FrancophonIA/ELRC3.0 huggingface dataset:
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Ολλανδία/Nizozemska/The Netherlands/Holland/
Maltese: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/ Hollandia/L-Olanda/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna
English: Date of latest renewal: 28 May 2018
Maltese: Data tal-aħħar tiġdid: 28 ta 'Mejju, 2018
English: Up to 270 mg intravenous infusion
Maltese: Sa 270 mg infużjoni ġol-vina
English: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/ Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Maltese: België/Belgique/Belgien/България/Česká republika/ Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/ Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/Norge/Österreich/Portugal/Slovenija/ Slovenská republika/Suomi/Finland/Sverige Sun Pharmaceutical Industries Europe B.V.
English: - Rash.
Maltese: - Raxx.
English: Mean value of volume of distribution was 18.3 ± 6.8 litres.
Maltese: Il-valur medju tal-volum tad-distribuzzjoni kien ta' 18.3 ± 6.8 litri.
English: Atosiban SUN contains atosiban (INN), a synthetic peptide ([Mpa1, D-Tyr(Et)2, Thr4,Orn8]-oxytocin) which is a competitive antagonist of human oxytocin at receptor level.
Maltese: Atosiban SUN fih atosiban (INN), peptide sintetiku ([Mpa1, D-Tyr(Et)2, Thr4,Orn8]-oxytocin) li jikkompeti ma' oxytocin għar-riċetturi fil-bniedem.
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000).
Maltese: Il-freqwenza ta' reazzjonijiet mhux mixtieqa li qegħdin fil-lista li ġejja hawn taħt huma definiti billi tuża l-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000).
English: Atosiban dose
Maltese: Doża ta' atosiban
English: Mean (SD) birth weight was 2491 (813) grams in the atosiban group and 2461 (831) grams in the β-agonist group (p=0.58).
Maltese: Il-piz medju (SD) fit-twelid kien ta' 2491 (813) gramma fil-grupp ta' atosiban, u 2461 (831) gramma fil-grupp talβ-agonist (p=0.58).
English: The ratios of the main metabolite M1 (des-(Orn8, Gly-NH2 9) -29)-[Mpa1, D-Tyr(Et)2, Thr4]-oxytocin) to atosiban concentrations in plasma were 1.4 and 2.8 at the second hour and at the end of the infusion respectively.
Maltese: Il-proporzjonijiet tal-metobolit prineipali M1 (des-(Orn8, Gly-NH2 9) -29)-[Mpa1, D-Tyr(Et)2, Thr4]-oxytocin) għallkonċentrazzjonijiet ta' atosiban fil-plażma kienu ta' 1.4 u 2.8 wara sagħtejn u fl-aħħar tal-infużjoni rispettivament.
English: 8 ml/hour (100 μg/min)
Maltese: 8 ml/siegħa (100 μg/min)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 July 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 31 ta' Lulju, 2013
English: 1 vial (6.75 mg/0.9 ml)
Maltese: 0.9 ml (6.75 mg/0.9 ml)
English: Treatment failures caused by insufficient efficacy were significantly (p=0.0003) more frequent in atosiban (n=48, 14.2%) than in the β-agonist-treated women (n=20, 5.8%).
Maltese: Il-fallimenti tal-kura għax ma kienx effikaċi biżżejjed kienu iktar frekwenti b'mod sinifikanti (p=0.0003) fin-nisa li ngħataw atosiban (n=48, 14.2%) milli fin-nisa li ngħataw β-agonist (n=20, 5.8%).
English: It is unlikely that atosiban is involved in cytochrome P450 mediated drug-drug interactions as in vitro investigations have shown that atosiban is not a substrate for the cytochrome P450 system, and does not inhibit the medicinal product metabolising cytochrome P450 enzymes.
Maltese: Mhux probabbli li atosiban hu involut f'interazzjonijiet bejn prodotti mediċinali permezz taċ-ċitokrom P450, billi investigazzjonijiet in vitro wrew li atosiban mhux substrat għas-sistema taċ-ċitokrom P450, u ma jwaqqafx l-enzimi taċ-ċitokrom P450 li jimmetabolizzaw prodotti mediċinali.
English: 2 years.
Maltese: minuta.
English: The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocin-induced uterine contractions in vitro.
Maltese: Il-metabolit prinċipali M1 huwa bejn wieħed u ieħor 10 darbiet inqas b'saħħtu minn atosiban biex iwaqqaf ilkontrazzjonijiet ta' l-utru kkaġunati minn oxytocin in vitro.
English: Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with: - regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes - a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50% - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate
Maltese: Atosiban hu indikat biex jittardja ħlas imminenti qabel iż-żmien f'nisa adulti tqal b': - kontrazzjonijiet regolari tal-utru twal mill-inqas 30 sekonda b'rata ta' ≥ 4 kull 30 minuta - fetħa ċervikali minn 1 sa 3 cm (0-3 nulliparas) u effacement ta' ≥ 50% - tqala minn 24 sa 33 ġimgħa magħluqa - rata tal-qalb tal-fetu normali
English: LIST OF EXCIPIENTS Excipients: mannitol, hydrochloric acid 1M, water for injections.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: mannitol, hydrochloric acid 1M, ilma għall-injezzjonijiet.
English: 02-954 Warszawa Polska tel. +48 22 642 07 75
Maltese: +48 22 642 07 75 România
English: Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and beta-mimetics are known to be associated with increased risk of pulmonary oedema.
Maltese: Tqala multipla u prodotti mediċinali b'attività tokolitika bħal imblokkaturi tal-kanal tal-calcium u betamimetiċi huma magħrufa li huma assoċjati ma' riskju miżjud ta' edema pulmonari.
English: No clinically relevant interaction was found between atosiban and bethamethasone or labetalol.
Maltese: Ma nstabet lebda interazzjoni klinika rilevanti bejn atosiban u betamethasone jew labetalol.
English: Mean (SD) gestational age at delivery was the same in the two groups: 35.6 (3.9) and 35.3 (4.2) weeks for the atosiban and β-agonist groups, respectively (p=0.37).
Maltese: 35.6 (3.9) u 35.3 (4.2) ġimgħa għall-gruppi ta' atosiban u tal-β-agonist, rispettivament (p=0.37).
English: The total dose given during a full course of atosiban therapy should preferably not exceed 330.75 mg of atosiban.
Maltese: Id-doża totali li tingħata waqt kors sħiħ ta' terapija preferibbilment m'għandhiex tkun iktar minn 330.75 mg ta' 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 litri/siegħa.
English: Atosiban is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with atosiban 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of atosiban 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of atosiban 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours.
Maltese: Atosiban jingħata ġol-vina fi tliet stadji wara xulxin: doża tal-bidu f'daqqa (6.75 mg), b'soluzzjoni għall-injezzjoni ta' atosiban 6.75 mg/0.9 ml, u eżatt wara infużjoni kontinwa ta' doża qawwija (infużjoni tal-bidu ta' 300 mikrogramma/min) ta' atosiban 37.5 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni għal tliet sigħat, u wara doża iktar baxxa ta' atosiban 37.5 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni (infużjoni ta' wara 100 mikrogramma/min) sa 45 siegħa.
English: Rambla de Catalunya 53-55 08007 Barcelona España tel. +34 93 342 78 90
Maltese: Sun Pharma Laboratorios, S.L. Rambla de Catalunya 53-55 08007 Barcelona
English: Ranbaxy Italia S.p.A. Viale Giulio Richard, 1 20143 Milano Italia tel. +39 02 33 49 07 93
Maltese: Viale Giulio Richard, 1 20143
English: Following completion of the infusion, plasma concentration rapidly declined with an initial (tα) and terminal (tβ) half-life of 0.21 ± 0.01 and 1.7 ± 0.3 hours, respectively.
Maltese: Wara li ntemmet l-infużjoni, il-konċentrazzjoni fil-plażma reġgħet niżlet malajr b'valuri tal-half-life tal-bidu (tα) u l-half-life terminali (tβ) ta' 0.21 ± 0.01 u 1.7 ± 0.3 sigħat, rispettivament.
English: Step
Maltese: Pass
English: Secondary endpoints: secondary efficacy parameters included the proportion of women remaining undelivered within 48 h of treatment initiation.
Maltese: Secondary endpoints: il-parametri sekondarji tal-effikaċja tal-prodott inkludew il-proporzjon ta' nisa li baqgħu ma ħelsux 48 siegha wara l-bidu tal-kura.
English: How to store Atosiban SUN
Maltese: Kif taħżen Atosiban SUN
English: Colourless tubular glass vial (type I) with bromobutyl flange grey rubber stopper and sealed with flip off violet colour aluminium seal.
Maltese: Kunjett tal-ħġieġ tubulari bla kulur (tip I) b'tapp griż tal-lastku flange tal-bromobutyl u ssiġillat b'siġill tal-aluminju flip off vjola.
English: IV after dilution
Maltese: IV wara dilwizzjoni
English: An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for atosiban.
Maltese: Microdrip chamber ġol-vina jista' jipprovdi medda konvenjenti ta' rati ta' infużjoni fillimiti tad-dożi rakkomandati għal atosiban.
English: Hollandia/L-Olanda/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Maltese: /тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
English: In a placebo-controlled study, fetal/infant deaths were 5/295 (1.7%) in the placebo group and 15/288 (5.2%) in the atosiban group, of which two occurred at five and eight months of age.
Maltese: Fi studju kkontrollat bil-plaċebo, ir-rata ta' mwiet tal-fetu jew tat-trabi kienet ta' 5/295 (1.7%) filgrupp tal-plaċebo u 15/288 (5.2%) fil-grupp ta' atosiban, li minnhom żewġt imwiet seħħew wara ħames u tmien xhur ta' ħajja.
English: Atosiban was neither oncogenic nor mutagenic in in vitro and in vivo tests.
Maltese: Atosiban ma kellux effett onkoġeniku u lanqas mutaġeniku f'testijiet in vitro u in vivo.
English: Embryo-fetal toxicity studies have not shown toxic effects of atosiban.
Maltese: Studji tossiċi fuq embrijofetali ma wrewx effetti tossiċi ta' atosiban.
English: - A continuous infusion at a rate of 8 ml/hour is given for up to 45 hours, or until the contractions of the uterus have subsided.
Maltese: - Infużjoni kontinwa f'rata ta' 8 ml/siegħa tingħata sa 45 siegħa, jew sakemm il-kontrazzjonijiet tal-utru jnaqqsu u jieqfu.
English: OTHER EU/1/13/852/002
Maltese: OĦRAJN EU/1/13/852/002
English: OTHER EU/1/13/852/001
Maltese: OĦRAJN EU/1/13/852/001
English: Phase III clinical trials (CAP-001 studies) include data from 742 women who were diagnosed with pre-term labour at 23-33 weeks of gestation and were randomised to receive either atosiban (according to this labelling) or β-agonist (dose-titrated).
Maltese: Provi kliniċi tal-Fażi III (studji CAP-001) jinkludu tagħrif minn 742 mara li kellhom djanjosi ta' ħlas qabel iż-żmien fit-23-33 ġimgħa tat-tqala u tqassmu bl-addoċċ biex jingħataw atosiban (skont din ittikketta) jew β-agonist (dose-titrated).
English: The most commonly reported adverse reaction in the mother is nausea (14 %).
Maltese: L-aktar effett mhux mixtieq li kien komuni fl-omm kien dardir (14%).
English: - Difficulty sleeping (insomnia).
Maltese: - Diffikultà biex torqod (insomnija).
English: 54 mg infusion Up to 45 hours subsequent
Maltese: 24 ml/siegħa (300 μg/min) 54 mg infużjoni Sa 45 siegħa sussegwenti
English: - If you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you would also have fits (convulsions).
Maltese: - Jekk għandek ‘eclampsia' li hi simili għal ‘severe pre-eclampsia' imma magħha jkollok il konvulżjonijiet.
English: Of the 361 women who received atosiban treatment in the phase III studies, 73 received at least one re-treatment, 8 received at least 2 re-treatments and 2 received 3 re-treatments (see section 4.4).
Maltese: III, 73 ngħataw mill-inqas kura waħda ripetuta, 8 ngħataw mill-inqas 2 kuri ripetuti u 2 ngħataw 3 kuri ripetuti (ara sezzjoni 4.4).
English: Provides 0.75 mg/ml when diluted as recommended.
Maltese: Jipprovdi 0.75 mg/ml meta dilwit kif rakkomandat.
English: Name and address of the manufacturer(s) responsible for batch release Sun Pharmaceutical Industries Europe B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Sun Pharmaceutical Industries Europe B.V.
English: NETHERLANDS
Maltese: L-OLANDA
English: In the CAP-001 studies the probability of remaining undelivered and not requiring alternative tocolytics within 7 days of treatment initiation was similar for atosiban and beta-mimetics treated women at gestational age of 24-28 weeks.
Maltese: Fl-istudji CAP-001 il-probabbilità li ma jkunx hemm ħlas u ma jkunx hemm bżonn tokolitiċi alternattivi fi żmien 7 ijiem wara l-bidu tal-kura, kienet simili għan-nisa bi tqala ta' bejn 24-28 ġimgħa li ngħataw atosiban jew il-betamimetiċi.
English: - Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.
Maltese: - Imbaghad infużjoni kontinwa (dripp) se tingħatalek b'doża ta' 18 mg/siegħa għal 3 sigħat.
English: The intravenous infusion is prepared by diluting Atosiban SUN 37.5 mg/5 ml, concentrate for solution for infusion in sodium chloride 9 mg/ml (0.9%) solution for injection, Ringer's lactate solution or 5% w/v glucose solution.
Maltese: Is-soluzzjoni ġol-vina tiġi ppreparata billi tiddilwi Atosiban SUN 37.5 mg/5 ml, konċentrat għal soluzzjoni għall-infużjoni f'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni, soluzzjoni ta' Ringer's lactate jew 5% w/v soluzzjoni ta' glucose.
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: In healthy non-pregnant subjects receiving atosiban infusions (10 to 300 micrograms/min over 12 hours), the steady state plasma concentrations increased proportionally to the dose.
Maltese: F'nisa f'saħħithom mhux tqal li ngħataw infużjonijiet ta' atosiban (minn 10 sa 300 mikrogramma/min fuq medda ta' 12-il siegħa), il-konċentrazzjonijiet fissi fil-plażma żdiedu proporzjonalment mad-doża.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.9 ml (6.75 mg/0.9 ml)
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni 1 kunjett (6.75 mg/0.9 ml)
English: Further treatment with Atosiban SUN can be used if your contractions start again.
Maltese: Trattament b'Atosiban SUN jista' jiġi ripetut sa tliet darbiet oħra.
English: The data show that 59.6% (n=201) and 47.7% (n=163) of atosiban- and β-agonist-treated women (p=0.0004), respectively, were undelivered and did not require alternative tocolysis within 7 days of starting treatment.
Maltese: 7% (n=163) min-nisa li ngħataw atosiban u β-agonist (p=0.0004), rispettivament, ma welldux u ma kellhomx bżonn tokolisi alternattiva fi żmien 7 ijiem wara li tinbeda l-kura.
English: The observed adverse reactions were generally of a mild severity.
Maltese: Ir-reazzjonijiet mhux mixtieqa li ġew osservati b'mod ġenerali ma kinux severi.
English: Uterine haemorrhage, uterine atony
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda
English: Metabolite M1 is excreted in milk (see section 4.6).
Maltese: Il-metabolit M1 jitneħħa fil-ħalib (ara sezzjoni 4.6).
English: It is not known whether M1 accumulates in tissues.
Maltese: Mhux magħruf jekk il-metabolit M1 jakkumulax fit-tessut.
English: In women in pre-term labour receiving atosiban by infusion (300 micrograms/min for 6 to 12 hours), steady state plasma concentrations were reached within one hour following the start of the infusion (mean 442 ± 73 ng/ml, range 298 to 533 ng/ml).
Maltese: F'nisa bi ħlas qabel iż-żmien li kienu qed jingħataw atosiban bl-infużjoni (300 mikrogramma/min għal bejn 6 sa 12-il siegħa), il-konċentrazzjonijiet fissi tal-plażma ntlaħqu siegħa wara l-bidu tal-infużjoni (medja ta' 442 ± 73 ng/ml, medda ta' 298 sa 533 ng/ml).
English: No studies were performed that covered fertility and early embryonic development (see section 5.3).
Maltese: Ma sar ebda studju dwar ilfertilità u l-iżvilupp bikri tal-embriju (ara taqsima 5.3).
English: Hyperglycaemia
Maltese: Disturbi fil-qalb
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
Maltese: Kull kunjett ta' 0.9 ml soluzzjoni fih 6.75 mg atosiban (bħala acetate).
English: Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion atosiban
Maltese: Atosiban SUN 37.5 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni
English: - Itching.
Maltese: - Tirremetti.
English: Uncommon (may affect less than 1 in 100 people) - High temperature (fever).
Maltese: Mhux komuni (jistgħu jaffettwaw inqas minn 1 f'100 persuna) - Temperatura għolja (deni).
English: - Gestational age below 24 or over 33 completed weeks - Premature rupture of the membranes >30 weeks of gestation - Abnormal foetal heart rate - Antepartum uterine haemorrhage requiring immediate delivery - Eclampsia and severe pre-eclampsia requiring delivery - Intrauterine foetal death - Suspected intrauterine infection - Placenta praevia - Abruptio placenta - Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous - Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Maltese: - Plaċenta praevia - Abruptio plaċenta - Xi kondizzjoni oħra tal-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: Atosiban SUN 6.75 mg/0.9 ml solution for injection atosiban
Maltese: Atosiban SUN 6.75 mg/0.9 ml injezzjoni atosiban
English: - Each vial of Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
Maltese: 37.5 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni fih atosiban acetate ekwivalenti għal 37.5 mg ta' atosiban f'5 ml.
English: One pack contains one vial containing 0.9 ml solution.
Maltese: Kull pakkett fih kunjett wieħed li fih soluzzjoni ta' 0.9 ml.
English: For intravenous infusion, following the bolus dose, atosiban 37.5 mg/5 ml concentrate for solution for infusion should be diluted in one of the following solutions: - sodium chloride 9 mg/ml (0.9%) solution for injection - Ringer's lactate solution - 5% w/v glucose solution.
Maltese: Għal infużjoni għal ġol-vina, wara li tingħata d-doża f'daqqa, atosiban 37.5/5 ml konċentrat għal soluzzjoni għall-infużjoni għandu jkun dilwit ma' waħda minn dawn is-soluzzjonijiet: - sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni - soluzzjoni ta' Ringer's lactate - 5% w/v soluzzjoni ta' glucose.
English: - If you are more than 33 weeks pregnant.
Maltese: - Jekk it-tqala tiegħek hija ta' iktar minn 33 ġimgħa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate).
Maltese: Kull kunjett ta' 5 ml soluzzjoni fih 37.5 mg atosiban (bħala acetate).
English: Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and betamimetics, and/or in women with multiple pregnancy, have been reported post-marketing.
