FrancophonIA/ELRC3.0 huggingface dataset:
English: Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Maltese: iron oxide isfar (E172) (għas-60 mg biss) u inkjostru aħdar li jittiekel (30 mg) jew inkjostru abjad li jittiekel (60mg).
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of Duloxetine Lilly 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Maltese: F'pazjenti fejn ir-rispons ma jkunx suffiċjenti d doża għandha tiżdied għal 60 mg li hija d-doża ta' manteniment li s-soltu tintuża fil-parti l-kbira tal pazjenti.
English: Duloxetine Lilly showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
Maltese: Duloxetine Lilly wera riżultati ta' effikaċja simili għal venlafaxine f'dak li għandu x'jaqsam titjib fil-punteġġ totali tal-HAM-A.
English: Throat tightness Epistaxis
Maltese: Żieda talkolesterol fiddemm
English: Paraesthesia
Maltese: Apatija
English: Other psychiatric conditions for which Duloxetine Lilly is prescribed can also be associated with an increased risk of suicide-related events.
Maltese: Kundizzjonijiet psikjatriċi oħra li għalihom jista' jiġi mogħti Duloxetine Lilly huma wkoll assoċjati ma' riskju akbar ta' avvenimenti marbuta ma' suwiċidju.
English: Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8).
Maltese: Sospensjoni tal-kura Huma komuni r-reazzjonijiet ta' rtirar meta l-kura tiġi sospiża, partikolarment jekk is-sospensjoni ssir f'daqqa waħda (ara sezzjoni 4.8).
English: Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
Maltese: Kull kapsula fiha 30 mg jew 60 mg ta' duloxetine (bħala hydrochloride).
English: The safety and efficacy of duloxetine for the treatment of generalised anxiety disorder in paediatric patients aged 7-17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' duloxetine fil-kura tad-disturb ta' ansjetà ġeneralizzata f'pazjenti pedjatriċi ta' etajiet bejn 7 - 17-il sena ma ġewx stabbiliti.
English: − are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Duloxetine Lilly')
Maltese: qiegħed/qiegħda tieħu mediċini oħra biex tikkura d-depressjoni (ara ‘Mediċini oħra u Duloxetine Lilly')
English: If you forget to take Duloxetine Lilly
Maltese: Kif gћandek tieћu Duloxetine Lilly
English: Angio-neurotic oedema6
Maltese: Sturdament Ħedla
English: Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures.
Maltese: Huwa rrakkomandat li jiġu osservati s-sinjali kardijaċi u dawk vitali, flimkien ma' miżuri sintomatiċi u ta' sostenn adattati.
English: Discontinuation symptoms seen with duloxetine may include hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures.
Maltese: Sintomi ta' sospensjoni li dehru b'duloxetine jistgħu jinkludi ipotonja, tregħid, nervożiżmu, diffikultà biex tieħu l-ħalib, problemi biex tieħu n-nifs u konvulżjonijiet.
English: The pharmacokinetics of duloxetine and its metabolites have not been studied in patients with mild or severe hepatic insufficiency.
Maltese: Il-farmakokinetika ta' duloxetine u l-prodotti metaboliċi tiegħu ma kienux studjati f'pazjenti b'insuffiċjenza tal-fwied gravi jew ħafifa.
English: The full EPAR and risk management plan summary for Obizur 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: Hypersensitivity (allergic) reactions may occur with Obizur, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations.
Maltese: Jistgħu jseħħu reazzjonijiet (allerġiċi) ta' sensittività eċċessiva b'Obizur, u jistgħu jinkludu anġjoedima (nefħa tat-tessuti taħt il-ġilda), ħruq u tingiż fil-post tal-injezzjoni, tertir, fwawar, raxx bil-ħakk, uġigħ ta' ras, ħorriqija, pressjoni baxxa (pressjoni tad-demm baxxa), tħossok għajjien jew mingħajr kwiet, nawsja (tħossok ma tiflaħx) jew rimettar, takikardija (taħbit tal-qalb mgħaġġel), tagħfis fis-sider, tħarħir u sensazzjonijiet ta' tingiż.
English: Why is Obizur approved?
Maltese: Għaliex ġiet approvat Obizur?
