FrancophonIA/ELRC3.0 huggingface dataset:
English: If your dose is 140 mg and you are using two Aimovig 70 mg pens, repeat steps 1(D) to 4 with the second pen to inject the full dose.
Maltese: Jekk id-doża tiegħek hi ta' 140 mg u qed tuża żewġ siringi ta' Aimovig 70 mg, irrepeti l-passi 1(D) sa 4 bit-tieni siringa biex tinjetta d-doża kollha.
English: Yellow window (injection complete)
Maltese: Soluzzjoni għall-injezzjoni (injezzjoni)
English: Barrel
Maltese: Koxxa
English: Aimovig showed similar exercise duration compared to placebo and did not aggravate myocardial ischaemia in these patients.
Maltese: Differenzi minn plaċebo kienu osservati mill-Ewwel Xahar 'il quddiem.
English: EU/1/18/1293/001-006
Maltese: FIS-SUQ EU/1/18/1293/001-006
English: Each 140 mg dose is given either as one subcutaneous injection of 140 mg or as two subcutaneous injections of 70 mg.
Maltese: Jekk ittabib tiegħek jiktiblek doża ta' 140 mg inti trid tingħata żewġ injezzjonijiet ta' Aimovig 70 mg darba kull 4 ġimgħat.
English: The CGRP receptor is located at sites that are relevant to migraine pathophysiology, such as the trigeminal ganglion.
Maltese: Ir-riċettur tas-CGRP jinsab f'siti li huma rilevanti għall-patofiżjoloġija tal-emigranja, bħallgangliju triġeminali.
English: Package size blister (PVC/Aclar/PVC-alu) 1 tablet
Maltese: Mnejn jingħata Il-pakkett
English: The full EPAR for NovoRapid 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: It contains the active substance insulin aspart, a rapid-acting insulin.
Maltese: Jinkludi s-sustanza attiva insulina aspart, insulina b'azzjoni rapida.
English: NovoRapid reduced HbA1c levels by 0.12% and by 0.15% more than human insulin did after six months.
Maltese: NovoRapid naqqas il-livelli ta' HbA1c b'0.12% u b'0.15% iktar milli għamlet linsulina umana wara sitt xhur.
English: The usual dose is between 0.5 and 1.0 units per kilogram body weight per day.
Maltese: Id-doża normali hija bejn 0.5 u 1.0 unità għal kull kilogramm ta' piż tal-ġisem kuljum.
English: Why is NovoRapid approved?
Maltese: Għaliex ġie approvat NovoRapid?
English: The European Commission granted a marketing authorisation valid throughout the European Union for NovoRapid on 7 September 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal NovoRapid valida fl-Unjoni Ewropea kollha fis-7 ta' Settembru 1999.
English: This is a summary of the European public assessment report (EPAR) for NovoRapid.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal NovoRapid.
English: What are the risks associated with NovoRapid?
Maltese: X'riskji huma assoċjati ma' NovoRapid?
English: NovoRapid insulin aspart
Maltese: Sommarju tal-EPAR għall-pubbliku insulina aspart
English: Other information about NovoRapid
Maltese: Aktar informazzjoni dwar NovoRapid
English: NovoRapid gave almost identical results to human insulin in two studies involving 1,954 patients with type 1 diabetes (when the pancreas cannot produce insulin) and in one study involving 182 patients with type 2 diabetes (when the body is unable to use insulin effectively).
Maltese: NovoRapid ta riżultati kważi identiċi għall-insulina umana f'żewġ studji li involvew 1,954 pazjent li jbatu mid-dijabete tat-tip 1 (meta l-frixa ma tkunx tista' tipproduċi insulina) u fi studju wieħed li involva 182 pazjent li jbatu mid-dijabete tat-tip 2 (meta l-ġisem mhuwiex kapaċi juża l-insulina b'mod effikaċi).
English: NovoRapid is a solution for injection available in vials, cartridges (PenFill and PumpCart) and pre-filled pens (FlexPen, FlexTouch and InnoLet) and can only be obtained with a prescription.
