FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Maltese: Tagħrif mhux kliniku bbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika u effett tossiku minn dożi ripetuti ma juri l-ebda periklu speċjali għall-bnedmin.
English: Para-aminosalicylic acid is acetylated in the liver and converted into the inactive metabolite, N-acetylpara-aminosalicylic acid which is devoid of bacteriostatic activity.
Maltese: L-aċidu para-aminosaliċiliku jiġi aċetilat fil-fwied u konvertit fil-metabolit inattiv, N-aċetil-aċidu para-aminosaliċiliku li m'għandux attività batterjostatika.
English: The drug does not cross the blood brain barrier in patients unless the meninges are inflamed, when the concentration of para-aminosalicylic acid in cerebrospinal fluid is about 10 to 50% of the plasma.
Maltese: Il-mediċina ma taqsamx il-barriera bejn id-demm u l-moħħ filpazjenti sakemm il-meninġi ma jkunux infjammati, meta l-konċentrazzjoni tal-para-aminosalicylic filfluwidu ċerebrospinali tkun madwar 10 sa 50% tal-plażma.
English: Serum digoxin levels should be monitored in patients on concomitant therapy.
Maltese: Il-livelli ta' digoxin fis-serum għandhom jiġu mmonitorjati f'pazjenti li jkunu qegħdin jieħdu terapija konkomitanti.
English: An in vivo genotoxicity study (micronucleus test) has been conducted with para-aminosalicylic acid.
Maltese: Studju tal-effett tossiku fuq il-ġeni in vivo (test mikronukleu) twettaq bl-aċidu para-aminosaliċiliku.
English: Lucane Pharma Tél/Tel: + 33 153 868 750 info@lucanepharma.com
Maltese: Tél/Tel: + 33 153 868 750 info@lucanepharma.com
English: Ethionamide should be withdrawn if these effects are significant.
Maltese: Ethionamide għandu jitwaqqaf jekk dawn l-effetti jkunu sinifikanti.
English: The sachets can be stored below 25°C up to 24 hours after opening.
Maltese: Il-qratas jistgħu jinħażnu f'temperatura taħt 25°C sa 24 siegħa wara l-ftuħ.
English: Lucane Pharma Tél: + 33 153 868 750 info@lucanepharma.com
Maltese: Tél: + 33 153 868 750 info@lucanepharma.com
English: GRANUPAS is a gastro-resistant preparation and, therefore, the acid-resistant coating of the granules protects against degradation in the stomach therefore preventing the formation of meta-aminophenol (a known hepatotoxin).
Maltese: GRANUPAS huwa preparazzjoni gastro-reżistenti u, għalhekk, il-kisja tal-granijiet li hija reżistenti għall-aċidu tipproteġi kontra d-degradazzjoni fl-istonku u għalhekk timpedixxi l-formazzjoni tal-metaaminophenol (epatotossina magħrufa).
English: • tendon pain,
Maltese: • ippurgar artab,
English: This medicine is presented as light brown gastro-resistant granules in sachets.
Maltese: • ħsara fin-nervituri tal-idejn u s-saqajn,
English: Lucane Pharma Tel.: + 33 153 868 750 info@lucanepharma.com
Maltese: Tel.: + 33 153 868 750 info@lucanepharma.com
English: Package leaflet: Information for the patient GRANUPAS 4 g gastro-resistant granules para-aminosalicylic acid
Maltese: GRANUPAS 4 g granijiet (granules) gastro-reżistenti aċidu para-aminosaliċiliku
English: Medical Need Europe AB Tlf: + 46 8 533 39 500 info@medicalneed.com
Maltese: Tlf: + 46 8 533 39 500 info@medicalneed.com
English: Lucane Pharma Tel: + 33 153 868 750 info@lucanepharma.com
Maltese: Tel: + 33 153 868 750 info@lucanepharma.com
English: The active substance is para-aminosalicylic acid.
Maltese: Is-sustanza attiva hi aċidu para-aminosaliċiliku .
English: *see Description of selected adverse reactions below Description of selected adverse reactions
Maltese: *ara Deskrizzjoni ta' reazzjonijiet avversi magħżula hawn taħt
English: • itchy rash.
Maltese: • Ixorbu mill-ewwel.
English: Bone defects were observed at 77 mg/kg only.and increased foetal weight was noted at the other doses.