English: This is a summary of the European public assessment report (EPAR) for Obizur.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Obizur.
English: Obizur contains the active substance susoctocog alfa.
Maltese: Obizur fih is-sustanza attiva susoctocog alfa.
English: Factor VIII is one of the proteins needed for normal clotting of the blood.
Maltese: Il-fattur VIII huwa wieħed mill-proteini meħtieġa għall-koagulazzjoni normali tad-demm.
English: Patients with acquired haemophilia caused by antibodies against factor VIII may develop antibodies against susoctocog alfa.
Maltese: Pazjenti b'emofilja akkwiżita kkawżata minn antikorpi kontra lfattur VIII jistgħu jiżviluppaw antikopri kontra s-susoctocog alfa.
English: Obizur has been investigated in one main study involving 28 adult patients with acquired haemophilia caused by antibodies against factor VIII who were experiencing a serious bleeding episode.
Maltese: Obizur ġie investigat fi studju ewlieni wieħed li involva 28 pazjent adult b'emofilja akkwiżita kkawżata minn antikopri kontra l-fattur VIII li kienu qegħdin jesperjenzaw episodju ta' fsada serja.
English: Other information about Obizur
Maltese: Informazzjoni oħra dwar Obizur
English: Patients with acquired haemophilia caused by antibodies against factor VIII have blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Maltese: Pazjenti b'emofilja akkwiżita kkawżata minn antikorpi kontra l-fattur VIII għandhom problemi filkoagulazzjoni tad-demm, bħal fsada fil-ġogi, fil-muskoli jew fl-organi interni.
English: Obizur is a medicine used for the treatment of bleeding episodes in adults with acquired haemophilia, a bleeding disorder caused by the spontaneous development of antibodies that inactivate factor VIII.
Maltese: Obizur huwa mediċina li tintuża għall-kura ta' episodji ta' fsada f'adulti b'emofilja akkwiżita, disturb ta' fsada kkawżat mill-iżvilupp spontanju ta' antikorpi li jiddiżattivaw il-fattur VIII.
English: Obizur is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Maltese: Obizur huwa disponibbli bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni ġol-vina.
English: Obizur must not be used in patients who have had a severe allergic reaction to susoctocog alfa, any of its other ingredients, or hamster protein.
Maltese: Obizur ma għandux jintuża f'pazjenti li kellhom reazzjoni allerġika severa għas-susoctocog alfa, kwalunkwe wieħed mill-ingredjenti l-oħrajn tiegħu jew, il-proteina tal-ħemster.
English: What information is still awaited for Obizur?
Maltese: Liema informazzjoni għadha mistennija għal Obizur?
English: How does Obizur work?
Maltese: Kif jintuża Obizur?
English: Obizur was not compared with any other medicine.
Maltese: Obizur ma tqabbel ma' ebda mediċina oħra.
English: Since Obizur has been approved under exceptional circumstances, the company that markets the medicine will establish and maintain a patient registry to collect and analyse short- and long-term data on the effectiveness and safety of Obizur in patients with acquired haemophilia caused by antibodies against factor VIII.
Maltese: Peress li Obizur ġie approvat taħt ċirkostanzi eċċezzjonali, il-kumpanija li tikkummerċjalizza l-mediċina ser tistabbilixxi u żżomm reġistru tal-pazjenti biex tiġbor u tanalizza dejta fuq perjodu ta' żmien qasir u twil dwar l-effikaċja u s-sigurtà ta' Obizur f'pazjenti b'emofilja akkwiżita kkawżata minn antikopri kontra l-fattur VIII.
English: The CHMP noted the lack of specific treatments for acquired haemophilia caused by antibodies against factor VIII.
Maltese: Is-CHMP innota n-nuqqas ta' kuri speċifiċi għal emofilja akkwiżita minn antikorpi kontra l-fattur VIII.
English: The results of the main study showed that Obizur was effective in treating serious bleeding episodes in adults with the disorder.
Maltese: Ir-riżultati tal-istudju ewlieni wrew li Obizur kien effikaċi fil-kura ta' episodji ta' fsada serji f'adulti bid-disturb.
English: --1 Recombinant Protein Q from Leishmania infantum MON-1 ≥ 36.7 ELISA Units (EU)* * Antigen content determined in an ELISA against an internal standard.
