natgillin/translations-raw huggingface dataset:
The herbal preparation St John's wort (Hypericum perforatum) should not be taken concomitantly with this medicine as this could potentially lead to a loss of contraceptive effect.
Zeliščnega pripravka šentjanževke (Hypericum perforatum) naj ne bi jemali skupaj s tem zdravilom, ker lahko povzroči izgubo kontracepcijskega učinka.
− acne, seborrhoea, hypertricosis
− - akne, seboreja, hipertrihoza
− pituitary adenoma with prolactinoma (rarely accompanied by galactorrhoea)
− adenom hipofize s prolaktinomom (redko ga spremlja galaktoreja)
The results of most epidemiological studies to date neither show an increased risk of birth defects in children born to women taking contraceptive pills before pregnancy, nor any teratogenic or fetotoxic effect in case of inadvertent fetal exposure to combinations of estrogens and progestagens.
Rezultati večine epidemioloških študij do danes ne kažejo povečanega tveganja za okvare plodu pri otrocih žensk, ki jemljejo kontracepcijske tablete pred nosečnostjo, niti nobenih teratogenih ali fetotoksičnih učinkov če pride do nenamerne izpostavitve plodu kombinaciji estrogenov in progestagenov.
− postterapeutic amenorrhoea.
-postterapevtska amenoreja
Rigevidon coated tablets.
Rigevidon obložene tablete
For short-term use of any of these enzyme-inducing active substances, additional use of barrier methods is recommended from the time of commencing the concurrent active substance, during treatment and for 4 weeks after cessation of treatment.
Za kratkotrajno uporabo vsake od učinkovin, ki inducirajo encime, se priporoča dodatna uporaba pregradnih metod od začetka uživanja spremljajoče učinkovine, med zdravljenjem in še 4 tedne po končanem zdravljenju.
The intra-individual and interindividual variability in pharmacokinetics of COCs is significant.
Individualna in populacijska variabilnost farmakokinetičnih lastnosti kombiniranih peroralnih kontraceptivov je precejšnja.
All women who use oral contraceptives should be strongly advised not to smoke.
Vsem ženskam, ki uporabljajo peroralna kontracepcijska sredstva, je treba kajenje strogo odsvetovati.
Because of marked species differences preclinical results possess a limited predictive value for the application of estrogens in humans.
Zaradi velikih razlik med vrstami, imajo predklinični podatki omejeno napovedno vrednost za uporabo estrogenov pri človeku.
Hereafter, she continues taking the tablets at the usual time point.
Potem jemlje tablete ob običajnem času.
The woman may also be advised to stop taking tablets from the current blister pack.
Ženski lahko svetujemo, da preneha jemati tablete iz dosedanjega omota.
− Considerable or multiple risk factors for venous or arterial thrombosis (see section 4.4)
pomembni ali multipli dejavniki tveganja za vensko ali arterijsko trombozo (glejte 4.4.)
A liver tumour must be taken into consideration as a differential diagnosis when severe pain occurs in the upper abdomen, if there is hepatomegaly, or if there are signs of intra-abdominal haemorrhage in women taking oral contraceptives.
Tumor jeter je treba upoštevati kot diferencialno diagnozo, kadar se pojavijo močne bolečine v zgornjem delu trebuha, kadar je prisotna heptomegalija ali če obstajajo znaki intraabdominalne krvavitve pri ženskah, ki jemljejo peroralna kontracepcijska sredstva.
Clinically, data on a limited number of exposed pregnancies indicate no adverse effects of levonorgestrel alone on the fetus.
Klinično pa podatki o omejenem številu izpostavljenih nosečnosti ne kažejo škodljivih učinkov levonorgestrela na zarodek.
The physician must then decide, whether the use of oral contraceptives should be discontinued.
Zdravnik naj odloči, ali je treba prekiniti peroralno kontracepcijo.
Not all pack size may be marketed.
Na trgu ni vseh navedenih pakiranj.
The prescribing information of concomitant medications should be consulted to identify potential interactions.
Treba je preveriti navodila za uporabo zdravil, ki jih jemljemo sočasno in ugotoviti morebitne možne interakcije.
Hence, the evaluation of any irregular bleeding should be considered after a period of adaptation of approximately 3 cycles.
Zato se taka krvavitev upošteva kot neredna šele po treh ciklih prilagajanja.
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE
PRILOGA III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
This bleeding will usually start on the 2nd or 3rd day after the last tablet has been taken and it may not have stopped, before the next blister pack is started.
Krvavitev navadno nastopi drugi ali tretji dan po tem, ko ženska vzame zadnjo tableto in morda ne preneha, ko prične jemati naslednji pretisni omot zdravil.
The woman should take the tablet as soon as she remembers this, and the remaining tablets should be taken as usual.
Tableto mora vzeti takoj, ko se spomni in preostale tablete jemati kot po navadi.
Thus, the current prerequisite for bioequivalence, i.e. the demonstration of bioequivalence within 80 - 125%, is considered appropriate for Rigevidon as it will sufficiently prove its performance as an essentially similar product in terms of rate and extent of absorption.
Iz tega razloga je obstoječ predpogoj glede bioekvivalence (dokazana bioekvivalenca znotraj 80 - 125 %) ustrezen tudi za Rigevidon, saj se bo na ta način zanesljivo potrdilo, da v smislu hitrosti in stopnje absorpcije deluje Rigevidon enako kot bistveno podoben pripravek.
Metabolic clearance is subject to marked inter-individual variation which may partly explain the wide variation in the concentrations of levonorgestrel observed among patients.
Presnovni očistek je podvržen znatnim razlikam med posamezniki, kar bi lahko delno pojasnilo velike odklone v koncentracijah levonorgestrela, ki jih opažamo med bolniki.
White, biconvex, circular tablets
Obložena tableta Bele, bikonveksne, okrogle tablete
Other active substances suspected of having the capacity to reduce the efficacy of oral contraceptives include oxcarbazepine, topiramate, and griseofulvin.
Med drugimi učinkovinami, za katere obstaja sum, da zmanjšujejo učinkovitost peroralnih kontracepcijskih sredstev, so oksibazepin, topiramat in grizeofulvin.
Special precautions for storage This medicinal product does not require any special storage conditions.
6.4 Posebna navodila za shranjevanje Za shranjevanje zdravila niso potrebna posebna navodila.
ANNEX II SCIENTIFIC CONCLUSIONS PRESENTED BY THE EMEA
PRILOGA II ZNANSTVENI ZAKLJUČKI EVROPSKE AGENCIJE ZA ZDRAVILA
For lactating women - see section 4.6.
Za doječe matere - glejte poglavje 4.6
If persistent clinical hypertension develops during treatment with oral contraceptives they should be discontinued and the hypertension treated.
Če se med uporabo peroralnih kontracepcijskih sredstev razvije vztrajna klinična hipertenzija, je treba uporabo prekiniti in hipertenzijo zdraviti.
Hence, from a pharmacokinetic point of view there is no evidence to suggest that a COC such as Rigevidon should be categorised as a narrow therapeutic index product.
Zato z vidika farmakokinetike ni nobenega dokaza, da je treba kombinirani peroralni kontraceptiv, kot je Rigevidon, uvrstiti med pripravke z nizkim terapevtskim indeksom.
Hypericum perforatum (St. John's wort)
Hypericum perforatum (šentjanževka)
Even though slight increases in blood pressure have been reported in many women taking oral contraceptives, clinically important increases in blood pressure are rare.
Čeprav so poročali o pojavu nekoliko zvišanega krvnega tlaka pri ženskah, ki jemljejo peroralna kontracepcijska sredstva, so klinično značilna zvišanja redka.
Core:
Jedro:
Women on short term treatment with these antibiotics must temporarily use a barrier method concomitantly with the contraceptive pills, i.e. during the period of other concomitant active substance intake and for 7 days after cessation of this active substance.
Ženske, ki kratkotrajno uživajo te antibiotike, morajo poleg kontracepcijskih tablet začasno, tj. v času sočasnega jemanja učinkovin in še 7 dni po končanem zdravljenju, uporabljati tudi pregradne kontracepcijske metode.
If the patient does not have a withdrawal bleed at the end of the second pack, she must return to her doctor to exclude the possibility of pregnancy.
Če bolnica nima krvavitve ob koncu druge škatle, mora znova obiskati zdravnika in izključiti možnost zanositve.
Ethinylestradiol undergoes presystemic conjugation both in the small intestinal mucosa and in the liver.
Etinilestradiol je podvržen predsistemski konjugaciji tako v sluznici tankega črevesa kot v jetrih.
If any of the risk factors below is present in any individual woman,the benefits of combined oral contraception must be weighed against possible risks in each individual case and discussed with the woman before combined oral contraception is commenced.
Če pri katerikoli ženski obstaja katerikoli od spodaj navedenih dejavnikov tveganja, je treba v vsakem posameznem primeru pred začetkom uporabe peroralne kontracepcije pretehtati korist in morebitno tveganje.
The majority of the metabolites circulating in the blood are sulphates of 3α, 5β-tetrahydro-levonorgestrel, while excretion mainly takes place as glucuronides.
Večina presnovkov v krvnem obtoku so sulfati 3α, 5βtetrahidrolevonorgestrel, izločajo pa se večinoma v obliki glukoronidov.
Note: This SPC is the one that was Annexed to the Commission Decision on this Article 29 referral for levonogestrel and ethinylestradiol containing medicinal products.
za obložene tablete Rigevidon Opomba: Ta Povzetek glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi s tem postopkom, ki je bil sprožen v skladu s členom 29, za zdravila, ki vsebujejo levonogestrel in etinilestradiola.
Maximal enzyme induction is generally not observed until 2-3 weeks after start of treatment, but may then persist for at least 4
Največje indukcije encima se navadno ne opazi do 2-3 tednov po začetku jemanja tablet, vendar ostaja še najmanj 4 tedne po koncu zdravljenja.
An increase in the frequency or severity of migraine (which may be prodromal for a cerebrovascular condition) during use of oral contraceptives must lead to consideration of immediate discontinuation of oral contraceptives.
Ob povečanju pogostosti ali jakosti migrenskih napadov (ki so lahko svarilni znaki cerebrovaskularnih motenj) med uporabo peroralnih kontracepcijskih sredstev, je treba pretehtati možnost takojšnjega prenehanja njihove uporabe.
If the woman does not want to change her usual tablet intake, she should take the required extra tablet(s) from another blister pack.
Če ženska ne želi spremeniti običajnega časovnega jemanja tablet, naj dodatno tableto vzame iz drugega omota.
Missed tablets
Izpuščene tablete
The extension can be carried on for as long as desired until the end of the second blister pack.
Podaljševanje lahko traja poljubno dolgo, do konca drugega omota.
The Pearl Index (number of pregnancies/100 woman years) for combined low-dose monophasic oral contraceptives containing 0.15 mg levonorgestrel and 0.03 mg ethinylestradiol is 0.1 (method failure).
Indeks Pearl (število nosečnosti/100 ženskih let) za kombinirana enofazna peroralna kontracepcijska sredstva z majhnimi odmerki, ki vsebujejo 0,15 mg levonogestrela in 0,03 mg etinilestradiola je 0,1
Venous thromboembolism (VTE), manifesting itself as deep venous thrombosis and/or pulmonary embolic disorder, may occur with any oral contraceptive.
Do venske tromboembolije (VTE), ki se kaže kot obsežna globoka venska tromboza in/ali pljučne embolije, lahko pride pri uporabi katerih koli kontracepcijskih tablet.
However, if the oral contraceptive has not been taken according to the instructions, before the first absent withdrawal bleed, or if two withdrawal bleeds are overdue, pregnancy should be excluded before the oral contraceptive is continued.
Če pa pred prvim izostankom odtegnitvene krvavitve tablet ni jemala po navodilih, ali če krvavitev izostane dvakrat, je treba pred nadaljevanjem uporabe peroralnih kontracepcijskih sredstev nosečnost izključiti.
Women with hypertriglyceridaemia, or a family history thereof, may be at increased risk of pancreatitis when taking oral contraceptives.
Pri ženskah s hipertrigliceridemijo ali njeno družinsko anamnezo je ob uporabi peroralnih kontracepcijskih sredstev večje tveganje za pankreatitis.
Amenorrhoea with anovulation (more frequent in women with irregular cycles in medical history) may be observed at termination of treatment It usually disappears spontaneously.
Ob prekinitvi zdravljenja lahko opazimo amenorejo z anovulacijo (pogostejša pri ženskah z anamnezo nerednih menstrualnih ciklov), ki navadno izgine spontano.
− breast tenderness, spotting, oligomenorrhoea, amenorrhoea, changes in libido
− - občutljivost v prsih, mazanje, oligomenoreja, amenoreja, spremembe libida
Lactation may be influenced by COCs as they may reduce the amount and change the composition of human milk.
Kombinirana peroralna sredstva za kontracepcijo lahko vplivajo na dojenje, ker lahko zmanjšajo količino človeškega mleka in spremenijo njegovo sestavo.
- Prolonged immobilisation, major surgery, surgery on the legs or major trauma.
− -podaljšano imobilizacijo, večjim kirurškim posegom, operacijo nog ali večjimi poškodbami.
If such a condition should occur for the first time during use of oral contraceptives, the use of oral contraceptives must be discontinued immediately:
Če se taka bolezen prvič pojavi med jemanjem peroralne kontracepcije, je treba peroralna kontracepcijska sredstva nemudoma prenehati jemati .
Therefore, by following one of the following two alternatives, it is not necessary to take further contraceptive precautions, provided that all tablets have been taken correctly during the 7 days preceding the forgotten tablet.
Tako v primeru, da se ženska drži ene od naslednjih dveh možnosti, ni potrebna dodatna kontracepcijska zaščita, če je zadnjih 7 dni pred pozabljeno tableto tablete jemala pravočasno.
− serious, abnormal headache, migraine, dizziness, visual disturbances
− resen, nenormalen glavobol, migrena, vrtoglavica, motnje vida
The treatment must cease if symptoms indicating imminent complications occur: serious abnormal headache, visual disturbances, increased blood pressure, clinical signs of deep venous thrombosis or pulmonary embolic disorders.
Jemanje tablet je treba prekiniti, če se pojavljajo simptomi, ki kažejo na neposredne zaplete: resni nenormalni glavoboli, motnje vida, povečan krvni pritisk, klinični znaki globoke venske tromboze ali pljučne embolije.
Tumours: In some epidemiological studies an increased risk of cervical cancer has been reported in longterm users of oral contraceptives, but it is still not clear to which extent this finding may be influenced by impacts of sexual behaviour and other factors, such as human papilloma virus (HPV).
V nekaterih epidemioloških študijah so poročali o povečanem tveganju nastanka raka materničnega vratu pri dolgoletnih uporabnicah peroralnih kontracepcijskih sredstev, vendar ni povsem jasno koliko na to vpliva spolno obnašanje uporabnic in drugi dejavniki, kot npr. humani papilomavirus
Biochemical factors indicating hereditary or acquired predisposition for venous or arterial thrombosis, include activated protein C (APC) resistance, hyperhomocysteinaemia, antithrombin III deficiency, protein C
Med biokemičnimi dejavniki, ki kažejo na dedno ali pridobljeno nagnjenje za vensko ali arterijsko trombozo, so odpornost na aktivirani protein C (APC), hiperhomocisteinemija, pomanjkanje antitrombina III, pomanjkanje proteina C, pomanjkanje proteina S, protitelesa proti fosfolipidi
The conclusion is that bioequivalence studies with narrower acceptance limits would not contribute to the ability to extrapolate safety and efficacy data for Rigevidon.
Iz tega sledi, da z bioekvivalenčnimi raziskavami, kjer bi veljala strožja izbirna merila, ne bi mogli pridobiti podatkov o zanesljivosti in učinkovitosti Rigevidona.
Drug interactions resulting in an increased clearance of sexual hormones may lead to break through bleeding and contraceptive failure.
Medsebojni vplivi zdravil, ki povečajo očistek spolnih hormonov, lahko povzročijo vmesne krvavitve in zmanjšajo kontracepcijsko zaščito.
Every subsequent blister pack is started after a 7 day tablet-free interval during which time a withdrawal bleed usually occurs.
Naslednji pretisni omot začne jemati po sedemdnevnem premoru, med katerim navadno pride do odtegnitvene krvavitve.
With all combined oral contraceptives, irregular bleeding (spotting or break through bleeding) may occur, especially during the first months.
Pri vseh kombiniranih peroralnih kontracepcijskih sredstvih, zlasti v prvih mesecih, lahko pride do nerednih krvavitev (mazanja ali vmesnih krvavitev).
In such cases, it is recommended that treatment with oral contraceptives be discontinued (in the case of elective surgery at least 4 weeks prior to the operation) and should not be resumed until 2 weeks after complete remobilisation.
takih primerih je priporočeno prenehati uporabo peroralnih kontracepcijskih sredstev (pri elektivnem kirurškem posegu vsaj 4 tedne pred posegom).
Inadequate exposure could also lead to disruption of cycle control and increase the occurrence of breakthrough bleeding, which may affect compliance and cause discontinuation of COC use.
Neustrezna izpostavljenost lahko vodi tudi do motenj pri nadzoru menstruacijskega ciklusa in pogostejših vmesnih krvavitev, kar vpliva na izgubo želje po jemanju in posledično prenehanje jemanja kombiniranega peroralnega kontraceptiva.
How to start Rigevidon
Kako začeti jemanje Rigevidona?
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with rare hereditary problems of fructose intolerance should not take this medicinal product.
Tega zdravila ne smejo jemati bolniki z redkimi dednimi težavami zaradi netolerance za galaktozo, Lappovega pomanjkanja laktaze ali okvarjene absorpcije glukoze/galaktoze ter z redkimi dednimi težavami zaradi netolerance za fruktozo.
− Arterial thromboembolism or medical history of arterial thromboembolism, in particular myocardial infarction, cerebrovascular disorder (see section 4.4)
arterijski trombembolizem ali anamneza arterijskega trombembolizma, predvsem miokardni infarkt, cerebrovaskularne motnje (glejte 4.4.)
⇒ Adequate contraceptive efficacy has been demonstrated with COCs even containing lower doses than Rigevidon and with lower dosed progestogen-only products,
Ustrezna učinkovitost kontracepcije je dokazana pri kombiniranih peroralnih kontraceptivih, ki vsebujejo celo manjše odmerke kakor Rigevidon, ter pri izključno progestogenskih pripravkih z manjšimi odmerki.
If bleeding irregularities persist or occur after previously regular cycles, then non-hormonal causes should be considered, and adequate diagnostic measures are indicated to exclude malignancy or pregnancy.
Če se neredne krvavitve nadaljujejo, je treba ugotoviti nehormonske vzroke in z ustreznimi diagnostičnimi ukrepi izključiti maligne bolezni ali nosečnost.
There is no consensus, whether the occurrence of these cases is related to use of oral contraceptives.
Mnenja o tem, ali je pojavnost teh primerov povezana z uporabo peroralnih kontracepcijskih sredstev, so deljena.
The primary route of metabolism of ethinylestradiol is cytochrome P-450-mediated hydroxylation, where the primary metabolites are 2-OH-Ethinylestradiol and 2-methoxy-Ethinylestradiol.
Primarna pot presnove etinilestradiola je hidroksilacija, ki jo posreduje citokrom P-450, kjer sta glavna presnovka 2-OH-etinilestradiol in 2
However, if she already has had intercourse, pregnancy must be excluded, before she starts the tablets, or she should wait for her first menstrual bleed.
Če je že imela spolne odnose, je treba pred začetkom jemanja tablet izključiti nosečnost ali počakati do naslednje menstruacije.
Week 3:
Tretji teden
carmellose sodium
− natrijev karmelozat
Epidemiological studies indicate a relationship between the use of oral contraceptives and an increased risk of arterial and venous thrombosis and thromboembolic disorders, such as myocardial infarction, stroke, deep venous thrombosis (DVT) and pulmonary embolic disorders.
Epidemiološke študije kažejo na povezavo med uporabo peroralnih kontracepcijskih sredstev in povečanim tveganjem arterijske in venske tromboze ter trombemboličnimi motnjami, kot so miokardni infarkt, možganska kap, globoka venska tromboza (GVT) in pljučna embolija.
However, if this is not the case, or if more than 1 tablet has been forgotten, the woman should be advised to use another contraceptive method for 7
Če pa to ne drži, ali če je pozabila vzeti več tablet, ji je treba svetovati, naj naslednjih sedem dni uporablja druge kontracepcijske metode.
It has been reported that the following conditions may occur, or worsen both during pregnancy and during use of oral contraceptives, but the evidence of a relationship with use of oral contraceptives is inconclusive: Jaundice and/or pruritus in connection with cholestasis; development of gallstones; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; loss of hearing due to otosclerosis.
Poročali so o pojavu ali poslabšanju naslednjih bolezni med nosečnostjo ali uporabo peroralnih kontracepcijskih sredstev, vendar dokazov o povezavi z uporabo peroralnih kontracepcijskih sredstev ni: zlatenica in/ali pruritus v povezavi s holestazo, nastanek žolčnih kamnov, porfirija, sistemski lupus eritematozus, hemolitični uremični sindrom, Sydenhamova korea, herpes gestitionis in izguba sluha zaradi otoskleroze.
During the extension the woman may experience break through bleeding or spotting.
Med podaljševanjem lahko pride do vmesne krvavitve ali mazanja.
If the woman has missed tablets and does not get a withdrawal bleed during the first, normal tablet-free interval, the possibility of pregnancy must be considered.
Če je ženska pozabila jemati tablete in v prvem premoru ne dobi odtegnitvene krvavitve, je treba upoštevati možnost zanositve.
− venous thromboembolic disorders (phlebitis, pulmonary embolism)
− venska tromembolija (flebitis, pljučni embolizem)
Other medical conditions which have been related to circulatory disorders, include diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or colitis ulcerosa) and sickle cell anaemia.
Med drugimi boleznimi, povezanimi z motnjami krvnega obtoka, so sladkorna bolezen, sistemski lupus eritematosus, hemolitični uremični sindrom, kronična vnetna črevesna bolezen (ulcerozni kolitis ali Chronova bolezen) in anemija srpastih celic.
− nausea, mild headache, weight increase, irritability, heavy feeling in legs
− - slabost, blag glavobol, povečanje telesne teže, razdraženost, občutek težkih nog
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.
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.
This is due to induction of drug metabolising enzymes by St John's wort.
To je posledica indukcije presnovnih encimov, ki jo povzroča šentjanževka.
If it is of longer duration, it should be examined for pituitary disorders , before further prescription.
Če pa traja dlje časa, jo je treba raziskati in izključiti motnje delovanja hipofize, preden se nadaljuje predpisovanje.
In all these cases the woman should be advised to use a concomitant barrier method for the first 7 days of the tablet intake.
V vseh teh primerih je treba ženski svetovati, naj prvih sedem dni jemanja tablet sočasno uporablja pregradno kontracepcijsko metodo.
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.
Sicer ji je treba svetovati, naj se drži prve od obeh možnosti in naslednjih sedem dni sočasno uporablja druge kontracepcijske metode.