FrancophonIA/ELRC3.0 huggingface dataset:
English: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril or an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.
Maltese: inibitur tal-enzima li tikkonverti angiotensin bħal enalapril, lisinopril, ramipril jew
English: You may need to stop Rasilez.
Maltese: Jista' jkun li jkollok twaqqaf Rasilez.
English: In hypertensive patients, once-daily administration of aliskiren at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Maltese: Effikaċja klinika u sigurtà F'pazjenti bil-pressjoni għolja, l-għotja darba kuljum ta' aliskiren b'dożi ta' 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid-doża fil-pressjoni tad-demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta' 24 siegħa ta' l-intervall bejn id-dożi (b'hekk żammew il-benefiċċju ta' kmieni filgħodu) b'medja fil-proporzjon bejn l-ogħla u l-anqas għar-rispons dijastoliku sa' 98% għad-doża ta'
English: The study showed no benefit of aliskiren when administered on top of standard therapy for acute heart failure and an increased risk of cardiovascular events in patients with diabetes mellitus.
Maltese: L-istudju ma wera l-ebda benefiċċju meta mogħti mat-terapija standard għal insuffiċjenza akuta tal qalb u wera żieda fir-riskju ta' episodji kardjovaskulari f'pazjenti bid-dijabete mellitus.
English: It induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Maltese: sindrome nefrotika jew pressjoni għolja renovaskulari.
English: This study was extended with a 52-week double-blind, randomised study to evaluate the safety, tolerability and efficacy of aliskiren compared to enalapril in 208 paediatric hypertensive patients aged 6 to 17 years (at baseline in the previous study).
Maltese: Dan l-istudju kien estiż ma' studju randomizzat, double-blind ta' 52 ġimgħa sabiex jevalwa s-sigurtà, it-tollerabbiltà u l-effikaċja ta' aliskiren imqabbel ma' enalapril f'208 pazjenti pedjatriċi bi pressjoni għolja ta' bejn 6 u 17-il sena (li kienu fil-linja bażi fl-istudju preċedenti).
English: There is a potential for aliskiren overexposure in children with an immature MDR1 (P-gp) system (see section “Transporters” above and sections 4.2, 4.4 and 5.3).
Maltese: “Trasportaturi” aktar 'il fuq u sezzjonijiet 4.2, 4.4 u 5.3).
English: When administered with atorvastatin, steady-state Rasilez AUC and Cmax increased by 50%.
Maltese: Meta ngħata ma' atorvastatin, l-AUC u Cmax fi stat fiss ta' Rasilez żdiedu b'50%.
English: P-gp potent inhibitors
Maltese: GĦAMLA KWALITATTIVA
English: Capsules content Lactose monohydrate, Pregelatinized maize starch, Talc.
Maltese: Kontenut tal-kapsuli Lactose monohydrate Pregelatinized maize starch Talc
English: Renal failure, oliguria, urinary retention
Maltese: Insuffiċjenza tal-kliewi, oliguria, ritenzjoni urinarja
English: Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
Maltese: Studji in vivo u analiżi farmakokinetika tal-popolazzjoni F'dan ir-rigward, fi studji in vivo ma kienu osservati ebda interazzjonijiet farmakokinetiċi klinikament rilevanti bejn pregabalin u phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone jew ethanol.
English: Pregabalin Zentiva contains lactose monohydrate.
Maltese: Pregabalin Zentiva fih lactose monohydrate.
English: Stevens-Johnson syndrome, cold sweat Musculoskeletal and connective tissue disorders Common
Maltese: Sindrome ta' Stevens-Johnson, għaraq kiesaħ Disturbi muskoluskeletriċi u tat-tessuti konnettivi Komuni
English: The percentage of subjects with at least a 50% reduction in partial onset seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day (p = 0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p = 0.2600 versus placebo) and 22.6% of those receiving placebo.
Maltese: Il-persentaġġ ta' suġġetti li kellhom tal-inqas tnaqqis ta' 50% flaċċessjonijiet ta' bidu parzjali kkomparat mal-linja bażi kien ta' 40.6% mis-suġġetti kkurati bi pregabalin 10mg/kg/jum (p = 0.0068 kontra il-placebo), 29.1% ta' suġġetti kkurati bi pregabalin 2.5mg/kg/jum (p = 0.2600 kontra il-plaċebo) u 22.6% ta' dawk li kienu qed jircievu l-plaċebo.