Maltese: --1 Proteina Rikombinanti Q minn Leishmania infantum MON-1 ≥ 36.7 Unitajiet Elisa (EU)* * Kontenut ta' antiġen determinat f'ELISA meta mqabbel ma' standard intern.
English: 4 ml
Maltese: 10 mg/ml
English: Subcutaneous use Vial (glass)
Maltese: Użu għal taħt il-ġilda kunjett (tal-ħġieġ)
English: Desloratadine/pseudoephedrine
Maltese: Desloratadina/psewdoefedrina
English: The full EPAR for Aerinaze can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Aerinaze jinsab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Aerinaze is a medicine containing the active substances desloratadine (2.5 mg) and pseudoephedrine (120 mg).
Maltese: Aerinaze huwa mediċina li fiha s-sustanzi attivi desloratadina (2.5 mg) u psewdoefedrina (120 mg).
English: The effectiveness of Aerinaze was assessed in two main studies involving a total of 1,248 adult and adolescent patients.
Maltese: L-effikaċja ta' Aerinaze ġiet ivvalutata f'żewġ studji ewlenin fuq total ta' 1,248 pazjent adult u adolexxenti.
English: This summary was last updated in 10-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2011.
English: Other information about Aerinaze
Maltese: Aktar informazzjoni dwar Aerinaze
English: When looking at all hayfever symptoms except for nasal congestion, patients taking Aerinaze reported a reduction in symptoms of 46.0%, compared with 35.9% in those taking pseudoephedrine alone.
Maltese: Inkwantu s-sintomi kollha tar-riħ tal-ħuxlief ħlief il-konġestjoni nażali, pazjenti li ħadu Aerinaze rrapportaw tnaqqis fis-sintomi ta' 46.0%, apparagun ma' 35.9% ta' dawk li ħadu l-psewdoefedrina waħidha.
English: This is a summary of the European public assessment report (EPAR) for Aerinaze.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Aerinaze.
English: The most common side effects with Aerinaze (seen in between 1 and 10 patients in 100) are tachycardia (fast heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness), pharyngitis (sore throat), anorexia (loss of appetite), constipation, headache, fatigue (tiredness), insomnia (difficulty sleeping), somnolence (sleepiness), sleep disorders and nervousness.
Maltese: L-effetti sekondarji l-aktar komuni rrapportati b'Aerinaze (li dehru f'bejn pazjent 1 sa 10 f'kull 100) kienu takikardja (rata mgħaġġla fit-taħbit tal-qalb), ħalq xott, sturdament, attività psikomotorili eċċessiva (nuqqas ta' sabar), farinġite (uġigħ fil-ġrieżem), anoressja (telf fl-aptit), stitikezza, uġigħ ta' ras, għeja kbira, insomnja (diffikultà fl-irqad), somnolenza (ngħas), disturbi fl-irqad u nervożiżmu.
English: When looking at nasal congestion, patients taking Aerinaze had a reduction in symptoms of 37.4%, compared with 26.7% in those taking desloratadine alone.
Maltese: Inkwantu l-konġestjoni nażali, pazjenti li ħadu Aerinaze kellhom tnaqqis fis-sintomi ta' 37.4%, apparagun ma' 26.7% ta' dawk li ħadu d-desloratadina waħidha.
English: What is the risk associated with Aerinaze?
Maltese: X'inhuma r-riskji assoċjati ma' Aerinaze?
English: What is Aerinaze?
Maltese: X'inhu Aerinaze?
English: Why has Aerinaze been approved?
Maltese: Għaliex ġie approvat Aerinaze?
English: Aerinaze contains two active substances: desloratadine, an antihistamine, and pseudoephedrine, which is a nasal decongestant.
Maltese: Aerinaze fih żewġ sustanzi attivi: id-desloratadina (mediċina kontra l-istamina) u l-psewdoefedrina (dekonġestant nażali).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aerinaze on 30 July 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Aerinaze fit-30 ta' Lulju 2007.
English: How has Aerinaze been studied?
Maltese: Kif ġie studjat Aerinaze?
