FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC also considered the proposed risk minimisation measures to reduce the risk of overdose through education, communication and restricting availability and concluded that these measures would not be sufficient to minimise the risk of intentional and accidental overdoses to an acceptable level.
Maltese: • Il-PRAC ikkunsidra wkoll l-attivitajiet tal-minimizzar tar-riskju proposti sabiex jitnaqqas irriskju ta' doża eċċessiva permezz tal-edukazzjoni, tal-komunikazzjoni u tar-restrizzjoni taddisponibbiltà, u kkonkluda li dawn il-miżuri ma jkunux biżżejjed sabiex ir-riskju ta' dożi eċċessivi intenzjonati u aċċidentali jiġi minimizzat għal livell aċċettabbli.
English: While no cases of overdose were reported in children below 12 years of age, the PRAC noted that the risk of unintentional overdose with Doreta SR is minimal in the patient population due to e.g. the restricted use in children, the child resistant package.
Maltese: Filwaqt li ma ġie rrapportat l-ebda każ ta' doża eċċessiva fi tfal ta' taħt it-12-il sena, il-PRAC innota li rriskju ta' doża eċċessiva mhux intenzjonata b'Doreta SR huwa minimu fil-grupp ta' pazjenti minħabba, eżempju, l-użu ristrett fit-tfal, il-pakkett reżistenti għat-tfal.
English: Having reviewed the PRAC recommendation, the CMDh agree with the PRAC overall conclusions and grounds for recommendation.
Maltese: Wara li ġiet riveduta r-rakkomandazzjoni tal-PRAC, is-CMDh jaqbel mal-konklużjonijiet u r-raġunijiet globali għar-rakkomandazzjoni tal-PRAC.
English: 4941 SJ Raamsdonksveer The Netherlands
Maltese: 4941 SJ Raamsdonksveer L-Olanda
English: Anise aroma
Maltese: Aroma tal-aniżetta
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/02/2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21/02/2011
English: Manufacturer responsible for batch release: Produlab Pharma B.V.
Maltese: Manifattur responsabbli għall-ħruġ tal-lott: Produlab Pharma B.V.
English: Excipient:
Maltese: Eċċipjenti:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions during) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: PACKAGE SIZE 125 ml
Maltese: DAQS TAL-PAKKETT 125 ml
English: Chronic musculo-skeletal disorders:
Maltese: Disturbi muskolu-skeletriċi kroniċi:
English: Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Maltese: Meloxicam hu Mediċina Mhux Sterojdi Kontra l-Infjammazzjoni (NSAID) tal-klassi oxicam li taġixxi bl-inibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, analġesiċi, kontra t-tnixxija u antipiretiċi.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATC vet code: QM01AC06
Maltese: Kodiċi ATC veterinarja: QM01AC06
English: OTHER INFORMATION 10, 25, 50 or 125 ml bottle.
Maltese: Flixkun ta' 10, 25, 50 jew 125 ml.
English: ROUTE(S) OF ADMINISTRATION Oral use
Maltese: MOD(I) TA' AMMINISTRAZZJONI Użu orali
English: EXPIRY DATE EXP {month/year} Use by …
Maltese: DATA TA' SKADENZA EXP {xahar/sena} Uża fi żmien…
English: Excipients: Sodium benzoate 1.75 mg/ml
Maltese: Sodium benzoate 1.75mg/ml
English: Polyethylene bottle containing 10 ml, 25 ml, 50 ml or 125 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.
Maltese: Flixkun tal-polyethylene li fih 10 ml, 25 ml, 50 ml jew 125 ml b'qattara tal-polyethylene u b'tapp li jirreżisti l-ftuħ mit-tfal żgħar.
English: In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
Maltese: F'każijiet rari ħafna ġew rrappurtati każijiet ta' dijarea emorraġika, ematemesi, ulċeri gastrointestinali u livelli ogħla ta' enzimi tal-fwied.
English: In guinea pigs, an overdose of 0.6 mg/kg body weight administered during 3 days followed by a dose of 0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam.
