FrancophonIA/ELRC3.0 huggingface dataset:
English: The first infusion should be initiated as soon as possible, within the first six hours after the accident.
Slovenian: S prvo infuzijo je treba začeti čim prej, v roku prvih šest ur po dogodku.
English: • Difficulties in breathing
Slovenian: • težave pri dihanju,
English: Volume of distribution is independent of dose.
Slovenian: Volumen porazdelitve je neodvisen od odmerka.
English: Date of latest renewal: 18 July 2011
Slovenian: Datum prve odobritve 28. julij 2006 Datum zadnjega podaljšanja 18. julij 2011
English: Haematological monitoring should therefore be undertaken regularly.
Slovenian: Zato je potrebno redno hematološko spremljanje.
English: Both of these effects are expected for this class of compound.
Slovenian: Za to skupino spojin se pričakujeta oba učinka.
English: In both studies all patients had received anthracycline.
Slovenian: V obeh raziskavah so vsi bolniki prejeli antraciklin.
English: For patients with a body surface area of more than 2 m2 the single dose should not exceed 2000 mg.
Slovenian: Pri bolnikih, katerih površina telesa presega 2 m2, posamezni odmerek ne sme preseči 2.000 mg.
English: - In order to avoid the potential contamination of the medicine by microbes, the product should be used immediately.
Slovenian: - Da preprečite morebitno kontaminacijo zdravila z mikrobi, je treba zdravilo uporabiti takoj.
English: Calcium Total (Hypo)
Slovenian: Skupni kalcij (hipo)
English: The concentrate is slightly yellow.
Slovenian: Koncentrat je rahlo rumene barve.
English: Adverse reactions observed in the two studies are listed below.
Slovenian: Neželeni učinki, ki so jih opazili v omenjenih dveh študijah, so napisani spodaj.
English: Eighteen were evaluable for efficacy and safety and a further five patients were evaluable for toxicity only.
Slovenian: Osemnajst bolnikov je bilo mogoče vrednotiti za učinkovitost in varnost, pet bolnikov pa le za toksičnost.
English: Use of gloves and other protective clothing to prevent skin contact is recommended.
Slovenian: Priporočljiva je uporaba rokavic in drugih zaščitnih oblačil, da preprečite stik s kožo.
English: This is equivalent to 81% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 81 % priporočenega največjega dnevnega vnosa natrija s hrano za odraslo osebo.
English: Savene will not be used again at the time of your next anthracycline cycle, except if extravasation occurs again.
Slovenian: Zdravila Savene ob naslednjem antraciklinskem ciklu ne boste prejeli, razen, če se ponovno pojavi ekstravazacija.
English: Overall, the most commonly received anthracycline was epirubicin (56 % of the patients).
Slovenian: Najpogosteje so bolniki prejeli antraciklin epirubicin (56 % bolnikov).
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Slovenian: Pogosti (≥1/100 do <1/10) Občasni (≥1/1.000 do <1/100) Redki (≥1/10.000 do <1/1.000) Zelo redki (<1/10.000)
English: There is insufficient data available to draw any definite conclusions regarding intrinsic pharmacokinetic factors such as age, gender, race and weight.
Slovenian: Zaradi pomanjkljivih podatkov ni mogoče postaviti dokončnih zaključkov o intrinzičnih farmakokinetičnih dejavnikih, kot so starost, spol, rasa in telesna masa.
English: SN: {number} [serial number]
Slovenian: SN: {številka}
English: - Ciclosporin or tacrolimus (both treatments lower the body's immune system and are used to prevent organ rejection after an organ transplant).
Slovenian: - Ciklosporin ali takrolimus (obe zdravili oslabita imunski sistem in se uporabljata za preprečevanje zavračanja organov po presaditvah).
English: Pharmacokinetics in patients with extravasations
Slovenian: Farmakokinetika pri bolnikih z ekstravazacijami
English: 3.2.2 Inject the required volume back into the opened Savene solvent bottle (see point 3.1.5).
Slovenian: 3.2.2 Vbrizgajte potreben volumen nazaj v odprto steklenico z vehiklom Savene (glejte točko 3.1.5).