English: Aerinaze is used to treat the symptoms of seasonal allergic rhinitis (hayfever, inflammation of the nasal passages caused by an allergy to pollen) in patients who have nasal congestion (a blocked nose).
Maltese: Aerinaze jintuża biex jittratta s-sintomi tar-rinite allerġika staġjonali (riħ tal-ħuxlief, infjammazzjoni tal-passaġġi nażali kkaġunata minn allerġija għall-polline) f'pazjenti li jkollhom konġestjoni nażali (mnieħer imblokkat).
English: Aerinaze should also not be taken by people who have narrow angle glaucoma (increased pressure inside the eye), urinary retention (difficulty in passing urine), heart or blood vessel diseases including hypertension (high blood pressure), hyperthyroidism (an overactive thyroid gland), or a history or risk of haemorrhagic stroke (stroke caused by bleeding within the brain).
Maltese: Aerinaze m'għandux jintuża minn persuni li jkollhom glawkoma b'angolu dejjaq (żieda fil-pressjoni ġol-għajn), tiżmim tal-urina (diffikultà fir-rilaxx tal-awrina), mard fil-qalb jew fil-vini u fl-arterji inklużi pressjoni għolja, ipertirojdiżmu
English: In adults and adolescents over 12 years of age, the recommended dose of Aerinaze is one tablet twice a day, taken whole with a full glass of water.
Maltese: F'adulti u f'adolexxenti ikbar minn 12-il sena, id-doża rrakkomandata ta' Aerinaze hija pillola darbtejn kuljum, li tittieħed sħiħa ma' tazza mimlija bl-ilma.
English: Treatment for more than 10 days is not advisable, as the medicine's effects on nasal congestion may wear off. Once the nose has cleared, patients can use desloratadine alone.
Maltese: Mhux irrakkomandat trattament tul aktar minn 10 ijiem, minħabba li l-effetti tal-mediċina fuq il-konġestjoni nażali jistgħu ma jibqgħux effettivi.
English: Desloratadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Maltese: Id-desloratadina taħdem billi timblokka r-riċetturi fejn normalment teħel listamina, sustanza fil-ġisem li tikkaġuna sintomi allerġiċi.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze's benefits are greater than its risks for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion and recommended that Aerinaze be given marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Aerinaze huma akbar mir-riskji tiegħu għat-trattament sintomatiku tar-rinite allerġika staġjonali meta akkumpanjata minn konġestjoni nażali, u għaldaqstant irrakkomanda li Aerinaze jingħata lawtorizzazzjoni għat-tqegħid fis-suq.
English: Aerinaze tablets have two layers, one containing desloratadine, and the other containing pseudoephedrine.
Maltese: Il-pilloli Aerinaze fihom żewġ saffi, wieħed bid-desloratadina u l-ieħor bil-psewdoefedrina.
English: Κύπρος Teva Ελλάς Α.Ε., Ελλάδα
Maltese: Ελλάς Α.Ε., Ελλάδα
English: Mean ± SD (d)
Maltese: Medja ± SD (d)
English: Possible side effects”).
Maltese: Effetti sekondarji possibbli”).
English: Incidence (%)
Maltese: Inċidenza(%)
English: Filgrastim is an un-glycosylated recombinant methionyl human G-CSF.
Maltese: Filgrastim hu un-glycosylated recombinant methionyl human G-CSF.
English: Date of latest renewal: 08 May 2018
Maltese: Data tal-aħħar tiġdid: 8 ta' Mejju 2018.
English: 0.121 to 1.260
Maltese: 0.121 sa 1.260
English: Ελλάδα Teva Ελλάς Α.Ε.
Maltese: Ελλάς Α.Ε.
English: -2.089 to -1.232
Maltese: -2.089 sa -1.232
English: -0.461 to 0.089
Maltese: -0.461 sa 0.089
English: 0.206 to 0.512
Maltese: 0.206 sa 0.512
English: Median ANC (x 109 cells/l)
Maltese: Medjan ta' ANC (x 109 ċelluli/l)
English: - Aortitis (see section 4.4)
Maltese: - Aortite (ara sezzjoni 4.4).
English: p-value SN
Maltese: valur p SN
English: See section 4.2.
Maltese: Ara sezzjoni 4.2.
English: CI = confidence interval
Maltese: CI = intervall ta' kunfidenza
English: Leukocytosis*, Splenomegaly*
Maltese: Lewkoċitosi*, Splenomegalija*
English: Merckle GmbH, Graf-Arco-Straße 3 89079 Ulm Germany
Maltese: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm
English: Pulmonary adverse reactions*, Pulmonary Haemorrhage
Maltese: Reazzjonijiet pulmonari avversi*, emorraġija pulmonari
English: Lonquex contains sorbitol and sodium
Maltese: Lonquex fih sorbitol u sodium
English: NL-2031 GA Haarlem The Netherlands
Maltese: NL-2031 GA Haarlem L-Olanda
English: • The active substance is lipegfilgrastim.
Maltese: - Is-sustanza attiva hi lipegfilgrastim.
English: 2031 GA Haarlem Netherlands
Maltese: 2031 GA Haarlem L-Olanda
English: Incidence (%) Odds ratio 95 % CI
Maltese: Proporzjon tal-odds 95 % CI
English: It could be a consequence of a pulmonary disorder (see section4 “Possible side effects”).
Maltese: disturb pulmonari (ara sezzjoni 4 “Effetti sekondarji possibbli”).
English: EU/1/13/856/001 1 pre-filled syringe with safety device EU/1/13/856/002 1 pre-filled syringe
Maltese: EU/1/13/856/001 1 siringa mimlija għal-lest b'tagħmir tas-sigurtà EU/1/13/856/002 1 siringa mimlija għal-lest
English: Limited patient data indicate that the pharmacokinetics of lipegfilgrastim in elderly patients (65 - 74 years) is similar to that in younger patients.
Maltese: Data limitata minn pazjenti tindika li l-farmakokinetika ta' lipegfilgrastim f'pazjenti anzjani (65 - 74 sena) hi simili għal dik f'pazjenti iżgħar.
English: Teva Pharma Belgium N.V./S.A./AG, Belgique/Belgien
Maltese: Teva Pharma Belgium N.V./S.A./AG Tél/Tel:
English: Capillary leak syndrome* Aortitis*
Maltese: Sindromu ta' tnixxija kapillari*, aortite*
English: Teva Biotech GmbH Dornierstraße 10 89079 Ulm Germany
Maltese: Teva Biotech GmbH Dornierstraße 10 89079 Ulm
English: Allergic reactions and immunogenicity
Maltese: Reazzjonijiet allerġiċi u immunoġeniċità
English: Table 2: DSN, severe neutropenia (SN) and febrile neutropenia (FN) in cycle 1 of study XM22-03 (ITT)
Maltese: Tabella 2: DSN, newtropenija severa (SN) u newtropenija bid-deni (FN) f'ċiklu 1 ta' studju XM22-03 (ITT)
English: Musculoskeletal pains*
Maltese: Uġigħ muskoloskeletriku*
English: In vitro data indicate that lipegfilgrastim is has little or no direct or immune system-mediated effects on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 activity.
Maltese: Data in vitro tindika li lipegfilgrastim għandu ftit jew m'għandu l-ebda effetti diretti jew li jsiru permezz tas-sistema immuni fuq l-attività ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, u
English: Hypokalaemia*
Maltese: Ipokalemija*
English: Frequency groupings are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti skont il-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000),
English: Lonquex 6 mg injection lipegfilgrastim
Maltese: Lonquex 6 mg injezzjoni lipegfilgrastim
English: The active substance is a covalent conjugate of filgrastim** with methoxy polyethylene glycol (PEG) via a carbohydrate linker.
Maltese: Is-sustanza attiva hu konjugat kovalenti ta' filgrastim** ma' methoxy polyethylene glycol (PEG) permezz ta' carbohydrate linker.
English: Lipegfilgrastim is a covalent conjugate of filgrastim with a single methoxy polyethylene glycol (PEG) molecule via a carbohydrate linker consisting of glycine, N-acetylneuraminic acid and N-acetylgalactosamine.
Maltese: Lipegfilgrastim hu konjugat kovalenti ta' filgrastim b'molekula waħda ta' methoxy polyethylene glycol (PEG) permezz ta' carbohydrate linker li jikkonsisti minn glycine, N-acetylneuraminic acid u N-acetylgalactosamine.
