FrancophonIA/ELRC3.0 huggingface dataset:
English: Carbonic anhydrase (CA) is an enzyme found in many tissues of the body, including the eye. Carbonic anhydrase catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid.
Maltese: Carbonic anhydrase jikkatalizza r-reazzjoni riversibbli li tinvolvi l-idrazzjoni ta' carbon dioxide u d-disidrazzjoni ta' carbonic acid.
English: What AZOPT looks like and contents of the pack AZOPT is a milky liquid (a suspension) supplied in a pack containing a 5 ml or a 10 ml plastic (droptainer) bottle with a screw cap, or in a pack containing three 5 ml plastic (droptainer) bottles with screw caps.
Maltese: AZOPT huwa likwidu qisu ħalib (suspensjoni) disponibbli f'pakkett li fih flixkun tal-plastik (droptainer) ta' 5 ml jew 10 ml b'għatu tal-kamin, jew f'pakkett li fih tlett ifliexken tal-plastik (droptainer) ta' 5 ml b'għotjien tal-kamin.
English: Rare: tinnitus Not Known: vertigo
Maltese: Rari: żarżir fil-widnejn Mhux Magħruf: vertigo
English: N-desethylbrinzolamide RBC concentrations increased and total RBC CA activity decreased with decreasing creatinine clearance but brinzolamide RBC concentrations and CA-II activity remained unchanged.
Maltese: Il-konċentrazzjoni ta' N-desethylbrinzolamide fir-RBCs żdiedet u l-attivita totali tal-RBS CA naqset minħabba t-tnaqqis fit-tneħħija tal-krejatinina, iżda il-konċentrazzjoni ta' brinzolamide fir-rBCs u l-attivita tal-CA-II baqgħu l-istess.
English: The events were mild and did not affect the overall discontinuation rates in the studies (see also section 4.8).
Maltese: L-avvenimenti kienu ħfief u ma' affetwawx ir-rati globali ta' twaqqif fl-istudji (ara wkoll sezzjoni 4.8).
English: Common: blurred vision, eye irritation, eye pain, foreign body sensation in eyes, ocular hyperaemia Uncommon: corneal erosion, keratitis, punctate keratitis, keratopathy, deposit eye, corneal staining, corneal epithelium defect, corneal epithelium disorder, blepharitis, eye pruritus, conjunctivitis, eye swelling, meibomianitis, glare, photophobiadry eye, allergic conjunctivitis, pterygium, scleral pigmentation, asthenopia, ocular discomfort, abnormal sensation in eye, keratoconjunctivitis sicca, subconjunctival cyst, conjunctival hyperaemia, eyelids pruritus, eye discharge, eyelid margin crusting, lacrimation increased Rare: corneal oedema, diplopia, visual acuity reduced, photopsia, hypoaesthesia eye, periorbital oedema, intraocular pressure increased, optic nerve cup/disc ratio increased Not Known: corneal disorder, visual disturbance, eye allergy, madarosis, eyelid disorder, erythema of eyelid
Maltese: Komuni: vista mċajpra, irritazzjoni fl-għajn, uġigħ fl-għajn, sensazzjoni ta' xi ħaġa fl-għajnejn, iperimja fl-għajnejn Mhux Komuni: barxa tal-korneja, keratite, keratite ittikkjata, keratopatija, depożitu fl-għajn, tebgħa fil-korneja, difett flepitilju tal-korneja, disturb fl-epitilju tal-korneja, blefarite, ħakk fl-għajn, konġuntivite, nefħa fl-għajn, meibomianitis, leħħa, fotofobija, għajn tinħass xotta, konġuntivite allerġika, pteriġjum, pigmentazzjoni tal-isklera, astenopija, skomdu flgħajn, sensazzjoni mhux normali fl-għajn, keratokonġuntivite xotta, ċista taħt il-konġuntiva, iperimja konġuntivali, ħakk filkappell tal-għajn, nixxija mill-għajn, qoxra fix-xifer talkappell tal-għajn, żjieda fid-dmugħ Rari: edima fil-korneja, vista doppja, tnaqqis fl-akutezza viżiva, fotopsija, ipoestesija tal-għajn, edima madwar l-għajn, żieda fil-pressjoni ta' ġewwa l-għajn, żieda fil-proporzjon tat-tazza/disk tan-nerv ottiku
English: Acid-base disturbances have been reported with oral carbonic anhydrase inhibitors.
Maltese: Disturbi tat-tip acid-base dehru meta ntużaw inibituri ta' carbonic anhydrase.
English: The safety and efficacy of AZOPT in infants, children and adolescents aged 0 to 17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' AZOPT fi trabi, tfal u adolexxenti b'età minn 0 sa 17-il sena ma ġewx determinati s'issa.
English: - General side effects: decreased or reduced heart function, a forceful heartbeat that may be rapid or irregular, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased red blood cell count in blood, increased chlorine level in blood, dizziness, difficulty with memory, depression, nervousness, decreased emotional interest, nightmare, generalized weakness, fatigue, feeling abnormal, pain, movement problems, decreased sex drive, male sexual difficulty, cold symptoms, chest congestion, sinus infection, throat irritation, throat pain, abnormal or decreased sensation in mouth, inflammation of the lining of the oesophagus, abdominal pain, nausea, vomiting, upset stomach, frequent bowel movements, diarrhoea, intestinal gas, digestive disorder, kidney pain, muscle pain, muscle spasms, back pain, nose bleeds, runny nose, stuffy nose, sneezing, rash, abnormal skin sensation, itching, smooth skin rash or redness covered by elevated bumps, skin tightness, headache, dry mouth, debris in eye.
Maltese: - Effetti sekondarji ġenerali: funzjoni tal-qalb imnaqqsa, taħbit tal-qalb qawwi li jista' jkun mgħaġġel ħafna jew irregolari, rata ta' taħbit tal-qalb imnaqqsa, diffikultà biex tieħu n-nifs, qtugħ ta' nifs, tnaqqis fl-għadd ta' ċelluli ħomor fid-demm, żjieda fil-livelli ta' chlorine fiddemm, sturdament, diffikultà bil-memorja, depressjoni, nervi, nuqqas ta' interess emozzjonali, ħmar il-lejl, indebboliment ġeneralizzat, tħossok mhux normali, uġigħ, problemi ta' ċaqliq, tnaqqis fil-ħajra sesswali, diffikultà sesswali fl-irġiel, sintomi ta' riħ, konġestjoni fis-sider, infezzjoni fis-sinus, irritazzjoni fil-griżmejn, uġigħ fil-griżmejn, sensazzjoni mhux normali jew imnaqqsa fil-ħalq, infjammazzjoni tal-kisja ta' ġewwa ta' l-esofagu, uġigħ ta' żaqq, dardir, rimettar, stonku mdardar, purgar frekwenti, dijarea, gass fl-imsaren, disturbi fis-sistema diġestiva, uġigħ fil-kliewi, uġigħ fil-muskoli, spażmi fil-muskoli, uġigħ ta' dahar, fsada mill-imnieħer, imnieħer iqattar, imnieħer misdud, għatis, raxx, sensazzjoni mhux normali filġilda, ħakk, raxx lixx tal-ġilda jew ħmura miksija b'ponot imqabżin, ġilda miġbuda, uġigħ ta' ras, ħalq xott, frak fl-għajn.
English: Manufacturer S.A. Alcon - Couvreur N.V. Rijksweg 14
Maltese: Il-Manifattur S.A. Alcon-Couvreur N.V.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-rRskju (RMP)
English: Pharmacotherapeutic group: Antiglaucoma preparations and miotics, carbonic anhydrase inhibitors, ATC code: S01EC04
Maltese: Prodotti li jintużaw għall-kura tal-glawkoma u mijotiċi, inibituri ta' carbonic anhydrase, Kodiċi ATC:
English: AZOPT is a sulphonamide inhibitor of carbonic anhydrase with systemic absorption.
Maltese: AZOPT huwa sulphonamide inibitur ta' carbonic anhydrase b'assorbiment sistemiku.
English: Opened (3):
Maltese: Miftuh (3):
English: Other medicines and AZOPT
Maltese: Mediċini oħra u AZOPT
English: Similar studies in rats resulted in slightly reduced ossification of skull and sternebrae of foetuses of dams receiving brinzolamide at doses of 18 mg/kg/day (375 times the recommended human ophthalmic dose), but not 6 mg/kg/day.
Maltese: Studji simili fil-firien urew li kien hemm tnaqqis żgħir fl-ossifikazzjoni tal-għadam tar-ras u ta' l-isternebrae talfetu, f'bhejjem li ngħataw dożi ta' 18 mg/kg/ġurnata ta' brinzolamide (375 darba akbar mid-doża rakkomandata għal użu fl-għajnejn tal-bnedmin) iżda dawn l-effetti ma deherux meta ngħataw doża ta' 6 mg/kg/ġurnata.
English: Among patients who were naive to IOP therapy (10 patients), the efficacy of AZOPT was similar to that seen previously in adults, with mean IOP reductions from baseline ranging up to 5 mmHg.
Maltese: Fost dawk il-pazjenti li ma kienu fuq l-ebda terapija (10 pazjenti), l-effikaċja ta AZOPT kienet simili ta' dik osservata iktar kmieni fl-adulti, b'medja ta' tnaqqis tal-pressjoni fl-għajnejn mill-bażi li wassal sa 5 mmHg.
English: Each millilitre contains 10 mg of brinzolamide.
Maltese: Kull millilitru fih 10 mg ta' brinzolamide.
English: This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic side effects.
Maltese: Dan jista' jnaqqas l-assorbiment sistemiku ta' prodotti mediċinali mogħtija fl-għajn u jirriżulta f'inqas effetti sekondarji sistemiċi.
English: In plasma, both brinzolamide and Ndesethylbrinzolamide concentrations are low and generally below assay quantitation limits (<7.5 ng/ml).
Maltese: Il-konċentrazzjoni ta' brinzolamide u ta' Ndesethylbrinzolamide fil-plażma hija baxxa ħafna u ġeneralment tkun inqas mill-ammont li jista jiġi kwantifikat b'analiżi (<7.5 ng/ml).
English: If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.
Maltese: Jekk ikun hemm sinjali ta' reazzjonijiet serji jew sensittività eċċessiva, waqqaf l-użu ta' din il-preparazzjoni.
English: Electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur.
Maltese: Jista' jkun hemm żbilanċ fl-elektroliti, aċidożi fiddemm, u possibbilment xi effetti mhux mixtieqa fuq is-sistema nervuża.
English: Following a 4 week run-in with travoprost, patients with an IOP ≥19 mmHg were randomized to receive added treatment with brinzolamide or timolol.
Maltese: Wara prova ta' 4 ġimgħat b'travoprost, pazjenti b'IOP ≥19 mmHg kienu randomised biex jirċievu kura addizzjonali bi brinzolamide jew timolol.
English: ANNEX III
Maltese: Dublin 4
English: AZOPT has not been studied in patients with severe renal impairment (creatinine clearance < 30 ml/min) or in patients with hyperchloraemic acidosis.
Maltese: AZOPT ma' ġiex studjat f'pazjenti li għandhom indeboliment sever tal-kliewi (tneħħija tal-krejatinina <30 ml/min) jew f'pazjenti li għandhom aċidożi iperklorimika.
English: The adverse reactions were obtained from clinical trials and post-marketing spontaneous reports.
Maltese: Ir-reazzjonijiet avversi kienu miksuba minn provi kliniċi u minn rapporti spontanji ta' wara ttqegħid fis-suq.
English: Oral carbonic anhydrase inhibitors may impair the ability to perform tasks requiring mental alertness and/or physical coordination (see also section 4.4 and section 4.8).
Maltese: Inibituri ta' carbonic anhydrase li jittieħdu mill-ħalq jistgħu jnaqqsu l-ħila li jitwettaq xogħol li jeħtieġ viġilanza mentali u/jew koordinazzjoni fiżika (ara wkoll sezzjoni 4.4 u sezzjoni 4.8).
English: AZOPT 10 mg/ml eye drops, suspension
Maltese: AZOPT 10 mg/ml qtar għall-għajnejn, suspensjoni.
English: AZOPT contains brinzolamide which belongs to a group of medicines called carbonic anhydrase inhibitors.
Maltese: AZOPT fih brinzolamide li jagħmel parti minn grupp ta' mediċini li jissejħu inibituri ta' carbonic anhydrase.
English: Brinzolamide saturation of RBC CA-II was achieved within 4 weeks (RBC concentrations of approximately 20 µM).