Maltese: Każijiet respiratorji bħal qtugħ ta' nifs u edema pulmonari, partikularment b'rabta mal-għoti fl-istess ħin ta' prodotti mediċinali b'attività tokolitika bħal antagonisti tal-calcium u betamimetiċi u/jew f'nisa bi tqala multipla, ġew irrappurtati wara t-tqegħid fis-suq.
English: Pharmacotherapeutic group: Other gynecologicals, ATC code: G02CX01
Maltese: Atosiban m'għandux jintuża f'dawn il-kondizzjonijiet:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 ml (7.5 mg/ml)
Maltese: 5 ml (7.5 mg/ml)
English: Infusion rate
Maltese: Mhux applikabbli
English: - Low blood pressure.
Maltese: - Pressjoni baxxa.
English: This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Atosiban SUN 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: Dan isir billi tneħħi 10 ml ta' soluzzjoni minn borża tal-infużjoni ta' 100 ml u tibdilha b'10 ml ta' Atosiban SUN 37.5 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni minn żewġ kunjetti ta' 5 ml biex ikollok konċentrazzjoni ta' 75 mg ta' atosiban f'100 ml.
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 tal-utru u d-dmija wara l-ħlas, għalhekk għandu jsir monitoraġġ tad-dmija wara l-ħlas.
English: 0.9 ml intravenous bolus
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: - If your contractions start again, treatment with Atosiban SUN can be repeated up to three more times.
Maltese: - Jekk il-kontrazzjonijiet jerġgħu jibdew, trattament b'Atosiban SUN jista' jiġi ripetut sa 3 darbiet oħra.
English: - Each vial of Atosiban SUN 6.75 mg/0.9 ml solution for injection contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.
Maltese: - Kull kunjett ta' Atosiban SUN 6.75 mg/0.9 ml soluzzjoni għall-injezzjoni fih atosiban acetate ekwivalenti għal 6.75 mg ta' atosiban f'0.9 ml.
English: - A continuous infusion at a rate of 24 ml/hour is given for 3 hours.
Maltese: - Infużjoni kontinwa f'rata ta' 24 ml/siegħa tingħata għal 3 sigħat.
English: Each ml of solution contains 7.5 mg atosiban.
Maltese: Kull ml ta' soluzzjoni fih 7.5 mg atosiban.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Withdraw 0.9 ml of a 0.9 ml labelled vial of atosiban 6.75 mg/0.9 ml, solution for injection and administer slowly as an intravenous bolus dose over one minute, under adequate medical supervision in an obstetric unit.
Maltese: 6.75 mg/0.9 ml, u agħtiha bil-mod ġol-vina f'doża waħda f'medda ta' minuta, taħt superviżjoni medika xierqa f'dipartiment ostetriku.
English: - If you are between 24 and 27 weeks pregnant.
Maltese: - Jekk it-tqala tiegħek hi ta' inqas minn 24 ġimgħa.
English: In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 5.2).
Maltese: F'pazjenti b'indeboliment fil-funzjoni tal-fwied, atosiban għandu jintuża b'kawtela (ara sezzjonijiet 4.2 u 5.2).
English: Replace it by 10 ml atosiban 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 atosiban 37.5 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni minn żewġ kunjetti ta' 5 ml biex ikollok konċentrazzjoni ta' 75 mg ta' atosiban f'100 ml.
English: This may increase the risk of lung oedema (accumulation of fluid in the lungs).
Maltese: jżid ir-riskju ta' edema tal-pulmun (akkumulazzjoni ta' fluwidu fil-pulmun).
English: In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 4.4).
Maltese: F'pazjenti b'indeboliment fil-funzjoni tal-fwied, atosiban għandu jintuża b'kawtela (ara sezzjonijiet 4.2 u 4.4).
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 prematur jiġi dijanjostikat bejn l-24 u t-33 ġimgħa magħluqa ta' tqala.
English: One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Kunjett ta' soluzzjoni għall-injezzjoni fih 0.9 ml ta' soluzzjoni, li jikkorrispondi għal 6.75 mg atosiban.