natgillin/translations-raw huggingface dataset:
I en støttende fase 2-enkeltdosisundersøgelse med i alt 129 patienter med skizofreni og skizoaffektiv sygdom var ændringen i PEC efter to timer -5,0 for placebo, -6,7 for ADASUVE 4,5 mg og -8,6 (p<0,001) for ADASUVE 9,1 mg. Der blev givet redningsmedicin til henholdsvis 32,6 %, 11,1 % og 14,6 % af patienterne.
In a supportive Phase 2 single dose study enrolling a total of 129 patients with schizophrenia and schizoaffective disorder the decrease in PEC change after 2 hours was -5.0 for placebo, -6.7 for ADASUVE 4.5 mg, and -8.6 (p<0.001) for ADASUVE 9.1 mg.
(se pkt.
Pull tab.
Der bør udvises forsigtighed ved anvendelse af loxapin sammen med andre lægemidler, der vides at sænke krampetærsklen, f.eks. phenothiaziner eller butyrofenoner, clozapin, tricykliske antidepressiva eller selektive serotoningenoptagshæmmere (SSRI), tramadol og mefloqin (se pkt.
Caution is advised if loxapine is combined with other medicinal products known to lower the seizure threshold, e.g. phenothiazines or butyrophenones, clozapine, tricyclics or selective serotonine reuptake inhibitors (SSRIs), tramadol, mefloquine (see section 4.4).
Ændring to timer efter dosering
Change at 2 hr post dose
De farmakokinetiske parametre af loxapin blev bestemt efter gentagen administration af ADASUVE hver 4. time med i alt tre doser (på enten 4,5 mg eller 9,1 mg) hos patienter i kronisk, stabilt antipsykotisk behandlingsregimen.
The pharmacokinetic parameters of loxapine were determined in subjects on chronic, stable antipsychotic regimens following repeat administration of ADASUVE every 4 hours for a total of 3 doses (either 4.5 mg or 9.1 mg).
Sådan skal du bruge ADASUVE
How to use ADASUVE
Tre
Three
CGI-Irespondere
PEC Responders
- Hvis du får bivirkninger, skal du sige det til lægen eller sygeplejersken.
- If you get any side effects, talk to your doctor or nurse.
Bronkospasme blev derimod beskrevet som almindelig hos patienter med aktiv luftvejssygdom, hos hvem den ofte krævede behandling med en korttidsvirkende bronkodilaterende beta-agonist.
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.
Der bør udvises forsigtighed ved anvendelse af ADASUVE til berusede eller delirøse patienter (se pkt.
ADASUVE should be used with caution in patients who are intoxicated or delirious (see section 4.5).
Der bør udvises forsigtighed ved anvendelse af ADASUVE til patienter med ekstrapyramidale symptomer i anamnesen.
ADASUVE should be used with caution in patients with a known history of extrapyramidal symptoms.
• tidligere har fået ADASUVE og har fået hvæsende vejrtrækning eller stakåndethed
• already used ADASUVE and you developed symptoms of wheezing or shortness of breath
Symptomerne kan bestå af høj feber, muskelstivhed og ujævn eller hurtig hjerterytme eller puls.
irregular or fast heart rate or pulse.
Brug af anden medicin sammen med ADASUVE Fortæl det altid til lægen, hvis du bruger anden medicin eller har brugt det for nylig, herunder:
Tell your doctor if you are using or have recently used or might use any other medicines, including:
Din dosis kan også blive sat ned til 4,5 mg, hvis lægen mener, at det er en bedre dosis til at behandle din tilstand.
The recommended initial dose is 9.1 mg. After 2 hours, your doctor may prescribe a second dose after carefully considering your condition and your dose may be reduced to 4.5 mg if your doctor believes that this is a more appropriate dose to treat your condition.
Hos patienter med krampeanfald i anamnesen bør anvendelse af loxapin ske med forsigtighed, da det sænker krampetærsklen.
Loxapine should be used with caution in patients with a history of convulsive disorders since it lowers the convulsive threshold.
Hvis du har brugt for meget ADASUVE
If you use more ADASUVE than you should
A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse FERRER INTERNACIONAL, S.A.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Hver enkeltdosisinhalator indeholder 5 mg loxapin og afgiver 4,5 mg loxapin.
Each single-dose inhaler contains 5 mg loxapine and delivers 4.5 mg of loxapine.
• har eller har haft tilbageholdelse af urinen
• have or had urinary retention (incomplete emptying of the bladder)
• medicin, der kan medføre kramperisiko (f.eks. clozapin, tricykliske antidepressiva eller selektive serotoningenoptagshæmmere [SSRI], tramadol, mefloqin)
• medicines that may put you at a risk for seizures (for example, clozapine, tricyclics or SSRIs,
ADASUVE indeholder:
What ADASUVE contains
• hvis du har problemer med lungerne såsom astma eller kronisk obstruktiv lungesygdom (KOL)
• if you have lung problems like asthma or chronic obstructive pulmonary disease (which your doctor may have called “COPD”).
Hver enkeltdosisinhalator indeholder 10 mg loxapin og afgiver 9,1 mg loxapin.
Each single-dose inhaler contains 10 mg loxapine and delivers 9.1 mg of loxapine.
Inhalationspulver, afdelt
Inhalation powder, pre-dispensed
ADASUVE 9,1 mg inhalationspulver, afdelt, består af en hvid engangsinhalator af plast, der indeholder en enkelt dosis af loxapin.
What ADASUVE looks like and contents of the pack ADASUVE 9.1 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine.
Én
One
ADASUVE 9,1 mg leveres i en karton med 1 eller 5 enkeltdosisinhalatorer.
ADASUVE 9.1 mg is supplied in a carton of 1 or 5 single dose inhalers.
Der var klart mindsket agitation 10 minutter efter dosis 1, som var det første vurderingstidspunkt, samt ved alle de efterfølgende vurderinger i den 24-timers vurderingsperiode.
Decreased agitation was evident 10 minutes after Dose 1, the first assessment time, and at all subsequent assessments during the 24 hour evaluation period, for both 4.5 mg and 9.1 mg doses in both schizophrenia and bipolar disorder patients.
Én enkeltdosisinhalator
1 single dose inhaler
Hver inhalator afgiver 9,1 mg loxapin.
Each inhaler delivers 9.1 mg loxapine.
ADASUVE 4,5 mg inhalationspulver, afdelt, består af en hvid engangsinhalator af plast, der indeholder en enkelt dosis af loxapin.
What ADASUVE looks like and contents of the pack ADASUVE 4.5 mg inhalation powder, pre-dispensed consists of a single-dose, disposable white plastic inhaler that contains loxapine.
Krampeanfald
Cardiovascular
Adrenalin bør ikke anvendes, da det kan forstærke eksisterende hypotension hos patienter med partiel adrenerg blokade (se pkt.
Adrenaline should not be used since its use in a patient with partial adrenergic blockage may further lower the blood pressure (see sections 4.4 and 4.5).
ADASUVE 4,5 mg leveres i en karton med 1 eller 5 enkeltdosisinhalatorer.
ADASUVE 4.5 mg is supplied in a carton of 1 or 5 single dose inhalers.
ADASUVE 9,1 mg, leveres i en karton á 1 eller 5 stk.
ADASUVE 9.1 mg is supplied in a carton of 1 or 5 units.
Almindelig: mundtørhed
Common: dry mouth
Inhalér Inhalér gennem mundstykket med en stabil, dyb indånding.
Inhale Inhale through the mouthpiece with a steady deep breath.
Fortæl det til lægen eller sygeplejersken, hvis du er bekymret for, at du får mere ADASUVE, end du mener er nødvendigt.
If you are concerned that you are given more ADASUVE than you feel necessary, tell your doctor or nurse of your concern.
ANORDNINGENS HUS
DEVICE HOUSING
Hver inhalator afgiver 4,5 mg loxapin.
Each inhaler delivers 4.5 mg loxapine.
ADASUVE 4,5 mg inhalationspulver loxapin
ADASUVE 4.5 mg inhalation powder loxapine
ADASUVE 9,1 mg, inhalationspulver, afdelt
ADASUVE 9.1 mg inhalation powder, pre-dispensed
ADASUVE 9,1 mg inhalationspulver loxapin
ADASUVE 9.1 mg inhalation powder loxapine
ADASUVE 4,5 mg, leveres i en karton á 1 eller 5 stk.
ADASUVE 4.5 mg is supplied in a carton of 1 or 5 units.
Der var ingen forskelle i respons mellem undergrupper inddelt efter alder, race og køn.
Examination of population subsets (age, race, and gender) did not reveal any differential responsiveness on the basis of these subgroupings.
• har eller har haft kramper
• have or had seizures (convulsions)
ADASUVE 9,1 mg inhalationspulver, afdelt loxapin
ADASUVE 9.1 mg inhalation powder, pre-dispensed loxapine
ADASUVE 4,5 mg inhalationspulver, afdelt loxapin
ADASUVE 4.5 mg inhalation powder, pre-dispensed loxapine
Der blev meget ofte iagttaget bronkospasme i de placebokontrollerede kliniske undersøgelser hos patienter med astma eller KOL.
In placebo-controlled clinical trials in subjects with asthma or COPD, bronchospasm was very commonly observed.
C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske opdaterede sikkerhedsberetninger
• Periodic safety update reports
ADASUVE er ikke blevet undersøgt hos patienter med nedsat nyre- eller leverfunktion.
Renal and/or hepatic impairment ADASUVE has not been studied in patients with renal or hepatic impairment.
Inhalér.
Inhale.
ADASUVE 4,5 mg, inhalationspulver, afdelt.
ADASUVE 4.5 mg inhalation powder, pre-dispensed
De vil vurdere hvor meget du har brug for.
They will decide how much you need.
Dette kan give blødning.
This may cause bleeding.
Der er ingen kendt specifik behandling i tilfælde af overdosering.
There is no known specific treatment in case of an overdose.
Dette resultat er dog baseret på et meget lille antal (n=129 patienter).
However, this finding is based on a very small sample (n=129 patients).
Dato for første markedsføringstilladelse: 20. januar 2000 Dato for seneste fornyelse: 20. januar 2010
Date of first authorisation: 20 January 2000 Date of latest renewal: 20 January 2010
- Brug ikke dette lægemiddel efter udløbsdatoen, der er angivet på etiketten efter EXP.
Do not use this medicine after the expiry date which is stated on the label after EXP.
Tractocile må ikke anvendes under følgende omstændigheder:
Tractocile must not be used in the following conditions:
Fordelen ved atosiban i disse undergrupper er derfor uvis.
The benefit of atosiban in these subgroups is therefore uncertain.
2300 København S Danmark
2300 København S Denmark
De fleste af de fejlslåede behandlinger i CAP-001 var forårsaget af dårlig tolerance.
Most of the treatment failures in CAP-001 were caused by poor tolerability.
Op til 270 mg
Up to 270 mg
Det blev fundet, at clearance, fordelingsvolumen og halveringstid var uafhængig af dosis.
The clearance, volume of distribution and half-life were found to be independent of the dose.
Følgende bivirkninger kan forekomme ved brug af denne medicin:
The following side effects may happen with this medicine:
8]-oxytocin), der er en kompetitiv antagonist til humant oxytocin på receptorniveau.
8]-oxytocin) which is a competitive antagonist of human oxytocin at receptor level.
• når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
• 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.
Metabolitten M1 udskilles i mælk (se afsnit 4.6).
Metabolite M1 is excreted in milk (see section 4.6).
Den højeste subkutane atosiban dosis, som ikke fremkaldte nogen bivirkninger, var ca. to gange den terapeutiske dosis for mennesker.
The highest atosiban subcutaneous dose not producing any adverse effects was approximately two times the therapeutic human dose.
Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
• 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.
Forholdet mellem koncentrationen af hovedmetabolliten M1 (des-(Orn
The ratios of the main metabolite M1 (des-(Orn
Hvis det er nødvendigt at indgive andre medikamenter intravenøst på samme tidspunkt, kan intravenøs kanylen deles eller et andet intravenøs indgivelsessted benyttes.
If other medicinal products need to be given intravenously at the same time, the intravenous cannula can be shared or another site of intravenous administration can be used.
Dette giver fortsat uafhængig kontrol over infusionshastigheden.
This permits the continued independent control of the rate of infusion.
Tractocile indeholder atosiban (INN), et syntetisk peptid ([Mpa
Tractocile contains atosiban (INN), a synthetic peptide ([Mpa
Børn og teenagere Tractocile er ikke undersøgt hos gravide kvinder under 18 år.
Children and adolescents Tractocile has not been studied in pregnant women less than 18 years old.
Gentaget behandling med Tractocile er mulig, men der er kun begrænset klinisk erfaring med flere gentagne behandlinger, op til 3 gentagne behandlinger (se afsnit 4.2).
Re-treatment with Tractocile is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see section 4.2).
Middelværdi for fordelingsvolumen var 18,3 ± 6,8 liter.
Mean value of volume of distribution was 18.3 ± 6.8 litres.
Atosiban fordeles ikke til de røde blodlegemer.
Atosiban does not partition into red blood cells.
Frekvensen af bivirkninger, som er anført nedenfor, er defineret ved brug af følgende konvention: Meget almindelig (≥1/10): Almindelig (≥1/100, <1/10): Ikke almindelig (≥1/1.000, <1/100): Sjælden (≥1/10.000, <1/1.000).
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).
Hovedmetabolitten M1 er ca. 10 gange mindre potent end atosiban med hensyn til at hæmme oxytocin-inducerede uteruskontraktioner in vitro.
The main metabolite M1 is approximately 10 times less potent than atosiban in inhibiting oxytocininduced uterine contractions in vitro.
Tractocile anvendes til gravide voksne kvinder fra uge 24 til uge 33 i graviditeten.
Tractocile is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Tractocile bør ikke blandes med andre lægemidler i infusionsposen.
Tractocile should not be mixed with other medicinal products in the infusion bag.
Plasmaproteinbindingen af atosiban er hos gravide kvinder 46 til 48%.
Plasma protein binding of atosiban is 46 to 48% in pregnant women.
I urin fandtes Atosiban kun i små mængder, urinkoncentrationen er ca. 50 gange lavere end koncentrationen af M1.
Atosiban is found in only small quantities in urine, its urinary concentration is about 50 times lower than that of M1.
Sekundære slutpunkter: sekundære effektparametre omfattede den andel af kvinderne, der forblev uforløste inden for 48 timer fra iværksættelsen af behandlingen.
Secondary endpoints: secondary efficacy parameters included the proportion of women remaining undelivered within 48 h of treatment initiation.
Der blev ikke observeret nogen systemiske, toksiske virkninger, hverken i løbet af de to-ugers intravenøs toksicitetsafprøvninger (hos rotter og hunde) ved doser cirka 10 gange højere end den terapeutiske dosis for mennesker, eller i løbet af tre måneders toksicitetsafprøvninger hos rotter og hunde (op til 20 mg/kg/dag s.c.).
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.).
4]-oxytocin) og atosiban i plasma var 1,4 og 2,8 ved henholdsvis den anden time og ved infusionens afslutning.
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.
I tilfælde af intrauterin vækstretardering, afhænger beslutningen om at fortsætte eller genindlede Tractocile indgivelsen af vurderingen af fosterets modenhed.
In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Tractocile depends on the assessment of fetal maturity.
Af de 361 kvinder, der modtog atosiban behandling under fase III afprøvninger, modtog 73 mindst én gentaget behandling, 8 modtog mindst 2 gentagne behandlinger og 2 modtog 3 gentagne behandlinger (se afsnit 4.4).
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).
Du får Tractocile på et hospital af en læge, sygeplejerske eller jordemoder.
Tractocile will be given to you in a hospital by a doctor, nurse or midwife.
Når atosiban bruges til patienter, hvor præmatur hindebristning ikke kan udelukkes, bør fordelene ved at forsinke forløsning opvejes mod den potentielle risiko for chorioamnionitis.
When atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis.
Det vides ikke om M1 ophobes i væv.
It is not known whether M1 accumulates in tissues.
I alt oplevede 48% af patienterne som blev behandlet med atosiban, bivirkninger under de kliniske forsøg.
In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials.
Fremstil nye 100 ml poser, som beskrevet ovenfor, for at infusionen kan fortsættes.
Prepare new 100 ml bags in the same way as described to allow the infusion to be continued.
Der er vist, at små mængder atosiban passerer fra plasma over i brystmælken hos ammende kvinder.
Small amounts of atosiban have been shown to pass from plasma into the breast milk of breast-feeding women.
Inden for hver enkelt frekvensgruppe er bivirkningerne opsat efter aftagende alvorlighed.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Indlæggelse på neonatal intensiv afdeling var den samme for de to behandlingsgrupper (ca. 30%), ligeledes varigheden af opholdet og ventilationsbehandlingen.
Admission to a neonatal intensive care unit (NICU) was similar for both treatment groups (approximately 30%), as was length of stay and ventilation therapy.
Der er kun begrænset klinisk erfaring i brugen af atosiban ved multisvangerskaber eller ved en gestationsalder fra 24 til 27 uger, pga. det lille antal behandlede patienter.
There is only limited clinical experience in the use of atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated.
Behandlingen med Tractocile kan gentages op til tre gange mere.
Treatment with Tractocile can be repeated up to three more times.
Efter tre timer reduceres infusionshastigheden til 8 ml/time.
After three hours the infusion rate is reduced to 8 ml/hour.
Behandling med Tractocile skal initieres og vedligeholdes af en læge, som har erfaring i at behandle for tidlig fødsel.
Treatment with Tractocile should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
For kvinder med en gestationsalder over 24 uger var der ikke forskel i dødeligheden (1,7% i placebogruppen og 1,5% i atosibangruppen).
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).
Reproduktionstoksicitetsafprøvninger, med administration fra implantation til sent i graviditeten, viste ingen effekt på hverken mødre eller fostre.
Reproduction toxicity studies, with dosing from implantation up to late stage pregnancy, showed no effects on mothers and fetuses.
Behandlingens varighed bør ikke overstige 48 timer.
The duration of the treatment should not exceed 48 hours.
Tractocile kan bruges til at modvirke for tidlig fødsel af dit barn.
Tractocile can be used to delay the premature birth of your baby.
Instruktioner for brug
INSTRUCTIONS ON USE
Tractocile virker ved at gøre sammentrækningerne i livmoderen (uterus) mindre kraftige.
Tractocile works by making the contractions in your womb (uterus) less strong.
Det er usandsynligt at atosiban hæmmer hepatisk cytochrom P450 isoformer i mennesker (se afsnit
It is unlikely that atosiban inhibits hepatic cytochrome P450 isoforms in humans (see section 4.5).
To metabolitter blev identificeret i plasma og urin fra forsøgspersoner.
Two metabolites were identified in the plasma and urine from human subjects.
Det blev desuden vist, at atosiban binder sig til vasopressin receptoren, hvorved effekten af vasopressin hæmmes.
Atosiban was also shown to bind to the vasopressin receptor, thus inhibiting the effect of vasopressin.
Middelværdi for clearance var 41,8 ± 8,2 liter/time.
Mean value for clearance was 41.8 ± 8.2 litres/h.
- hvis du er allergisk over for atosiban eller et af de øvrige indholdsstoffer i Tractocile (angivet i punkt 6)
- if you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).
Hvis der bruges en infusionspose med et andet volumen, skal en forholdsmæssig udregning udføres for denne.
If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Det tilrådes ikke at foretage mere end tre genbehandlinger under en graviditet.
It is recommended that no more than three re-treatments should be used during a pregnancy.
Den samlede indgivne dosis under et fuldt behandlingsforløb med Tractocile bør ikke overstige 330,75 mg atosiban.
The total dose given during a full course of Tractocile therapy should preferably not exceed 330.75 mg of atosiban.
Atosiban var hverken onkogent eller mutagent i in vitro og in vivo forsøg.
Atosiban was neither oncogenic nor mutagenic in in vitro and in vivo tests.
Fase III kliniske afprøvninger (CAP-001 undersøgelser) omfatter data fra 742 kvinder, som fik stillet diagnosen for tidlig fødsel ved 23-33 ugers gestation og blev randomiseret til at modtage enten atosiban (i henhold til doseringsanvisningerne) eller -agonist (dosistitreret).
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).
Data viste, at henholdsvis 59,6% (n=201) og 47,7% (n=163) af atosiban- og -agonist-behandlede kvinder (p=0,0004) var uforløste og ikke krævede alternativ tocolyse indenfor 7 dage fra iværksættelsen af behandlingen.
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.
De fejlslåede behandlinger forårsaget af utilstrækkelig effekt var signifikant (p=0,0003) hyppigere med atosiban (n=48, 14,2%) end hos -agonist-behandlede kvinder (n=20, 5,8%).
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%).
Bivirkningerne hos børnene lå i størrelsesordenen for normal variation og kan sidestilles med forekomsterne i både placebo- og beta-mimetika-gruppen.
The infant adverse reactions were in the range of normal variation and were comparable with both placebo and betamimetic group incidences.
Mulige bivirkninger ved atosiban blev beskrevet for moderen under brugen af atosiban under kliniske afprøvninger.
Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials.
For at opnå korrekt dosering anbefales det at bruge en kontrolleret infusionsenhed for at tillade en justering af flowhastighed i dråber/min.
To achieve accurate dosing, a controlled infusion device is recommended to adjust the rate of flow in drops/min.