Maltese: Kien hemm saturazzjoni b'brinzolamide tal-RBC CA-II fi żmien erba' ġimgħat (b'konċentrazzjoni fir-RBCs ta' bejn wieħed u ieħor 20 µM).
English: Uncommon: pain, chest discomfort, fatigue, feeling abnormal Rare: chest pain, feeling jittery, asthenia, irritability Not Known: peripheral oedema, malaise
Maltese: Rari: uġigħ fis-sider, tħossok nervuż, astenja, irritabilità Mhux Magħruf: edima periferali, telqa
English: - General side effects: bad taste.
Maltese: - Effetti sekondarji ġenerali: togħma ħażina.
English: Brinzolamide RBC concentration ranged from about 20 to 40 µM by week 4 of treatment.
Maltese: Il-konċentrazzjoni ta' brinzolamide fir-RBCs varjat minn 20 sa 40 µM sar-raba' ġimgħa tal-kura.
English: How to store AZOPT
Maltese: Jekk tuża AZOPT aktar milli suppost
English: The safety and efficacy of AZOPT in infants, children and adolescents aged 0 to 17 years have not been established and its use is not recommended in infants, children or adolescents
Maltese: Is-sigurtà u l-effikaċja ta' AZOPT fi trabi, tfal u adolexxenti b'età minn 0 sa 17-il sena ma ġewx determinati s'issa u l-użu tiegħu mhux irrakkomandat fi trabi, tfal jew adolexxenti.
English: Uncommon: rash, rash maculo-papular, skin tightness Rare: urticaria, alopecia, pruritus generalised Not Known: dermatitis, erythema
Maltese: Mhux Komuni: uġigħ fid-dahar, spażmi tal-muskoli, majalġja Mhux Magħruf: artralġja, uġigħ fl-estremitajiet
English: AZOPT contains a preservative (benzalkonium chloride) which may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Maltese: AZOPT fih preservattiv (benzalkonium chloride) li jista' jigi assorbit mil-lentijiet tal-kuntatt rotob u jista' jbiddel l-kulur tal-lentijiet tal-kuntatt.
English: - General side effects: memory impairment, drowsiness, chest pain, upper respiratory tract congestion, sinus congestion, nasal congestion, dry nose, ringing in ears, hair loss, generalized itching, feeling jittery, irritability, irregular heart rate, body weakness, difficulty sleeping, wheezing, itchy skin rash.
Maltese: - Effetti sekondarji ġenerali: indeboliment fil-memorja, ngħas, uġigħ fis-sider, konġestjoni flapparat respiratorju ta' fuq, konġestjoni fis-sinus, konġestjoni fl-imnieħer, imnieħer xott, żarżir fil-widnejn, telf ta' xagħar, ħakk ġeneralizzat, tħossok nervuż, irritabilità, rata ta' taħbit tal-qalb irregolari, dgħufija tal-ġisem, diffikultà biex torqod, tħarħir, raxx bil-ħakk.
English: Pregnancy and breast-feeding
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: About 20% of the dose has been accounted for in urine as metabolite.
Maltese: Madwar 20% tad-doża toħrog flawrina bħala prodott tal-metaboliżmu.
English: 5 and 10 ml opaque low density polyethylene bottles with polypropylene screw caps (droptainer).
Maltese: Fliexken opaki magħmula mill-polietilin ta' densita baxxa ta' volum ta' 5 u 10 ml b'tapp tal-kamin magħmul minn polipropalin (bil-qattara).
English: Do not use this medicine after the expiry date which is stated on the bottle and box after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-flixkun u l-kartuna wara “EXP”.
English: Studies have not been performed to evaluate the effect of topical ocular administration of brinzolamide on human fertility.
Maltese: Ma twettqux studji biex jevalwaw l-effett ta' għoti topiku fl-għajnejn ta' brinzolamide fuq il-fertilità umana.
English: Uncommon: dyspnoea, epistaxis, oropharyngeal pain, pharyngolaryngeal pain, throat irritation, upper airway cough syndrome, rhinorrhoea, sneezing Rare: bronchial hyperreactivity, upper respiratory tract congestion, sinus congestion, nasal congestion, cough, nasal dryness
Maltese: Mhux Komuni: qtugħ ta' nifs, epistassi, uġigħ fil-ħalq u filfarinġi, uġigħ fil-farinġi u l-larinġi, irritazzjoni fil-griżmejn, sindrome ta' sogħla fil-parti ta' fuq tal-passaġġ tan-nifs, rinoreja, għatis
English: Common: dysgeusia
Maltese: Popolazzjoni anzjana
English: In small short-term clinical trials, approximately 12.5% of paediatric patients were observed to experience adverse reactions, the majority of which were local, non-serious ocular reactions such as conjunctival hyperaemia, eye irritation, eye discharge, and lacrimation increased (see also section 5.1).