English: Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.
Maltese: Pregabalin jeħel ma' subunit awżiljarju (2-proteini) ta' kanali tal-kalċju kkontrollati b'vultaġġfis-sistema nervuża ċentrali.
English: Pregabalin may potentiate the effects of ethanol and lorazepam.
Maltese: Prodotti mediċinali li jinfluwenzaw is-sistema nervuża ċentrali Pregabalin jista' jżid l-effetti ta' ethanol u lorazepam.
English: Pregabalin Zentiva is used to treat generalised anxiety disorder (GAD).
Maltese: Pregabalin Zentiva jintuża għall-kura ta' disturb ta' ansjetà ġeneralizzata (GAD - generalised anxiety disorder).
English: Creatinine clearance (CLcr) (ml/min)
Maltese: Tneħħija tal-krejatinina (CLcr) (ml/min)
English: Pregabalin Zentiva 25 mg hard capsules are packed into alu/alu (OPA/alu/PVC/alu) blisters as primary packaging.
Maltese: Pregabalin Zentiva 25 mg kapsuli ibsin huma ppakkjati ġo folji tal-alu/alu (OPA/alu/PVC/alu) bħala lippakkjar ewlieni.
English: Syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, mental impairment, speech disorder, hyporeflexia, hyperaesthesia, burning sensation, ageusia, malaise
Maltese: Sinkope, sturdament, myoclonus, ħass ħażin, attività psikomotorili eċċessiva, dyskinesia, sturdament tal-pożizzjoni, tregħid waqt moviment volontarju, nystagmus, disturb konoxxittiv, indeboliment mentali, disturb fid-diskors, nuqqas ta' riflessi, ipoestesija, sensazzjoni ta' ħruq, telf tattogħma, telqa
English: • Kidney failure, reduced urine volume, urinary retention.
Maltese: • Insuffiċjenza tal-kliewi, volum ta' awrina, ritenzjoni urinarja..
English: Date of first authorisation: 17 July 2015.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel Awtorizzazzjoni : 17 ta' Lulju 2015
English: Pregabalin Zentiva 100 mg, 200 mg is available in pack of 21, 84, 98 and 100 hard capsules.
Maltese: Pregabalin Zentiva 100 mg, 200 mg huma disponibbli f'pakketti ta' 21, 84, 98 u 100 kapsula ibsin.
English: Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness
Maltese: Dispnea, epistassi, sogħla, konġestjoni fl-imnieħer, rinite, inħir, nixfa fl-imnieħer
English: Pregabalin Zentiva 25 mg hard capsules Pregabalin Zentiva 50 mg hard capsules Pregabalin Zentiva 75 mg hard capsules Pregabalin Zentiva 100 mg hard capsules Pregabalin Zentiva 150 mg hard capsules Pregabalin Zentiva 200 mg hard capsules Pregabalin Zentiva 225 mg hard capsules Pregabalin Zentiva 300 mg hard capsules Pregabalin
Maltese: Pregabalin Zentiva 25 mg kapsuli ibsin Pregabalin Zentiva 50 mg kapsuli ibsin Pregabalin Zentiva 75 mg kapsuli ibsin Pregabalin Zentiva 100 mg kapsuli ibsin Pregabalin Zentiva 150 mg kapsuli ibsin Pregabalin Zentiva 200 mg kapsuli ibsin Pregabalin Zentiva 225 mg kapsuli ibsin Pregabalin Zentiva 300 mg kapsuli ibsin Pregabalin
English: Capsule body
Maltese: Korp tal-kapsula
English: Pregabalin Zentiva 225 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Zentiva 225 mg
English: Pregabalin Zentiva may be taken with oral contraceptives.
Maltese: Pregabalin Zentiva jista' jittieħed ma' kontraċettivi orali.
English: Peripheral and central neuropathic pain, epilepsy or generalised anxiety disorder Take the number of hard capsules as instructed by your doctor.
Maltese: Uġigħ nevrotiku periferali u ċentrali, epilessija jew disturbi ta' ansjetà ġeneralizzata Ħu n-numru ta' kapsuli ibsin kif ordnalek it-tabib tiegħek.
English: Pregabalin Zentiva belongs to a group of medicines used to treat epilepsy, neuropathic pain and generalised anxiety disorder (GAD) in adults.
