FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical studies with both atypical and conventional antipsychotic medicinal products have demonstrated that elderly patients with dementia-related psychosis are at an increased risk of death compared to placebo.
Maltese: Studji kliniċi bi prodotti mediċinali antipsikotiċi kemm atipiċi kif ukoll konvenzjonali wrew li pazjenti anzjani bi psikożi relatata mad-dimenzja huma f'riskju akbar ta' mewt meta mqabbel mal-plaċebo.
English: POUCH
Maltese: PAWĊ
English: In studies in agitated patients, bronchospasm was reported as an uncommon, but serious adverse reaction, while in subjects with active airways disease, bronchospasm was commonly reported and often required treatment with a short-acting beta-agonist bronchodilator.
Maltese: Fl-istudji fuq pazjenti aġitati, bronkospażmu kien irrappurtat bħala reazzjoni avversa mhux komuni iżda serja, filwaqt li f'individwi b'mard attiv tal-passaġġi tal-arja, bronkospażmu kien irrappurtat b'mod komuni u ħafna drabi kien jeħtieġ trattament bi bronkodilatur beta-agonist li jaħdem malajr.
English: ADASUVE is not recommended in patient populations with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions which would predispose patients to hypotension (dehydration, hypovolaemia, and treatment with antihypertensive medicinal products).
Maltese: ADASUVE mhuwiex rakkomandat f'popolazzjonijiet ta' pazjenti b'mard kardjovaskulari magħruf (storja ta' infart mijokardijaku jew mard tal-qalb iskemiku, insuffiċjenza tal-qalb jew abnormalitajiet fil-konduzzjoni), mard ċerebrovaskulari, jew kundizzjonijiet li jippredisponu lill-pazjenti għallpressjoni baxxa (deidrazzjoni, ipovolemija, u trattament bi prodotti mediċinali kontra l-pressjoni għolja).
English: Common (may affect up to 1 in 10 people): dizziness, throat irritation, dry mouth or tiredness.
Maltese: Komuni (tista' taffettwa sa persuna waħda minn kull 10 persuni): sturdament, irritazzjoni fil-griżmejn, ħalq xott jew għeja.
English: Pregnancy
Maltese: Tlieta
English: • (Schizophrenia) Hearing, seeing, or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Maltese: • (Skizofrenija) Li tisma', li tara, jew li tħoss affarijiet li mhumiex hemm, li tkun suspettuż, twemmin żbaljat, diskors u mġiba inkoerenti u nuqqas ta' emozzjonijiet.
English: 6.3 Shelf life
Maltese: 3. Jonfoħ 'il barra
English: Up to 270 mg
Maltese: sa 270 mg
English: Placenta praevia
Maltese: Plaċenta praevia
English: Tractocile contains atosiban.
Maltese: Tractocile fih atosiban.
English: The ratios of the main metabolite M1 (des-(Orn
Maltese: Il-proporzjonijiet tal-metobolit prinċipali M1 (des-(Orn
English: D-24109 Kiel Germany
Maltese: D-24109 Kiel
English: 2300 København S Denmark
Maltese: København S Danimarka
English: Abruptio placenta
Maltese: Abruptio plaċenta
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: Mhux komuni (≥1/1,000 sa <1/100); Rari (≥1/10,000 to <1/1,000).
English: Mean (SD) birth weight was 2491 (813) grams in the atosiban group and 2461 (831) grams in the -agonist group (p=0.58).
Maltese: Il-piz medju (SD) fittwelid kien ta' 2491 (813) g fil-grupp ta' atosiban, u 2461 (831) g fil-grupp tal--agonist (p=0.58).
English: Tractocile contains atosiban (INN), a synthetic peptide ([Mpa
Maltese: G02CX01 Tractocile fih atosiban(INN), peptide sintetiku ([Mpa
English: Τηλ: +30 210 68 43 449
Maltese: Ferring Ελλάς ΜΕΠΕ Τηλ: +30 210 68 43 449
English: Pruritis, Rash
Maltese: Ħakk, Raxx
English: Plasma protein binding of atosiban is 46 to 48% in pregnant women.
Maltese: L-ammont ta' rbit ta' atosiban mal-proteina tal-plażma huwa ta' 46 sa 48% f'nisa tqal.
English: 4]-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: 4]- oxytocin) għall-konċentrazzjonijiet ta' atosiban fil-plażma kienu ta' 1.4 u 2.8 wara sagħtejn u fl-aħħar ta' l-infużjoni rispettivament.
English: Treatment failures caused by insufficient efficacy were significantly (p=0.0003) more frequent in atosiban (n=48, 14.2%) than in the -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 -agonist (n=20, 5.8%).
English: Ferring Magyarország Gyógyszerkereskedelmi Kft.
Maltese: Magyarország Ferring Magyarország Gyógyszerkereskedelmi
English: It is unlikely that atosiban inhibits hepatic cytochrome P450 isoforms in humans (see section 4.5).
Maltese: Ma jidhirx li l-atosiban iwaqqaf l-effett ta' l-isoforomi ta' cytochrome P450 tal-fwied (ara sezzjoni 4.5).
English: Tractocile 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: Tractocile hu indikat biex jittardja ħlas imminenti qabel iż-żmien f'nisa adulti tqal b': kontrazzjonijiet regolari ta' l-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: 8 ml/hour (100 µg/min)
Maltese: 8 ml/ siegħa (100 µg/min)
English: Up to 45 hours subsequent intravenous infusion
Maltese: Sa 45 siegħa infużjoni sussegwenti fil-vina
English: In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials.
Maltese: B'kollox 48% tal-pazjenti mogħtija atosiban kellhom effetti mhux mixtieqa waqt il-provi kliniċi.
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 l.
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 drug metabolising cytochrome P450 enzymes.
Maltese: Mhux probabbli li atosiban hu involut f'interazzjonijiet bejn prodotti mediċinali permezz taċ-ċitokroma P450, billi investigazzjonijiet in vitro wrew li atosiban mhux substrat għas-sistema taċ-ċitokroma P450, u ma jwaqqafx l-enzimi taċ-ċitokroma P450 li jimmetabolizzaw prodotti mediċinali.
English: Ferring Ελλάς ΜΕΠΕ Τηλ.
Maltese: Dan jista' jikkawża fsada.
English: The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocininduced uterine contractions in vitro.
Maltese: Il-metabolit prinċipali M1 huwa bejn wieħed u ieħor 10 darbiet inqas b'saħħtu minn atosiban biex iwaqqaf il-kontrazzjonijiet ta' l-utru kaġunati minn oxytocin in-vitro.
English: No clinically relevant interaction was found between atosiban and bethamethasone or labetalol.
Maltese: Ma nstabet lebda interazzjoni klinika relevanti bejn atosiban u betamethasone jew labetalol.
English: Date of first authorisation: 20 January 2000 Date of latest renewal: 20 January 2010
Maltese: Data tal-aħħar t-tiġdid: 20 ta' Jannar, 2010
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 -agonist groups, respectively (p=0.37).
Maltese: 35.6 (3.9) u 35.3 (4.2) ġimgħa għall-gruppi ta' atosiban u tal--agonist, rispettivament (p=0.37).
English: Uncommon (affects less than 1 in 100 people) - high temperature (fever) - difficulty sleeping (insomnia) - itching - rash
Maltese: Mhux komuni (jistgħu jaffettwaw inqas minn 1 f'100 persuna) - Temperatura għolja (deni) - Diffikulta biex torqod (insomnia) - Ħakk - Raxx
English: Colourless glass vials, clear borosilicated (type I) sealed with grey siliconised bromo-butyl rubber stopper, type I, and flip-off cap of polypropylene and aluminium.
Maltese: Kunjett trasparenti tal-ħġieġ, borosilikata ċara (tip I) issiġillat b'tapp silikonat griż tal-gomma bromobutyl, tip I, u għatu ta' polypropylene u aluminium li jinfetaħ min-naħa waħda.
English: Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and betamimetics 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: Atosiban dose
Maltese: Doża ta' Atosiban
English: Psychiatric disorder
Maltese: Disturbi psikjatriċi
English: Hydrochloric acid 1M Water for injections
Maltese: Mannitol hydrochloric acid 1M ilma għall-injezzjoni.
English: Mannitol, Hydrocloric acid, water for injections
Maltese: Mannitol, Hydrochloric acid, ilma għall-injezzjoni
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen f'temperatura ta' bejn 2C - 8C.
English: Tractocile 37.5 mg/5 ml sterile concentrate atosiban
Maltese: Tractocile 37.5 mg/5 ml konċentrat sterili atosiban
English: Ελλάδα Ferring Ελλάς ΜΕΠΕ
Maltese: Hu jagħmel ilkontrazzjonijiet inqas frekwenti ukoll.
English: Re-treatment:
Maltese: Manifattur:
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 talbidu (tα) u ta' l-aħħar (tβ) ta' 0.21 ± 0.01 u 1.7 ± 0.3 siegħa, rispettivament.
English: Withdraw 10 ml solution from a 100 ml infusion bag and discard.
Maltese: Iġbed soluzzjoni ta' 10 ml minn borża għall-infużjoni tal-100 ml u armi.
English: Other medicines and Tractocile
Maltese: Mediċini oħra u Tractocile
English: Tractocile is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Tractocile 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Tractocile 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Tractocile 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours.
Maltese: Tractocile jingħata fil-vina fi tliet stadji wara xulxin: doża tal-bidu f'daqqa (6.75 mg), b'soluzzjoni għallinjezzjoni ta' Tractocile 6.75 mg/0.9 ml, u eżatt wara infużjoni kontinwa ta' doża qawwija (infużjoni talbidu ta' 300 mikrogrammi/min) ta' Tractocile 37.5 mg/ml konċentrat ta' soluzzjoni għall-infużjoni għal tliet sigħat, u wara doża inqas ta' Tractocile 37.5 mg/5 ml konċentrat ta' soluzzjoni għall-infużjoni (infużjoni ta' wara 100 mikrogrammi/min) sa 45 siegħa.
English: • Periodic Safety Update Reports requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew talmediċini.
English: MedDRA System Organ Class (SOC)
Maltese: Sistema tal-Klassifika talorgani fid-database MedDRA
English: (See also section 3)
Maltese: (ara ukoll sezzjoni 3)
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 ta' l-effikaċja tal-prodott inkudew il-proporzjon ta' nisa li baqgħu ma ħelsux 48 siegha wara l-bidu tal-tkura.
English: The observed adverse reactions were generally of a mild severity.
Maltese: Ir-reazzjonijiet mhux mixtieqa li ġew osservati b'mod ġenerali ma kienux severi.
English: The most commonly reported adverse reaction in the mother is nausea (14 %).
Maltese: L-aktar effett mhux mixtieqli kien komuni fl-omm kien dardir (14%).
English: Two metabolites were identified in the plasma and urine from human subjects.
Maltese: Ġew identifikati żewġ metaboliti fil-plażma u l-awrina tal-bnedmin.
English: For women with a gestational age greater than 24 weeks there was no difference in mortality rate (1.7% in the placebo group and 1.5% in the atosiban group).
Maltese: Għan-nisa li kellhom tqala ta' iktar minn 24 ġimgħa ma kienx hemm differenza fir-rata ta' mwiet (1.7% fil-grupp tal-plaċebo u 1.5% fil-grupp ta' atosiban).
English: Tractocile 6.75 mg/0.9 ml injection atosiban
Maltese: Tractocile 6.75 mg/0.9 ml injezzjoni atosiban
English: Uterine haemorrhage, uterine atony
Maltese: 3 sigħat infużjoni tal-bidu filvina
English: Tractocile will be given to you in a hospital by a doctor, nurse or midwife.
Maltese: Tractocile se jiġi mgħoti lilek fi sptar minn tabib, nurse jew qabla.
English: Nausea Vomiting
Maltese: Disturbi vaskulari
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-probabilita` li ma jkunx hemm ħlas u ma jkunx hemm bżonn tokolitiċi alternattivi fi żmien 7 ijiem wara l-bidu tal-kura kien simili għan-nisa bi tqala ta' bejn 24-28 ġimgħa li ngħataw atosiban jew il-beta-mimetiċi.
English: 8]-oxytocin) which is a competitive antagonist of human oxytocin at receptor level.
Maltese: 8]- oxytocin) li jikkompeti ma' oxytocin għar-riċetturi fil-bniedem.
English: Concentrate for solution for infusion (7.5 mg/ml)
Maltese: Konċentrat għal soluzzjoni għall-infużjoni (7.5 mg/ml)
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Maltese: Metodu ta' kif għandu jingħata Għal istruzzjonijiet fuq il-preparazzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
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 ilkonvulżjonijiet.
English: Solution for injection (6.75 mg/0.9 ml) 1 vial
Maltese: Soluzzjoni għall-injezzjoni (6.75 mg /0.9 ml) 1 vjala
English: CentralPharma Communication SIA Tālr: +371 674 50497 centralpharma@centralpharma.lv
Maltese: +371 6 674 50497 centralpharma@centralpharma.lv
English: 24 ml/hour (300 µg/min)
Maltese: 24 ml/siegħa (300 µg/min) 54 mg
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: Ferring Arzneimittel GmbH Tel: +49 431 5852 0 info-service@ferring.de
Maltese: Ferring Arzneimittel GmbH Tel: +49 431 5852 0
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 bill-plaċebo, ir-rata ta' mwiet tal-fetu jew tat-trabi kienet ta' 5/295 (1.7%) fil-grupp tal-plaċebo u 15/288 (5.2%) fil-grupp ta' atosiban, li minnhom żewġt imwiet seħħew wara ħames u tmien xhur ta' ħajja.
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 -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 (skond din ittikketta) jew -agonist (dose-titrated).
English: Atosiban was neither oncogenic nor mutagenic in in vitro and in vivo tests.
Maltese: Atosiban ma kellux effett onkoġeniku u l-anqas mutaġeniku f'testijiet in vitro u in vivo.
English: Withdraw 0.9 ml of a 0.9 ml labelled vial of Tractocile 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: Iġbed soluzzjoni għall-injezzjoni ta' 0.9 ml minn kunjett ta' 0.9 ml bit-tikketta Tractocile 6.75 mg/0.9 ml, u agħtiha bilmod fil-vina f'doża waħda f'medda ta' minuta, taħt superviżjoni medika xierqa f'dipartiment ostetriku.
English: In the case of persistence of uterine contractions during treatment with Tractocile, alternative therapy should be considered.
Maltese: F'każ li lkontrazzjonijiet ta' l-utru ma jiqfux waqt il-kura bi Tractocile, għandha titqies terapija alternattiva.
English: Treatment with Tractocile can be repeated up to three more times.
Maltese: Trattament bi Tractocile jista' jiġi repetut sa tlett darbiet oħra.
English: 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: One pack contains one vial containing 0.9 ml solution.
Maltese: Kull pakkett fih kunjett wieħed li fih soluzzjoni ta'0.9 ml.
English: The intravenous infusion is prepared by diluting Tractocile 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: Għall-infużjoni għal ġol-vina, wara li tingħata d-doża f'daqqa ta' Tractocile 7.5 mg/ml, il-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: Mannitol
Maltese: Rimettar
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 µg/min għal bejn 6 sa 12-il siegħa), il-konċentrazzjonijiet fissi tal-plażma ntlaħqu siegħa wara l-bidu ta' l-infużjoni (medja ta' 442 ± 73 ng/ml, medda ta' 298 sa 533 ng/ml).
English: Metabolite M1 is excreted in milk (see section 4.6).
Maltese: Il-metabolit M1 jitneħħa fil-ħalib (ara sezzjoni 4.6
English: Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate).
Maltese: Kull kunjett ta' 0.9ml soluzzjoni fih 6.75mg atosiban (bħala acetate).
English: The data show that 59.6% (n=201) and 47.7% (n=163) of atosiban- and -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 -agonist (p=0.0004), rispettivament, ma welldux u ma kellhomx bżonn tokolisi alternattiva fi żmien 7 ijiem wara li tinbeda lkura.
English: Of the 361 women who received atosiban treatment in the phase III studies, 73 received at least one retreatment, 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, Avviżi speċjali u prekawzjonijiet speċjali għall-użu).
English: The total dose given during a full course of Tractocile therapy should preferably not exceed 330.75 mg of atosiban.
Maltese: Id-doża totali li tingħata waqt kors sħiħ ta' terapija bi Tractocile preferibbilment m'għandhiex tkun iktar minn 330.75 mg ta' atosiban.
English: Embryo-fetal toxicity studies have not shown toxic effects of atosiban.
Maltese: Studji tossiċi fuq embrijo-fetali ma wrewx effetti tossiċi ta' atosiban.
English: An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for Tractocile.
Maltese: Microdrip chamber fil-vina tista' tipprovdi medda konvenjenti ta' rati ta' infużjoni fil-limiti taddożi rakkomandati għal Tractocile.
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 beta-mimetiċi u/jew f'nisa bi tqala multipla, ġew irrappurtati wara t-tqegħid fis-suq.
English: Preparation of the intravenous infusion solution:
Maltese: CentralPharma Communication SIA Tālr:
English: One vial of 0.9 ml contains 6.75 mg of atosiban (as acetate).
Maltese: Kull kunjett ta' 0.9 ml fih 6.75 mg ta' atosiban (bħala acetate).
English: Atosiban passes the placenta.
Maltese: Atosiban jgħaddi mill-plaċenta.
English: • Whenever the risk management system is modified, especially as the result of new informationbeing received that may lead to a significant change to the benefit/risk profile or as the result ofan important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.
Maltese: Kunjett ta' soluzzjoni għall-injezzjoni fih 0.9 ml jikkorrispondi għal 6.75mg atosiban.
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'nies f'saħħithom mhux tqal li ngħataw infużjonijiet ta' atosiban (minn 10 sa 300 µg/min fuq medda ta' 12-il siegħa), il-konċentrazzjonijiet fissi fil-plażma żdiedu proporzjonalment mad-doża.
English: - The other ingredients are mannitol, hydrochloric acid and water for injections.
Maltese: - Is-sustanzi l-oħra huma mannitol, hydrochloric acid u ilma għall-injezzjoni.
English: - Each vial of Tractocile 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
Maltese: - Is-sustanza attiva hi atosiban - Kull kunjett ta' Tractocile 37.5 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni fiha atosiban acetate ekwivalenti għal 37.5mg ta'atosiban f'5 ml.
English: For storage conditions after first opening and dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-ewwel ftuħ tal-prodott mediċinali, ara sezzjoni 6.3.
English: United Kingdom Ferring Pharmaceuticals Ltd. Tel: +44 844 931 0050 contact2@ferring.com
Maltese: Tel: +44 844 931 0050 contact2@ferring.com
English: The loading infusion is given by infusing 24 ml/hour (i.e. 18 mg/h) of the above prepared solution over the 3 hour period under adequate medical supervision in an obstetric unit.
Maltese: L-infużjoni tal-bidu tingħata billi ssir infużjoni ta' 24 ml/siegħa (i.e. 18 mg/siegħa) tas-soluzzjoni li tkun ġiet preparata, fuq medda ta' tliet sigħat taħt superviżjoni medika xierqa f'dipartiment ostetriku.