FrancophonIA/ELRC3.0 huggingface dataset:
English: This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Tractocile 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Maltese: Minflokha ixħet 10 ml Tractocile 37.5 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni minn żewġ fjali ta' 5 ml biex ikollok konċentrazzjoni ta' 75 mg ta' atosiban f'100 ml.
English: VIAL
Maltese: Lott
English: It is not known whether M1 accumulates in tissues.
Maltese: Mhux magħruf jekk il-metabolit M1 jakkumulax fit-tessuti.
English: - allergic reactions
Maltese: - Reazzjonijiet allerġiċi
English: The following table shows the full posology of the bolus injection followed by the infusion:
Maltese: Il-freqwenza ta'reazzjonijiet mhux mixtieqa li qedin fil-lista li ġejja hawn taħt huma definiti billi tuża ilkonvenzjoni li ġejja:
English: One vial of 5 ml contains 37.5 mg of atosiban (as acetate).
Maltese: Kull kunjett ta' 5 ml fih 37.5 mg ta' atosiban (bħala acetate)
English: Pharmacotherapeutic group: Other gynecologicals, ATC code: G02CX01
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl Ladarba jinfetħ il-kunjett, is-soluzzjoni għandha tintuża fil-pront.
English: - Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.
Maltese: - imbaghad infużjoni kontiwa(dripp) se jingħatalek b'doża ta' 18mg/siegħa għal 3 sigħat.
English: After dilution, the concentration of atosiban is 0.75 mg/ml.
Maltese: Wara li jiġi dilwit il-konċentrazzjoni ta' atosiban issir 0.75 mg/ml.
English: This permits the continued independent control of the rate of infusion.
Maltese: Dan jippremetti li jkun hemm kontroll indipendenti tar-rata ta' l-infużjoni.
English: - A continuous infusion at a rate of 24 ml/hour is given for 3 hours.
Maltese: - Infużjoni kontiwa f'rata ta' 24 ml/siegħa tingħata għal 3 sigħat.
English: Insomnia
Maltese: Pożoloġija
English: Interaction studies have been performed with labetalol and betamethasone in healthy, female volunteers.
Maltese: Saru studji ta' interazzjoni ma' labetalol u betamethasone f'voluntiera nisa b'saħħithom.
English: As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored.
Maltese: Billi atosiban jaħdem kontra oxytocin, teoretikament jista' jgħin ir-rilassament ta' l-utru u d-dmija wara lħlas, għalhekk għandu jsir monitoraġġ tad-dmija wara l-ħlas.
English: One pack contains one vial containing 5 ml solution.
Maltese: Kull pakkett fih kunjett wieħed li fih soluzzjoni ta'5 ml.
English: No studies were performed that covered fertility and early embryonic development (see section 5.3).
Maltese: Ma sar ebda studju dwar il-fertilità u l-iżvilupp bikri ta' l-embriju (ara taqsima 5.3)
English: After three hours the infusion rate is reduced to 8 ml/hour.
Maltese: Wara tliet sigħat ir-rata ta' l-infużjoni titnaqqas għal 8 ml/siegħa.
English: If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding should be discontinued during treatment with Tractocile, since the release of oxytocin during breast-feeding may augment uterine contractility, and may counteract the effect of tocolytic therapy.
Maltese: Jekk waqt it-tqala l-omm qed tredda tarbija oħra li kellha qabel, it-treddih ghandu jitwaqqaf waqt it-trattament bi Tractocile, dan għaliex ir-rilaxx ta oxytocin waqt it-treddih jista jżzid ilkontrazzjonijiet tal-utru i jista jaħdem kontral-effett tat-terapija tokolitika.
English: Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of Tractocile 37.5 mg/5 ml, concentrate for solution for infusion).
Maltese: Ladarba l-injezzjoni f'daqqa tkun saret, kompli bl-infużjoni (ara sSommarju tal-Karatteristiċi tal-Prodott ta' Tractocile 37.5 mg/5 ml, konċentrat għas-soluzzjoni għallinfużjoni).
English: One vial of concentrate for solution for infusion contains 5 ml solution, corresponding to 37.5 mg atosiban.
Maltese: Kunjett ta' konċentrat għal soluzzjoni għall-infużjoni li fih 5 ml, li jikkorrispondi għal 37.5 mg atosiban.
English: Solution for injection (injection).
Maltese: .3, Kontraindikazzjonijiet).
English: It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.
Maltese: Dan jagħmlu billi jibblokka l-effett ta' ormon naturali fil-ġisem tiegħek jismu “oxytocin” li jikkawża il-kontrazzjonijiet fil-ġuf (utru).
English: Antepartum uterine haemorrhage requiring immediate delivery Eclampsia and severe pre-eclampsia requiring delivery Intrauterine foetal death
Maltese: Indeboliment renali aktarx mhux se jiggarantixxi aġġustament tad-doża, dan għaliex ammont żgħir ħafna ta' atosiban jiġi mneħħi fl-urina.
English: Tractocile must not be used in the following conditions:
Maltese: Tużax Tractocile:
English: Tractocile 6.75 mg/0.9 ml solution for injection
Maltese: Tractocile 6.75 mg/0.9 ml soluzzjoni għall-injezzjoni
English: In rats and guinea pigs, atosiban was shown to bind to oxytocin receptors, to decrease the frequency of contractions and the tone of the uterine musculature, resulting in a suppression of uterine contractions.
Maltese: Fil-firien u l-fniek ta' l-Indi, atosiban intwera li jingħaqad marriċetturi ta' oxytocin, biex inaqqas il-frekwenza tal-kontrazzjonijiet u s-sodizza tal-muskoli ta' l-utru, birriżultat li jnaqqas il-kontrazzjonijiet ta' l-utru.
English: Each ml of solution contains 7.5 mg atosiban.
Maltese: Kull ml ta' soluzzjoni fiha 7.5mg atosiban.
English: In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of Tractocile 6.75 mg/0.9 ml, solution for injection followed by infusion with Tractocile 37.5 mg/5 ml, concentrate for solution for infusion.
Maltese: F'każ li jkun hemm bżonn kura ripetuta, din għandha tibda b'injezzjoni f'daqqa ta' 6.75 mg/0.9 ml soluzzjoni għall-injezzjoni ta' Tractocile, u wara infużjoni ta' konċentrat ta' soluzzjoni għall-infużjoni ta' 37.5 mg/5 ml ta' Tractocile.
English: Suomi/Finland Ferring Lääkkeet Oy Puh/Tel: +358 207 401 440 info@ferring.fi
Maltese: +358 207 401 440 info@ferring.fi
English: Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation.
Maltese: Atosiban għandu jintuża biss meta twelid pre-matur jiġi dijanjożizzat bejn l-24 u t-33 ġimgħa magħluqa ta' tqala.
English: Gestational age below 24 or over 33 completed weeks Premature rupture of the membranes >30 weeks of gestation Abnormal foetal heart rate
Maltese: Tqala ta' inqas minn 24 ġimgħa jew f'dik ta' iktar minn 33 ġimgħa magħluqa L-ilma jinfaqa' qabel iż-żmien > 30 ġimgħa tqala
English: Tractocile 37.5 mg/5 ml concentrate for solution for infusion Atosiban
Maltese: Tractocile 37.5 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni atosiban
English: Mean value for clearance was 41.8 ± 8.2 litres/h.
Maltese: Il-volum medju tat-tneħħija kien ta' 41.8 ± 8.2 l/siegħa.
English: Common (affects less than 1 in 10 people) - headache - feeling dizzy - hot flushes - being sick (vomiting) - fast heartbeat - Low blood pressure.
Maltese: Komuni (jistgħu jaffettwaw sa 1 f'10 persuni) - Uġiegħ ta'ras - Tħossok tistordi - Sħaniet/fwawar - Tħossok ma tiflaħx (se tirrametti) - Il-qalb tħabbat tgħaġġel - Pressjoni baxxa:
English: Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Maltese: Xi kondizzjoni oħra ta' l-omm jew tal-fetu li minħabba fiha t-tkomplija tat-tqala tkun perikoluża Sensitività eċċessiva għas-sustanza attiva jew jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Therefore, atosiban should be used with caution in case of multiple pregnancy and/or concomitant administration of other medicinal products with tocolytic activity (see section 4.8).
Maltese: Għalhekk, atosiban għandu jintuża b'kawtela f'każ ta' tqaliet multipli u/jew l-għoti fl-istess ħin ta' prodotti mediċinali b'attività tokolitika (ara sezzjoni 4.8).
English: No systemic toxic effects were observed during the two-week intravenous toxicity studies (in rats and dogs) at doses which are approximately 10 times higher than the human therapeutic dose, and during the threemonths toxicity studies in rats and dogs (up to 20 mg/kg/day s.c.).
Maltese: Ma deherx li kien hemm effetti tossiċi sistemiċi waqt studji ta' gimagħtejn dwar it-tossicita` li fihom ilprodott ingħata fil-vina (fil-firien u l-klieb) b'dożi li kienu bejn wieħed u ieħor 10 darbiet ogħla mid-doża terapewtika għall-bnedmin, kif ukoll waqt studji ta' tliet xhur dwar it-tossiċita` fil-firien u l-klieb (sa 20 mg/kg kuljum s.c.).
English: Eleven out of the 15 deaths in the atosiban group occurred in pregnancies with a gestational age of 20 to 24 weeks, although in this subgroup patient distribution was unequal (19 women on atosiban, 4 on placebo).
Maltese: għalkemm id-distribuzzjoni ta' dawn il-pazjenti skond il-grupp ta' kura ma kinitx l-istess (19-il mara fuq atosiban, 4 nisa fuq il-plaċebo).
English: It is available as tablets (15, 30 and 45 mg).
Maltese: Huwa disponibbli bħala pilloli (15, 30 u 45 mg).
English: The full EPAR for Pioglitazone Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Pioglitazone Krka jista' jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 08-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 08-2011.
English: Pioglitazone Krka is a ‘generic medicine'.
Maltese: Pioglitazone Krka huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Krka on 21 March 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pioglitazone Krka fil-21 ta' Marzu 2012.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone Krka has been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Is-CHMP kkonkluda li, f'konformità mar-rekwiżiti tal-UE, Pioglitazone Krka wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Actos.
English: Pioglitazone Krka can also be used with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Maltese: Pioglitazone Krka jista' jintuża wkoll mas-sulphonylurea (tip ieħor ta' mediċina antidijabetika) meta lmetformina ma tkunx tista' tintuża (‘terapija doppja').
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Krka.
Maltese: Dan huwa sommarju tar-Rappport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Pioglitazone Krka.
English: EPAR summary for the public pioglitazone
Maltese: Sommarju tal-EPAR għall-pubbliku pijoglitazone
English: This means that Pioglitazone Krka is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Dan ifisser li Pioglitazone Krka huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: The active substance in Pioglitazone Krka, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva f'Pioglitazone Krka, pioglitazone, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi.
English: The recommended starting dose of Pioglitazone Krka is 15 or 30 mg once a day.
Maltese: Id-doża tal-bidu rakkomandata ta' Pioglitazone Krka hi 15 jew 30 mg darba kuljum.
English: Other information about Pioglitazone Krka
Maltese: Aktar tagħrif dwar Pioglitazone Krka
English: What is Pioglitazone Krka?
Maltese: Kif jaħdem Pioglitazone Krka?
English: Because Pioglitazone Krka is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Peress li Pioglitazone Krka huwa mediċina ġenerika, l-istudji f'pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Actos.
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Maltese: Din id-doża tista' teħtieġ li tiżdied wara ġimgħa jew ġimgħatejn sa 45 mg darba kuljum jekk ikun meħtieġ kontroll aħjar ta' glukożju fid-demm (zokkor).
English: Pioglitazone Krka is a medicine that contains the active substance pioglitazone.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: Because Pioglitazone Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Pioglitazone Krka huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Why has Pioglitazone Krka been approved?
Maltese: Għaliex ġie approvat Pioglitazone Krka?
English: Pioglitazone Krka is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Maltese: Pioglitazone Krka jintuża għall-kura tad-dijabete tat-tip 2 f'adulti (minn 18-il sena 'l fuq), b'mod partikolari dawk b'piż eċċessiv.
English: Pioglitazone Krka is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Maltese: Pioglitazone Krka jintuża waħdu f'pazjenti li ma jkunux jistgħu jieħdu l-metformina (mediċina antidijabetika oħra).
English: Pioglitazone Krka should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Maltese: Pioglitazone Krka m'għandux jintuża f'pazjenti bid-dijaliżi (teknika ta' tisfija tad-demm użata f'nies b'mard fil-kliewi).
English: In adults, the recommended dose is 250 micrograms, injected into a vein over 30 seconds.
Maltese: Fl-adulti, id-doża rrakkomandata hija 250 mikrogramma injettata f'vina tul 30 sekonda.
English: The active substance in Palonosetron Hospira, palonosetron, is a ‘5HT3 antagonist'.
Maltese: Is-sustanza attiva f'Palonosetron Hospira, il-palonosetron, hija ‘5HT3 antagonist'.
English: Palonosetron Hospira EMA/173510/2016
Maltese: EMA/173510/2016
English: Palonosetron Hospira is a ‘generic medicine'.
Maltese: Palonosetron Hospira huwa ‘mediċina ġenerika'.
English: Palonosetron Hospira palonosetron
Maltese: Palonosetron Hospira
English: the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Maltese: tingħata b'infużjoni (dripp) fil-vina tul 15-il minuta b'doża ta' 20 mikrogramma għal kull kilogramm ta' piż tal-ġisem.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku palonosetron
English: This is a summary of the European public assessment report (EPAR) for Palonosetron Hospira.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Palonosetron Hospira.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Maltese: Dan ifisser li twaqqaf kimika fil-ġisem imsejħa 5-idrossitriptamina (5HT, magħrufa wkoll bħala serotonina) milli teħel ma' riċetturi ta' 5HT3 fil-musrana.
English: Other information about Palonosetron Hospira
Maltese: Informazzjoni oħra dwar Palonosetron Hospira
English: Palonosetron Hospira is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Maltese: Palonosetron Hospira jintuża sabiex jipprevjeni n-nawżja (tħoss id-dardir) u r-remettar li huma kkawżati mill-kimoterapija (mediċini użati fil-kura tal-kanċer).
English: This means that Palonosetron Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aloxi.
Maltese: Dan ifisser li Palonosetron Hospira huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Aloxi.
English: The company provided data from the published literature on palonosetron.
Maltese: Il-kumpanija pprovdiet data minn dokumentazzjoni ppubblikata dwar il-palonosetron.
English: Palonosetron Hospira contains the active substance palonosetron.
Maltese: Palonosetron Hospira fih is-sustanza attiva palonosetron .
English: Why is Palonosetron Hospira approved?
Maltese: Għaliex ġie approvat Palonosetron Hospira?
English: It is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Maltese: Jintuża f'adulti u tfal fl-età ta' xahar jew akbar għall-kimoterapija ma' mediċini li jew jikkawżaw tqanqil qawwi ta' nawżja u remettar (bħaċċisplatinu) jew tqanqil moderat (bħaċ-ċiklofosfamide, id-doksorubiċin jew il-karboplatinu).
English: A risk management plan has been developed to ensure that Palonosetron Hospira is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Palonosetron Hospira jintuża bl-aktar mod sigur possibbli.
English: Because Palonosetron Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Palonosetron Hospira huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The full EPAR for Palonosetron Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Għal aktar informazzjoni rigward ilkura b'Palonosetron Hospira, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew spiżjar tiegħek.
English: It is available as a solution for injection which should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Maltese: Jiġi bħala soluzzjoni għall-injezzjoni li għandha tingħata minn professjonista tal-kura tas-saħħa madwar 30 minuta qabel tinbeda l-kimoterapija.
English: Therefore, the CHMP's view was that, as for Aloxi, the benefit outweighs the identified risk.
Maltese: Għalhekk, ilfehma tas-CHMP kienet li, bħal Aloxi, il-benefiċċju huwa akbar mir-riskju identifikat.
English: No additional studies were needed as Palonosetron Hospira is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali peress li Palonosetron Hospira huwa mediċina ġenerika mogħtija permezz ta' injezzjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Aloxi.
English: When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Maltese: Meta 5HT jeħel ma' dawn ir-riċetturi, normalment jikkawża d-dardir u rrimettar.
English: The Committee recommended that Palonosetron Hospira be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Palonosetron Hospira jkun approvat għall-użu fl-UE.
English: How has Palonosetron Hospira been studied?
Maltese: Kif jintuża Palonosetron Hospira?
English: How is Palonosetron Hospira used?
Maltese: Kif jaħdem Palonosetron Hospira?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Hospira has been shown to be comparable to Aloxi.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Palonosetron Hospira wera li huwa komparabbli ma' Aloxi.
English: Date of first authorisation: 10 January 2008 Date of latest renewal: 20 September 2012
Maltese: Data tal-aħħar tiġdid: 20 Settembru 2012
English: Tel.: +39 06 91393303 addendapharma@legalmail.it
Maltese: +39 06 91393303 addendapharma@legalmail.it
English: - an allergic reaction to TESAVEL (see section 4).
Maltese: - reazzjoni allerġika għal TESAVEL (ara sezzjoni 4).
English: Film coating: poly(vinyl alcohol) macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
Maltese: Rita ta' barra: poly(vinyl alcohol) macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
English: Tablet core: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Maltese: Qalba tal-pillola: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
English: Sitagliptin is a substrate for human organic anion transporter-3 (hOAT-3), which may be involved in the renal elimination of sitagliptin.
Maltese: Sitagliptin huwa sustrat għat-trasportatur-3 tal-anjonu organiku uman (hOAT-3 - human organic anion transporter-3), li jista' jkun involut fl-eliminazzjoni renali ta' sitagliptin.
English: Merck Sharp & Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3JU United Kingdom
Maltese: Shotton Lane, Cramlington Northumberland NE23 3JU Ir-Renju Unit
English: Other medicines and TESAVEL
Maltese: Mediċini oħra u TESAVEL
English: TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Maltese: TESAVEL huwa membru ta' klassi ta' sustanzi anti-ipergliċemiċi orali li jissejħu inibituri ta' dipeptidyl peptidase 4 (DPP-4).
English: In vitro, sitagliptin did not inhibit OAT3 (IC50=160 M) or p-glycoprotein (up to 250 M) mediated transport at therapeutically relevant plasma concentrations.
Maltese: In vitro, sitagliptin ma kienx jinibixxi transport permezz ta' OAT3 (IC50=160 mM) jew p-glycoprotein (sa 250 mM) f'konċentrazzjonijiet fil-plażma terapewtikament relevanti.
English: Nederland
Maltese: L-Olanda
English: Initial therapy (twice daily) Sitagliptin 50 mg + metformin 500 mg (N=183)
Maltese: Sitagliptin 50 mg + metformin 500 mg (N=183)
English: The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyzes the incretin hormones to produce inactive products.
Maltese: L-attività ta' GLP-1 u GIP hija limitata mill-enzima DPP-4, li malajr tidrolizza l-ormoni incretin biex b'hekk tipproduċi prodotti inattivi.
English: a as monotherapy
Maltese: bħala monoterapija
English: Tel: +34 93 291 30 00 info.spain@almirall.com
Maltese: Tel: +34 93 291 30 00 comercial@almirall.es
English: How to take TESAVEL
Maltese: Tiħux TESAVEL:
English: EU/1/07/435/013 EU/1/07/435/014 EU/1/07/435/015 EU/1/07/435/016 EU/1/07/435/017 EU/1/07/435/018 EU/1/07/435/023 EU/1/07/435/024
Maltese: EU/1/07/435/016 EU/1/07/435/017 EU/1/07/435/018 EU/1/07/435/023 EU/1/07/435/024
English: TESAVEL 25 mg tablets Sitagliptin
Maltese: Pilloli TESAVEL 25 mg Sitagliptin
English: SIA Merck Sharp & Dohme Latvija Tel: +371 67364 224 msd_lv@merck.com
Maltese: Tel: +371 67364 224 msd_lv@merck.com
English: TESAVEL 100 mg tablets Sitagliptin
Maltese: Pilloli TESAVEL 100 mg Sitagliptin
English: TESAVEL 50 mg tablets Sitagliptin
Maltese: Pilloli TESAVEL 50 mg Sitagliptin
English: Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 M•hr, Cmax was 950 nM.
Maltese: Wara l-amministrazzjoni orali ta' doża ta' 100 mg f'individwi f'saħħithom, sitagliptin kien assorbit malajr, b'konċentrazzjonijiet massimi fil-plażma (Tmax medjana) jintlaħqu minn siegħa sa 4 sigħat wara d-doża, l-AUC medja ta' sitagliptin fil-plażma kienet ta' 8.52 mM•hr, Cmax kienet 950 nM.
English: HbA1c (%) at week 24.
Maltese: % HbA1c (%) f'ġimgħa 24. #