FrancophonIA/ELRC3.0 huggingface dataset:
English: o have previously had a treatment cycle of controlled stimulation of the ovaries that resulted in the growth of more than 30 follicles with a size of 11 mm or larger o have a basal antral follicle count (the number of small follicles present in your ovaries at the beginning of a menstrual cycle) higher than 20
Maltese: o fil-passat kellek ċiklu ta' trattament ta' stimulazzjoni kkontrollata tal-ovarji li rriżulta fi tkabbir ta' iktar minn 30 follikulu b'daqs ta' 11 mm jew ikbar o għandek għadd bażiku ta' follikuli antrali (in-numru ta' follikuli żgħar preżenti fl-ovarji tiegħek fil-bidu ta' ċiklu tal-mestrwazzjoni) ta' iżjed minn 20
English: Each pre-filled syringe contains 150 micrograms of corifollitropin alfa in 0.5 mL solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 150 mikrogramma ta' corifollitropin alfa f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: Each pre-filled syringe contains 100 micrograms of corifollitropin alfa* in 0.5 mL solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 100 mikrogramma ta' corifollitropin alfa* f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: Sucrose
Maltese: Nawsja
English: Early OHSS usually occurs within 10 days after hCG administration and may be associated with an excessive ovarian response to gonadotropin stimulation.
Maltese: Jekk tiżviluppa OHSS, għandu jiġi implimentat u segwit immaniġġjar standard u xieraq ta' OHSS.
English: Treatment with (rec)FSH is then stopped and the eggs are matured by giving hCG (human Chorionic Gonadotropin).
Maltese: Il-kura b'(rec)FSH imbagħad titwaqqaf u l-bajd jiġu mmaturati billi jingħata hCG (Gonadotropin Korjoniku uman).
English: Each pre-filled syringe contains 100 micrograms of corifollitropin alfa in 0.5 mL solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 100 mikrogramma ta' corifollitropin alfa f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: IVF involves collecting the eggs from the ovary, fertilising them in the laboratory, and transferring the embryos into the uterus a few days later.
Maltese: IVF tinvolvi l-ġbir ta' bajd mill-ovarju, il-fertilizzazzjoni tagħhom fil-laboratorju, u t-trasferiment tal-embriji fl-utru ftit jiem wara.
English: This may be due to cross-reactivity of hCG pregnancy tests with the carboxy-terminal peptide of the beta subunit of Elonva.
Maltese: F'każ ta' espożizzjoni involontarja għal Elonva matul it-tqala, id-dejta klinika mhijiex biżżejjed biex teskludi riżultat avvers tat-tqala.
English: Common (may affect up to 1 in 10 women) - Ovarian hyperstimulation syndrome (OHSS) - Pelvic pain - Feeling sick (nausea) - Headache - Pelvic discomfort - Breast tenderness - Tiredness (fatigue)
Maltese: - Nefħa fl-addome - Rimettar - Dijarea - Stitikezza - Uġigħ fid-dahar - Uġigħ fis-sider - Tbenġil jew uġigħ fis-sit tal-injezzjoni - Irritabilità
English: Uncommon ( may affect up to 1 in 100 women) - Twisting of an ovary (ovarian torsion) - Liver enzyme increases - Miscarriage - Pain after oocyte retrieval - Procedural pain - Releasing an egg too early (premature ovulation) - Abdominal distension - Vomiting - Diarrhoea - Constipation - Back pain - Breast pain - Bruising or pain at the injection site - Irritability - Mood swings - Dizziness - Hot flush
Maltese: Riproduttiva Assistita (ART) jew tqala sussegwenti F'każijiet rari, bħal ma jiġri b'gonadotropins oħra, terapija b'Elonva ġiet assoċjata ma' tagħqid ta' demm (trombożi) li fforma ġewwa l-arterji jew il-vini, inqala', u vvjaġġa mad-demm fil-ġisem fejn imblokka arterja jew vina oħra (tromboemboliżmu).
English: There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment.
Maltese: Kien hemm rapporti ta' neoplażmi tal-ovarji u ta' neoplażmi oħrajn fis-sistema riproduttiva, kemm beninni kif ukoll malinni, f'nisa li kienu ħadu korsijiet multipli għall-kura tal-infertilità.
English: EU/1/09/609/001 EU/1/09/609/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/609/002
English: Clinical signs and symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhoea, mild to moderate enlargement of ovaries and ovarian cysts.
Maltese: Sinjali u sintomi kliniċi ta' OHSS ħafif u moderat huma wġigħ addominali, nawseja, dijarea, tkabbir minn ħafif sa moderat tal-ovarji u ċisti tal-ovarji. OHSS sever jista' jkun ta' periklu għall-ħajja.
English: Keep the syringe in the outer carton in order to protect from light.
Maltese: Dan jista' jiġi ċċekkjat permezz ta' eżami ultrasoniku.
English: Do not inject Elonva without talking with your doctor.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni b'Elonva u mediċini oħra .
English: Tel: + 386 1 5204201 msd_slovenia@merck.com
Maltese: Tel: + 386 1 5204201
English: Elonva 100 micrograms solution for injection Elonva 150 micrograms solution for injection corifollitropin alfa
Maltese: Elonva 100 mikrogramma soluzzjoni għall-injezzjoni Elonva 150 mikrogramma soluzzjoni għall-injezzjoni corifollitropin alfa
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Elonva in one or more subsets of the paediatric population in hypogonadotrophic hypogonadism (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Elonva f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fl-ipogonadiżmu ipogonadotrofiku (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, Section 4.2).
Maltese: U L-UŻU Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Elonva must be injected under the skin (subcutaneously) into a skin fold (that you pinch between your thumb and index finger), preferably just below the navel.
Maltese: Elonva jrid jiġi injettat taħt il-ġilda (b'mod subkutaneju) ġo ġilda mitwija (li inti toqros bejn is-saba' l-kbir u l-werrej), preferibbilment kemm kemm taħt iż-żokra.
English: Merck Sharp & Dohme (Sweden) AB Tel: + 46 (0)77 5700488 medicinskinfo@merck.com
Maltese: Tel: + 46 (0)77 5700488
English: Call your doctor right away if you have: - severe abdominal swelling and pain in the stomach area (abdomen) - feeling sick (nausea) - vomiting - sudden weight gain due to fluid build up - diarrhoea - decreased urine output - trouble breathing
Maltese: F'każijiet aktar severi dan jista' jwassal għal tkabbir tal-ovarji, ġbir ta' fluwidu fladdome u/jew fis-sider (li jista' jikkawża żieda f'daqqa fil-piż minħabba akkumulazzjoni ta' fluwidu)
English: In rare instances, thromboembolism has been associated with Elonva therapy as with other gonadotropins.
Maltese: F'każijiet rari, tromboemboliżmu ġie assoċjat ma' terapija b'Elonva bħal ma jiġri b'gonadotropins oħra.
English: Elonva is supplied in pre-filled luerlock syringes of 1 mL (type I hydrolytic glass), closed with a bromobutyl elastomer plunger and a tip cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Elonva hu fornut f'siringi mimlija għal-lest luerlock ta' 1 mL (ħġieġ idrolitiku ta' tip I), magħluqa bi planġer tal-bromobutyl elastomer u b'għatu tat-tarf.
English: Elonva causes the growth and development of several follicles at the same time by a controlled stimulation of the ovaries.
Maltese: Elonva jikkawża t-tkabbir u l-iżvilupp ta' diversi follikuli fl-istess ħin permezz ta' stimulazzjoni kkontrollata tal-ovarji.
English: This trial also provided safety data on the infants born from cryopreserved embryos.
Maltese: Din il-prova pprovdiet ukoll dejta ta' sigurtà fuq it-trabi mwielda minn embrijuni krijopreservati.
English: In the ENGAGE Study, 1,506 healthy normal ovulatory women, aged 18 to 36 years with a body weight greater than 60 kg and less than or equal to 90 kg, were treated for one cycle with 150 micrograms of Elonva and pituitary suppression with a GnRH antagonist as part of an ART program.
Maltese: b'piż tal-ġisem ta' aktar minn 60 kg sa inqas minn jew ta' 90 kg, kienu kkurati għal ċiklu wieħed b'150 mikrogramma ta' Elonva u soppressjoni tal-glandola pitwitarja b'antagonist ta' GnRH bħala parti minn programm ta' ART. L-iskopijiet finali koprimarji tal-effikaċja kienu r-rata ta' tqala li kompliet u n-numru ta' ooċiti rkuprati.
English: Preparing the injection
Maltese: Kondizzjonijiet mediċi oħra
English: The primary efficacy endpoint in the PURSUE study was vital pregnancy rate defined as the percentage of subjects with at least one foetus with heart activity assessed 5 to 6 weeks after embryo transfer.
Maltese: individwi b'mill-inqas fetu wieħed b'attività tal-qalb stmata minn 5 sa 6 ġimgħat wara t-trasferiment tal-embriju.
English: Dosing during the stimulation cycle
Maltese: Għoti ta' dożi waqt iċ-ċiklu ta' stimulazzjoni
English: Infertile women undergoing ART have an increased incidence of ectopic pregnancies.
Maltese: Flimkien ma' dan, kien hemm rapporti ta' tqala ektopika u tqaliet multipli.
English: Hepatic metabolism contributes to a minor extent to the elimination of corifollitropin alfa.
Maltese: Il-metaboliżmu fil-fwied jikkontribwixxi sa ċertu punt minuri għall eliminazzjoni ta' corifollitropin alfa.
English: Immediate Packaging Pack size calendar blister (PVC/PE/PVdC/alu)
Maltese: Il-pakkett li jmiss malprodott
English: calendar blister (OPA/alu/PVC/alu)
Maltese: Isem (Ivvintat)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Qawwa Għamla farmaċewtika
English: Pack size powder: vial (glass); solvent: vial (glass)
Maltese: Daqs talpakkett trab: kunjett (ħġieġ); solvent: kunjett (ħġieġ)
English: 5 vials + 5 cartridges
Maltese: 5 kunjetti + 5 skartoċċi
English: 1 vial + 1 cartridge
Maltese: 1 kunjett + 1 skartoċċ
English: Strength Pharmaceutical Form Route of Administration
Maltese: Isem Qawwa Għamla Farmaċewtika
English: MA (EU) number (Invented) name
Maltese: Numru ta' lEU
English: Immediate Packaging Content (concentration)
Maltese: Il-pakkett
English: EMEA/V/C/125
Maltese: EMEA/V/C/125 RAPPORT TA' VALUTAZZJONI
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA European Medicines Agency, 2008.
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA European Medicines Agency, 2008.
English: Nobilis Influenza H5N6 is a vaccine containing an inactivated avian influenza virus H5N6 (inactivated means that the virus has been killed so that it cannot cause the disease any more).
Maltese: Nobilis Influenza H5N6 is a vaccine containing an inactivated avian influenza virus H5N6 (inactivated means that the virus has been killed so that it can no longer cause the disease).
English: The virus used for the vaccine carries the H5 (haemagglutinin 5) and N6 (neuramidase 6) antigens.
Maltese: Il-vajrus użat fil-vaċċin iġorr l-antiġeni H5 (haemagglutinin 5) u n-N6 (neuramidase 6).
English: Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N6 component.
Maltese: Għasafar vaċċinati jistgħu jiġu differenzjati b'identifikazzjoni minn għasafar infettati permezz ta' test dijanjostiku għal antikorpi kontra l-komponent N6.
English: • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens.
Maltese: • Il-vaċċin wera li jnaqqas is-sinjali kliniċi u l-mortalità u jnaqqas it-tixrid tal-vajrus f'tiġieġ infettati.
English: • If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Maltese: • Jekk il-vajrus ta' l-influwenza avjarju li jiċċirkola għandu komponent N differenti mill-N6li jinsab fil-vaċċin, jista' jkun possibbli li wieħed jagħmel differenza bejn vaċċin minn għasfur infettat u dak vaċċinat permezz ta' test dijanjostiku sabiex jiġu misjuba antikorpi Neuraminidase.
English: The company carried out laboratory safety studies using a vaccine very similar to Nobilis Influenza H5N6.
Maltese: Il-kumpanija wetqet studji ta' laboratorju fuq is-sigurtà bl-użu ta' vaċċin simili ħafna għal Nobilis Influenza H5N6.
English: Nobilis Influenza H5N6 has been authorised under “Exceptional Circumstances”.
Maltese: Influwenza Nobilis H5N6 ġie awtorizzat taħt “Ċirkustanzi Eċċezzjonali”.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropea (EPAR).
English: They also tested the safety of three standard production batches of Nobilis Influenza H5N6.
Maltese: Barra minn hekk, il-kumpanija vverifikat is-sigurtà ta' tliet lottijiet ta' produzzjoni standard ta' Nobilis Influenza H5N6.
English: This summary was last updated on 31.01.2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fil- 01.2008.
English: Nobilis Influenza H5N6 is a vaccine used in chickens to protect against avian influenza.
Maltese: Nobilis Influenza H5N6 huwa vaċċin użat għat-tiġieġ sabiex jiġu protetti kontra l-influwenza avjarja.
English: Other information about Nobilis Influenza H5N6:
Maltese: Informazzjoni oħra dwar l-Influwenza Nobilis H5N6:
English: The vaccine reduces the signs of flu and the excretion (shedding) of the virus by the infected birds.
Maltese: Il-vaċċin inaqqas is-sinjali ta' l-influwenza u ta' tkeċċija ta' eskrementi (tixrid) tal-vajrus mit-tjur infettat.
English: Nobilis Influenza H5N6 is a vaccine.
Maltese: L-Influwenza Nobilis H5N6 huwa vaċċin.
English: What is Nobilis Influenza H5N6?
Maltese: Kif ġie studjat Nobilis Influenza H5N6?
English: The Committee for Medicinal Products for Veterinary use concluded that the vaccine has been shown to be effective in preventing clinical disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection.
Maltese: Il-Kumitat għall Użu ta' Prodotti Mediċinali għal użu Veterinarju kkonkluda li l-vaċċin wera li huwa effettiv fit-tnaqqis ta' mard kliniku fit-tjur u jista' jkun għodda utli fil-kontroll tal-firxa ta' infezzjoni ta' l-influwenza avjarja.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H5N6 to Intervet International BV on 31.01.2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq madwar l-Unjoni Ewropea, għall-Influweza Nobilis H5N6 lil Intervet International BV fil-31.01.2008.
English: What is the risk associated with Nobilis Influenza H5N6?
Maltese: X'inhu r-riskju assoċjat ma' l-Influwenza Nobilis H5N6?
English: When it is given to chickens, the birds' immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease.
Maltese: Meta tingħata lit-tiġieġ, is-sistema immunitorja ta' lgħasafar (il-mekkaniżmu tad-difiża naturali tagħhom) toħloq antikorp (tip speċjali ta' proteina) sabiex tiġġieled il-mard.
English: They included studies in other avian species (ducks, turkeys, pheasants), and studies using either the subcutaneous or intramuscular routes.
Maltese: Din id-differenzjazzjoni hija importanti għas-sorveljanza u l-kontroll talmard.
English: The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H5N6 are still ongoing and will be assessed.
Maltese: Il-vaċċin huwa evalwat fil-kuntest ta' sitwazzjoni ta' emerġenza li jfisser għadu għaddej studju ulterjuri fuq in-Nobili sH5N6 u dan ser jiġi evalwat.
English: Copovidone (K-value nominally 28)
Maltese: Copovidone (valur-K nominali 28)
English: 45-60 ml/min/1.73 m2 and 7.7% of 30-45 ml/min/1.73 m
Maltese: 45-60 ml/min/1.73 m2 u 7.7% ta' 30-45 ml/min/1.73 m
English: No Met mg mg
Maltese: Ebda Met mg mg
English: Do not take Synjardy:
Maltese: Tiħux Synjardy:
English: Metformin may act via 3 mechanisms:
Maltese: Metformin jista' jaġixxi permezz ta' 3 mekkaniżmi:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 May 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 ta' Mejju 2015
English: Film-coating Hypromellose Macrogol 400
Maltese: Rita tal-pillola Hypromellose Macrogol 400
English: Empagliflozin and metformin
Maltese: Empagliflozin u metformin
English: The mean volume of distribution (Vd) ranged between 63 - 276 l.
Maltese: Il-medja tal-volum ta' distribuzzjoni (Vd) varjat bejn 63 - 276 l.
English: The apparent steady-state volume of distribution was estimated to be 73.8 l based on the population pharmacokinetic analysis.
Maltese: Il-volum fi stat fiss apparenti ta' distribuzzjoni kien stmat li hu 73.8 l skont l-analiżi farmakokinetika tal-popolazzjoni.
English: Necrotising fasciitis of the perineum (Fournier´s gangrene)
Maltese: Fasciitis nekrotika tal-perineum (kankrena ta' Fournier)
English: Pruritus (generalised) Rash
Maltese: (ġeneralizzat) Raxx
English: The frequency of reported nocturia was comparable between placebo and empagliflozin (<1%).
Maltese: Il-frekwenza ta' nokturja rapportata kienet paragunabbli bejn plaċebo u empagliflozin (< 1%).
English: The red blood cells most likely represent a secondary compartment of distribution.
Maltese: Iċ-ċelloli tad-demm ħomor probabbilment jirrappreżentaw kompartiment sekondarju ta' distribuzzjoni.
English: Add-on to pioglitazone + metformin therapy Placebo
Maltese: Terapija aġġuntiva ma' pioglitazone + metformin Plaċebo
English: The mean age was 63 years, the mean HbA1c was 8.1%, and 71.5% were male.
Maltese: L-età medja kienet ta' 63 sena, l-HbA1c medju kien ta' 8.1%, u 71.5% kienu rġiel.
English: • and delay of intestinal glucose absorption.
Maltese: • u jdewwem l-assorbiment tal-glukosju intestinali.
English: • Hepatic impairment, acute alcohol intoxication, alcoholism (see section 4.5).
Maltese: • Indeboliment tal-fwied, intossikazzjoni akuta bl-alkoħol, alkoħoliżmu (ara sezzjoni 4.5)
English: Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment-β (HOMA-β) was noted.
Maltese: Kien innotat titjib fil-markaturi sostituti tal-funzjoni taċ-ċelluli beta li jinkludu l-Mudell Omeostatiku ta' Assessjar (HOMA-β - Homeostasis Model Assessment-B).
English: • a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Maltese: • tnaqqis sinifikanti tar-riskju assolut ta' infart mijokardijaku: metformin 11 avveniment/1,000 sena ta' pazjenti, dieta biss 18-il avveniment/1,000 sena, (p = 0.01).
English: Gastrointestinal symptoms
Maltese: Sintomi gastro-intestinal
English: In the EMPA-REG OUTCOME study, for time to first nephropathy event, the HR was 0.61 (95 % CI 0.53, 0.70) for empagliflozin (12.7 %) vs placebo (18.8 %).
Maltese: Fl-istudju EMPA-REG OUTCOME, għaż-żmien sal-ewwel avveniment ta' nefropatija, l-HR kien ta' 0.61 (CI ta' 95% 0.53, 0.70) għal empagliflozin (12.7%) vs plaċebo (18.8%).
English: - Film coating: hypromellose, macrogol 400, titanium dioxide (E171), talc.
Maltese: - Qalba tal-pillola: maize starch, copovidone, colloidal anhydrous silica, magnesium stearate - Kisja tar-rita: hypromellose, macrogol 400, titanium dioxide (E171), talc.
English: The tablets are available in PVC/PVDC/aluminium perforated unit dose blisters.
Maltese: Folji perforati tad-doża tal-unità tal-PVC/PVDC/aluminju.
English: Organic cation transporters (OCT) Metformin is a substrate of both transporters OCT1 and OCT2.
Maltese: Trasportaturi ta' ketajins organiċi (OCT - organic cation transporters) Metformin huwa sottostrat kemm tat-trasportaturi OCT1 kif ukoll ta' OCT2.
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h/l and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h/l and 687 nmol/l with empagliflozin 25 mg once daily.
Maltese: Il-plażma fl-istat fiss medju AUC u Cmax kienu ta' 1870 nmol/h/l u 259 nmol/l b'empagliflozin 10 mg u 4740 nmol.h/l u 687 nmol/l b'empagliflozin 25 mg li jingħata darba kuljum.
English: • reduced body temperature and heartbeat
Maltese: • temperatura tal-ġisem u taħbit tal-qalb imnaqqsa
English: Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Maltese: Studji ta' interazzjoni li saru fuq voluntiera b'saħħithom jissuġġerixxu li empagliflozin ma kellux effett klinikament rilevanti fuq il-farmakokinetika ta' metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, dijuretiċi u kontraċettivi orali.
English: It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Maltese: Huwa supponut li l-farmakokinetika tal-assorbiment ta' metformin mhijiex lineari.
English: Possible signs are listed in section 4, ‘Possible side effects', dehydration;
Maltese: Sinjali possibbli huma elenkati f'sezzjoni 4, “Effetti sekondarji possibbli” taħt “deidratazzjoni”.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Maltese: Wara doża orali, il-half-life terminali tal-eliminazzjoni apparenti hija ta' madwar 6.5 sigħat.
English: For metformin, AUC decreased by 12% and Cmax decreased by 26% compared to fasting conditions.
Maltese: Għal metformin, l-AUC naqas bi 12% u s Cmax naqas b'26% mqabbel mal-kundizzjonijiet fejn il-persuna tkun sajma.
English: At week 18, empagliflozin provided statistically significant improvement in HbA1c.
Maltese: F'Ġimgħa 18, empagliflozin ġab titjib statistikament sinifikanti fl-HbA1c.
English: Pack sizes of 10 x 1, 14 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 and 100 x 1 film-coated tablets and multipacks containing 120 (2 packs of 60 x 1), 180 (2 packs of 90 x 1) and 200 (2 packs of 100 x 1) film-coated tablets.
Maltese: Id-daqsijiet tal-pakkett huma ta' 10 x 1, 14 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 u 100 x 1 pilloli miksijin b'rita u pakketti multipli li fihom 120 (2 pakketti ta' 60 x 1), 180 (2 pakketti ta' 90 x 1) u 200 (2 pakketti ta' 100 x 1) pillola miksija b'rita.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 microgram/ml, even at maximum doses.
Maltese: Fi provi kliniċi kkontrollati, il-livelli massimi ta' metformin fil-plażma (Cmax) ma qabżux 5 mikrogrammi/ml, anki fid-dożi massimi.
English: • certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Maltese: • ċerti mediċini għat-trattament ta' pressjoni għolja (inibituri ta' ACE u antagonisti tar-riċetturi ta' angiotensin II)
English: Synjardy 12.5 mg/850 mg and Synjardy 12.5 mg/1,000 mg tablets also contain iron oxide black (E172) and iron oxide red (E172).
Maltese: Synjardy 12.5 mg/850 mg u Synjardy 12.5 mg/1,000 mg pilloli fihom ukoll iron oxide black (E172) u iron oxide red (E172).
English: Interaction studies suggest that the pharmacokinetics of empagliflozin were not influenced by co-administration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Maltese: Studji ta' interazzjoni jissuġġerixxu li l-farmakokinetika ta' empagliflozin ma kinitx influwenzata bl-għoti flimkien ma' metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide u hydrochlorthiazide.
English: • medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib).
Maltese: • mediċini li jistgħu jibdlu l-ammont ta' metformin fid-demm tiegħek, speċjalment jekk għandek funzjoni tal-kliewi mnaqqsa (bħal verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib).