natgillin/translations-raw huggingface dataset:
- Although combined hormonal contraceptives may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetes during use of combined hormonal contraceptives.
- Čeprav kombinirani hormonski kontraceptivi lahko vplivajo na periferno rezistenco za insulin in toleranco za glukozo, ni dokaza, da bi bilo treba pri sladkorni bolezni med uporabo kombiniranih hormonskih kontraceptivov spreminjati režim zdravljenja.
The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given.
Ženski je treba svetovati, naj natančno prebere navodilo za uporabo in upošteva navodila.
These subjects received six or 13 cycles of contraception (EVRA or oral contraceptive comparator), took at least one dose of study medicinal product and provided safety data.
Podatki o varnosti so bili pridobljeni pri preiskovankah, ki so prejele 6 ali 13 ciklov kontracepcije (obliž EVRA ali primerjalni peroralni kontraceptiv) in vzele vsaj en odmerek študijskega zdravila.
Current Cycle Next Cycle
Naslednji cikel
In this case you could have a hereditary blood clotting disorder;
V tem primeru imate morda dedno bolezen strjevanja krvi;
Your doctor may decide that EVRA needs to be stopped.
Vaš zdravnik se bo morda odločil, da morate z uporabo zdravila EVRA prenehati.
• A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as: - diabetes mellitus with vascular symptoms - severe hypertension - severe dyslipoproteinaemia
• Visoko tveganje arterijske trombembolije zaradi več dejavnikov tveganja (glejte poglavje 4.4) ali prisotnosti katerega od resnih dejavnikov tveganja, kot so: - sladkorna bolezen s simptomi na ožilju - huda hipertenzija - huda dislipoproteinemija
The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both.
Ugotovljeni vzorec povečanega tveganja je lahko posledica zgodnejše diagnoze raka na prsih pri ženskah, ki jemljejo KPKS, bioloških učinkov KPKS ali pa kombinacije obojih.
With respect to weight, 5 of the 15 pregnancies reported with EVRA were among women with baseline body weight equal or greater than 90 kg, which constituted < 3% of the study population.
Kar zadeva telesno maso pa je pri 5 od 15 žensk, ki so zanosile med uporabo obliža EVRA, izhodiščna telesna masa znašala 90 kg ali več, kar predstavlja < 3 % proučevane populacije.
As the EVRA transdermal patch contains similar hormones to those used in combined birth control pills, it is likely to have the same risks.
Ker zdravilo EVRA transdermalni obliž vsebuje podobne hormone kot kombinirane kontracepcijske tablete, ima verjetno ista tveganja.
Enzyme induction may be observed after a few days of treatment.
Indukcija encimov se lahko opazi po nekajdnevnem zdravljenju.
• Do not use creams, oils, lotions, powder or makeup on the skin where you are placing a patch or near a patch you are wearing.
• Ne uporabljajte krem, olj, losjonov, pudra ali ličil na koži, kamor boste nalepili obliž ali v bližini obliža, ki ga nosite.
Used transdermal patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
Uporabljenih transdermalnih obližev ne smemo odvreči v stranišče in niti v sisteme za odstranjevanje odplak.
• if you have (or have ever had) a type of migraine called ‘migraine with aura';
• če imate (ali ste kadar koli imeli) vrsto migrene, imenovane "migrena z avro"
(Week 3)
(3. teden)
• Abnormal breast milk production
• nenormalno nastajanje mleka
• loss of consciousness or fainting with or without seizure.
• izguba zavesti ali omedlevica z napadi krčev ali brez njih.
EVRA can be restarted approximately 2 weeks after completion of this treatment.
Obliž EVRA lahko ponovno začnete uporabljati približno 2 tedna po zaključku zdravljenja s temi zdravili.
In this case you could also have a higher risk of having a heart attack or stroke;
tem primeru je morda pri vas tudi večje tveganje za srčni infarkt ali možgansko kap;
When using a combined hormonal contraceptive like EVRA you are advised to stop smoking.
Če uporabljate kombinirani hormonski kontraceptiv, kot je zdravilo EVRA, se vam svetuje, da prenehate kaditi.
• Your “Patch Change Day” should remain the same.
• Dan zamenjave obliža ostane isti.
3 transdermal patches 9 transdermal patches 18 transdermal patches
3 transdermalni obliži 9 transdermalnih obližev 18 transdermalnih obližev
An increased risk of blood clots in your veins [venous thromboembolism (VTE)] or blood clots in your arteries [arterial thromboembolism (ATE)] is present for all women taking combined hormonal contraceptives.