Maltese: NovoRapid huwa soluzzjoni għall-injezzjoni disponibbli fi vjali, stoċċijiet (PenFill u PumpCart) u pinen mimlija lesti (FlexPen, FlexTouch u InnoLet) u jista' jinkiseb biss b'riċetta ta' tabib.
English: The most common side effect with NovoRapid (seen in between 1 and 10 patients in 100) is hypoglycaemia (low blood glucose levels).
Maltese: L-effett sekondarju l-aktar komuni b'NovoRapid (li deher f'bejn pazjent 1 u 10 minn 100) hu ipogliċemija (livelli baxxi ta' glukożju fid-demm).
English: NovoRapid is used to treat adults, adolescents and children over one year old who have diabetes.
Maltese: NovoRapid jintuża għall-kura ta' adulti, adolexxenti u tfal li għandhom aktar minn sena li jbatu middijabete.
English: This allows it to start acting faster than human insulin.
Maltese: Dan jippermetti li tibda taħdem aktar malajr millinsulina umana.
English: The safety has been found to be the same as human insulin when compared in two studies involving 349 pregnancies in women with type 1 or gestational diabetes (diabetes caused by pregnancy).
Maltese: Instab li s-sigurtà tiegħu kienet l-istess bħall-insulina umana meta tqabblu f'żewġ studji li involvew 349 mara fl-istat tat-tqala li jbatu mid-dijabete tat-tip 1 jew ġestazzjonali (dijabete kkawżata mit-tqala).
English: When it is used with meals, 50 to 70% of the insulin requirement may be provided by NovoRapid and the remainder by an intermediate or long-acting insulin.
Maltese: Meta jintuża mal-ikel, 50 sa 70% tar-rekwiżit ta' insulina jistgħu jiġu pprovduti minn NovoRapid u l-bqija minn insulina b'azzjoni intermedja jew imtawla.
English: NovoRapid is a replacement insulin that is very similar to the insulin made by the body but is absorbed faster by the body.
Maltese: NovoRapid huwa insulina ta' sostituzzjoni simili ħafna għall-insulina prodotta millġisem iżda li tiġi assorbita mill-ġisem aktar malajr.
English: The studies compared NovoRapid with human insulin by measuring the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: L-istudji qabblu NovoRapid mal-insulina umana billi kejlu l-livell fid-demm ta' sustanza magħrufa bħala emoglobina glikosilata (HbA1c), li tagħti indikazzjoni ta' kemm hu kkontrollat tajjeb ilglukożju fid-demm.
English: The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Maltese: Il-glukożju (zokkor) fid-demm tal-pazjent għandu jiġi ttestjat regolarment biex tinstab id-doża effettiva l-aktar baxxa.
English: For the full list of all side effects and restrictions with NovoRapid, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u rrestrizzjonijiet kollha ta' NovoRapid, ara l-fuljett ta' tagħrif.
English: The replacement insulin works in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Maltese: L-insulina ta' sostituzzjoni taġixxi bl-istess mod bħall-insulina prodotta b'mod naturali u tgħin lill-glukożju jidħol fiċ-ċelloli mid-demm.
English: How is NovoRapid used?
Maltese: Kif jaħdem NovoRapid?
English: NovoRapid can also be used in a pump system for continuous insulin infusion under the skin or alternatively, it can be given into a vein but only by a doctor or a nurse.
Maltese: NovoRapid jista' jintuża wkoll f'sistema b'pompa għal infużjoni tal-insulina kontinwa taħt il-ġilda jew bħala alternattiva, jista' jingħata ġo vina iżda minn tabib jew infermier biss.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that NovoRapid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' NovoRapid huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fissuq.
English: Patients can inject themselves under the skin with NovoRapid if they have been trained appropriately.
Maltese: Dan mhux maħsub biex jipprovdi parir prattiku dwar l-użu ta' NovoRapid.
English: 17 September 2012
Maltese: 17 ta' Settembru 2012
English: Article 33(4) of Directive 2001/82/EC
Maltese: Artikolu 33(4) tad-Direttiva 2001/82/KE
English: International non-proprietary name (INN): florfenicol
Maltese: Isem internazzjonali komuni (INN): florfenicol
English: The decentralised procedure (IE/V/0269/001/DC) started on 13 August 2010.