Maltese: Fi provi kliniċi żgħar ta' tul qasir, kien osservat li madwar 12.5% tal-pazjenti pedjatriċi kellhom reazzjonijiet avversi, li l-maġġoranza tagħhom kienu reazzjonijiet lokali, mhux serji fl-għajn, bħal iperimija tal-konġuntiva, irritazzjoni fl-għajn, nixxija mill-għajn, u żieda fid-dmugħ (ara wkoll sezzjoni 5.1).
English: - if you have dry eyes or cornea problems.
Maltese: - Jekk għandek għajnejk xotti jew għandek xi problemi fil-korneja.
English: Not Known: asthma
Maltese: Rari: insomnja
English: The IOP-reducing effect of AZOPT as adjunctive therapy to the prostaglandin analogue travoprost was studied.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: How to use AZOPT
Maltese: X'fih AZOPT
English: In subjects with the highest degree of renal impairment inhibition of total CA activity was greater although it was inferior to 90% at steady-state.
Maltese: F'persuni b'indeboliment serju fil-kliewi, l-inibizzjoni tal-attivita totali tal-CA kienet akbar għalkemm kienet inqas minn 90% fl-istat fiss.
English: Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humour secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport.
Maltese: L-inibizzjoni ta' carbonic anhydrase fil-proċċess ciljari tal-għajnejn inaqqas is-sekrezzjoni ta' l-aqueous humour, billi jnaqqas il-produzzjoni tal-bicarbonate ions li jikkawza tnaqqis fit-trasport tas-sodium u tal-fluwidu.
English: Potential rebound effects following cessation of treatment with AZOPT have not been studied; the IOP-lowering effect is expected to last for 5-7 days.
Maltese: Ma' ġietx studjata l-possibilta' ta' l-effetti kuntrarji li jista' jkun hemm wara li wieħed jieqaf juża AZOPT; l-effett fuq l-IOP hu mistenni li jdum minn 5 sa 7 ijiem.
English: AZOPT is a sulphonamide inhibitor of carbonic anhydrase and, although administered topically, is absorbed systemically.
Maltese: AZOPT huwa mediċina tat-tip sulfonamide u inibitur ta' carbonic anhydrase, u għalkemm jintuża b'mod topiku, jiġi assorbit fis-sistema.
English: The following side effects have been seen with AZOPT.
Maltese: L-effetti sekondarji li ġejjin kienu osservati b'AZOPT.
English: Uncommon: oesophagitis, diarrhoea, nausea, vomiting, dyspepsia, upper abdominal pain, abdominal discomfort, stomach discomfort, flatulence, frequent bowel movements, gastrointestinal disorder, hypoaesthesia oral, paraesthesia oral, dry mouth
Maltese: Mhux Komuni: esofaġite, dijarea, dardir, rimettar, dispepsja, uġigħ fin-naħa ta' fuq taż-żaqq, skomdu fiż-żaqq, skomdu flistonku, gass fl-istonku, purgar spiss, disturb gastro-intestinali, ipoestesija fil-ħalq, paresteżija fil-ħalq, ħalq xott
English: There was an overall higher incidence of non-serious ocular adverse reactions, mainly related to signs of local irritation, in the brinzolamide/travoprost groups.
Maltese: Fil-gruppi ta' brinzolamide/travoprost kien hemm inċidenza globali ogħla ta' reazzjonijiet avversi mhux serji, fil-biċċa l-kbira relatati ma' sinjali ta' irritazzjoni lokali.
English: • ocular hypertension
Maltese: Disturbi psikjatriċi
English: Ear and labyrinth disorders
Maltese: Disturbi fil-widnejn u fis-sistema labirintika
English: Do not use a double dose to make up for a forgotten dose.
Maltese: L-ebda każ ta' doza eċċessiva ma' ġie rrappurtat.
