natgillin/translations-raw huggingface dataset:
The most common side effects (which may affect more than 1 in 10 people) are diarrhoea, rash, itching, tiredness, nausea (feeling sick), vomiting, decreased appetite and abdominal pain (belly ache).
Najpogostejši neželeni učinki (ki se lahko pojavijo pri več kot 1 bolniku od 10) so driska, izpuščaj, srbenje, utrujenost, navzeja (siljenje na bruhanje), bruhanje, zmanjšan tek in abdominalne bolečine (bolečine v trebuhu).
However, patients treated with the higher dose had more side effects and were less likely to complete treatment as a result.
Vendar so imeli bolniki, ki so prejemali večji odmerek, več neželenih učinkov, zato je bilo pri njih verjetneje, da ne bodo mogli zaključiti zdravljenja.
The doctor may delay doses if certain side effects occur, and stop treatment altogether if side effects are severe.
Zdravnik bo morda odložil nadaljnje odmerke, če se pojavijo nekateri neželeni učinki, ali popolnoma prekinil zdravljenje, če so neželeni učinki resni.
For renal cell carcinoma, Yervoy is given to patients who have not been treated before and are at moderate or high risk of their cancer getting worse.
Pri zdravljenju karcinoma ledvičnih celic se zdravilo Yervoy daje bolnikom, ki predhodno še niso bili zdravljeni in so izpostavljeni zmernemu ali visokemu tveganju za poslabšanje rakavega obolenja.
However, about one-third of the patients could not complete Yervoy treatment due to side effects.
Približno tretjina bolnikov, ki so prejemali zdravilo Yervoy, pa zaradi neželenih učinkov ni mogla zaključiti zdravljenja.
The European Medicines Agency noted that Yervoy improves survival in melanoma, a condition where overall survival rates are low.
Evropska agencija za zdravila je menila, da zdravilo Yervoy izboljšuje preživetje pri bolnikih z melanomom, tj. boleznijo, za katero je značilna nizka celokupna stopnja preživetja.
The results showed that in patients at moderate or high risk of their cancer getting worse, patients given the combination lived overall longer than those given sunitinib.
Rezultati so pokazali, da so v skupini bolnikov z zmernim ali visokim tveganjem za poslabšanje rakavega obolenja, na splošno dlje časa živeli tisti, ki so prejemali omenjeno kombinacijo zdravil, kot tisti, ki so prejemali sunitinib.
Yervoy can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in treating cancer.
Predpisovanje in izdaja zdravila Yervoy je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem raka.
The active substance in Yervoy, ipilimumab, is a monoclonal antibody.
Učinkovina v zdravilu Yervoy, ipilimumab, je monoklonsko protitelo.
Yervoy is usually used in combination with another medicine, nivolumab, but can also be used on its own for melanoma.
Običajno se uporablja v kombinaciji z drugim zdravilom, nivolumabom, vendar se lahko pri zdravljenju melanoma uporablja tudi kot samostojno zdravilo.
The most frequent side effects of the medicine are mild to moderate in severity.
Večina pogostih neželenih učinkov zdravila je blagih do zmernih.
Yervoy is a cancer medicine used in adults and adolescents from 12 years of age with advanced melanoma (a type of skin cancer) and in adults with advanced renal cell carcinoma (a kidney cancer).
Yervoy je zdravilo za zdravljenje raka, ki se uporablja pri odraslih in mladostnikih, starejših od 12 let, z napredovalim melanomom (vrsto kožnega raka) in pri odraslih z napredovalim karcinomom ledvičnih celic (rakom ledvic).
Finally, two studies found the combination of Yervoy and nivolumab effective for treating advanced melanoma in adults who had not been treated previously, and whose cancer produced a protein called PD-L1.
V dveh študijah so ugotovili, da je kombinacija zdravila Yervoy in nivolumaba učinkovita pri zdravljenju napredovalega melanoma pri odraslih, ki se predhodno niso zdravili in pri katerih rak tvori beljakovino, imenovano PD-L1.
For the full list of side effects and restrictions with Yervoy, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Yervoy glejte navodilo za uporabo.
It acts on T cells by attaching to and blocking the activity of CTLA-4, a protein that controls the activity of T cells.
Na celice T vpliva tako, da se veže na beljakovino CTLA-4, ki nadzira delovanje teh celic, in zavira njeno delovanje.
In the treatment of advanced renal cell carcinoma, Yervoy in combination with nivolumab also increases patients' survival, and side effects are considered acceptable.
Pri zdravljenju napredovalega karcinoma ledvičnih celic je kombinacija zdravila Yervoy in nivolumaba podaljšala tudi obdobje preživetja bolnikov, neželeni učinki pa veljajo za sprejemljive.
After 24 months, 66.5% of patients given the combination were alive compared with 52.9% in the sunitinib group.
Po 24 mesecih je bilo živih 66,5 % bolnikov, ki so prejemali kombinacijo zdravil, v primerjavi z 52,9 % bolnikov v skupini, ki je prejemala sunitinib.
Yervoy is commonly associated with side effects resulting from excessive activity of the immune system, including severe reactions and inflammation.
Pri uporabi zdravila Yervoy se pogosto pojavljajo neželeni učinki, ki so posledica čezmernega delovanja imunskega sistema, vključno s hudimi reakcijami in vnetjem.
In two small studies involving a total of 30 adolescents aged 12 to 18 years with advanced melanoma, treatment with Yervoy produced similar levels of medicine in blood as in adults.
V dveh manjših študijah, ki sta skupaj vključevali 30 mladostnikov z napredovalim melanomom, starih od 12 do 18 let, je zdravilo Yervoy ustvarilo podobne ravni učinkovine v krvi kot pri odraslih.
In the second study involving 142 adults, the disease was controlled in 56% of patients receiving Yervoy and nivolumab compared with 9% of patients receiving Yervoy alone.
V drugi študiji, v kateri je sodelovalo 142 odraslih bolnikov, je bila bolezen obvladana pri 56 % bolnikov, ki so prejemali kombinacijo zdravila Yervoy in nivolumaba, in pri 9 % bolnikov, ki so prejemali samo zdravilo Yervoy.
When used with nivolumab, the patient receives a dose of Yervoy and of nivolumab every 3 weeks for 4 doses followed by treatment with nivolumab alone.
Pri uporabi v kombinaciji z nivolumabom bolnik prejme odmerek zdravila Yervoy in nivolumaba vsake tri tedne, in sicer skupno štiri odmerke, temu pa sledi zdravljenje samo z nivolumabom.
When Yervoy is used alone, the patient receives a dose every 3 weeks for a total of 4 doses.
Če se zdravilo Yervoy uporablja kot samostojno zdravilo, bolnik prejme odmerek vsake tri tedne, in sicer skupno štiri odmerke.
A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific target in the body.
To je vrsta beljakovine, ki je bila zasnovana tako, da v telesu prepozna določeno prijemališče in se veže nanj.
Several other studies involving previously untreated adults found that patients treated with Yervoy at 3 mg per kg lived for 13.5 months on average.
V več drugih študijah, v katere so bili vključeni predhodno nezdravljeni odrasli bolniki, so ugotovili, da so bolniki, zdravljeni z zdravilom Yervoy v odmerku 3 mg na kg telesne mase, v povprečju živeli 13,5 meseca.
In the first of these studies involving 945 adults, patients treated with Yervoy and nivolumab lived for 11.7 months on average without their disease getting worse compared with 6.9 months for those treated with nivolumab alone and 2.9 months for those treated with Yervoy alone.
V prvi od teh dveh študij, v kateri je sodelovalo 945 odraslih bolnikov, so bolniki, zdravljeni z zdravilom Yervoy in nivolumabom, živeli brez poslabšanja bolezni v povprečju 11,7 meseca, medtem ko je bilo to obdobje pri bolnikih, zdravljenih samo z nivolumabom, 6,9 meseca, pri bolnikih, zdravljenih samo z zdravilom Yervoy, pa 2,9 meseca.
Additional common side effects when Yervoy is used with nivolumab include fever, reduced or increased levels of thyroid hormones, colitis (inflammation of the lower gut), joint pain, headache and breathing difficulty.
Drugi pogosti neželeni učinki uporabe zdravila Yervoy v kombinaciji z nivolumabom so zvišana telesna temperatura, znižane ali zvišane ravni ščitničnih hormonov, kolitis (vnetje spodnjih prebavil), bolečine v sklepih, glavobol in oteženo dihanje.
In a study involving 676 adults in whom previous treatment for advanced melanoma had not worked or had stopped working, overall survival with Yervoy combined with an experimental medicine called ‘gp100' was 10 months, compared with 6 months in patients receiving gp100 alone.
V študiji, v katero je bilo vključenih 676 odraslih bolnikov, pri katerih predhodno zdravljenje napredovalega melanoma ni bilo učinkovito ali je prenehalo učinkovati, je bilo celokupno preživetje pri uporabi zdravila Yervoy v kombinaciji s poskusnim zdravilom, imenovanim „gp100“, deset mesecev v primerjavi s šestimi meseci pri bolnikih, ki so prejemali samo gp100.
One main study involving 1,096 adults with previously untreated advanced renal cell carcinoma compared treatment with Yervoy and nivolumab versus treatment with another cancer medicine for renal cell carcinoma, sunitinib.
V glavni študiji, v katero je bilo vključenih 1 096 odraslih bolnikov s predhodno nezdravljenim napredovalim karcinomom ledvičnih celic, so zdravljenje s kombinacijo zdravila Yervoy in nivolumaba primerjali z drugim zdravilom za zdravljenje karcinoma ledvičnih celic, sunitinibom.
How does Yervoy work?
Kako zdravilo Yervoy deluje?
How is Yervoy used?
Kako se zdravilo Yervoy uporablja?
In a study involving 727 adults with advanced melanoma, patients treated with Yervoy 3 mg per kg lived for around 12 months on average compared with 16 months for those treated with 10 mg per kg.
V študiji, v katero je bilo vključenih 727 odraslih bolnikov z napredovalim melanomom, so bolniki, zdravljeni z zdravilom Yervoy v odmerku 3 mg na kg telesne mase, v povprečju živeli približno 12 mesecev, medtem ko so bolniki, ki so prejemali odmerek 10 mg na kg telesne mase, živeli približno 16 mesecev.
In a study involving 502 adults whose advanced melanoma had not been treated previously, patients treated with high-dose Yervoy and dacarbazine lived for 11 months on average, compared with 9 months for those given placebo (a dummy treatment) plus dacarbazine.
V študiji, v katero sta bila vključena 502 odrasla bolnika z napredovalim melanomom, ki predhodno nista bila zdravljena, so bolniki, ki so prejemali visok odmerek zdravila Yervoy in dakarbazina, povprečno živeli 11 mesecev v primerjavi z devetimi meseci pri bolnikih, ki so prejemali kombinacijo placeba (zdravila brez učinkovine) in dakarbazina.
The time patients lived before their disease got worse was 11.6 months with the combination compared with 8.4 with sunitinib.
Čas do poslabšanja bolezni je bil 11,6 meseca v skupini, ki je prejemala kombinacijo zdravil, v skupini bolnikov, ki so prejemali sunitinib, pa 8,4 meseca.
Yervoy contains the active substance ipilimumab.
Zdravilo Yervoy vsebuje učinkovino ipilimumab.
The effectiveness of the vaccine was first studied in a number of laboratory studies in pigs.
Učinkovitost cepiva so najprej proučevali v več laboratorijskih študijah na prašičih.
Affected pigs often have a cough and fail to thrive.
Oboleli prašiči pogosto kašljajo in se ne razvijajo.
Protection starts three weeks after vaccination and lasts for 23 weeks after vaccination.
