FrancophonIA/ELRC3.0 huggingface dataset:
English: − nausea, mild headache, weight increase, irritability, heavy feeling in legs
Slovenian: − - slabost, blag glavobol, povečanje telesne teže, razdraženost, občutek težkih nog
English: A withdrawal bleed is unlikely until the end of the second blister pack, but she may experience spotting or break through bleeding on the days she is taking tablets.
Slovenian: Do konca jemanja tablet iz drugega omota verjetno ne bo prišlo do krvavitve, lahko pa pride do mazanja ali vmesnih krvavitev v dneh, ko jemlje tablete.
English: This is due to induction of drug metabolising enzymes by St John's wort.
Slovenian: To je posledica indukcije presnovnih encimov, ki jo povzroča šentjanževka.
English: If it is of longer duration, it should be examined for pituitary disorders , before further prescription.
Slovenian: Če pa traja dlje časa, jo je treba raziskati in izključiti motnje delovanja hipofize, preden se nadaljuje predpisovanje.
English: In all these cases the woman should be advised to use a concomitant barrier method for the first 7 days of the tablet intake.
Slovenian: V vseh teh primerih je treba ženski svetovati, naj prvih sedem dni jemanja tablet sočasno uporablja pregradno kontracepcijsko metodo.
English: If this is not the case, the woman should be advised to follow the first of the two alternatives and use another contraceptive method concomitantly for the next 7 days.
Slovenian: Sicer ji je treba svetovati, naj se drži prve od obeh možnosti in naslednjih sedem dni sočasno uporablja druge kontracepcijske metode.
English: To shift her period to another day of the week, rather than the one the woman is used to with the present tablet intake, she may be advised to shorten the forthcoming tablet-free interval by as many days as she likes.
Slovenian: Če ženska želi prestaviti menstruacijo na kakšen drug dan v tednu od tega, kot je navajena ob dosedanjem jemanju tablet, ji svetujemo, da obdobje brez tablet skrajša za želeno število dni.
English: Therefore the CHMP has recommended that there are no objections for the granting of the Marketing
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) zato meni, da za Rigevidon ne obstajajo nobeni pridržki za odobritev dovoljenja za promet z zdravilom.
English: Women with a tendency to chloasma should avoid exposure to sunlight or ultraviolet radiation while taking oral contraceptives.
Slovenian: Ženske, ki so nagnjene h kloazmi, se med jemanjem peroralnih kontracepcijskih sredstev ne smejo izpostavljati sončni svetlobi ali ultravijoličnemu sevanju.
English: Changing from another combined hormonal contraceptive (combined oral pills, vaginal ring or transdermal patch): The woman should start with Rigevidon on the day after she took the last active tablet in her previous blister pack of contraceptive pills (or removed the vaginal ring or transdermal patch) but, no later than on the day after the usual tablet-free (or placebo, patch-free or ring-free) interval with her previous contraceptive.
Slovenian: Ženska mora začeti jemati Rigevidon na dan, ko je iz prejšnjega pretisnega omota vzela zadnjo aktivno kontracepcijsko tableto (ali odstranila vaginalni obroček ali transdermalni obliž), vendar ne pozneje kot na dan po običajnem premoru za jemanje tablet prejšnjih kontracepcijskih tablet (ali placeba, obliža ali obročka).
English: The occurrence of VTE during oral contraceptive use is, however, much lower than the occurrence related to pregnancy (i.e. 6/10,000 woman years).
Slovenian: Vendar je pojavnost VTE med jemanjem peroralnih kontracepcijskih sredstev mnogo manjša kot v nosečnosti (t.j.
English: The woman should take the last missed tablet as soon as she remembers this, even if this means that she has to take 2 tablets at the same time.
Slovenian: Ženska mora vzeti zadnjo izpuščeno tableto takoj, ko se spomni, čeprav to pomeni, da mora hkrati vzeti dve tableti.
English: This increased risk gradually declined over 10 years following cessation of oral contraception.
Slovenian: V 10 letih po prenehanju uporabe peroralne kontracepcije se je to tveganje nekoliko zmanjšalo.
English: The mechanism of action seems to be based on the liver enzyme inducing properties of these active substances.
Slovenian: Mehanizem delovanja teh učinkovin verjetno temelji na njihovem induciranju jetrnih encimov.
English: Changing from a progestogen-only method (progestogen-only or mini-pills, injection, implant) The woman may switch from progestogen-only pills on any day (from an implant on the day the implant is removed or from injection, when the next injection should have been given).
Slovenian: Ženska lahko kadarkoli preide na tablete, ki vsebujejo samo progesteron (z vsadka na dan, ko je vsadek odstranjen ali z injekcije, ko naj bi dobila naslednjo injekcijo).
English: Took the Pill at these ages:
Slovenian: Jemale »Tabletko« v starosti:
English: The diagnosed cases of breast cancer in users of oral contraceptives, have a tendency to be clinically less advanced, compared to the diagnosed cases of breast cancer in non-users.
Slovenian: Diagnosticirani primeri raka dojk pri uporabnicah peroralnih kontracepcijskih sredstev so na splošno manj napredovali kot diagnosticirani primeri pri neuporabnicah.
English: In order to delay a period, the woman should continue the next blister pack of Rigevidon, after taking the last tablet in the current pack, without.
Slovenian: Ženska, ki želi poznejšo menstruacijo, mora nadaljevati z naslednjim pretisnim omotom tablet Rigevidon potem, ko vzame zadnjo tableto iz obstoječe škatle, ne da bi vmes prenehala jemati tablete.
English: She should use a barrier method concomitantly, e.g. a condom, for the next 7 days.
Slovenian: V naslednjih sedmih dneh naj sočasno uporablja pregradno zaščito npr. kondom.
English: 4.6 Pregnancy and lactation Rigevidon is not indicated during pregnancy.
Slovenian: Rigevidon med nosečnostjo ni indiciran.
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Progestogens and estrogens, fixed combinations
Slovenian: Farmakoterapevtska skupina : Gestageni in estrogeni, enofazni pripravki
English: Seven days of uninterrupted tablet taking is required to maintain adequate suppression of the hypothalamus-pituitary-ovarian-axis.
Slovenian: Za vzdrževanje primerne supresije hipotalamusno-hipofizno-ovarijske osi je potrebno sedem dni neprekinjenega jemanja tablet.
English: − hyperlipidaemia (hypertriglyceridaemia and/or hypercholesterolaemia), diabetes
Slovenian: − hiperlipidemija (hipertrigliceridemija in/ali hiperholesterolemija), sladkorna bolezen
English: Levonorgestrel is rapidly and completely absorbed after oral administration of Rigevidon.
Slovenian: Po peroralni uporabi Rigevidona se levonorgestrel absorbira hitro in popolno.
English: Other methods of contraception should be considered for those women over 35 years old who smoke.
Slovenian: Pri ženskah, ki kadijo in so starejše od 35 let, je treba pretehtati možnost uporabe drugih kontracepcijskih metod.
English: Regular intake of Rigevidon is resumed after the usual 7 days tablet-free interval.
Slovenian: Rigevidon znova začne jemati po sedemdnevnem premoru.
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort.
Slovenian: Učinek indukcije lahko vztraja še dva tedna po prenehanju uživanja šentjanževke.
English: Provided that the tablets have been taken correctly during the 7 days preceding the forgotten tablet, it is not necessary to take further contraceptive precautions.
Slovenian: Če je sedem dni pred tem tablete jemala pravočasno, ni treba uporabljati drugih kontracepcijskih metod.
English: Week 2:
Slovenian: Drugi teden
English: However, a review of the literature suggests that effects on ovarian function and the endometrium occur at doses that are considerably lower than those in currently approved COCs and does not support the view that COCs in general have a narrow therapeutic margin in terms of efficacy/safety parameters.
Slovenian: Vendar pa sodeč po strokovni literaturi tudi znatno nižji odmerki od tistih, ki jih vsebujejo že odobreni kombinirani peroralni kontraceptivi, učinkujejo na delovanje jajčnikov in endometrij, kar pa ne zagovarja stališča, da imajo kombinirani peroralni kontraceptivi na splošno ozko terapevtsko okno v smislu učinkovitosti in varnosti.
English: - Obesity (body mass index above 30 kg/m²).
Slovenian: − -debelostjo (BMI nad 30 kg/m2) − -dislipoproteinemijo
English: ⇒ There are no safety issues placing COCs with 0.030 mg ethinyloestradiol and 0.150 mg levonorgestrel in the category of narrow therapeutic index drugs.
Slovenian: Glede zanesljivosti ni razloga, da bi kombinirane peroralne kontraceptive z 0,030 mg etinilestradiola in 0,150 mg levonorgestrela uvrstili v skupino zdravil z nizkim terapevtskim indeksom.
English: - Age.
Slovenian: − -starostjo
English: Therefore, diabetics should be monitored closely during use of oral contraceptives.
Slovenian: Zato morajo biti diabetiki, kadar jemljejo peroralna kontracepcijska sredstva, pod nadzorom.
English: In the case of suspected hereditary predisposition, the woman should be referred to a specialist before she decides to use oral contraception.
Slovenian: Če sumimo, da gre za dedno nagnjenost, je treba žensko, če želi uporabljati peroralno kontracepcijo, napotiti k specialistu.
English: Hyperlipidaemic women should be closely monitored if they choose to use contraceptive pills.
Slovenian: Če se ženske s hiperlipidemijo odločijo, da bodo jemale kontracepcijske tablete, jih je treba pozorno opazovati.
English: Herbal preparations containing St John's wort (Hypericum perforatum) should not be used while taking Rigevidon due to the risk of decreased plasma concentrations and reduced clinical effects of Rigevidon (see section 4.5).
Slovenian: Med jemanjem Rigevidona ženske ne smejo uživati zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum), ker obstaja tveganje zmanjšanja koncentracije v serumu in zmanjšanja kliničnih učinkov Rigevidona.
English: Inadequate exposure to the active components of a combined oral contraceptive (COC) may lead to therapeutic failure, i.e. pregnancy, which has a large impact on people's life.
Slovenian: Neustrezna izpostavljenost zdravilnim učinkovinam v kombiniranem peroralnem kontraceptivu lahko vodi do neuspeha terapije, t.j.
English: Women should be advised that oral contraceptives do not protect against HIV (AIDS) or other sexually transmitted infections (STI).
Slovenian: Opozorila Ženske je treba opozoriti, da jih peroralna kontracepcijska sredstva ne ščitijo pred okužbo z virusom
English: The efficacy of oral contraceptives may be reduced in the case of missed tablets or vomiting (see section 4.2) or concomitant use of other medicinal product (see section 4.5).
Slovenian: Če ženska pozabi vzeti tableto ali bruha (glejte poglavje 4.2) in pri sočasni uporabi drugih zdravil
English: The approximate occurrence of VTE in users of oral contraceptives with a low content of estrogen (less than 50 microgram ethinylestradiol) is up to 4/10,000 woman years compared to 0.5-1/10,000 woman years in non-users.
Slovenian: mikrogramov etinilestradiola) je do 4/10.000 ženskih let v primerjavi z 0,5-1/10.000 ženskih let pri ženskah, ki peroralne kontracepcije ne uporabljajo.
English: If these extra precautions overrun the end of the pack, the next pack should be started without a break.
Slovenian: Če zaradi teh varnostnih ukrepov ne zadostuje količina tablet v eni škatli, je treba z naslednjo škatlo tablet nadaljevati brez premora.
English: Thus, the following advice may be given in daily practice: Week 1:
Slovenian: Zato predlagamo naslednje ukrepe za dnevno uporabo:
English: Chloasma may occasionally occur, in particular in women with a medical history of chloasma gravidarum.
Slovenian: Občasno se lahko pojavi kloazma, zlasti pri ženskah z anamnezo nosečnostne kloazme.
English: DATE OF REVISION OF THE TEXT
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET DATUM REVIZIJE BESEDILA
English: 4.2 Posology and method of administration
Slovenian: Peroralna kontracepcija 4.2 Odmerjanje in način uporabe
English: If the tablets have been taken according to the instructions described in section 4.2, it is unlikely that the woman is pregnant.
Slovenian: Občasno med premorom pri jemanju tablet do odtegnitvenih krvavitev sploh ne pride.Če je ženska jemala tablete v skladu z navodili v poglavju 4.2., ni verjetno, da bi bila noseča.
English: The excretion of conjugates of ethinylestradiol and its metabolites takes place via urine and faeces.
Slovenian: Izločanje konjugatov etinilestradiola in njegovih presnovkov poteka prek urina in blata (v razmerju 1 : 1).
English: There is no consensus concerning the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism.
Slovenian: O morebitni vlogi varikoznih ven ali povrhnjega tromboflebitisa pri pojavu venske trombembolije so mnenja deljena.
English: It is acceptable to start the tablets on day 2-5, but during the first cycle the concomitant use of a barrier method for the first 7 days is recommended.
Slovenian: Lahko jih začne jemati od drugega do petega dne, vendar pa je priporočljivo, da se v prvih sedmih dneh sočasno uporablja dodatna pregradna zaščita.
English: Benign and malignant liver tumours have been reported in users of combined oral contraceptives.
Slovenian: Pri uporabnicah peroralnih kontracepcijskih sredstev so poročali o primerih benignih in malignih tumorjev jeter.
English: Oral contraception may be resumed if appropriate, when normotensive values are reached with antihypertensive therapy.
Slovenian: S peroralno kontracepcijo lahko nadaljujemo, ko se zaradi zdravljenja vrednosti krvnega tlaka vrnejo na normalo.
English: Levonorgestrel is eliminated with a mean T½ of approximately 36 hours at steady state.
Slovenian: Pri stalni koncentraciji je srednja vrednost T1/2 levonorgestrela približno 36 ur.
English: COCs generally exhibit wide variation with regard to pharmacokinetics.
Slovenian: Z vidika farmakokinetike so kombinirani peroralni kontraceptivi na splošno zelo raznoliki.
English: Women who get severely depressed during the use of contraceptive pills should stop taking the pills and be advised to use an alternative contraceptive method while trying to determine if the symptoms are due to the oral contraceptive preparation.
Slovenian: Svetovati jim je treba uporabo druge kontracepcijske metode, medtem pa je treba ugotoviti, ali so simptomi posledica peroralnih kontracepcijskih pripravkov.
English: Hydrolysis of the direct conjugates of ethinylestradiol by the intestinal flora gives ethinylestradiol,
Slovenian: Črevesna flora hidrolizira direktne konjugate etinilestradiola v etinilestradiol, ki se lahko znovna absorbira in tako ustvarja enterohepatični obtok.
English: The use of contraceptive steroids may have an influence on the results of certain laboratory tests, including biochemical parameters for liver, thyroid, adrenal and renal function; on the plasma levels for (transport)proteins, e.g. corticosteroid-binding globulin and lipid/lipoprotein fractions; on parameters for carbohydrate metabolism and parameters for coagulation and fibrinolysis.
Slovenian: Uporaba kontraceptivnih steroidov lahko vpliva na rezultate nekaterih laboratorijskih testov, vključno z biokemičnimi parametri za jetra, ščitnico, delovanje nadledvične žleze in ledvic, na koncentracijo
English: If she starts later than this, she should be advised to use a concomitant barrier method during the first 7 days of tablet intake.
Slovenian: Če začne jemati tablete pozneje, ji svetujemo, naj prvih sedem dni jemanja sočasno uporablja pregradno kontracepcijo.
English: There have been case reports of retinal thrombosis with the use of oral contraceptives.
Slovenian: Očesne razjede Obstajajo poročila o trombozi mrežnice zaradi uporabe peroralnih kontracepcijskih sredstev.
English: Crohn's disease and colitis ulcerosa have been associated with the use of combined oral contraceptives.
Slovenian: Uporaba kombiniranih peroralnih sredstev je povezana s Crohnovo boleznijo in ulceroznim kolitisom.
English: Thrombosis in other blood vessels has very rarely been reported, i.e. hepatic, mesenteric, renal or retinal veins and arteries, in users of oral contraceptives.
Slovenian: mezenteričnih, ledvičnih ali retinalnih venah in arterijah, poročali zelo redko.
English: In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors the woman should be advised to contact her physician.
Slovenian: Ženski je treba svetovati, naj v primeru poslabšanja ali prvega pojava katerekoli bolezni ali dejavnika tveganja, obišče svojega zdravnika.
English: The risk of contraceptive failure is imminent because of the ensuing tablet-free interval.
Slovenian: Zaradi bližanja obdobju nejemanja tablet je nevarnost nedelovanja kontracepcije veliko večja.
English: − arterial hypertension, coronapathies
Slovenian: − arterijska hipertenzija, bolezni srca
English: − vomiting;
Slovenian: − - bruhanje
English: PHARMACOLOGICAL PROPERTIES
Slovenian: 5.2 Farmakokinetične lastnosti
English: 1.Circulatory disorders
Slovenian: Motnje krvnega obtoka
English: Hence, the use of oral contraceptives cannot generally be recommended until the lactating mother has completely weaned off the child. Small amounts of contraceptive steroids and/or their metabolites may be excreted with the milk.
Slovenian: Manjše količine kontraceptivnih steroidov in/ali njihovi presnovki se lahko izločajo z mlekom.
English: Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions.
Slovenian: Kadar pride do delne ali popolne izgube vida, proptosisa ali diplopije, papiledema ali razjed ožilja v mrežnici, je treba jemanje peroralnih kontracepcijskih sredstev prekiniti.
English: 4.7 Effects on ability to drive and use machines
Slovenian: 6.6 NAVODILA ZA PRIPRAVO IN RAVNANJE Z ZDRAVILOM
English: Instructions for use and handling No special requirements.
Slovenian: Ni posebnih zahtev.
English: The woman should take the last missed tablet as soon as she remembers this, even if this means that she has to take 2 tablets at the same time.Thereafter, she should continue to take the tablets at the usual time point.
Slovenian: Ženska naj vzame zadnjo izpuščeno tableto takoj, ko se spomni, čeprav to pomeni, da mora vzeti dve tableti hkrati.
English: − Undiagnosed vaginal bleeding
Slovenian: − laktoza monohidrat
English: Preclinical data based on conventional studies of repeated dose toxicity, genotoxicity and carcinogenic potential revealed no particular human risks beyond those discussed in other sections of the SPC.
Slovenian: genotoksičnosti in karcinogenosti, niso pokazali nobenih posebnih tveganj za človeka, razen tistih, ki so navedeni v drugih poglavjih Povzetka glavnih značilnosti zdravila.
English: ⇒ Despite wide inter- and intra-individual variations of steroid plasma concentrations, high contraceptive efficacy is consistently demonstrated in COC's with 0.030 mg ethinylestradiol and 0150 mg levonorgestrel, ⇒ There is a poor correlation between plasma steroid levels and contraceptive efficacy, ⇒ The pharmacokinetics of progestogens and EE do not adequately reflect safety parameters, such as endometrial bleeding or common adverse events nor rare effects such as risk of thromboembolic disease,
Slovenian: Kljub visoki populacijski in individualni variabilnosti koncentracij steroidov v plazmi je dokazano, da kombinirani peroralni kontraceptivi z 0,030 mg etinilestradiola in 0,150 mg levonorgestrela zagotavljajo zelo učinkovito kontracepcijo.
English: Reduced efficacy
Slovenian: (glejte 4.5) Zmanjšan učinek
English: deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
Slovenian: (protitelesa proti kardiolipinu, lupusni antikoagulant).
English: Women who have previously suffered from depression should be closely monitored and stop the use of the oral contraceptive preparation if the symptoms of depression relapse.
Slovenian: Če se znaki depresije znova pojavijo, je treba z uporabo peroralnih kontracepcijskih pripravkov prenehati.
English: Furthermore, high contraceptive efficacy has been demonstrated with lower doses in marketed products than those found in Rigevidon and high contraceptive efficacy has also been shown for progestogenonly methods with considerably lower doses than those found in COCs.
Slovenian: Poleg tega je dokazano, da so tudi pripravki, ki so že na trgu in vsebujejo manjše odmerke kakor Rigevidon, zelo učinkoviti kontraceptivi.
English: − hepatic adenoma, cholestatic jaundice − chloasma.
Slovenian: − jetrni adenom, holestatska zlatenica
English: − Pregnancy or suspected pregnancy (see section 4.6)
Slovenian: 4.6 Nosečnost in dojenje
English: 4 years.
Slovenian: 6.3 Rok uporabnosti 4 leta
English: − arterial thromboembolic disorders (in particular myocardial infarction, cerebrovascular disorder)
Slovenian: Razmeroma redki vendar resni zapleti, ki zahtevajo prekinitev zdravljenja: − arterijska trombembolija (zlasti miokardni infarkt, cerebrovaskularne motnje)
English: − Previous prodromal symptoms of thrombosis (e.g. transient cerebral ischaemia, angina pectoris)
Slovenian: prodromalni simptomi tromboze v preteklosti (prehodni ishemični napadi, angina pektoris) nosečnost ali sum na nosečnost (glejte 4.6.)
English: − Venous thromboembolism or medical history of venous thromboembolism (deep venous thrombosis, pulmonary embolism) with or without risk factors (see section 4.4)
Slovenian: pljučna embolija) z dejavniki tveganja ali brez njih (glejte 4.4.)
English: - Hypertension.
Slovenian: − kloazma
English: silica, colloidal anhydrous magnesium stearate talc maize starch lactose monohydrate
Slovenian: − silicijev dioksid, koloidni, brezvodni
English: She should start on the next blister pack immediately after taking the last tablet in the current blister pack, i.e. there will be no tablet-free interval between the blister packs.
Slovenian: Ko vzame zadnjo tableto iz enega omota, naj nadaljuje s tabletami iz drugega, tako da med njima ni premora.
English: Coating:
Slovenian: Presnova:
English: silica, colloidal anhydrous povidone K30
Slovenian: − povidon K30
English: Dzuveo should not be used for more than 48 hours.
Slovenian: Zdravilo Dzuveo se ne sme uporabljati dlje kot 48 ur.
English: Further information on Dzuveo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Dzuveo so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Dzuveo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dzuveo?
English: The tablet must not be chewed or swallowed.
Slovenian: Tableta se ne sme žvečiti ali pogoltniti.
English: The European Medicines Agency therefore decided that Dzuveo's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Dzuveo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: They can be given the tablets as needed but should wait at least one hour after one tablet before having another.
Slovenian: Tableta se lahko vzame po potrebi, vendar je treba po eni tableti počakati vsaj eno uro, preden se vzame naslednja.
English: The most common side effects (which may affect more than 1 in 10 people) are nausea, vomiting and fever.
Slovenian: Najpogostejši neželeni učinki (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so navzeja (siljenje na bruhanje), bruhanje in vročina.
English: This means that it is similar to a ‘reference medicine' (called Sufenta Forte) containing the same active substance.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu (imenovanemu Sufenta Forte) in vsebuje enako učinkovino.
English: Attaching to these receptors in the brain helps relieve the patient's pain.
Slovenian: Vezava na te receptorje v možganih pomaga ublažiti bolečino pri bolnikih.