Maltese: Il-proċedura deċentralizzata (IE/V/0269/001/DC) bdiet fit-13 ta' Awwissu 2010.
English: Opinion following an Article 33(4)
Maltese: Opinjoni wara referenza għall-Artikolu 33(4)
English: The Committee appointed Prof Christian Friis as rapporteur and Dr David Murphy as co-rapporteur.
Maltese: Il-Kumitat ħatar lil Prof Christian Friis bħala rapporteur u lil Dr David Murphy bħala co-rapporteur.
English: The application was submitted to Ireland as reference Member State and Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain and the United Kingdom as concerned Member States.
Maltese: Lapplikazzjoni ġiet sottomessa lill-Irlanda bħala l-Istat Membru ta' referenza u lill-Belġju, lid-Danimarka, lil Franza, lill-Ġermanja, lill-Greċja, lill-Italja, lil-Lussemburgu, lill-Pajjiżi l-Baxxi, lill-Portugall, lil Spanja u lir-Renju Unit bħala l-Istati Membri kkonċernati.
English: Oral explanations were given on 15 May 2012.
Maltese: Spjegazzjonijiet bil-fomm ingħataw fil-15 ta' Mejju 2012.
English: The applicant, Intervet International BV, submitted an application for a decentralised procedure for Nuflor 300 mg/ml solution for injection for cattle and sheep.
Maltese: L-applikant, Intervet International BV, ippreżenta applikazzjoni għal proċedura deċentralizzata għal Nuflor 300 mg/ml soluzzjoni għal injezzjoni għal frat u ngħaġ.
English: Opinion following an Article 33(4) referral for Nuflor 300 mg/ml solution for injection for cattle and sheep
Maltese: Opinjoni wara referenza għall-Artikolu 33(4) għal Nuflor 300 mg/ml soluzzjoni għal injezzjoni għal frat u ngħaġ
English: The referral procedure started on 12 October 2011.
Maltese: Il-proċedura ta' referenza bdiet fit-12 ta' Ottubru 2011.
English: Veterinary Medicines and Product Data Management
Maltese: Mediċini Veterinarji u Ġestjoni tad-Dejta dwar il-Prodotti
English: Nuflor 300 mg/ml solution for injection for cattle and sheep contains 300 mg florfenicol per ml.
Maltese: Nuflor 300 mg/ml soluzzjoni għal injezzjoni għal frat u ngħaġ fih 300 mg florfenicol għal kull ml.
English: Written explanations were provided by the applicant on 9 January 2012 and 23 April 2012.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti fid-9 ta' Jannar 2012 u fit-23 ta' April 2012.
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States, by France regarding the proposed indications and by Denmark regarding the efficacy of the product.
Maltese: Riskji serji potenzjali ġew identifikati matul il-proċedura deċentralizzata minn żewġ Stati Membri kkonċernati, minn Franza fir-rigward tal-indikazzjonijiet proposti u mid-Danimarka fir-rigward tal-effikaċja tal-prodott.
English: On 21 September 2011, the reference Member State, Ireland, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Maltese: Fil-21 ta' Settembru 2011, l-Istat Membru ta' referenza, l-Irlanda, innotifika lill-Aġenzija Ewropea talMediċini li s-CMD(v) naqas milli jasal għal ftehim fuq il-prodott u rrefera l-kwistjoni lis-CVMP skont lArtikolu 33(4) tad-Direttiva 2001/82/KE.
English: This application was an extension (Article 19 of Regulation 1234/2008/EC) to add sheep as new target species.
Maltese: Din l-applikazzjoni kienet estensjoni (Artikolu 19 tar-Regolament 1234/2008/KE) sabiex in-ngħaġ jiżdied bħala speċi ġdida fil-mira.
English: The active substance is included in veterinary medicinal products currently authorised in several Member States in the European Union for use in cattle and pigs for the treatment of respiratory diseases.
Maltese: Issustanza attiva hija inkluża fil-prodotti mediċinali veterinarji li fil-preżent huma awtorizzati f'bosta Stati Membri fl-Unjoni Ewropea għall-użu fil-frat u fil-majjali għall-kura ta' mard respiratorju.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 22 July 2011.
Maltese: Fil-jum 210, dawn il-kwistjonijiet baqgħu mhux solvuti u għaldaqstant, fit-22 ta' Lulju 2011, inbdiet referenza skont l-Artikolu 33(1) tad-Direttiva 2001/82/KE lill-grupp ta' Koordinazzjoni għarrikonoxximent Reċiproku u l-proċeduri Deċentralizzati (veterinarji) (CMD(v)).
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit-risk profile of Nuflor 300 mg/ml solution for injection for cattle and sheep is positive subject to changes in the product information in order to clarify that the recommended treatment dose and treatment interval for sheep is based on the time mean florfenicol concentrations are maintained above MIC90.
Maltese: Fuq il-bażi tal-valutazzjoni tar-rapporteurs tad-dejta disponibbli attwalment, is-CVMP qies li l-profil talbenefiċċju-riskju ta' Nuflor 300 mg/ml soluzzjoni għal injezzjoni għal frat u ngħaġ huwa wieħed pożittiv soġġett għal tibdiliet fl-informazzjoni dwar il-prodott sabiex jiġi ċċarat li d-doża tal-kura rrakkomandata u l-intervall tal-kura għal ngħaġ huma bbażati fuq il-konċentrazzjonijiet ta' florfenicol medji tal-ħin jinżammu fuq MIC90.
English: Therefore, the Committee adopted a positive opinion on 12 June 2012 recommending the granting of a marketing authorisation for Nuflor 300 mg/ml solution for injection for cattle and sheep.
Maltese: Għaldaqstant, il-Kumitat adotta opinjoni pożittiva fit-12 ta' Ġunju 2012 u rrakkomanda l-għoti ta' awtorizzazzjoni għat-tqegħid fis-suq għal Nuflor 300 mg/ml soluzzjoni għal injezzjoni għal frat u ngħaġ.
English: Day 60 of the CMD(v) procedure was on 20 September 2011, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Maltese: Jum 60 tal-proċedura tas-CMD(v) kien fl-20 ta' Settembru 2011, u minħabba li l-Istati Membri naqsu milli jilħqu ftehim dwar il-prodott, il-proċedura ġiet riferuta lisCVMP.
English: During the procedure the applicant provided additional data and the issues raised by France regarding the proposed indications were resolved.
Maltese: applikant ipprovda dejta addizzjonali u l-kwistjonijiet imqajma minn Franza fir-rigward talindikazzjonijiet proposti ġew solvuti.
English: referral for Nuflor 300 mg/ml solution for injection for cattle and sheep
Maltese: 1 għal Nuflor 300 mg/ml soluzzjoni għal injezzjoni għal frat u ngħaġ
English: The final opinion was converted into a Decision by the European Commission on 17 September 2012.
Maltese: L-opinjoni finali inqalbet f'Deċiżjoni mill-Kummissjoni Ewropea fis-17 ta' Settembru 2012.
English: Date of first authorisation: 10 April 2014 Date of last renewal: 12 December 2018
Maltese: Data tal-aħħar tiġdid: 12 ta' Diċembru 2018
English: Pregabalin Pfizer contains lactose monohydrate.
Maltese: Pregabalin Pfizer fiha lactose monohydrate.
English: * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Maltese: Tnaqqis fl-għadd ta' ċelloli bojod tad-demm *Żieda fl-alanine aminotransferase (ALT) u żieda fl-aspartate aminotransferase (AST)
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' individwi b'mill-inqas tnaqqis ta' 50% f'aċċessjonijiet ta' bidu parzjali meta mqabbel mal-linja bażi kien ta' 40.6% ta' suġġetti kkurati b'pregabalin 10 mg/kg/jum (p = 0.0068 kontra plaċebo), 29.1% ta' suġġetti kkurati b'pregabalin 2.5 mg/kg/jum (p = 0.2600 kontra plaċebo) u 22.6% ta' dawk li rċevew plaċebo.
English: Pregabalin Pfizer is available in seven pack sizes made of PVC with an aluminium foil backing: a 14 capsules pack containing 1 blister strip, a 21 capsules pack containing 1 blister strip, a 56 capsules pack containing 4 blister strips, a 84 capsules pack containing 4 blister strips, a 100 capsules pack containing 10 blister strips, a 112 capsules pack containing 8 blister strips and 100 x 1 capsules as perforated unit dose blisters.
Maltese: Pregabalin Pfizer hu disponibbli f'pakketti ta' sitt daqsijiet differenti magħmulin mill-PVC b'rinforz ta' folja ta' l-aluminju: pakkett ta' 14-il kapsula li fih 1 strixxa ta' folji, pakkett ta' 21 kapsula li fih 1 strixxa ta' folji, pakkett ta' 56 kapsula li fih 4 strixxi ta' folji, pakkett ta' 84 kapsula li fih 4 strixxi ta' folji, pakkett ta' 100 kapsula li fih 10 folji, pakkett ta' 112-il kapsula li fih 8 strixxi ta' folji u 100 x 1 kapsula bħala folji ta' doża waħda perforati.
English: The most common adverse events observed in the 14-day study with pregabalin treatment were somnolence, upper respiratory tract infection, and pyrexia (see sections 4.2, 5.1 and 5.2).
Maltese: L-avvenimenti avversi l-aktar komuni osservati fl-istudju ta' 14-il jum b'kura bi pregabalin kienu sonnolenza, infezzjoni fil-parti ta' fuq tal-apparat respiratorju, u deni (ara sezzjonijiet 4.2, 5.1 u 5.2).
English: Pregabalin Pfizer 25 mg hard capsules Pregabalin Pfizer 50 mg hard capsules Pregabalin Pfizer 75 mg hard capsules Pregabalin Pfizer 100 mg hard capsules Pregabalin Pfizer 150 mg hard capsules Pregabalin Pfizer 200 mg hard capsules Pregabalin Pfizer 225 mg hard capsules Pregabalin Pfizer 300 mg hard capsules
Maltese: Pregabalin Pfizer 25 mg kapsuli iebsin Pregabalin Pfizer 50 mg kapsuli iebsin Pregabalin Pfizer 75 mg kapsuli iebsin Pregabalin Pfizer 100 mg kapsuli iebsin Pregabalin Pfizer 150 mg kapsuli iebsin Pregabalin Pfizer 200 mg kapsuli iebsin Pregabalin Pfizer 225 mg kapsuli iebsin Pregabalin Pfizer 300 mg kapsuli iebsin Pregabalin
English: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva gћas-sustanza attiva jew gћal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Weight increased
Maltese: weight x
English: Results of a 12-week placebo-controlled study of 295 paediatric patients aged 4 to 16 years and a 14-day placebo-controlled study of 175 paediatric patients aged 1 month to younger than 4 years of age performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Maltese: Ir-riżultati ta' studju ta' 12-il ġimgħa kkontrollat bil-plaċebo ta' 295 pazjent pedjatriku li kellhom bejn 4 u 16-il sena u studju kkontrollat bil-plaċebo ta' 14-il jum ta' 175 pazjent pedjatriku li kellhom bejn xahar sau iżgħar minn 4 snin sar biex jevalwa l-effikaċja u s-sigurtà ta' pregabalin bħala terapija aġġuntiva għallkura ta' aċċessjonijiet ta' bidu parzjali u studju open label dwar is-sigurtà li dam sena, li sar fuq 54 pazjent pedjatriku li kellhom minn 3 xhur sa 16-il sena, bl-epilessija, jindikaw li l-avvenimenti avversi ta' deni u infezzjonijiet respiratorji fil-parti ta' fuq, ġew osservati b'mod aktar frekwenti milli fl-istudji li saru fuq l-adulti ta' pazjenti b'epilessija (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: Median 24-hour seizure frequencies at baseline and at the final visit were 4.7 and 3.8 for pregabalin 7 mg/kg/day, 5.4 and 1.4 for pregabalin 14 mg/kg/day, and 2.9 and 2.3 for placebo, respectively.
Maltese: Il-frekwenzai medjani ta' aċċessjoni fi 24 siegħa fil-linja bażi medjanau fl-aħħar vista kienetu 4.7 u 3.8 għal pregabalin 7 mg/kg/jum, 5.4 u 1.4 għal pregabalin 14 mg/kg/ jum,u 2.9 u 2.3 għall-plaċebo, rispettivament.
English: Pregabalin Pfizer 75 mg, 100 mg, 200 mg, 225 mg, 300 mg hard capsules
Maltese: Pregabalin Pfizer 75 mg, 100 mg, 200 mg, 225 mg, 300 mg kapsuli iebsin
English: The pregabalin safety profile observed in four paediatric studies in patients with partial seizures with or without secondary generalisation (12-week efficacy and safety study in patients 4 to 16 years of age, n=295; 14-day efficacy and safety study in patients 1 month to younger than 4 years of age, n=175; pharmacokinetic and tolerability study, n=65; and 1 year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy.
Maltese: Il-profil tas-sigurtà ta' pregabalin osservat f'erba' i tliet studji pedjatriċi f'pazjenti b'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja (studju ta' 12-il ġimgħa dwar l-effikaċja u ssigurtà f'pazjenti ta' età ta'li kellhom bejn 4 sau 16-il sena, b'aċċessjonijiet ta' bidu parzjali, n=295; studju ta' 14-il jum dwar l-effikaċja u s-sigurtà f'pazjenti ta' età ta'li kellhom bejn xahar sau iżgħar minn 4 snin, n=175; studju farmakokinetiku u studju dwar it-tollerabilità, n=65; u studju dwar issigurtà open label follow on, n=54, li dam sena) kien simili għal dak osservat fl-istudji fuq l-adulti ta' pazjenti b'epilessija.
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 talposizzjoni, tregħid waqt moviment volontarju, nystagmus, disturb konoxxittiv, indeboliment mentali, disturb fid-diskors, nuqqas ta' riflessi, iperestesija, sensazzjoni ta' ħruq, telf tattogħma, telqa
English: In the 12-week placebo-controlled study, paediatric patients (4 to 16 years of age) were assigned to pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 600 mg/day), or placebo.
Maltese: Fl-istudju ta' 12-il ġimgħa, il-pazjenti pedjatriċi (età ta' 4 sa 16-il sena) ġew assenjati għal pregabalin 2.5 mg/kg/jum (massimu, 150 mg/jum), pregabalin 10/mg/kg/jum (massimu, 600 mg/jum), jew ilplaċebo.
English: Generalised anxiety disorder Pregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Pfizer huwa indikat għall-kura tad-Disturb ta' Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) f'persuni adulti.
English: • When Pregabalin Pfizer is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel).
Maltese: • Meta Pregabalin Pfizer tkun qed tittieħed ma' mediċini oħrajn li jikkawżaw l-istitikezza (bħal ċerti tipi ta' mediċini li jingħataw għall-uġigħ) jista' jkun possibli li jkun hemm problemi gastroinestinali (eż. stitikezza, imsaren imblukkati jew paralizzati).
English: Pregabalin Pfizer 300 mg hard capsules Each hard capsule also contains 33 mg lactose monohydrate.
Maltese: Pregabalin Pfizer 300 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 33 mg lactose monohydrate.
English: When taken with certain other medicines which have sedative effects (including opioids), Pregabalin Pfizer may potentiate these effects, and could lead to respiratory failure, coma and death.
Maltese: Meta Pregabalin Pfizer tiġi meħuda ma' ċertu mediċini oħra li għandhom effetti sedattivi (inklużi l-opjojdi), tista tqawwi dawn l-effetti u tista twassal għal insuffiċjenza respiratorja, koma u mewt.
English: Pregabalin Pfizer 150 mg hard capsules Each hard capsule also contains 16.50 mg lactose monohydrate.
Maltese: Pregabalin Pfizer 150 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 16.50 mg lactose monohydrate.
English: EU/1/14/916/001-005 EU/1/14/916/006 EU/1/14/916/007
Maltese: EU/1/14/916/006 EU/1/14/916/007