natgillin/translations-raw huggingface dataset:
During the period 2002-2012, a total of 210 cases including at least one adverse event after ritodrine treatment were reported. 
V obdobju od leta 2002 do 2012 so poročali o skupno 210 primerih, ki so vključevali vsaj en neželen dogodek po zdravljenju z ritodrinom.
CMDh Agreement 
Sporazum skupine CMDh
However these data only gave limited safety information. 
Vendar pa so iz teh podatkov pridobili malo informacij glede varnosti.
Careful control of the level of hydration is essential to avoid the risk of maternal pulmonary oedema. 
Skrben nadzor nad stopnjo hidracije je ključen za to, da se prepreči tveganje za maternalni pljučni edem.
Treatment should be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetus health status. 
Zdravljenje mora potekati v ustanovah, ki so dovolj dobro opremljene za stalno spremljanje zdravstvenega stanja matere in ploda.
This delay may be used to administer glucocorticoids or to implement other measures known to improve perinatal health. 
Ta zakasnitev se lahko izkoristi za dajanje glukokortikoidov ali izvajanje drugih ukrepov, ki lahko izboljšajo perinatalno zdravje.
The product information for these medicinal products should be updated accordingly; therefore these marketing authorisations should be varied. 
Informacije o zdravilu za ta zdravila je treba ustrezno posodobiti; posledično je treba spremeniti dovoljenja za promet z njimi.
Many of these reports occurred in association with both salbutamol intravenous (i.v.) 
Veliko teh primerov se je pojavilo tako v povezavi s salbutamolom za intravensko uporabo (i.v.)
Hibbard (1996) performed a casecontrol study to investigate whether there is an association between long-term oral terbutaline use and peripartum cardiomyopathy. 
Hibbardova (1996) je izvedla študijo „primer-kontrola“, da bi raziskala, ali obstaja povezava med dolgotrajno uporabo peroralnega terbutalina in peripartalno kardiomiopatijo.
Therefore, in order to help optimise safe and effective use, the gestational age should be reflected in the indication 
Da bi zagotovili čim varnejšo in učinkovitejšo uporabo, mora biti gestacijska starost vključena v indikacijo.
Hungary considered it was in the interest of the Union to refer the matter to the PRAC and expressed concerns with regards to the posology and warnings reflected in the product information. 
Madžarska je menila, da je v interesu Evropske unije, da zadevo napoti na odbor PRAC, in izrazila zaskrbljenost glede odmerjanja in opozoril, vključenih v informacije o zdravilu.
Furthermore, premature delivery is an established risk factor of neonatal morbidity and mortality. 
Poleg tega je prezgodnji porod znan dejavnik tveganja za neonatalno obolevnost in smrtnost.
Therefore these medicinal products should no longer be indicated in the obstetrics therapeutic indication. 
To pomeni, da ta zdravila ne smejo biti več indicirana za terapevtske indikacije v porodništvu.
In 10 clinical studies comprising 425 pregnant women, angina pectoris and arrhythmia were reported only in one case each. 
V 10 kliničnih študijah, ki so zajele 425 nosečnic, so poročali o samo enem primeru angine pektoris in enem primeru aritmije.
Approximately 9% of the 425 women in these trials were exposed to the oral formulation and approximately 2% of the reported adverse events were associated with the oral formulation of the drug. 
Približno 9 % od 425 žensk, ki so sodelovale v teh preskušanjih, je bilo izpostavljenih peroralni obliki zdravila, pri čemer sta bila s to obliko povezana približno 2 % neželenih dogodkov, o katerih so poročali.
Published studies deliver conflicting results and interpretations on the safety of terbutaline (and beta agonists) in tocolysis. 
Objavljene študije navajajo nasprotujoče si rezultate in razlage, povezane z varnostjo terbutalina (in beta agonistov) za tokolizo.
However, the CMDh considered that a minor change was necessary to the wording proposed in the conditions to the Marketing Authorisations (Annex IV). 
Vendar pa je menila, da je potrebna manjša sprememba predlaganega besedila za pogoje dovoljenj za promet z zdravili (Priloga IV).
The duration of treatment should not exceed 48 hours as data show that the main effect of tocolytic therapy is a delay in delivery of up to 48 hours. 
Zdravljenje ne sme trajati več kot 48 ur, saj podatki kažejo, da je glavni učinek zdravljenja s tokolitiki zakasnitev poroda za do 48 ur.
With the exception of reports on rhabdomyolysis and SCARs, the cases were mostly in accordance with the known safety profile of ritodrine. 
Z izjemo poročil o rabdomiolizi in hudih kožnih neželenih reakcijah so bili primeri večinoma v skladu z znanim varnostnim profilom ritodrina.
The conditions for the revocation of the marketing authorisations of these products, as applicable, are set out in Annex IV. 
Pogoji za razveljavitev dovoljenj za promet s temi zdravili so opredeljeni v Prilogi IV.
Scientific conclusions and grounds for revocation or variation as applicable to the terms of the marketing authorisations and detailed explanation for the differences from the PRAC recommendation 
Znanstveni zaključki in podlaga za razveljavitev dovoljenj za promet z zdravili ali spremembo pogojev dovoljenj za promet z zdravili ter podrobna obrazložitev odstopanj od priporočila odbora PRAC
The PRAC as well recommended that the use of the parental formulations for ECV and emergency is considered favourable where these indications are already authorised. 
PRAC je zaključil tudi, da je uporaba parenteralnih oblik za ECV in v nujnih primerih ustrezna, kjer so te indikacije že odobrene.
These should be administered as early as possible after the diagnosis of premature labour, and after evaluation of the patient to eliminate any contra-indications of use. 
To se mora začeti čim prej po diagnozi prezgodnjega poroda in po pregledu bolnice, med katerim se izključijo morebitne kontraindikacije uporabe.
The PRAC noted eight infant fatalities, two of which were in association with pulmonary oedema and cardiovascular events. 
PRAC je zabeležil osem primerov smrti otrok, od katerih sta bila dva povezana s pljučnim edemom in srčno-žilnimi dogodki.
Information on fatal foetal or neonatal conditions was not sufficient to draw any conclusions on the association with intrauterine exposure to terbutaline. 
Podatki o okoliščinah, ki so povzročile smrt ploda ali novorojenčka, niso zadoščali za to, da bi lahko potegnili zaključke glede povezave z intrauterino izpostavljenostjo terbutalinu.
For oral hexoprenaline there are very few safety data. 
Za peroralni heksoprenalin je na voljo zelo malo podatkov o varnosti.
A total of 98 reports which included cardiovascular events were identified, the majority of which were cardiac arrhythmias, such as, tachycardia or palpitations. 
Zabeleženih je bilo skupno 98 poročil, ki so vključevala srčno-žilne dogodke, med katerimi so bile v glavnem srčne aritmije, kot so tahikardija in palpitacije.
Regardless of this, 18 serious cardiovascular cases have been identified in EudraVigilance showing that, not only predisposed, but also otherwise healthy subjects have developed serious cardiovascular complications. 
Kljub temu pa so v sistemu EudraVigilance našli 18 resnih srčno-žilnih primerov, ki kažejo, da so se ne samo pri posameznicah, ki so bile nagnjene k temu, temveč tudi pri sicer zdravih posameznicah pojavili resni srčno-žilni zapleti.
The review of all cardiovascular events for salbutamol showed this medicinal product can induce serious cardiovascular adverse events, which can result in the death of the mother and/or foetus. 
Pregled vseh srčno-žilnih dogodkov za salbutamol je pokazal, da lahko to zdravilo povzroči resne srčno-žilne neželene dogodke, ki se lahko končajo s smrtjo matere in/ali ploda.
Two of the reports of tachycardia developed further and were fatal. 
V dveh primerih se je tahikardija nadalje razvila in povzročila smrt.
Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the PRAC recommends the variation to the terms of the marketing authorisations, or revocation, as applicable, for all medicinal products referred to in Annex I and for which the amendments to the product information are set out in Annex III of the recommendation. 
V skladu s členoma 31 in 32 Direktive 2001/83/ES zato PRAC priporoča spremembo pogojev dovoljenj za promet z zdravili ali razveljavitev dovoljenj za promet z zdravili za vsa zdravila, ki so navedena v Prilogi I in za katera so spremembe informacij o zdravilu navedene v Prilogi III k temu priporočilu.
This again highlights the importance of close medical surveillance during therapy, and questions the safety of outpatient tocolysis with terbutaline. 
To dejstvo znova opozarja na pomembnost natančnega zdravniškega nadzora med zdravljenjem in poraja vprašanja o varnosti ambulantne tokolize s terbutalinom.
These cases of adverse events under ritodrine therapy included both welldocumented case reports from the literature and cases recorded by the MAH from spontaneous reporting from healthcare personnel or Health Authorities. 
Ti primeri neželenih dogodkov med zdravljenjem z ritodrinom so vključevali tako izčrpno dokumentirana poročila o primerih iz literature kot tudi primere, ki jih je imetnik dovoljenja za promet zabeležil na podlagi spontanih poročil zdravstvenih delavcev ali zdravstvenih organov.
The CMDh proposed to shorten the time for recall of the products with only obstetric indications and for which revocation is applicable to ensure that prompt action is taken on products with no marketing authorisation. 
Skupina CMDh je predlagala skrajšanje roka za odpoklic zdravil, ki so odobrena samo za indikacije v porodništvu in za katere velja razveljavitev dovoljenj za promet, da se zagotovijo hitri ukrepi v zvezi z zdravili brez dovoljenja za promet.
The use of ritodrine is associated with risks of major cardiac and pulmonary dysfunction (rarely myocardial infarction), alteration in glycaemia and blood potassium concentration, gastro-intestinal disorders, tremors, headache and erythema. 
Uporaba ritodrina je povezana s tveganji za večje srčne in pljučne disfunkcije (redko srčni infarkt), spremembe koncentracij sladkorja in kalija v krvi, bolezni prebavil, tremorje, glavobol in eritem.
and oral salbutamol; it would appear that this adverse event is not specific to a particular formulation. 
kot tudi salbutamolom za peroralno uporabo, zato se zdi, da omenjeni neželeni dogodek ni vezan na določeno farmacevtsko obliko.
Fenoterol also contains descriptions of emergency uses in the indications such as dystocias in the dilation and expulsion stages of labour (such as uterine hyperactivity or spasm occurring either spontaneously or as a result of mechanical obstruction or over stimulation by oxytocic agents); intrauterine asphyxia (as indicated by signs such as foetal heart rate decelerations or incipient to moderate foetal acidosis); obstetric emergencies (such as cord prolapse or imminent uterine rupture); uterine relaxation in acute indications such as caesarean section. 
Fenoterol vsebuje tudi opise uporabe v nujnih primerih za indikacije, kot so distocije med porodom v fazi dilatacije in iztisa (na primer čezmerna aktivnost maternice ali maternični krči, ki se pojavijo spontano ali kot posledica mehanske ovire ali pretirane stimulacije z oksitocini); intrauterina asfiksija (ki se kaže z znaki, kot so upočasnjeno bitje srca ploda ali začetna do zmerna acidoza ploda); nujni porodniški primeri (na primer prolaps popkovnice ali preteča ruptura maternice); sprostitev maternice pri akutnih indikacijah, kot je carski rez.
For the oral and suppositories formulations in view of the overall available safety data, in particular in relation to the risk of serious cardiovascular events, and very limited efficacy data, the PRAC concluded in accordance with Article 116 of Directive 2001/83/EC that the benefit-risk balance is not favourable and therefore these medicinal products should no longer be indicated in the obstetrics therapeutic indication. 
v zvezi s peroralnimi oblikami in svečkami je PRAC na podlagi vseh razpoložljivih podatkov o varnosti, zlasti podatkov o tveganju za resne srčno-žilne dogodke, in zelo omejenih podatkov o učinkovitosti v skladu s členom 116 Direktive 2001/83/ES zaključil, da razmerje med tveganji in koristmi ni ugodno, zato ta zdravila ne smejo biti več indicirana za terapevtsko indikacijo v porodništvu;
Authorised obstetric indications for SABAs differ across Member States. 
Indikacije v porodništvu, ki so odobrene za kratkodelujoče beta agoniste, se v posameznih državah članicah razlikujejo.
The authorised obstetric indications include partus prematurus, tocolysis (for some products use is restricted to particular weeks of gestation but for others no specific gestation period is specified), external cephalic version (ECV), and hyper-uterine contractility. 
Odobrene indikacije v porodništvu vključujejo partus prematurus, tokolizo (uporaba nekaterih zdravil je omejena na določene tedne nosečnosti, pri drugih pa ni opredeljenega posebnega obdobja nosečnosti), zunanji obrat otroka v glavično vstavo (external cephalic versionECV) in čezmerne kontrakcije maternice.
Occurrence of typical adverse effects characteristic of beta receptor stimulation are well documented, and range from mild and transient discomfort to serious cardiovascular side effects requiring prompt medical intervention, e.g. in case of arrhythmias or pulmonary oedema. 
Tipični neželeni učinki, ki se pogosto pojavijo pri stimulaciji receptorjev beta, so izčrpno dokumentirani in vključujejo vse od blagega in prehodnega neugodja do resnih srčnožilnih neželenih učinkov, ki zahtevajo takojšnjo zdravniško oskrbo - na primer v primeru aritmij in pljučnega edema.
On 27 November 2012, further to evaluation of data resulting from pharmacovigilance activities, Hungary informed the European Medicines Agency, pursuant to Article 31 of Directive 2001/83/EC, of their consideration that the risk-benefit balance of short-acting beta-agonists (SABAs) containing medicinal products authorised in obstetric indications has become unfavourable, taking into account the cardiovascular events reported. 
27. novembra 2012 je Madžarska po pregledu podatkov, pridobljenih med izvajanjem dejavnosti farmakovigilance, v skladu s členom 31 Direktive 2001/83/ES obvestila Evropsko agencijo za zdravila, da meni, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo kratkodelujoče beta agoniste (SABA) in so odobrena za indikacije v porodništvu, postalo neugodno, če se upoštevajo poročila o srčno-žilnih dogodkih.
A review of safety data for fenoteral showed that the cardiovascular events tachycardia and palpitations were frequently reported in clinical studies and are listed as very common side effects of the drug. 
Pregled podatkov o varnosti fenoterala je pokazal, da so v kliničnih študijah pogosto poročali o srčno-žilnih dogodkih tahikardiji in palpitacijah, ki so navedeni kot zelo pogosti neželeni učinki zdravila.
In addition specific guidance on the method of administration should be given for these injectable formulations. 
Poleg tega so za te oblike za injiciranje potrebna podrobna navodila v zvezi z načinom dajanja.
Some of the products for oral use or suppositories referred in this procedure are authorised only in obstetric indications. 
Nekatera zdravila za peroralno uporabo in svečke, ki so jih obravnavali v tem postopku, so odobreni samo za indikacije v porodništvu.
During this review, data from clinical studies, post-marketing reporting and published literature, including relevant treatment guidelines, have been assessed. 
Med tem pregledom so bili ocenjeni podatki iz kliničnih študij, poročil iz obdobja trženja in objavljene literature, vključno z zadevnimi smernicami za zdravljenje.
There is hardly any evidence of maternal death in these studies and very limited data on adverse foetal outcomes (e.g. tachycardia, hyperinsulinaemia). 
Podatkov o smrti mater v teh študijah skoraj ni, o neželenih izidih pri plodu (npr. tahikardiji in hiperinzulinemiji) pa je na voljo zelo malo podatkov.
The seriousness of AEs seems to be directly related to the dose of ritodrine administered to the patient, but also to the treatment duration as most of life-threatening AEs occurred after prolonged ritodrine administration (>72h to months). 
Zdi se, da je stopnja resnosti neželenih dogodkov neposredno povezana z odmerkom ritodrina, ki ga prejme bolnica, pa tudi s trajanjem zdravljenja, saj se je večina smrtno nevarnih neželenih dogodkov pojavila po daljši uporabi ritodrina (od več kot 72 ur do več mesecev).
The PRAC identified serious limitations of the efficacy data for oral and suppository formulations, and noted the available new evidence and/or current medical knowledge on the use of these products for obstetric indications. 
PRAC je ugotovil, da so podatki o učinkovitosti peroralnih oblik in svečk zelo pomanjkljivi, ter upošteval razpoložljive nove dokaze in/ali trenutna medicinska spoznanja o uporabi teh zdravil za indikacije v porodništvu.
For the oral tablet, three serious AEs were reported (loss of consciousness, trismus and a serious skin reaction), and six nonserious AEs for the tablet. 
Pri uporabi peroralnih tablet so poročali o treh resnih neželenih dogodkih (izgubi zavesti, trizmusu in resni kožni reakciji) ter šestih neželenih dogodkih, ki niso bili resni.
There were a number of reports of pulmonary oedema contributing to the events and one case reported pulmonary oedema in association with cardiomegaly, after taking a course of tablets for five weeks, when tocolysis failed. 
Zabeležili so številna poročila o pljučnem edemu kot enem od vzrokov za dogodke in eno poročilo o pljučnem edemu v povezavi s kardiomegalijo po 5-tedenskem zdravljenju s tabletami, potem ko tokoliza ni bila uspešna.
This should include an adequate assessment of the patient's cardiovascular status with monitoring by electrocardiogram (ECG) throughout treatment in order to identify the early onset of cardiovascular events and further minimise the risk of a serious cardiovascular event. 
Med drugim je treba v času zdravljenja izvajati preglede z elektrokardiogramom (EKG), s katerimi se ustrezno oceni stanje srca in ožilja bolnice, tako da se lahko prepozna začetne znake srčno-žilnih dogodkov ter dodatno zmanjša tveganje za resne srčno-žilne dogodke.
This review by PRAC assessed all existing data in terms of safety of cardiovascular events when in use in these indications and the outcome of the review is summarised below. 
V tem pregledu je odbor PRAC ocenil vse razpoložljive podatke glede varnosti v povezavi s srčno-žilnimi dogodki pri uporabi za te indikacije; izid pregleda je povzet v nadaljevanju.
Having considered the cardiovascular adverse reactions profile associated with the use of these medicinal products in obstetric indications, the PRAC concluded that oral forms and suppositories should no longer be used to supress contractions of the womb. 
Potem ko je proučil profil srčno-žilnih neželenih učinkov, povezanih z uporabo teh zdravil za indikacije v porodništvu, je PRAC zaključil, da se peroralne oblike in svečke ne smejo več uporabljati za zmanjševanje krčenja maternice.
The Committee concluded that there was need for further risk minimisation measures such as information to healthcare professionals to inform on the outcome of the review and the safe use of the parenteral formulations in the obstetric indications. 
odbor je zaključil, da so potrebni dodatni ukrepi za zmanjšanje tveganja, na primer informacije za zdravstvene delavce, da se jih seznani z izidom tega pregleda in z varno uporabo parenteralnih farmacevtskih oblik za indikacije v porodništvu.
Safety data from MAH clinical trials and meta-analyses of well-designed clinical trials have been assessed. 
Ocenjeni so bili podatki o varnosti iz kliničnih preskušanj imetnika dovoljenja za promet z zdravilom in meta analiz dobro zasnovanih kliničnih preskušanj.
For these specific products a recall of the products is being recommended by the PRAC. 
Za ta zdravila je PRAC priporočil odpoklic s trga.
The risk to the mother and foetus could be minimised if active substances are administered by obstetricians/physicians experienced in the use of tocolytic agents. 
Tveganje za mater in plod je mogoče zmanjšati, če zdravilne učinkovine daje porodničar ali zdravnik, ki ima izkušnje z uporabo tokolitikov.
Both formulations of hexoprenaline are also indicated for immobilisation of the uterus pre, during and post cerclage surgery. 
Obe farmacevtski obliki heksoprenalina sta indicirani še za imobilizacijo maternice pred in med cerklažo ter po njej.
The short-acting beta-agonists (SABAs) (also known as beta-mimetics), salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine are all nationally authorised and have been on the market within the EU since the 1960s. 
Kratkodelujoči beta agonisti (SABA) (znani tudi pod imenom beta mimetiki) salbutamol, terbutalin, fenoterol, ritodrin, heksoprenalin in izoksuprin so odobreni na nacionalni ravni in so na trgu znotraj EU na voljo od 60. let prejšnjega stoletja.
As part of the risk minimisation measures the PRAC proposed revised indications for the parenteral formulations taking all the data into account, and making clear the conditions for which these products are indicated. 
V okviru ukrepov za zmanjšanje tveganja je PRAC predlagal spremenjene indikacije za parenteralne farmacevtske oblike v skladu z vsemi podatki in jasno opredelitvijo zdravstvenih stanj, za katera so tovrstna zdravila indicirana.
Oral, parenteral and suppositories formulations have been included in this assessment. 
V postopek ocenjevanja so bile vključene peroralne in parenteralne oblike ter svečke.
Even after correction of potentially confounding variables, the relationship remained significant between long-term oral terbutaline therapy for preterm labour and subsequent peripartum cardiomyopathy. 
Tudi po prilagoditvi možnih drugih sočasnih dejavnikov, je bila povezava med dolgotrajnim zdravljenjem s peroralnim terbutalinom za preprečitev prezgodnjega poroda in poznejšo peripartalno kardiomiopatijo še vedno izrazita.
The CMDh, having considered the PRAC recommendation dated 5 September 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the variation or revocation as applicable of the marketing authorisations of terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol and isoxsuprine containing products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV. 
Skupina CMDh je na podlagi proučitve priporočila, ki ga je dne 5. septembra 2013 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES izdal PRAC, sprejela sporazum o spremembi ali razveljavitvi dovoljenj za promet z zdravili, ki vsebujejo terbutalin, salbutamol, heksoprenalin, ritodrin, fenoterol in izoksuprin, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III, in pod pogoji, določenimi v Prilogi IV.
Isoxsuprine and hexoprenaline tablets also have ‘threatened abortion' within the indications and a posology for prophylaxis of labour. 
Tablete izoksuprina in heksoprenalina imajo tudi indikacijo „grozeč splav“ in odmerjanje za preprečevanje poroda.
a. Oral and suppository formulations which are only authorised in the indications proposed to be removed (in accordance with changes to the product information as set out in Annex III) should have their marketing authorisations revoked and should be recalled within given deadlines. 
a. Dovoljenja za promet s peroralnimi oblikami in svečkami, ki so odobrene samo za indikacije, ki naj bi bile odstranjene (v skladu s spremembami informacij o zdravilu, opredeljenimi v Prilogi III), je treba razveljaviti in zadevna zdravila v določenih rokih odpoklicati s trga.
According to the published studies intravenous administration of hexoprenaline is very commonly accompanied with occurrence of adverse drug reactions. 
Po podatkih objavljenih študij je intravensko dajanje heksoprenalina zelo pogosto povezano s pojavom neželenih učinkov zdravila.