Maltese: Fil-fniek tal-Indi, doża eċċessiva ta' 0.6 mg/kg piż tal-ġisem mogħtija matul 3 ijiem segwita minn doża ta' 0.3 mg/kg matul 6 ijiem addizzjonali ma kkawżatx avvenimenti avversi tipiċi għal meloxicam.
English: Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.
Maltese: Għas-serħan ta' wġigħ minn ħafif sa moderat u infjammazzjoni wara operazzjoni wara proċeduri kirurġiċi fil-qtates, eż. operazzjoni ortopedika u tat-tessut artab.
English: Yellow/green suspension.
Maltese: Suspensjoni safra/ħadranija.
English: Use a small container (e.g. a teaspoon) and drop Melosus oral suspension into the container (it is advised to dispense a few drops more than required into the small container).
Maltese: Uża kontenitur żgħir (eż. kuċċarina) u qattar Melosus suspensjoni orali fil-kontenitur (huwa rakkomandat li tagħti ftit aktar qtar milli meħtieġ fir-reċipjent iż-żgħir).
English: Post-operative pain and inflammation following surgical procedures: After initial treatment with meloxicam solution for injection for cats, continue treatment 24 hours later with Melosus 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight.
Maltese: Wara l-kura inizjali b'meloxicam soluzzjoni għall-injezzjoni għal qtates, kompli l-kura 24 siegħa wara b'Melosus 0.5 mg/ml suspensjoni orali għal qtates f'dożaġġ ta' 0.05 mg ta' meloxicam/kg ta' piż talġisem.
English: Guinea pigs:
Maltese: Uża fi żmien…
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 0.5 mg/ml
Maltese: TAS-SUSTANZA(I) ATTIVA Meloxicam 0.5 mg/ml
English: Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight
Maltese: Wara l-kura inizjali b'meloxicam 2 mg/ml soluzzjoni għall-injezzjoni għal qtates, kompli l-kura 24 siegħa wara b'Melosus 0.5 mg/ml suspensjoni orali għal qtates f'dożaġġ ta' 0.05 mg ta' meloxicam/kg ta' piż tal-ġisem.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER CP-Pharma Handelsgesellschaft mbH, Germany
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ CP-Pharma Handelsgesellschaft mbH
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 1.5 mg/ml oral suspension for dogs Meloxicam
Maltese: VETERINARJU Melosus 1.5 mg/ml Suspensjoni orali għall-klieb Meloxicam
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 1.5 mg/ml oral suspension for dogs meloxicam
Maltese: VETERINARJU Melosus 1.5 mg/ml suspensjoni orali għall-klieb meloxicam
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Maltese: U INGREDJENT(I) OĦRA Sustanza attiva
English: Typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Maltese: Reazzjonijiet avversi tipiċi ta' Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) bħal nuqqas t'aptit, rimettar, dijarea, demm moħbi fl-ippurgar, apatija u insuffiċjenza renali kienu rrappurtati xi kultant.
English: MARKETING AUTHORISATION NUMBERS EU/2/10/116/007 5 ml
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/2/10/116/007 5 ml
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 1.5 mg/ml
Maltese: TAS-SUSTANZA(I) ATTIVA Meloxicam 1.5 mg/ml
English: Disposal: read package leaflet.
Maltese: Is-suspensjoni tista' tingħata bis-siringa tal-kejl ipprovduta fil-pakkett.
English: In very rare cases elevated liver enzymes have been reported.
Maltese: F'każijiet rari ħafna livelli għoljin ta' enzimi tal-fwied ġew rrappurtati.
English: Melosus 0.5 mg/ml oral suspension for cats should not be used following parenteral injection of meloxicam or any other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) as appropriate dosage regimens for such follow-up treatments have not been established in cats.
Maltese: Melosus 0.5 mg/ml suspensjoni orali għall-qtates ma għandux jintuża wara injezzjoni parenterali ta' meloxicam jew ta' kwalunkwe Mediċina Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) oħra minħabba li reġimen ta' dożaġġi xierqa għal kuri ta' follow-up bħal dawn għadhom ma ġewx stabbiliti fil-qtates.
English: The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.
Maltese: Id-doża orali tal-follow-up tista' tingħata darba kuljum (f'intervalli ta' 24 siegħa) sa erbat ijiem.
English: Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
Maltese: Madwar 75 % tad-doża mogħtija tiġi eliminata malippurgar u l-bqija permezz tal-awrina.
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains:
Maltese: Sustanza mhux attiva:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 1.5 mg/ml oral suspension for dogs
Maltese: VETERINARJU Melosus 1.5 mg/ml Suspensjoni orali għall-klieb
English: Please carefully follow the instructions of the veterinarian.
Maltese: Jekk jogħġbok segwi blattenzjoni l-istruzzjonijiet tal-veterinarju.
English: 15 OTHER INFORMATION 5, 10 or 25 ml bottle.
Maltese: Flixkun ta' 5, 10 jew 25 ml.
English: In cats, Melosus 0.5 mg/ml oral suspension for cats should be used.
Maltese: Fil-qtates, għandha tintuża Melosus 0.5 mg/ml suspensjoni orali għal qtates.
English: Do not use in pregnant or lactating animals (See section 4.3).
Maltese: Tużax waqt it-tqala jew f'annimali li qed ireddgħu (ara sezzjoni 4.3).
English: Active substance: Meloxicam 1.5 mg/ml
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA SUSTANZI Meloxicam 1.5 mg/ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 0.5 mg/ml oral suspension for cats and guinea pigs meloxicam
Maltese: VETERINARJU Melosus 0.5 mg/ml suspensjoni orali għall-qtates u l-fniek tal-Indi Meloxicam
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 0.5 mg/ml oral suspension for cats and guinea pigs Meloxicam
Maltese: VETERINARJU Melosus 0.5 mg/ml suspensjoni orali għall-qtates u l-fniek tal-Indi meloxicam
English: Polyethylene bottle containing 5 ml, 10 ml or 25 ml with a tamper proof child resistant closure and a polypropylene measuring syringe
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mal-prodott Flixkun tal-polypropylene li fih 5 ml, 10 ml jew 25 ml b'tapp li jirreżisti l-ftuħ mit-tfal żgħar u siringa tal-kejl tal-polypropylene.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melosus 0.5 mg/ml oral suspension for cats and guinea pigs
Maltese: VETERINARJU Melosus 0.5 mg/ml suspensjoni orali għall-qtates u l-fniek tal-Indi
English: Do not use the cat syringe with the kg-body weight scale for guinea pigs.
Maltese: F'każijiet rari ħafna, ġew irrapportati ulċerazzjoni gastrointestinali u livelli għolja ta' enzimi tal-fwied.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/116/003 125 ml
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/2/10/116/003 125 ml
English: Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
Maltese: It-trattament għandu jitkompla darba kuljum bl-għoti orali (f'intervalli ta' 24 siegħa) bid-doża tal-manteniment ta' 0.1 mg meloxicam / kg ta' piż tal-ġisem.
English: The full EPAR for Respiporc FLUpan H1N1 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The vaccine contains inactivated (killed) influenza A virus/Jena/VI5258/2009(H1N1)pdm09, a strain of the virus that causes swine influenza.
Maltese: Il-vaċċin fih vajrus ta' influwenza A/Jena/VI5258/2009(H1N1)pdm09 inattivat (maqtul), razza tal-vajrus li tikkawża l-influwenza tal-ħnieżer.
English: The most common side effects with Respiporc FLUpan H1N1 (which may affect up to 1 in 10 animals) are a short-lived increase in rectal temperature, not exceeding 2 °C, which does not last for more than one day and a transient swelling up to 2 cm3 at the site of injection which usually resolves within
Maltese: L-effetti sekondarji l-aktar komuni b'Respiporc FLUpan H1N1 (li jistgħu jaffettwaw sa 1 minn kull 10) huma żieda għal perjodu qasir fit-temperatura rettali, li ma taqbiżx 2°C, li ma ddumx aktar minn jum wieħed u nefħa temporanja sa 2 cm3 fis-sit tal-injezzjoni li normalment tgħaddi fi żmien 5 ijiem.