English: Due to the rarity of the condition only historical data could be used for comparison (demonstrating surgical rates of 35-50 %, in one country 100% in biopsy proven cases).
Slovenian: Zaradi redkosti stanja je bilo možno za primerjavo uporabiti le zgodovinske podatke (ki kažejo stopnjo uporabe kirurškega posega 35-50 %, v eni državi 100 % v primerih, dokazanih z biopsijo).
English: Powder and solvent: 3 years.
Slovenian: Prašek in vehikel: 3 leta
English: - Anticoagulants (blood thinners) (your blood may need to be monitored more frequently).
Slovenian: - Antikoagulanti (sredstva za redčenje krvi) (morda bo treba pogosteje spremljati kri).
English: A number of published reports comprising more than 1000 patients have demonstrated a uniform pattern of dose dependent adverse reactions.
Slovenian: Številna objavljena poročila, ki so obravnavala več kot 1.000 bolnikov, so pokazala enakomeren vzorec od odmerka odvisnih neželenih učinkov.
English: Dexrazoxane has two major mechanisms of action:
Slovenian: Deksrazoksan ima dva glavna mehanizma delovanja:
English: The infusion will last 1-2 hours.
Slovenian: Infundiranje traja 1-2 uri.
English: Myelosuppression is thus common.
Slovenian: Mielosupresija je potemtakem pogosta.
English: Most anti-cancer medicines are administered intravenously (into a vein).
Slovenian: Večina zdravil proti raku se daje intravensko (v veno).
English: The chelating property is probably also responsible for an increased urinary excretion of iron and zinc and a decreased serum concentration of calcium as described in a few studies.
Slovenian: Sposobnost kelacije je verjetno odgovorna tudi za povečano izločanje železa in cinka v urinu ter znižane serumske koncentracije kalcija, ki jih opisujejo v nekaj študijah.
English: The apparent volumes of distribution are 0.13-1.3 l/kg (median 0.49 l/kg).
Slovenian: Navidezni volumen porazdelitve je 0,13-1,3 l/kg (mediana 0,49 l/kg).
English: Inter- and intra-individual pharmacokinetic variabilities have not been studied systematically.
Slovenian: Variabilnost znotraj posameznika in med posamezniki ni bila sistematično preučena.
English: None of the patients required surgical intervention.
Slovenian: Bolniki niso potrebovali kirurškega posega.
English: ADR-925 is reported to increase three-fold within 15 min after infusion of 1500 mg/m2 and remain relatively constant on a plateau for 4 hours and then decreased to about half at 24 hours.
Slovenian: Ugotovili so, da se raven ADR-925 v 15 min po infuziji 1.500 mg/m2 zviša na trikratno raven, nato ostane relativno konstantna na platoju 4 ure, zatem pa se zniža na približno polovico po 24 urah.
English: It is a serious complication as it can cause severe tissue damage.
Slovenian: Ekstravazacija je resen zaplet, saj lahko povzroči hude poškodbe tkiva.
English: Use a graduated syringe filled with a needle.
Slovenian: Uporabite graduirano brizgo, ki ima nameščeno iglo.
English: • Reduction in any of your senses (sight, smell, hearing, touch, taste)
Slovenian: • zmanjšan občutek v čutilih (vid, vonj, sluh, dotik, okus),
English: The first infusion will be given as soon as possible and within the first six hours after extravasation of an anthracycline medicine.
Slovenian: Prvo infuzijo boste dobili čim prej in v roku prvih šest ur po ekstravazaciji z antraciklinskim zdravilom.
English: The systemic clearances were similar between day 1 (9.9 L/h ± 3.1) and day 2 (11.1 L/h ± 4.5), and did not differ from those reported in the literature.
Slovenian: Sistemski očistki so bili podobni med 1. dnevom (9,9 l/h ±3,1) in 2. dnevom (11,1 l/h ±4,5) in se niso razlikovali od vrednosti očistkov, ki so navedeni v literaturi.
English: - A product called DMSO (which is a cream to treat some skin diseases).
Slovenian: - Izdelek, imenovan DMSO (v obliki krem za zdravljenje nekaterih kožnih bolezni).
