natgillin/translations-raw huggingface dataset:
Once-a-day dosing of Tadalafil Lilly both for the treatment of erectile dysfunction and benign prostatic hyperplasia has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see sections 4.4 and 5.2). 
Pri bolnikih z okvaro jeter niso ocenjevali odmerjanja zdravila Tadalafil Lilly enkrat na dan za zdravljenje erektilne disfunkcije in benigne hiperplazije prostate; torej, v kolikor ga predpišemo, naj zdravnik, ki zdravilo predpiše, skrbno ovrednoti razmerje med koristmi in tveganjem pri posamezniku (glejte poglavji 4.4 in 5.2).
EU/1/17/1177/003 
EU/1/17/1177/002 EU/1/17/1177/003 EU/1/17/1177/004
• Drinking alcohol may affect your ability to get an erection so avoid excessive drinking with Tadalafil Lilly. 
• Pitje alkohola lahko vpliva na vašo sposobnost doseganja erekcije, zato se pri jemanju zdravila
Once-aday dosing has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see sections 4.4 and 5.2). 
Pri bolnikih z okvaro jeter niso ocenjevali odmerjanja enkrat na dan; torej, v kolikor ga predpišemo, naj zdravnik, ki zdravilo predpiše, skrbno ovrednoti razmerje med koristmi in tveganjem pri posamezniku (glejte poglavji 4.4 in 5.2).
Conjunctival hyperaemia, Nonarteritic anterior ischemic optic neuropathy (NAION)2, Retinal vascular occlusion2 
nearterična anteriorna ishemična optična nevropatija (NAION) zapora retinalnih žil2
In a clinical trial that compared tadalafil 5 mg coadministered with finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified. 
5 mg, in placebo skupaj s finasteridom 5 mg za lajšanje simptomov benigne hiperplazije prostate, niso odkrili nobenih novih neželenih učinkov.
How to take Tadalafil Lilly 
Kako jemati zdravilo Tadalafil Lilly
Tadalafil is principally metabolised by CYP3A4. 
Zaviralci citokroma P450 Tadalafil se v prvi vrsti presnavlja s CYP3A4.
Uncommon (seen in 1 to 10 in every 1,000 patients) - dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired. 
težave pri dihanju, prisotnost krvi v urinu, podaljšana erekcija, občutek razbijanja srca, hitro bitje srca, visok krvni tlak, nizek krvni tlak, krvavitve iz nosu,zvonjenje v ušesih, otekanje dlani, stopal ali gležnjev in občutek utrujenosti.
In one of the studies, which also included tamsulosin 0.4 mg as an active comparator, the improvement in total international prostate symptom score with Tadalafil Lilly 5 mg, tamsulosin and placebo were -6.3, -5.7 and -4.2 respectively. 
V eni od študij, ki je vključevala tudi tamsulozin 0,4 mg kot aktivno primerjalno zdravilo, je izboljšanje skupnega rezultata na mednarodni lestvici prostatičnih simptomov z zdravilom Tadalafil
When taken once a day for erectile dysfunction, Tadalafil Lilly allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. 
Jemanje zdravila Tadalafil Lilly enkrat na dan za zdravljenje erektilne disfunkcije vam bo ob spolni stimulaciji omogočilo doseganje erekcije, kadarkoli tekom 24 ur dneva.
Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Lilly. 
Glede na vaš odziv na zdravilo Tadalafil Lilly vam bo vaš zdravnik morda prilagodil odmerek na 2,5 mg. Tega boste prejeli kot 2,5 mg tableto.
As a precautionary measure, it is preferable to avoid the use of Tadalafil Lilly during pregnancy. 
Med nosečnostjo odsvetujemo uporabo zdravila Tadalafil Lilly.
INFORMATION IN BRAILLE tadalafil lilly 2.5 mg 
PODATKI V BRAILLOVI PISAVI tadalafil lilly 2,5 mg
Rare (seen in 1 to 10 in every 10,000 patients) - fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating. 
- omedlevica, epileptični napadi in prehodna izguba spomina, otekanje vek, rdeče oči, nenadno zmanjšanje sluha ali gluhost, koprivnica (srbeče rdeče maroge na površini kože), krvavitev iz penisa,
INFORMATION IN BRAILLE tadalafil lilly 20 mg 
PODATKI V BRAILLOVI PISAVI tadalafil lilly 20 mg
Tadalafil Lilly is a treatment for adult men with erectile dysfunction. 
Kaj je zdravilo Tadalafil Lilly in za kaj ga uporabljamo Zdravilo Tadalafil Lilly je namenjeno zdravljenju odraslih moških z erektilno disfunkcijo.
In the two primary efficacy studies of general populations, the mean per-subject proportion of successful intercourse attempts were 57 and 67 % on Tadalafil Lilly 5 mg, 50 % on Tadalafil Lilly 2.5 mg as compared to 31 and 37 % with placebo. 
Lilly 5 mg, uspešnih 57 in 67 % poskusov spolnega odnosa, sorazmerno z bolniki, zdravljenimi z zdravilom Tadalafil Lilly 2,5 mg 50 %, v primerjavi s 31 in 37 % pri placebu.
See leaflet for further information. 
laktoza Za nadaljnje informacije glejte navodilo za uporabo.
If Tadalafil Lilly is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. 
Če zdravnik predpiše zdravila Tadalafil Lilly, mora skrbno ovrednotiti razmerje med koristmi in tveganjem pri posamezniku.
If Tadalafil Lilly is prescribed once-a-day, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. 
Če zdravnik predpiše zdravilo Tadalafil Lilly enkrat na dan, mora skrbno ovrednotiti razmerje med koristmi in tveganjem pri posamezniku.
Visual defects and cases of NAION have been reported in connection with the intake of Tadalafil Lilly and other PDE5 inhibitors. 
V povezavi z jemanjem zdravila Tadalafil Lilly in drugih zaviralcev PDE5 so poročali o NAION.
Cytochrome P450 inducers 
Zdravila, ki se presnavljajo prek citokroma P450
There is limited clinical data on the safety of Tadalafil Lilly in patients with severe hepatic insufficiency (Child-Pugh Class C). 
O varnosti zdravila Tadalafil Lilly pri bolnikih s hudo insuficienco jeter (razred C po Child-Pughu) obstajajo le omejeni klinični podatki.
What Tadalafil Lilly looks like and contents of the pack Tadalafil Lilly 2.5 mg is a light orange-yellow film-coated tablet in the shape of an almond and has "C 2 ½" marked on one side. 
Izgled zdravila Tadalafil Lilly in vsebina pakiranja Tablete Tadalafil Lilly 2,5 mg so svetlo oranžno-rumene filmsko obložene tablete v obliki mandlja in imajo na eni strani oznako "C 2 ½".
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1177/002-004 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/17/1177/002-004
INFORMATION IN BRAILLE tadalafil lilly 10 mg 
PODATKI V BRAILLOVI PISAVI tadalafil lilly 10 mg
INFORMATION IN BRAILLE tadalafil lilly 5 mg 
PODATKI V BRAILLOVI PISAVI tadalafil lilly 5 mg
What Tadalafil Lilly looks like and contents of the pack Tadalafil Lilly 20 mg is a yellow film-coated tablet in the shape of an almond and has "C 20" marked on one side. 
Izgled zdravila Tadalafil Lilly in vsebina pakiranja Tablete Tadalafil Lilly 20 mg so rumene filmsko obložene tablete v obliki mandlja in imajo na eni strani oznako "C 20".
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1177/006-009 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/17/1177/006-009
Tadalafil Lilly 2.5 mg film-coated tablets Tadalafil 
Tadalafil Lilly 2,5 mg filmsko obložene tablete tadalafil
QUALITATIVE AND QUANTITATIVE COMPOSITION Tadalafil Lilly 10 mg film-coated tablets Each tablet contains 10 mg tadalafil. 
Tadalafil Lilly 10 mg filmsko obložene tablete Ena tableta vsebuje 10 mg tadalafila.
For Tadalafil Lilly on demand, three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness. 
Opravljene so bile tri klinične študije za določitev obdobja odzivnosti na zdravilo Tadalafil Lilly zaužit po potrebi, v katerih je bilo vključenih 1054 bolnikov v domačem okolju.
Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to Tadalafil Lilly. 
Opravljene so bile tri klinične študije za določitev obdobja odzivnosti na zdravilo Tadalafil Lilly, v katerih je bilo vključenih 1054 bolnikov v domačem okolju.
NAME OF THE MEDICINAL PRODUCT Tadalafil Lilly 20 mg tablets tadalafil 
IME ZDRAVILA Tadalafil Lilly 20 mg tablete tadalafil
Tadalafil Lilly 20 mg film-coated tablets 
Tadalafil Lilly 20 mg filmsko obložene tablete tadalafil
How to store Tadalafil Lilly 
Shranjevanje zdravila Tadalafil Lilly
Tadalafil Lilly 5 mg film-coated tablets Tadalafil 
Tadalafil Lilly 5 mg filmsko obložene tablete tadalafil
NAME OF THE MEDICINAL PRODUCT Tadalafil Lilly 10 mg tablets tadalafil 
IME ZDRAVILA Tadalafil Lilly 10 mg tablete tadalafil
Tadalafil Lilly 10 mg film-coated tablets Tadalafil 
Tadalafil Lilly 10 mg filmsko obložene tablete tadalafil
NAME OF THE MEDICINAL PRODUCT Tadalafil Lilly 2.5 mg tablets tadalafil 
IME ZDRAVILA Tadalafil Lilly 2,5 mg tablete tadalafil
NAME OF THE MEDICINAL PRODUCT Tadalafil Lilly 2.5 mg film-coated tablets 
IME ZDRAVILA Tadalafil Lilly 2,5 mg filmsko obložene tablete
What Tadalafil Lilly looks like and contents of the pack Tadalafil Lilly 5 mg is a light yellow film-coated tablet in the shape of an almond and has "C 5" marked on one side. 
Izgled zdravila Tadalafil Lilly in vsebina pakiranja Tablete Tadalafil Lilly 5 mg so svetlo rumene filmsko obložene tablete v obliki mandlja in imajo na eni strani oznako "C 5".
What Tadalafil Lilly looks like and contents of the pack Tadalafil Lilly 10 mg is a light yellow film-coated tablet in the shape of an almond and has "C 10" marked on one side. 
Izgled zdravila Tadalafil Lilly in vsebina pakiranja Tablete Tadalafil Lilly 10 mg so svetlo rumene filmsko obložene tablete v obliki mandlja in imajo na eni strani oznako "C 10".
Blurred vision, Sensations described as eye pain 
občutki opisani kot bolečina v očeh izpad v vidnem polju,
NAME OF THE MEDICINAL PRODUCT Tadalafil Lilly 5 mg film-coated tablets 
IME ZDRAVILA Tadalafil Lilly 5 mg filmsko obložene tablete
NAME OF THE MEDICINAL PRODUCT Tadalafil Lilly 5 mg tablets tadalafil 
IME ZDRAVILA Tadalafil Lilly 5 mg tablete tadalafil
Once daily. 
Enkrat na dan. Za peroralno uporabo.
Visual field defect, Swelling of eyelids, 
občutki opisani kot bolečina v očeh izpad v vidnem polju, otečene veke,
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1177/001 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1177/001
Transient amnesia 
Bolezni sečil hematurija
Tadalafil Lilly contains lactose: If you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Če ne prenašate nekaterih sladkorjev, se posvetujte s svojim zdravnikom pred jemanjem tega zdravila.
Stroke1 (including haemorrhagic events), Syncope, Transient ischaemic attacks1, Migraine2, Seizures2, Transient amnesia 
migrena2, epileptični napadi2, tranzitorna amnezija
Hepatic impairment 
Srčne bolezni1
Grapefruit juice may affect how well Tadalafil Lilly will work and should be taken with caution. 
Tadalafil Lilly, zato ga je treba uživati previdno.
Mechanism of action 
Način uporabe
In the study in patients with erectile dysfunction secondary to diabetes, the mean persubject proportion of successful attempts were 41 and 46 % on Tadalafil Lilly 5 mg and 2.5 mg, respectively, as compared to 28 % with placebo. 
V študiji pri bolnikih z erektilno disfunkcijo poleg diabetesa je bilo v povprečju pri bolnikih, zdravljenih z zdravilom Tadalafil Lilly 5 mg oziroma
There is limited clinical data on the safety of single-dose administration of Tadalafil Lilly in patients with severe hepatic insufficiency (Child-Pugh Class C). 
Pri bolnikih s hudo jetrno insuficienco (razred C po Child-Pughu) je na voljo le malo kliničnih podatkov o varnosti zdravila Tadalafil Lilly pri enkratnem odmerjanju.
Before treatment with Tadalafil Lilly 
Če zdravnik predpiše zdravilo Tadalafil Lilly,
Check with your doctor or pharmacist if you are not sure. 
se posvetujte z zdravnikom ali s farmacevtom.
especially on one side of the body; 
predvsem na eni strani telesa;
Not yet known. 
ni znano
VTE may be fatal in 1-2% of cases. 
VTE se v 1-2 % primerov lahko konča smrtno.
• if you gave birth less than a few weeks ago 
• če ste pred nekaj tedni rodili.
It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. 
Pomembno je, da zdravnika obvestite, če se katero od teh stanj nanaša na vas, tudi če niste prepričani.
The frequency and nature of examinations should be based on established practice guidelines and be adapted to the individual woman. 
Pogostnost in naravo pregledov je treba določiti glede na smernice za prakso in ju prilagoditi posamezni ženski.
Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases. 
Ženske je treba poučiti, da hormonski kontraceptivi ne varujejo pred okužbo z virusom HIV (AIDS-em) in drugimi spolno prenosljivimi boleznimi.
The product information shall be subsequently updated by the Member State competent authorities and in liaison with the Reference Member State for medicinal product(s) authorised under Chapter 4 of Title III of Directive 2001/83/EC. 
Informacije o zdravilu bodo pristojni organi držav članic v sodelovanju z referenčno državo članico kasneje posodobili za zdravilo(a) odobrena v skladu s poglavjem 4 naslova III Direktive 2001/83/ES.
• increased warmth in the affected leg 
• večji občutek toplote v prizadeti nogi
Particularly above 35 years 
Predvsem pri starejših od 35 let.
Another method of contraception should be used to avoid unintentional pregnancy. 
Za preprečevanje neželene nosečnosti je treba uporabiti druge kontracepcijske metode.
Arterial thromboembolic events may be fatal. 
Arterijske trombembolije so lahko smrtne.
If you do have any of the conditions listed below, you must tell your doctor. 
Če imate katerega od spodaj opisanih stanj, morate o tem obvestiti zdravnika.
If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive; 
Če ne morete prenehati kaditi in ste starejši kot 35 let, vam lahko zdravnik svetuje, da uporabljate drugo kontracepcijsko metodo;
Before you start using [invented name] you should read the information on blood clots in section 2. 
Preden začnete uporabljati zdravilo [izmišljeno ime], morate prebrati informacije o krvnih strdkih v poglavju 2.
When you stop [invented name] your risk of a blood clot returns to normal within a few weeks. 
Ko prenehate jemati zdravilo [izmišljeno ime], se vaše tveganje za nastanek krvnega strdka v nekaj tednih vrne na normalne vrednosti.
Women over 35 who continue to smoke should be strongly advised to use a different method of contraception. 
Ženskam, starim več kot 35 let, ki še naprej kadijo, je treba svetovati, da uporabijo drugačno kontracepcijsko metodo.
Rarely, there may be serious lasting effects or, very rarely, they may be fatal. 
V redkih primerih lahko ostanejo resne trajne posledice ali zelo redko pride do smrti.
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 [invented name]”. 
Za podrobnejše informacije o različnih tveganjih zaradi jemanja kombiniranih hormonskih kontraceptivov glejte poglavje 2 "Kaj morate vedeti, preden boste uporabili zdravilo [izmišljeno ime]".
[For dienogest containing products in combination with low dose (<50μg) ethinylestradiol] 
[Za zdravila, ki vsebujejo dienogest v kombinaciji z majhnimi odmerki (< 50 mikrogramov) etinilestradiola]
Combined hormonal contraceptives (CHCs) should not be used in the following conditions. 
Kombiniranih hormonskih kontraceptivov (CHC) ni dovoljeno uporabljati pri naslednjih stanjih:
[VTE or ATE should be listed in the adverse events table, under the frequency “Rare”.] 
[VTE ali ATE morata biti navedena v preglednici neželenih učinkov pod pogostnostjo "Redki".]
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed. 
Polet z letalom (> 4 ure) lahko začasno poveča vaše tveganje za nastanek krvnih strdkov, predvsem če imate tudi katere druge naštete dejavnike.
Like all medicines, [Invented name] can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo [izmišljeno ime] neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Women using [Invented name] 
Ženske, ki uporabljajo zdravilo [izmišljeno ime]
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking. 
Tveganje je odvisno od vašega obstoječega tveganja za VTE in vrste kombiniranega hormonskega kontraceptiva, ki ga jemljete.
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 nasvete.
For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”. 
Za opis simptomov teh resnih neželenih učinkov glejte poglavje "Kako prepoznati krvni strdek".
• They are one of the most reliable reversible methods of contraception if used correctly 
• Če se jih uporablja pravilno, so ena najbolj zanesljivih reverzibilnih kontracepcijskih metod
Other products such as [invented name] may have up to twice this level of risk. 
Pri drugih zdravilih, kot je zdravilo [izmišljeno ime], je lahko tveganje do dvakrat večje.
What you need to know before you use [Invented name] 
Kaj morate vedeti, preden boste uporabili zdravilo [izmišljeno ime]
The use of [invented name] may need to be stopped several weeks before surgery or while you are less mobile. 
Uporabo zdravila [izmišljeno ime] bo morda treba nekaj tednov pred kirurškim posegom ali v času zmanjšane mobilnosti prekiniti.
If the occlusion occurs in the eye symptoms can range from painless blurring of vision which can progress to loss of vision. 
Če se pojavi zapora v očesu, lahko simptomi segajo od zameglitve vida brez bolečine, ki lahko napreduje do izgube vida.
When using a combined hormonal contraceptive like [invented name] you are advised to stop smoking. 
Če uporabljate kombinirani hormonski kontraceptiv, kot je zdravilo [izmišljeno ime], vam svetujemo, da prenehate kaditi.
• pain or tenderness in the leg which may be felt only when standing or walking 
• bolečina ali občutljivost noge, ki jo lahko občutite le med stanjem ali hojo
• if you get migraines, especially migraines with aura; 
• če imate migrene, predvsem migrene z avro;
• sudden, severe or prolonged headache with no known cause; 
• nenaden, hud ali dolgotrajen glavobol brez znanega razloga;
• sudden trouble walking, dizziness, loss of balance or coordination; 
• nenadne težave s hojo, omotičnost, izguba ravnotežja ali koordinacije;
[The folllowing text should be included as these products will be in the Additional monitoring list] 
[Naslednje besedilo mora biti vključeno, ker bodo ta zdravila na seznamu za dodatno spremljanje]
Particularly important to consider if other risk factors also present. 
Predvsem pomembno je, da se upošteva to tveganje ob prisotnosti drugih dejavnikov tveganja.
It is particularly important to read the symptoms of a blood clot - see Section 2 “Blood clots”). 
Predvsem pomembno je, da preberete kakšni so simptomi krvnih strdkov - glejte poglavje 2 "Krvni strdki").
Non-CHC user (2 events) 
Neuporabnice CHC (2 dogodka)
• severe pain in your stomach; 
• hude bolečine v želodcu.
• with increasing age (beyond about 35 years); 
• s starostjo (predvsem po 35 letu);
• sharp chest pain which may increase with deep breathing; 
• ostra bolečina v prsnem košu, ki se lahko z globokim dihanjem poslabša;
• if you have ever had a heart attack or a stroke; 
• če ste kadarkoli imeli srčni infarkt ali možgansko kap;
Note: temporary immobilisation including air travel >4 hours can also be a risk factor for VTE, particularly in women with other risk factors 
Opozorilo: začasna imobilizacija, tudi zaradi letalskega poleta, ki traja več kot 4 ure, je lahko dejavnik tveganja za VTE, zlasti pri ženskah z drugimi dejavniki tveganja.
Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke. 
Včasih so lahko simptomi možganske kapi kratkotrajni s skoraj takojšnjim in popolnim okrevanjem, vendar morate kljub temu poiskati zdravniško pomoč, saj obstaja nevarnost za ponovno možgansko kap.
• swelling of one leg or along a vein in the leg or foot especially when accompanied by: 
• oteklost ene noge ali oteklina vzdolž vene v nogi ali stopala, predvsem, če jo spremlja:
• 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 kdaj imeli) angino pektoris (stanje, ki povzroča hude bolečine v prsnem košu in je lahko prvi znak srčnega infarkta) ali prehodne simptome možganske kapi (TIAtranzitorna ishemična ataka);
• 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 weeks 
• Nekoliko povečajo tveganje za nastanek krvnih strdkov v venah in arterijah, predvsem v prvem letu uporabe ali pri ponovni uvedbi kombiniranega hormonskega kontraceptiva po 4- ali večtedenski prekinitvi.
Your doctor will discuss with you what other form of birth control would be more appropriate. 
Vaš zdravnik se bo z vami pogovoril o drugih, bolj primernih načinih preprečevanja neželene nosečnosti.
This corresponds to between about 6 and 12 VTEs in a year out of 10,000 women who use [Invented name]. 
To ustreza med 6 in 12 VTE na leto na 10.000 žensk, ki uporabljajo zdravilo [izmišljeno ime].
In these situations it is advisable to discontinue use of the patch/pill/ring (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation. 
V teh primerih se priporoča prekiniti uporabo obliža/tablete/obročka (vsaj štiri tedne pred načrtovanim kirurškim posegom) in jih ponovno začeti uporabljati šele dva tedna po popolni remobilizaciji.
• 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, motnjo srčnega ritma, imenovano atrijska fibrilacija);
Blood pressure should be measured and a physical examination should be performed, guided by the contra-indications (see section 4.3) and warnings (see section 4.4). 
Izmeriti je treba krvni tlak in opraviti klinični pregled, predvsem glede kontraindikacij (glejte poglavje 4.3) in posebnih opozoril (glejte poglavje 4.4).
The risk of developing a blood clot increases the more conditions you have. 
Tveganje za nastanek krvnega strdka se veča s številom stanj, ki jih imate.
• if you have systemic lupus erythematosus (SLE -; a disease affecting your natural defence system); 
• če imate sistemski eritematozni lupus (bolezen, ki vpliva na naravni obrambni sistem);
Section 4.1 - Therapeutic indications [The wording below should be inserted at the end of this section] 
Poglavje 4.1 - Terapevtske indikacije [Spodnje besedilo je treba vstaviti na koncu tega poglavja]
Blood clots blocking other blood vessels 
krvni strdki, ki so zamašili druge krvne žile
However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below). 
Vendar pa je lahko pri vsaki posamezni ženski tveganje veliko večje, kar je odvisno od njenih prisotnih dejavnikov tveganja (glejte spodaj).
• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”) 
• Bodite pozorni in zdravnika obvestite, če menite, da imate morda simptome krvnega strdka (glejte poglavje 2 "Krvni strdki").