English: Excipients: Glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.
Maltese: Glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 u ilma għallinjezzjonijiet.
English: The maximum blood concentrations were reached after a median time (tmax) of 23.9 hours, 30.0 hours and 95.8 hours, respectively.
Maltese: Il-konċentrazzjonijiet massimi fid-demm intlaħqu wara ħin medjan (tmax) ta' 23.9 sigħat, 30.0 siegħa u 95.8 sigħat, rispettivament.
English: Pre-filled syringe (type I glass) with a plunger stopper [poly(ethylene-co-tetrafluoroethylene)-coated bromobutyl rubber] and a fixed injection needle (stainless steel, 29G [0.34 mm] or 27G [0.4 mm] x 0.5 inch [12.7 mm]).
Maltese: Siringa mimlija għal-lest (ħġieġ ta' tip I) bi planġer-tapp [poly(ethylene-co-tetrafluoroethylene) miksi b'lastku tal-bromobutyl] u labra fissa tal-injezzjoni (azzar, 29G [0.34 mm] jew 27G [0.4 mm] x 0.5 pulzier [12.7 mm]).
English: The solution should be allowed to reach a comfortable temperature (15°C - 25°C) for injection.
Maltese: Is-soluzzjoni għandha titħalla tilħaq temperatura komda (15°C - 25°C) għall-injezzjoni.
English: Thrombocytopenia*
Maltese: Tromboċitopenija*
English: Table 3: DSN, SN and FN in cycle 1 of study XM22-04 (ITT) Placebo (n = 125)
Maltese: Tabella 3: DSN, SN u FN fiċ-ċiklu 1 ta' studju XM22-04 (ITT)
English: ● Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP)
English: Haematopoietic system
Maltese: Sistema ematopoijetika
English: Elevation in white blood cells (WBC) is consistent with the pharmacodynamic effects of lipegfilgrastim.
Maltese: Żieda fiċ-ċelluli tad-demm bojod (WBC) hi konsistenti mal-effetti farmakodinamiċi ta' lipegfilgrastim.
English: Lonquex contains the active substance lipegfilgrastim.
Maltese: Lonquex fih is-sustanza attiva lipegfilgrastim.
English: Δ LS mean (least square mean difference lipegfilgrastim - pegfilgrastim) and CI out of multivariate Poisson regression analysis
Maltese: Δ medja ta' LS (differenza tal-least square mean lipegfilgrastim - pegfilgrastim) u CI minn analiżi ta' rigressjoni ta' Poisson multivarjata
English: even if their signs of illness are the same as yours.
Maltese: Din l-injezzjoni tingħata ġot-tessut kemm kemm taħt il-ġilda (injezzjoni taħt il-ġilda).
English: An analysis of anti-drug antibodies of 579 patients and healthy volunteers treated with lipegfilgrastim, 188 patients and healthy volunteers treated with pegfilgrastim and 121 patients treated with placebo was performed.
Maltese: Immunoġeneċità Twettqet analiżi tal-antikorpi kontra l-mediċina ta' 579 pazjent u voluntiera b'saħħithom ittrattati b'lipegfilgrastim, 188 pazjent u voluntiera b'saħħithom ittrattati b'pegfilgrastim u 121 pazjent ittrattati bi plaċebo.
English: Lipegfilgrastim is metabolised via intra- or extracellular degradation by proteolytic enzymes.
Maltese: Lipegfilgrastim jiġi metabolizzat permezz ta' degradazzjoni intra- jew extraċellulari minn enzimi proteolitiċi.
English: No pharmacokinetic data are available in patients ≥ 75 years.
Maltese: L-ebda data farmakokinetika mhi disponibbli f'pazjenti li għandhom ≥ 75 sena.
English: The safety and efficacy of Lonquex in children and adolescents aged up to 17 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Lonquex fit-tfal u adolexxenti ta' età sa 17 il-sena ma ġewx determinati s'issa.
English: Pulmonary adverse reactions
Maltese: Reazzjonijiet pulmonari avversi
English: Median serum concentration of lipegfilgrastim (ng/ml)
Maltese: lipegfilgrastim (ng/ml)