FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine contains small amounts of a protein from PCV2 and whole Mycoplasma hyopneumoniae bacteria that have been killed (inactivated) so that they do not cause disease.
Slovenian: Cepivo vsebuje majhne količine beljakovine iz PCV2 in cele bakterije Mycoplasma hyopneumoniae, ki so bile uničene (inaktivirane), tako da ne povzročajo bolezni.
English: The most common side effect with Suvaxyn Circo+MH RTU (which may affect more than 1 in 10 pigs) are an increase in body temperature (on average 1 °C) in the first 24 hours after vaccination which resolves within 48 hours without treatment.
Slovenian: Najpogostejši nečeleni učinek zdravila Suvaxyn Circo+MH RTU (ki lahko prizadene več kot 1 prašiča od 10) je kratkotrajno zvišanje telesne temperature (v povprečju za 1°C) v prvih 24 urah po cepljenju, ki samodejno izzveni v 48 urah po cepljenju.
English: This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo+MH RTU.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Suvaxyn Circo+MH RTU.
English: The European Commission granted a marketing authorisation valid throughout the EU for Suvaxyn Circo+MH RTU on 6 November 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Suvaxyn Circo+MH RTU, veljavno po vsej Evropski uniji, izdala 6. novembra 2015.
English: The withdrawal period for meat from pigs treated with Suvaxyn Circo+MH RTU for is ‘zero' days, which means there is no mandatory waiting time.
Slovenian: Karenca za meso prašičev, zdravljenih z zdravilom Suvaxyn Circo+MH RTU, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
English: The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
Slovenian: Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko čival zakolje in meso uporabi za prehrano ljudi.
English: Suvaxyn Circo+MH RTU, which is available as a liquid for injection, is given to pigs from three weeks of age as a single injection into the muscle in the neck behind the ear.
Slovenian: Cepivo Suvaxyn Circo+MH RTU, ki je na voljo kot tekočina za injiciranje, se daje prašičem, starejšim od treh tednov, kot enkratna injekcija v mišico v vrat za uho.
English: The effectiveness of Suvaxyn Circo+MH RTU against PCV2 infection was also studied in three field studies.
Slovenian: Učinkovitost cepiva Suvaxyn Circo+MH RTU proti okučbi s PCV2 so proučevali tudi v treh terenskih š tudijah.
English: Suvaxyn Circo+MH RTU also contains adjuvants (ingredients that strengthen the immune response) called squalene, poloxamer 401 and polysorbate 80.
Slovenian: Cepivo Suvaxyn Circo+MH RTU vsebuje adjuvanse (sestavine, ki pomagajo okrepiti imunski odziv), in sicer skvalen, poloksamer 401 in polisorbat 80.
English: The purpose of these studies was to establish how long it took pigs to be fully protected and how long the protection against PCV2 and Mycoplasma hyopneumonia lasted.
Slovenian: Namen teh študij je bil ugotoviti, po kolikem času je nastopila popolna zaščita prašičev pred PCV2 in bakterijo Mycoplasma hyopneumoniae in kako dolgo je ta zaščita trajala.
English: Porcine circovirus type 2 (PCV2) infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).
Slovenian: Okučbe s prašičjim cirkovirusom tipa 2 (PCV2) se kačejo s kliničnimi znaki, kot so zmanjšanje telesne mase ali zastoj rasti, povečane bezgavke, otečeno dihanje, bleda koča in zlatenica (rumeno obarvanje koče).
English: The studies showed that the vaccine had its full effect against PCV2 and Mycoplasma hyopneumonia by three weeks after vaccination.
Slovenian: Študije so pokazale, da je cepivo svoj polni učinek proti PCV2 in bakteriji Mycoplasma hyopneumoniae doseglo v treh tednih po cepljenju.
English: Mycoplasma hyopneumoniae infection in pigs causes a disease of the airways called enzootic pneumonia.
Slovenian: Okučba z bakterijo Mycoplasma hyopneumoniae pri prašičih povzroči bolezen dihalnih poti, imenovano enzootska pljučnica.
English: The field studies showed that Suvaxyn Circo+MH RTU reduced the PCV2 viraemia (presence of virus in the blood) compared to pigs given dummy vaccination.
Slovenian: Terenske študije so dokazale, da je cepivo Suvaxyn Circo+MH RTU zmanjšalo viremijo s PCV2 (prisotnost virusa v krvi) v primerjavi s prašiči, ki so bili cepljeni s cepivom brez zdravilne učinkovine.
English: When Suvaxyn Circo+MH RTU is given to pigs the animals' immune system recognises the viral protein and bacteria as ‘foreign' and makes antibodies against them.
Slovenian: Ko prašiči prejmejo cepivo Suvaxyn Circo+MH RTU, imunski sistem čivali prepozna virusne beljakovine in bakterije kot „tujke“ ter začne proti njim tvoriti protitelesa.
English: This will help protect the pigs against porcine circovirus and Mycoplasma hyopneumoniae infections.
Slovenian: To bo prašič em pomagalo pri zaščiti pred okučbami s prašičjim cirkovirusom in bakterijo Mycoplasma hyopneumoniae.
English: Suvaxyn Circo+MH RTU contains inactivated (killed) active substances derived from porcine circovirus type 2 and Mycoplasma hyopneumoniae bacteria.
Slovenian: Cepivo Suvaxyn Circo+MH RTU vsebuje inaktivirano (uničeno) zdravilno učinkovino, pridobljeno iz praši čjega cirkovirusa tipa 2 in bakterije Mycoplasma hyopneumoniae.
English: For practical information about using Suvaxyn Circo+MH RTU, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Suvaxyn Circo+MH RTU naj lastniki ali skrbniki čivali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For more information about treatment with Suvaxyn Circo+MH RTU, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Suvaxyn Circo+MH RTU naj lastniki ali skrbniki čivali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: Suvaxyn Circo+MH RTU is a vaccine.
Slovenian: Zdravilo Suvaxyn Circo+MH RTU je cepivo.
English: For the full list of all side effects reported with Suvaxyn Circo+MH RTU, see the package leaflet.
Slovenian: Za celoten seznam nečelenih učinkov, o katerih so poročali pri uporabi zdravila Suvaxyn Circo+MH RTU, glejte navodilo za uporabo.
English: Suvaxyn Circo+MH RTU is a veterinary vaccine used to protect pigs over the age of 3 weeks against infections with porcine circovirus and the bacteria Mycoplasma hyopneumoniae.
Slovenian: Zdravilo Suvaxyn Circo+MH RTU je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito prašičev, starejših od 3 tednov, proti okučbam s prašičjim cirkovirusom in bakterijo Mycoplasma hyopneumoniae.
English: What benefits of Suvaxyn Circo+MH RTU have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Suvaxyn Circo+MH RTU izkazalo v študijah?
English: What are the risks associated with Suvaxyn Circo+MH RTU?
Slovenian: Kakšna tveganja so povezana z zdravilom Suvaxyn Circo+MH RTU?
English: porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
Slovenian: inaktivirano cepivo proti prašičjemu cirkovirusu in prašičji enzootski pljučnici
English: What is Suvaxyn Circo+MH RTU and what is it used for?
Slovenian: Kaj je zdravilo Suvaxyn Circo+MH RTU in za kaj se uporablja?
English: Why is Suvaxyn Circo+MH RTU approved?
Slovenian: Zakaj je bilo zdravilo Suvaxyn Circo+MH RTU odobreno?
English: Other information about Suvaxyn Circo+MH RTU?
Slovenian: Druge informacije o zdravilu Suvaxyn Circo+MH RTU
English: Protection lasted 23 weeks after vaccination for PCV2 and Mycoplasma hyopneumonia.
Slovenian: Zaščita proti PCV2 in bakteriji Mycoplasma hyopneumoniae je trajala 23 tednov po cepljenju.
English: How is Suvaxyn Circo+MH RTU used?
Slovenian: Kako se zdravilo Suvaxyn Circo+MH RTU uporablja?
English: Suvaxyn Circo+MH RTU is only available on prescription.
Slovenian: Predpisovanje in izdaja cepiva Suvaxyn Circo+MH RTU je le na recept.
English: How does Suvaxyn Circo+MH RTU work?
Slovenian: Kako zdravilo Suvaxyn Circo+MH RTU deluje?
English: No further amendments were considered necessary.
Slovenian: Druge spremembe niso bile potrebne.
English: 1 - Overall summary of the scientific evaluation
Slovenian: 1 - Splošni povzetek znanstvenega vrednotenja
English: There was no evidence for differences between these medicinal products in terms of beneficial effects.
Slovenian: Dokazov o razlikah med temi zdravili v smislu koristnih učinkov ni.
English: Having assessed all the available data, the PRAC concluded that:
Slovenian: Potem ko je ocenil vse razpoložljive podatke, je PRAC zaključil:
English: For dienogest and nomegestrol studies are on going and results will be submitted when available.
Slovenian: Študiji z dienogestom in nomegestrolom že potekata, rezultati pa bodo predloženi, ko bodo na voljo.
English: After an initially higher risk during the first year of use, the risk decreases to a constant lower level.
Slovenian: Začetno visoko tveganje med prvim letom uporabe se kasneje zmanjša na konstantno nižjo raven.
English: The risk of VTE is also higher in the presence of intrinsic risk factors.
Slovenian: Tveganje za VTE je večje tudi, če so prisotni notranji dejavniki tveganja.
English: These are combined with varying doses of ethinylestradiol (EE) or with estradiol (E2).
Slovenian: Ti so kombinirani z različnimi odmerki etinilestradiola (EE) ali z estradiolom (E2).
English: Scientific conclusions and grounds for the conclusions
Slovenian: Znanstveni zaključki in podlaga zanje
English: Considering that risk factors for VTE change over time the PRAC noted that an individual's risk should be re-evaluated periodically.
Slovenian: Glede na to, da se dejavniki tveganja za VTE sčasoma spremenijo, je PRAC izpostavil, da je treba tveganje pri posameznicah redno ocenjevati.
English: Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions and grounds for recommendation.
Slovenian: Potem ko je CHMP pregledal priporočilo, ki ga je izdal PRAC, se je strinjal s splošnimi znanstvenimi zaključki in podlago za priporočilo.
English: Overall, venous thromboembolic events (VTE) could be fatal in 1-2% of the cases.
Slovenian: Na splošno se venska trombembolija (VTE) lahko konča s smrtjo v 1-2 % primerov.
English: For comparison, in women who are not using CHCs (no-users) and who are not pregnant, there will be around 2 cases of VTE each year per 10,000 women.
Slovenian: Za primerjavo: pri ženskah, ki ne uporabljajo kombiniranih hormonskih kontraceptivov (neuporabnice) in niso noseče, se bosta vsako leto pojavila približno 2 primera VTE na 10 000 žensk.
English: When diagnosis is not made and no treatment is started, or when clear symptoms of thrombosis are not identifiable, the clot can move upwards to the lung (pulmonary embolism, PE) or the brain (cerebral embolism, CE).
Slovenian: Če se ne postavi diagnoze in začne zdravljenja ali če se tromboza ne kaže z jasnimi simptomi, lahko strdek potuje navzgor v pljuča (pljučna embolija - PE) ali možgane (možganska embolija - ME).
English: In February 2013, the French medicines agency (ANSM) initiated a referral procedure under Article 31 of Directive 2001/83/EC on the basis that the benefit-risk balance of these combined hormonal contraceptives had become unfavourable in the currently authorised indication of contraception due to the increased risk of thromboembolism (TE) and therefore it was in the interest of the Union to refer the matter to the PRAC.
Slovenian: Francoska agencija za zdravila (ANSM) je februarja 2013 sprožila napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES, saj je menila, da razmerje med tveganji in koristmi omenjenih kombiniranih hormonskih kontraceptivov za trenutno odobreno indikacijo kontracepcije ni več pozitivno zaradi povečanega tveganja za trombembolijo (TE) in da je zato v interesu Unije, da zadevo napoti na odbor PRAC.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for the combined hormonal contraceptives containing medicinal products.
Slovenian: • PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo kombinirane hormonske kontraceptive;
English: “The increased risk of VTE during the postpartum period should be considered when re-starting [invented name] (see section 4.2 and 4.4).”
Slovenian: „Ob ponovni uvedbi zdravila [lastniško ime] je treba proučiti povečano tveganje za VTE v poporodnem obdobju (glejte poglavje 4.2 in 4.4).“
English: Further changes to the product information will contribute to better inform the healthcare professionals and women on the risk of thromboembolism.
Slovenian: Dodatne spremembe informacij o zdravilu bodo prispevale k temu, da bodo zdravstveni delavci in uporabnice bolje seznanjeni s tveganjem za trombembolijo;
English: The revised Summary of Product Characteristics (SmPC) and Package Leaflet (PL) are set out in the respective annexes I and IIIB for Evra, Ioa and Zoely.
Slovenian: Spremenjena povzetek glavnih značilnosti zdravila (SmPC) in navodilo za uporabo (PL) sta opredeljena v ustreznih prilogah I in IIIB za zdravila Evra, Ioa in Zoely.
English: The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for Evra, Ioa and Zoely should be varied.
Slovenian: Potem ko je CHMP proučil priporočilo, ki ga je dne 10. oktobra 2013 v skladu s členom 107k(3) Direktive 2001/83/ES izdal PRAC, je menil, da bi bilo treba spremeniti dovoljenja za promet z zdravili Evra, Ioa in Zoely.
English: Based on the totality of the available data the PRAC concluded that the risk of VTE differs between products - with the lower risk products being those containing the progestogens levonorgestrel, norethisterone and norgestimate.
Slovenian: Na podlagi vseh razpoložljivih podatkov je PRAC zaključil, da se tveganje za VTE razlikuje med posameznimi zdravili - tveganje je najmanjše pri zdravilih, ki vsebujejo progestogene levonorgestrel, noretisteron in norgestimat.
English: In addition the marketing authorisation holders of chlormadinone should perform a post-authorisation safety study.
Slovenian: Poleg tega morajo imetniki dovoljenj za promet s klormadinonom opraviti študijo varnosti zdravila v obdobju trženja.
English: For some products (i.e. chlormadinone, dienogest, nomegestrol) there are currently insufficient data to establish the risk compares with the lower risk products.
Slovenian: Za nekatera zdravila (tj. klormadinon, dienogest in nomegestrol) je trenutno na voljo premalo podatkov, da bi lahko ugotovili, kakšno je tveganje v primerjavi z zdravili z majhnim tveganjem.
English: Grounds for the variation to the terms of the marketing authorisations
Slovenian: Podlaga za spremembo pogojev dovoljenj za promet z zdravili
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation CHMP Members' Divergent Positions
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili ter podrobna obrazložitev odstopanj od priporočila odbora PRAC
English: Thromboembolic events are adverse events which usually occur in a vein of the leg (deep vein thrombosis, DVT).
Slovenian: Trombembolični dogodki so neželeni dogodki, ki običajno prizadenejo veno noge (globoka venska tromboza - GVT).
English: The current review confirmed the previous understanding that the level of VTE risk with CHCs containing low dose of ethinylestradiol (ethinylestradiol <50µg) is small, but differences in the VTE risk were observed between most products depending on the type of progestogen they contain.
Slovenian: Ta pregled je potrdil prejšnje ugotovitve, da je stopnja tveganja za VTE pri uporabi kombiniranih hormonskih kontraceptivov, ki vsebujejo majhen odmerek etinilestradiola (etinilestradiol < 50 µg), majhna, vendar pa so bile opažene stopnje tveganja za VTE pri večini zdravil različne, in sicer so bile odvisne od vrste vsebovanega progestogena.
English: Known risk factors for VTE include history of VTE, pregnancy, trauma, surgery, immobilisation (e.g. after surgery or long flights), obesity and smoking (i.e. all situations of a pro-thrombotic state).
Slovenian: Med znanimi dejavniki tveganja za VTE so VTE v anamnezi, nosečnost, poškodba, kirurški poseg, imobilizacija (npr. po kirurškem posegu ali daljših poletih), debelost in kajenje (tj. vsi primeri protrombotičnega stanja).
English: However, the PRAC recommended routine risk minimisation measures, including a strengthening of the wording of the product information to reflect the current knowledge of risks (incidence rate) as well as symptoms for VTE and ATE and clarifying the situations for which these products are contraindicated.
Slovenian: Kljub temu pa je PRAC priporočil običajne ukrepe za zmanjšanje tveganja, med katerimi so razširitev besedila v informacijah o zdravilu, da se vključi vse, kar je trenutno znanega o tveganjih (stopnja incidence) in simptomih VTE ter ATE, in pojasni stanja, pri katerih so ta zdravila kontraindicirana.
English: The following sentence was therefore inserted in the Pregnancy section of the SmPC:
Slovenian: Zato je bil v poglavje povzetka glavnih značilnosti zdravila o nosečnosti vključen naslednji stavek:
English: Therefore, on the basis of the available evidence, the PRAC acknowledged that the benefits associated with using a CHC far outweigh the risk of serious adverse events in most women.
Slovenian: PRAC je zato na podlagi razpoložljivih dokazov potrdil, da so koristi, povezane z uporabo kombiniranih hormonskih kontraceptivov, pri večini žensk veliko večje od tveganja za resne neželene dogodke.
English: The PRAC confirmed the known risk of thromboembolism of combined hormonal contraceptive containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk factors for thromboembolic events.
Slovenian: PRAC je potrdil že znano tveganje za trombembolijo, povezano z zdravili, ki vsebujejo kombinirane hormonske kontraceptive, in priporočil, naj se jasno označijo simptomi trombemboličnih dogodkov ter tudi dejavniki tveganja za trombembolične dogodke;
English: It is known that the risk of arterial thromboembolism (ATE) (myocardial infarction, cerebrovascular accident) is also increased with use of CHCs, however there was no evidence for differences between CHCs in their relative risk of ATE.
Slovenian: Znano je, da se z uporabo kombiniranih hormonskih kontraceptivov poveča tudi tveganje za arterijsko trombembolijo (ATE, tj. srčni infarkt in cerebrovaskularni dogodki), vendar pa ni dokazov, da bi med kombiniranimi hormonskimi kontraceptivi obstajale razlike v relativnem tveganju za ATE.
English: Misdiagnosis is possible, since TE presents with diffuse symptoms and is a rare event in a population of healthy young women.
Slovenian: Ker se trombembolija kaže z razpršenimi simptomi in se redko pojavi pri populaciji zdravih mladih žensk, je mogoča napačna diagnoza.
English: • The PRAC is of the opinion that the benefits of combined hormonal contraceptive containing medicinal products continue to outweigh the risks in the indication of contraception.
Slovenian: • PRAC meni, da so koristi zdravil, ki vsebujejo kombinirane hormonske kontraceptive, za indikacijo kontracepcije še naprej večje od tveganj;
English: • The estimated incidence of risk is lowest with the CHCs containing the progestogens levonorgestrel, norgestimate and norethisterone: it is estimated that each year there will be between 5 and 7 cases of VTE per 10,000 women who use these medicines.
Slovenian: • da je ocenjena incidenca tveganja najmanjša pri kombiniranih hormonskih kontraceptivih, ki vsebujejo progestogene levonorgestrel, norgestimat in noretisteron: ocenjuje se, da se bo vsako leto pojavilo od 5 do 7 primerov VTE na 10 000 žensk, ki uporabljajo ta zdravila;
English: In particular, these medicinal products should be contraindicated in patients with multiple risk factors, in patients after major surgery with prolonged immobilisation, patients who smoke and patients with history or hereditary predisposition of thromboembolism.
Slovenian: Predvsem morajo biti ta zdravila kontraindicirana pri bolnicah z več dejavniki tveganja, pri bolnicah, ki so prestale večji kirurški poseg z daljšo imobilizacijo, bolnicah, ki kadijo, in bolnicah z anamnezo trombembolije ali dedno predispozicijo zanjo.
English: The PRAC was requested to give a recommendation on whether the indication of medicinal products containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol combined with an oestrogen (ethinylestradiol or estradiol) should be restricted and/or any other regulatory measure(s) taken.
Slovenian: PRAC so zaprosili, naj poda priporočilo v zvezi s tem, ali bi bilo treba omejiti indikacijo zdravil, ki vsebujejo klormadinon, dezogestrel, dienogest, drospirenon, etonogestrel, gestoden, norelgestromin, norgestimat ali nomegestrol v kombinaciji z estrogenom (etinilestradiolom ali estradiolom), in/ali sprejeti kakršne koli druge regulativne ukrepe.
English: The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, as well as the views of an ad hoc expert meeting on the efficacy and safety of the CHCs, in particular in relation to the risk of thromboembolism.
Slovenian: PRAC je pregledal vse razpoložljive podatke iz kliničnih študij, farmakoepidemioloških študij, objavljene literature in izkušenj v obdobju trženja, vključno z odgovori, ki so jih v obliki pisnih in ustnih obrazložitev podali imetniki dovoljenj za promet, ter tudi mnenje izvedencev s sestanka ad hoc v zvezi z učinkovitostjo in varnostjo kombiniranih hormonskih kontraceptivov, še zlasti v povezavi s tveganjem za trombembolijo.
English: • The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, on the efficacy and safety of the combined hormonal contraceptive containing medicinal products, in particular with regards to the risk of thromboembolism.
Slovenian: • PRAC je pregledal vse razpoložljive podatke iz kliničnih študij, farmakoepidemioloških študij, objavljene literature in izkušenj v obdobju trženja, vključno z odgovori, ki so jih v obliki pisnih in ustnih obrazložitev podali imetniki dovoljenj za promet, v zvezi z učinkovitostjo in varnostjo zdravil, ki vsebujejo kombinirane hormonske kontraceptive, še zlasti v povezavi s tveganjem za trombembolijo.
English: In addition the PRAC imposed a post-authorisation safety study in order to better characterise the relative risk of thromboembolic events due to chlormadinone compared to the levonorgestrelcontaining medicinal products.
Slovenian: Poleg tega je PRAC zahteval, da se opravi študija varnosti zdravila v obdobju trženja, s katero bi podrobneje opredelili, kakšno je relativno tveganje za trombembolične dogodke zaradi klormadinona v primerjavi z zdravili, ki vsebujejo levonorgestrel.
English: • The PRAC considered that further data are required for the combined hormonal contraceptives containing chlormadinone and imposed the conduct of a post authorisation safety study (PASS) to evaluate the relative risk of thromboembolic events due to these products compared to the ones containing levonorgestrel.
Slovenian: • PRAC je menil, da so za kombinirane hormonske kontraceptive, ki vsebujejo klormadinon, potrebni dodatni podatki, in zahteval, da se opravi študija varnosti zdravila v obdobju trženja (PASS), s katero se bo ocenilo, kakšno je relativno tveganje za trombembolične dogodke zaradi teh zdravil v primerjavi s tistimi, ki vsebujejo levonorgestrel.