Zaščita se začne tri tedne po cepljenju in traja 23 tednov po cepljenju.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
Kakšne previdnostne ukrepe mora upoštevati oseba, ki daje zdravilo ali pride v stik z čivaljo?
In the future, if the animals are exposed to the virus or the bacteria the immune system will be able to respond more quickly.
Ob ponovni izpostavitvi čivali virusu ali bakteriji v prihodnosti se bo imunski sistem tako hitreje odzval.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Suvaxyn Circo+MH RTU'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 Suvaxyn Circo+MH RTU večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The full EPAR for Suvaxyn Circo+MH RTU 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 Suvaxyn Circo+MH RTU je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Swelling, less than 2 cm in diameter, heat, redness at the injection site and pain to the touch which may last up to 2 days were also seen.
Opačeni so bili tudi otekanje, v premeru manj kot 2 cm, vroč ina in rdečina na mestu injiciranja ter bolečina na dotik, ki lahko traja do dva dni.
What is the withdrawal period in food-producing animals?
Kako dolgo traja karenca pri čivalih, namenjenih za proizvodnjo hrane?
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.
Cepivo vsebuje majhne količine beljakovine iz PCV2 in cele bakterije Mycoplasma hyopneumoniae, ki so bile uničene (inaktivirane), tako da ne povzročajo bolezni.
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.
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.
This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo+MH RTU.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Suvaxyn Circo+MH RTU.
The European Commission granted a marketing authorisation valid throughout the EU for Suvaxyn Circo+MH RTU on 6 November 2015.
Evropska komisija je dovoljenje za promet z zdravilom Suvaxyn Circo+MH RTU, veljavno po vsej Evropski uniji, izdala 6. novembra 2015.
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.
Karenca za meso prašičev, zdravljenih z zdravilom Suvaxyn Circo+MH RTU, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
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.
Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko čival zakolje in meso uporabi za prehrano ljudi.
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.
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.
The effectiveness of Suvaxyn Circo+MH RTU against PCV2 infection was also studied in three field studies.
Učinkovitost cepiva Suvaxyn Circo+MH RTU proti okučbi s PCV2 so proučevali tudi v treh terenskih š tudijah.
Suvaxyn Circo+MH RTU also contains adjuvants (ingredients that strengthen the immune response) called squalene, poloxamer 401 and polysorbate 80.
Cepivo Suvaxyn Circo+MH RTU vsebuje adjuvanse (sestavine, ki pomagajo okrepiti imunski odziv), in sicer skvalen, poloksamer 401 in polisorbat 80.
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.
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.
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).
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).
The studies showed that the vaccine had its full effect against PCV2 and Mycoplasma hyopneumonia by three weeks after vaccination.
Študije so pokazale, da je cepivo svoj polni učinek proti PCV2 in bakteriji Mycoplasma hyopneumoniae doseglo v treh tednih po cepljenju.
Mycoplasma hyopneumoniae infection in pigs causes a disease of the airways called enzootic pneumonia.
Okučba z bakterijo Mycoplasma hyopneumoniae pri prašičih povzroči bolezen dihalnih poti, imenovano enzootska pljučnica.
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.
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.
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.
Ko prašiči prejmejo cepivo Suvaxyn Circo+MH RTU, imunski sistem čivali prepozna virusne beljakovine in bakterije kot „tujke“ ter začne proti njim tvoriti protitelesa.
This will help protect the pigs against porcine circovirus and Mycoplasma hyopneumoniae infections.
To bo prašič em pomagalo pri zaščiti pred okučbami s prašičjim cirkovirusom in bakterijo Mycoplasma hyopneumoniae.
Suvaxyn Circo+MH RTU contains inactivated (killed) active substances derived from porcine circovirus type 2 and Mycoplasma hyopneumoniae bacteria.
Cepivo Suvaxyn Circo+MH RTU vsebuje inaktivirano (uničeno) zdravilno učinkovino, pridobljeno iz praši čjega cirkovirusa tipa 2 in bakterije Mycoplasma hyopneumoniae.
For practical information about using Suvaxyn Circo+MH RTU, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
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.
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.
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.
Suvaxyn Circo+MH RTU is a vaccine.
Zdravilo Suvaxyn Circo+MH RTU je cepivo.
For the full list of all side effects reported with Suvaxyn Circo+MH RTU, see the package leaflet.
Za celoten seznam nečelenih učinkov, o katerih so poročali pri uporabi zdravila Suvaxyn Circo+MH RTU, glejte navodilo za uporabo.
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.
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.
What benefits of Suvaxyn Circo+MH RTU have been shown in studies?
Kakšne koristi je zdravilo Suvaxyn Circo+MH RTU izkazalo v študijah?
What are the risks associated with Suvaxyn Circo+MH RTU?
Kakšna tveganja so povezana z zdravilom Suvaxyn Circo+MH RTU?
porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
inaktivirano cepivo proti prašičjemu cirkovirusu in prašičji enzootski pljučnici
What is Suvaxyn Circo+MH RTU and what is it used for?
Kaj je zdravilo Suvaxyn Circo+MH RTU in za kaj se uporablja?
Why is Suvaxyn Circo+MH RTU approved?
Zakaj je bilo zdravilo Suvaxyn Circo+MH RTU odobreno?
Other information about Suvaxyn Circo+MH RTU?
Druge informacije o zdravilu Suvaxyn Circo+MH RTU
Protection lasted 23 weeks after vaccination for PCV2 and Mycoplasma hyopneumonia.
Zaščita proti PCV2 in bakteriji Mycoplasma hyopneumoniae je trajala 23 tednov po cepljenju.
How is Suvaxyn Circo+MH RTU used?
Kako se zdravilo Suvaxyn Circo+MH RTU uporablja?
Suvaxyn Circo+MH RTU is only available on prescription.
Predpisovanje in izdaja cepiva Suvaxyn Circo+MH RTU je le na recept.
How does Suvaxyn Circo+MH RTU work?
Kako zdravilo Suvaxyn Circo+MH RTU deluje?
No further amendments were considered necessary.
Druge spremembe niso bile potrebne.
1 - Overall summary of the scientific evaluation
1 - Splošni povzetek znanstvenega vrednotenja
There was no evidence for differences between these medicinal products in terms of beneficial effects.
Dokazov o razlikah med temi zdravili v smislu koristnih učinkov ni.
Having assessed all the available data, the PRAC concluded that:
Potem ko je ocenil vse razpoložljive podatke, je PRAC zaključil:
For dienogest and nomegestrol studies are on going and results will be submitted when available.
Študiji z dienogestom in nomegestrolom že potekata, rezultati pa bodo predloženi, ko bodo na voljo.
After an initially higher risk during the first year of use, the risk decreases to a constant lower level.
Začetno visoko tveganje med prvim letom uporabe se kasneje zmanjša na konstantno nižjo raven.
The risk of VTE is also higher in the presence of intrinsic risk factors.
Tveganje za VTE je večje tudi, če so prisotni notranji dejavniki tveganja.
These are combined with varying doses of ethinylestradiol (EE) or with estradiol (E2).
Ti so kombinirani z različnimi odmerki etinilestradiola (EE) ali z estradiolom (E2).
Scientific conclusions and grounds for the conclusions
Znanstveni zaključki in podlaga zanje
Considering that risk factors for VTE change over time the PRAC noted that an individual's risk should be re-evaluated periodically.
Glede na to, da se dejavniki tveganja za VTE sčasoma spremenijo, je PRAC izpostavil, da je treba tveganje pri posameznicah redno ocenjevati.
Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions and grounds for recommendation.
Potem ko je CHMP pregledal priporočilo, ki ga je izdal PRAC, se je strinjal s splošnimi znanstvenimi zaključki in podlago za priporočilo.
Overall, venous thromboembolic events (VTE) could be fatal in 1-2% of the cases.
Na splošno se venska trombembolija (VTE) lahko konča s smrtjo v 1-2 % primerov.
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.
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.
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).
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).
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.
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.