Maltese: Pregabalin Zentiva jappartjeni għal grupp ta' mediċini li jintużaw għall-kura ta l-epilessija, l-uġigħ nevrotiku u d-disturb ta' ansjetà ġeneralizzata (GAD - generalised anxiety disorder) fl-adulti.
English: Pregabalin Zentiva 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Zentiva 200 mg
English: Pregabalin Zentiva 25 mg and 50 mg is available in pack of 14, 21, 56, 84, 98 and 100 hard capsules.
Maltese: Pregabalin Zentiva 25 mg u 50 mg huma disponibbli f'pakketti ta' 14, 21, 56, 84, 98 u 100 kapsula ibsin.
English: 225 mg capsules Flesh opaque cap and light grey body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “225”, containing almost white powder.
Maltese: Kapsuli ta' 225 mg Għatu opak kulur il-ġilda u korp griż ċar; b'tul ta' madwar 19.4 mm, kapsula iebsa tal-ġelatina stampata b'“225”, li fiha trab kważi abjad.
English: Other medicines and Pregabalin Zentiva
Maltese: Mediċini oħra u Pregabalin Zentiva
English: Pregabalin Zentiva 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Zentiva 75 mg
English: Pregabalin Zentiva 75 mg, 150 mg, 225 mg and 300 mg is available in pack of 14, 56, 98 and 100 hard capsules.
Maltese: Pregabalin Zentiva 75 mg, 150 mg, 225 mg u 300 mg huma disponibbli f'pakketti ta' 14, 56, 98 u 100 kapsula ibsin.
English: Pregabalin Zentiva 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Zentiva 25 mg
English: Pregabalin Zentiva 150 mg hard capsules: EU/1/15/1021/017
Maltese: Pregabalin Zentiva 150 mg kapsuli ibsin: EU/1/15/1021/017
English: EU/1/15/1021/006 EU/1/15/1021/007 EU/1/15/1021/008 EU/1/15/1021/009 EU/1/15/1021/030 EU/1/15/1021/010
Maltese: EU/1/15/1021/006 EU/1/15/1021/007 EU/1/15/1021/008 EU/1/15/1021/009 EU/1/15/1021/010
English: Pregabalin Zentiva 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Zentiva 100 mg
English: Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Maltese: - Iron oxide iswed (E172) - Titanium dioxide (E171) - Ġelatina
English: Pregabalin Zentiva 225 mg hard capsules Pregabalin
Maltese: Pregabalin Zentiva 225 mg kapsuli ibsin Pregabalin
English: How to store Pregabalin Zentiva
Maltese: Kif taħżen Pregabalin Zentiva
English: Pregabalin Zentiva 50 mg hard capsules: EU/1/15/1021/006
Maltese: Pregabalin Zentiva 50 mg kapsuli ibsin: EU/1/15/1021/006
English: Pregabalin Zentiva 75 mg hard capsules: EU/1/15/1021/011
Maltese: Pregabalin Zentiva 75 mg kapsuli ibsin: EU/1/15/1021/011
English: Pregabalin Zentiva 75 mg hard capsules Capsule cap
Maltese: Pregabalin Zentiva 75 mg kapsuli ibsin Għatu tal-kapsula
English: Pregabalin Zentiva 100 mg hard capsules: EU/1/15/1021/014
Maltese: Pregabalin Zentiva 100 mg kapsuli ibsin: EU/1/15/1021/014
English: Pregabalin Zentiva 75 mg hard capsules Pregabalin
Maltese: Pregabalin Zentiva 75 mg kapsuli ibsin Pregabalin
English: Funduscopic changes were observed in 1.7% of pregabalin-treated and 2.1% of placebo-treated patients.
Maltese: Bdil fundoskopiku kien innutat f'1.7% ta' dawk ittrattati bi pregabalin u 2.1% tal-pazjenti ttrattati bi plaċebo.
English: Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules are packed into PVC/alu blisters as primary packaging.
Maltese: Pregabalin Zentiva 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg u 300 mg kapsuli ibsin huma ppakkjati ġo folji tal-PVC/alu bħala l-pakkett ewlieni.
English: Generalised anxiety disorder Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Maltese: Pregabalin Zentiva huwa indikat għall-kura tad-disturb ta' ansjetà ġeneralizzata (GAD - generalised anxiety disorder) f'persuni adulti.
English: Pregabalin Zentiva 225 mg hard capsules: EU/1/15/1021/023
Maltese: Pregabalin Zentiva 225 mg kapsuli ibsin: EU/1/15/1021/023
English: Pregabalin Zentiva 300 mg hard capsules Capsule cap
Maltese: Pregabalin Zentiva 300 mg kapsuli ibsin Għatu tal-kapsula
English: 150 mg capsules
Maltese: Pregabalin Zentiva 150 mg kapsuli ibsin
English: Pregabalin Zentiva 225 mg hard capsules
Maltese: Pregabalin Zentiva 225 mg kapsuli ibsin
English: Pregabalin Zentiva 200 mg hard capsules: EU/1/15/1021/020
Maltese: Pregabalin Zentiva 200 mg kapsuli ibsin: EU/1/15/1021/020
English: Pregabalin Zentiva 25 mg hard capsules: EU/1/15/1021/001
Maltese: Pregabalin Zentiva 25 mg kapsuli ibsin: EU/1/15/1021/001
English: Pregabalin Zentiva 225 mg hard capsules Capsule cap
Maltese: Pregabalin Zentiva 225 mg kapsuli ibsin Għatu tal-kapsula
English: Pregabalin Zentiva 150 mg hard capsules Pregabalin
Maltese: Pregabalin Zentiva 150 mg kapsuli ibsin Pregabalin
English: Pregabalin Zentiva 75 mg hard capsules
Maltese: Pregabalin Zentiva 75 mg kapsuli ibsin
English: Zentiva logo
Maltese: Zentiva
English: Pregabalin Zentiva 200 mg hard capsules Pregabalin
Maltese: Pregabalin Zentiva 200 mg kapsuli ibsin Pregabalin
English: Pregabalin Zentiva 300 mg hard capsules Pregabalin
Maltese: Pregabalin Zentiva 300 mg kapsuli ibsin Pregabalin
English: 75 mg capsules Red cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “75”, containing almost white powder.
Maltese: Kapsuli ta' 75 mg Għatu aħmar u korp griż ċar; b'tul ta' madwar 14.3 mm, kapsula iebsa talġelatina stampata b'“75”, li fiha trab kważi abjad.
English: Pregabalin Zentiva 50 mg hard capsules
Maltese: Pregabalin Zentiva 50 mg kapsuli ibsin
English: Pregabalin Zentiva 100 mg hard capsules Pregabalin
Maltese: Pregabalin Zentiva 100 mg kapsuli ibsin Pregabalin
English: Pregabalin Zentiva 25 mg hard capsules Pregabalin
Maltese: Pregabalin Zentiva 25 mg kapsuli ibsin Pregabalin
English: Pregabalin Zentiva 300 mg
Maltese: Kapsuli ta' 300 mg
English: Pregabalin Zentiva 200 mg hard capsules
Maltese: Pregabalin Zentiva 200 mg kapsuli ibsin
English: Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults.
Maltese: Uġigħ nevrotiku Pregabalin Zentiva huwa indikat għall-kura ta' uġigħ periferali u ċentrali f'persuni adulti.
English: Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
Maltese: Alluċinazzjoni, attakk ta' paniku, irrekwitezza aġitazzjoni, depressjoni, burdata depressa, burdata ta' entużjażmu, agressjoni, bidla fil-burdata minn tajba ħafna għal ħażina ħafna fi żmien qasir, spersonalizzazzjoni, diffikultà biex issib kelma, ħolm anormali, żieda fil-libido, inkapaċità li tilħaq orgażmu, apatija
English: Pregabalin Zentiva 300 mg hard capsules
Maltese: Pregabalin Zentiva 300 mg kapsuli ibsin
English: Pregabalin Zentiva 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Zentiva 50 mg
English: EU/1/15/1021/020 EU/1/15/1021/021 EU/1/15/1021/034 EU/1/15/1021/022
Maltese: EU/1/15/1021/021 EU/1/15/1021/022 EU/1/15/1021/034
English: Pregabalin Zentiva 50 mg hard capsules Pregabalin
Maltese: Pregabalin Zentiva 50 mg kapsuli ibsin Pregabalin
English: EU/1/15/1021/001 EU/1/15/1021/002 EU/1/15/1021/003 EU/1/15/1021/004 EU/1/15/1021/029 EU/1/15/1021/005
Maltese: EU/1/15/1021/001 EU/1/15/1021/002 EU/1/15/1021/003 EU/1/15/1021/004
English: Pregabalin Zentiva 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Zentiva 150 mg
English: • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased,
Maltese: • Bidliet fir-riżultati tat-testijiet tad-demm u tal-fwied (żieda fil-kreatina phosphokinase fid demm, żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, tnaqqis fl-għadd ta' pjastrini, newtropenja, żieda fil-krejatinina fid-demm, tnaqqis fil-potassju fid-demm).
English: Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Maltese: Pregabalin Zentiva huwa indikat bħala terapija aġġuntiva f'persuni adulti li jbatu minn aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: EU/1/15/1021/014 EU/1/15/1021/015 EU/1/15/1021/032 EU/1/15/1021/016
Maltese: EU/1/15/1021/015 EU/1/15/1021/016 EU/1/15/1021/032
English: Pregabalin Zentiva 100 mg hard capsules
Maltese: Pregabalin Zentiva 100 mg kapsuli ibsin
English: Black iron oxide (E172) Propylene glycol
Maltese: - Shellac - Iron oxide iswed (E172) - Propylene glycol - Soluzzjoni qawwija ta' ammonja - Potassium hydroxide
English: • Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
Maltese: • Diffikultà biex tieħu nifs, nixfa fl-imnieħer, konġestjoni fl-imnieħer.
English: If you are an elderly patient (over 65 years of age), you should take Pregabalin Zentiva normally except if you have problems with your kidneys.
Maltese: Jekk int pazjenti anzjan ('il fuq minn 65 sena), inti għandek tieħu Pregabalin Zentiva b'mod normali ħlief jekk ikollok problemi bil-kliewi.
English: 100 mg capsules Red cap and red body; approx. 15,9 mm in length, hard gelatin capsule with imprinting “100”, containing almost white powder.
Maltese: Kapsuli ta' 150 mg Għatu griż ċar u korp griż ċar; b'tul ta' madwar 18.0 mm, kapsula iebsa talġelatina stampata b'“150”, li fiha trab kważi abjad.
English: Pregabalin Zentiva 25 mg hard capsules
Maltese: Pregabalin Zentiva 25 mg kapsuli ibsin
English: Red cap and light grey body; approx. 21,7 mm in length, hard gelatin capsule with imprinting “300”, containing almost white powder.
Maltese: Għatu aħmar u korp griż ċar; b'tul ta' madwar 21.7 mm, kapsula iebsa tal-ġelatina stampata b'“300”, li fiha trab kważi abjad.
English: 200 mg capsules Flesh opaque cap and Flesh opaque body; approx. 19,4 mm in length, hard gelatin capsule with imprinting “200”, containing almost white powder.
Maltese: Għatu opak kulur il-ġilda u korp opak kulur il-ġilda; b'tul ta' madwar 19.4 mm, kapsula iebsa tal-ġelatina stampata b'“200”, li fiha trab kważi abjad.
English: How to store Pregabalin Zentiva Contents of the pack and other information
Maltese: Kif taħżen Pregabalin Zentiva Kontenut tal-pakkett u informazzjoni oħra
English: Pregabalin Zentiva is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Maltese: Pregabalin Zentiva jintuża sabiex tiġi kkurata ċerta forma ta' epilessija (aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja) fl-adulti.
English: 300 mg capsules Red cap and light grey body; approx. 21,7 mm in length, hard gelatin capsule with imprinting “300”, containing almost white powder.
Maltese: Għatu aħmar u korp griż ċar; b'tul ta' madwar 21.7 mm, kapsula iebsa talġelatina stampata b'“300”, li fiha trab kważi abjad.
English: As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in table 1 determined using the following formula.
Maltese: Billi t-tneħħija ta' pregabalin hija direttament proporzjonali mat-tneħħija talkreatinina (ara sezzjoni 5.2), it-tnaqqis fid-doża f'pazjenti b'funzjoni renali kompromessa jrid ikun individwalizzat skond it-tneħħija tal-kreatinina (CLcr), kif indikat f'tabella 1 stabbilit billi tintuża lformula li ġejja:
English: Light grey cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “50”, containing almost white powder.
Maltese: Għatu griż ċar u korp griż ċar; b'tul ta' madwar 14.3 mm, kapsula iebsa tal-ġelatina stampata b'“50”, li fiha trab kważi abjad.
English: Strong ammonia solution Potassium hydroxide
Maltese: .8 Effetti mhux mixtieqa
English: 50 mg capsules Light grey cap and light grey body; approx. 14,3 mm in length, hard gelatin capsule with imprinting “50”, containing almost white powder.
Maltese: Għatu griż ċar u korp griż ċar; b'tul ta' madwar 14.3 mm, kapsula iebsa talġelatina stampata b'“50”, li fiha trab kważi abjad.
English: Central nervous system influencing medical products
Maltese: PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Ilaris;
Maltese: • Ir-riskju ta' infezzjonijiet serji, fosthom infezzjonijiet opportunistiċi bil-batterji, bil-viruses u bil-fungi f'pazjenti kkurati b'Ilaris;
English: • The risk of acute injection-related reactions;
Maltese: • Ir-riskju ta' reazzjonijiet akuti li għandhom x'jaqsmu mal-injezzjoni;
English: • Physician information
Maltese: MILL-ISTATI
English: • The identified or potential risk of immunogenicity that might lead to immune-mediated symptoms;
Maltese: • L-immunoġeniċità identifikata jew dik li jista' jkun hemm li tista' twassal għal sintomi medjati mis-sistema immuni;
English: • The need for Health Care Professionals to perform an annual clinical assessment of patients regarding a potential increased risk for the development of malignancies;
Maltese: • Il-bżonn li l-Professjonijiet fil-Qasam Mediku jagħmlu stima klinika tal-pazjenti darba fissena dwar iż-żieda fir-riskju li jista' jkun hemm għall-iżvilupp ta' tumuri malinni;
English: • The unknown safety of Ilaris in pregnant and lactating women, thus the need for physicians to discuss this risk with patients if they become or plan to become pregnant;
Maltese: • Is-sigurtà ta' Ilaris li mhix magħrufa f'nisa tqal u li qed ireddgħu, u għaldaqstant il-ħtieġa li ttobba jiddiskutu dan ir-riskju mal-pazjenti jekk huma jinqabdu tqal jew ikunu qed jippjanaw li joħorġu tqal;
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Ilaris are provided with a physician information pack containing the following:
Maltese: ANNESS KUNDIZZJONIJIET JEW RESTRIZZJONJIET FIR-RIGWARD TA' L-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU IMPLIMENTATI
English: • The need to monitor patients for changes in their lipid profiles;
Maltese: • Il-ħtieġa li l-pazjenti jiġu mmonitorjati għal tibdiliet fil-profili tal-lipidi;
English: • Educational material
Maltese: • Materjal edukkattiv
English: The potential for thromboembolic events in patients with chronic ITP and those known risk factors for thromboembolic events (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome).
Maltese: Jista' jkun hemm avvenimenti tromboemboliċi f'pazjenti b'ITP kronika u f'dawk b'fatturi ta' riskju magħrufa għal avvenimenti tromboemboliċi (eż., Fattur V Leiden, defiċjenza ta' ATIII, sindrome antifosfolipidu).
English: Romiplostim may induce the progression of existing haematological malignancies and myelodysplastic syndrome (MDS).
Maltese: Romiplostim jista' jikkawża l-progressjoni ta' tumuri malinni ematoloġiċi eżistenti u tassindrome mijelodisplastika (MDS).
English: The incidence in clinical trials of thrombotic/thromboembolic complications.
Maltese: L-inċidenza ta' kumplikazzjonijiet trombotiċi / tromboemboliċi fil-provi kliniċi.
English: Data from clinical trials in MDS on the incidence of blast cell increases and progression to AML.
Maltese: Data minn provi kliniċi b'MDS dwar linċidenza ta' żjieda ta' ċelluli blastiċi u progressjoni għal AML.
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq se jiftiehem ma' l-Awtoritajiet Kompetenti Nazzjonali dwar id-dettalji ta' programm edukattiv, u għandu jimplimenta programm bħal dan b'mod nazzjonali biex jiżgura li qabel jiġi preskritt Nplate it-tobba kollha jkollhom pakkett ta' informazzjoni għall-professjonisti fil-qasam tas-saħħa li fih dan li ġej:
English: The incidence of medication errors in clinical trials.
Maltese: L-inċidenza ta' żbalji fil-medikazzjoni fil-provi kliniċi.