Maltese: Id-difetti fl-għadam kienu osservati b'doża ta' 77 mg/kg biss, u kienet innotata żieda fil-piż tal-fetu bid-dożi l-oħra.
English: Gastric ulcer
Maltese: TAGĦRIF
English: • Vitamin B12
Maltese: • Vitamina
English: Unknown Hepatitis
Maltese: • epatite
English: Common abdominal pain, vomiting, nausea, bloating, diarrhea, soft stools.
Maltese: Komuni uġigħ addominali, rimettar, dardir, nefħa, dijarea, ippurgar artab,
English: Medical Need Europe AB Sími: + 46 8 533 39 500 info@medicalneed.com
Maltese: Sími: + 46 8 533 39 500 info@medicalneed.com
English: • vomiting,
Maltese: • mejt,
English: • metallic taste,
Maltese: • togħma metallika,
English: 28 pessaries + 6 applicators
Maltese: 28 pessarju + 6 applikaturi
English: 6.5 mg
Maltese: 6.5 mg Pessarju
English: Vaginal use blister (PVC/PE)
Maltese: Għal użu fil-vaġina folja (PVC/PE)
English: Immediate Packaging
Maltese: Imballaġġ Primarju Daqs tal-pakkett
English: The full EPAR for Pantoloc Control 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: The active substance in Pantoloc Control, pantoprazole, is a proton pump inhibitor.
Maltese: Is-sustanza attiva f'Pantoloc Control, pantoprazole, hija inibitur tal-pompa tal-proton.
English: Pantoloc Control is a medicine that contains the active substance pantoprazole.
Maltese: Pantoloc Control huwa mediċina li fiha s-sustanza attiva pantoprazole.
English: This is a summary of the European public assessment report (EPAR) for Pantoloc Control.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Pantoloc Control.
English: Pantoloc Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantoloc.
Maltese: Pantoloc Control huwa simili għal ‘mediċina ta' referenza' msejħa Pantoloc li hija diġà awtorizzata flUnjoni Ewropea (UE).
English: The European Commission granted a marketing authorisation valid throughout the EU for Pantoloc Control on 12 June 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Pantoloc Control fit-12 ta' Ġunju 2009.
English: Other information about Pantoloc Control
Maltese: Informazzjoni oħra dwar Pantoloc Control
English: What is the risk associated with Pantoloc Control?
Maltese: X'inhu r-riskju assoċjat ma' Pantoloc Control?
English: The reference medicine, Pantoloc, is only available with a prescription.
Maltese: Il-mediċina ta' referenza, Pantoloc, hija disponibbli biss permezz ta' riċetta tat-tabib.
English: What is Pantoloc Control?
Maltese: X'inhu Pantoloc Control?
English: Pantoloc Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Maltese: Pantoloc Control jintuża għall-kura għal żmien qasir tas-sintomi ta' rifluss tal-aċidu fl-adulti.
English: Why has Pantoloc Control been approved?
Maltese: Għaliex ġie approvat Pantoloc Control?
English: Pantoloc Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Maltese: Pantoloc Control m'għandux jintuża f'nies li huma ipersensittivi (allerġiċi) għal pantoprazole, soja jew għal xi sustanza oħra tiegħu.
English: The CHMP therefore decided that Pantoloc Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Pantoloc Control huma akbar mirriskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The most common side effects with Pantoloc Control (seen in around 1 patient in 100) are diarrhoea and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Pantoloc Control (li dehru f'madwar pazjent wieħed minn kull 100) huma dijarrea u wġigħ ta' ras.
English: The type II variation procedure (FR/V/0201/002/II/006) started on 16 May 2012.
Maltese: Il-proċedura tal-varjazzjoni tat-tip II (FR/V/0201/002/II/006) inbdiet fis-16 ta' Mejju 2012.
English: The reference Member State was France and 12 concerned Member States were involved: Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Slovenia, Spain and United Kingdom.
Maltese: L-Istat Membru ta' referenza kien Franza u kienu involuti 12-il Stat Membru kkonċernati: l-Awstrija, il-Belġju, id-Danimarka, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Lussemburgu, il-Portugall, is-Slovenja, Spanja u r-Renju Unit.
English: International non-proprietary names (INN): moxidectin and triclabendazole
Maltese: Ismijiet mhux proprjetarji internazzjonali (INN): moxidectin u triclabendazole
English: Article 13 of Commission Regulation (EC) No. 1234/2008
Maltese: L-Artikolu 13 tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008
English: The Committee appointed Dr B. Urbain as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur.
Maltese: Holzhauser-Alberti bħala co-rapporteur.
English: The CVMP concluded that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field.
Maltese: Is-CVMP, ikkonkluda li wieħed jista' jistenna effikaċja sodisfaċenti għal Linognatus vituli, Bovicola bovis u Solenopotes capillatus.
English: The CMD(v) 60-day referral procedure was initiated on 14 January 2013.
Maltese: CMD(v) inbdiet fl-14 ta' Jannar 2013.
English: The marketing authorisation holder, Pfizer Animal Health, submitted an application for a type II variation, according to Article 16 of Commission Regulation (EC) 1234/2008, to add a new indication against lice species (Linognatus vituli, Bovicola bovis and Solenopotes capillatus) for Cydectin TriclaMox 5 mg/ml and 200 mg/ml pour-on solution for cattle.
Maltese: Id-detentur tral-awtorizzazzjoni għat-tqegħid fis-suq, Pfizer Animal Health, issottometta applikazzjoni għal varjazzjoni tat-tip II, skont l-Artikolu 16 tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008, biex iżid indikazzjoni ġdida kontra speċi ta' qamel (Linognatus vituli, Bovicola bovis u Solenopotes capillatus) għas-soluzzjoni li titferra' ta' Cydectin TriclaMox 5 mg/ml u 200 mg/ml għall-frat.
English: The procedure was thus referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Veterinary (CMD(v)) under Article 13(1) of Commission Regulation (EC) No 1234/2008 on 11 December 2012 by the RMS (France).
Maltese: Għalhekk, ilproċedura ġiet riferuta lill-Grupp ta' Koordinazzjoni għal Proċedura ta' Rikonoxximent Reċiproku u dik Deċentralizzata - Veterinarju (CMD(v)) skont l-Artikolu 13(1) tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008 fil-11 ta' Diċembru 2012 mir-RMS (Franza).
English: Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle is a veterinary medicinal product containing 5 mg moxidectin per ml and 200 mg triclabendazole per ml.
Maltese: Is-soluzzjoni li titferra' ta' Cydectin TriclaMox (5 mg/ml u 200 mg/ml) għall-frat hija prodott mediċinali veterinarju li fiha 5 mg ta' moxidectin għal kull ml u 200 mg ta' triclabendazole għal kull ml.
English: On 3 April 2013, France referred the matter to the CVMP under Article 13(2) of Commission Regulation (EC) No 1234/2008.
Maltese: Fit-3 ta' April 2013, Franza rreferiet il-kwistjoni lis-CVMP skont l-Artikolu 13(2) tar-Regolament talKummisjoni (KE) Nru 1234/2008.
English: The referral procedure started on 10 April 2013.
Maltese: Il-proċedura ta' riferiment inbdiet fl-10 ta' April 2013.
English: Written explanations were provided by the marketing authorisation holder on 20 May 2013.
Maltese: Fl-20 ta' Mejju 2013, ġew ipprovduti spjegazzjonijiet bil-miktub mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Based on the evaluation of the available data, the CVMP adopted, on 16 July 2013, an opinion recommending the granting of the variation to the marketing authorisations for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle.
Maltese: Abbażi tal-evalwazzjoni tad-dejta disponibbli, fis-16 ta' Lulju 2013, is-CVMP adotta opinjoni li tirrakkomanda l-għoti tal-varjazzjoni għall-awtorizzazzjonijiet għat-tqegħid fis-suq għas-soluzzjoni li titferra' ta' Cydectin TriclaMox (5 mg/ml u 200 mg/ml) għall-frat.
English: Opinion following an Article 130F referral for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle
Maltese: għas soluzzjoni li titferra' (5 mg/ml u 200 mg/ml) ta' Cydectin
English: 25 September 2013
Maltese: 25 ta' Settembru 2013 EMA/549503/2013
English: On Day 90, major issues raised by the CMS, Belgium, remained unsolved.
Maltese: Fil-jum 90, kwistjonijiet ewlenin imqajma mis-CMS tal-Belġju, baqgħu mhux solvuti.
English: Day 60 of the CMD(v) procedure was on 14 March 2013, and since there was no agreement the procedure was referred to the CVMP.
Maltese: Il-jum 60 tal-proċedura tas-CMD(v) kien fl-14 ta' Marzu 2013, u peress li ma ntlaħaq l-ebda qbil, il-proċedura ġiet riferuta lis-CVMP.
English: The final opinion was converted into a Decision by the European Commission on 25 September 2013.
Maltese: L-opinjoni finali ġiet ikkonvertita f'Deċiżjoni mill-Kummissjoni Ewropea fil-25 ta' Settembru 2013.
English: During the variation procedure a potential serious risk to animal health was identified by Belgium and in particular that the efficacy against the lice species had been insufficiently substantiated.
Maltese: Matul ilproċedura ta' varjazzjoni, ġie identifikat mill-Belġju riskju potenzjali serju għas-saħħa tal-annimali u b'mod partikolari li l-effikaċja kontra l-ispeċi ta' qamel kienet ġiet sostanzjata b'mod insuffiċjenti.
English: ATC code: A10AE56
Maltese: Kodiċi ATC: A10AE56
English: Hallas Alle, Kalundborg, 4400, Denmark Novo Nordisk A/S
Maltese: Hallas Alle, Kalundborg, 4400, Id-Danimarka Novo Nordisk A/S
English: In both groups 66%-67% achieved HbA1c < 7%.
Maltese: Fiż-żewġ gruppi 66%-67% kisbu HbA1c < 7%.
English: Transfer from insulin glargine (100 units/mL)
Maltese: Trasferiment minn insulina glargine (100 unitl/ml)
English: • Inflamed pancreas (pancreatitis).
Maltese: • Frixa infjammata (pankreatite).
English: Liraglutide was superior in preventing MACE vs placebo (Figure 6).
Maltese: Liraglutide kien superjuri fil-prevenzjoni ta' MACE vs plaċebo (Figura 6).
English: Two minor plasma metabolites were detected (≤9% and ≤5% of total plasma radioactivity exposure).
Maltese: Instabu żewġ metaboliti minuri fil-plażma (≤9% u ≤5% tal-esponiment totali tal-plażma għar-radjuattività).
English: Add on to sulfonylurea ± metformin
Maltese: Żieda ma' sulfonylurea ± metformin
English: Antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
Maltese: Prodotti mediċinali kontra d-dijabete, inibituri ta' monoamine oxidase (MAOI), imblokkaturi tarriċetturi beta, inibituri tal-enzima li tibdel angiotensin (ACE), salicylates, sterojdi anaboliċi u sulfonamides.
English: Transfer from basal insulin (NPH, insulin detemir, insulin glargine)
Maltese: Trasferiment minn insulina bażilari (NPH, insulina detemir, insulina glargine)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Glycerol
English: IDegLira=Xultophy, IDeg=insulin degludec, Lira=liraglutide, obs. rate=observed rate, PYE=patient year of exposure
Maltese: IDegLira=Xultophy, IDeg=insulina degludec, Lira=liraglutide, obs. rate= rata osservata (observed rate), PYE= sena ta' esponiment ta' pazjent (patient year of exposure)
English: The duration of observation was minimum 3.5 years and up to a maximum of 5 years.
Maltese: L-osservazzjoni damet minimu ta' 3.5 snin u sa massimu ta' 5 snin.
English: Insulin degludec and liraglutide are extensively bound to plasma proteins (>99% and >98%, respectively).
Maltese: L-insulina degludec u liraglutide huma marbuta b'mod estensiv mal-proteini tal-plażma (>99% u >98%, rispettivament).
English: Novo Allé, Bagsværd, 2880, Denmark
Maltese: Novo Allé, Bagsværd, 2880, Id-Danimarka
English: Name and address of the manufacturer of the biological active substances Novo Nordisk A/S
Maltese: Name and address of the manufacturer responsible for batch release Novo Nordisk A/S
English: The differences were not statistically significant.
Maltese: Id-differenzi ma kinux statistikament sinifikanti.
English: Table 1 Adverse reactions reported in phase 3 controlled studies MedDRA System organ class Frequency
Maltese: Tabella 1 Reazzjonijiet avversi rrapportati fl-istudji kkontrollati tal-fażi 3 Klassi tas-sistemi u tal organi MedDRA
English: Figure 7 Forest plot of analysis of the composite 3-point MACE and individual cardiovascular endpoints in DEVOTE
Maltese: Figura 7 Forest plott ta' analiżi tat-taħlita tat-3-komponenti ta' MACE u punti finali individwali kardjovaskulari f'DEVOTE
English: Estimated odds ratio
Maltese: Hazard Ratio
English: IDegLira=Xultophy, GLP-1 RA=GLP-1 receptor agonist
Maltese: IDegLira=Xultophy, GLP-1 RA=agonist tar-riċettur GLP-1
English: Insulin degludec, maximum 50 units allowed
Maltese: Insulina degludec, massimu ta' 50 unità permessibbli
English: It contains 3 mL of Xultophy solution.