English: Signs can include fever, depression, coughing, sneezing, difficulty breathing and loss of appetite.
Maltese: Is-sinjali jistgħu jinkludu deni, dipressjoni, sogħla, għatis, diffikultà fit-teħid tan-nifs u nuqqas ta' aptit.
English: The effectiveness of Respiporc FLUpan H1N1 was shown in three laboratory studies and one combined field/laboratory study.
Maltese: L-effettività ta' Respiporc FLUpan H1N1 intweriet fi tliet studji tal-laboratorju u fi studju wieħed fuq il-post/tal-laboratorju kkombinat.
English: The European Commission granted a marketing authorisation valid throughout the EU for Respiporc FLUpan H1N1 on 17 May 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Respiporc FLUpan H1N1 f'17/05/2017.
English: Respiporc FLUpan H1N1 is a vaccine used to protect pigs from eight weeks of age against swine influenza caused by pandemic subtype H1N1.
Maltese: Respiporc FLUpan H1N1 huwa vaċċin li jintuża sabiex tipproteġi lill-ħnieżer minn età ta' tmien ġimgħat kontra influwenza tal-ħnieżer ikkawżata minn sottotip pandemiku H1N1.
English: This is a summary of the European public assessment report (EPAR) for Respiporc FLUpan H1N1.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Respiporc FLUpan H1N1.
English: Other information about Respiporc FLUpan H1N1:
Maltese: Informazzjoni oħra dwar Respiporc FLUpan H1N1:
English: Respiporc FLUpan H1N1 contains an adjuvant (carbomer) to enhance the immune response.
Maltese: Respiporc FLUpan H1N1 fih aġġuvant (karbomeru) biex isaħħaħ ir-rispons immuni.
English: Porcine influenza vaccine (inactivated)
Maltese: Vaċċin tal-influwenza tal-ħnieżer (inattivat)
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Respiporc FLUpan H1N1's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Respiporc FLUpan H1N1 huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Respiporc FLUpan H1N1 is a vaccine.
Maltese: Respiporc FLUpan H1N1 huwa vaċċin.
English: Why is Respiporc FLUpan H1N1 approved?
Maltese: Għaliex ġie approvat Respiporc FLUpan H1N1?
English: What are the risks associated with Respiporc FLUpan H1N1?
Maltese: X'inhuma r-riskji assoċjati ma' Respiporc FLUpan H1N1?
English: How is Respiporc FLUpan H1N1 used?
Maltese: Kif jintuża Respiporc FLUpan H1N1?
English: CI: 95% confidence interval.
Maltese: CI: 95% Intervall ta' Kunfidenza-confidence interval.
English: Date of first authorisation: 21 January 2013 Date of latest renewal: 21 September 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Jannar 2013 Data tal-aħħar tiġdid: 21 Settembru 2017
English: MI: Myocardial infarction.
Maltese: IM: Infart Mijokardijaku.
English: 1 x 3 mL + 7 NovoFine needles 1 x 3 mL + 7 NovoTwist needles 5 x 3 mL
Maltese: 1 x 3 mL + 7 labar NovoFine 1 x 3 mL + 7 labar NovoTwist 5 x 3 mL
English: There were no statistically significant differences between the two treatment groups.
Maltese: Ma kien hemm ebda differenza statistikament sinifikanti bejn iż-żewġ gruppi ta' trattament.
English: CV: Cardiovascular.
Maltese: KV: Kardjovaskulari.
English: IDegAsp 0.8 U/kg
Maltese: Ħin mill-injezzjoni (sigħat) Kura IDegAsp 0.8 U/kg
English: Favours insulin degludec
Maltese: Tifavorixxi insulin degludec
English: EAC: Event adjudication committee.
Maltese: EAC:Kumitat li jevalwa l-avveniment-Event adjudication committee.
English: It delivers 1-80 units in steps of 1 unit.
Maltese: Tforni 1-80 unità f'passi ta' 1 unità.
English: Favours insulin glargine
Maltese: Tifavorixxi insulin glargine
English: EU/1/12/806/001 1 pen of 3 mL EU/1/12/806/002 1 pen of 3 mL and 7 NovoFine needles EU/1/12/806/003 1 pen of 3 mL and 7 NovoTwist needles EU/1/12/806/004 5 pens of 3 mL
Maltese: EU/1/12/806/001 Pinna 1 ta' 3 mL EU/1/12/806/002 Pinna 1 ta'3 mL u 7 labar NovoFine EU/1/12/806/003 Pinna 1 ta'3 mL u 7 labar NovoTwist EU/1/12/806/004 5 pinen ta' 3 mL
English: For more information, see ‘serious allergic reaction' above.
Maltese: Għal aktar informazzjoni ara ‘reazzjoni allerġika serja' taħt.
English: Hypersensitivity Urticaria
Maltese: Sensittività eċċessiva Urtikarja
English: Solution for injection (FlexTouch) 5 x 3 mL.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni (FlexTouch) 5 x 3 ml.
English: Difference: -1.14 [-1.53;-0.76]
Maltese: Differenza: -1.14 [-1.53;-0.76]
English: • The active substances are insulin degludec and insulin aspart.
Maltese: • Is-sustanzi attivi huma insulina degludec u insulina aspart.
English: Figure 1: Pharmacodynamics, single dose - Mean glucose infusion rate profile - Patients with type 1 diabetes - 0.8 U/kg Ryzodeg - Trial 3539
Maltese: Figura 1: Farmakodinamika, doża waħda - Medja tal-profil tar-rata tal-infużjoni tal-glukosjuPazjenti b'dijabete ta' tip 1 - 0.8 U/kg Ryzodeg - Prova 3539
English: 1 Once-daily regimen + Metformin
Maltese: 1 Kors ta' darba kuljum + Metformin
English: 24 units selected
Maltese: Magħżula 24 unità
English: Fasting Plasma Glucose (FPG) (mmol/L)
Maltese: Glukosju fil-Plażma fl-Istat Sajjem (FPG) (mmol/L)
English: Glucose Infusion Rate (mg/(kg*min))
Maltese: Rata ta' Infużjoni tal-Glukożju/(kg*min)
English: The rates (events per patient-year of exposure) of confirmed hypoglycaemia (ISPAD 2009 definition: 46.23 vs 49.55) and nocturnal confirmed hypoglycaemia (5.77 vs 5.40) were comparable with Ryzodeg vs insulin detemir whereas the rate of severe hypoglycaemia (0.26 vs 0.07) was higher in the Ryzodeg arm although the difference was not statistically significant.
Maltese: Ir-rati (avvenimenti għal kull sena ta' espożizzjoni ta' pazjent) ta' ipogliċemija kkonfermata (definizzjoni ISPAD 2009 : 46.23 vs 49.55) u ta' ipogliċemija kkonfermata mal-lejl (5.77 vs 5.40) kienu simili għal Ryzodeg u insulina detemir, filwaqt li r-rata ta' ipogliċemija severa (0.26 vs 0.07) kienet ogħla fil-fergħa ta' Ryzodeg għalkemm id-differenza ma kinitx statistikament sinifikanti.
English: Ryzodeg with alcohol
Maltese: Ryzodeg mal-alkoħol
English: Ratio: 1.43 [1.07;1.92]
Maltese: Proporzjon: 1.43 [1.07;1.92]
English: Difference: -1.06 [-1.43;-0.70]
Maltese: Differenza: -1.06 [-1.43;-0.70]
English: The following substances may reduce the insulin requirement Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
Maltese: Prodotti mediċinali kontra d-dijabete li jittieħdu mill-ħalq, agonisti ta' riċetturi GLP-1, inibituri ta' monoamine oxidase (MAOI), betablokkanti, inibituri tal-enzima li tibdel angiotensin (ACE), salicylates, sterojdi anaboliċi u sulfonamides.
