qanastek/EMEA-V3 huggingface dataset:
Actelion Pharmaceuticals Austria GmbH Tel: +43 1 505 4527
Österreich Actelion Pharmaceuticals Austria GMBH Tel: +43 1 505 4527
55 This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’
< Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
56 PACKAGE LEAFLET:
59 FULJETT TA ’ TAGĦRIF:
Tracleer 125 mg film-coated tablets Bosentan
Bosentan
57 • glibenclamide (for diabetes) • cyclosporine A (a medicine used after transplants and to treat psoriasis), or any other drugs used to prevent rejection of transplanted organs • fluconazole (to treat fungal infections) • rifampicin (to treat tuberculosis)
60 • glibenclamide (għad- dijabete) • cyclosporine A (mediċina li tintuża wara t- trapjanti u biex tikkura l- psorjasi), jew kwalunkwe mediċini oħrajn użati għal prevenzjoni tar- rifjut ta ’ organi trapjantati • fluconazole (għall- kura ta ’ infezzjonijiet ikkawżati mill- fungi) • rifampicin (biex tikkura t- tuberkulosi)
If you forget to take Tracleer If you forget to take Tracleer, take a dose as soon as you remember, then continue to take your tablets at the usual times.
61 Jekk tinsa tieħu Tracleer, ħu d- doża malli tiftakar, u mbagħad kompli ħu l- pilloli fil- ħinijiet li suppost.
58 If you stop taking Tracleer Suddenly stopping your treatment with Tracleer may lead to your symptoms getting worse.
Jekk tieqaf tieħu Tracleer Jekk tieqaf tieħu Tracleer f’ daqqa waħda, dan jista ’ jwassal biex is- sintomi tiegħek imorru għall- agħar.
You may also notice one or more of the following side effects:
62 Tista ’ tinnota wkoll wieħed jew iktar minn dawk l- effetti sekondarji li ġejjin:
59 Other less common side effects that you might notice include: • vomiting, abdominal pain, diarrhoea, skin rash, reduced blood platelet number.
• rimettar, uġigħ ta ’ żaqq, dijarea, raxx tal- ġilda, numru mnaqqas ta ’ plejtlits fid- demm.
Tracleer 125 mg film-coated tablets.
Pilloli Tracleer ta ’ 125 mg miksija b’ rita.
Orange-white, oval film-coated tablets with “125” on one side.
Pilloli miksija b’ rita, oranġjo- bojod, ovali, b ’ “ 125 ” miktuba fuq naħa minnhom.
Cartons contain 56 or 112 film-coated tablets.
Kaxxi tal- kartun fihom 56 jew 112- il pillola miksija b’ rita.
Manufacturer responsible for batch release:
63 Manifattur responsabbli għall- ħruġ tal- lott:
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63-65 79100 Freiburg Germany
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63- 65 79100 Freiburg Il- Ġermanja
Actelion Pharmaceuticals Austria GmbH Tel: +43 1 505 4527
Actelion Pharmaceuticals Austria GMBH Tel: +43 1 505 4527
Italia Actelion Pharmaceuticals Italia S.r.l.
64 Italia Actelion Pharmaceuticals Italia S. r. l.
61 This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’
What is Tractocile?
X’ inhu Tractocile?
Tractocile is a solution for injection or a concentrate for infusion (drip into a vein) that contains the active substance atosiban (7.5 mg per millilitre).
Tractocile huwa soluzzjoni injettabbli jew konċentrat għal infużjoni (drip fil- vina) li fih is- sustanza attiva atosiban (7. 5 mg/ ml).
What is Tractocile used for?
Għal xiex jintuża Tractocile?
Tractocile is used to delay birth in pregnant women who are at least 18 years of age, and who are 24 to 33 weeks pregnant, when they show signs that they may give birth pre-term (prematurely).
Tractocile jintuża biex jittardja t- twelid f’ nisa tqal ta ’ età mhux inqas minn 18- il sena u li qegħdin fl - 24- 33 ġimgħa tat- tqala, jekk juru sinjali li aktarx se jixtru qabel iż- żmien (prematur).
These signs include: • regular contractions lasting at least 30 seconds at a rate of  at least four every 30 minutes; • dilation of the cervix (the neck of the womb) of 1 to 3 cm and an effacement (a measure of the thinness of the cervix) of 50% or more.
Dawn is- sinjali jinkludu: • mill- inqas 4 kontrazzjonijiet regolari kull 30 minuta ta ’ mill- inqas 30 sekonda kull waħda; • twessigħ ċervikali (tal- għonq tal- utru) ta ’ 1- 3 cm u traqqiq tal- għonq tal- utru (tnaqqis tal- wisa ’ tiegħu) ta ’ mill- inqas 50%.
In addition the baby must have a normal heart rate.
Barra minn dawn il- kundizzjonijiet, il- fetu għandu jkollu frekwenza kardijaka normali.
How is Tractocile used?
Kif jintuża Tractocile?
Treatment with Tractocile should be carried out by a doctor who has experience in the treatment of pre-term labour.
It- terapija bi Tractocile għandu jsir minn tobba b’ esperjenza fit- trattament tal- ħlas qabel iż- żmien.
Treatment should be started as soon as possible after diagnosis of pre-term labour.
It - trattament għandu jinbeda mill- aktar fis possibbli wara d- dijanjożi tal- ħlas qabel iż- żmien.
Tractocile is given into a vein in three stages, over a maximum of 48 hours: an initial injection (6.75 mg), followed by a high-dose infusion (300 micrograms/ min) over three hours, then a lower dose infusion (100 micrograms/ min) lasting up to 45 hours.
Tractocile jingħata fil- vina fi tliet fażijiet, fi żmien massimu ta ’ 48 siegħa: injezzjoni inizjali (6. 75 mg) u wara infużjoni b’ dożaġġ qawwi (300 mikrogramma/ min) għal tliet sigħat, imbagħad infużjoni b’ dożaġġ baxx (100 mikrogramma/ min) sa mhux aktar minn 45 siegħa.
The total dose given during a full course of Tractocile therapy should not be more than 330 mg.
Id- doża totali ta ’ Tractocile mogħtija matul it- terapija kollha ma għandhiex tkun aktar minn 330 mg.
If contractions come back, treatment with Tractocile can be repeated up to three more times during the pregnancy.
Jekk jerġgħu jibdew il- kontrazzjonijiet, it- trattament bi Tractocile jista ’ jerġa ’ jingħata għal tliet darbiet oħra matul l- istess tqala.
There is no information about whether the dose needs to be adjusted for patients with kidney or liver problems.
M’ hemm l - ebda tagħrif dwar il- ħtieġa li tiġi aġġustata d- doża għall- pazjenti bi problemi fil- kliewi jew fil- fwied.
How does Tractocile work?
Kif jaħdem Tractocile?
The active substance in Tractocile, atosiban, is an antagonist of the natural hormone oxytocin.
Is- sustanza attiva fi Tractocile, atosiban, hija antagonista tal- ossitoċina (oxytocin), ormon naturali.
This means that atosiban blocks the action of oxytocin.
Dan ifisser li atosiban jimblokka l- azzjoni tal- ossitoċina.
Oxytocin is the hormone involved in starting contractions of the womb.
L- ossitoċina hija ormon involut fil- bidu tal - kontrazzjonijiet tal- ġuf.
By blocking the action of oxytocin, Tractocile prevents contractions and causes the womb to relax, helping to delay birth.
Billi jimblokka l- azzjoni tal- ossitoċina, Tractocile jimpedixxi l - kontrazzjonijiet u jikkawża r- rilassament tal- ġuf u b’ hekk jittardja t- twelid.
How has Tractocile been studied?
Kif ġie studjat Tractocile?
The effectiveness of Tractocile as a treatment to delay pre-term birth was studied in 742 women who were 23 to 33 weeks pregnant in three main studies.
L- effikaċja di Tractocile bħala trattament biex jittardja t- twelid prematur ġie eżaminat fi tliet studji ewlenin li involvew 742 mara li kienu qegħdin fit- 23- 33 ġimgħa tat- tqala.
Tractocile was compared with ritodine, terbutaline and salbutamol (all from a different class of medicines used in pre-term labour called beta-agonists).
Tractocile tqabbel mar - ritodina (ritodine), terbutalina (terbutaline) u salbutamol (sustanzi li jagħmlu parti minn klassijiet differenti ta ’ mediċini msejħin beta- agonisti użati fil- każijiet ta ’ ħlas qabel iż- żmien).
The main measure of effectiveness was whether the treatment had worked after a week.
Il- kejl ewlieni tal- effikaċja kien is- suċċess tat- trattament wara ġimgħa.
What benefit has Tractocile shown during the studies?
Liema benefiċċju wera Tractocile fl- istudji mwettqa?
Looking at the results of the three main studies together, 60% of the women treated with Tractocile were still pregnant one week after treatment (201 out of 337) compared with 48% of the women treated with the comparator medicines (163 out of 342).
Mir- riżultati tat- tliet studji ewlenin meħudin flimkien jidher li 60% tan- nisa ttrattati bi Tractocile kienu għadhom ma welldux wara ġimgħa mill- bidu tat- trattament (201 minn 337) meta mqabbla ma ’ 48% tan- nisa ttrattati bil- mediċni tat- tqabbil (163 minn 342).
There were too few women with a pregnancy at less than 28 weeks for the effectiveness of Tractocile in comparison to beta-agonists to be established in this group.
In- numru ta ’ pazjenti li ma waslux fit - 28 ġimgħa tat- tqala kien baxx wisq biex setgħet tiġi ddeterminata l- effikaċja ta ’ Tractocile għal dan il - grupp ta ’ pazjenti meta mqabbel mal- beta- agonisti.
The better result with Tractocile over the beta-agonists might have been because it caused fewer side effects, thereby allowing the patients to receive a full course of treatment.
L- akbar effikaċja ta ’ Tractocile meta mqabbel mal - beta- agonisti tista ’ tkun dovuta għall- fatt li Tractocile ikkawża numru iżgħar ta ’ effetti sekondarji, b’ hekk ippermetta lill- pazjenti jispiċċaw it- trattament kollu.
What is the risk associated with Tractocile?
X’ inhu r- riskju assoċjat ma ’ Tractocile?
The most common side effect with Tractocile (seen in more than 1 patient in 10) is nausea (feeling sick).
L- effett sekondarju l- aktar komuni bi Tractocile (li deher f’ aktar minn pazjent 1 minn 10) hu nawżea (dardir).
No side effects have been noted in the newborn baby.
Ma ġie osservat l- ebda effett sekondarju għat- tarbija tat- twelid.
For the full list of all side effects reported with Tractocile, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrapportati bi Tractocile, ara l- Fuljett ta ’ Tagħrif.
Tractocile should not be used in people who may be hypersensitive (allergic) to atosiban or any of the other ingredients.
Tractocile ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal atosiban jew għal xi sustanza oħra tiegħu.
It must not be used in women whose pregnancy is less than 24 weeks or more than 33 weeks, or who have premature rupture of the membranes, bleeding from the womb, eclampsia (a dangerous condition at the end of pregnancy caused by toxins in the blood), pre-eclampsia (a condition that can lead to eclampsia) or problems with the placenta.
Barra minn hekk, ma għandux jintuża fin- nisa li ma waslux fl- 24 ġimgħa jew li għaddew it- 33 ġimgħa tat- tqala jew li nfaqgħulhom il- membrani (infaqa ’ l- ilma) qabel iż- żmien, bi dmija mill- ġuf, eklampsija (kundizzjoni perikoluża fit- tmiem tat- tqala kkawżata mit- tossini fid- demm), preeklampsija (kundizzjoni li tista ’ twassal għal eklampsija) jew problemi tal- plaċenta (tas- sekonda).
Why has Tractocile been approved?
Għaliex ġie approvat Tractocile?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Tractocile has shown an effectiveness in delaying pre-term birth that is the same as seen with beta-agonists, and that the better outcome with Tractocile was due to the medicine being better tolerated.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l- effikaċja ta ’ Tractocile fl- ittardjar tat- twelid qabel iż- żmien hija ndaqs bħal dik tal- beta- agonisti u l- aħjar riżultati miksuba bi Tractocile kienu dovuti għal tolleranza aħjar tal- mediċina.
The Committee decided that Tractocile’ s benefits are greater than its risks to delay imminent pre-term birth in pregnant women.
Il- Kumitat iddeċieda li l - benefiċċji ta ’ Tractocile huma akbar mir- riskji tiegħu biex jittardja t- twelid qabel iż- żmien fin- nisa tqal.
The Committee recommended that Tractocile be given marketing authorisation.
Il- Kumitat irrakkomanda li Tractocile jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Tractocile:
Aktar tagħrif dwar Tractocile:
The European Commission granted a marketing authorisation valid throughout the European Union for Tractocile on 20 January 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq fl- Unjoni Ewropea kollha għal Tractocile fl- 20 ta ’ Jannar 2000.
The marketing authorisation was renewed on 20 January 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet mġedda fl- 20 ta ’ Jannar 2005.
The marketing authorisation holder is Ferring Pharmaceuticals A/ S.
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq huwa Ferring Pharmaceuticals A/ S.
The full EPAR for Tractocile is available here.
L- EPAR sħiħ dwar Tractocile jista ’ jiġi kkonsultat hawn.
EU number
Isem ivvintat
Invented name
Mod ta ’ kif u
Pharmaceutical form
Daqs tal- Pakkett
Route of administration
g all- kummer
Packaging
7. 5 mikrogrammi
Content
Soluzzjoni g all -
Package size
mnejn jing ata
Vial (glass)
TRACTOCILE
1
f’ kull 1 ml 7. 5 mikrogrammi
Intravenous use
U u g al ol- vini
Vial (glass)
kunjett (gieg)
1
f’ kull 1 ml
1/ 1
Soluzzjoni g all- infuzjoni
TRACTOCILE 7.5 mg/ ml solution for injection
Tractocile 7. 5 mg/ ml soluzzjoni għall- injezzjoni
One ml solution contains 7.5 mg atosiban free-base in the form of atosiban acetate.
Kull ml fih 7. 5 mg atosiban ħieles fil- forma ta 'atosiban acetate.
For excipients, see section 6.1.
Għal sustanzi mhux attivi, ara 6. 1.
Solution for injection Visual appearance: clear, colourless solution without particles.
Soluzzjoni għall- injezzjoni Kull kunjett fih 37. 5mg atosiban Dehra: soluzzjoni trasparenti bla lewn u mingħajr frak..
TRACTOCILE is indicated to delay imminent pre-term birth in pregnant 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% − age ≥ 18 years − a gestational age from 24 until 33 completed weeks − a normal fetal heart rate
Tractocile indikat biex jittardja ħlas imminenti qabel iż- żmien f' nisa 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% − eta` ta' ≥ 18- il sena − tqala minn 24 sa 33 ġimgħa magħluqa − rata tal- qalb tal- fetu normali
Treatment with TRACTOCILE should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Il- kura bi Tractocile għandha tinbeda u titkompla minn tabib bl- esperjenza fil- kura tal- ħlas qabel iż - żmien.
TRACTOCILE is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with TRACTOCILE 7.5 mg/ ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/ min) of TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion during three hours, followed by a lower dose of TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion (subsequent infusion 100 micrograms/ min) up to 45 hours.
Tractocile jingħata fil- vina fi tliet stadji wara xulxin: doża tal- bidu f' daqqa (6. 75 mg), b' soluzzjoni għall- injezzjoni ta 'Tractocile 7. 5 mg/ ml, u eżatt wara infużjoni kontinwa ta' doża qawwija (infużjoni tal- bidu ta '300 μg/ min) bi Tractocile 7. 5 mg/ ml konċentrat ta' soluzzjoni għall- infużjoni għal tliet sigħat, u wara doża inqas ta 'Tractocile 7. 5 mg/ ml konċentrat ta' soluzzjoni għall- infużjoni (infużjoni ta 'wara 100 μg/ min) sa 45 siegħa.
The duration of the treatment should not exceed 48 hours.
Il- kura m' għandhiex iddum iktar minn 48 siegħa.
The total dose given during a full course of TRACTOCILE therapy should preferably not exceed 330 mg of the active substance.
Id- doża totali li tingħata waqt kors sħiħ ta 'terapija bi Tractocile preferibbilment m' għandhiex tkun iktar minn 330 mg tas- sustanza attiva.
Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour.
It- terapija fil- vina bl- użu ta 'l- injezzjoni f' daqqa tal- bidu għandha tinbeda kemm jista' jkun malajr wara d- djanjosi tal- ħlas qabel iż- żmien.
Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion).
Ladarba l- injezzjoni f' daqqa tkun saret, kompli bl- infużjoni (ara s - Sommarju tal- Karatteristiċi tal- Prodott ta 'Tractocile 7. 5 mg/ ml, konċentrat għas- soluzzjoni għall - infużjoni).
In the case of persistence of uterine contractions during treatment with TRACTOCILE, alternative therapy should be considered.
F' każ li l- kontrazzjonijiet ta 'l- utru ma jiqfux waqt il- kura bi Tractocile, għandha titqies terapija alternattiva.
There is no data available regarding the need for dose adjustments in patients with renal or liver insufficiency.
M' hemmx tagħrif dwar il- bżonn ta 'bdil fid- doża f' pazjenti b' insuffiċjenza tal- kliewi jew tal- fwied.
2 The following table shows the full posology of the bolus injection followed by the infusion:
It- tabella li ġejja turi l- pożoloġija sħiħa ta 'l- injezzjoni f' daqqa segwita b' infużjoni:
Step 1 2
2 Pass 1 2
Regimen 0.9 ml intravenous bolus 3 hours intravenous loading infusion
Kura 0. 9 ml f' daqqa fil- vina 3 sigħat infużjoni tal- bidu fil - vina
Injection/ infusion rate over 1 minute 24 ml/ hour
Rata ta 'injezzjoni/ infużjoni F’ minuta 24 ml/ siegħa
Atosiban dose 6.75 mg 18 mg/ hour
Doża ta 'Atosiban 6. 75 mg 18 mg / siegħa
subsequent intravenous infusion
Infużjoni sussegwenti fil- vina
8 ml/ hour
8 ml / siegħa
6 mg/ hour
6 mg / siegħa
Re-treatment
Kura ripetuta
In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of TRACTOCILE 7.5 mg/ ml, solution for injection followed by infusion with TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion.
F' każ li jkun hemm bżonn kura ripetuta, din għandha tibda b' injezzjoni f' daqqa ta '7. 5 mg/ ml soluzzjoni għall- injezzjoni ta' Tractocile, u wara infużjoni ta 'konċentrat ta' soluzzjoni għall- infużjoni ta '7. 5 mg/ ml ta' Tractocile.
TRACTOCILE should not be used in the following conditions:
Tractocile m' għandux jintuża f' dawn il- kondizzjonijiet:
− Gestational age below 24 or over 33 completed weeks − Premature rupture of the membranes > 30 weeks of gestation − Intrauterine growth retardation and abnormal fetal heart rate − Antepartum uterine haemorrhage requiring immediate delivery − Eclampsia and severe pre-eclampsia requiring delivery − Intrauterine fetal death − Suspected intrauterine infection − Placenta praevia − Abruptio placenta − Any other conditions of the mother or fetus, in which continuation of pregnancy is hazardous − Known hypersensitivity to the active substance or any of the excipients.
− fi tqala ta ’ inqas minn 24 ġimgħa jew f’ dik ta ’ iktar minn 33 ġimgħa magħluqa − l- ilma jinfaqa 'qabel iż- żmien > 30 ġimgħa tqala − nuqqas ta ’ żvilupp fil- ġuf u taħbit mhux normali tal- qalb tal- fetu − emorraġija ta' l- utru qabel il- ħlas li tinħtieġ ħlas ma ’ l- ewwel − Eklampsja u pre- eklampsja serja li teħtieġ il- ħlas − Mewt tal- fetu fil- ġuf − Suspett ta 'infezzjoni fil- ġuf − Plaċenta praevia − Abruptio plaċenta − Xi kondizzjoni oħra ta' l- omm jew tal- fetu li minħabba fiha t- tkomplija tat- tqala tkun perikoluża − sensitivita` eċċessiva magħrufa għas- sustanza attiva jew is- sustanzi mhux attivi.
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.
Meta Tractocile jintuża f’ pazjenti li dwarhom ma jistax jiġi eskluż li l- ilma jinfaqa ’ qabel iż- żmien, il - benefiċċji tad- dewmien fil- Hlas iridu jitkejlu mar- riskju potenzjali ta ’ chorioamnionitis.
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys (see sections 4.2 and 5.2).
(ara sezzjonijiet 4. 2 u 5. 2).
Atosiban has not been used in patients with an abnormal placental site.
Tractocile ma ntużax ma 'pazjenti bi plaċenta anormali.
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.
Ftit hemm tagħrif kliniku dwar l- użu ta 'Tractocile fi tqala b' iktar minn fetu wieħed jew bi tqala ta' bejn l- 24 u s- 27 ġimgħa, minħabba li n- numru ta 'pazjenti kurati biha kien żgħir.
The benefit of atosiban in these subgroups is therefore uncertain.
Għalhekk il- benefiċċju ta ’ Tractocile f' dawn il- gruppi mhux ċar.
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).
Għalkemm Tractocile tista ’ tarġa ’ tużaha għall- kura, għad hemm ftit wisq tagħrif dwar l- effetti meta din tintuża għal aktar minn darba sa mill- inqas tliet darbiet wara (ara sezzjoni 4. 2, Pożoloġija u metodu ta 'kif jingħata).
In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of TRACTOCILE depends on the assessment of fetal maturity.
F' każ ta 'nuqqas fl- iżvilupp ta ’ l- utru, id- deċiżjoni jekk għandhiex titkompla jew terġa' tibda l- għotja ta 'Tractocile tiddependi minn kif titqies il- maturita` tal- fetu.
Monitoring of uterine contractions and fetal heart rate during administration of atosiban and in case of persistent uterine contractions should be considered.
Għandu jitqies il- monitoraġġ tal- kontrazzjonijiet ta 'l- utru u tar- rata tat- taħbit tal- qalb tal- fetu waqt li qed jingħata Tractocile u f' każ ta ’ kontrazzjonijiet persistenti ta' l- utru.
As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored.
Billi atosiban jaħdem kontra oxytocin, teoretikament jista 'jgħin ir- rilassament ta' l- utru u d- dmija wara l- ħlas, għalhekk għandu jsir monitoraġġ tad- dmija wara l- ħlas.
However, inadequate uterus contraction postpartum was not observed during the clinical trials.
Madankollu fi provi kliniċi ma ġewx osservati wara l- ħlas kontrazzjonijiet mhux adegwati ta 'l- utru.
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.
Mhux probabbli li Atosiban hu involut f' interazzjonijiet bejn prodotti mediċinali permezz ta ’ ċitokroma P450, billi investigazzjonijiet in vitro wrew li Atosiban mhux substrat għas- sistema ta ’ ċitokroma P450, u ma jwaqqafx l- enzimi ta ’ ċitokroma P450 li jimmetabolizzaw prodotti mediċinali.
Interaction studies were performed in healthy, female volunteers with betamethasone and labetalol.
Saru studji dwar interazzjoni f' voluntiera nisa żgħażagħ b 'betamethasone u labetalol.
No clinically relevant interaction was observed between atosiban and betamethasone.
Ma ġiet osservata l- ebda interazzjoni klinikament relevanti bejn Tractocile u betamethasone.
When atosiban and labetalol were co-administrated, Cmax of labetalol was decreased by 36% and Tmax increased by 45 minutes.
Meta Tractocile u labetalol ngħataw flimkien, Cmax ta 'labetalol naqas bi 36% u Tmax żdied b' 45 minuta.
However, the extent of labetalol bioavailability in terms of AUC did not change.
Madankollu, il - biodisponibbilta` ta 'labetalol fil- ġisem mill- aspett ta' l- AUC ma nbidlitx.
The interaction observed has no clinical relevance.
L- interazzjoni li ġiet osservata ma kienx fiha relevanza klinika.
Labetalol had no effect on atosiban pharmacokinetics.
Labetalol ma kellux effett fuq il- karatteristiċi farmakokinetiċi ta 'Tractocile.
No interaction study has been performed with antibiotics, ergot alkaloids, and anti-hypertensive agents other than labetalol.
Ma sarx studju dwar interazzjoni ma 'antibijotiċi, ergot alkaloids, u prodotti mediċinali li jnaqqsu l - pressjoni għolja ħlief għal labetalol.
Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation.
Tractocile għandu jintuża biss meta ssir djanjosi ta 'ħlas qabel iż- żmien bejn l- 24 u t- 33 ġimgħa magħluqa tat- tqala.
In atosiban clinical trials no effects were observed on lactation.
Fil- provi kliniċi ta ’ Tractocile ma ġewx osservati effetti fuq it- treddigħ.
Small amounts of atosiban have been shown to pass from plasma into the breast milk of lactating women.
Deher biss li ammonti żgħar ta 'atosiban għaddew mill- plażma għall- ħalib ta' l- omm li qed tredda '.
No studies were performed that covered fertility and early embryonic development (see section 5.3).
Studju dwar effetti tossiċi fuq l- embriju ma wrewx li kien hemm effetti tossiċi ta 'Atosiban Ma sar ebda studju dwar il- fertilità u l- iżvilupp bikri ta ’ l- embrijun (ara taqsima 5. 3)
Not applicable.
Mhux rilevanti
Possible undesirable effects of atosiban were described for the mother during the use of atosiban in clinical trials.
Waqt provi kliniċi deher li seta ’ kien hemm xi effetti mhux mixtieqa għall- omm waqt l- użu ta 'atosiban.
The observed undesirable effects were generally of a mild severity.
L- effetti mhux mixtieqa li ġew osservati, ġeneralment ma kinux severi.
In total 48% of the patients treated with atosiban experienced undesirable effects.
B’ kollox 48% tal - pazjenti mogħtija Tractocile, kellhom effetti mhux mixtieqa.
For the newborn, the clinical trials did not reveal any specific undesirable effects of atosiban.
It- testijiet kliniċi ma wrew ebda effetti speċifiċi mhux mixtieqa ta 'atosiban fit - tarbija li għadha kemm twieldet.
The infant adverse events were in the range of normal variation and were comparable with both placebo and beta-mimetic group incidences.
Meta fit- trabi kien hemm effetti avversi kienu fil- medda normali ta 'varjazzjoni, u setgħu jitqabblu tajjeb mad- drabi li ġraw bl- użu tal- plaċebo u tal- grupp beta- mimetiku.
4 The undesirable effects in the women were the following:
L- effetti mhux mixtieqa fuq in- nisa kienu:
Very common (> 1/ 10)
4 Komuni ħafna (> 10%)
Gastrointestinal disorders: nausea.
Mard gastro- intestinaliTqalligħ Mard marbut mal- metaboliżmu u n- nutrizzjoni: ipergliċemija
Common (> 1/ 100, < 1/ 10)
Komuni (1- 10%)
Metabolism and nutrition disorders: hyperglycaemia Nervous system disorders: headache, dizziness Cardiac disorders: tachycardia, Vascular disorders: hot flush, hypotension Gastrointestinal disorders: vomiting General disorders and administration site conditions: injection site reaction
Mard tas- sistema nervuża: uġigħ ta 'ras, sturdament Mard tal- qalb: takikardja Mard vaskulari: fwawar, pressjoni baxxa Mard gastro- intestinali: rimettar Mard ġenerali u kondizzjonijiet ta ’ mnejn jingħata: reazzjoni fil- post ta' l - injezzjoni
Uncommon (> 1/ 1000, < 1/ 100)
Mhux komuni (0. 1- 1%)
Psychiatric disorders: insomnia Skin and subcutaneous tissue disorders: pruritis, rash General disorders and administration site conditions: pyrexia
Mard tal- ġilda u tat- tessuti ta ’ taħt il- ġilda: prurite, raxx Mard ġenerali u kondizzjonijiet ta ’ mnejn jingħata: deni
Rare (> 1/ 10,000, < 1/ 1,000)
Rari Ġew rappurtati 'l hawn u' l hinn każi ta 'emorraġija (< 0. 1%)
Incidental cases of uterine haemorrhage/ uterine atony were reported.
utru/ uterine atony.
The frequency did not exceed that of the control groups in clinical trials.
Il- frekwenza ma kinitx ogħla minn tal- gruppi ta 'kontroll fi provi kliniċi.
One case of allergic reaction was reported, which was considered to be probably related to atosiban.
Każ rappurtat ta 'reazzjoni allerġika, sata ’ kien marbut ma' atosiban.
Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms.
Kien hemm ftit każi rappurtati li seħħew ta 'doża eċċessiva ta' Tractocile, mingħajr ebda sinjali jew sintomi speċifiċi.
There is no known specific treatment in case of an overdose.
Mhux magħruf x’ kura speċifika hemm f' każ ta 'doża eċċessiva.
Other gynecologicals, ATC code:
Kategorija farmakoterapewtika: ġinekoloġiċi oħra, Kodiċi ATC:
TRACTOCILE 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.
Tractocile fih atosiban( INN), peptide sintetiku ([Mpa1, D- Tyr( Et) 2, Thr4, Orn8] - oxytocin) li jikkompeti ma 'oxytocin għar- riċetturi fil- bniedem.
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.
Fil- firien u l- fniek ta 'l- Indi, Atosiban intwera li jingħaqad mar- riċetturi ta' oxytocin, biex inaqqas il- frekwenza tal- kontrazzjonijiet u s- sodizza tal- muskoli ta 'l - utru, bir- riżultat li jnaqqas il- kontrazzjonijiet ta' l- utru.
Atosiban was also shown to bind to the vasopressin receptor, thus inhibiting the effect of vasopressin.
Intwera wkoll li atosiban jingħaqad mar - reċettur ta 'vasopressin, u b' hekk itellef l- effett ta' vasopressin.
In animals atosiban did not exhibit cardiovascular effects.
Fl- annimali atosiban ma kellux effetti kardjovaskulari.
In human pre-term labour, atosiban at the recommended dosage antagonises uterine contractions and induces uterine quiescence.
Fit- tqala qabel iż- żmien fil- bnedmin, meta atosiban jittieħed fid- doża rakkomandata jaħdem kontra l - kontrazzjonijiet ta 'l- utru u jikkalma l- utru.
The onset of uterus relaxation following atosiban is rapid, uterine contractions being significantly reduced within 10 minutes to achieve stable uterine quiescence (≤ 4 contractions/ hour) for 12 hours.
Wara l- għoti ta ’ atosiban l- utru malajr jistrieħ, billi f’ 10 minuti l- kontrazzjonijiet ta 'l- utru jonqsu sew ħalli tintlaħaq stabbiltà fl- utru (≤ 4 kontrazzjonijiet/ siegħa) għal 12- il siegħa.
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).
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 Tractocile (skond din it - tikketta) jew β- agonist (dose- titrated).
Primary endpoint: the primary efficacy outcome was the proportion of women remaining undelivered and not requiring alternative tocolysis within 7 days of treatment initiation.
Primary endpoint: ir- riżultat ewlieni ta 'l- effikaċja tal- prodott kien il- proporzjon ta' nisa li jibqgħu ma jeħilsux u li ma jkollhomx bżonn tokolisi alternattiva fi żmien 7 ijiem wara li tinbeda l- kura.
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.
It- tagħrif juri li 59. 6% (n=201) u 47. 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.
Most of the
Il- fallimenti tal- kura għax ma kienx effikaċi biżżejjed kienu iktar frekwenti b' mod
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%).
5 sinifikanti (p=0. 0003) fin- nisa li ngħataw atosiban (n=48, 14. 2%) milli fin- nisa li ngħataw β- agonist (n=20, 5. 8%).
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.
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.
However, this finding is based on a very small sample (n=129 patients).
Madankollu, dan it- tagħrif nħadem fuq numru żgħir ħafna (n=129 pazjenti).
Secondary endpoints: secondary efficacy parameters included the proportion of women remaining undelivered within 48 h of treatment initiation.
Secondary endpoints: il- parametri sekondarji ta 'l- effikaċja tal- prodott inkludew il- proporzjon ta' nisa li baqgħu ma ħelsux 48 siegħa wara l- bidu tal- kura.
There was no difference between the atosiban and beta-mimetic groups with regard to this parameter.
F' dan il- kuntest ma kienx hemm differenza bejn atosiban u l- gruppi beta- mimetiċi.
Mean (SD) gestational age at delivery was the same in the two groups:
Iż- żmien medju (SD) tat- tqala meta sar il- ħlas kien l- istess fiż- żewġ gruppi:
35.6 (3.9) and 35.3 (4.2) weeks for the atosiban and β -agonist groups, respectively (p=0.37).
35. 6 (3. 9) u 35. 3 (4. 2) ġimgħa għall- gruppi ta 'atosiban u tal- β- agonist, rispettivament (p=0. 37).
Admission to a neonatal intensive care unit (NICU) was similar for both treatment groups (approximately 30%), as was length of stay and ventilation therapy.
Ir- rata ta 'dħul f' dipartiment ta' kura intensiva tat- trabi (NICU) kien l- istess għaż- żewġ gruppi (bejn wieħed u ieħor 30%), u dan jgħodd ukoll għal kemm it- trabi damu għall- kura u għall- użu tal- terapija tal- ventilazzjoni.
Mean (SD) birth weight was 2491 (813) grams in the atosiban group and 2461 (831) grams in the β -agonist group (p=0.58).
Il- piz medju (SD) fit- twelid kien ta '2491 (813) g fil- grupp ta' Atosiban, u 2461 (831) g fil- grupp tal- β- agonist (p=0. 58).
Fetal and maternal outcome did apparently not differ between the atosiban and the β -agonist group, but the clinical studies were not powered enough to rule out a possible difference.
Ma kienx hemm differenza bejn il- grupp ta ’ atosiban u dak tal- β- agonist fejn kellhom x’ jaqsmu il- fetu u l- omm, imma l- istudji kliniċi setgħu ma kinux tajba biżżejjed biex jeskludu l- possibbilta ’ li hemm xi differenzi.
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).
Mit- 361 mara li ngħataw il- kura ta 'Tractocile fi studji ta' fażi 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).
As the safety and efficacy of atosiban in women with a gestational age of less than 24 completed weeks has not been established in controlled randomised studies, the treatment of this patient group with atosiban is not recommended (see section 4.3).
Billi, fi studji kontrollati miġbura bl- addoċċ, għadha ma ġietx stabbilita s- sigurta` u l- effikaċja ta 'Tractocile f' nisa bi tqala ta' inqas minn 24 ġimgħa magħluqa, il- kura bi Tractocile lil dan il- grupp ta 'pazjenti mhix rakkomandata (ara sezzjoni 4. 3, Kontra- indikazzjonijiet).
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.
Fi studju kontrollat 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 'Tractocile, li minnhom żewġt imwiet seħħew wara ħames u tmien xhur ta' ħajja.
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).
Ħdax mill- 15- il mewt fil- grupp ta 'Tractocile seħħew fit- tqala ta' bejn l- 20 u l- 24 ġimgħa, għalkemm id- distribuzzjoni ta 'dawn il- pazjenti skond il- grupp ta' kura ma kinitx l- istess (19 - il mara fuq Tractocile, 4 nisa fuq il- plaċebo).
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).
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 'Tractocile).
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.
F' nies f' saħħithom mhux tqal li ngħataw infużjonijiet ta 'Tractocile (minn 10 sa 300 µg/ min fuq medda ta' 12- il siegħa), il- konċentrazzjonijiet fissi fil- plażma żdiedu proporzjonalment mad- doża.
The clearance, volume of distribution and half-life were found to be independent of the dose.
Instab li t- tneħħija, il- volum tad- distribuzzjoni u l- half- life ma jiddependux mid- doża.
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).
F' nisa bi ħlas qabel iż- żmien li kienu qed jingħataw Tractocile 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).
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.
Wara li ntemmet l- infużjoni, il- konċentrazzjoni fil- plażma reġgħet niżlet malajr b' valuri tal- half- life tal- bidu (tα) u ta 'l- aħħar (tβ) ta' 0. 21 ± 0. 01 u 1. 7 ± 0. 3 siegħa, rispettivament.
Mean value for clearance was 41.8 ± 8.2 litres/ h.
Il- volum medju tat - tneħħija kien ta '41. 8 ± 8. 2 l/ siegħa.
Mean value of volume of distribution was 18.3 ± 6.8 litres.
Il- valur medju tal - volum tad- distribuzzjoni kien ta '18. 3 ± 6. 8 l.
Plasma protein binding of atosiban is 46 to 48% in pregnant women.
L- ammont ta 'rbit ta' atosiban mal- proteina tal- plażma huwa ta '46 sa 48% f' nisa tqal.
It is not known whether the free fraction in the maternal and fetal compartments differs substantially.
Mhux magħruf jekk il- parti mhix marbuta fl- omm jew fil- fetu hix differenti b' mod sostanzjonali.
Atosiban does not partition into red blood cells.
Atosiban ma jinqasamx fiċ- ċelloli ħomor tad- demm.
Atosiban passes the placenta.
6 Atosiban jgħaddi mill- plaċenta.
Following an infusion of 300 micrograms/ min in healthy pregnant women at term, the fetal/ maternal atosiban concentration ratio was 0.12.
Wara infużjoni ta '300 µg/ min f' nisa tqal f' saħħithom fl- aħħar tat- tqala, il- proporzjon ta' konċentrazzjoni ta 'atosiban bejn il- fetu u l- omm kien ta' 0. 12.
6 Two metabolites were identified in the plasma and urine from human subjects.
Ġew identifikati żewġ metaboliti fil- plażma u l- awrina tal- bnedmin.
The ratios of the main metabolite M1 (des-(Orn8, Gly-NH29)-[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.
Il- proporzjonijiet tal- metobolit prinċipali M1 (des - (Orn8, Gly- NH29) - [Mpa1, D- Tyr( Et) 2, Thr4] - oxytocin) għall- konċentrazzjonijiet ta 'atosiban fil- plażma kienu ta' 1. 4 u 2. 8 wara sagħtejn u fl- aħħar ta 'l- infużjoni rispettivament.
It is not known whether M1 accumulates in tissues.
Mhux magħruf jekk il- metabolit M1 jakkumulax fit- tessuti.
Atosiban is found in only small quantities in urine, its urinary concentration is about 50 times lower than that of M1.
Atosiban instab biss f’ ammonti żgħar fl- awrina, il- konċentrazzjoni fl- awrina kienet 50 darba inqas minn dik ta 'l- M1.
The proportion of atosiban eliminated in faeces is not known.
Il- proporzjon ta 'atosiban eliminat fl- ippurgar mhux magħruf.
Main metabolite M1 is apparently as potent as the parent compound in inhibiting oxytocin-induced uterine contractions in vitro.
Il- metabolit prinċipali M1 in vitro milli jidher huwa b’ saħħtu biżżejjed biex iwaqqaf il- kontrazzjonijiet ta 'l- utru kaġunati minn oxytocin daqs is- sustanza oriġinali.
Metabolite M1 is excreted in milk (see section 4.6).
Il- metabolit M1 jitneħħa fil- ħalib (ara sezzjoni 4. 6 Tqala u effetti fuq il- ħalib tas- sider).
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys (see sections 4.2 and 4.4).
(ara sezzjonijiet 4. 2 u 4. 4).
It is unlikely that atosiban inhibits hepatic cytochrome P450 isoforms in humans (see section 4.5).
Ma jidhirx li l- atosiban iwaqqaf l- effett ta ’ l- isoforomi ta ’ cytochrome P450 tal- fwied (ara sezzjoni 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott).
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 three-months toxicity studies in rats and dogs (up to 20 mg/ kg/ day s. c.).
Ma deherx li kien hemm effetti tossiċi sistemiċi waqt studji ta 'gimagħtejn dwar it- tossicita` li fihom il - prodott 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.).
The highest atosiban subcutaneous dose not producing any adverse effects was approximately two times the therapeutic human dose.
L- ikbar doża subkutanja ta 'Atosiban li ma kellhiex effetti avversi kienet bejn wieħed u ieħor darbtejn id- doża terapewtika li tingħata lill- bnedmin.
No studies were performed that covered fertility and early embryonic development.
Ma sarux studji dwar il- fertilita u l- izvilupp bikri tal- embriju.
Reproduction toxicity studies, with dosing from implantation up to late stage pregnancy, showed no effects on mothers and fetuses.
Studji dwar tossiċità riproduttiva ma wrew l- ebda effett fuq l- ommijiet jew il- feti, meta ngħataw dożi mill- bidu sa l- aħħar stadji tat- tqala.
The exposure of the rat fetus was approximately four times that received by the human fetus during intravenous infusions in women.
Il - fetu tal- far kien espost għal bejn wieħed u ieħor erba 'darbiet id- doża li jiġi espost għaliha l- fetu uman waqt infużjonijiet fil- vina fin- nisa.
Animal studies have shown inhibition of lactation as expected from the inhibition of action of oxytocin.
Studji fuq l- annimali wrew li kien hemm waqfien fil- produzzjoni tal- ħalib kif inhu mistenni meta titwaqqaf l- azzjoni ta 'oxytocin.
Atosiban was neither oncogenic nor mutagenic in in vitro and in vivo tests.
Atosiban ma kellux effett onkoġeniku u l- anqas mutaġeniku f' testijiet in vitro u in vivo.
Mannitol Hydrochloric acid 1M Water for injections
Mannitol hydrochloric acid 1M ilma għall- injezzjoni.
Once the vial has been opened, the product must be used immediately.
Minħabba li ma sarux studji dwar prodotti li ma jaqblux miegħu, dan il- prodott mediċinali ma għandux jitħallat ma ’ prodotti mediċinali oħrajn.
Store in a refrigerator (2°C - 8°C).
Sentejn.
Store in the original package.
Ladarba jinfetaħ il- kunjett, il- prodott għandu jintuża fil- pront.
7 6.5 Nature and contents of container
7 Aħżen fil- kontenitur oriġinali.
One vial of solution for injection contains 0.9 ml solution, corresponding to 6.75 mg atosiban.
Kunjett ta 'soluzzjoni għall- injezzjoni li fih 0. 9 ml.
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.
Kunjett tal- ħġieġ borosilikata ċara (tip I), issiġillata b' tapp tal- gomma bromo- butyl silikonat griż, tip I, u għatu li jinfetaħ minn naħa waħda ta ’ polypropylene u aluminium.
The vials should be inspected visually for particulate matter and discoloration prior to administration.
Qabel ma tuża l- prodott agħti daqqa ta ’ għajn lill- kunjett għal xi frak li jista ’ jkun fihom jew xi bidla fil- lewn.
Preparation of the initial intravenous injection:
Kif tipprepara l- ewwel injezzjoni għal ġol- vina:
Withdraw 0.9 ml of a 0.9 ml labelled vial of TRACTOCILE 7.5 mg/ ml, solution for injection and administer slowly as an intravenous bolus dose over one minute, under adequate medical supervision in an obstetric unit.
Iġbed soluzzjoni ta ’ 0. 9 ml minn fjala ta '0. 9 ml ta' Tractocile 7. 5 mg/ ml, għall- injezzjoni u agħtiha bilmod f' doża waħda fil- vina f’ medda ta 'minuta, taħt superviżjoni medika xierqa f' dipartiment ostetriku.
The TRACTOCILE 7.5 mg/ ml, solution for injection should be used immediately.
Is- soluzzjoni għall- injezzjoni ta ’ Tractocile 7. 5 mg/ ml għandha tintuża fil- pront.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products (see section 6.2).
Billi dan il- prodott mediċinali ma sarux studji dwar liema huma l- prodotti li ma jaqblux miegħu, m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn (ara sezzjoni 6. 2, Inkompatibilitajiet).
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 2300 København S Denmark
Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 2300 København S Danimarka
20.01.2000 / 31.01.05
20. 01. 2000
TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion
Tractocile 7. 5 mg/ ml konċentrat għal soluzzjoni għall- infużjoni
One ml solution contains 7.5 mg atosiban free-base in the form of atosiban acetate.
Kull ml fih 7. 5 mg atosiban ħieles ta 'atosiban acetate.
After dilution, the concentration of atosiban is 0.75 mg/ ml.
Wara li jiġi dilwit skond l- istruzzjonijiet f' sezzjoni 6. 6 (Struzzjonijiet għall- użu u maniġġar), il- konċentrazzjoni ta 'Atosiban issir 0. 75 mg/ ml.
Concentrate for solution for infusion Visual appearance: clear, colourless solution without particles.
Soluzzjoni trasparenti bla lewn u mingħajr frak.
TRACTOCILE is indicated to delay imminent pre-term birth in pregnant 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% − age ≥ 18 years − a gestational age from 24 until 33 completed weeks − a normal fetal heart rate
Tractocile huwa indikat biex ijittardja ħlas imminenti qabel iż- żmien f' nisa tqal b ’: kontrazzjonijiet regolari ta 'l- utru twal mill- inqas 30 sekonda tul b' rata ta' ≥ 4 kull 30 minuta fetħa ċervikali minn 1sa 3 cm (0- 3 nulliparas) u effacement ta '≥ 50% eta` ta' ≥ 18- il sena tqala minn 24 sa 33 ġimgħa magħluqa rata tal- qalb tal- fetu normali
Intravenous therapy using the initial bolus injection of TRACTOCILE 7.5 mg/ ml, solution for injection (see Summary of Product Characteristics of this product) should be started as soon as possible after diagnosis of pre-term labour.
It- terapija fil- vina bl- użu ta 'l- injezzjoni f' daqqa tal- bidu għandha tinbeda kemm jista' jkun malajr wara d- djanjosi tal- ħlas qabel iż- żmien.
Once the bolus has been injected, proceed with the infusion.
Ladarba l- injezzjoni f' daqqa tkun saret, kompli bl- infużjoni (ara s - Sommarju tal- Karatteristiċi tal- Prodott ta 'Tractocile 7. 5 mg/ ml, konċentrat għas- soluzzjoni għall - infużjoni).
9 The following table shows the full posology of the bolus injection followed by the infusion:
It- tabella li ġejja turi l- pożoloġija sħiħa ta 'l- injezzjoni f' daqqa segwita b' infużjoni:
Step 1 2
9 Pass 1 2
subsequent intravenous infusion
Infużjoni sussegwenti fil- vina li tiġi wara
− Gestational age below 24 or over 33 completed weeks − Premature rupture of the membranes > 30 weeks of gestation − Intrauterine growth retardation and abnormal fetal heart rate − Antepartum uterine haemorrhage requiring immediate delivery − Eclampsia and severe pre-eclampsia requiring delivery − Intrauterine fetal death − Suspected intrauterine infection − Placenta praevia − Abruptio placenta − Any other conditions of the mother or fetus, in which continuation of pregnancy is hazardous − Known hypersensitivity to the active substance or any of the excipients.
tqala f’ inqas minn 24 jew f’ iktar minn 33 ġimgħa magħluqa l- ilma jinfaqa 'qabel iż- żmien > 30 ġimgħa tqala nuqqas ta ’ żvilupp fil- ġuf u taħbit mhux normali tal- qalb tal- fetu emorraġġija ta' l- utru qabel il- ħlas li teħtieġ ħlas mal- ewwel Eklampsja u pre- eklampsja serja li teħtieġ il- ħlas Mewt tal- fetu fil- ġuf Suspett ta 'infezzjoni fil- ġuf Plaċenta praevia Abruptio plaċenta Xi kondizzjoni oħra ta' l- omm jew tal- fetu li minħabba fiha t- tkomplija tat- tqala hija perikoluża sensittivita` eċċessiva magħrufa għas- sustanza attiva jew is- sustanzi mhux attivi.