni)
English: --1 Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/turkey/Turkey/1/2005 (H5N1) - like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
Maltese: Razza li tixbah lill- A/turkey/Turkey/1/2005 (H5N1) (NIBRG-23) (clade 2.2.1) 7.5 mikrogrammi** għal kull doża ta' 0.5 ml
English: Adjuvant MF59C.1 containing: squalene
Maltese: L-adjuvant MF59C.1 fih: squalene polysorbate 80
English: 10 pre-filled syringes
Maltese: 10 siringi mimlijin għal-lest
English: 1 pre-filled syringe
Maltese: sorbitan trioleate
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istat(i) Membru(i) jew l-Istat(i) Membru(i) ta' Referenza jekk applikabbli, għandhom jiżguraw li l-kondizzjonijiet li ġejjin ikunu sodisfatti mill-MAH(s):
English: The MAHs shall identify a specific patient population for which the benefits of the product outweigh the risk.
Maltese: L-MAHs għandhom jidentifikaw popolazzjoni speċifika ta' pazjenti li għalihom il-benefiċċji tal-prodott huma akbar mir-riskju.
English: Annex IV Conditions for lifting the suspension of the marketing authorisation
Maltese: Anness IV
English: 02181 Espoo Finland
Maltese: 02181 Espoo
English: Roche România SRL Piaţa Presei Libere, Nr. 3-5, Clădirea City Gate-Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti, România
Maltese: Ir-Rumanija Roche România SRL Piaţa Presei Libere, Nr. 3-5, Clădirea City Gate-Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti, România.
English: Roche Pharma AG Emil-Barell-Str. 1
Maltese: Il-Ġermanja Roche Pharma AG Emil-Barell-Str.
English: Rocephin zur Infusion 2 g 2 g
Maltese: Rocephin zur Infusion 2 g
English: Roche (Hungary) Ltd. Edison utca 1
Maltese: Roche (Hungary) Ltd.
English: Roche Oy Klovinpellontie 3 PL 12
Maltese: Il-Finlandja Roche Oy Klovinpellontie 3
English: Rocephalin cum lidocain 1 g
Maltese: Rocephalin cum lidocain
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fl
English: Rocephin 2 i.v.
Maltese: Rocephin 2 i.v. 2 g
English: Germany
Maltese: France
English: Rocephin 1 i.v.
Maltese: Rocephin 1 i.v. 1 g
English: Rocephin i.v.
Maltese: Rocephin i.v. 1g
English: la Selva, 135
Maltese: Avda. la Selva, 135
English: - Temperature rise of maximum 1.1 °C was observed.
Maltese: - Ġiet osservata żieda massima ta' 1.1°C fit-temperatura.
English: ATCvet code: QI09AB02.
Maltese: Kodiċi ATC veterinarja QI09AB02.
English: Aluminium hydroxide ............................................................................ 2.117 mg (aluminium) DEAE-dextran
Maltese: Aluminium hydroxide ............................................................................... 2.117 mg (aluminju) DEAE-Dextran
English: EU/2/17/214/001 (10 doses (10 ml)) EU/2/17/214/002 (50 doses (50 ml)) EU/2/17/214/003 (100 doses (100 ml)) EU/2/17/214/004 (250 doses (250 ml)) EU/2/17/214/005 (10 x 10 doses (10 ml))
Maltese: EU/2/17/214/001 (10 doża (10 ml)) EU/2/17/214/002 (50 doża (50 ml)) EU/2/17/214/003 (100 doża (100 ml)) EU/2/17/214/004 (250 doża (250 ml)) EU/2/17/214/005 (10 x 10 dożi (10 ml))
English: Whitish suspension.
Maltese: Suspensjoni bajdanija.
English: Date of first authorisation: 17/08/2017
Maltese: Data tal-ewwel awtorizzazzjoni: 17/08/2017
English: 10 doses (10 ml) 50 doses (50 ml) 100 doses (100 ml) 250 doses (250 ml) 10 x 10 doses (10 ml)
Maltese: 10 dożi (10 ml) 50 doża (50 ml) 100 doża (100 ml) 250 doża (250 ml) 10 x 10 dożi (10 ml)
English: Adjuvants:
Maltese: Adjuvanti:
English: Store and transport refrigerated (2 ºC - 8 ºC).
Maltese: Aħżen u ttrasporta fil-friġġ (2°C - 8°C).
English: Recombinant verotoxin 2e of E. coli.
Maltese: Verotoxin 2e rikombinanti tal-E. coli
English: Polyethylene (PET) vials of 10, 50, 100 and 250 ml.
Maltese: Kunjetti tal-polyethylene (PET) ta' 10, 50, 100 u 250 ml.
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia).
Maltese: Immunoloġiċi għal suidae, tilqim batteriku inattivat (inkluż il mikoplażma, it-tossojde u l-klamidja).
English: 10 doses (10 ml) 50 doses (50 ml)
Maltese: 50 doża (50 ml)
English: Temperatures returned to normal within 24 hrs.
Maltese: It-temperaturi rritornaw għan-normal fi żmien 24 siegħa.
English: Active immunisation of piglets from 2 days of age to prevent mortality and reduce clinical signs of oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain during the finishing period in the face of infections with verotoxin 2e producing E. coli until slaughter from 164 days of age.
Maltese: It-tlaqqim attiv ta' majjalini mill-età ta' jumejn għall-prevenzjoni tal-mortalità u t-tnaqqis ta' sinjali kliniċi tal-marda tal-edema (kkawżata mill-verotossina 2e prodotti mill-E. coli) u għat-tnaqqis tażżieda ta' kuljum fil-piż tul l-aħħar fażi minħabba infezzjonijiet bil-verotossina li tipproduċi l-E. coli sal-qatla mill-età ta' 164 jum.
English: The vaccine consisting of recombinant verotoxin 2e stimulates an active immunity against VT2e toxin produced by the causative agent of oedema disease in pigs.
Maltese: Il-vaċċin li jikkonsisti f'verotoxin 2e rikombinanti jistimula immunità attiva kontra t-tossin VT2e prodott mill-aġent kawżattiv tal-marda tal-edema fil-ħnieżer.
English: la Selva, 135 17170 Amer (Girona) SPAIN
Maltese: Laboratorios Hipra, S.A. Avda. la Selva, 135 17170 Amer (Girona) SPAIN
English: Aluminium hydroxide (Al 3+) ........................................................................... 2.117 mg DEAE-dextran ...................................................................................................... 10 mg.
Maltese: Aluminium hydroxide (Al 3+) ...........................................................................
English: Allow the vaccine to reach room temperature (15-25 ºC) before administration.
Maltese: Ħalli l-vaċċin jilħaq it-temperatura ambjentali (15-25 ºC) qabel tagħtih.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Cardboard box with vials of 10, 50, 100 or 250 doses.
Maltese: Kaxxa tal-kartun b'kunjetti ta' 10, 50, 100 jew 250 doża.
English: Very common adverse reactions: - Mild inflammation at the injection site (< 5 cm in diameter) that typically resolves within three days post-vaccination without treatment.
Maltese: Reazzjonijiet avversi komuni ħafna: - Infjammazzjoni ħafifa fis-sit tal-injezzjoni (< 5 cm bħala dijametru) li normalment tgħaddi fi żmien tlett ijiem wara t-tilqima mingħajr kura.
English: Veterinary medicinal product subject to prescription.
Maltese: kwalunkwe prodott mediċinali veterinarju ieħor.
English: Each dose of 1 ml contains: Recombinant verotoxin 2e of E. coli ................................................................ RP ≥ 1.50.
Maltese: Verotoxin 2e rikombinanti tal-E. Coli .............................................................
English: EXP {month/year} Once broached use within 10 hours.
Maltese: Ladarba jittaqqab, uża fi żmien 10 sigħat.
English: Cardboard box with 1 PET vial of 250 doses (250 ml).
Maltese: Kaxxa tal-kartun b'kunjett 1 ta' 250 doża (250 ml).
English: Cardboard box with 1 PET vial of 100 doses (100 ml).
Maltese: Kaxxa tal-kartun b'kunjett 1 ta' 100 doża (100 ml).
English: Pigs.
Maltese: Ħnieżer.
English: Whitish suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni.
English: Administer a single intramuscular injection of 1 ml in the neck muscles.
Maltese: U METODU TA' AMMINISTRAZZJONI Użu għal ġol-muskoli.
English: Cardboard box with 1 polyethylene (PET) vial of 10 doses (10 ml).
Maltese: Kaxxa tal-kartun b'kunjett 1 ta' 10 dożi (10 ml).
English: Pack sizes:
Maltese: Teл:
English: Recombinant verotoxin 2e of E. coli ................................................................ RP* ≥ 1.50 * RP - relative potency (ELISA)
Maltese: Verotoxin 2e tal-E. Coli rikombinanti ..............................................................
English: Cardboard box with 10 vials of 10 doses (10 ml).
Maltese: Kaxxa tal-kartun b'10 kunjetti ta' 10 dożi (10 ml).
English: Name and address of the manufacturers of the biological active substance: Laboratorios Hipra, S.A.
Maltese: Isem u indirizz tal-manufattur tas-sustanza bioloġika attiva
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Maltese: TAS-SUSTANZA(I) ATTIVA(I)
English: Cardboard box with 1 PET vial of 50 doses (50 ml).
Maltese: Kaxxa tal-kartun b'kunjett 1 ta' 50 doża (50 ml).
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju lill-ispiżjar tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: The vials are closed with a bromobutyl rubber stopper and aluminium cap.
Maltese: VETERINARJU VEPURED Suspensjoni għall-injezzjoni għall-ħnieżer.
English: Vial of 100 or 250 doses.
Maltese: Kunjett ta' 100 jew 250 doża
English: Cardboard box with vial of 10 x10 doses.
Maltese: Kaxxa tal-kartun b'kunjett ta' 10 x10 dożi
English: VEPURED suspension for injection for pigs recombinant verotoxin 2e of E. coli
Maltese: VETERINARJU VEPURED Suspensjoni għall-injezzjoni tal-ħnieżer
English: Duration of immunity: 112 days after vaccination.
Maltese: 112-il ġurnata wara t-tilqim.
English: HIPRA UK AND IRELAND, Ltd. Tel: (+44) 0115 845 6486
Maltese: Tel: (+44) 0115 845 6486
English: VEPURED suspension for injection for pigs
Maltese: VETERINARJU VEPURED Suspensjoni għall-injezzjoni għall-ħnieżer
English: 21 days after vaccination.
Maltese: 21 jum wara t-tilqima.
English: Route of administration Packaging
Maltese: Daqs tal-pakkett
English: ANNEX A
Maltese: ANNESS A
English: EU/1/99/124/001 Tractocile 6,75 mg/0,9 ml Solution for injection
Maltese: EU/1/99/124/001 TRACTOCILE 6,75 mg/ 0,9 ml
English: EU/1/99/124/002 Tractocile 37,5 mg/ 5 ml
Maltese: EU/1/99/124/002 TRACTOCILE 37,5 mg/ 5 ml Konċentrat għal soluzzjoni għall-infużjoni
English: Content Pack size
Maltese: Kontenut Daqs talpakkett
English: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom
Maltese: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF
English: Elevations in lactate dehydrogenase and alkaline phosphatase1;
Maltese: Żidiet f'lactate dehydrogenase u alkaline phosphatase1;
English: Common (≥ 1/100 to
Maltese: Komuni (≥ 1/100 sa
English: Date of first authorisation: 21st September 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta 'Settembru 2018
English: Common cases of leukocytosis (WBC > 100 x 109/L) have been reported (see section 4.4).
Maltese: Kienu rrappurtati każijiet komuni ta' lewkoċitosi (WBC > 100 x 109/L) (ara sezzjoni 4.4).
English: • alcohol swab.
Maltese: • swab tal-alkoħol.
English: • have an allergy to latex.
Maltese: • għandek allerġija għal-latex.
English: *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Maltese: *Sodium acetate huwa magħmul permezz ta' titrazzjoni ta' glacial acetic acid ma' sodium hydroxide.
English: • abnormal blood test results (lactate dehydrogenase, uric acid and alkaline phosphatase).
Maltese: • riżultati mhux normali tat-testijiet tad-demm (lactate dehydrogenase, uric acid u alkaline phosphatase).
English: (see section 2).
