FrancophonIA/ELRC3.0 huggingface dataset:
English: Capsule content Lactose monohydrate Hydroxypropylcellulose Sodium laurilsulfate Magnesium stearate Carmellose calcium
Slovenian: Magnezijev stearat Kalcijev karmelozat
English: Capsule shell Hypromellose Carrageenan Potassium chloride Titanium dioxide (E171) Maize starch Carnauba wax
Slovenian: Titanov dioksid (E171) Koruzni škrob Karnauba vosek
English: Permanently discontinue Alecensa.
Slovenian: Takoj prekinite zdravljenje z zdravilom Alecensa.
English: Talk to your doctor, pharmacist or nurse before taking Alecensa:
Slovenian: Pred začetkom jemanja zdravila Alecensa se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: This is to check you do not have any liver problems while taking Alecensa.
Slovenian: da med jemanjem zdravila Alecensa nimate težav z jetri.
English: Your doctor will take blood tests before you start treatment, then every 2 weeks for the first 3 months of your treatment and then less often.
Slovenian: nato na 2 tedna v prvih 3 mesecih zdravljenja, pozneje pa manj pogosto.
English: Table 6 Summary of the pooled analysis of CNS endpoints from studies NP28673 and NP28761 CNS Parameters (NP28673 and NP28761)
Slovenian: Povzetek kumulativne analize opazovanih dogodkov v osrednjem živčevju v študijah NP28673 in NP28761
English: When Alecensa is co-administered with BCRP substrates (e.g., methotrexate, mitoxantrone, topotecan and lapatinib), appropriate monitoring is recommended.
Slovenian: Če zdravilo Alecensa uporabljamo sočasno s substrati BCRP (takšni so npr. metotreksat, mitoksantron,
English: ● mitoxantrone, a medicine used to treat certain types of cancer or autoimmune diseases (e.g.
Slovenian: ● mitoksantron, zdravilo za zdravljenje nekaterih vrst raka ali za zdravljenje avtoimunskih bolezni
English: Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Slovenian: pozitivnim (ALK - anaplastična limfomska kinaza), napredovalim nedrobnoceličnim rakom pljuč.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje alektinibijev klorid, kolikor ga ustreza 150 mg alektiniba.
English: 1) includes cases of anaemia and haemoglobin decreased includes cases of dysgeusia and hypogeusia 3) includes cases of blurred vision, visual impairment, vitreous floaters, reduced visual acuity, asthenopia, and diplopia 4) includes cases of bradycardia and sinus bradycardia includes cases of stomatitis and mouth ulceration 6) includes cases of blood bilirubin increased, hyperbilirubinaemia and bilirubin conjugated increased includes two patients with reported MedDRA term of drug-induced liver injury as well as one patient with reported Grade 4 increased AST and ALT who had documented drug-induced liver injury by liver biopsy includes cases of rash, rash maculopapular, dermatitis acneiform, erythema, rash generalised, rash papular, rash pruritic, rash macular and exfoliative rash includes cases of myalgia and musculoskeletal pain includes cases of oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema
Slovenian: Vključuje primere izpuščaja, makulopapuloznega izpuščaja, akneiformnega dermatitisa, eritema, generaliziranega izpuščaja, papuloznega izpuščaja, pruritičnega izpuščaja, makuloznega izpuščaja in eksfoliativnega izpuščaja.
English: ALT or AST elevation of Grade ≥ 3 (> 5 times
Slovenian: Zvišanje ALT ali AST ≥ stopnje 3 (> 5-kratna ZMN) in celokupni bilirubin ≤ 2-kratna ZMN
English: ILD/pneumonitis of any severity grade
Slovenian: Intersticijska bolezen pljuč (IBP)/pnevmonitis katere koli stopnje
English: Name and address of the manufacturer(s) responsible for batch release Roche Pharma AG
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
English: Number of patients with events N (%) Median (months) [95% CI]
Slovenian: Število bolnikov z dogodkom n (%) Mediana (meseci) [95-% IZ]
English: NE [17.3, NE]
Slovenian: [17,3; NO]
English: The majority of these events were of Grade 1 and 2 intensity, and events of Grade ≥ 3 were reported in 3.7% and 3.7% of the patients, respectively.
Slovenian: 2, zvišanje stopnje ≥ 3 so zabeležili pri 3,7 % (AST) oziroma 3,7 % (ALT) bolnikov.
English: ● weight gain.
Slovenian: ● povečanje telesne mase.
English: In pregnant rabbits, alectinib caused embryo-foetal loss, small fetuses and increased incidence of skeletal variations at exposures 2.9-fold of the human AUC exposure at the recommended dose.
Slovenian: 2,9-krat večja od izpostavljenosti pri človeku ob uporabi priporočenih odmerkov, povzročil embriofetalno izgubo, majhne plodove in povečano incidenco skeletnih sprememb.
English: Investigations Weight increased
Slovenian: Preiskave povečanje telesne mase zelo pogosti
English: Although PK simulations for Alecensa do not indicate a low exposure in patients with extreme body weight (i.e. >130 kg), alectinib is widely distributed and clinical studies for alectinib enrolled patients within a range of body weights of 36.9−123 kg.
Slovenian: Alektinib se dobro porazdeljuje in v klinične študije so vključili bolnike z razponom telesne mase od 36,9 do 123 kg. Za bolnike s telesno maso nad 130 kg podatkov ni na voljo.
English: Cases of bradycardia (8.9%) of Grade 1 or 2 have been reported in patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Alecensa med kliničnimi preskušanji (NP28761, NP28673, BO28984), so bili opisani primeri bradikardije (8,9 %) stopnje 1 ali 2.
English: Vomiting
Slovenian: Mutagenost
English: In vitro, alectinib and its major active metabolite M4 are inhibitors of the efflux transporter P-glycoprotein (P-gp).
Slovenian: Substrati P-gp Alektinib in njegov glavni aktivni presnovek M4 in vitro zavirata izločevalni prenašalec P
English: Across clinical trials (NP28761, NP28673, BO28984), 1 out of 405 patients treated with Alecensa (0.2%) had a Grade 3 ILD.
Slovenian: V kliničnih preskušanjih (NP28761, NP28673, BO28984) se je IBP stopnje 3 pojavila pri 1 od 405
English: Diarrhoea
Slovenian: Kancerogenost
English: Concurrent elevations in ALT or AST greater than or equal 3 times the ULN and total bilirubin greater than or equal 2 times the ULN, with normal alkaline phosphatase, occurred in one patient treated in Alecensa clinical trials.
Slovenian: V kliničnih preskušanjih z zdravilom Alecensa so pri enem bolniku zabeležili sočasno zvišanje ALT ali AST na več ali enako kot 3-kratno ZMN in celokupnega bilirubina na več ali enako kot 2-kratno ZMN,
English: CNS responders n (%)
Slovenian: Število bolnikov z dogodki n (%)
English: Renal and urinary disorders Blood creatinine increased
Slovenian: Bolezni sečil zvišan kreatinin v krvi pogosti akutna poškodba jeter pogosti
English: Hrvatska
Slovenian: alecensa
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijska bolezen pljuč/pnevmonitis občasni
English: Patients with measurable CNS lesions at baseline CNS ORR (IRC)
Slovenian: ORR v osrednjem živčevju (IRC)
English: CNS-DOR, median (months) [95% CI]
Slovenian: Mediana (meseci) [95-% IZ]
English: Responders (%) [95% CI]
Slovenian: Odzivni bolniki (%) [95-% IZ] Popolni odziv Delni odziv
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BOTTLE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE
English: Eye disorders Vision disorders3)
Slovenian: Glicerilmonooleat 6.2 Inkompatibilnosti
English: Do not expose yourself to the sun for any long period of time while you are taking Alecensa and for 7 days after you stop.
Slovenian: Med jemanjem zdravila Alecensa in še 7 dni po prenehanju jemanja se izogibajte dolgotrajnejšemu izpostavljanju soncu.
English: ALK-positive NSCLC status should be established prior to initiation of Alecensa therapy.
Slovenian: Za izbiro bolnikov, ki imajo ALK-pozitivnega nedrobnoceličnega raka pljuč, je treba opraviti validiran preizkus za ALK. Ali je bolnikov nedrobnocelični rak pljuč ALK-pozitiven, je treba ugotoviti pred začetkom zdravljenja z zdravilom Alecensa.
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Slovenian: Roche Registration GmbH
English: Median time to onset for constipation, nausea, diarrhea, and/or vomiting events across clinical trials (NP28761, NP28673, BO28984) was 21 days.
Slovenian: V kliničnih preskušanjih (NP28761, NP28673, BO28984) je bil mediani čas do pojava zaprtosti, navzee, driske in/ali bruhanja 21 dni.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Slovenian: PODATKI NA STIČNI OVOJNINI NALEPKA NA PLASTENKI
English: Cases of myalgia (28%) including myalgia events (22%) and musculoskeletal pain (7.4%) have been reported in patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Alecensa vkliničnih preskušanjih (NP28761, NP28673, BO28984) so zabeležili primere mialgije (28 %), ki so obsegali mialgične dogodke (22 %) in mišičnoskeletne bolečine (7,4 %).
English: Alecensa has not been studied in patients with severe renal impairment.
Slovenian: Pri bolnikih s hudo okvaro ledvic zdravilo Alecensa ni raziskano.
English: Common
Slovenian: pogosti
English: 31 October
Slovenian: 31. oktober
English: Special attention should be paid to the interaction with lamotrigine.
Slovenian: Posebej je treba biti pozoren na interakcijo z lamotriginom.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2011
Slovenian: Datum prve odobritve: 16. november 2011
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Interakcije
English: Before you can begin taking IOA, your doctor will ask you some questions about your personal health history and that of your close relatives.
Slovenian: Preden lahko začnete jemati zdravilo IOA, vam bo zdravnik postavil nekaj vprašanj o vašem zdravju v preteklosti in o zdravju vaših bližnjih sorodnikov.
English: Keep taking IOA as usual.
Slovenian: Nadaljujte z jemanjem zdravila IOA kot običajno.
English: • as you get older (particularly above about 35 years); • if you gave birth less than a few weeks ago
Slovenian: • z višjo starostjo (zlasti nad 35 let); • če ste rodili pred manj kot nekaj tedni.
English: If you have missed one or more periods Clinical trials with IOA have shown that you may occasionally miss your regular monthly period after Day 24.
Slovenian: Če niste dobili ene ali več menstruacij Klinična preskušanja z zdravilom IOA so pokazala, da vam lahko občasno izostane redna mesečna menstruacija po 24. dnevu.
English: • changes to menstrual periods (e.g. absence or irregularity)
Slovenian: • akne • spremembe menstruacije (npr. odsotnost ali nerednost)
English: Combined hormonal contraceptives (CHCs) should not be used in the following conditions.
Slovenian: Kombiniranih hormonskih kontraceptivov (KHK) se ne sme uporabljati pri naslednjih stanjih.
English: If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive;
Slovenian: Če kajenja ne morete opustiti in ste starejši od 35 let, vam bo zdravnik morda svetoval drugačno vrsto kontracepcije,
English: For more detailed information on the different risks from taking combined hormonal contraceptives, please see section 2, “What you need to know before you use IOA”.
Slovenian: Za podrobnejše informacije o različnih tveganjih jemanja kombiniranih hormonskih kontraceptivov glejte poglavje 2, "Kaj morate vedeti, preden boste uporabili zdravilo IOA".
English: Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
Slovenian: 1 Srednja točka razpona 5-7 na 10.000 žensk-let glede na relativno tveganje za CHC, ki vsebujejo levonorgestrel v primerjavi s približno 2,3 do 3,6 za neuporabo
English: There are no antidotes and further treatment should be
Slovenian: Antidotov ni in nadaljnje zdravljenje mora biti simptomatsko.
English: The duration of the withdrawal bleeding in women using IOA is on average 3-4 days.
Slovenian: Trajanje odtegnitvene krvavitve pri ženskah, ki jemljejo zdravilo IOA, je v povprečju 3 do 4 dni.
English: If you forgot to take one of these tablets the reliability of IOA is maintained.
Slovenian: Tudi če ste pozabili vzeti eno od teh tablet, je zanesljivost zdravila IOA ohranjena.
English: So contact your doctor immediately.
Slovenian: zato se morate nemudoma posvetovati z zdravnikom.
English: Average serum concentrations are 50 pg/ml and these estradiol levels correspond with the early and late phase of a woman's menstrual cycle.
Slovenian: Povprečna serumska koncentracija je 50 pg/ml in ta koncentracija estradiola ustreza zgodnji in pozni fazi menstruacijskega ciklusa pri ženski.
English: It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”).
Slovenian: Posebej pomembno je, da preberete simptome krvnega strdka - glejte poglavje 2 "Krvni strdki").
English: A relationship between COC use and clinical hypertension has not been established.
Slovenian: Povezava med uporabo KPK in klinično hipertenzijo še ni bila ugotovljena.
English: Prior to the initiation or reinstitution of IOA use a complete medical history (including family history) should be taken and pregnancy must be ruled out.
Slovenian: Pred začetkom ali ponovno uvedbo zdravila IOA se je treba seznaniti s celotno anamnezo (vključno z družinsko) in izključiti nosečnost.
English: • Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare.
Slovenian: • Čeprav so pri mnogih ženskah, ki jemljejo KPK, poročali o majhnem povečanju krvnega tlaka, pa je klinično pomembno povečanje redko.
English: If you are having any blood or urinary test, tell your doctor that you are using IOA as it may affect the results of some tests.
Slovenian: Če imate kakršnokoli preiskavo krvi ali urina, povejte zdravniku, da uporabljate zdravilo IOA, saj bi lahko le-to vplivalo na izvide nekaterih preiskav.
English: Before you start using IOA you should read the information on blood clots (thrombosis) in section 2.
Slovenian: Pred začetkom uporabe zdravila IOA morate prebrati informacije o krvnih strdkih (trombozi) v poglavju 2.
English: When you stop IOA your risk of a blood clot returns to normal within a few weeks.
Slovenian: Ko prenehate jemati zdravilo IOA, se tveganje za nastanek krvnega strdka v nekaj tednih vrne na normalno raven.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, ali zeliščne pripravke.
English: What IOA is and what it is used for
Slovenian: Kaj je zdravilo IOA in za kaj ga uporabljamo
English: However, it must be borne in mind that sex steroids can promote the growth of certain hormone
Slovenian: Treba pa je upoštevati, da lahko spolni steroidni hormoni spodbujajo rast določenih hormonsko odvisnih tkiv in tumorjev.
English: If this is not possible or 12 hours have passed, you should follow the advice given under "If you forget to take IOA".
Slovenian: Če to ni mogoče ali je 12 ur že minilo, morate slediti navodilom v poglavju "Če ste pozabili vzeti zdravilo IOA".
English: What you need to know before you use IOA
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo IOA
English: Influence of IOA on other medicinal products
Slovenian: Vpliv zdravila IOA na druga zdravila
English: Excretion of nomegestrol acetate was nearly complete after 10 days and amounts excreted were higher in feces than in urine.
Slovenian: Izločanje nomegestrolacetata je bilo skoraj popolno po 10 dneh, njegove izločene količine pa so bile večje v blatu kot v urinu.
English: 4.4 Special warnings and precautions for use Warnings
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi
English: • There are medicines that can make IOA less effective in preventing pregnancy, or can cause unexpected bleeding.
Slovenian: • Obstajajo zdravila, ki lahko zmanjšajo učinkovitost zdravila IOA pri preprečevanju nosečnosti in lahko povzročajo nepričakovane krvavitve.
English: You should not use IOA if you have any of the conditions listed below.
Slovenian: Zdravila IOA ne smete uporabljati, če imate katero od spodaj naštetih stanj.
English: If you cannot remember how many white active tablets you have missed, follow the first option, use a barrier method as a precaution for the next 7 days and contact your doctor.
Slovenian: Če se ne morete spomniti, koliko belih aktivnih tablet ste pozabili vzeti, izberite 1. možnost, naslednjih 7 dni uporabljajte pregradno metodo kontracepcije in se posvetujte z zdravnikom.
English: Breastfeeding may be influenced by COCs as they may reduce the quantity and change the composition of breast milk.
Slovenian: KPK bi lahko vplivali na dojenje, ker lahko zmanjšajo količino materinega mleka in spremenijo njegovo sestavo.
English: Schedule: if you are more than 12 hours late taking white tablets
Slovenian: Shema: Če ste zamudili z jemanjem belih tablet več kot 12 ur
English: Concomitant use of rifampicin decreases the AUC0-∞ of nomegestrol acetate by 95 % and increases the AUC0-tlast of estradiol by 25 %.
Slovenian: Sočasna uporaba rifampicina zmanjša vrednost AUC0-∞ nomegestrolacetata za 95 % in poveča vrednost AUC0-tlast estradiola za 25 %.
English: For a description of the symptoms of these serious side effects please go to “How to recognise a blood
Slovenian: Za opis simptomov teh resnih neželenih učinkov glejte "Kako prepoznati krvni strdek".
English: Women who are not using a combined hormonal pill and are not
Slovenian: Ženske, ki ne uporabljajo kombiniranih hormonskih tablet in niso noseče
English: • if you have (had) severe liver disease and your liver is not yet working normally;
Slovenian: • če imate (oziroma ste kdaj imeli) hudo jetrno bolezen in vam jetra še ne delujejo normalno;
English: These include medicines used to treat:
Slovenian: Sem sodijo zdravila za zdravljenje:
English: Your risk is
Slovenian: Vaše tveganje je večje:
English: In isolated cases, these tumours have led to life-threatening intraabdominal haemorrhages.
Slovenian: V osamljenih primerih so ti tumorji vodili do pojava smrtno nevarnih intraabdominalnih krvavitev.
English: This includes any possible side You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: • if you notice any changes in your own health, especially involving any of the items mentioned in this leaflet (see also in section 2 ‘When you should not use IOA'; do not forget about the changes in the health of your immediate family);
Slovenian: • če opazite kakršne koli spremembe v svojem zdravju, še posebej pa motnje, ki so omenjene v tem navodilu (glejte tudi poglavje 2 "Kdaj ne smete uporabljati zdravila IOA" ter ne pozabite na spremembe v zdravju svojih bližnjih družinskih članov);
English: Approximately 80 % of the dose is excreted in urine and feces within 4 days.
Slovenian: V 4 dneh se z urinom in blatom izloči približno 80 % odmerka.
English: Important things to know about combined hormonal contraceptives (CHCs):
Slovenian: Pomembne informacije, ki jih morate vedeti o kombiniranih hormonskih kontraceptivih (CHC - combined hormonal contraceptives):
English: IOA is a contraceptive pill that is used to prevent pregnancy.
Slovenian: IOA je kontracepcijska tableta, ki se uporablja za preprečevanje nosečnosti.
English: Each time you start a new blister of IOA, take the number 1 white active tablet in the left-hand top corner (see ‘Start').
Slovenian: Vsakič, ko začnete jemati tablete iz novega pretisnega omota zdravila IOA, vzemite belo aktivno tableto številka 1 iz levega zgornjega kota (glejte oznako "Začetek").
English: • A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using COCs.
Slovenian: • Po meta-analizi 54 epidemioloških študij so poročali o rahlo povečanem relativnem tveganju (RR = 1,24), da bodo pri ženski, ki trenutno jemlje KPK, odkrili rak dojke.
English: IOA contains 17β-estradiol.
Slovenian: Zdravilo IOA vsebuje 17β-estradiol.
English: 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.
Slovenian: Ker je pri ženskah, mlajših od 40 let, rak dojke redka bolezen, je dodatno število diagnoz raka dojke pri ženskah, ki trenutno uporabljajo KPK oz. so jih uporabljale pred kratkim, v resnici majhno glede na celokupno tveganje za rak dojke.
English: The use of IOA may need to be stopped several weeks before surgery or while you are less mobile.
Slovenian: Uporabo zdravila IOA je lahko treba prekiniti več tednov pred kirurškim posegom ali v času zmanjšane gibljivosti.
English: During clinical trials, absence of withdrawal bleeding ranged over the cycles 1-12 from 18 % to 32 %.
Slovenian: kliničnih preskušanjih je bila odsotnost odtegnitvene krvavitve v ciklusih 1-12 od 18 % do 32 %.
English: • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more
Slovenian: • Rahlo povečajo tveganje za nastanek krvnih strdkov v venah in arterijah, zlasti v prvem letu uporabe ali ob ponovnem začetku uporabe kombiniranega hormonskega kontraceptiva po presledku, ki je trajal 4 tedne ali več.
English: IOA must not be used by women who are pregnant, or who think they may be pregnant.
Slovenian: Nosečnost in dojenje Zdravila IOA ne smejo uporabljati ženske, ki so noseče ali menijo, da bi lahko bile noseče.
English: Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs.
Slovenian: Estrogeni se obsežno porazdelijo po telesu in so običajno v večjih koncentracijah navzoči v tarčnih organih za spolne hormone.
English: When using a combined hormonal contraceptive like IOA you are advised to stop smoking.
Slovenian: Če uporabljate kombiniran hormonski kontraceptiv, kot je zdravilo IOA, je priporočljivo, da prenehate kaditi.
English: • if you have epilepsy (see in section 2 ‘Other medicines and IOA');
Slovenian: • če imate epilepsijo (glejte poglavje 2 "Druga zdravila in zdravilo IOA");
English: • Contraceptive pills that contain two different hormones, like IOA, are called ‘combined pills'.
Slovenian: • Kontracepcijske tablete, ki vsebujejo dva različna hormona, kakršne so tablete IOA, imenujemo
English: Further information on the possible side effect changes to menstrual periods (e.g. absence or irregular) during the use of IOA is described in section 3 ‘When and how to take the tablets', ‘If you have unexpected bleeding' and ‘If you have missed one or more periods').
Slovenian: Dodatne informacije o možnih neželenih učinkih, ki se kažejo v spremembah menstruacijskega ciklusa (npr. odsotnost menstruacije ali neredne menstruacije) med jemanjem zdravila IOA so podane v poglavju 3 "Kdaj in kako jemati tablete", "Če imate nepričakovano krvavitev" in "Če niste dobili ene ali več menstruacij").
English: • Some medicines can increase the levels of the active substances of IOA in the blood.
Slovenian: • Nekatera zdravila lahko povečajo koncentracijo zdravilnih učinkovin zdravila IOA v krvi.