natgillin/translations-raw huggingface dataset:
The company has presented data from both laboratory and field studies to establish the safety and effectiveness of the vaccine, including how long it took for the dogs to be fully protected and how long the vaccine could provide protection.
Družba je predstavila podatke iz laboratorijskih in terenskih študij, s katerimi je določila varnost in učinkovitost cepiva, vključno s podatkom, kako dolgo traja, da je pes popolnoma zaščiten, ter kako dolgo cepivo zagotavlja zaščito.
An occasional temporary, acute (short-term) hypersensitivity (allergic) reaction may occur.
Občasno se lahko pojavi prehodna akutna (kratkotrajna) preobčutljivostna (alergijska) reakcija.
This will help protect them against leptospirosis.
To jim bo pomagalo pri zaščiti pred leptospirozo.
It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Pojasnjuje, kako je agencija ocenila zdravilo za uporabo v veterinarski medicini, na podlagi česar je priporočila njegovo odobritev v Evropski uniji (EU) in pogoje njegove uporabe.
Protection starts three weeks after vaccination and lasts one year.
Zaščita je učinkovita od tretjega tedna po cepljenju in traja eno leto.
The full EPAR for Canigen L4 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Canigen L4 je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Canigen L4's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Canigen L4 večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This vaccine is the same as Nobivac L4, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Nobivac L4, ki je že odobreno v Evropski uniji (EU).
Canigen L4 contains four types of inactivated (killed) Leptospira strains: L. interrogans serogroup Canicola serovar Portland-vere, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, L. kirschneri serogroup Grippotyphosa serovar Dadas.
Zdravilo Canigen L4 vsebuje štiri vrste inaktiviranih (mrtvih) sevov bakterije Leptospira: serološko skupino L. interrogans Canicola serovar Portland-vere, serološko skupino L. interrogans Icterohaemorrhagiae serovar Copenhageni, serološko skupino L. interrogans Australis serovar Bratislava in serološko skupino L. kirschneri Grippotyphosa serovar Dadas.
This is a summary of the European public assessment report (EPAR) for Canigen L4.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Canigen L4.
In dogs, leptospirosis can cause bleeding, hepatitis (inflammation of the liver) and jaundice (yellowing of the skin and eyes) or nephritis (kidney inflammation).
Pri psih lahko leptospiroza povzroči krvavitev, hepatitis (vnetje jeter), zlatenico (porumenelost kože in oči) ali nefritis (vnetje ledvic).
The bacteria are spread via the urine of infected animals.
Bakterija se širi z urinom okuženih živali.
In the future, if the animals are exposed to these Leptospira bacteria the immune system will be able to respond more quickly.
Če so živali pozneje izpostavljene tem vrstam bakterije Leptospira, se lahko imunski sistem nanje hitreje odzove.
A small, temporary swelling may occur at the injection site, which will either disappear or reduce in size within two weeks after vaccination.
Na mestu injiciranja se lahko pojavi majhna prehodna oteklina, ki izgine ali se zmanjša v dveh tednih po cepljenju.
Canigen L4 is a veterinary vaccine used to vaccinate dogs from six weeks of age to protect against leptospirosis caused by one of four specific types of Leptospira bacteria.
Zdravilo Canigen L4 je veterinarsko cepivo, ki se uporablja za cepljenje psov, starih šest tednov ali več, za zaščito pred leptospirozo, ki jo povzroča ena od štirih specifičnih vrst bakterije Leptospira.
The European Commission granted a marketing authorisation valid throughout the EU for Canigen L4 on 3 July 2015.
Evropska komisija je dovoljenje za promet z zdravilom Canigen L4, veljavno po vsej Evropski uniji, izdala 3. julija 2015.
They also showed that the vaccine is safe to give to pregnant bitches.
Pokazale so tudi, da je cepivo varno za uporabo pri brejih psicah.
Canine leptospirosis vaccine (inactivated)
cepivo proti pasji leptospirozi (inaktivirano)
The studies showed that the vaccine reduces infection with Leptospira and excretion of the bacteria into the urine.
Študije so pokazale, da cepivo zmanjša okužbo z bakterijo Leptospira in njeno izločanje v urin.
For some strains of Leptospira, the vaccine also reduces the excretion (shedding) of the bacteria into the urine by the infected dogs, thereby reducing the risk of transmission.
Pri nekaterih sevih bakterije Leptospira cepivo prav tako zmanjša izločanje (razsejanje) bakterij v urin okuženih psov in tako zmanjšuje tveganje prenosa.
The strains of Leptospira bacteria in Canigen L4 are killed (inactivated) so that they do not cause disease.
Sevi bakterije Leptospira v zdravilu Canigen L4 so mrtvi (inaktivirani), zato ne povzročajo bolezni.
Canigen L4 is available as a suspension for injection and can only be obtained with a prescription.
Zdravilo Canigen L4 je na voljo v obliki suspenzije za injiciranje in se izdaja le na recept.
A mild and temporary increase in body temperature (1°C or less) may occur for a few days after vaccination, with some puppies showing less activity and/or a reduced appetite.
Za nekaj dni po cepljenju se lahko blago in prehodno poveča telesna temperatura (za 1 °C ali manj), zaradi česar so lahko nekateri mladiči manj aktivni in/ali imajo zmanjšan tek.
The company that makes Nobivac L4 has agreed that its scientific data can be used for Canigen L4 (‘informed consent').
Družba, ki proizvaja zdravilo Nobivac L4, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Canigen L4 („uporaba dokumentacije s soglasjem“).
Canigen L4 is a vaccine.
Zdravilo Canigen L4 je cepivo.
When Canigen L4 is given to dogs the animals' immune system recognises the bacteria as ‘foreign' and makes defences against them.
Ko pse cepimo z zdravilom Canigen L4, njihov imunski sistem bakterije prepozna kot „tujke“ in proti njim razvije obrambo.
For more information about treatment with Canigen L4, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Canigen L4 naj lastniki ali imetniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For practical information about using Canigen L4, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Canigen L4 naj lastniki ali imetniki živali preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What is Canigen L4 and what is it used for?
Kaj je zdravilo Canigen L4 in za kaj se uporablja?
What are the risks associated with Canigen L4?
Kakšna tveganja so povezana z zdravilom Canigen L4?
Other information about Canigen L4
Druge informacije o zdravilu Canigen L4
A single ‘booster' injection should be given every year to maintain the vaccine's effect.
Za vzdrževanje učinka cepiva je treba nato vsako leto psu injicirati enkratni obnovitveni odmerek.
What benefits of Canigen L4 have been shown in studies?
Kakšne koristi je zdravilo Canigen L4 izkazalo v študijah?
Why is Canigen L4 approved?
Zakaj je bilo zdravilo Canigen L4 odobreno?
The vaccine is given to dogs as two injections, four weeks apart, under the skin.
Cepivo se psu vbrizga v podkožje z dvema injekcijama, med katerima mora biti štiritedenski premor.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom high levels of maternally derived antibodies (special type of proteins, received from the mother in the milk, that help the body to fight infection), it is recommended that the first vaccination is given at nine weeks of age.
Kadar je znano, da imajo mladiči visoko raven maternalno pridobljenih protiteles (posebna vrsta beljakovin, ki jih prejmejo z materinim mlekom in ki pomagajo pri boju z okužbo), je prvo cepljenje priporočeno pri starosti devet tednov.
How is Canigen L4 used?
Kako se zdravilo Canigen L4 uporablja?
It is not intended to provide practical advice on how to use Canigen L4.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How does Canigen L4 work?
Kako zdravilo Canigen L4 deluje?
The European Commission granted a marketing authorisation valid throughout the European Union for Otezla on 15 January 2015.
Evropska komisija je dovoljenje za promet z zdravilom Otezla, veljavno po vsej Evropski uniji, izdala 15. januarja 2015.
These usually occur within the first two weeks of treatment, and get better within 4 weeks.
Ti se običajno pojavijo v prvih dveh tednih zdravljenja in se izboljšajo v štirih tednih.
What measures are being taken to ensure the safe and effective use of Otezla?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Otezla?
The medicine is available as tablets (10, 20 and 30 mg).
Zdravilo je na voljo v obliki tablet (10 mg, 20 mg in 30 mg).
The full EPAR and risk management plan summary for Otezla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Otezla sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Otezla and what is it used for?
Kaj je zdravilo Otezla in za kaj se uporablja?
Treatment is started with a dose of 10 mg on day 1 and gradually increased over a week to the recommended dose of 30 mg twice a day.
Začetni odmerek na prvi dan zdravljenja je 10 mg, nato pa se v enem tednu postopno poveča na priporočeni odmerek 30 mg dvakrat dnevno.
It is not intended to provide practical advice on how to use Otezla.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Otezla must not be used during pregnancy, and women who can become pregnant should use an effective means of contraception during treatment.
Zdravilo Otezla se ne sme uporabljati med nosečnostjo, zato morajo ženske, ki lahko zanosijo, med zdravljenjem uporabljati učinkovito kontracepcijsko sredstvo.
Patients who were already taking other so-called ‘small-molecule DMARDs' such as the medicine methotrexate continued this treatment during the study.
Bolniki, ki so že jemali druge tako imenovane „nizkomolekularne DMARD“, kot je zdravilo metotreksat, so s tovrstnim zdravljenjem nadaljevali tudi med študijo.
What benefits of Otezla have been shown in studies?
Kakšne koristi je zdravilo Otezla izkazalo v študijah?
Of the patients given Otezla in these two studies, 33% (168 of 562) and 29% (79 of 274) responded to treatment.
Med bolniki, ki so prejemali zdravilo Otezla v teh dveh študijah, se je na zdravljenje odzvalo 33 % (168 od 562) in 29 % (79 od 274) bolnikov.
A risk management plan has been developed to ensure that Otezla is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Otezla je bil pripravljen načrt obvladovanja tveganj.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Otezla's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Otezla večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Otezla may be used alone or combined with other DMARDs.
Zdravilo Otezla se lahko uporablja samostojno ali v kombinaciji z drugimi DMARD.
This was achieved in between 32 and 41% of patients given the approved dose of Otezla in the three studies, compared with 18 to 19% of those given placebo.
Takšno izboljšanje je doseglo od 32 do 41 % bolnikov, ki so prejemali odobreni odmerek zdravila Otezla v treh glavnih študijah, v primerjavi z 18 do 19 % tistih, ki so prejemali placebo.
The main measure of effectiveness in both studies was the proportion of patients who ‘responded' to treatment after 16 weeks.
Glavno merilo učinkovitosti v obeh študijah je bil delež bolnikov, ki so se odzvali na zdravljenje po 16 tednih.
The Committee therefore considered that it was useful as a second-line treatment in patients who do not respond to or cannot use the first-line treatments.
Odbor je zato menil, da je zdravilo koristno kot zdravilo druge izbire pri bolnikih, ki se niso odzvali na zdravila prve izbire ali teh ne morejo jemati.
This is a summary of the European public assessment report (EPAR) for Otezla.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Otezla.
• moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin).
• zmerno do hudo psoriazo v plakih (boleznijo, ki povzroča rdeče, luskaste zaplate na koži).
Otezla is a medicine used to treat adults with:
Zdravilo Otezla se uporablja za zdravljenje odraslih z:
This compared with 5% (15 of 282) and 6% (8 of 137) given placebo.
Pri placebu sta ta deleža znašala 5 % (15 od 282) in 6 % (8 od 137).
PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen' before being exposed to ultraviolet light.
PUVA je vrsta zdravljenja, pri katerem bolnik prejme zdravilo, ki vsebuje spojino „psoralen“, nato pa je izpostavljen ultravijolični svetlobi;
What are the risks associated with Otezla?
Kakšna tveganja so povezana z zdravilom Otezla?
Why is Otezla approved?
Zakaj je bilo zdravilo Otezla odobreno?
The main measure of effectiveness was a 20% improvement in a score measuring symptoms such as tender and swollen joints (ACR-20) after 16 weeks of treatment.
Glavno merilo učinkovitosti je bilo 20-odstotno izboljšanje ocene simptomov, kot so občutljivi in otekli sklepi (ACR-20), po 16 tednih zdravljenja.
Benefit was seen both in patients taking Otezla alone and those also taking other DMARDs.
Koristi so opazili tako pri bolnikih, ki so prejemali samo zdravilo Otezla, kot pri tistih, ki so prejemali tudi druge DMARD.
For psoriatic arthritis, Otezla has been compared with placebo in 3 main studies, involving 1,493 patients with active disease despite prior treatment.
Kar zadeva zdravljenje psoriatičnega artritisa, so zdravilo Otezla primerjali s placebom v treh glavnih študijah, v katerih je sodelovalo 1 493 bolnikov, pri katerih je bila bolezen aktivna kljub predhodnemu zdravljenju.
Response to treatment should be evaluated regularly and use of Otezla should be reconsidered if there is no improvement after six months.
Redno je treba ocenjevati, kako se bolnik odziva na zdravljenje, in če po šestih mesecih ni opaziti izboljšanja, je treba premisliti o smiselnosti nadaljnje uporabe zdravila Otezla.
Although the medicine had not been compared with other authorised treatments, and for psoriatic arthritis X-ray evidence of an effect on the progress of the disease was not available, the mostly mild or moderate side effects and the fact that the medicine could be taken by mouth might make it more acceptable to patients.
Čeprav zdravila niso primerjali z drugimi odobrenimi zdravili in pri psoriatičnem artritisu niso bile na voljo rentgenske slike, ki bi dokazovale učinek na napredovanje bolezni, bi utegnilo biti zdravilo Otezla zaradi blagih do zmernih neželenih učinkov in peroralnega načina uporabe bolj sprejemljivo za bolnike.
The other common side effects (which may affect up to 1 in 10 people) are upper respiratory tract infections (colds) and headaches or tension headaches.
Drugi pogosti neželeni učinki (ki lahko prizadenejo največ 1 osebo od 10) so okužbe zgornjih dihal (prehladi) in glavoboli ali tenzijski glavoboli.
Lower doses should be given to patients with severe impairment of kidney function.
Bolnikom s hudo okvaro delovanja ledvic je treba predpisati manjše odmerke.
For more information about treatment with Otezla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Otezla preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
• active psoriatic arthritis (inflammation of the joints associated with psoriasis) in patients who cannot take or who have not responded well enough to other treatments called disease-modifying antirheumatic drugs (DMARDs).
• aktivnim psoriatičnim artritisom (vnetjem sklepov, povezanim s psoriazo) pri bolnikih, ki ne smejo jemati drugih zdravil, imenovanih antirevmatična zdravila, ki modificirajo bolezen (DMARD), ali pa se nanje niso dovolj dobro odzvali.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Otezla, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Otezla in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
How is Otezla used?
Kako se zdravilo Otezla uporablja?
By blocking PDE4, apremilast reduces the level of these cytokines in the body, and so reduces the inflammation and other symptoms of psoriasis and psoriatic arthritis.
Apremilast z zaviranjem PDE4 znižuje raven teh citokinov v telesu ter tako zmanjšuje vnetje in druge simptome psoriaze in psoriatičnega artritisa.
Response to treatment was defined as patients having a 75% or more reduction in a symptom score known as Psoriasis Area Severity Index (PASI-75).
Odziv na zdravljenje je bil opredeljen kot vsaj 75-odstotno zmanjšanje ocene simptomov po lestvici, imenovani indeks jakosti psoriaze in telesne površine, prizadete s psoriazo (PASI-75).
It is used in patients who have not responded to or cannot use other systemic (affecting the whole body) treatments for psoriasis, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A).
Uporablja se pri bolnikih, ki se niso odzvali na druge vrste sistemskega zdravljenja (zdravljenja, ki deluje na celotno telo) psoriaze, kot so zdravljenje s ciklosporinom, metotreksatom ali PUVA (psoralen in obsevanje z ultravijolično svetlobo A), ali pa teh vrst zdravljenja ne morejo uporabljati.
The active substance in Otezla, apremilast, blocks the action of an enzyme inside cells called phosphodiesterase 4 (PDE4).
Zdravilna učinkovina zdravila Otezla, apremilast, zavira delovanje encima v celicah, imenovanega fosfodiesteraza 4 (PDE4).
This enzyme plays a role in triggering the production of messenger molecules in the immune system (the body's natural defences) called cytokines, which are involved in the inflammation and other processes that cause psoriasis and psoriatic arthritis.
Ta encim sodeluje pri proženju tvorbe signalnih molekul, imenovanih citokini, v imunskem sistemu (naravni obrambi telesa), citokini pa sodelujejo pri vnetnih in drugih procesih, ki povzročajo psoriazo in psoriatični artritis.
Otezla can only be obtained with a prescription and treatment should only be started by a doctor experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis.
Izdaja zdravila Otezla je le na recept, zdravljenje pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze ali psoriatičnega artritisa.
For both psoriasis and psoriatic arthritis benefit there was evidence of maintained benefit when treatment was extended (to 32 and 52 weeks respectively).
Tako pri psoriazi kot pri psoriatičnem artritisu so se koristi ohranile tudi, kadar so bolniki nadaljevali z zdravljenjem (do 32 tednov pri psoriazi in do 52 tednov pri psoriatičnem artritisu).
In psoriasis, Otezla has been investigated in 2 main studies involving a total of 1,257 patients with moderate to severe plaque psoriasis, in which treatment with Otezla was compared with placebo (a dummy treatment).
Kar zadeva zdravljenje psoriaze, so zdravilo Otezla preučevali v dveh glavnih študijah, v kateri je bilo vključenih skupno 1 257 bolnikov z zmerno do hudo psoriazo v plakih in v katerih so to zdravilo primerjali s placebom (zdravilom brez zdravilne učinkovine).
The most common side effects with Otezla (which may affect more than 1 in 10 people) are effects on the digestive system such as diarrhoea and nausea (feeling sick).
Najpogostejši neželeni učinki zdravila Otezla (ki lahko prizadenejo več kot 1 osebo od 10) so učinki na prebavni sistem, kot sta driska in navzeja (slabost).
Other information about Otezla
Druge informacije o zdravilu Otezla
For the full list of all side effects and restrictions with Otezla, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri zdravilu Otezla glejte navodilo za uporabo.
For practical information about using Otezla, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Otezla naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The CHMP considered that benefit had been shown in psoriasis and psoriatic arthritis.
CHMP je menil, da je zdravilo izkazalo koristi pri zdravljenju psoriaze in psoriatičnega artritisa.
Otezla contains the active substance apremilast.
Zdravilo Otezla vsebuje zdravilno učinkovino apremilast.
How does Otezla work?
Kako zdravilo Otezla deluje?
Treatment should be started as soon as possible after diagnosis of pre-term labour.
Zdravljenje je treba začeti čim prej po diagnozi prezgodnjega poroda.
The full EPAR for Atosiban SUN can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Atosiban SUN je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
• redne kontrakcije maternice, ki trajajo vsaj 30 sekund, s pogostnostjo najmanj štiri v 30 minutah,
This means that Atosiban SUN is similar to a ‘reference medicine' already authorised in the European Union (EU) called Tractocile.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Tractocile.
The European Commission granted a marketing authorisation valid throughout the European Union for Atosiban SUN on 31 July 2013.
Evropska komisija je dovoljenje za promet z zdravilom Atosiban SUN, veljavno po vsej Evropski uniji, odobrila dne 31. julija 2013.
This is a summary of the European public assessment report (EPAR) for Atosiban SUN.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Atosiban SUN.
What measures are being taken to ensure the safe and effective use of Atosiban SUN?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Atosiban SUN?
If contractions come back, treatment with Atosiban SUN can be repeated up to three more times during the pregnancy.
Če se kontrakcije maternice spet pojavijo, se lahko zdravljenje z zdravilom Atosiban SUN v času nosečnosti ponovi največ trikrat.
The CHMP concluded that, in accordance with EU requirements, Atosiban SUN has been shown to have comparable quality and to be comparable to Tractocile.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Atosiban Sun primerljivo raven kakovosti kot zdravilo Tractocile ter da mu je podobno.
The company provided data from the published literature on atosiban.
Družba je predstavila podatke o atosibanu iz objavljene literature.
A risk management plan has been developed to ensure that Atosiban SUN is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Atosiban SUN je bil pripravljen načrt obvladovanja tveganj.