Povečano tveganje krvnih strdkov v venah [venska trombembolija (VTE)] ali krvnih strdkov v arterijah [arterijska trombembolija (ATE)] je prisotno pri vseh ženskah, ki jemljejo kombinirane hormonske kontraceptive.
• sharp chest pain which may increase with deep breathing;
• ostre bolečine v prsnem košu, ki se lahko z globokim dihanjem poslabša;
Temporary symptoms suggest the event is a transient ischaemic attack (TIA).
Začasni simptomi kažejo, da gre za prehodni ishemični napad (TIA).
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.
Tveganje je lahko večje tudi, če boste kombinirani hormonski kontraceptiv (enako ali drugačno zdravilo) začeli jemati ponovno po 4- ali večtedenskem presledku.
If more than 7 days elapse after taking the last active oral contraceptive tablet, the woman may have ovulated and should, therefore, be advised to consult a physician before initiating treatment with EVRA.
Če je od takrat, ko je ženska zaužila zadnjo kontracepcijsko tableto z učinkovino, minilo več kot 7 dni, je lahko imela ovulacijo in ji moramo zato svetovati, da se pred začetkom uporabe obliža EVRA posvetuje z zdravnikom.
The primary mechanism of action is inhibition of the ovulation, but the alterations of the cervical mucus, and to the endometrium may also contribute to the efficacy of the product.
Osnovni mehanizem delovanja je preprečevanje ovulacije, vendar pa k učinkovitosti obliža lahko prav tako prispevajo spremembe cervikalne sluzi in endometrija.
Breast-feeding may be influenced by combined hormonal contraceptives as they may reduce the quantity and change the composition of breast milk.
Kombinirani hormonski kontraceptivi lahko vplivajo na dojenje, saj lahko zmanjšajo količino mleka in spremenijo njegovo sestavo.
Risks of using combined hormonal contraceptives The following information is based on information about combined birth control pills.
Tveganja pri uporabi kombiniranih hormonskih kontraceptivov Naslednje poglavje temelji na podatkih o kombiniranih kontracepcijskih tabletah.
If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to EVRA, please talk to your doctor.
Če se pri vas pojavi kateri koli neželeni učinek, zlasti, če je resen ali trdovraten, ali če se vaše zdravje spremeni in menite, da je lahko to posledica zdravila EVRA, se posvetujte z zdravnikom.
Each used transdermal patch is removed and immediately replaced with a new one on the same day of the week (Change Day) on Day 8 and Day 15 of the cycle.
Vsak uporabljeni transdermalni obliž odstranimo in ga takoj, vedno na isti dan v tednu (t.i. dan zamenjave) zamenjamo z novim na 8. in 15. dan cikla.
If any of the conditions/risk factors mentioned below is present, the suitability of EVRA should be discussed with the woman.
V prisotnosti katerega od spodaj navedenih stanj ali dejavnikov tveganja se je treba o ustreznosti zdravila EVRA pogovoriti z žensko.
Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer.
Ker se rak na prsih redko pojavi pri ženskah, mlajših od 40 let, je presežek v številu diagnosticiranega raka na prsih pri ženskah, ki jemljejo ali so nedavno jemale KPKS, v primerjavi s celotnim tveganjem za raka na prsih majhen.
Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE.
Zdravila, ki vsebujejo levonorgestrel, norgestimat ali noretisteron, so povezana z nižjim tveganjem za VTE.
• However, if you miss two periods in a row, talk to your doctor or pharmacist as you may be pregnant.
• Če pa vam izostaneta dve menstruaciji zapored, se posvetujte s svojim zdravnikom ali farmacevtom, saj ste morda noseči.
• 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).
• če je imel kdo od vaših bližnjih sorodnikov krvni strdek v nogi, pljučih ali v drugem organu v mladih letih (npr. pri starosti manj kot 50 let).
EVRA is not indicated for post-menopausal women and is not intended for use as hormonal replacement therapy.
Obliž EVRA ni indiciran pri ženskah po menopavzi in se ne uporablja za hormonsko nadomestno zdravljenje.
• Swelling of face, mouth, throat, or tongue
• otečen obraz, usta, žrelo ali jezik
• You can take it off and replace it with a new patch in a different place on your body until your next “Patch Change Day”
• ga lahko odstranite in nadomestite z novim, ki ga do vašega “dne zamenjave obliža” namestite na drugo mesto na koži.
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 EVRA is very small but can increase:
Dejavniki, ki povečajo tveganje za krvni strdek v arteriji Pomembno je povedati, da je tveganje srčnega infarkta ali možganske kapi zaradi uporabe zdravila EVRA zelo majhno, vendar se lahko poveča:
• Vaginal yeast infection, sometimes called thrush
• vaginalna glivična okužba, včasih imenovana tudi soor
EU/1/02/223/001: 3 transdermal patches EU/1/02/223/002: 9 transdermal patches EU/1/02/223/003: 18 transdermal patches
EU/1/02/223/001: 3 transdermalni obliži EU/1/02/223/002: 9 transdermalnih obližev EU/1/02/223/003: 18 transdermalnih obližev
- Although small increases of blood pressure have been reported in many women using hormonal contraceptives, clinically relevant increases are rare.
- Čeprav so poročali, da se je pri mnogih ženskah, ki uporabljajo hormonske kontraceptive, krvni tlak nekoliko zvišal, so klinično pomembna zvišanja redka.
• Sudden sharp increase in blood pressure (hypertensive crisis)
• nenadno močno zvišan krvni tlak (hipertenzivna kriza)
Combined hormonal contraceptives (CHCs) should not be used in the following conditions.
Kombiniranih kontraceptivov (CHC) ob naslednjih stanjih ni dovoljeno jemati.
• if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation);
• če imate težave s srcem (okvaro srčnih zaklopk, motnje srčnega ritma, imenovane atrijske fibrilacije)
Pearl Index (95% CI)
Indeks neučinkovito sti metode po Pearlu (95% CI)
• High blood pressure or rise in blood pressure
• visok krvni tlak ali zvišanje krvnega tlaka
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).
Dejavniki tveganja za venske trombembolične zaplete pri uporabnicah CHC se lahko bistveno povečajo pri ženskah z dodatnimi dejavniki tveganja, zlasti, če je dejavnikov tveganja več (glejte preglednico).
With the use of higher dosed COCs (50 microgram ethinyl estradiol) the risk of endometrial and ovarian cancer is reduced.
Pri uporabi večjih odmerkov KPKS (50 mikrogramov etinilestradiola) se zmanjša tveganje za raka na endometriju in jajčniku.
• If you cannot get a patch back on, put on a new patch immediately.
• Če ga ne morete ponovno namestiti, takoj nalepite novega.
- Acute or chronic disturbances of liver function may necessitate the discontinuation of combined hormonal contraceptives until markers of liver function return to normal.
- Zaradi akutnih ali kroničnih motenj v delovanju jeter bo morda treba prekiniti z uporabo kombiniranih peroralnih kontraceptivov, dokler se vrednosti označevalcev jetrnih funkcij ne normalizirajo.
• swelling and slight blue discolouration of an extremity; • severe pain in your stomach (acute abdomen).
• oteklina in nekoliko modrikavo obarvanje okončine; • hude bolečine v želodcu (akutni abdomen)
• If one or more days have elapsed since the start of your period, talk to your doctor about temporarily using a non-hormonal contraceptive.
• Če je od začetka menstruacije pretekel dan ali več dni, se s svojim zdravnikom pogovorite o začasni uporabi nehormonskega kontraceptiva.
However, general experience with combined oral contraceptives during pregnancy did not provide evidence for an actual undesirable effect in humans.
Vendar izkušnje z uporabo peroralnih kontraceptivov med nosečnostjo, niso dokazale neželenega učinka pri ljudeh.
Another method of contraception should be used to avoid unintentional pregnancy.
Za preprečitev neželene nosečnosti je treba uporabiti drugi način kontracepcije.
• The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis).
• Uporabo kombiniranih hormonskih kontraceptivov so povezovali z večjim tveganjem krvnih strdkov v venah (venska tromboza).
In rare cases a blood clot can block blood vessels and cause serious problems.
V redkih primerih lahko krvni strdek zamaši krvno žilo in povzroči resne težave.
Animal studies have shown undesirable effects during pregnancy and lactation (see section 5.3).
Študije na živalih so v obdobju brejosti in laktacije pokazale neželene učinke (glejte poglavje 5.3).
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA - temporary stroke symptoms);
• če imate (ali ste kadar koli imeli) angino pektoris (stanje, ki povzroča hude bolečine v prsnem košu in je lahko prvi znak srčnega infarkta) ali prehodni ishemični napad [kratka epizoda nevroloških znakov, TIA, temporary stroke symptoms])
• if you have ever had liver tumours or a liver disease because of which your liver does not function properly;
• če ste imeli tumor jeter ali bolezni jeter, zaradi katerih vaša jetra ne delujejo kot bi morala
• if you know you have a disorder affecting your blood clotting - for instance, protein C
• če veste, da imate bolezen, ki vpliva na strjevanje krvi, na primer pomanjkanje proteina C,
Medical tests
Zdravstveni testi
At the end of your patch cycle (Week 4):
ob koncu cikla (4. teden):
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.
Simptomi VTE (globoke venske tromboze in pljučne embolije) Če se pojavijo simptomi, je treba ženski svetovati, da poišče nujno medicinsko pomoč in obvesti zdravstvenega delavca da jemlje CHC.
There is no clinical evidence indicating that a transdermal patch is, in any aspect, safer than combined oral contraceptives.
Kliničnega dokaza, da je transdermalni obliž iz kateregakoli vidika varnejši od kombiniranih peroralnih kontraceptivov, ni.
It is important to draw a woman's attention to the information on venous and arterial thrombosis, including the risk of EVRA 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.
Pomembno je, da se pozornost ženske usmeri na informacije glede venske in arterijske tromboze, vključno s tveganjem zdravila EVRA v primerjavi z drugimi CHC, simptomi VTE in ATE, znanimi dejavniki tveganja in kaj je treba narediti ob sumu na trombozo.
EVRA has not been studied in children and adolescents under 18 years of age.
Obliža EVRA pri otrocih in mladostnicah, mlajših od 18 let niso preučevali.
• You should have your period during this time
• V tem času bi morali dobiti menstruacijo.
After miscarriage or abortion after 20 weeks of pregnancy • Talk to your doctor.
Po spontanem ali umetnem splavu pred 20. tednom nosečnosti • Posvetujte se s svojim zdravnikom.
• Sometimes patches can stick to the inside of the sachet - be careful not to accidentally remove the clear covering as you remove the patch
• Včasih se obliž prilepi na notranjo stran blazinice - pazite, da ponesreči ne odstranite prozorne plasti, ko obliž vzamete ven.
It is important to remember that the overall risk of a harmful blood clot due to EVRA is small.
Pomembno je, da veste, da je skupno tveganje za nevarne krvne strdke zaradi uporabe zdravila EVRA majhno.
Do not use EVRA if you have Hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme).
Ne uporabljajte obliža EVRA, če imate hepatitis C in jemljete zdravila, ki vsebujejo ombitasvir/paritaprevir/ritonavir in dasabuvir, ker lahko zvečajo rezultate krvnih testov jetrne funkcije (zvečanje vrednosti ALT jetrnih encimov).
blood clots in the liver, stomach/intestine, kidneys or eye.
• krvni strdki v jetrih, želodcu/črevesju, ledvicah ali očesu.
To achieve maximum contraceptive effectiveness, patients must be advised to use EVRA exactly as directed.
Za maksimalno učinkovitost kontracepcije, ženskam svetujemo, da obliž EVRA uporabljajo natančno po navodilih.
You may start this medicine on Day 21 following the abortion or miscarriage, or on the first day of your next period, whichever comes first.
To zdravilo lahko začnete uporabljati na 21. dan po splavu ali na prvi dan naslednje menstruacije, kateri koli je prej.
• Then take off the other half of the covering
• Nato odstranite še drugo polovico zaščitne plasti.
• if you have SLE (systemic lupus erythematosus; a disease affecting your natural defence system);
• če imate sistemski eritematozni lupus (bolezen, ki vpliva na naravni obrambni sistem);
During Week 4, you may pick a new Change Day and apply the first patch on that day.
V 4. tednu si lahko izberete nov dan zamenjave in namestite prvi obliž na ta dan.
If you do you are more likely to cause irritation.
Če to naredite, je bolj verjetno, da bo prišlo do draženja kože.
Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma
Dolgotrajna imobilizacija, večji kirurški poseg, vsak kirurški poseg na nogi ali v predelu medenice, nevrološka operacija ali velika poškodba
• Do this no matter when your period begins or ends.
• Obliž namestite ne glede na to, kdaj ste dobili menstruacijo in kdaj se je končala.
During the transdermal patch-free week a new Change Day may be selected by applying the first EVRA transdermal patch of the next cycle on the first occurrence of the desired day.
V tednu premora lahko nov dan zamenjave izbere tako, da prvi transdermalni obliž EVRA naslednjega cikla namesti na želeni dan.
(Week 2)
(2. teden)
• if a member of your immediate family has had a heart attack or stroke at a young age (less then about 50).
• če je imel bližnji sorodnik srčni infarkt ali možgansko kap v mladih letih (manj kot 50 let).
Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity.
Drugi znaki zapore žilja lahko vključujejo: nenadna bolečina, oteklost in nekoliko modrikava barva okončine.
• On Day 15 (Week 3), take off the used patch • Put on another new one.
• 15. dan (3. teden) odstranite uporabljeni obliž.
Effect of EVRA on other medicinal products
Učinek obliža EVRA na druga zdravila
See enclosed leaflet for disposal instructions.
Za navodila za odlaganje obližev glejte navodilo za uporabo.
• if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);
• če imate vi ali vaš bližnji sorodnik visoko koncentracijo maščob v krvi (holesterol ali trigliceridi);
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.
Če se pojavijo simptomi, je treba ženski svetovati, da poišče nujno medicinsko pomoč in obvesti zdravstvenega delavca da jemlje CHC.
Prior to the initiation or reinstitution of EVRA a complete medical history (including family history) should be taken and pregnancy should be ruled out.
Preden začne ženska jemati zdravilo EVRA ali pred njegovo ponovno uvedbo, se mora zdravnik seznaniti z njeno anamnezo (tudi z družinsko) in izključiti nosečnost.
An increased risk of cervical cancer in long-term users of COCs has been reported in some epidemiological studies, but there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV).
V nekaterih epidemioloških raziskavah so pri ženskah, ki so dalj časa jemale KPKS, poročali o zvečanem tveganju za raka na materničnem vratu, še vedno pa ni enotnega mnenja o tem, v kolikšni meri lahko to ugotovitev pripišemo sočasnim učinkom spolnega vedenja in drugih dejavnikov, npr. papilomavirusu (HPV - Human Papilloma Virus).
• A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4);
• Višje tveganje za vensko trombembolijo zaradi prisotnosti več dejavnikov tveganja (glejte poglavje 4.4)
Hepatic metabolism of norelgestromin occurs and metabolites include norgestrel, which is largely bound to SHBG, and various hydroxylated and conjugated metabolites.
Norelgestromin se presnavlja v jetrih, metaboliti pa vključujejo norgestrel (ki se v veliki meri veže na SHBG) in različne hidroksilirane in konjugirane metabolite.
• if you have ever had a heart attack or a stroke;
• če ste kadar koli imeli srčni infarkt ali možgansko kap
What to do if the transdermal patch comes off or partly detaches If the EVRA transdermal patch partly or completely detaches and remains detached, insufficient medicinal product delivery occurs.
Kaj storiti, če se transdermalni obliž deloma ali povsem odlepi Če se transdermalni obliž EVRA deloma ali povsem odlepi in ga ne prilepimo nazaj, se v telo ne sprosti zadostna količina učinkovine.
Epidemiological studies indicate no increased risk of birth defects in children born to women who used combined oral contraceptives prior to pregnancy.
Epidemiološke raziskave niso pokazale zvečanega tveganja za prirojene anomalije pri otrocih žensk, ki so pred nosečnostjo jemale kombinirane peroralne kontraceptive.
You will need to complete the current cycle and remove the third patch on the correct day.
Zaključiti morate trenutni cikel in tretji obliž odstraniti na dan, ki je za to določen.
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and estrogens, fixed combination; ATC-code: G03AA13.
Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, gestageni in estrogeni, enofazna zdravila, oznaka ATC: G03AA13.
In the event of aggravation, or first appearance of any of the conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of EVRA should be discontinued.
Ob poslabšanju ali prvem pojavi katerega od teh stanj je treba ženski svetovati, da se posvetuje s svojim zdravnikom in ugotovi, ali je treba uporabo zdravila EVRA prekiniti.
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).
Epidemiološke študije so uporabo CHC povezale z večjim tveganjem za arterijsko trombembolijo (miokardni infarkt) ali cerebrovaskularni dogodek (npr. prehodni ishemični napad, možganska kap).
Pregnancy EVRA is not indicated during pregnancy.
Nosečnost Obliž EVRA je kontraindiciran med nosečnostjo.
Pulmonary embolism
pljučna embolija
EVRA is not indicated during pregnancy (see section 4.6).
Med nosečnostjo uporaba obliža EVRA ni indicirana (glejte poglavje 4.6).
• Abnormal taste
• nenavaden okus
• if you have unexplained vaginal bleeding
• če imate nepojasnjene krvavitve iz nožnice