FrancophonIA/ELRC3.0 huggingface dataset:
English: During the clinical trials, there were no indications of development of neutralising antibodies to epoetin delta in humans based on the clinical response.
Maltese: Matul il-provi kliniċi, ma kien hemm l-ebda indikazzjonijiet ta' żvilupp ta' antikorpi li jinnewtralizzaw, għal epoetin delta fil-bnedmin, ibbażati fuq ir-rispons kliniku.
English: The solution is clear, colourless and waterlike with no visible particles.
Maltese: Is-soluzzjoni hi ċara, bla kulur u qisha ilma, mingħajr ebda partikuli viżibbli.
English: Hampshire, RG 24 8EP
Maltese: Dawn il-miżuri jgħinu għal
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Maltese: Fi studji li m'humiex kliniċi, effetti dehru biss wara esponimenti meqjusa ferm aktar għolja millmassimu ta' l-esponimenti lill-bnedmin, li juru ftit li xejn rilevanza ma' l-użu kliniku.
English: Severe reactions, possibly fatal, involving the heart and blood vessels may occur.
Maltese: Reazzjonijiet severa, possibbilment fatali, li jinvolvu l-qalb u l-vini jew arterji, jistgħu jseħħu.
English: Like all medicines, Dynepo can cause side effects, although not everybody gets them.
Maltese: Bħal kull mediċina oħra, Dynepo jista' jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
English: Dynepo is used for treating the symptoms of anaemia (which include tiredness, weakness and shortness of breath) associated with chronic renal failure in adult patients, Anaemia is a blood disorder characterised by a decrease in red blood cells.
Maltese: Dynepo jintuża biex jikkura s-sintomi ta' anemija (li jinkludu għeja, dgħjufija u qtugħ ta' nifs) marbuta ma' insuffiċjenza kronika renali f'pazjenti adulti.
English: Solution for injection, 0.4ml of epoetin delta in a pre-filled syringe: pack size of 6
Maltese: 4ml ta' epoetin delta f'siringa mimlija għal-lest: daqs tal-pakkett ta' 6
English: Dynepo 4,000 IU/0.4 ml injection
Maltese: Siringa mimlija għal-lest li fiha 4,000 IU f'kull doża ta' 0.4 ml (10,000
English: Epoetin delta is a human erythropoietin made by a technology process called gene-activation, which uses a human cell line.
Maltese: Epoetin delta hu erythropoietin uman magħmul minn proċess tat-teknoloġija msejjaħ attivazzjoni talEpoetin delta hu ormon li jistimula l-produzzjoni taċ-ċelluli ħomor tad-demm fl-għadma tal-mudullun.
English: Pruritus
Maltese: FIS
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.3 ml (20,000 IU/ml)
Maltese: IU/ml), 0.3 ml ta' soluzzjoni fih 3,000 IU (10,000
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva
English: Animal studies conducted with both Dynepo and epoetin alfa in pregnant female rats and rabbits did not show any teratogenic effect, but indicated class-related reversible effects on growth and haematopoiesis in the offspring.
Maltese: Studji fuq l-annimali li saru kemm b'Dynepo u b'epoetin alfa fuq firien u fniek tqal ma wrew l-ebda effett teratoġeniku, iżda indikaw effetti riversibbli relatati mal-klassi, fuq it-tkabbir u ematopoiesi filfrieħ.
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Antianaemic - ATC code: B03XA.
Maltese: Studji fuq il-bhejjem rigward l-effetti fuq it-tqala (ara sezzjoni 5.3) m'humiex suffiċjenti.
English: For subcutaneous injection, the whole length of the needle should be inserted perpendicularly into a skin fold held between thumb and forefinger, the skin fold should be held throughout the injection.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni tal-Manifattura jwiegħed li jkun obbligat li jwettaq l-istudji u attivitajiet ta' farmako-viġilanza addizzjonali deskritti fil-pjan tal-Farmakoviġilanza.
English: NAME OF THE MEDICINAL PRODUCT Dynepo 8,000 IU/0.4ml Injection
Maltese: Siringa mimlija għal-lest li fiha 8,000 IU f'kull doża ta' 0.4 ml (20,000
English: Unopened pre-filled syringes may be kept un-refrigerated but below 25oC for a sinlge maximum period of 5 days.
Maltese: Siringi mimlija għal-lest mhux miftuħa jistgħu jinżammu barra mill-friġġ, iżda f'temperatura ta' inqas minn 25oC għal perjodu wieħed sa massimu ta' 5 ijiem.
English: Dynepo 2,000 IU/0.5 ml injection
Maltese: Dynepo 1,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Dynepo 2,000
English: Exposure to erythropoietin following administration of epoetin delta increases proportionately in patients given intravenous doses of 50 IU/kg to 300 IU/kg.
Maltese: L-espożizzjoni għal erythropoietin wara l-għoti ta' epoetin delta tiżdied proporzjonalment f'pazjenti li jingħataw dożi ta' 50
English: It acts as a mitosis stimulating factor and differentiation hormone.
Maltese: Jaġixxi bħala fattur li jistimula l-mitosi u l-ormon taddifferenzazzjoni.
English: Prefilled Type I glass syringe with bromobutyl rubber stopper, 27 gauge stainless steel needle with rigid natural rubber and polystyrene needle shield, polystyrene plunger rod and a needle safety guard.
Maltese: Il-kura tista' tirriżulta f'poliċitemija jekk l-emoglobina/ematokrit ma tkunx immonitorjata blattenzjoni u d-doża tkun aġġustata kif suppost.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe containing 8,000 IU per 0.4 ml dose (20,000 IU/ml) of the active substance epoetin delta.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi.
English: INFORMATION IN BRAILLE Dynepo 3000
Maltese: Dynepo 2,000
English: Dynepo 5,000 IU/0.5 ml injection
Maltese: Dynepo 1,000 IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: Mineral oil (Marcol 52)
Maltese: Żejt Minerali (Marcol 52)
English: Disodiumhydrogenphosphate Sodiumhydrogenphosphate Mannitol
Maltese: Disodiumhydrogenphosphate Sodiumhydrogenphosphate
English: EU/2/98/009/001 EU/2/98/009/002 EU/2/98/009/003 EU/2/98/009/004 EU/2/98/009/005 EU/2/98/009/006
Maltese: EU/2/98/009/001 EU/2/98/009/002 EU/2/98/009/003 EU/2/98/009/004
English: ATCvet code: QI09 AD01.
Maltese: QI 09 AD 01
English: 100 doses
Maltese: 100 dożi
English: Zoetis Polska Sp. z o.o.
Maltese: Polska Zoetis Polska Sp. z o.o.
English: 50 doses
Maltese: 50 dożi
English: Zoetis B.V., Podružnica Zagreb za promidžbu
Maltese: Slovenija Zoetis B.V., Podružnica Zagreb za promidžbu
English: Date of last renewal: 22/08/2008
Maltese: Data tal-aħħar tiġdid: 22/08/2008
English: Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80 (Tween 80), Thiomersal.
Maltese: Aluminium hydroxide, Żejt Minerali (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80 (Tween 80), Thiomersal
English: Zoetis B.V.
Maltese: Nederland Zoetis B.V.
English: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgium
Maltese: Rue Laid Burniat 1 1348 Louvain-la-Neuve Il-Belġju
English: Aluminium hydroxide Mineral oil (Marcol 52) Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80) Thiomersal
Maltese: Aluminium hydroxide Żejt minerali(Marcol 52)l Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80)
English: Excipient: Thiomersal
Maltese: Thiomersal
English: Luxembourg/ Luxemburg Zoetis Belgium SA Tél/Tel.
Maltese: Luxembourg/ Luxemburg Zoetis Belgium SA
English: 4.6 Adverse reactions (frequency and seriousness)
Maltese: 4.6 Effetti mhux mixtieqa (frekwenza u gravita')
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton label 1 x 10 doses, 1 x 50 doses, 1 x 100 doses, 10 x 10 doses, 10 x 50 doses, 10 x 100 doses
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Tikketta tal-Kartuna 1 x 10 dożi, 1 x 50 dożi, 1 x 100 dożi, 10 x 10 dożi, 10 x 50 dożi, 10 x 100 dożi
English: Zoetis Italia S.r.l.
Maltese: Italia Zoetis Italia S.r.l.
English: Manufacturer responsible for the batch release: Zoetis Manufacturing & Research Spain, S.L.
Maltese: Zoetis Manufacturing & Research Spain, S.L.
English: Adjuvants:
Maltese: Ingredjenti:
English: QUANTITY
Maltese: U KWANTITATTIVA
English: MARKETING AUTHORISATION NUMBER(S) EU/2/98/009/001-006
Maltese: EU/2/98/009/001-006
English: Live attenuated Aujeszky's disease virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion.
Maltese: Virus inattivat tal-Marda Aujeszky, tal-grupp NIA 3-783: ≥ 10 5.2 CCID50* għal kull doża ta' 2 ml ta'
English: In very rare cases (<1/100,000), hypersensitivity can be observed.
Maltese: F'każijiet rari ħafna (<1/100 000), jistgħu jkunu osservati reazzjonijiet ta' sensittività eċċessiva.
English: * CCID50 - the quantity of virus, which infects 50 % of the cell cultures inoculated.
Maltese: * TCID 50 = il-kwantita ta' virus, li jinfetta 50 % tal-kolturi ta' ċelluli tat-tessut inokulat.
English: Use sterile syringes and needles.
Maltese: Uża siringi u labar steriliżżati.
English: 20 ml, 100 ml or 200 ml bottles of Type I hydrolytic glass containing solvent for the 10-doses, 50doses or 100-doses presentation or Type II glass rinsed with WFI containing solvent for the 50-doses and 100-doses presentation.
Maltese: Fliexken ta' 20 ml, 100 ml jew 200 ml tal-ħġieġ idrolitiku tat-Tip I li fihom solvent għal formulazzjonijiet tal-10 dożi, tal-50 doża jew tal-100 doża jew fliexken tal-ħġieġ tat-Tip II mlaħalħa b'solvent li fih WFI li fihom solvent għal formulazzjonijiet ta' 50 u 100 doża.
English: Zoetis Belgium SA Tel: +353 (0) 1 256 9800
Maltese: Tel: +353 (0) 1 256 9800
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta go friġġ (2 °C - 8 °C).
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Disposal: read package leaflet.
Maltese: Mhux id- daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: België/Belgique/Belgien Zoetis Belgium SA Tél/Tel.
Maltese: België/Belgique/Belgien
English: Pharmacotherapeutic group: live Aujeszky's disease vaccine.
Maltese: Grupp farmako-terapewtiku: vaċċin ħaj tal-marda ta' Aujeszky Kodici ATĊ veterinarja:
English: INDICATION(S) Active and passive immunisation of pigs against Aujeszky's disease.
Maltese: Immunizzazzjoni attiva u passiva tal-majjali kontra l-Marda Aujeszky.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/08/1998
Maltese: Data tal-ewwel awtorizazzjoni: 07/08/1998
English: The active substance stimulates active immunity against Aujeszky's disease in pigs.
Maltese: Is-sustanza attiva tistimula l-immunita' attiva kontra l-Marda Aujeszky fil-majjali.
English: Solvent for emulsion for injection:
Maltese: Solvent għal emulsjoni għal injezzjoni:
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista, skont il-liġijiet nazzjonal tiegħu, jipprojbixxi il-manifattura, l-importazzjoni, il-pussess, ilbejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Zoetis Finland Oy Tlf: +358 (0)9 4300 40
Maltese: Tlf: +358 (0)9 4300 40
English: Vaccination programme:
Maltese: Programm ta' tilqim:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live attenuated Aujeszky's disease virus
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Virus ħaj inattivat tal-Marda Aujeszky
English: • Inject one dose per gilt or sow during each gestation at 3-6 weeks before the expected date of farrowing.
Maltese: • Injetta doża kull majjala waqt kull tqala mit- 3 - 6 ġimgħat qabel id-data mistennija li twelled.
English: Powder for emulsion for injection:
Maltese: Trab għal emulsjoni għal injezzjoni:
English: PHARMACEUTICAL PARTICULARS
Maltese: TAL-PRODOTT MEDICINALI
English: PHARMACEUTICAL FORM Powder and solvent for emulsion for injection.
Maltese: Trab u solvent għall-emulsjoni għall-injezzjoni.
English: Slight, transient and local reactions up to 2 cm in diameter after first vaccination and up to 5 cm after second vaccination may occur up to 50 % of the pigs.
Maltese: Reazzjonijiet lokali ħfief u temporanji sa 2 ċm fid-dijametru wara l-ewwel tilqima u sa 5 ċm wara t-tieni tilqima jistgħu jiġru f'sa 50 % mill-majjali ttrattati.
English: 10 vials with powder for injection (each containing 100 doses) and 10 bottles of solvent for injection (each containing 200 ml).
Maltese: 10 fjali bi trab għall-injezzjoni (kull fjala konenenti 100 dożi) u 10 fliexken ta' solvent ghall-injezzjoni (kull flixkun kontenenti 200 ml)
English: PHARMACEUTICAL FORM Powder and solvent for emulsion for injection
Maltese: Trab u solvent għall-emulsjoni għall-injezzjoni
English: Zoetis Finland Oy Sími: +358 (0)9 4300 40
Maltese: Tel: +358 (0)9 4300 40
English: Ìsland
Maltese: Deutschland
English: PACKAGE LEAFLET Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection for pigs
Maltese: Suvaxyn Aujeszky 783 + O/W, solvent għall-injezzjoni għall-majjali.
English: MANUFACTURER'S BATCH NUMBER Lot: {number} for the powder:
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott:
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Apart from an increase in the extent of the tissue reaction at the site of injection, no other undesirable effects have been observed.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn Minbarra minn żjieda fir-reazzjoni tat-tessut fil-post fejn ingħatat l-injezzjoni, ma ġewx osservati effetti oħra mhux mixtieqa.
English: Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Maltese: Immunizzazzjoni attiva tal-majjali mill-eta' ta' 10 ġimgħat sabiex tiġi evitata l-mortalita' u s-sinjali kliniċi tal-Marda Aujeszky u sabiex jitnaqqas it-tixrid tal-virus tal-Marda Aujeszky li jinstab fil-beraħ.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles for the solvent: 10 doses, 50 doses, 100 doses
Maltese: Fliexken għas-solvent: 10 dożi, 50 dożi, 100 dożi ISEM
English: To the user:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Aujeszky 783 + O/W, powder for injection for pigs
Maltese: Suvaxyn Aujeszky 783 + O/W, trab għall-injezzjoni għall-majjali.
English: The presence of maternal antibodies against Aujeszky's disease virus may have a negative influence on the result of vaccination.
Maltese: Il-presenza ta' anti-korpi materni kontra l-Virus tal
English: To the physician:
Maltese: GĦAL:
English: 4.2 Indications for use, specifying the target species Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Maltese: INDIKAZZJONI(JIET) L-immunizzazzjoni attiva tal-majjali mill-eta' ta' 10 ġimgħat sabiex tiġi evitata l-mortalita' u s-sinjali kliniċi tal-Marda Aujeszky u sabiex jitnaqqas it-tixrid tal-virus tal-Marda Aujeszky li jinstab fil-beraħ.
English: Name and address of the manufacturers of the biological active substances Zoetis Manufacturing & Research Spain, S.L.
Maltese: Isem u indirizz tal-manufattur tas-sustanzi bioloġikaċi attivi
English: 10 vials with powder for injection (each containing 50 doses) and 10 bottles of solvent for injection (each containing 100 ml).