Maltese: (ara sezzjoni 2).
English: • spleen rupture.
Maltese: • Spezzjona l-likwidu fit-tieqa.
English: Pelgraz is a biosimilar medicinal product.
Maltese: Pelgraz huwa prodott mediċinali bijoloġiku simili.
English: Gastrointestin al disorders
Maltese: Disturbi gastrointestinali
English: Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Maltese: Pegfilgrastim huwa proteina magħmula permezz tal bijoteknoloġija f'batterja msejħa E. coli.
English: The concentration is 10 mg/mL based on protein only**.
Maltese: Il konċentrazzjoni hija ta' 10 mg/mL ibbażata fuq il-proteina biss**.
English: Bone pain
Maltese: FEJN MA
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Maltese: Respiratorju Akut (ARDS - Acute Respiratory Distress Syndrome).
English: AST1
Maltese: jew AST1
English: Read the package leaflet for further information.
Maltese: Kontenut tal-pakkett u informazzjoni oħra.
English: Pelgraz contains sorbitol (E420) and sodium acetate
Maltese: Pelgraz fih sorbitol (E420) u sodium acetate.
English: Pelgraz contains the active substance pegfilgrastim.
Maltese: Pelgraz fih is-sustanza attiva Pegfilgrastim.
English: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1% of patients receiving pegfilgrastim.
Maltese: Għadd ta' ċelluli bojod tad-demm (WBC - white blood cell) ta' 100 x 109/L jew aktar ġew osservati f'inqas minn 1% tal-pazjenti li kienu qed jirċievu pegfilgrastim.
English: How to store Pelgraz
Maltese: Tużax Pelgraz
English: • Inject within 5 minutes of removing bottom cap.
Maltese: • Injetta f'5 minuti minn meta tneħħi l-għatu t'isfel.
English: Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis)
Maltese: Reazzjonijiet avversi relatati mal-pulmun (pulmonite talinterstizju, edima fil-pulmun, infiltrati filpulmun u fibrosi fil-pulmun)
English: Pegfilgrastim is a covalent conjugate of recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd PEG molecule.
Maltese: Pegfilgrastim huwa magħmul minn G-CSF rikombinanti uman (r-metHuG-CSF - recombinant human G-CSF)
English: Glomerulonephrit is2
Maltese: Glomerulonefrite2
English: • bleeding from the lung (pulmonary haemorrhage)
Maltese: • fsada mill-pulmun (emorraġija pulmonari).
English: In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 mcg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 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: Fi studju b'aktar minn ċentru wieħed, randomised, open-label ta' fażi II (n = 37) fuq pazjenti pedjatriċi b'sarkoma li kienu qed jirċievu 100 mcg/kg pegfilgrastim wara ċiklu 1 ta' kimoterapija ta' vincristine, doxorubicin u cyclophosphamide (VAdriaC/IE), kien osservat 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' adulti.
English: Pulmonary adverse reactions
Maltese: Reazzjonijiet avversi pulmonari
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 randomised
English: Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of up to 72 hours.
Maltese: Pelgraz jista' jiġi espost għal temperatura ambjentali (mhux aktar minn 25°C ± 2°C) għal perjodu massimu wieħeħd sa 72 siegħa.
English: Sickle cell crisis2; Splenomegaly2;
Maltese: Kriżi taċ-ċellula forma ta' minġel2;
English: • abnormal blood test results related to the liver (alanine aminotransferase and aspartate aminotransferase).
Maltese: • riżultati mhux normali tat-testijiet tad-demm relatati mal-fwied (alanine aminotransferase u aspartate aminotransferase).
English: Pulmonary haemorrha ge
Maltese: Emorraġija pulmonari
English: Musculoskelet al and connective tissue disorders
Maltese: Disturbi muskolu skeletriċi u tat tessuti konnettivi
English: These measures will help to protect the environment.
Maltese: Pelgraz ma ġiex ittestjat f'nisa tqal.
English: Each pre-filled syringe or pre-filled injector contains 30 mg sorbitol (E420) (see section 4.4).
Maltese: Kull siringa mimlija għal-lest jew injettatur mimli għal-lest fih 30 mg sorbitol (E-420) (ara sezzjoni 4.4).