Maltese: Fiha 3 mL ta' soluzzjoni Xultophy.
English: Diarrhoea and vomiting were reported in 7.5% and 3.9% of patients, respectively.
Maltese: Kienu rrapportati dijarea u rimettar f'7.5% u f'3.9% tal-pazjenti, rispettivament.
English: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists, including liraglutide.
Maltese: Ġiet osservata pankreatite akuta bl-użu ta' agonisti tar-riċetturi ta' GLP-1, inkluż liraglutide.
English: Xultophy Placebo
Maltese: Xultophy Plaċebo
English: Thyroid adverse events
Maltese: Avvenimenti avversi tat-tirojde
English: Figure 6 Forest plot of analyses of individual cardiovascular event types - FAS population
Maltese: Figura 6 Skema Forest ta' analiżi tat-tipi individwali ta' avvenimenti kardjovaskulari
English: IDegLira=Xultophy, IGlar=insulin glargine
Maltese: IDegLira=Xultophy, IGlar=insulina glargine
English: IDegLira=Xultophy, IDeg=insulin degludec
Maltese: IDegLira=Xultophy, IDeg=insulina degludec
English: IDegLira Placebo
Maltese: IDegLira Plaċebo
English: • Increase of pancreatic enzymes, such as lipase and amylase.
Maltese: • Żieda fl-enzimi pankreatiċi bħal lipase u amylase.
English: Mean change Estimated difference
Maltese: Bidla medja Differenza stmata
English: The Xultophy clinical development programme included approximately 1,900 patients treated with Xultophy.
Maltese: Il-programm ta' żvilupp kliniku ta' Xultophy inkluda madwar 1,900 pazjent ikkurati b'Xultophy.
English: Pack sizes of 1, 3, 5 and a multipack containing 10 (2 packs of 5) pens of 3 mL.
Maltese: Daqsijiet tal-pakkett ta' 1, 3, 5 u pakkett multiplu li fih 10 (2 pakketti ta' 5) pinen ta' 3 mL.
English: Frequency categories are defined as: 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) and not known
Maltese: 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); rari ħafna (<1/10,000); mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: • Do not store your pen at temperatures above 30°C.
Maltese: • Taħżinx il-pinna tiegħek f'temperaturi 'l fuq minn 30°C.
English: • Insulin secretion/beta-cell function Xultophy improves beta-cell function compared to insulin degludec as measured by the homeostasis model assessment for beta-cell function (HOMA-β).
Maltese: • Sekrezzjoni ta' insulina/funzjoni taċ-ċelloli beta Xultophy itejjeb il-funzjoni taċ-ċelloli beta meta mqabbel mal-insulina degludec kif imkejjel bilvalutazzjoni tal-mudell ta' omeostasi għall-funzjoni taċ-ċelloli beta (HOMA-β - homeostasis model assessment for beta-cell function).
English: Liraglutide exposure was lowered by 33%, 14%, 27% and 26%, in patients with mild (creatinine clearance, CrCl 50-80 mL/min), moderate (CrCl 30-50 mL/min), and severe (CrCl <30 mL/min) renal impairment and in end-stage renal disease requiring dialysis, respectively.
Maltese: L-esponiment għal liraglutide naqas bi 33%, 14%, 27% u 26%, f'pazjenti b'indeboliment renali ħafif (tneħħija tal-kreatinina, CrCl 50-80 mL/min), moderat (CrCl 30-50 mL/min), u sever (CrCl <30 mL/min) u meta kien hemm mard tal-kliewi li wasal fl-aħħar stadju u li kien jeħtieġ id-dijalisi, rispettivament.
English: Insulin degludec Liraglutide
Maltese: Insulina degludec Liraglutide
English: The proportion was significantly larger than observed with insulin degludec (40.9%, odds ratio 2.28, p <0.0001) and similar to that observed with liraglutide (57.7%, odds ratio 1.13, p=0.3184).