Maltese: 10 fjali bi trab għall-injezzjoni (kull fjala fiha 50 doża) u 10 fliexken ta' solvent għall-injezzjoni (kull flixkun fih 100 ml)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials for the powder: 10 doses, 50 doses, 100 doses
Maltese: Fjali tat-trab: 10 dożi, 50 dożi, 100 dożi ISEM
English: 4.3 Contraindications
Maltese: 4.3 Kontra indikazzjonijiet Xejn
English: Danmark
Maltese: Magyarország
English: Lot: {number} for the solvent:
Maltese: {numru} għas-solvent:
English: Any person intending to manufacture, import, possess, sell, supply and use Suvaxyn Aujeszky 783 + O/W must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Maltese: Kull persuna li għandha l-ħsieb li timmanifattura, timporta, tieħu pussess, tbiegħ, tipprovdi u/jew tuża Suvaxyn Aujeszky 783 + O/W għandha tikkonsulta ma' l-Awtorità Kompetenti ta' l-Istat Membru dwar il-programmi ta' tilqim fis-seħħ qabel ma timmanifattura, timporta, tieħu pussess, tbiegħ, tipprovdi u/jew tuża.
English: Passive immunisation of piglets from vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Maltese: Immunizzazzjoni passiva tal-frieħ tal-majjaliet vaċċinati sabiex titnaqqas il-mortalita' u s-sinjali kliniċi tal-Marda Aujeszky u sabiex jitnaqqas it-tixrid tal-virus tal-Marda Aujeszky li jinstab fil-beraħ.
English: Active substance
Maltese: ATTIVA(I)
English: For intramuscular use.
Maltese: emulsjoni rikostitwita.
English: Pigs
Maltese: VETERINARJU
English: The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Maltese: Il-manifattura, l-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu tal-prodott mediċinali veterinarju huwa jew jista' jiġi pprojibit f'ċerti Stati Membri fit-territorju kollu tagħhom jew f'parti minnu, ara l-fuljett ta' tagħrif għal aktar informazzjoni.
English: Do not mix with any other vaccine or immunological product.
Maltese: Tħallatx ma' tilqim jew prodotti immunoloġiċi oħra.
English: ATC code: A10AB01.
Maltese: Kodiċi ATC: A10AB01.
English: Date of latest renewal: 18 September 2007
Maltese: Data tal-aħħar tiġdid: 18 ta' Settembru 2007
English: Elderly (≥ 65 years old)
Maltese: Anzjani ( ≥ 65 sena)
English: 24 units selected
Maltese: Isselezzjonati 24 unità
English: Name and address of the manufacturers of the biological active substance Novo Nordisk A/S
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Novo Nordisk A/S
English: The pharmacokinetic profile of Actrapid has been studied in a small number (n=18) of diabetic children (aged 6-12 years) and adolescents (aged 13-17 years).
Maltese: Il-profil farmakokinetiku ta' Actrapid kien studjat f'numru żgħir (n=18) ta' tfal dijabetiċi (6-12-il sena) u adolexxenti (13-17-il sena).
English: 5 units selected
Maltese: 5 unitajiet
English: For intravenous use, infusion systems with Actrapid at concentrations from 0.05 international unit/ml to 1.0 international unit/ml human insulin in the infusion fluids 0.9% sodium chloride, 5% dextrose and 10% dextrose with 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at room temperature for 24 hours.
Maltese: Għal użu ġol-vini, sistemi ta' infużjoni b'Actrapid f'konċentrazzjonijiet minn 0.05 unitajiet internazzjonali/ml sa 1.0 unitjiet internazzjonali/ml ta' insulina umana fil-fluwidi tal-infużjoni 0.9% sodium chloride, 5% dextrose u 10% dextrose ma' 40 mmol/l potassium chloride bl-użu ta' boroż tal infużjoni tal-polypropylene, huma stabbli għal 24 siegħa f'temperatura ambjentali.
English: SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Maltese: SAS, 45, Avenue d'Orléans, F-28000 Chartres, Franza.
English: Actrapid vial, Penfill and FlexPen:
Maltese: Actrapid kunjett, Penfill u FlexPen:
English: zinc chloride, glycerol, metacresol, sodium hydroxide/hydrochloric acid for pH adjustment and water for injections
Maltese: zinc chloride, glycerol, metacresol, sodium hydroxide/hydrochloric acid għall-aġġustament tal-pH u ilma għall-injezzjonijiet
English: A clinical trial in a single intensive care unit treating hyperglycaemia (blood glucose above 10 mmol/l) in 204 diabetic and 1344 non-diabetic patients undergoing major surgery showed that normoglycaemia (blood glucose 4.4 - 6.1 mmol/l) induced by intravenous Actrapid reduced mortality by 42% (8% versus 4.6%).
Maltese: (livell ta' glukosju fid-demm ogħla minn 10 mmol/l) wera li n-normogliċemija (livell ta' glukosju fiddemm ta' 4.4 - 6.1 mmol/l), li nkisbet permezz ta' Actrapid mogħti minn ġol-vini, naqqset il mortalita' bi 42% (8% kontra 4.6%) f'204 pazjent dijabetiku u f'1344 pazjent mhux dijabetiku li kellhom operazzjoni maġġura.
English: Uncommon - Refraction disorders Very rare - Diabetic retinopathy
Maltese: Rari ħafna - Disturbi rifrazzjonali
English: 1 ml solution contains 40 international units insulin human* (equivalent to 1.4 mg).
Maltese: Millilitru ta' soluzzjoni fih 40 unità internazzjonali ta' insulina umana* ( ekwivalenti għal 1.4 mg).
English: 2 units selected
Maltese: 2 unitajiet isselezzjonati
English: Solution for injection 1 x 3 ml cartridge 5 x 3 ml cartridges 10 x 3 ml cartridges
Maltese: Skartoċċ 1 ta' 3 ml 5 skrataċ ta' 3 ml 10 skrataċ x 3 ml
English: Actrapid vial (40 international units/ml)/Actrapid vial (100 international units/ml) Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of solution.
Maltese: Actrapid f'kunjett (40 unità internazzjonali/ml)/Actrapid f'kunjett (100 unità internazzjonali/ml) Kunjett (tal-ħġieġ ta' tip 1) magħluq b'disk (gomma tal-bromobutyl/polyisoprene) u b'għatu protettiv tal-plastik li jingħalaq b'sikurezza u li fih soluzzjoni ta' 10 ml.
English: Novo Nordisk Production SAS 45, Avenue d'Orléans F-28000 Chartres France
Maltese: 45, Avenue d'Orléans F-28000 Chartres
English: - The other ingredients are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.
Maltese: - Is-sustanzi l-oħra huma zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid u ilma għall-injezzjonijiet.
English: 1 ml solution contains 100 international units insulin human* (equivalent to 3.5 mg).
Maltese: Millilitru ta' soluzzjoni fih 100 unità internazzjonali ta' insulina umana* ( ekwivalenti għal 3.5 mg).
English: Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
Maltese: inibituri ta' l-enzima li tikkonverti l-anġjotensin (ACE), saliċilati, sterojdi anaboliċi u sulfonamidi.
English: Human insulin is reported to be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase.
Maltese: l-insulina u possibbilment mill-proteina disulfide isomerase.
English: Actrapid contains sodium
Maltese: Actrapid fih sodium
English: Solution for injection 1 x 3 ml pre-filled pen 5 x 3 ml pre-filled pens 10 x 3 ml pre-filled pens
Maltese: 1 x 3 ml pinna mimlija għal-lest 5 x 3 ml pinen mimlijin għal-lest 10 x 3 ml pinen mimlijin għal-lest
English: - If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d'Orléans, F-28000 Chartres, France.
Maltese: - Jekk it-tieni u t-tielet karattri huma T6 il-manifattur huwa Novo Nordisk Production SAS, 45 Avenue d'Orléans F-28000 Chartres, Franza.