English: If you get any of the above symptoms, seek medical advice immediately.
Slovenian: Če opazite katerega od zgornjih simptomov, takoj poiščite zdravniško pomoč.
English: Other possible side effects are listed below:
Slovenian: Drugi možni neželeni učinki so navedeni spodaj:
English: • Blood clot in the vein, usually in an arm or leg
Slovenian: • krvni strdek v veni, navadno v roki ali nogi,
English: It is important that you read the entire content of this procedure prior to the preparation of Savene.
Slovenian: Pomembno je, da pred pripravo zdravila Savene preberete celoten postopek.
English: • Muscle pain, tremor (uncontrolled muscle movement)
Slovenian: • bolečina v mišicah, tremor (nenadzorovano premikanje mišic),
English: Interactions common to all cytotoxics:
Slovenian: Interakcije skupne vsem citotoksikom:
English: Potassium 98 mg/500 ml or 5.0 mmol/l Sodium 1.61 g/500 ml or 140 mmol/l
Slovenian: Kalij 98 mg/500 ml oz. 5,0 mmol/l Natrij 1,61 g/500 ml oz. 140 mmol/l
English: If you are at risk of high potassium levels in your blood, your doctor will monitor this.
Slovenian: Če imate tveganje za visoke ravni kalija v krvi, jih bo zdravnik spremljal.
English: Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: 36 patients were evaluable for efficacy.
Slovenian: Za učinkovitost zdravila je bilo ovrednotenih 36 bolnikov.
English: - Myelosuppressive medicines (decrease production of red, white, or coagulating blood cells).
Slovenian: - Mielosupresivna zdravila (zmanjšajo nastajanje rdečih krvničk, belih krvničk in krvnih ploščic).
English: What Savene is and what it is used for What you need to know before you use Savene How to use Savene
Slovenian: Kaj je zdravilo Savene in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Savene Kako uporabljati zdravilo Savene
English: WTC Schiphol Airport, D Tower 11th floor 1118BJ Schiphol
Slovenian: WTC Schiphol Airport, D Tower 11th floor
English: Only one of the 36 patients required surgery.
Slovenian: En bolnik izmed 36 je potreboval kirurški poseg.
English: All items for preparation, administration or cleaning, including gloves, as well as liquid waste should be disposed of in accordance with local requirements.
Slovenian: Ves material, ki ga uporabite za pripravo, dajanje ali čiščenje (vključno z zaščitnimi rokavicami), ter tekoče odpadke zavrzite v skladu z lokalnimi predpisi.
English: The first and second doses were 1000 mg/m2 and the third was 500 mg/m2.
Slovenian: Prvi in drugi odmerek sta bila 1.000 mg/m2, tretji pa je bil 500 mg/m2.
English: • Changes in liver function (these may be seen in test results)
Slovenian: • spremembe jetrnega delovanja (ki jih lahko opazijo pri krvnih preiskavah).
English: Based on a limited number of patients, interindividual variability calculated as the coefficient of variation (CV %) was estimated to be approximately 30 % for the main pharmacokinetic parameters.
Slovenian: Na osnovi omejenega števila bolnikov, je bila variabilnost med posamezniki za glavne farmakokinetične parametre, izračunana kot koeficient variacije (CV- coefficient of variation %), ocenjena na približno 30 %.
English: You will receive your infusion once daily for 3 consecutive days.
Slovenian: Pogostnost uporabe Infuzijo boste dobili enkrat dnevno 3 zaporedne dni.
English: The following serious side effect has been reported in patients during treatment with Savene (frequency not known):
Slovenian: Pri bolnikih so med zdravljenjem z zdravilom Savene poročali o naslednjih resnih neželenih učinkih (pogostnost neznana):
English: A requirement for inclusion in the efficacy part of the study was that the anthracycline extravasation was proven by fluorescence microscopy of one or more biopsies.
Slovenian: Kriterij za vključitev v del študije, ki je preučeval učinkovitost, je bil dokaz antraciklinske ekstravazacije s fluorescenčno mikroskopijo enega ali več biopsijskih vzorcev.
English: If you are sexually active, you are advised to use effective birth control to prevent pregnancy during and for six months after treatment, whether you are male or female (see section 2 ‘Do not use Savene').
Slovenian: Če ste spolno aktivni, uporabljajte učinkovito kontracepcijo za preprečitev nosečnosti med zdravljenjem in šest mesecev po njem ne glede na to, ali ste moški ali ženska (glejte poglavje 2 »Ne uporabljajte zdravila Savene«).
English: • Due to an increased thrombotic risk in patients with malignant diseases, the use of anticoagulants treatment is frequent.
Slovenian: • zaradi nevarnosti trombotičnega dogodka bolniki z malignimi boleznimi pogosto prejemajo antikoagulacijsko zdravljenje.
English: The apparent effects were greater during chronic than acute administration.
Slovenian: Zabeleženi učinki so bili očitnejši pri kroničnem dajanju kot pri akutnem dajanju.
English: It contains no antibacterial preservative.
Slovenian: Ne vsebuje konzervansov proti bakterijam.
English: Dexrazoxane undergoes intracellular hydrolysis first to its two one-ring open intermediates (B and C) and then to the two-ring opened form (ADR-925) which has a structure similar to EDTA and is a strong chelator of iron and divalent cations as calcium ions.
Slovenian: Deksrazoksan se znotrajcelično najprej hidrolizira v odprta intermediata z enim obročem (B in C) in nato v odprto obliko z dvema obročema (ADR-925), ki je po strukturi podobna EDTA in je močen kelator železa in dvovalentnih kationov (npr. kalcijevih ionov).
English: PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
Slovenian: PRIPRAVA ZA INTRAVENSKO UPORABO
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/350/001
Slovenian: EU/1/06/350/001
English: There is limited evidence from studies that suggests epirubicin clearance may be increased when dexrazoxane is pre-administered, this occurred at high doses of epirubicin (120-135 mg/m2).
Slovenian: Obstaja le malo dokazov iz raziskav, ki kažejo, da se lahko očistek epirubicina poveča s predhodnim dajanjem deksrazoksana, to se je zgodilo pri velikih odmerkih epirubicina (120-135 mg/m2).
English: Cooling procedures such as ice packs should have been removed from the area at least 15 minutes before the Savene administration in order to allow sufficient blood flow.
Slovenian: Na tem področju je treba prenehati s postopki hlajenja, npr. z ledenimi obkladki, vsaj 15 minut pred dajanjem zdravila Savene, da se vzpostavi zadostna prekrvavitev.
English: The treatment is considered to have a limited influence on the ability to drive and use machines.
Slovenian: Zdravljenje ima omejen vpliv na sposobnost vožnje in upravljanja s stroji.
English: - During treatment with Savene the area where the extravasation has occurred will be examined on a regular basis and you will have blood tests taken regularly to check your blood cells.
Slovenian: - Med zdravljenjem z zdravilom Savene vam bodo redno pregledovali območje ekstravazacije in opravljali preiskave krvi, da bodo preverjali celice v krvi.
English: Concomitant use not recommended:
Slovenian: Sočasna uporaba ni priporočljiva v naslednjih primerih:
English: If you receive more Savene than you should, you will be closely monitored with specific attention to your blood cells, potential gastro-intestinal signs, skin reactions and hair loss.
Slovenian: Če prejmete večji odmerek zdravila Savene, kot bi smeli Če prejmete več zdravila Savene, kot bi smeli, vas bodo podrobno opazovali s specifičnim poudarkom na spremljanju stanja krvnih celic, potencialnih gastro-intestinalnih znakih, kožnih reakcijah in izgubi las.
English: There are no data from the use of dexrazoxane in pregnant women.
Slovenian: Ni podatkov o uporabi deksrazoksana pri nosečnicah.
English: Cenexi-Laboratoires Thissen SA Rue de la Papyrée 2-4-6 B-1420 Braine-L'Alleud Belgium
Slovenian: Cenexi-Laboratoires Thissen SA Rue de la Papyrée 2-4-6 B-1420 Braine-L'Alleud Belgija
English: The pharmacokinetics of the metabolites is derived from a single study with five patients.
Slovenian: Farmakokinetika presnovkov je bila določena v eni študiji s petimi bolniki.
English: Inhibition of topoisomerase II.
Slovenian: Zaviranje topoizomeraze II.
English: Concomitant use to assess carefully: Ciclosporin, tacrolimus: Excessive immunosuppression with risk of lymphoproliferative disease.
Slovenian: Sočasno uporabo je treba pazljivo preučiti v naslednjih primerih: Ciklosporin, takrolimus: Čezmerna imunska supresija s tveganjem za limfoproliferativne bolezni.
English: Chelation of iron, especially through its ring-opened metabolite thus reducing the irondependent oxidative stress causing anthracycline-induced cardiotoxicity.
Slovenian: Kelacija železa, zlasti preko odprtega presnovka z obročem, s čimer se zmanjša od železa odvisni oksidativni stres, ki je odgovoren za kardiotoksičnost antraciklinov.
English: The indicated dose should be administered as an intravenous infusion over 1-2 hours into a large vein of an extremity or area other than the one affected by the extravasation.
Slovenian: Indiciran odmerek je treba dati kot intravensko infuzijo, ki traja 1-2 uri, v veliko veno na okončini/področju, ki ga ekstravazacija ni prizadela.
English: - Phenytoin (a treatment against seizures) (Savene may reduce the effectiveness of this medicine).
Slovenian: - Fention (zdravilo proti epileptičnim krčem) (zdravilo Savene lahko zmanjša učinkovitost tega zdravila).
English: If there is suspicion of extravasation by vesicant compounds other than anthracyclines through the same IV access, e.g. vincristine, mitomycin, and vinorelbine, Savene would not be effective against the effects from these compounds.
Slovenian: Če obstaja sum na ekstravazacijo z vezikulacijskimi snovmi, ki niso antraciklini, skozi isti IV pristop (npr. z vinkristinom, mitomicinom in vinorelbinom), zdravilo Savene ne bo učinkovito proti učinkom teh snovi.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije in redčenja zdravila pred dajanjem si oglejte poglavje 6.6.
English: The mean AUC0-24 values for day 1 and day 2 were comparable with each other, and the AUC0-last at day 3 was approximately half that of the first two days, suggesting that the pharmacokinetics of dexrazoxane are dose-dependent.
Slovenian: 1. in 2. dan so bile med seboj primerljive, AUC0-last za 3. dan pa je bil približno za polovico vrednosti prvih dveh dni, kar kaže, da je farmakokinetika deksrazoksana odvisna od odmerka.
English: It can reduce the amount of tissue damage caused by anthracycline extravasation.
Slovenian: Zmanjša lahko obseg poškodb tkiva, ki nastanejo zaradi ekstravazacije antraciklina.
English: 3.2.4 Savene should be administered aseptically as a 1-2 hours infusion under room temperature and normal light conditions.
Slovenian: 3.2.4 Zdravilo Savene je treba dati aseptično kot infuzijo, ki traja 1-2 uri pri sobni temperaturi in normalnimi pogoji osvetlitve.
English: Vomiting Diarrhoea Stomatitis Dry mouth
Slovenian: Bruhanje Driska Stomatitis suha usta
English: Systemic clearance is independent of dose.
Slovenian: Sistemski očistek je neodvisen od odmerka.
English: Savene solvent also contains 1.61 g sodium (main component of cooking/table salt) in each 500 ml bottle.
Slovenian: Vehikel Savene vsebuje tudi 1,61 g natrija (glavne sestavine kuhinjske soli) v vsaki 500 ml steklenici.
English: Children and adolescents Savene should not be administered to children below the age of 18 years.
Slovenian: Zdravila Savene pri otrocih, mlajših od 18 let ne smete uporabljati.
English: Two pharmacodynamic properties of dexrazoxane are described in the literature: Prevention of anthracycline cardiotoxicity, and Antineoplastic action
Slovenian: Farmakodinamični lastnosti deksrazoksana sta opisani v literaturi: Preprečevanje kardiotoksičnosti antraciklina in Antineoplastično delovanje
English: Dizziness Sensory loss Syncope Tremor
Slovenian: Pogosti izguba čutov sinkopa tremor
English: • Itching (pruritus)
Slovenian: • srbenje (pruritus),
English: Safety and efficacy have not been evaluated in the elderly and the use of dexrazoxane in such patients is not recommended.
Slovenian: Varnosti in učinkovitosti zdravila pri starostnikih niso preučevali, zato uporaba deksrazoksana pri teh bolnikih ni priporočljiva.
English: It is not known to what extent each of these mechanisms contributes to the preventive effect on tissue destruction following anthracycline extravasation.
Slovenian: Ni znano, v kakšni meri opisana mehanizma prispevata k preventivnemu učinku pri uničevanju tkiva po antraciklinski ekstravazaciji.
English: Savene infusion will be given at the same time every day of your treatment.
Slovenian: Infuzijo zdravila Savene boste vsak dan zdravljenja prejeli ob isti uri.
English: Patients with neutropenia and thrombocytopenia > CTC grade 1 (Common Toxicity Criteria) have not been included in the clinical studies.
Slovenian: Bolniki z nevtropenijo in trombocitopenijo > kriterij toksičnosti (CTC) stopnje 1 (kriterij splošne toksičnosti) niso bili vključeni v klinične študije.
English: - If you have kidney problems, your doctor will monitor for signs of changes to your blood cells.
Slovenian: - Če imate težave z ledvicami, vas bo zdravnik spremljal za znake sprememb krvnih celic.
English: Caution must be exercised during reconstitution and dilution and the normal procedures for proper handling of cytotoxic medicinal products should be adopted.
Slovenian: Pri rekonstituciji in redčenju je treba ravnati previdno ter upoštevati običajne postopke za pravilno ravnanje s citotoksičnimi zdravili.
English: The related razoxane has been demonstrated to be embryotoxic in mice, rats and rabbits and teratogenic in rats and mice.
Slovenian: Za sorodno spojino razoksan so ugotovili embriotoksičnost pri miših, podganah in kuncih ter teratogenost pri podganah in miših.
English: Co-administration of doxorubicin (50 to 60 mg/m2) or epirubicin (60 to 100 mg/m2) did not affect dexrazoxane pharmacokinetics significantly.
Slovenian: Sočasno dajanje doksorubicina (50-60 mg/m2) ali epirubicina (60-100 mg/m2) ni znatno vplivalo na farmakokinetiko deksrazoksana.
English: Bibliographical data demonstrate that serum kinetics of dexrazoxane after intravenous administration follow an open two-compartment model independent of schedule and dose.
Slovenian: Podatki v literaturi kažejo, da serumska kinetika deksrazoksana pri intravenskem dajanju sledi odprtemu modelu dveh kompartmentov neodvisno od režima in odmerka.
English: If Savene comes into contact with the skin, the affected area should immediately be rinsed thoroughly with water.
Slovenian: Če zdravilo Savene pride v stik s kožo, morate prizadeto območje takoj temeljito sprati z vodo.
English: Women must inform their doctor immediately if they become pregnant (see section 4.3 and 4.6).
Slovenian: Ženske morajo svojega zdravnika nemudoma obvestiti, če zanosijo (glejte poglavje 4.3 in 4.6).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine.
Slovenian: Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Very rare (<1/10,000)
Slovenian: Zelo pogosti (≥1/10).
English: Plasma potassium level must be closely monitored in patients at risk of hyperkalaemia.
Slovenian: Plazemsko raven kalija je treba natančno spremljati pri bolnikih, pri katerih se lahko pojavi hiperkaliemija.
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic agents, ATC code: V03AF02
Slovenian: Farmakoterapevtska skupina: Zdravila za zaščito organizma pred toksičnostjo citostatikov, oznaka ATC: V03AF02
English: • Women of childbearing potential not using contraceptive measures (see section 4.6).
Slovenian: • Ženske v rodni dobi, ki ne uporabljajo kontracepcije (glejte poglavje 4.6).
English: • Feeling tired, feeling sleepy, feeling dizzy, sudden fainting
Slovenian: • utrujenost, zaspanost, omotica, nenadna omedlevica,