natgillin/translations-raw huggingface dataset:
It was concluded that, although Combimox was shown to be similar to the reference product with respect to formulation, particle size and viscosity, this could only be seen as supportive in this case and could not substitute clinical studies to demonstrate efficacy.
Sklenjeno je bilo, da je bilo sicer dokazano, da je zdravilo Combimox podobno referenčnemu zdravilu glede formulacije, velikosti delcev in viskoznosti, vendar pa so v tem primeru to lahko le podporni podatki in ne morejo nadomestiti kliničnih študij za dokazovanje učinkovitosti.
When preparing the approach used to investigate similarity in terms of efficacy for Combimox, the applicant had not pursued conducting comparative clinical studies since it was expected that clinical trials would not be sensitive enough to pick up differences between Combimox and the reference product.
Predlagatelj pri pripravi pristopa, ki ga je uporabil za preučevanje podobnosti v zvezi z učinkovitostjo zdravila Combimox, ni izvedel primerjalnih kliničnih študij, saj je bilo pričakovano, da klinični preskusi ne bodo dovolj občutljivi, da bi odkrili razlike med zdravilom Combimox in referenčnim zdravilom.
Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals
Intramamarna uporaba pri govedu v obdobju laktacije z odmerkom treh brizg na prizadeto četrtino, ki se daje samostojno vsakih 12 ur
In support of Combimox, studies were submitted to compare milk and plasma pharmacokinetics between the generic and reference products.
V podporo zdravilu Combimox so bile predložene študije, v katerih so primerjali farmakokinetiko pri mleku in plazmi med generičnimi in referenčnimi zdravili.
The applicant further claimed that the formulation of Combimox was sufficiently similar to the reference product to allow a waiver from the need to present in vivo data.
Predlagatelj je trdil tudi, da je formulacija zdravila Combimox dovolj podobna referenčnemu zdravilu, da dopušča opustitev potrebe po predstavitvi podatkov in vivo.
The results of the milk studies demonstrated that the concentrations of the active substances were similar to those of the reference product following the intramammary infusion of Combimox, although it was noted that there was considerable inter-quarter and inter-animal variability in each of the pharmacokinetic parameters measured.
Rezultati študij pri mleku so pokazali, da so bile koncentracije zdravilne učinkovine po intramamarni infuziji zdravila Combimox podobne kot pri referenčnem zdravilu, čeprav je bilo ugotovljeno, da so se pri vsakem merjenem farmakokinetičnem parametru pojavljale bistvene razlike med četrtinami in živalmi.
Combimox is intended for the treatment of mastitis in lactating cows caused by the major pathogens commonly occurring from the bovine udder (Staphylococci, Streptococci and Escherichia coli).
Zdravilo Combimox je namenjeno zdravljenju mastitisa pri kravah v obdobju laktacije, ki ga povzročajo poglavitni patogeni, ki se običajno pojavljajo na vimenu govedi (stafilokoki, streptokoki in Escerichia coli).
Combimox Lactating Cow Intramammary Suspension (hereinafter referred to as Combimox) is an intramammary suspension containing amoxicillin (as amoxicillin trihydrate), clavulanic acid (as potassium clavulanate) and prednisolone.
Zdravilo Combimox Lactating Cow Intramammary Suspension (v nadaljevanju zdravilo Combimox) je intramamarna suspenzija, ki vsebuje amoksicilin (v obliki amoksicilin trihidrata), klavulansko kislino (v obliki kalijevega klavulanata) in prednizolon.
Combimox is presented in unit-dose syringes as an oily suspension to be administered via the intramammary route.
Zdravilo Combimox je na voljo v enoodmernih brizgah kot oljna suspenzija, ki se daje po intramamarni poti.
• the proposed withdrawal period for Combimox was insufficiently substantiated;
• Predlagana karenca za zdravilo Combimox ni bila ustrezno utemeljena.
This study also served to provide data on the residues of amoxicillin and clavulanic measured in the (udder) quarter milk samples obtained at regular timepoints after infusion of Combimox and the reference product.
S to študijo so dobili tudi podatke o ostankih amoksicilina in klavulanske kisline, izmerjenih v vzorcih mleka iz četrtin (vimen), ki so bili pridobljeni v rednih obdobjih po infundiranju zdravila Combimox in referenčnega zdravila.
When asked to further substantiate this claim, the applicant provided comparative data on the physico-chemical characteristics of the product, including viscosity, particle size and dissolution in milk, between Combimox and the reference product.
Ko so od predlagatelja zahtevali, da to trditev podrobneje utemelji, je predložil primerjalne podatke med zdravilom Combimox in referenčnim zdravilom o fizikalno-kemičnih lastnostih zdravila, vključno z viskoznostjo, velikostjo delcev in raztapljanjem v mleku.
Overall summary of the scientific evaluation of Combimox Lactating Cow Intramammary Suspension
Splošni povzetek znanstvenega vrednotenja zdravila Combimox Lactating Cow Intramammary Suspension
Lactating cattle
Govedo v obdobju laktacije
Grounds for refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisation
Podlaga za zavrnitev odobritve dovoljenja za promet z zdravilom in začasni umik obstoječih dovoljenj za promet z zdravilom
Three comparative pharmacokinetic studies were carried out with Combimox and the reference product, all with a two-period cross-over design.
Izvedene so bile tudi tri navzkrižne primerjalne farmakokinetične študije z dvema obdobjema, v katerih so primerjali zdravilo Combimox in referenčno zdravilo.
Overall safety conclusions
Splošni zaključki glede varnosti
c. All marketing authorisation holders should implement risk minimisation measures.
c. Vsi imetniki dovoljenj za promet z zdravili morajo izvajati ukrepe za zmanjšanje tveganja.
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.