English: Solution for injection (FlexTouch)
Maltese: Soluzzjoni għall-injezzjoni (FlexTouch)
English: Ryzodeg has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see section 5.2).
Maltese: Ryzodeg ingħata lil tfal u adolexxenti sa 18-il sena għall-investigazzjoni ta' propjetajiet farmakokinetiċi (ara sezzjoni 5.2).
English: Pack sizes of 5 and 10 cartridges.
Maltese: Daqsijiet tal-pakketti ta' 5 u 10 skrataċar.
English: Figure 2 Forest plot of analysis of the composite 3-point MACE and individual cardiovascular endpoints in DEVOTE
Maltese: 2 Dijagramma Forest tal-kompost MACE magħmul minn 3-komponenti u l-punti finali kardjovaskulari individwali f'DEVOTE
English: Insulin aspart has a low binding to plasma proteins (<10%), similar to that seen with regular human insulin.
Maltese: Insulina aspart għandu rabta baxxa mal-proteini fil-plażma (<10%), li hu simili għal dak osservat b'insulina umana regolari.
English: Glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections
Maltese: Glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid u sodium hydroxide (għal aġġustament tal-pH) u ilma għall-injezzjonijiet
English: Seven multinational, randomised, controlled, open-label, treat-to-target clinical studies of between 26 and 52 weeks' duration were conducted exposing a total of 1,761 patients with diabetes mellitus (1 study involving 362 patients in type 1 diabetes mellitus and 6 studies involving 1,399 patients in type 2 diabetes mellitus) to Ryzodeg.
Maltese: Twettqu seba' studji kliniċi multinazzjonali, ikkontrollati, open-label, magħmula b'mod arbitrarju, tattip treat-to-target, li damu bejn 26 u 52 ġimgħa u li esponew total ta' 1,761 pazjent b'dijabete mellitus (studju 1 kellu 362 pazjent b'dijabete mellitus ta' tip 1 u 6 studji kellhom 1,399 pazjent b'dijabete mellitus ta' tip 2) għal Ryzodeg.
English: Ratio: 1.00 [0.76;1.32]
Maltese: 52;0.89]* Proporzjon: 1.00 [0.76;1.32]
English: Dose button with 3 lines
Maltese: Buttuna tal injezzjoni b'3 linji
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,l-HbA1c kien 8.4% fiż-żewġ gruppi ta' trattament u wara sentejn l-HbA1c kien 7.5% kemm b'insulin degludec u kemm b'insulin glargine.
English: Dose counter stopped: 52 units left
Maltese: fadal 52 unità
English: The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of >99% in human plasma.
Maltese: L-affinità ta' insulina degludec għall-albumina fis-serum tikkorrispondi għal rabta mal-proteini ta' >99% fil-plażma umana.
English: Frequency categories 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
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) u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Ryzodeg 100 units/mL solution for injection in cartridge EU/1/12/806/007
Maltese: Ryzodeg 100 unità/mL soluzzjoni għall-injezzjoni f'skartoċċ EU/1/12/806/007
English: Primary analysis (3-point MACE) CV Death
Maltese: L-analiżi primarja (3-komponenti MACE)
English: One (1) unit of this insulin corresponds to 1 international unit of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart.
Maltese: Unità waħda (1) ta' din l-insulina tikkorrispondi għal unità internazzjonali 1 ta' insulina umana, unità 1 ta' insulina glargine, unità 1 ta' insulina detemir jew unità 1 ta' insulina aspart bifażika.
English: • sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline, for asthma
Maltese: • simpatomimetiċi bħal epinephrine (adrenaline), salbutamol jew terbutaline, użati fil-kura tal ażżma