natgillin/translations-raw huggingface dataset:
The following advice only refers to missed white active tablets.
Naslednji nasveti se nanašajo samo na primer, da ste pozabili vzeti belo aktivno tableto.
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.
Med simptomi cerebrovaskularnega dogodka so lahko: - nenadna omrtvelost ali šibkost obraza, roke ali noge, zlasti na eni strani telesa, - nenadne težave s hojo, omotica, izguba ravnotežja ali koordinacije, - nenadna zmedenost, težave z govorom ali razumevanjem,
Due to metabolism and enterohepatic circulation, a large circulating pool of estrogen sulfates and glucuronides is present.
Zaradi presnove in enterohepatičnega obtoka kroži po telesu velika količina estrogen sulfatov in glukuronidov.
However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait
Če pa je vmes že imela spolni odnos, je treba najprej izključiti nosečnost, preden lahko ženska začne jemati kombinirane peroralne kontraceptive, oziroma mora ženska počakati na prvo menstruacijo.
In the IOA group, acne was reported by 15.4 % of the women (versus 7.9 % in the comparator group), weight increased was reported by 8.6 % of the women (versus 5.7 % in the comparator group), and abnormal withdrawal bleeding (predominantly absence of withdrawal bleeding) was reported by 10.5 % of the women (versus 0.5 % in the comparator group).
V skupini, ki je jemala zdravilo IOA, je o aknah poročalo 15,4 % žensk (proti 7,9 % v primerjalni skupini), o povečanju telesne mase 8,6 % žensk
o A high risk of venous thromboembolism due to the presence of multiple risk factors (see
o Veliko tveganje za vensko trombembolijo zaradi prisotnosti večih dejavnikov tveganja
• Worsening of depression, Crohn's disease and ulcerative colitis have been associated with COC use.
• Z uporabo KPK je bilo povezano poslabšanje depresije, Crohnove bolezni in ulceroznega kolitisa.
Ferric oxide yellow (E172)
črni železov oksid (E 172)
Factors that increase your risk of a blood clot in a vein The risk of a blood clot with IOA is small but some conditions will increase the risk.
Tveganje za nastanek krvnega strdka je z zdravilom IOA majhno, vendar pa nekatera stanja to tveganje povečajo.
• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see
• Bodite pozorni in pojdite k zdravniku, če menite, da imate simptome krvnega strdka (glejte poglavje 2 "Krvni strdki").
- sweating, nausea, vomiting or dizziness; - extreme weakness, anxiety, or shortness of breath; - rapid or irregular heartbeats.
- znojenje, navzea, bruhanje ali omotica, - skrajna šibkost, tesnoba ali kratka sapa, - hitro ali neredno bitje srca.
The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time.
Zadnjo pozabljeno belo tableto naj ženska vzame takoj, ko se spomni, tudi če to pomeni, da bo vzela dve tableti hkrati.
IOA, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any
Tako kot druga hormonska kontracepcijska sredstva tudi zdravilo IOA ne varuje pred okužbo z virusom HIV (AIDS) ali katero drugo spolno prenosljivo boleznijo.
• Estradiol, the oestrogen in IOA, is identical to the hormone produced by your ovaries during a
• Estradiol, to je estrogen v zdravilu IOA, je popolnoma enak hormonu, ki nastaja v jajčnikih v času menstrualnega ciklusa.
Symptoms of deep vein thrombosis (DVT) can include: - unilateral swelling of the leg and/or foot or along a vein in the leg; - pain or tenderness in the leg which may be felt only when standing or walking; - increased warmth in the affected leg; red or discoloured skin on the leg.
Med simptomi globoke venske tromboze (DVT) so lahko: - enostranska oteklost noge in/ali stopala ali vzdolž vene na nogi, - bolečina ali občutljivost v nogi, ki je lahko prisotna le stoje ali med hojo,
IOA is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis (see section 4.3).
Zdravilo IOA je kontraindicirano, če ima ženska več dejavnikov tveganja, zaradi katerih je njeno tveganje za vensko trombozo veliko (glejte poglavje 4.3).
However, if she has missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days.
Če pa ste izpustili več kot 1 tableto, morate 7 dni uporabljati dodatna kontracepcijska sredstva.
Other medical conditions associated with VTE Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease
Rak, sistemski eritematozni lupus, hemolitičnouremični sindrom, kronična vnetna bolezen črevesja (Crohnova bolezen ali ulcerozni kolitis)
in the yellow placebo film-coated tablets: The tablet does not contain active substances.
v rumenih placebo filmsko obloženih tabletah: Te tablete ne vsebujejo zdravilnih učinkovin.
Maximum plasma concentrations of nomegestrol acetate of about 12 ng/ml are reached 1.5 h after dosing.
Največja plazemska koncentracija nomegestrolacetata približno 12 ng/ml je dosežena 1,5 h po njegovem zaužitju.
• It is estimated that out of 10,000 women who use a levonorgestrel-containing CHC about 61 will
• Ocenjujejo, da se VTE v enem letu pojavi pri približno 61 od 10.000 žensk, ki uporabljajo CHC, ki vsebujejo levonorgestrel.
• Presence or history of severe hepatic disease as long as liver function values have not returned
• Obstoječa huda jetrna bolezen ali huda jetrna bolezen v anamnezi, pri kateri se izvidi delovanja jeter niso povrnili na normalne vrednosti.
• if you are less than 12 hours late in taking a tablet, the reliability of the pill is maintained.
• Če z jemanjem tablete zamujate manj kot 12 ur, je zanesljivost kontracepcijskih tablet ohranjena.
Changing from a progestogen-only-method (minipill, implant, injectable) or from a hormone-medicated Intra Uterine System (IUS)
Prehod z jemanja izključno progestogenske metode (mini tabletke, vsadka, injekcij) ali materničnega sistema s hormoni (IUS)
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP ali Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Nomegestrol acetate has a strong affinity for the human progesterone receptor and has an anti-gonadotropic activity, a progesterone receptor-mediated anti-estrogenic activity, a moderate anti-androgenic activity, and is devoid of any estrogenic, androgenic, glucocorticoid or
Kaže proti-gonadotropno delovanje, s progesteronskim receptorjem posredovano proti-estrogeno delovanje, zmerno protiandrogeno delovanje, nima pa nikakršnega estrogenskega, androgenega, glukokortikoidnega ali mineralokortikoidnega delovanja.
You can start taking IOA the day after you have taken the last tablet from your present pill blister (this means no tablet-free break).
vaginalnega obročka ali transdermalnega obliža) Z jemanjem zdravila IOA lahko začnete dan po tem, ko ste vzeli zadnjo tableto iz trenutnega pretisnega omota s tabletami (to pomeni, da ne boste imeli premora brez jemanja tablet).
The elimination half-life Nomegestrol acetate is excreted via urine and feces.
Nomegestrolacetat se izloča prek urina in blata.
• The herbal product St. John's wort may also stop IOA from working properly.
• Tudi zeliščni pripravki, ki vsebujejo šentjanževko, lahko ovirajo pravilno delovanje zdravila IOA.
If possible take it within 12 hours of when you normally take your pill.
Če je le mogoče, jo vzemite v 12 urah po tem, kot je običajno.
The overall risk of a blood clot in the leg or lung (DVT or PE) with IOA is small.
Na splošno je tveganje za nastanek krvnega strdka v nogi ali pljučih (globoka venska tromboza ali pljučna embolija) pri zdravilu IOA majhno.
In the clinical trial performed with IOA in the United States the following Pearl Indices for the age
V kliničnem preskušanju, opravljenem z zdravilom IOA v Združenih državah, so izračunali naslednje
Vascular disorders hot flush venous thromboembolism
Žilne bolezni navali vročine venska tromboembolija
Common (may affect up to 1 in 10 people): • decreased interest in sex; depression/depressed mood; mood changes
• zmanjšano zanimanje za spolnost, depresija oz. depresivno razpoloženje, spremembe razpoloženja
• Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.
• Pri akutnih ali kroničnih motnjah delovanja jeter je lahko potrebna ukinitev uporabe KPK,
Risk factors for ATE
Dejavniki tveganja za VTE
Examples of active substances that induce hepatic enzymes and thus result in increased clearance of sex hormones are: phenytoin, phenobarbital, primidone, bosentan, carbamazepine, rifampicin, and medicinal products or herbal preparations containing St. John's wort, and, to a lesser extent, oxcarbazepine, topiramate, felbamate, and griseofulvin.
Med primere zdravilnih učinkovin, ki inducirajo jetrne encime in tako povzročijo povečan očistek spolnih hormonov, sodijo: fenitoin, fenobarbital, primidon, bosentan, karbamazepin, rifampicin in zdravila ali zeliščni pripravki, ki vsebujejo šentjanževko, v manjši meri pa tudi okskarbazepin,
However, no effects on ability to drive and use machines have been observed in users of COCs.
Pri uporabnicah KPK niso opažali nobenega vpliva na sposobnost vožnje in upravljanja s stroji.
• if you are more than 12 hours late in taking any tablet, the reliability of the pill may be reduced.
• Če z jemanjem katere koli tablete zamujate več kot 12 ur, je zanesljivost kontracepcijskih tablet lahko zmanjšana.
• Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of
• Ženske s hipertrigliceridemijo ali hipertrigliceridemijo v družinski anamnezi imajo lahko med jemanjem KPK povečano tveganje za nastanek pankreatitisa.
She should then take placebo tablets from the last row for up to 4 days, including the days she missed tablets, and subsequently continue with the next blister pack.
Jemlje naj jih do 4 dni, vključno z dnevi, ko je pozabila vzeti tablete, potem pa naj nadaljuje s tabletami iz naslednjega pretisnega omota.
You can also start, at the latest, on the day you would have started using the next ring or patch.
Z jemanjem zdravila lahko začnete najpozneje na dan, ko bi začeli uporabljati naslednji obroček ali
The estrogen contained in IOA is 17β-estradiol, a natural estrogen identical to the endogenous human
To je naravni estrogen, ki je popolnoma enak endogenemu humanemu 17β-estradiolu.
Oral exogenous estradiol is extensively metabolized.
Biotransformacija Peroralno uporabljen eksogeni estradiol se obsežno presnovi.
However, in any individual woman, the risk may be far higher, depending on her underlying risk factors (see below).
odvisno od njenih osnovnih dejavnikov tveganja (glejte spodaj).
The excess risk gradually disappears during the course of the 10 years after cessation of COC use.
V času 10 let po prenehanju uporabe KPK to dodatno tveganje postopoma izginja.
Symptoms of pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing; - sudden coughing which may be associated with haemoptysis;
- nenaden pojav nepojasnjene kratke sape ali hitrega dihanja, - nenaden kašelj, ki je lahko povezan s hemoptizo,
• Presence or risk of venous thromboembolism (VTE) o Venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]).
o Venska trombembolija - obstoječa VTE (zdravljena z antikoagulanti) ali VTE v anamnezi (npr. globoka venska tromboza [DVT - deep venous thrombosis] ali pljučna embolija [PE - pulmonary embolism]).
PVC/aluminium blister containing 28 film-coated tablets (24 white film-coated tablets and 4 yellow Pack sizes: 28 and 84 film-coated tablets.
Pretisni omot iz PVC in aluminija, ki vsebuje 28 filmsko obloženih tablet (24 belih filmsko obloženih tablet in 4 rumene filmsko obložene tablete).
Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma
vsak kirurški poseg na nogah ali v predelu medenice, nevrokirurška operacija ali večja poškodba
If any of the above conditions change while you are using IOA, for example, you start smoking, a close family member experiences a thrombosis for no known reason or you gain a lot of weight, tell
Zdravniku morate povedati, če se kaj od naštetega med vašo uporabo zdravila IOA spremeni, na primer če začnete kaditi, če se kakšnemu bližnjemu sorodniku pojavi tromboza brez znanega razloga, ali če se močno zredite.
If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors - in this case her total risk of VTE should be considered.
je lahko povečanje tveganja večje od seštevka posameznih dejavnikov - v takšnem primeru je treba upoštevati njeno celotno tveganje za VTE.
Positive family history (arterial thromboembolism ever in a sibling or parent especially at relatively
Pozitivna družinska anamneza (arterijska trombembolija pri sorojencu ali staršu, zlasti v sorazmerno zgodnji starosti, npr. pred 50. letom)
• Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the
• Znane maligne bolezni ali sum nanje (npr. genitalnih organov ali dojk), zaradi vpliva steroidnih spolnih hormonov.
But if you are having intercourse, make sure you also use a barrier method of contraception for the first 7 days that you are taking IOA.
Če pa imate spolne odnose, morate prvih 7 dni jemanja zdravila IOA uporabljati tudi pregradno metodo kontracepcije.
No clinically relevant effect of food was observed on the bioavailability
Opazili niso nobenega klinično pomembnega vpliva hrane na biološko uporabnost estradiola.
IOA is not indicated during pregnancy.
Nosečnost Zdravilo IOA ni indicirano za uporabo med nosečnostjo.
• swelling of one leg or along a vein in the leg or foot especially when • pain or tenderness in the leg which may be felt only when
• oteklost ene noge ali vzdolž vene v nogi ali stopalu, zlasti če jo spremlja:
At the end of the placebo tablet interval, start with the next blister.
Ko zaključite z jemanjem placebo tablet, začnite z jemanjem tablet iz naslednjega pretisnega omota.
Reproductive toxicity studies performed with the combination have shown foetotoxicity which is
Študije vpliva na sposobnost razmnoževanja, opravljene s kombinacijo obeh učinkovin, so pokazale fetotoksičnost, ki je ustrezala stopnji izpostavljenosti estradiolu.
• In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of COCs.
• V redkih primerih so pri uporabnicah KPK poročali o nastanku benignih jetrnih tumorjev, še redkeje pa o malignih jetrnih tumorjih.
IOA 2.5 mg/1.5 mg film-coated tablets Nomegestrol acetate/estradiol
IOA 2,5 mg/1,5 mg filmsko obložene tablete nomegestrolacetat/estradiol
When changing from another combined hormonal contraceptive (combined pill, vaginal ring, or
Prehod z drugega kombiniranega hormonskega kontraceptiva (kombiniranih kontracepcijskih tabletk,
The 4 placebo tablets from the last row must be discarded.
Vzeti mora placebo tablete iz zadnje vrste.
Stop taking the white active tablet immediately and go directly to the yellow placebo tablet interval.
Takoj prenehajte z jemanjem belih aktivnih tablet in začnite z jemanjem rumenih placebo tablet.
Maximum plasma concentrations of nomegestrol acetate of about 7 ng/ml are reached at 2 h after single administration.
Največjo plazemsko koncentracijo približno 7 ng/ml doseže nomegestrolacetat 2 h po enkratnem odmerku.
If she is more than 12 hours late in taking any active tablet, contraceptive protection may be reduced.
Če pa z jemanjem katere koli tablete z zdravilno učinkovino zamuja več kot 12 ur, je kontracepcijska zaščita lahko zmanjšana.
However, use a barrier method as an extra precaution for the next 7 days.
Naslednjih 7 dni uporabljajte pregradno metodo.
• if you know you have a disorder affecting your blood clotting - for instance, protein C deficiency, protein S deficiency, antithrombin - III deficiency, Factor V Leiden or
• če veste, da imate motnjo, ki poslabša strjevanje krvi - na primer pomanjkanje proteina C,
Lactose monohydrate (see section 2 ‘IOA contains lactose'), cellulose microcrystalline (E460), crospovidone (E1201), talc (E553b), magnesium stearate (E572) and silica colloidal anhydrous Tablet coating (white active film-coated tablets):
Jedro tablete (bele aktivne filmsko obložene tablete in rumene placebo filmsko obložene tablete): laktoza monohidrat (glejte poglavje 2 "Zdravilo IOA vsebuje laktozo"), mikrokristalna celuloza (E460), krospovidon (E1201), smukec (E553b), magnezijev stearat (E572) in brezvodni koloidni silikagel
If you have taken IOA every day according to these directions, it is unlikely that you are pregnant (see also section 3 ‘If you have missed one or more periods').
Upoštevajte, da nekatere uporabnice teh tablet nimajo menstruacije vsak mesec v času jemanja rumenih tablet in če ste zdravilo IOA jemali vsak dan v skladu s temi navodili, je zelo malo verjetno, da ste noseči (glejte tudi poglavje 3 "Če niste dobili ene ali več menstruacij").
- HIV infections (e.g. ritonavir, nevirapine, nelfinavir, efavirenz); - other infectious diseases (e.g. griseofulvin); - high blood pressure in the blood vessels in the lungs (bosentan).
felbamat); - tuberkuloze (npr. rifampicin); - okužbe z virusom HIV (npr. ritonavir, nevirapin, nelfinavir, evafirenz); - drugih infekcijskih bolezni (npr. grizeofulvin)
• 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;
• če imate (ali ste kdaj imeli) krvni strdek v žili v nogah (globoko vensko trombozo, DVT),
It is important to draw a woman's attention to the information on venous and arterial thrombosis, including the risk of IOA 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.
IOA v primerjavi z drugimi CHC, s simptomi VTE in ATE, znanimi dejavniki tveganja in z ukrepanjem v primeru suma na trombozo.
You can stop taking IOA at any time.
Če prenehate z jemanjem zdravila IOA Zdravilo IOA lahko prenehate jemati kadarkoli.
In the clinical trial performed with IOA in the European Union the following Pearl Indices for the age
V kliničnem preskušanju, opravljenem z zdravilom IOA v Evropski uniji, so izračunali naslednje
Symptoms of a myocardial infarction (MI) can include: - pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; - discomfort radiating to the back, jaw, throat, arm, stomach; - feeling of being full, having indigestion or choking;
- bolečina, nelagodje, tiščanje, teža, občutek stiskanja ali polnosti v prsih, roki ali za prsnico, - nelagodje, ki se širi v hrbet, čeljust, žrelo, roko ali proti želodcu, - občutek polnosti, prebavne motnje ali dušenje,
IOA contains lactose.
Zdravilo IOA vsebuje laktozo.
If any of the above conditions change while you are using IOA, for example a close family member experiences a thrombosis for no known reason or you gain a lot of weight, tell your doctor.
Zdravniku morate povedati, če se kaj od naštetega med vašo uporabo zdravila IOA spremeni, na primer, če se kakšnemu bližnjemu sorodniku pojavi tromboza brez znanega razloga, ali če se močno zredite.
However, the missed tablets should be discarded to avoid unintentionally prolonging the
Te pozabljene placebo tablete mora zavreči, da ne bi kdaj pozneje nenamerno podaljšala faze jemanja placebo tablet.
If you get pregnant while using IOA you should stop using IOA and contact your doctor.
Če zanosite med jemanjem zdravila IOA, ga prenehajte jemati in se posvetujte z zdravnikom.
For example, it can cause a heart attack or a stroke.
srčni infarkt ali možgansko kap.
In addition to the above mentioned adverse reactions, hypersensitivity reactions have been reported in
Poleg zgoraj navedenih neželenih učinkov so pri uporabnicah zdravila IOA poročali tudi o preobčutljivostnih reakcijah (neznana pogostnost).
It is unknown if this finding is due to the use of hormonal contraceptives or to other factors, such as difference in sexual behaviour.
Zanj so poročali, da se pogosteje pojavlja pri ženskah, ki dlje časa jemljejo kontracepcijske tablete, ni pa znano, ali je ta ugotovitev posledica jemanja hormonskih kontraceptivov ali drugih dejavnikov, na primer razlik v spolnem vedenju.
The woman should start with IOA preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.
Prehod z drugega kombiniranega hormonskega kontraceptiva (kombinirane peroralne kontracepcijske tablete (KPK), vaginalnega obročka ali transdermalnega obliža) Najbolje je, da ženska začne z jemanjem zdravila IOA dan potem, ko je vzela zadnjo tableto z zdravilnimi učinkovinami prejšnjih KPK, vendar najpozneje na dan po običajnem premoru brez jemanja tablet oziroma po jemanju placebo tablet od prejšnjih KPK.
Stroke
Slika
• if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial
• če imate migrene, zlasti migrene z avro, • če imate težave s srcem (okvaro srčnih zaklopk, motnjo srčnega ritma, ki jo imenujemo atrijska fibrilacija).
If you need to stop IOA ask your doctor when you
Če morate prenehati jemati zdravilo IOA, zdravnika vprašajte, kdaj ga lahko znova začnete uporabljati.
Eye disorders contact lens intolerance/dry eye
• suho oko, neprenašanje kontaktnih leč
• if you need an operation or if you are off your feet for a long time (see in section 2 ‘Blood clots).
• če potrebujete kirurški poseg ali če dolgo časa niste na nogah (glejte v poglavju 2 "Krvni strdki"); • če ste pravkar rodili, imate večje tveganje za krvne strdke.
• chest pain, discomfort, pressure, heaviness • sensation of squeezing or fullness in the chest, arm or below the
• bolečina, nelagodje, občutek pritiska ali teže v prsnem košu;
Antithrombotic treatment should be considered if IOA has not been discontinued in advance.
Če uporaba zdravila IOA ni predhodno prekinjena, je treba razmisliti o antitrombotičnem
Active film-coated tablets: white, round and coded ‘ne' on both sides.
Filmsko obložene tablete z zdravilno učinkovino: bele, okrogle, z oznako "ne" na obeh straneh Filmsko obložene placebo tablete: rumene, okrogle, z oznako "p" na obeh straneh
If you start later than day 28, you should also use a barrier method of contraception during the first 7 days of IOA use.
28. dnevu, morate prvih 7 dni jemanja zdravila IOA uporabljati še pregradno metodo kontracepcije.
Other medical conditions associated with
Druga klinična stanja, povezana z VTE
No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding).
Z jemanjem tablet mora ženska začeti na prvi dan svojega naravnega ciklusa (t.j.
When changing from a progestogen-only injectable, implant or a hormone-medicated intrauterine Start using IOA when your next injection is due or on the day that your implant or IUS is removed.
Zdravilo IOA začnite uporabljati, ko bi bila na vrsti naslednja injekcija ali na dan, ko vam odstranijo vsadek ali IUS.