English: Further information on Grastofil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Grastofil received a marketing authorisation valid throughout the EU on 18 October 2013.
Maltese: Grastofil irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fit-18 ta' Ottubru 2013.
English: Severe neutropenia lasted on average for 1.4 days which compared with 1.6 days and 1.8 days reported in studies using filgrastim found in the literature.
Maltese: Bħala medja, in-newtropenija severa damet għal 1.4 ijiem li tqabblet ma' 1.6 ijiem u 1.8 ijiem irrappurtati fl-istudji li użaw filgrastim li nstabu fil-letteratura.
English: Other information about Grastofil
Maltese: Informazzjoni oħra dwar Grastofil
English: Grastofil is a ‘biosimilar medicine'.
Maltese: Grastofil huwa "mediċina bijosimili".
English: The active substance in Grastofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Maltese: Is-sustanza attiva fi Grastofil, il-filgrastim, hija simili ħafna għal proteina tal-bniedem imsejħa fattur stimolanti tal-kolonja tal-granuloċiti (G-CSF).
English: Why is Grastofil approved?
Maltese: Għaliex ġie approvat Grastofil?
English: • to treat persistent neutropenia in patients with advanced human-immunodeficiency-virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Maltese: • biex tikkura newtropenija persistenti f'pazjenti b'infezzjoni avvanzata tal-virus talimmunodefiċjenza umana (HIV), biex tnaqqas ir-riskju ta' infezzjonijiet batteriċi meta kuri oħrajn ma jkunux xierqa.
English: The most common side effects with Grastofil (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni bi Grastofil (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma deni, uġigħ muskoloskeletali (uġigħ fil-muskoli u fl-għadam), anemija (għadd baxx taċ-ċelloli ħomor tad-demm), rimettar u dardir (tħossok ma tiflaħx).
English: The reference medicine for Grastofil is Neupogen.
Maltese: Il-mediċina ta' referenza għal Grastofil hija Neupogen.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes).
Maltese: • biex tnaqqas kemm iddum in-newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda taddemm) u biex tipprevjeni newtropenija febrili (newtropenija bid-deni) f'pazjenti bil-kanċer (minbarra pazjenti b'lewkimja mijelojde kronika jew b'sindromi mijelodisplastiċi).
English: Grastofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy (medicines to treat cancer) known to cause neutropenia.
Maltese: Grastofil ġie studjat fi studju ewlieni wieħed li involva 120 pazjenta mara adulta b'kanċer tas-sider li ġew ikkurati bil-kimoterapija (mediċini biex jikkuraw il-kanċer) magħrufa li tikkawża newtropenija.
English: What are the risks associated with Grastofil?
Maltese: X'inhuma r-riskji assoċjati ma' Grastofil?
English: As for all medicines, data on the use of Grastofil are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Grastofil hija ssorveljata kontinwament.
English: The medicine is available in prefilled syringes and is given by injection under the skin or infusion (drip) into a vein.
Maltese: Il-mediċina tiġi f'siringi mimlijin għal-lest u tingħata permezz ta' injezzjoni taħt il-ġilda jew infużjoni (dripp) ġo vina.
English: Side effects reported with Grastofil are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Grastofil huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Studies were also carried out to show that Grastofil produces levels of the active substance in the body that are comparable to the reference medicine, Neupogen.
Maltese: Saru wkoll studji biex juru li Grastofil jipproduċi livelli tas-sustanza attiva fil-ġisem li huma komparabbli mal-mediċina ta' referenza, Neupogen.
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Maltese: • biex tnaqqas il-livelli ta' newtrofili u tnaqqas ir-riskju ta' infezzjonijiet f'pazjenti b'newtropenija li jkollhom storja ta' infezzjonijiet severi u repetuti;
English: Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.
Maltese: Data minn studji ppubblikati tindika li l-benefiċċji u s-sigurtà ta' filgrastim huma simili kemm fl-adulti kif ukoll fit-tfal li jirċievu l-kimoterapija.
English: This means that Grastofil is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Grastofil huwa simili ħafna għal mediċina bijoloġika oħra (il-"mediċina ta' referenza") li diġà hija awtorizzata fl-UE.
English: Grastofil is a medicine that stimulates the production of white blood cells and is used:
Maltese: Aktar informazzjoni fuq Grastofil tinstab fis-sit elettroniku tal-Aġenzija: