natgillin/translations-raw huggingface dataset:
Like all medicines, Tracleer can cause side effects, although not everybody gets them.
Kot vsa zdravila lahko tudi zdravilo Tracleer povzroči neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you notice yellowing of the skin or eyes (jaundice), or if you have fever with vomiting or nausea, see your doctor at once because this may be related to abnormal liver function.
Če opazite porumenelost kože ali oči (zlatenica), ali če imate povišano telesno temperaturo, vam je slabo ali bruhate, nemudoma obiščite svojega zdravnika, ker je to lahko povezano z okvarjenim delovanjem jeter.
If you experience sudden worsening in breathing in the first weeks after starting treatment with Tracleer or changing to a higher dose of Tracleer, contact your doctor immediately as there might be a need to change your treatment.
Če se težave z dihanjem v prvih tednih po uvedbi zdravljenja z zdravilom Tracleer ali povišanju odmerka zdravila Tracleer nenadno poslabšajo ali pojavijo, nemudoma pokličite svojega zdravnika, saj bo morda treba vaše zdravljenje spremeniti.
• Headache was the most common side effect in clinical studies.
• Glavobol je bil v kliničnih študijah najpogostejši neželeni učinek.
You may also notice one or more of the following side effects:
Morebiti boste opazili tudi enega ali več naslednjih neželenih učinkov:
• flushed appearance, inflammation of the throat and nasal passages, swelling of the legs and ankles or other signs of fluid retention, low blood pressure, palpitations, heartburn, tiredness, itching, nausea, anaemia (low blood count).
53 • zardelost, vnetje grla in nosnih poti, otekanje spodnjih okončin in gležnjev ali druge znake zadrževanja tekočine, nizek krvni tlak, palpitacije, pekoča zgaga, utrujenost, srbenje, slabost, anemija (nizko število eritrocitov).
53 Other less common side effects that you might notice include: • vomiting, abdominal pain, diarrhoea, skin rash, reduced blood platelet number.
Drugi manj pogosti neželeni učinki, ki jih boste morebiti opazili: • bruhanje, bolečine v trebuhu, diareja, kožni izpuščaji, znižano število trombocitov.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet or signs of allergic reaction (e.g. swelling of the face or tongue, rash, pruritus) while you are taking Tracleer, or if any of the side effects mentioned above worry you, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, ali znake alergične reakcije (denimo, otekanje obraza ali jezika, izpuščaji, srbenje) ali če ste zaskrbljeni zaradi kateregakoli zgoraj omenjenega neželenega učinka, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE TRACLEER
SHRANJEVANJE ZDRAVILA TRACLEER
Do not use Tracleer after the expiry date which is stated on the carton.
Zdravila Tracleer ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici.
What Tracleer contains
Kaj vsebuje Tracleer
- The active substance is bosentan.
- Zdravilna učinkovina v zdravilu Tracleer je bosentan.
- The other ingredients in the tablet core are maize starch, pregelatinised starch, sodium starch
- Pomožne snovi v jedru tablete so koruzni škrob, predgelirani škrob, natrijev
glycollate, povidone, glycerol dibehenate and magnesium stearate.
karboksimetilškrob, povidon, glicerildibehenat in magnezijev stearat.
Tracleer 62.5 mg film-coated tablets.
Tracleer 62, 5 mg filmsko obložene tablete.
Orange-white, round film-coated tablets with “62,5” on one side.
Oranžno- bele okrogle filmsko obložene tablete z napisom "62, 5" na eni strani.
Cartons contain 14 (62.5mg only), 56 or 112 film-coated tablets.
Škatlice vsebujejo po 14 (samo 62, 5mg), 56 ali 112 filmsko obloženih tablet.
Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom
Imetnik dovoljenja za promet z zdravilom Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL Velika Britanija
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63-65 79100 Freiburg Germany
Izdelovalec, odgovoren za sproščanje serije Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63- 65 79100 Freiburg Nemčija
België/Belgique/Belgien Actelion Pharmaceuticals Belgium N.V.
54 België/ Belgique/ Belgien Actelion Pharmaceuticals Belgium N. V.
Tél/Tel: +32-(0)2 709 2160
Tél/ Tel: +32 - (0) 2 709 21 60
55 This leaflet was last approved in
55 Navodilo je bilo odobreno v:
< Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Podrobni podatki o zdravilu so na voljo na spletni strani Evropske agencije za vrednotenje zdravil (EMEA) http: // www. emea. europa. eu /.
Tracleer 125 mg film-coated tablets Bosentan
Tracleer 125 mg filmsko obložene tablete bosentan
What Tracleer is and what it is used for 2.
Kaj je zdravilo Tracleer in za kaj ga uporabljamo 2.
Before you take Tracleer 3.
Kaj morate vedeti, preden boste vzeli zdravilo Tracleer 3.
How to take Tracleer 4.
Kako jemati zdravilo Tracleer 4.
Tests during treatment 5.
Preiskave med zdravljenjem 5.
How to store Tracleer 7.
Shranjevanje zdravila Tracleer 7.
Your doctor and/or gynaecologist will establish the contraception which is appropriate for you.
Vaš zdravnik in/ ali ginekolog bo ugotovil, katera kontracepcija je za vas najprimernejša,
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)
57 • glibenklamid (za zdravljenje sladkorne bolezni), • ciklosporin A (zdravilo, ki se uporablja po presaditvah in za zdravljenje luskavice) ali katerokoli drugo zdravilo, ki preprečuje zavrnitev presajenih organov, • flukonazol (za zdravljenje glivičnih okužb), • rifampicin (za zdravljenje tuberkuloze).
You must not take Tracleer if you are pregnant and you must also not become pregnant while taking Tracleer, because it cannot be excluded that Tracleer may harm the foetus.
Zdravila Tracleer ne smete jemati, če ste noseči, v času, ko ga jemljete, pa tudi ne smete zanositi, ker škode za zarodek ni mogoče izključiti..
58 If you stop taking Tracleer Suddenly stopping your treatment with Tracleer may lead to your symptoms getting worse.
58 Če ste prenehali jemati zdravilo Tracleer Nenadna prekinitev zdravljenja z zdravilom Tracleer lahko povzroči, da bodo vaši simptomi postali bolj izraziti.
• Pregnancy tests for women of childbearing age Due to the risk of failure of hormonal contraception when taking Tracleer and the risk in patients with pulmonary hypertension of rapid and severe deterioration of the disease, monthly pregnancy tests are recommended before and during treatment with Tracleer.
• Testi nosečnosti za ženske v rodni dobi Zaradi tveganja neučinkovitosti hormonske kontracepcije med jemanjem zdravila Tracleer in tveganja hitrega in hudega poslabšanja bolezni pri bolnikih s pljučno hipertenzijo, se priporočajo mesečni testi nosečnosti pred in med zdravljenjem z zdravilom Tracleer.
• flushed appearance, inflammation of the throat and nasal passages, swelling of the legs and ankles or other signs of fluid retention, low blood pressure, palpitations, heartburn, tiredness, itching, nausea, anaemia (low blood count).
59 • zardelost, vnetje grla in nosnih poti, otekanje spodnjih okončin in gležnjev ali druge znake zadrževanja tekočine, nizek krvni tlak, palpitacije, pekoča zgaga, utrujenost, srbenje, slabost, anemija (nizko število eritrocitov.
59 Other less common side effects that you might notice include: • vomiting, abdominal pain, diarrhoea, skin rash, reduced blood platelet number.
Drugi manj pogosti neželeni učinki, ki jih boste morebiti opazili: • bruhanje, bolečine v trebuhu, diareja, kožni izpuščaji, znižano število trombocitov.
Tracleer 62.5 mg film-coated tablets.
Tracleer 125 mg filmsko obložene tablete.
Tracleer 125 mg film-coated tablets.
Oranžno- bele ovalne filmsko obložene tablete z napisom "125" na eni strani.
Cartons contain 56 or 112 film-coated tablets.
Škatlice vsebujejo po 56 ali 112 filmsko obloženih tablet.
België/Belgique/Belgien Actelion Pharmaceuticals Belgium N.V.
60 België/ Belgique/ Belgien Actelion Pharmaceuticals Belgium N. V.
61 This leaflet was last approved in
61 Navodilo je bilo odobreno v:
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).
Zdravilo Tractocile je raztopina za injiciranje ali koncentrat za pripravo raztopine za infundiranje (dajanje v veno po kapljicah), ki vsebuje zdravilno učinkovino atosiban (7, 5 mg na mililiter).
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).
Zdravilo Tractocile se uporablja za odložitev poroda pri nosečnicah, starih najmanj 18 let, ki so noseče 24 do 33 tednov, če izkazujejo znake, da bi utegnilo priti do prezgodnjega nastopa poroda.
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.
Ti znaki so: • redne kontrakcije maternice, ki trajajo vsaj 30 sekund, s pogostnostjo najmanj štiri v 30 minutah, • odprtje materničnega vratu od 1 do 3 cm in stanjšanje za 50% ali več.
In addition the baby must have a normal heart rate.
Poleg tega mora imeti plod normalno srčno frekvenco.
Treatment should be started as soon as possible after diagnosis of pre-term labour.
Zdravljenje je treba začeti čimprej po diagnozi prezgodnjega porajanja.
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.
Zdravilo Tractocile se daje veno v treh korakih v razponu največ 48 ur: najprej začetni odmerek (6, 75 mg), ki mu sledi triurna infuzija v visokem odmerku (300 mikrogramov/ min), ki traja tri ure, in nato infuzija z manjšim odmerkom (100 mikrogramov/ min), ki traja do 45 ur.
The total dose given during a full course of Tractocile therapy should not be more than 330 mg.
Celotni odmerek, prejet v celotnem ciklu terapije z zdravilom Tractocile, ne sme preseči 330 mg.
There is no information about whether the dose needs to be adjusted for patients with kidney or liver problems.
Informacije o tem, ali je pri osebah s težavami z ledvicami ali jetri morda treba odmerek prilagoditi, niso na voljo.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Zdravilo Tractocile so primerjali z ritodinom, terbutalinom in salbutamolom (vsi trije spadajo v drugo skupino zdravil, ki se uporablja pri 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
How has Tractocile been studied?
Reproduction is authorised provided the source is acknowledged. prezgodnjem porajanju, imenovano beta- agonisti).
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).
Rezultati vseh treh glavnih študij skupaj kažejo, da je bilo en teden po zdravljenju nosečih še 60% žensk (201 od 337), zdravljenih z zdravilom Tractocile, v primerjavi z 48% žensk (163 od 342), zdravljenih s primerjalnimi zdravili.
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.
V študije je bilo vključenih premalo žensk, nosečih manj kot 28 tednov, da bi bilo mogoče ovrednotiti učinkovitost zdravila Tractocile v primerjavi z beta- agonisti pri tej skupini.
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.
Zdravilo Tractocile je v primerjavi z beta- agonisti boljše rezultate morda izkazalo zato, ker povzroča manj neželenih učinkov, zaradi česar so bolnice lahko prejele celoten cikel zdravljenja.
The most common side effect with Tractocile (seen in more than 1 patient in 10) is nausea (feeling sick).
Najpogostejši neželeni stranski učinek zdravila Tractocile (opažen pri 1 bolnici od 10) je bila slabost.
No side effects have been noted in the newborn baby.
Pri novorojenčkih niso opazili nikakršnih učinkov.
For the full list of all side effects reported with Tractocile, see the Package Leaflet.
Za celoten seznam vseh neželenih stranskih učinkov, o katerih so poročali pri uporabi zdravila Tractocile, glejte navodilo za uporabo.
Tractocile should not be used in people who may be hypersensitive (allergic) to atosiban or any of the other ingredients.
Zdravila Tractocile ne smejo uporabljati osebe, ki utegnejo biti preobčutljive (alergične) na atosiban ali katero koli drugo sestavino zdravila.
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.
Ne sme se uporabljati pri ženskah, ki so noseče manj kot 24 tednov ali več kot 33 tednov, ali če pride do prezgodnjega razpoka plodnega mehurja, v primeru krvavitve iz maternice, eklampsije (nevarno stanje ob koncu nosečnosti, ki ga povzročijo toksini v krvi) ali preeklampsije ter v primeru težav s posteljico.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je zdravilo Tractocile izkazalo enako učinkovitost pri preprečevanju prezgodnjega poroda, kot jo ugotavljajo pri beta - agonistih, ter da so boljši rezultati, doseženi pri uporabi zdravila Tractocile, pogojeni z boljšim prenašanjem tega zdravila.
The Committee decided that Tractocile’ s benefits are greater than its risks to delay imminent pre-term birth in pregnant women.
Odbor je odločil, da so koristi zdravila Tractocile pri odložitvi iminentnega prezgodnjega poroda pri nosečih ženskah, večje od z njim povezanih tveganj.
The Committee recommended that Tractocile be given marketing authorisation.
Zato je priporočil, da se za zdravilo Tractocile odobri dovoljenje za promet.
The marketing authorisation was renewed on 20 January 2005.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 20. januarja 2005.
The marketing authorisation holder is Ferring Pharmaceuticals A/ S.
Imetnik dovoljenja za promet z zdravilom je družba Ferring Pharmaceuticals A/ S.
Vial (glass)
viala (steko)
1
1 viala
Concentrate for solution for infusion
Koncentrat za pripravo raztopine za infudiranje
TRACTOCILE 7.5 mg/ ml solution for injection
TRACTOCILE 7, 5 mg/ ml raztopina za injiciranje
One ml solution contains 7.5 mg atosiban free-base in the form of atosiban acetate.
En mililiter raztopine vsebuje 7, 5 mg proste baze atosibana v obliki atosibanijevega acetata.
For excipients, see section 6.1.
Za pomožne snovi glejte 6. 1.
Solution for injection Visual appearance: clear, colourless solution without particles.
Raztopina za injiciranje Videz: bistra, brezbarvna raztopina brez delcev.
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 je indiciran za odložitev iminentnega prezgodnjega poroda pri ženskah z: − rednimi kontrakcijami maternice, ki trajajo vsaj 30 sekund s pogostnostjo ≥ 4 na 30 minut, − odprtjem materničnega vratu od 1 do 3 cm (od 0 do 3 cm pri ženskah, ki niso rodile) in stanjšanjem ≥ 50%, − starih ≥ 18 let, − gestacijsko starostjo od 24 do 33 dopolnjenih tednov, − normalno srčno frekvenco ploda.
Treatment with TRACTOCILE should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Zdravljenje s TRACTOCILOM mora začeti in voditi zdravnik, ki ima izkušnje s prezgodnjim porajanjem.
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 se aplicira intravensko v treh zaporednih korakih: najprej bolusni odmerek (6, 75 mg) zdravila TRACTOCILE 7, 5 mg/ ml, raztopina za injiciranje, ki mu takoj sledi visokoodmerna triurna stalna infuzija (polnilna infuzija 300 mikrogramov/ min) zdravilaTRACTOCILE 7, 5 mg/ ml, koncentrat za pripravo raztopine za injiciranje ter nato infuzija z manjšim odmerkom zdravila TRACTOCILE 7, 5 mg/ ml, koncentrat za pripravo raztopine za injiciranje (nadaljnja infuzija 100 mikrogramov/ min) do 45 ur.
The total dose given during a full course of TRACTOCILE therapy should preferably not exceed 330 mg of the active substance.
Celotni odmerek med polnim ciklusom terapije s TRACTOCILOM naj ne bi presegel 330 mg učinkovine.
Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour.
Intravensko zdravljenje z uvodno bolusno injekcijo je treba začeti čim prej po diagnozi prezgodnjega porajanja.
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).
Ko je bolus injiciran, je treba nadaljevati z infuzijo (glejte povzetek glavnih značilnosti zdravila TRACTOCILE 7, 5 mg/ ml, koncentrat za pripravo raztopine za infundiranje).
In the case of persistence of uterine contractions during treatment with TRACTOCILE, alternative therapy should be considered.
Če se kontrakcije maternice med zdravljenjem s TRACTOCILOM nadaljujejo, je treba razmisliti o alternativni terapiji.
There is no data available regarding the need for dose adjustments in patients with renal or liver insufficiency.
Podatkov o potrebni prilagoditvi odmerka pri bolnicah z insuficienco ledvic ali jeter ni.
2 The following table shows the full posology of the bolus injection followed by the infusion:
hitrost injiciranja/ infundiranja
Step 1 2
1 2 3
Regimen 0.9 ml intravenous bolus 3 hours intravenous loading infusion
intravenski bolus 0, 9 ml 3- urna intravenska polnilna infuzija nadaljnja intravenska infuzija
Injection/ infusion rate over 1 minute 24 ml/ hour
v 1 minuti 24 ml/ uro 8 ml/ uro
Atosiban dose 6.75 mg 18 mg/ hour
6, 75 mg 18 mg/ uro 6 mg/ uro
TRACTOCILE should not be used in the following conditions:
TRACTOCILE se ne sme uporabljati v naslednjih primerih:
− 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.
− gestacijska starost pod 24 ali nad 33 dopolnjenih tednov, − prezgoden razpok plodnega mehurja > 30 tednov gestacije, − intrauterini zaostanek v rasti in nenormalna srčna frekvenca ploda, − predporodna maternična krvavitev, ki zahteva takojšen porod, − eklampsija ali huda predeklampsija, ki zahtevata porod, − intrauterina smrt ploda, − sum na intrauterino okužbo, − placenta praevia, − abruptio placentae, − vsako drugo stanje pri materi in plodu, zaradi katerega je nadaljevanje nosečnosti tvegano, − znana preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys (see sections 4.2 and 5.2).
Z zdravljenjem z atosibanom ni izkušenj pri bolnicah z okvarjenim delovanjem jeter ali ledvic (glejte poglavji 4. 2 in 5. 2).
Atosiban has not been used in patients with an abnormal placental site.
Atosibana niso uporabljali pri bolnicah z nenormalnim položajem placente.
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.
Klinične izkušnje z uporabo atosibana pri večplodnih nosečnostih ali v gestacijski starosti od 24. do 27. tedna so zaradi majhnega števila zdravljenih bolnic omejene.
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).
Ponovno zdravljenje s TRACTOCILOM je mogoče, vendar so klinične izkušnje z večkratnimi ponovitvami (do 3 ponovna zdravljenja) omejene (glejte poglavje 4. 2).
In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of TRACTOCILE depends on the assessment of fetal maturity.
V primeru intrauterinega zavrtja rasti je odločitev za nadaljevanje ali ponoven začetek uporabe TRACTOCILA odvisna od ocene zrelosti ploda.
As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored.
Atosiban bi kot antagonist oksitocina teoretično lahko olajšal sprostitev maternice in poporodno krvavitev, zato je treba nadzirati izgubo krvi po porodu.
However, inadequate uterus contraction postpartum was not observed during the clinical trials.
Vendar v kliničnih raziskavah niso opažali nezadostnih kontrakcij maternice po porodu.
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.
Ni verjetno, da bi bil atosiban vpleten v medsebojno delovanje zdravil, posredovano s citokromom P450; preiskave in vitro namreč kažejo, da atosiban ni substrat sistema citokroma P450 in ne zavira encimov citokroma P450, ki presnavljajo zdravila.
Interaction studies were performed in healthy, female volunteers with betamethasone and labetalol.
Raziskave medsebojnega delovanja so bile narejene z betametazonom in labetalolom pri zdravih prostovoljkah.
No clinically relevant interaction was observed between atosiban and betamethasone.
Med atosibanom in betametazonom niso ugotovili klinično pomembnih interakcij.
When atosiban and labetalol were co-administrated, Cmax of labetalol was decreased by 36% and Tmax increased by 45 minutes.
Med sočasno uporabo atosibana in labetalola se je Cmax labetalola zmanjšala za 36%, tmax pa se je podaljšal za 45 minut.
However, the extent of labetalol bioavailability in terms of AUC did not change.
Kljub temu se biološka uporabnost labetalola glede na AUC ni spremenila.
The interaction observed has no clinical relevance.
Ugotovljeno medsebojno delovanje klinično ni pomembno.
Labetalol had no effect on atosiban pharmacokinetics.
Labetalol ni vplival na farmakokinetiko atosibana.
No interaction study has been performed with antibiotics, ergot alkaloids, and anti-hypertensive agents other than labetalol.
Raziskav medsebojnega delovanja z antibiotiki, alkaloidi ergot in antihipertenzivnimi zdravili (razen labetalola) ni bilo.