FrancophonIA/ELRC3.0 huggingface dataset:
English: Factors that increase your risk of a blood clot in an artery It is important to note that the risk of a heart attack or stroke from using [invented name] is very small but can increase:
Slovenian: Dejavniki, ki povečujejo vaše tveganje za nastanek krvnega strdka v arteriji Pomembno je povedati, da je tveganje za srčni infarkt ali možgansko kap zaradi uporabe zdravila [izmišljeno ime] zelo majhno, vendar se lahko poveča:
English: • if you have (or have ever had) a type of migraine called ‘migraine with aura';
Slovenian: • če imate (ali ste kdaj imeli) vrsto migrene, imenovano "migrena z avro";
English: in the arteries (referred to as an ‘arterial thrombosis', ‘arterial thromboembolism' or ATE).
Slovenian: v arterijah (imenujejo se "arterijska tromboza", "arterijska trombembolija" ali ATE).
English: Using a combined hormonal contraceptive such as [invented name] increases your risk of developing a blood clot compared with not using one.
Slovenian: Z uporabo kombiniranega hormonskega kontraceptiva, kot je zdravilo [izmišljeno ime], se vaše tveganje za nastanek krvnega strdka v primerjavi z ženskami, ki ga ne uporabljajo, poveča.
English: Risk of developing a blood clot in a year
Slovenian: Tveganje za nastanek krvnega strdka na leto
English: Temporary symptoms suggest the event is a transient ischaemic attack (TIA).
Slovenian: Začasni simptomi kažejo na tranzitorno ishemično atako (TIA).
English: • if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
Slovenian: • če imate Crohnovo bolezen ali ulcerozni kolitis (kronično vnetno črevesno bolezen);
English: The increased risk of thromboembolism in pregnancy, and particularly the 6 week period of the puerperium, must be considered (for information on “Pregnancy and lactation” see section 4.6).
Slovenian: Upoštevati je treba povečano tveganje za trombembolije med nosečnostjo in predvsem v 6-tedenskem obdobju po porodu (za informacije glede nosečnosti in dojenja glejte poglavje 4.6;).
English: In this case you could also have a higher risk of having a heart attack or stroke;
Slovenian: V tem primeru obstaja pri vas morda tudi večje tveganje za srčni infarkt ali možgansko kap;
English: If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).
Slovenian: Če se oceni, da je razmerje med koristmi in tveganji negativno, se kombiniranih hormonskih kontraceptivov ne sme predpisati (glejte poglavje 4.3).
English: Important things to know about combined hormonal contraceptives (CHCs):
Slovenian: Pomembne informacije, ki jih je treba vedeti o kombiniranih hormonskih kontraceptivih:
English: Prior to the initiation or reinstitution of [invented name] a complete medical history (including family history) should be taken and pregnancy must be ruled out.
Slovenian: Preden začne ženska uporabljati zdravilo [izmišljeno ime] ali pred njegovo ponovno uvedbo, se mora zdravnik seznaniti z njeno anamnezo (tudi z družinsko) in izključiti nosečnost.
English: If any of the conditions or risk factors mentioned below is present, the suitability of [invented name] should be discussed with the woman.
Slovenian: Če je prisotno katero od spodaj navedenih stanj ali dejavnikov tveganja, se je treba o primernosti zdravila [izmišljeno ime] pogovoriti z žensko.
English: Your doctor may decide that [invented name] needs to be stopped.
Slovenian: Vaš zdravnik se bo morda odločil, da z uporabo zdravila [izmišljeno ime] prenehate.
English: It is important to draw a woman's attention to the information on venous and arterial thrombosis, including the risk of [invented name] compared with other CHCs, the symptoms of VTE and ATE, the known risk factors and what to do in the event of a suspected thrombosis.
Slovenian: Pomembno je žensko opozoriti na informacije glede venske in arterijske tromboze, vključno s tveganjem zdravila [izmišljeno ime] v primerjavi z drugimi kombiniranimi hormonskimi kontraceptivi, simptomi VTE in ATE, znanimi dejavniki tveganja in kaj je treba storiti ob sumu na trombozo.
English: Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma
Slovenian: Dolgotrajna imobilizacija, večji kirurški posegi, vsak kirurški poseg na nogah ali v medenici, nevrološka operacija ali velika poškodba
English: • if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition.
Slovenian: • če imate zvišane ravni maščob v krvi (hipertrigliceridemijo) ali pozitivno družinsko anamnezo za to stanje.
English: After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
Slovenian: Po prvem letu se tveganje zmanjša, vendar pa je še vedno blago povečano v primerjavi z neuporabo kombiniranega hormonskega kontraceptiva.
English: HOW TO RECOGNISE A BLOOD CLOT Seek urgent medical attention if you notice any of the following signs or symptoms.
Slovenian: KAKO PREPOZNATI KRVNI STRDEK Če opazite katerega od naslednjih znakov ali simptomov, poiščite nujno medicinsko pomoč.
English: Products that contain levonorgestrel, norgestimate (including [invented name]) or norethisterone are associated with the lowest risk of VTE.
Slovenian: Zdravila, ki vsebujejo levonorgestrel, norgestimat (tudi zdravilo [izmišljeno ime]) ali noretisteron, so povezana z manjšim tveganjem za VTE.
English: • if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50).
Slovenian: • če je imel kdo od vaših bližnjih sorodnikov krvni strdek v nogi, pljučih ali drugem organu v mladih letih (npr. pri starosti manj kot 50 let).
English: About 9-12 out of 10,000 women
Slovenian: približno 9-12 od 10.000 žensk
English: • if you have any of the following diseases that may increase your risk of a clot in the arteries: - severe diabetes with blood vessel damage - very high blood pressure - a very high level of fat in the blood (cholesterol or triglycerides) - a condition known as hyperhomocysteinaemia
Slovenian: • če imate katero od naslednjih bolezni, ki lahko povečajo tveganje za nastanek strdkov v arterijah: - hudo sladkorno bolezen z zapleti na ožilju - zelo visok krvni tlak - zelo veliko koncentracijo maščob v krvi (holesterola ali trigliceridov) - stanje, znano kot hiperhomocisteinemija
English: If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold').
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, saj je mogoče nekatere od teh simptomov, kot sta kašljanje ali zasoplost, zamenjati z bolj blagim stanjem, kot je okužba dihal (npr. prehlad).
English: The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table).
Slovenian: Dejavniki tveganja za venske trombembolične zaplete pri uporabnicah kombiniranih hormonskih kontraceptivov se lahko bistveno povečajo pri ženskah z dodatnimi dejavniki tveganja, predvsem če je dejavnikov tveganja več (glejte preglednico).
English: Section 4.8 - Undesirable effects [This following wording should be reflected in this section]
Slovenian: Poglavje 4.8 - Neželeni učinki [To poglavje mora vsebovati naslednje besedilo]
English: The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more
Slovenian: Tveganje je lahko večje tudi pri ponovni uvedbi kombiniranega hormonskega kontraceptiva (isto ali drugo zdravilo) po 4- ali večtedenskem premoru.
English: Section 4.4 - Special warnings and precautions for use [This section should be amended to reflect the following wording] Warnings
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi [To poglavje je treba spremeniti tako, da vsebuje naslednje besedilo] Opozorila
English: It is important to remember that the overall risk of a harmful blood clot due to [invented name] is small.
Slovenian: Pomembno je, da veste, da je skupno tveganje škodljivih krvnih strdkov zaradi zdravila [izmišljeno ime] majhno.
English: The overall risk of a blood clot in the leg or lung (DVT or PE) with [invented name] is small.
Slovenian: Splošno tveganje za nastanek krvnega strdka v nogah ali pljučih z zdravilom [izmišljeno ime] je majhno.
English: In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of [Invented name] should be discontinued.
Slovenian: Ob poslabšanju ali prvem pojavu katerega od teh stanj je treba ženski svetovati, da se posvetuje s svojim zdravnikom, če je treba uporabo zdravila [izmišljeno ime] prekiniti.
English: About 6-12 out of 10,000 women
Slovenian: približno 6-12 od 10.000 žensk
English: • loss of consciousness or fainting with or without seizure.
Slovenian: • izguba zavesti ali omedlevica z epileptičnim napadom ali brez njega.
English: • if a member of your immediate family has had a heart attack or stroke at a young age (less then about 50).
Slovenian: • če je imel bližnji sorodnik srčni infarkt ali možgansko kap v mladih letih (mlajši kot 50 let).
English: Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE.
Slovenian: Zdravila, ki vsebujejo levonorgestrel, norgestimat ali noretisteron, so povezana z manjšim tveganjem za VTE.
English: [The folllowing text should be included at the top of the SmPC]
Slovenian: [Spodnje besedilo je treba vstaviti na začetku SmPC-ja]
English: [The wording below should be inserted at the top of this section] The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use.
Slovenian: [Spodnje besedilo je treba vstaviti na začetku tega poglavja] Z uporabo katerega koli kombiniranega hormonskega kontraceptiva (CHC) je tveganje za venske trombembolije (VTE) večje kot pri neuporabi.
English: Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity.
Slovenian: Drugi znaki zapore žilja lahko vključujejo nenadno bolečino, oteklost in nekoliko modrikaste okončine.
English: Symptoms of VTE (deep vein thrombosis and pulmonary embolism) In the event of symptoms women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC.
Slovenian: Simptomi VTE (globoka venska tromboza in pljučna embolija) Če se pojavijo simptomi, je treba ženski svetovati, da poišče nujno medicinsko pomoč in obvesti zdravstvenega delavca, da jemlje kombinirani hormonski kontraceptiv.
English: • if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
Slovenian: • če imate (ali ste kdaj imeli) krvni strdek v krvni žili nog (globoka venska tromboza), pljučih (pljučna embolija) ali drugih organih;
English: Factors that increase your risk of a blood clot in a vein The risk of a blood clot with [invented name] is small but some conditions will increase the risk.
Slovenian: Dejavniki, ki povečujejo vaše tveganje za nastanek krvnega strdka v veni Tveganje za nastanek krvnega strdka z zdravilom [izmišljeno ime] je majhno, vendar nekatera stanja tveganje povečajo.
English: Seek urgent medical attention - if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clot' (thrombosis) section below.
Slovenian: Nujno medicinsko pomoč poiščite - če opazite možne znake krvnega strdka, ki lahko pomenijo, da imate krvni strdek v nogi (tj. globoko vensko trombozo), krvni strdek v pljučih (tj. pljučno embolijo), srčni infarkt ali možgansko kap (glejte spodnje poglavje "Krvni strdki".
English: It is not yet known how the risk with [invented name] compares with these lower risk products.
Slovenian: Ni znano kakšno je tveganje z zdravilom [izmišljeno ime] v primerjavi s temi zdravili, pri katerih je tveganje manjše.
English: The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot)
Slovenian: Možnost, da bo pri vas nastal krvni strdek, je morda večja, če imate tudi druga stanja, ki to tveganje povečujejo (glejte poglavje 2 za več informacij o stanjih, ki povečujejo tveganje za nastanek krvnih strdkov, in o simptomih nastalega krvnega strdka).
English: • if you are very overweight (body mass index or BMI over 30kg/m2);
Slovenian: • če ste predebeli (indeks telesne mase (BMI - body mass index) več kot 30 kg/m2);
English: When to take special care with [Invented name]
Slovenian: Kdaj morate biti posebno pozorni pri jemanju zdravila [izmišljeno ime]
English: An increase in frequency or severity of migraine during CHC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation
Slovenian: Če se pri ženskah, ki uporabljajo kombinirane hormonske kontraceptive, pogosteje pojavijo migrene ali so te hujše (kar je lahko prodrom cerebrovaskularnega dogodka), je to lahko razlog za takojšnjo prekinitev uporabe.
English: arm and stomach;
Slovenian: čeljust, žrelo, roko, želodec;
English: In the event of symptoms women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC.
Slovenian: Če se pojavijo simptomi, je treba ženski svetovati, da poišče nujno medicinsko pomoč in obvesti zdravstvenega delavca, da jemlje kombinirani hormonski kontraceptiv.
English: There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.
Slovenian: O možni vlogi varikoznih ven in povrhnjega tromboflebitisa pri nastanku ali napredovanju venske tromboze ni enotnega mnenja.
English: The relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Slovenian: Ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo so bila dogovorjena v postopku napotitve.
English: • sudden weakness or numbness of the face, arm or leg,
Slovenian: • nenadna odrevenelost ali šibkost obraza, rok ali nog,
English: If you need to stop [invented name] ask your doctor when you can start using it again.
Slovenian: [izmišljeno ime], se z zdravnikom posvetujte kdaj ga lahko ponovno začnete uporabljati.
English: Diabetes mellitus, hyperhomocysteinaemia, valvular heart disease and atrial fibrillation, dyslipoproteinaemia and systemic lupus erythematosus.
Slovenian: Sladkorna bolezen, hiperhomocisteinemija, bolezen srčnih zaklopk in atrijska fibrilacija, dislipoproteinemija in sistemski eritematozni lupus.
English: Blood clots can develop in veins (referred to as a ‘venous thrombosis', ‘venous thromboembolism' or VTE)
Slovenian: Krvni strdki lahko nastanejo v venah (imenujejo se "venska tromboza", "venska trombembolija" ali VTE)
English: • if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys);
Slovenian: • če imate hemolitično uremični sindrom (motnja strjevanja krvi, ki povzroča odpoved ledvic);
English: The risk of arterial thromboembolic complications or of a cerebrovascular accident in CHC users increases in women with risk factors (see table).
Slovenian: Tveganje za arterijske trombembolične zaplete ali cerebrovaskularne dogodke pri uporabnicah kombiniranih hormonskih kontraceptivov se pri ženskah z dejavniki tveganja poveča (glejte preglednico).
English: Risk increases substantially as BMI increases.
Slovenian: Tveganje se z večanjem indeksa telesne mase bistveno poveča.
English: Etonogestrel-containing CHC (6-12 events)
Slovenian: CHC, ki vsebujejo etonogestrel (6-12 dogodkov)
English: There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more.
Slovenian: Obstajajo nekateri dokazi, da se tveganje poveča, če se začne kombinirane hormonske kontraceptive ponovno uporabljati po 4 ali več tednih premora.
English: Obesity (body mass index over 30 kg/m2)
Slovenian: Debelost (indeks telesne mase več kot 30 kg/m2)
English: Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease
Slovenian: Druga klinična stanja, povezana z VTE Rak, sistemski eritematozni lupus, hemolitično uremični sindrom, kronična vnetna črevesna bolezen (Crohnova bolezen ali ulcerozni kolitis) in srpastocelična bolezen.
English: Epidemiological studies have associated the use of CHCs with an increased risk for arterial thromboembolism (myocardial infarction) or for cerebrovascular accident (e.g. transient ischaemic attack, stroke).
Slovenian: Tveganje za arterijsko trombembolijo (ATE) V epidemioloških študijah so uporabo kombiniranih hormonskih kontraceptivov povezali z večjim tveganjem za arterijsko trombembolijo (miokardni infarkt) ali cerebrovaskularni dogodek (npr. tranzitorna ishemična ataka, možganska kap).
English: • upper body discomfort radiating to the back, jaw, throat,
Slovenian: • nelagodje v zgornjem delu telesa, ki se širi v hrbet,
English: [The below wording should be added and the frequency of the adverse events should be aligned to that of the SmPC]
Slovenian: [Spodnje besedilo je treba dodati in pogostnost neželenih učinkov prilagoditi glede na povzetek glavnih značilnosti zdravila]
English: These incidences were estimated from the totality of the epidemiological study data, using relative risks for the different products compared with levonorgestrel-containing CHCs.
Slovenian: Ocene pogostnosti temeljijo na zbranih podatkih epidemioloških študij, z uporabo relativnih tveganj za različna zdravila v primerjavi s kombiniranimi hormonskimi kontraceptivi, ki vsebujejo levonorgestrel.
English: If any of the above conditions change while you are using [invented name], for example you start smoking, a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
Slovenian: Če se med uporabo zdravila [izmišljeno ime] katero od zgoraj navedenih stanj spremeni, na primer začnete kaditi ali pri bližnjem sorodniku nastane krvni strdek zaradi neznanega vzroka, ali če se močno zredite, obvestite zdravnika.
English: If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use.
Slovenian: Če obstaja sum na dedno nagnjenost, je treba žensko pred odločitvijo za uporabo kombiniranih hormonskih kontraceptivov napotiti po nasvet k specialistu.
English: [Invented name] is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis (see section 4.3).
Slovenian: Uporaba zdravila [izmišljeno ime] je kontraindicirana, če ima ženska en resen ali več dejavnikov tveganja za ATE, ker pri njej obstaja veliko tveganje za arterijsko trombozo (glejte poglavje 4.3).
English: The decision to prescribe [invented name] should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [invented name] compares with other CHCs (see sections 4.3 and 4.4).
Slovenian: Pri odločitvi za predpisovanje zdravila [izmišljeno ime] je treba upoštevati obstoječe dejavnike tveganja za vsako posamezno žensko, predvsem za vensko trombembolijo (VTE - venous thromboembolism), in kakšno je tveganje za VTE z zdravilom [izmišljeno ime] v primerjavi s tveganjem pri drugih kombiniranih hormonskih kontraceptivih [CHC - combined hormonal contraceptives] (glejte poglavji 4.3 in 4.4).
English: Symptoms of a cerebrovascular accident can include: - sudden numbness or weakness of the face, arm or leg, especially on one side of the body; - sudden trouble walking, dizziness, loss of balance or coordination; - sudden confusion, trouble speaking or understanding; - sudden trouble seeing in one or both eyes; - sudden, severe or prolonged headache with no known cause; - loss of consciousness or fainting with or without seizure.
Slovenian: Simptomi cerebrovaskularnega dogodka lahko vključujejo: - nenadno odrevenelost ali šibkost obraza, rok ali nog, predvsem na eni strani telesa; - nenadne težave s hojo, omotičnost, izgubo ravnotežja ali koordinacije; - nenadno zmedenost, nerazločno govorjenje ali težave z razumevanjem; - nenadne težave z vidom na enem ali obeh očesih; - nenaden, hud ali dolgotrajen glavobol brez znanega razloga; - izgubo zavesti ali omedlevico z epileptičnim napadom ali brez njega.
English: Antithrombotic treatment should be considered if [invented name] has not been discontinued in advance.
Slovenian: Če uporaba zdravila [izmišljeno ime] ni bila predhodno prekinjena, je treba razmisliti o antitrombotičnem zdravljenju.
English: Limited epidemiological data suggest that the risk of VTE with dienogest-containing CHCs may be similar to the risk with levonorgestrel-containing CHCs.
Slovenian: Omejeni epidemiološki podatki kažejo, da je morda tveganje za VTE pri kombiniranih hormonskih kontraceptivih, ki vsebujejo dienogest, podobno tveganju pri kombiniranih hormonskih kontraceptivih, ki vsebujejo levonorgestrel.
English: • If you have varicose veins.
Slovenian: • če imate varice (krčne žile).
English: Levonorgestrel-containing CHC (5-7 events)
Slovenian: CHC, ki vsebujejo levonorgestrel (5-7 dogodkov)
English: Women should be advised not to smoke if they wish to use a CHC.
Slovenian: Ženskam je treba odsvetovati kajenje, če želijo uporabljati kombinirane hormonske kontraceptive.
English: • If you have an inflammation in the veins under the skin (superficial thrombophlebitis);
Slovenian: • če imate vnetje podkožnih žil (povrhnji tromboflebitis);
English: Positive family history (venous thromboembolism ever in a sibling or parent especially at a relatively early age e.g. before 50).
Slovenian: Pozitivna družinska anamneza (venska trombembolija kadar koli pri sorojencu ali staršu, predvsem v sorazmerno zgodnji starosti, npr. pred 50 letom starosti)
English: [The following should be deleted (where applicable)] There is no consensus as to whether the occurrence of these events is associated with the use of CHCs.
Slovenian: [Naslednje besedilo je treba izbrisati (kjer je primerno)] O tem, ali so ti zapleti povezani z uporabo kombiniranih hormonskih kontraceptivov, ni enotnega mnenja.
English: - It is not yet known how the risk of a blood clot with [invented name] compares to the risk with a combined hormonal contraceptive that contains levonorgestrel.
Slovenian: - Ni znano kolikšno je tveganje za nastanek krvnih strdkov pri zdravilu [izmišljeno ime] v primerjavi s tveganjem pri kombiniranih hormonskih kontraceptivih, ki vsebujejo levonorgestrel.
English: Current evidence suggests that the risk of VTE with use of norgestimate-containing CHCs is similar to the risk with levonorgestrel-containing CHCs.
Slovenian: Trenutni dokazi kažejo, da je tveganje za VTE pri uporabi kombiniranih hormonskih kontraceptivov, ki vsebujejo norgestimat, podobno tveganju pri kombiniranih hormonskih kontraceptivih, ki vsebujejo levonorgestrel.
English: [The following wording to be kept/added (as appropriate)] Extremely rarely, thrombosis has been reported to occur in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries.
Slovenian: [Naslednje besedilo je treba izbrisati (kjer je primerno)] Izredno redko so pri ženskah, ki so uporabljale kombinirane hormonske kontraceptive, poročali o trombozi v drugih žilah, npr. jetrnih, mezenteričnih, ledvičnih ali mrežničnih venah in arterijah.