FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg)
Maltese: EU/2/13/155/002 (1 x 3 pilloli, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 pilloli, 270 mg/4.5 mg) EU/2/13/155/004 (1 pillola, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 pilloli, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 pilloli, 425 mg/7.1 mg)
English: At doses of 30 to 60 mg spinosad and 0.5 to 1 mg milbemycin oxime per kg bodyweight, lethargy, anorexia/decreased appetite, diarrhoea, pruritus, dermatitis and reddening of the skin and pinna were commonly seen.
Maltese: F'dożi ta' minn 30 sa 60 mg ta' spinosad u minn 0.5 sa 1 mg ta' milbemycin oxime għal kull kg ta' piż tal-ġisem, letarġija, anoreksja/tnaqqis fl-aptit, dijarea, ħakk, dermatite u ħmura tal-ġilda u pinna ġew osservati b'mod komuni.
English: EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg) EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg)
Maltese: EU/2/13/155/005 (1 x 3 pilloli, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 pilloli, 425 mg/7.1 mg) EU/2/13/155/007 (pillola 1, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 pilloli, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 pilloli, 665 mg/11.1 mg) EU/2/13/155/010 (pillola 1, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 pilloli, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 pilloli, 1040 mg/17.4 mg) EU/2/13/155/013 (pillola 1, 1620 mg/27.
English: For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently: - prevention of heartworm disease (L3, L4 Dirofilaria immitis), - prevention of angiostrongylosis by reducing the level of infection with immature adult (L5)
Maltese: Għall-kura u l-prevenzjoni ta' infestazzjonijiet bil-briegħed (Ctenocephalides felis) fil-klieb, fejn infezzjoni waħda jew aktar mill-indikazzjonijiet li ġejjin ikunu meħtieġa fl-istess ħin: - prevenzjoni ta' marda tal-lungworm (L3, L4 Dirofilaria immitis), - prevenzjoni ta' anġjostrongilożi bit-tnaqqis tal-livell ta' infezzjoni b'adulti immaturi (L5)
English: It does not interact with known binding sites of other nicotinic or GABAergic insecticides such as neonicotinides (imidacloprid or nitenpyram), fiproles (fipronil), milbemycins, avermectins (e.g. selamectin) or cyclodienes but through a novel insecticidal mechanism.
Maltese: Ma jinteraġixxix ma' siti magħrufa ta' twaħħil ta' insettiċidi nikotiniċi oħrajn jew insettiċidi GABAergic bħal neonicotinides (imidacloprid jew nitenpyram), fiproles (fipronil), milbemycins, avermectins (eż. selamectin) jew cyclodienes, iżda permezz ta' mekkaniżmu insettiċidali ġdid.
English: 4346 and 3 dimples
Maltese: 4346 u 3 ħofor żgħar
English: The activity of milbemycin oxime is related to its action on invertebrate neurotransmission.
Maltese: L-attività ta' milbemycin oxime hi relatata mal-azzjoni tiegħu fuq innewrotrasmissjoni invertebrata.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Eli Lilly and Company Ltd
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Eli Lilly and Company Ltd
English: EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg)
Maltese: EU/2/13/155/008 (1 x 3 pilloli, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 pilloli, 665 mg/11.1 mg) EU/2/13/155/010 (pillola 1, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 pilloli, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 pilloli, 1040 mg/17.4 mg) EU/2/13/155/013 (pillola 1, 1620 mg/27.
English: Interaction with other medicinal products and other forms of interaction: Spinosad and milbemycin oxime have been shown to be substrates for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħrajn ta' interazzjoni Intwera li spinosad u milbemycin oxime huma substrati għal P-glikoproteina (P-gp) u għalhekk jistgħu jinteraġixxu ma' substrati P-gp oħrajn (pereżempju, digoxin, doxorubicin) jew lactones makroċikliċi oħra.
English: Decreased activity was seen at the same frequency in both control and dogs treated with 3 times the maximum recommended dose.
Maltese: Attività mnaqqsa dehret fl-istess frekwenza kemm fil-klieb ta' kontroll kif ukoll fil-klieb ikkurati bi 3 darbiet id-doża massima rakkomandata.
English: The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 45 to 70 mg spinosad and 0.75 to 1.18 mg milbemycin oxime/kg bodyweight.
Maltese: Il-prodott mediċinali veterinarju għandu jingħata skont it-tabella li ġejja biex tiżgura doża ta' minn 45 sa 70 mg ta' spinosad u minn 0.75 sa 1.18 mg ta' milbemycin oxime/kg ta' piż tal-ġisem.
English: The safe use of the maximum recommended dose (70mg/kg spinosad and 1.18mg/kg milbemycin oxime) given as capsules has been demonstrated for 12 months.
Maltese: L-użu sigur tad-doża massima rakkomandata (70 mg/kg ta' spinosad u 1.18 mg/kg ta' milbemycin oxime) mogħti bħala kapsuli, kien demostrat għal 12-il xahar.
English: Neurotoxicity characterised by transient mild depression, ataxia, trembling, mydriasis, and excessive salivation has been observed in dogs given higher dose multiples of milbemycin oxime alone (5 to 10 mg/kg).
Maltese: Newrotossiċità kkaratterizzata minn dipressjoni ħafifa temporanja, atassija, rogħda, midrijasi, u tbeżliq eċċessiv, ġiet osservata fi klieb li ngħataw multipli ta' doża ogħla ta' milbemycin oxime waħdu (minn 5 sa 10 mg/kg).
English: The consistency of this figure in pharmacokinetic and other studies indicates comparability in the absorption, metabolism and elimination of the two major spinosyns.
Maltese: Il-konsistenza ta' din il-figura fi studji farmakokinetiċi u studji oħrajn tindika komparabilità fl-assorbiment, il-metaboliżmu u l-eliminazzjoni taż-żewġ spinosyns maġġuri.
English: Cartons containing a blister pack with 1, 3 or 6 chewable tablets.
Maltese: Kartun li fihom pakkett bil-blisters b'1, 3 jew 6 pilloli li jintmagħdu.
English: Trifexis 270 mg/4.5 mg for dogs (3.9 - 6.0 kg) Trifexis 425 mg/7.1 mg for dogs (6.1 - 9.4 kg) Trifexis 665 mg/11.1 mg for dogs (9.5 - 14.7 kg) Trifexis 1040 mg/17.4 mg for dogs (14.8 - 23.1 kg) Trifexis 1620 mg/27 mg for dogs (23.2 - 36.0 kg)
Maltese: Trifexis 270 mg/4.5 mg għall-klieb (3.9 - 6.0 kg) Trifexis 425 mg/7.1 mg għall-klieb (6.1 - 9.4 kg) Trifexis 665 mg/11.1 mg għall-klieb (9.5 - 14.7 kg) Trifexis 1040 mg/17.4 mg għall-klieb (14.8 - 23.1 kg) Trifexis 1620 mg/27 mg għall-klieb (23.2 - 36.0 kg)
English: It is active against mites, larval and adult stages of nematodes as well as larvae of Dirofilaria immitis.
Maltese: Hu attiv kontra l-mites, l-istadji tal-larva u tal-adulti tan-nematodi, kif ukoll il-larva ta' Dirofilaria immitis.
English: The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Maltese: Il-prodott mediċinali veterinarju jista' jintuża bħala parti minn strateġija ta' kura għall-kontroll ta' dermatite minn allerġija għall-briegħed (FAD - Flea Allergy Dermatitis).
English: At this time, the systemic exposure (AUC) in juveniles was comparable to adults.
Maltese: F'dan iż-żmien, l-esponiment sistemiku (AUC) filklieb ġuvenili kien komparabbli ma' dak tal-adulti.
English: The increase in plasma concentrations was strongly correlated with an increase in terminal elimination half-lives.
Maltese: Iż-żieda filkonċentrazzjonijiet fil-plasma kienet korrelatata ħafna ma' żieda fil-half-lives tal-eliminazzjoni terminali.
English: UNITED KINGDOM
Maltese: TAMMINISTRA
English: Chewable tablets.
Maltese: Kull pillola fiha:
English: Spinosad and milbemycin oxime have been shown to be substrates for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones.
Maltese: Intwera li spinosad u milbemycin oxime huma substrati għal P-glikoproteina (P-gp) u għalhekk jistgħu jinteraġixxu ma' substrati P-gp oħrajn (pereżempju, digoxin, doxorubicin) jew lactones makroċikliċi oħra.
English: Marketing authorisation holder: Eli Lilly and Company Ltd Elanco Animal Health Priestley Road
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq Eli Lilly and Company Ltd Elanco Animal Health
English: Plasma protein binding is high (>98%).
Maltese: It-twaħħil talproteini fil-plażma hu għoli (>98%).
English: The oral administration of spinosad and milbemycin oxime combination tablets at mean cumulative monthly doses of up to 255 mg spinosad and 4.2 mg milbemycin oxime per kg body weight (up to 3.6 times the maximum recommended dose) for 6 consecutive dosing periods in young dogs was well tolerated.
Maltese: L-għoti orali ta' pilloli kombinati ta' spinosad u milbemycin oxime f'dożi medji kumulattivi kull xahar sa 255 mg ta' spinosad u 4.2 mg ta' milbemycin oxime għal kull kg ta' piż tal-ġisem (sa 3.6 darbiet tad-doża massima rakkomandata) għal 6 perjodi konsekuttivi ta' dożaġġ fi klieb żgħar, ġie ttollerat tajjeb.
English: Bodyweight (kg) of dog
Maltese: Piż talġisem (kg) tal-kelb
English: After oral administration of 45 mg spinosad and 0.75 mg milbemycin oxime/kg bodyweight to fed dogs, spinosyns A and D are rapidly absorbed and extensively distributed.
Maltese: Wara l-għoti orali ta' 45 mg ta' spinosad u 0.75 mg ta' milbemycin oxime/kg ta' piż tal-ġisem lil klieb mitmugħa, spinosyns A u D jiġu assorbiti malajr u jiġu distribwiti b'mod estensiv.
English: At the discretion of the veterinarian, infected dogs must be treated with an adulticide to remove adult heartworms.
Maltese: Fiddiskrezzjoni tal-veterinarju, il-klieb infettati jridu jiġu kkurati bl-adultiċida biex jitneħħew heartworms adulti.
English: 4347 and no dimples
Maltese: 4347 u l-ebda ħofor żgħar
English: At acute overdoses corresponding to 1.5 times the maximum recommended dose, vomiting occurred in 17% of the dogs, and hypersalivation occurred in 8% of the dogs.
Maltese: F'dożi akuti eċċessivi li jikkorrispondu għal 1.5 darbiet tad-doża massima rakkomandata, ir-rimettar seħħ fi 17% tal-klieb, u tbeżliq eċċessiv seħħ fi 8% tal-klieb.
English: Spinosad therefore has a different mode of action to other flea control or insect control products.
Maltese: Għalhekk, spinosad għandu mod differenti ta' azzjoni minn prodotti oħrajn li jikkontrollaw il-briegħed jew l-insetti.
English: Spinosad comprises spinosyn A and spinosyn D. The insecticidal activity of spinosad is characterised by nervous excitation leading to muscle contractions and tremors, prostration, paralysis and rapid death of the flea.
Maltese: L-attività insettiċidali ta' spinosad hi kkaratterizzata minn tqanqil nervuż li jwassal għal kontrazzjonijiet tal-muskoli u rogħda, prostrazzjoni, paraliżi u mewt ta' malajr tal-bergħud.
English: The flea preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the veterinary medicinal product.
Maltese: L-effett preventiv kontra infestazzjonijiet mill-ġdid bil-briegħed hu riżultat tal-attività adultiċida u ttnaqqis fil-produzzjoni tal-bajd u jippersisti għal sa 4 ġimgħat wara amministrazzjoni waħda talprodott mediċinali veterinarju.
English: Post-marketing reports: following the concomitant use of spinosad with ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Maltese: Rapporti ta' wara t-tqegħid fis-suq: wara l-użu fl-istess ħin ta' spinosad ma' ivermectin jindikaw li lklieb kellhom rogħda/kontrazzjonijiet tal-muskoli, tbeżliq/legħba, aċċessjonijiet, atassija, midrijasi, għama u diżorjentament.
English: Laboratory studies (in rats and rabbits) on the effect of spinosad and milbemycin oxime have neither produced any evidence of teratogenic, foetotoxic or maternotoxic effects, nor any effect on the reproductive capacity in males and females.
Maltese: Studji tal-laboratorju (fil-firien u l-fniek) fuq l-effett ta' spinosad u milbemycin oxime ma pproduċew l-ebda evidenza ta' effetti teratoġeniċi, fetotossiċi jew maternotossiċi, u lanqas kwalunkwe effett fuq il-kapaċità riproduttiva fil-klieb irġiel u fi klieb nisa.
English: Post-marketing reports following the concomitant use of spinosad with ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Maltese: Rapporti ta' wara t-tqegħid fis-suq wara l-użu fl-istess ħin ta' spinosad ma' ivermectin jindikaw li lklieb kellhom rogħda/kontrazzjonijiet tal-muskoli, tbeżliq/legħba, aċċessjonijiet, atassija, midrijasi, għama u diżorjentament.
English: EXPIRY DATE EXP {month/year}
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: In dogs, hydroxymilbemycin A4 5-oxime was detected only in plasma, but not in urine or faeces, suggesting predominant excretion of conjugated metabolites in the dog.
Maltese: Fil-klieb, hydroxymilbemycin A4 5-oxime nstab biss fil-plażma, iżda mhux fl-awrina jew fl-ippurgar, u dan jissuġġerixxi eliminazzjoni predominanti ta' metaboliti konġugati fil-klieb.
English: After treatment of the nematode infection, further flea prevention should be continued with a monovalent product.
Maltese: Wara lkura tal-infezzjoni bin-nematodi, prevenzjoni addizzjonali kontra l-briegħed għandha titkompla bi prodott monovalenti.
English: Bioavailability was shown to be high.
Maltese: U/JEW UŻU Mhux applikabbli.
English: Trifexis can be used as part of the seasonal prevention of fleas (replacing treatment with a monovalent flea product) in dogs with diagnosed concurrent gastrointestinal nematode infections.
Maltese: Trifexis jista' jintuża bħala parti mill-prevenzjoni staġjonali tal-briegħed (jissostitwixxi l-kura bi prodott monovalenti kontra l-briegħed) fi klieb b'infezzjoni dijanjostikata gastrointestinali binnematodi fl-istess ħin.
English: PACKAGE LEAFLET FOR: Trifexis 270 mg/4.5 mg chewable tablets for dogs Trifexis 425 mg/7.1 mg chewable tablets for dogs Trifexis 665 mg/11.1 mg chewable tablets for dogs Trifexis 1040 mg/17.4 mg chewable tablets for dogs Trifexis 1620 mg/27 mg chewable tablets for dogs
Maltese: Trifexis 270 mg/4.5 mg pilloli li jintmagħdu għall-klieb Trifexis 425 mg/7.1 mg pilloli li jintmagħdu għall-klieb Trifexis 665 mg/11.1 mg pilloli li jintmagħdu għall-klieb Trifexis 1040 mg/17.4 mg pilloli li jintmagħdu għall-klieb Trifexis 1620 mg/27 mg pilloli li jintmagħdu għall-klieb
English: Monthly repeated oral administration of spinosad and milbemycin oxime over six months revealed evidence of spinosad and milbemycin oxime accumulation in juvenile dogs.
Maltese: Fil-klieb ġuvenili, lamministrazzjoni orali ripetuta ta' spinosad u milbemycin oxime fuq sitt xhur wasslet sabiex ilkonċentrazzjonijiet minimi fil-plasma ta' spinosad u milbemycin jiżdiedu tul l-istudju kollu.
English: In case of adverse reactions consult your veterinarian.
Maltese: F'każ ta' effetti mhux mixtieqa, ikkonsulta lill-veterinarju tiegħek.
English: Spinosad is excreted in the colostrum and milk of lactating bitches.
Maltese: Spinosad jinkludi spinosin A u spinosin D.
English: < 8.0 % ≥ 8 % to < 9.0 % ≥ 9.0 %
Maltese: < 8.0 % ≥ 8 % sa < 9.0 % ≥ 9.0
English: Study CV181168
Maltese: Studju CV181168
English: - Dexamethasone - a steroid medicine.
Maltese: Dexamethasone - mediċina sterojde.
English: C, urticaria
Maltese: C, urtikarja
English: EU/1/16/1108/001 14 film-coated tablets EU/1/16/1108/002 28 film-coated tablets EU/1/16/1108/003 98 film-coated tablets EU/1/16/1108/004 30 film-coated tablets
Maltese: EU/1/16/1108/001 14-il pillola miksija b'rita EU/1/16/1108/002 28 pillola miksija b'rita EU/1/16/1108/003 98 pillola miksija b'rita EU/1/16/1108/004 30 pillola miksija b'rita
English: UNIQUE IDENTIFIER 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)
Maltese: (Ara s-sezzjonijiet 4.2, 4.4, 4.5 u 5.1 għal dejta disponibbli fuq il-kombinazzjonijiet studjati.)
English: AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA
Maltese: AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA Ir-Renju Unit
English: Sequential add-on clinical trials Study MB102129
Maltese: Provi kliniċi add-on sekwenzjali Studju MB102129
English: D, oedema peripheral
Maltese: D, edima periferika
English: Abdominal pain C,
Maltese: Dermatite C,
English: PA/Alu/PVC-Alu blister
Maltese: Folja PA/Alu/PVC-Alu
English: p-value <0.0001.
Maltese: 0001. p-valur=0.
English: Microcrystalline cellulose (E460i) Croscarmellose sodium (E468) Lactose, anhydrous Magnesium stearate (E470b) Dental type silica (E551)
Maltese: Microcrystalline cellulose (E460i) Croscarmellose sodium (E468) Lactose, anhydrous Magnesium stearate (E470b) Silica tat-tip dentali (E551)
English: The volume of distribution of saxagliptin was 205 l.
Maltese: Il-volum tad-distribuzzjoni ta' saxagliptin kien 205 l.
English: AstraZeneca A/S Tlf: +45 43 66 64 62
Maltese: Danmark AstraZeneca A/S Tlf: +45 43 66 64 62
English: Additional analysis did not indicate a differential effect among NYHA classes.
Maltese: Analiżi addizzjonali ma tindikax effett differenzjali fost il-klassijiet NYHA.
English: The corresponding plasma Cmax values were 24 ng/ml and 47 ng/ml,
Maltese: Il-valuri korrespondenti Cmax tal-plażma kienu 24 ng/ml u 47 ng/ml, rispettivament.
English: HbA1c (%) at week 24
Maltese: HbA1c (%) fil-ġimgħa 24
English: Date of first authorisation: 15 July 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Lulju 2016
English: There is no restriction based solely on age.
Maltese: Ma hemm l-ebda restrizzjoni bbażata biss fuq l-età.
English: Experience in NYHA class III-IV is limited with saxagliptin.
Maltese: L-esperjenza fl-NYHA klassi III-IV hija limitata f'saxagliptin.
English: C-saxagliptin, 24 %, 36 %, and 75 % of the dose was excreted in the urine as saxagliptin, its active metabolite, and total radioactivity, respectively.
Maltese: C-saxagliptin, 24 %, 36 %, u 75 % ġiet eliminata fl-awrina bħala saxagliptin, il-metabolit attiv tiegħu, u radjoattività totali, rispettivament.
English: There was a numerical imbalance in non-CV death, with more events on saxagliptin (1.8 %) than placebo (1.4 %) [HR=1.27; (95 % CI 1.00, 1.62); P=0.051].
Maltese: Kien hemm żbilanċ numeriku f'imwiet mhux kardjovaskulari, b'aktar avvenimenti fuq saxagliptin (1.8 %) minn plaċebo (1.4 %) [HR=1.27; (95 % CI 1.00, 1.62); P=0.051].
English: SE-151 85 Södertälje Sweden
Maltese: SE-151 85 Södertälje
English: Musculo-skeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi
English: Elevated haematocrit
Maltese: Ematokrit elevat
English: Dapagliflozin: Dapagliflozin is approximately 91 % protein bound.
Maltese: Dapagliflozin huwa 91% imwaħħal mal-proteini.
English: Saxagliptin: Elderly patients (65-80 years) had about 60 % higher saxagliptin AUC than young patients (18-40 years).
Maltese: Pazjenti anzjani (65-80 sena) kellhom bejn wieħed u ieħor 60 % AUC ta' saxagliptin minn pazjenti żgħażagħ (18-40 sena).
English: A clinically relevant effect with other inducers (e.g. carbamazepine, phenytoin, phenobarbital) is not expected.
Maltese: Effett klinikament relevanti ma' induċituri oħrajn (eż. carbamazepine, phenytoin, phenobarbital) mhuwiex mistenni.
English: Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19 % increase in AUC of simvastatin and 31 % increase in AUC of simvastatin acid.
Maltese: Il-kombinament ta' doża waħda ta' dapagliflozin ta' 20 mg u simvastatin (substrat CYP3A4) irriżulta f'żieda ta' 19 % fl-AUC ta' simvastatin u żieda ta' 31 % fl-AUC tal-aċidu tas-simvastatin.
English: United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836
Maltese: Ir-Renju Unit AstraZeneca UK Ltd Tel: +44 1582 836 836
English: Qtern 5 mg/10 mg tablets saxagliptin/dapagliflozin
Maltese: Qtern 5 mg/10 mg pilloli saxagliptin/dapagliflozin
English: Difference from dapagliflozin + metformin (adjusted mean (95 % CI)
Maltese: Differenza minn dapagliflozin + metformin (medja aġġustata3) (95 % CI)
English: Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2).
Maltese: Dapagliflozin huwa inibitur qawwi ħafna (Ki: 0.55 nM), selettiv u riversibbli tal-ko-trasportatur tassodium glucose 2 (SGLT2).
English: Saxagliptin: Females had approximately 25 % higher systemic exposure values for saxagliptin.
Maltese: In-nisa kellhom approssimament 25 % ta' valuri tal-esponiment sisteimiku ta' saxagliptin.
English: Iron oxide yellow (E172) Iron oxide red (E172)
Maltese: Titanium dioxide (E171) Talc (E553b) Iron oxide yellow (E172) Iron oxide red (E172)
English: • For renal function approaching moderate renal impairment, at least 2 to 4 times per year.
Maltese: • Għall-funzjoni tal-kliewi li tqarreb lejn l-indeboliment moderat tal-kliewi, tal-anqas 2 sa 4 darbiet kull sena.
English: At 24 weeks, reductions in serum uric acid concentrations ranged from -48.3 to -18.3 micromoles/l (-0.87 to -0.33 mg/dl).
Maltese: F'24 ġimgħa, it-tnaqqis fil-konċentrazzjonijiet tal-uric acid tasserum ivarja minn -48.3 sa -18.3 micromoles/l (-0.87 to -0.33 mg/dl).
English: Erectile dysfunction, pruritus genital, vulvovaginal pruritus
Maltese: Problema filfunzjoni erettili, prurite ġenitali, prurite vulvovaġinali
English: The study population included those ≥ 65 years (n=8561) and ≥ 75 years (n=2330), with normal or mild renal impairment (n=13,916) as well as moderate (n=2240) or severe (n=336) renal impairment.
Maltese: Ilpopolazzjoni ta' studju inkludiet dawk ≥ 65 sena (n=8561) u ≥ 75 sena (n=2330), b'indeboliment normali jew ħafif tal-kliewi (n=13,916) kif ukoll indeboliment moderat (n=2240) jew sever (n=336) tal-kliewi.
English: Hypoglycaemia (when used with SU)
Maltese: Ipogliċemija (meta użat ma' SU)
English: Dapagliflozin: Dapagliflozin is extensively metabolised, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite.
Maltese: Dapagliflozin huwa metabolizzat b'mod estensiv, primarjament sabiex jagħti dapagliflozin 3-O-glucuronide, li huwa metabolit inattiv.
English: Frequency categories were defined according to very common (≥ 1/10), common (≥ 1/100 to ˂ 1/10), uncommon (≥ 1/1000 to ˂ 1/100), rare ( 1/10,000 to < 1/1000) and not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza kienu definiti skont komuni ħafna (≥ 1/10), komuni ≥ 1/100 sa ˂ 1/10, mhux komuni ≥ 1/1000 sa ˂ 1/100, rari ( 1/10,000 sa < 1/1000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Dysuria, polyuria
Maltese: Disurja, poliurja
English: Necrotising fasciitis of the perineum (Fournier's gangrene)
Maltese: Faxxite nekrotizzanti tal-perinew (kankrena ta' Fournier)
English: Each tablet contains saxagliptin hydrochloride equivalent to 5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Maltese: Kull pillola fiha saxagliptin hydrochloride ekwivalenti għal 5 mg saxagliptin u dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin.