natgillin/translations-raw huggingface dataset:
Therefore, co-administration of Senshio with strong/moderate CYP3A4 inhibitors should be avoided in patients who are known, or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates.
Zato se je treba sočasnemu dajanju zdravila Senshio z močnimi/zmernimi zaviralci CYP3A4 pri bolnicah, za katere je znano ali pri se sumi, da imajo slabo presnovo s CYP2C9 na podlagi genotipiziranja ali z obstoječo anamnezo/izkušnjami z drugimi substrati CYP2C9, izogniti.
Therefore, co-administration with strong CYP3A inducers (e.g., rifampicin, St. John’s wort [Hypericum perforatum]) is not recommended (see section 4.5).
Zato sočasno dajanje z močnimi spodbujevalci CYP3A (npr. rifampicinom ali šentjanževko [Hypericum perforatum]) ni priporočljivo (glejte poglavje 4.5).
Therefore, Coagadex should be used during breast- feeding only if clearly indicated.
Zato se lahko zdravilo Coagadex v času dojenja uporablja le, če je to jasno indicirano.
Therefore, concomitant administration of CYP3A4 inducers (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or herbal preparations containing St John’s wort/Hypericum perforatum) may reduce efficacy of the treatment and should be avoided (see section 4.5).
Zato lahko sočasna uporaba induktorjev CYP3A4 (npr. fenitoina, karbamazepina, rifampicina, barbituratov ali zeliščnih pripravkov, ki vsebujejo šentjanževko/Hypericum perforatum) zmanjša učinkovitost zdravljenja in se ji je treba izogniti (glejte poglavje 4.5).
Therefore, concomitant administration of CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John’s wort) is likely to result in subtherapeutic levels of telithromycin and loss of effect.
Med sočasno uporabo induktorjev CYP3A4 (kot so rifampicin, fenitoin, karbamazepin, fenobarbital, šentjanževka) zato obstaja možnost za pojav subterapevtskih koncentracij telitromicina in izgubo učinka.
Therefore, concomitant administration of lopinavir/ritonavir with salmeterol is not recommended (see section 4.4).
priporočljivo pribolnikih, ki ne prenašajo
Therefore, concomitant administration of tolvaptan with potent CYP3A inducers (e.g., rifampicin, rifabutin, rifapentin, phenytoin, carbamazepine, and St. John’s Wort) is to be avoided.
Zato se je treba sočasni uporabi tolvaptana z močnimi induktorji CYP3A (npr. rifampicinom, rifabutinom, rifapentinom, fenitoinom, karbamazepinom in šentjanževko) izogniti.
Therefore, concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy.
Zaradi tega se sočasno zdravljenje sme začeti samo pri bolniku, ki jemlje zaviralec receptorjev alfa in čigar zdravstveno stanje je stabilno.
Therefore, concomitant treatment with agents that have CYP3A4/5 induction potential should be avoided (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, and St. John’s wort) (see section 4.4).
Zato se je treba izogibati sočasnemu zdravljenju z zdravili, ki inducirajo CYP3A4/5 [npr. karbamazepin, fenobarbital, fenitoin, rifampicin in šentjanževka] (glejte poglavje 4.4).
Therefore, concomitant treatment with other P-gp substrates could lead to enhanced toxicity.
To pomeni, da sočasno zdravljenje z drugimi P-gp-substrati lahko vodi v povečano toksičnost.
Therefore, concomitant use of lumacaftor/ivacaftor with CYP3A substrates may decrease the exposure of these substrates.
Zato lahko sočasna uporaba lumakaftorja/ivakaftorja s substrati CYP3A zmanjša izpostavljenost tem substratom.
Therefore, concomitant use of moderate and strong CYP3A inducers (e.g. carbamazepine, rifampicin, phenytoin, and St. John’s Wort) should be avoided.
Zato se je treba izogibati sočasni uporabi z zmernimi in močnimi induktorji CYP3A (npr. s karbamazepinom, rifampicinom, fenitoinom ali šentjanževko).
Therefore, concomitant use of posaconazole and vinca alkaloids should be avoided unless the benefit to the patient outweighs the risk.
Zato se je treba sočasni uporabi posakonazola in alkaloidov vinke izogibati, razen če korist za bolnika odtehta tveganje.
Therefore, concomitant use should be undertaken with caution (see section 4.4).
Zato moramo biti pri sočasni uporabi previdni (glejte poglavje 4.4).
Therefore, concurrent therapy with ORENCIA and a TNF-inhibitor is not recommended.
Sočasnega zdravljenja z zdravilom ORENCIA in zaviralcem TNF ne priporočamo.
Therefore, consideration should be given to a dose reduction of Inovelon in patients <30 kg who are initiated on valproate therapy (see section 4.2).
Zato je treba pri bolnikih, katerih telesna masa je manjša od 30 kg, ko jim uvedemo zdravljenje z valproatom, pretehtati možnost zmanjšanja odmerka zdravila Inovelon (glejte poglavje 4.2).
Therefore, consideration should be given to a dose reduction of Inovelon in patients <30 kg who are initiated on valproate therapy (see sections 4.2).
Zato je treba pri bolnikih, katerih telesna masa je manjša od 30 kg, ko jim uvedemo zdravljenje z valproatom, pretehtati možnost zmanjšanja odmerka zdravila Inovelon (glejte poglavje 4.2).
Therefore, constipation should be included in the section 4.8 of the SmPC.
Zato je zaprtje treba vključiti v poglavje 4.8 SmPC.
Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are metabolized predominantly by UGT1A1 (e.g., raltegravir, irinotecan) or UGT2B7 (e.g., morphine, naloxone).
Torej lahko zveča plazemsko koncentracijo sočasno uporabljenih zdravil, ki se večinoma presnavljajo prek UGT1A1 (npr. raltegravir, irinotekan) ali UGT2B7 (npr. morfin, nalokson).
Therefore, current smokers should be advised to stop smoking, as plasma concentrations of erlotinib in smokers as compared to non-smokers are reduced.
Zato je treba bolnikom kadilcem svetovati, naj prenehajo kaditi, saj so plazemske koncentracije erlotiniba pri kadilcih manjše kot pri nekadilcih.
Therefore, CYP3A inhibitors such as azol antifungals, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, and grapefruit juice are not anticipated to have a significant effect on the pharmacokinetics of the active metabolite.
Zato se za zaviralce CYP3A, kot so azolski antimikotiki, zaviralci HIV proteaze, klaritromicin, telitromicin, verapamil, diltiazem, indinavir, ciprofloksacin in sok grenivke ne predvideva, da imajo značilen učinek na farmakokinetiko aktivnega presnovka.
Therefore, CYP3A4 substrates known to have a narrow therapeutic index (e.g. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids [ergotamine, dihydroergotamine]) should be administered with caution in patients receiving dasatinib (see section 4.4).
Pri bolnikih, ki se zdravijo z dasatinibom, je potrebna previdnost pri predpisovanju substratov za CYP3A4 z znano ozkim terapevtskim indeksom (npr. astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil ali alkaloidi ergot [ergotamin, dihidroergotamin]) (glejte poglavje 4.4).
Therefore, cysteamine bitartrate should not be used during pregnancy, particularly during the first trimester, unless clearly necessary (see section 4.4).
Zato se cisteaminijevega bitartrata ne sme uporabljati med nosečnostjo, zlasti pa ne v prvem trimesečju, razen če to ni absolutno nujno (glejte poglavje 4.4).
Therefore, darunavir must only be used in combination with a pharmacokinetic enhancer (see section 5.2).
Darunavir smete torej uporabljati samo v kombinaciji s farmakokinetičnim ojačevalcem (glejte poglavje 5.2).
Therefore, despite of the limited number of cases, hypertensive crisis should be included in section 4.8 of the SmPC.
Zato je, kljub omejenemu številu primerov, hipertenzivno krizo treba vključiti v poglavje 4.8 SmPC.
Therefore, despite the limited information available, the CHMP decided that Ammonaps’s benefits are greater than its risks as adjunctive therapy in the chronic management of urea cycle disorders.
Tako je odbor kljub omejenim informacijam sklenil, da so koristi zdravila Ammonaps kot dodatnega zdravljenje pri kronični obravnavi motenj ciklusa sečnine večje od z njim povezanih tveganj.
Therefore, diarrhoea should be included in section 4.8 of the SmPC.
Zato je diarejo treba vključiti v poglavje 4.8 SmPC.
Therefore, dizziness should be included in the section 4.8 of the SmPC.
Zato je vrtoglavico treba vključiti v poglavje 4.8 SmPC.
Therefore, do not take Comtan and iron supplements at the same time.
Zato ne jemljite zdravila Comtan in dodatkov železa istočasno.
Therefore, do not take Comtess and iron supplements at the same time.
Zato ne jemljite zdravila Comtess in dodatkov železa istočasno.
Therefore, do not take Oprymea if you are pregnant unless your doctor tells you to do so.
Če ste noseči, ne jemljite zdravila Oprymea razen, če vam je tako svetoval zdravnik.
Therefore, do not take Pramipexole Teva if you are pregnant unless your doctor tells you to do so.
Zato ne jemljite zdravila Pramipeksol Teva,če ste noseči, razen če vam je tako svetoval zdravnik.
Therefore, do not use in breeding, pregnant or lactating animals.
Zdravila zato ne uporabljajte pri rejnih in brejih živalih ali živalih v laktaciji.
Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
Zato ga nosečnice ne smejo uporabljati, razen če je to nuno potrebno.
Therefore, dosage for adult and paediatric patients with mild, moderate or severe hepatic impairment should be started at the lower end of the recommended dosing range (4.5 ml/m2/day) and kept at the lowest dose necessary to control the patient’s ammonia levels.
Zato mora biti začetni odmerek za odrasle in otroke z blago, zmerno ali hudo okvaro jeter na spodnji ravni priporočenega razpona odmerjanja (4,5 ml/m2/na dan) ter ga je treba obdržati na najnižji ravni, ki je potrebna za nadzor ravni amoniaka.
Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets).
Odmerki so zato tu navedeni za obe obliki, pramipeksol in pramipeksolijevo sol (v oklepaju).
Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with Rasilez.
Iz tega razloga se napitkov, ki vsebujejo rastlinske izvlečke, vključno z zeliščnimi čaji, ne sme uživati skupaj z zdravilom Rasilez.
Therefore, drug interactions would not be expected to occur.
Medsebojno delovanje z drugimi zdravili zato ni verjetno.
Therefore, due to the limited clinical experience, ticagrelor should be used with caution in these patients (see section 5.1).
Zato je treba ticagrelor zaradi skromnih kliničnih izkušenj pri takšnih bolnikih uporabljati previdno (glejte poglavje 5.1).
Therefore, due to the metformin active substance, Competact should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Zaradi vsebnosti zdravilne učinkovine metformin je potrebno zdravilo Competact ukiniti pred preiskavo ali v času preiskav, ponovno pa se sme uvesti šele po 48 urah in le v primeru, da je bilo pri ponovnem vrednotenju ugotovljeno normalno delovanje ledvic (glejte poglavje 4.5).
Therefore, due to the metformin active substance, Eucreas should be discontinued prior to, or at the time of, the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Ker zdravilo Eucreas vsebuje zdravilno učinkovino metformin, ga je treba ukiniti pred preiskavo ali v času preiskave, ponovno pa se ga sme uvesti šele 48 ur po preiskavi in sicer samo v primeru, da ponovno vrednotenje pokaže normalno delovanje ledvic (glejte poglavje 4.5).
Therefore, due to the metformin active substance, Glubrava should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Zaradi vsebnosti zdravilne učinkovine metformin je potrebno zdravilo Glubrava ukiniti pred preiskavo ali v času preiskav, ponovno pa se sme uvesti šele po 48 urah in le v primeru, da je bilo pri ponovnem vrednotenju ugotovljeno normalno delovanje ledvic (glejte poglavje 4.5).
Therefore, due to the metformin active substance, Icandra should be discontinued prior to, or at the time of, the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Ker zdravilo Icandra vsebuje zdravilno učinkovino metformin, ga je treba ukiniti pred preiskavo ali v času preiskave, ponovno pa se ga sme uvesti šele 48 ur po preiskavi in sicer samo v primeru, da ponovno vrednotenje pokaže normalno delovanje ledvic (glejte poglavje 4.5).
Therefore, due to the metformin active substance, Zomarist should be discontinued prior to, or at the time of, the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
Ker zdravilo Zomarist vsebuje zdravilno učinkovino metformin, ga je treba ukiniti pred preiskavo ali v času preiskave, ponovno pa se ga sme uvesti šele 48 ur po preiskavi in sicer samo v primeru, da ponovno vrednotenje pokaže normalno delovanje ledvic (glejte poglavje 4.5).
Therefore, due to the risk of haemorrhage, notably with NSAIDs with elimination half-lives > 12 hours, close observation for signs of bleeding is recommended (see section 4.4).
Zaradi tveganja krvavitve priporočajo pri uporabi NSAR, predvsem tistih z daljšo razpolovno dobo izločanja od 12 ur, natančno spremljanje bolnika, da bi odkrili znake krvavitve (glejte poglavje 4.4).
Therefore, due to the studies reported, the spontaneous report and the strong likelihood of a class effect, section 4.4 and 5.2 of the Summary of Product Characteristics should be updated with this safety concern.
Zaradi predloženih študij, spontanega poročanja in velike verjetnosti razrednega učinka je treba poglavji 4.4 in 5.2 Povzetka glavnih značilnosti zdravila posodobiti s tem varnostnim zadržkom.
Therefore, dulaglutide does have a high degree of protection against DPP-4 inactivation (see section 5.1).
Tako ima dulaglutid visoko stopnjo zaščite pred inaktivacijo DPP-4 (glejte poglavje 5.1).
Therefore, during the concomitant use of thiotepa and these medicinal products, patients should be carefully monitored clinically.
Zato je treba bolnike pozorno klinično spremljati med sočasno uporabo tiotepe in teh zdravil.
Therefore, during treatment with belatacept, vaccinations may be less effective although this has not been studied in clinical trials.
Med zdravljenjem z belataceptom je učinkovitost cepljenja lahko manjša, vendar pa v kliničnih študijah tega niso raziskovali.
Therefore, DUTREBIS should be used with caution in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Zdravilo DUTREBIS je zato treba pri bolnikih s hudo okvaro jeter previdno uporabljati (glejte poglavji 4.4 in 5.2).
Therefore, each vial contains an excess amount of solvent and PegIntron powder to ensure delivery of the labelled dose in 0.5 ml of PegIntron, solution for injection.
Zato vsaka viala vsebuje dodatno količino vehikla in PegIntron praška, da zagotovimo dajanje na nalepki navedenega odmerka v 0,5 ml zdravila PegIntron, raztopina za injiciranje.
Therefore, each vial contains an excess amount of solvent and ViraferonPeg powder to ensure delivery of the labelled dose in 0.5 ml of ViraferonPeg, solution for injection.
Zato vsaka viala vsebuje dodatno količino vehikla in ViraferonPeg praška, da zagotovimo dajanje na nalepki navedenega odmerka v 0,5 ml zdravila ViraferonPeg, raztopina za injiciranje.
Therefore, each vial contains an extra amount of solvent and PegIntron powder to ensure delivery of the labeled dose in 0.5 ml of PegIntron, solution for injection.
Zato vsaka viala vsebuje dodatno količino vehikla in PegIntron praška, kar zagotavlja dajanje predpisanega odmerka v 0,5 ml raztopine zdravila PegIntron.
Therefore, each vial contains an extra amount of solvent and ViraferonPeg powder to ensure delivery of the labeled dose in 0.5 ml of ViraferonPeg, solution for injection.
Zato vsaka viala vsebuje dodatno količino vehikla in ViraferonPeg praška, kar zagotavlja dajanje predpisanega odmerka v 0,5 ml raztopine zdravila ViraferonPeg.
Therefore, ECG monitoring during the following 24-48 hours should be applied for patients found to have a prolongation to this extent.
Zato je treba pri bolnikih, pri katerih so ugotovili podaljšanje v taki meri, uvesti nadziranje z EKG v obdobju naslednjih 24–48 ur.
Therefore, Efient can be administered without regard to food; however, the administration of prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 4.2).
Zato lahko zdravilo Efient dajemo neodvisno od hrane; vendar lahko dajanje polnilnega odmerka prasugrela v obdobju stradanja nudi najhitrejši začetek delovanja (glejte poglavje 4.2).
Therefore, eluxadoline is contraindicated in this population as well as in those with previous biliary tract problems (see sections 4.2, 4.3 and 4.4).
Zato je eluksadolin kontraindiciran pri tej populaciji in pri bolnikih s predhodnimi težavami z žolčevodom (glejte poglavja 4.2, 4.3 in 4.4).
Therefore, epidemiological information about current susceptibility of the target species should be taken into account in order to limit the possibility of a future selection for resistance.
Zato je potrebno upoštevati epidemiološke podatke o trenutni občutljivosti ciljnih organizmov, da se zmanjša verjetnost nastanka kasnejše selekcionirane rezistence.
Therefore, epoetin alfa should not be used in patients with baseline haemoglobin > 13 g/dl (> 8.1 mmol/l).
Zato se epoetin alfa pri bolnikih z izhodiščno koncentracijo hemoglobina > 13 g/dl (> 8,1 mmol/l) ne sme uporabljati.
Therefore, Eurartesim should be taken with water only as described in section 4.2. Eurartesim should not be taken with grapefruit juice as it is likely to lead to increased piperaquine plasma concentrations.
Zato je treba zdravilo Eurartesim jemati z vodo, kot je opisano v poglavju 4.2. Zdravilo Eurartesim se ne sme dajati s sokom grenivke, saj lahko to povzroči višje koncentracije piperakina v plazmi.
Therefore, EVARREST should be administered to pregnant and breast-feeding women only if clinically indicated.
Zato se zdravilo EVARREST pri nosečih in doječih ženskah uporablja samo, kadar je klinično indicirano.
Therefore, EXUBERA should be used with caution in patients of low body weight.
Zato je treba EXUBERO pri bolnikih z majhno telesno maso uporabljati previdno.
Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated.
Zato naj bi faktor VIII med nosečnostjo in obdobjem dojenja uporabljali le, če je to jasno indicirano.
Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Zato se lahko faktor VIII uporablja med nosečnostjo in dojenjem le, če je jasno indiciran.
Therefore, fluoxetine should be used with caution with other veterinary medicinal products.
Zato je treba fluoksetin v kombinaciji z drugimi zdravili za uporabo v veterinarski medicini previdno uporabljati.
Therefore, following HBeAg seroconversion, patients should be periodically monitored to determine that serologic and clinical responses are being maintained.
Po serokonverziji HBeAg se torej priporoča občasno preverjanje, ali sta se serološki in klinični odziv ohranila.
Therefore, fondaparinux is not recommended for treatment of superficial-vein thrombosis in these patients (see section 4.2).
Zato fondaparinuks ni priporočljiv za zdravljenje povrhnje venske tromboze pri takšnih bolnikih (glejte poglavje 4.2).
Therefore, food should not be consumed for at least 3 hours before and at least 1 hour after taking GIOTRIF (see sections 4.2 and 4.5).
Zato naj bolnik najmanj 3 ure pred jemanjem zdravila GIOTRIF in 1 uro po njem ne uživa hrane (glejte poglavji 4.2 in 4.5).
Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended.
Zato se za asepso ampule pred uporabo priporoča 60 % etanol ali 70 % izopropilalkohol.
Therefore, for dogs receiving treatments in addition to the veterinary medicinal product, drug interactions should be monitored closely.
Pri psih, ki dobivajo dodatna zdravljenja je potrebno natančno spremljati medsebojne učinke apliciranih zdravil.
Therefore, for dogs receiving treatments in addition to the veterinary medicinal product, drug interactions should be monitored closely.
Zato je treba pri psih, hkrati zdravljenimi z drugimi zdravili, natančno opazovati njihovo medsebojno delovanje.
Therefore, for patients with renal cell carcinoma, continuous administration beyond 5-7 days with agents that have CYP3A4/5 induction potential should be avoided.
Zato se je treba pri bolnikih s karcinomom ledvičnih celic izogibati neprekinjeni uporabi zdravil, ki inducirajo CYP3A4/5, daljši od 5-7 dni.
Therefore, from a microbiological point of view, the reconstituted solution must be used immediately.
Z mikrobiološkega stališča je zato treba zdravilo uporabiti takoj po pripravi.
Therefore, GANFORT should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular oedema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).
Zato je potrebna previdnost pri uporabi zdravila GANFORT pri bolnikih z afakijo, bolnikih s psevdofakijo oziroma s poškodovano zadnjo lečno kapsulo in pri bolnikih z znanimi dejavniki tveganja za makularni edem (npr. intraokularna operacija, okluzija retinalne vene, vnetna očesna bolezen in diabetična retinopatija).
Therefore, Gilenya is not recommended in people taking certain antiarrhythmic medicines (medicines used to restore normal cardiac rhythm) and in patients taking certain medicines that lower the heart rate.
Zato ni priporočljivo za ljudi, ki jemljejo določena zdravila proti aritmiji (zdravila, ki se uporabljajo za vzpostavitev normalnega srčnega ritma), in bolnike, ki jemljejo določena zdravila za zniževanje srčnega utripa.
Therefore, headache should be included in section 4.8 of the SmPC.
Zato je glavobol treba vključiti v poglavje 4.8 SmPC.
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings
Zdravnik mora presoditi koristi in možno tveganje uporabe cepiva pri osebah s trombocitopenijo ali katero koli motnjo koagulacije, pri kateri je intramuskularno injiciranje kontraindicirano, razen če pričakovane koristi odtehtajo tveganje krvavitve.
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings
Zdravnik mora presoditi koristi in možno tveganje uporabe cepiva pri osebah s trombocitopenijo ali katero koli motnjo koagulacije, pri kateri je kontraindicirano intramuskularno injiciranje, razen če pričakovane koristi odtehtajo tveganje krvavitve.
Therefore, hepatic impairment may increase ceritinib plasma concentrations.
Zaradi okvare jeter bi torej lahko prišlo do zvišanja koncentracije ceritiniba v plazmi.
Therefore, higher doses of rFVIIa may be needed in paediatric patients to achieve similar plasma concentrations as in adult patients (see section 5.2).
Pediatrični bolniki utegnejo zato potrebovati večje odmerke rFVIIa za doseganje podobne koncentracije v plazmi, kot je dosežena pri odraslih bolnikih (glejte poglavje 5.2).
Therefore, hormone- based contraceptives alone, regardless of the route of administration (i.e., oral, injectable, transdermal or implantable forms), are not considered as reliable methods of contraception (see sections 4.4 and 4.6).
Zato kontracepcija, ki temelji samo na hormonih, ni zanesljiv način kontracepcije, ne glede na način apliciranja (npr. peroralno, parenteralno, transdermalno ali v obliki vsadka) (glejte poglavji 4.4, 4.6).