Maltese: Il-proporzjon kien akbar b'mod sinifikanti minn dak li ġie osservat bl-insulina degludec (40.9%, proporzjoni ta' probabbiltà 2.28, p<0.0001) u simili għal dak osservat b'liraglutide (57.7%, proporzjoni ta' probabbiltà 1.13, p=0.3184).
English: Date of first authorisation: 18 September 2014 Date of latest renewal: 08 July 2019
Maltese: Data tal-aħħar tiġdid: 08 Lulju 2019
English: • Inflamed gallbladder.
Maltese: • Infjammazzjoni tal-bużżieqa tal-marrara.
English: For further instructions on administration, see section 6.6.
Maltese: Għal aktar istruzzjonijiet dwar l-għoti, ara sezzjoni 6.6.
English: Liraglutide lowered ethinylestradiol and levonorgestrel Cmax by 12 and 13%, respectively, following administration of a single dose of an oral contraceptive product.
Maltese: Liraglutide baxxa s-Cmax ta' ethinylestradiol u levonorgestrel bi 12 u 13%, rispettivament, wara l-għoti ta' doża waħda ta' prodott kontraċettiv orali.
English: FPG (mmol/L)
Maltese: mmol/L
English: At baseline, HbA1c was 8.4% in both treatment groups and after 2 years HbA1c was 7.5% both with insulin degludec and insulin glargine.
Maltese: Fil-linja bażi,HbA1c kien 8.4% fiż-żewġ gruppi ta' trattament u wara sentejn HbA1c kien 7.5% kemm b'insulin degludec u kemm b'insulin glargine.
English: • medicines called ‘sympathomimetics' such as epinephrine (adrenaline), salbutamol or terbutaline - for asthma
Maltese: • mediċini msejħa ‘simpatomimetiċi' bħal epinephrine (adrenaline), salbutamol jew terbutaline għall-ażma
English: Patients (%) achieving HbA1c ≤6.5% All patients
Maltese: Pazjenti (%) li kisbu HbA1c ≤6.5% Il-pazjenti kollha
English: • monoamine oxidase (MAO) inhibitors - for depression
Maltese: • inibituri ta' monoamine oxidase (MAO) - għad-dipressjoni
English: Add on to metformin ± pioglitazone
Maltese: Żieda ma' metformin±pioglitazone
English: The trials were of 26 weeks duration randomising between 199 and 833 patients to Xultophy.
Maltese: Il-provi damu 26 ġimgħa u b'mod arbitrarju bejn 199 u 833 pazjent ingħataw Xultophy.
English: Pen scale Pen window
Maltese: Skala tal pinna
English: In three trials with patients inadequately controlled on basal insulin, systolic blood pressure was reduced by 5.4 mmHg with Xultophy and 1.7 mmHg with insulin degludec, with a statistically significant estimated treatment difference of -3.71 mmHg (p=0.0028), reduced by 3.7 mmHg with Xultophy vs 0.2 mmHg with insulin glargine, with a statistically significant estimated treatment difference of -3.57 mmHg (p<0.001) and reduced by 4.5 mmHg with Xultophy vs 1.16 mmHg with insulin glargine U100 plus insulin aspart, with a statistically significant estimated treatment difference of -3.70 mmHg (p=0.0003).
Maltese: Fi tliet provi b'pazjenti li ma kinux ikkontrolati b'mod adegwat b'insulina bażali, ilpressjoni sistolika tad-demm tnaqqset b'5.4 mmHg b'Xultophy u b'1.7 mmHg b'insulina degludec, b'stima ta' differenza fit-trattament ta' -3.71 mmHg (p=0.0028), li huwa statistikament sinifikanti, tnaqqset bi 3.7 mmHg b'Xultophy vs. 0.2 mmHg b'insulina glargine, b'stima ta' differenza fittrattament ta' -3.57 mmHg (p<0.
English: • Cardiovascular Safety
Maltese: • Sigurtt kardjovaskulari
English: Transfer to Xultophy from doses of basal insulin <20 and >50 units has not been studied.
Maltese: It-trasferiment ta' Xultophy minn dożi ta' insulina bażali <20 u >50 unità ma ġiex studjat.
English: Limited data are available with regard to overdose of Xultophy.
Maltese: Id-data disponibbli dwar doża eċċessiva ta' Xultophy hija limitata.
English: Do not use Xultophy:
Maltese: Tużax Xultophy:
English: Important things to know before you use this medicine:
Maltese: Affarijiet importanti li għandek tkun taf waqt li tuża din il-mediċina: