natgillin/translations-raw huggingface dataset:
Pregnancy Reproduction studies have been conducted in Cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation and have revealed no evidence of impaired fertility or harm to the fetus. 
Študije vpliva na sposobnost za razmnoževanje so opravili pri opicah Cynomolgus z odmerki, ki so bili do 25-krat večji od tedenskega vzdrževalnega odmerka pri ljudeh, ki je 2 mg/kg trastuzumaba za intravensko uporabo.
• Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles, which was followed by Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles, 
in sicer takole: • doksorubicin 60 mg/m2 in paklitaksel 150 mg/m2,vsake 3 tedne, 3 cikle, temu je sledil
• abnormal or impaired blood clotting 
• nenormalno ali upočasnjeno strjevanje krvi,
• nausea 
• nahod,
Time to steady-state 
Čas do stanja ravnovesja*
Table 8 Final overall survival analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831 
Vnaprej načrtovana končna analiza OS iz združene analize študij NSABP B-31 in NCCTG N9831
The infusion may be continued after the symptoms improve. 
Po ublažitvi simptomov boste lahko z infuzijo nadaljevali.
Hazard ratio vs AC→D (95% CI) 
Razmerje tveganja proti AC→D (95 % IZ)
Ontruzant 150 mg powder for concentrate for solution for infusion 
Ontruzant 150 mg prašek za koncentrat za raztopino za infundiranje
Trastuzumab and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting. 
Pri adjuvantnem zdravljenju trastuzumaba in antraciklinov ne smemo dajati sočasno.
The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose. 
Priporočen vzdrževalni odmerek zdravila Ontruzant je 6 mg/kg telesne mase na 3 tedne, s katerim začnemo po 3 tednih od prejema polnilnega odmerka.
- The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery. 
- Študiji NSABP B-31 in NCCTG N9831, ki sta del združene analize, sta bili zasnovani za proučevanje klinične koristi kombiniranja zdravljenja s trastuzumabom in paklitakselom po kemoterapiji z antraciklinom in ciklofosfamidom (kemoterapiji AC).
AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH 
AC→D = doksorubicin in ciklofosfamid, ki jima je sledil docetaksel; AC→DH = doksorubicin in ciklofosfamid, ki sta jima sledila docetaksel in trastuzumab; IZ = interval zaupanja.
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. 
Rekonstitucija da 7,4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba s pH približno 6,0.
Faint ⁄ barely perceptible membranous reactivity in ≥10% of tumour cells; cells are reactive only in part of their membrane 
Šibka ⁄ komaj opazna membranska reaktivnost v ≥ 10 % tumorskih celic.
Congestive heart failure (NYHA Class II-IV) is a common adverse reaction associated with the use of trastuzumab and has been associated with a fatal outcome (see section 4.4). 
Kongestivno srčno popuščanje ( NYHA razred II-IV) je pogost neželeni učinek trastuzumaba.
In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9% and 12% when it was combined with paclitaxel compared with 1%-4% for paclitaxel alone. 
V ključnih preskušanjih z intravensko danim trastuzumabom pri metastatski bolezni je bila incidenca motenj v delovanju srca pri bolnikih, ki so zdravilo prejemali sočasno s paklitakselom, v razponu od 9
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab. 
Rekonstitucija da 7,4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba.
This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. 
Rekonstitucija da 21 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba s pH približno 6,0.
Distant recurrence No. patients with event p<0.0001 
Pojav oddaljenih metastaz število bolnikov z dogodkom p < 0,0001
p-value versus 
Vrednost p proti AC→P
Table 6 Efficacy results from Study BO16348 Median follow-up 12 months* 
Rezultati učinkovitosti iz preskušanja BO16348
Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer 
Priporočeni način vrednotenja rezultatov obarvanja preparatov po metodi IHC pri raku želodca Ocena Kirurški vzorec - videz preparata po obarvanju
In patients with EBC eligible for neoadjuvant-adjuvant treatment, trastuzumab should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m2 or epirubicin 360 mg/m2. 
Neoadjuvantno-adjuvantno zdravljenje Pri bolnikih z zgodnjim rakom dojk, ki so primerni za neoadjuvantno-adjuvantno zdravljenje, se trastuzumab uporablja sočasno z antraciklini le pri bolnikih, ki še niso bili zdravljeni s kemoterapijo, in to samo pri shemah z majhnimi odmerki antraciklinov (največji kumulativni odmerek doksorubicina
+Pleural effusion 
+dihalna stiska neznana
Onychoclasis 
Ontruzant
Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg loading dose as an intravenous infusion and 2 mg/kg infusion weekly) and docetaxel (60 mg/m2 intravenous infusion) in Japanese women with HER2-positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel. 
Podatki iz študije JP16003 z eno skupino, v kateri so japonski bolniki s HER2-pozitivnim metastatskim rakom dojk prejemali trastuzumab (polnilni odmerek 4 mg/kg v obliki intravenske infuzije in infuzija 2 mg/kg enkrat na teden) in docetaksel (intravenska infuzija 60 mg/m2) so nakazali,
When trastuzumab was administered after completion of adjuvant chemotherapy NYHA Class III-IV heart failure was observed in 0.6% of patients in the one-year arm after a median follow-up of 12 months. 
Srčno popuščanje razreda III−IV po NYHA se je po medianem času spremljanja 12 mesecev pojavilo pri 0,6 % bolnikov v skupini, ki se je s trastuzumabom po zaključku adjuvantne kemoterapije zdravila eno leto.
* defined as absence of any invasive cancer both in the breast and axillary nodes 
število bolnikov z dogodkom p = 0,0555 * opredeljen kot odsotnost kakršnega koli invazivnega raka tako v dojkah kot v aksilarnih bezgavkah.
These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Ontruzant. 
lahko poškodujejo srčno mišico in zvečajo tveganje težav s srcem pri uporabi zdravila Ontruzant;
These include, but are not limited to, pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency (see section 4.4). 
pljučnico, pnevmonitis, plevralni izliv, dihalno stisko, akutni pljučni edem in respiracijsko insuficienco (glejte poglavje 4.4).
- intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days, given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle. 
- 5-fluorouracil intravensko - 800 mg/m2/dan v obliki kontinuirane intravenske infuzije 5 dni, dane vsake 3 tedne, skupaj 6 ciklov (1.do 5. dan vsakega cikla).
The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster nonlinear clearance (lower Km) (P<0.001). 
HER2 ECD odcepljeni (krožeči) antigen v krvnem obtoku Eksplorativne analize sospremenljivk, opravljene samo s podatki za podskupino bolnikov, kažejo, da so imeli bolniki z večjimi vrednostmi odcepljenega antigena HER2-ECD hitrejši nelinearni očistek
This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab. 
Rekonstitucija da 21 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba.
Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model. 
Obdobje spiranja trastuzumaba so ocenili po intravenskem dajanju zdravila enkrat na teden ali enkrat na 3 tedne s pomočjo populacijskega farmakokinetičnega modela.
Score 
Shema
Each vial contains either: 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection, or 420 mg trastuzumab that has to be dissolved in 20 mL of water for injection. 
- 150 mg trastuzumaba, ki ga je treba raztopiti v 7,2 ml vode za injekcije, ali
• vomiting 
• zasoplost,
Hazard ratio vs AC→P (95% CI) p-value 
Razmerje tveganja proti AC→P (95 % IZ) vrednost p
Talk to your doctor, pharmacist or nurse before you are given Ontruzant if: 
povejte zdravniku, farmacevtu ali medicinski sestri, da ste prejemali zdravilo Ontruzant.
Disease-free survival No. patients with event p<0.0001 
Preživetje brez bolezni število bolnikov z dogodkom p < 0,0001
One 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab 
Ontruzant 150 mg prašek za koncentrat za raztopino za infundiranje Ena 15 ml viala iz prozornega stekla tipa I z zamaškom iz butilne gume, laminiranim s prevleko iz fluorove smole, ki vsebuje 150 mg trastuzumaba.
Ontruzant vial 
Viala zdravila Ontruzant
Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter 
Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine
• dyspepsia (heartburn) 
• dispepsija (zgaga),
After a median follow-up of 12 months, the hazard ratio (HR) for disease free survival (DFS) was 0.54 (95% CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8% versus 78.2%) in favour of the trastuzumab arm. 
Po medianem spremljanju 12 mesecev je bilo razmerje tveganja (hazard ratio - HR) za preživetje brez bolezni (disease-free survival - DFS) 0,54 (95 % IZ 0,44, 0,67).
- intravenous paclitaxel - 80 mg/m2 as a continuous intravenous infusion, given every week for 12 weeks. 
Odmerjanje paklitaksela v kombinaciji s trastuzumabom je bilo naslednje: - paklitaksel intravensko - 80 mg/m2 v obliki kontinuirane intravenske infuzije, vsak teden,
Docetaxel was administered as follows: - intravenous docetaxel - 100 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle) 
Odmerjanje docetaksela je bilo naslednje: - docetaksel intravensko - 100 mg/m2 v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj
Ear and labyrinth disorders Deafness 
Ušesne bolezni, vključno z motnjami labirinta gluhost občasni
The reconstituted Ontruzant solution contains 21 mg/mL of trastuzumab. 
Pripravljena raztopina zdravila Ontruzant vsebuje 21 mg/ml trastuzumaba.
• itchiness 
• omotica,
Detection of HER2 overexpression or HER2 gene amplification in breast cancer Trastuzumab should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. 
Trastuzumab se sme uporabljati samo pri bolnikih, katerih tumorji čezmerno izražajo HER2 ali imajo amplifikacijo gena HER2, dokazano z natančno in validirano metodo.
Patients who receive anthracyclines after stopping trastuzumab may possibly be at increased risk of cardiac dysfunction. 
Pri bolnikih, ki prejemajo antracikline po prenehanju zdravljenja s trastuzumabom,
• liver damage/failure 
• okvara/odpoved jeter,
Upper respiratory tract infection 
+pljučnica astma bolezni pljuč
Ontruzant contains the active substance trastuzumab, which is a monoclonal antibody. 
Kaj je zdravilo Ontruzant in za kaj ga uporabljamo Zdravilo Ontruzant vsebuje učinkovino trastuzumab, ki je monoklonsko protitelo.
Hazard ratio vs AC→D (95% CI) p-value 
Razmerje tveganja proti AC→D (95 % IZ) vrednost p
The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 mL of 0.9% sodium chloride solution. 
polietilena ali polipropilena, ki vsebuje 250 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
Equivocal 
negotovo
The median overall survival for the high HER2-expressing group was 11.8 months versus 16 months, HR 0.65 (95% CI 0.51-0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95% CI 0.51-0.79) for FP versus FP + H, respectively. 
Mediano celotno preživetje v skupini z visokim izraženim HER2 je bilo 11,8 meseca za skupino, ki ni prejemala trastuzumaba, v primerjavi s 16 meseci za skupino, ki je prejemala tudi trastuzumab - HR 0,65 (95 % IZ 0,51-0,83).
PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. 
FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje Bel do rahlo rumen liofiliziran prašek.
In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered trastuzumab concurrently with a taxane following anthracycline therapy up to 2.37% compared to approximately 1% in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and trastuzumab). 
so pri bolnikih, ki so trastuzumab prejeli sočasno s taksanom po antraciklinski terapiji, opazili stalno naraščanje kumulativne pogostnosti simptomatskih neželenih učinkov, povezanih s srcem, ali neželenih učinkov, povezanih z iztisnim deležem levega prekata (LVEF), do 2,37 %, v primerjavi z
Signs and symptoms of cardiac dysfunction such as dyspnoea, orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction, have been observed in patients treated with trastuzumab (see section 4.4). 
pljučni edem, galop S3 ali zmanjšan prekatni iztisni delež (glejte poglavje 4.4).
+Hypoxia 
+hipoksija neznana
• chest pain 
• vnetje jeter,
B. PACKAGE LEAFLET 
PRILOGA IV
- intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC=6 mg/mL/min administered by intravenous infusion over 30-60 minutes repeated every 3 weeks for a total of six cycles 
ali - docetaksel intravensko - 75 mg/m2 v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 6 ciklov (na 2. dan prvega cikla z docetakselom, nato na 1. dan vsakega nadaljnjega cikla).
- intravenous cyclophosphamide, at 600 mg/m2 over 30 minutes, given every 3 weeks for 4 cycles. 
- doksorubicin v obliki intravenskega bolusa - 60 mg/m2, vsake 3 tedne, 4 cikle; - ciklofosfamid intravensko - 600 mg/m2 v 30 minutah, vsake 3 tedne, 4 cikle.
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Z zdravilom Ontruzant je treba med rekonstitucijo previdno ravnati.
One 40 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab 
Ontruzant 420 mg prašek za koncentrat za raztopino za infundiranje Ena 40 ml viala iz prozornega stekla tipa I z zamaškom iz butilne gume, laminiranim s prevleko iz fluorove smole, ki vsebuje 420 mg trastuzumaba.
Median duration of response (months) (range) 
Odzivnost (95 % IZ) Mediano trajanje odziva (meseci) (razpon)
Ontruzant 150 mg powder for concentrate for solution for infusion Ontruzant 420 mg powder for concentrate for solution for infusion trastuzumab 
Navodilo za uporabo Ontruzant 150 mg prašek za koncentrat za raztopino za infundiranje Ontruzant 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
Ask your doctor or pharmacist for advice before taking any medicine. 
Pred začetkom jemanja katerega koli zdravila se posvetujte z zdravnikom ali farmacevtom.
Tumour lysis syndrome 
• bolezni ledvic,
• haemorrhoids 
• vnetje dojke,
+Respiratory failure 
+insuficienca dihanja neznana
Trastuzumab washout 
Trastuzumab in docetaksel3
The pre-planned final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831 was performed when 707 deaths had occurred (median follow-up 8.3 years in the AC→PH group). 
je bila opravljena, ko je nastopilo 707 smrti (mediano spremljanje 8,3 leta v skupini AC→PH).
Common side effects of Ontruzant (may affect up to 1 in 10 people): 
Pogosti neželeni učinki zdravila Ontruzant (lahko se pojavijo pri največ 1 od 10 bolnikov):
Hazard ratio (95% CI) 
Celotno preživetje razmerje tveganja (95 % IZ)
Interstitial lung disease 
Žilne bolezni vročinski oblivi
• inflammation or scarring of the lungs 
• šok, • otekanje osrčnika,
Uncommon side effects of Ontruzant (may affect up to 1 in 100 people): 
Občasni neželeni učinki zdravila Ontruzant (lahko se pojavijo pri največ 1 od 100 bolnikov): • naglušnost,
Febrile neutropenia 
Psihiatrične motnje nespečnost anksioznost
30 June 2020 
30. junij 2020
Your risk is higher: 
Vaše tveganje je večje:
• if you smoke. 
• če kadite.
It may harm them. 
Njim bi lahko celo škodovalo.
When and how to take the tablets 
Kdaj in kako jemati tablete
Not yet known 
Še ni znano
• if you gave birth less than a few weeks ago 
• če ste rodili pred manj kot nekaj tedni.
Date of first authorisation: 27 July 2011 Date of latest renewal: 21 April 2016 
Datum prve odobritve: 27. julij 2011 Datum zadnjega podaljšanja: 21. april 2016
Seek urgent medical attention 
Poiščite nujno medicinsko pomoč
The clinical relevance of this result is unknown. 
Klinični pomen tega rezultata ni znan.
Particularly above 35 years 
Zlasti nad 35 let
Contraceptive protection is not reduced. 
Kontracepcijska zaščita ni zmanjšana.
When should you contact your doctor? 
Kdaj se morate posvetovati z zdravnikom?
Sometimes loss of vision can occur almost immediately. 
Včasih se lahko izguba vida pojavi skoraj takoj.
Changes generally remain within the normal laboratory range. 
Te spremembe običajno ostanejo v okviru razpona normalnih laboratorijskih vrednosti.
There were no abnormal results. 
Nenormalnih rezultatov ni bilo.
About 2 out of 10,000 women 
Približno 2 od 10.000 žensk
Similar conclusions are expected in women of childbearing potential. 
Podobne zaključke pričakujemo pri ženskah v rodni dobi.
• disturbance in attention 
• motnje pozornosti
The absolute bioavailability is about 1 %. 
Njegova absolutna biološka uporabnost je približno 1 %.
Reduced efficacy 
Zmanjšana učinkovitost
This allows you to check whether you took your daily tablet. 
Tako boste lahko sproti preverjali, ali ste vzeli svojo dnevno tableto.
There are no antidotes and further treatment should be symptomatic. 
Antidotov ni in nadaljnje zdravljenje mora biti simptomatsko.
Are you experiencing any of these signs? 
Imate katerega od teh znakov?
Recovery from blood clots is not always complete. 
Okrevanje po krvnih strdkih ni vedno popolno.
• increased interest in sex 
• povečano zanimanje za spolnost
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 po uveljavljenih smernicah za prakso in ju prilagoditi posamezni ženski.
Women should be advised not to smoke if they wish to use a CHC. 
Ženskam je treba svetovati, naj, če želijo uporabljati CHC, ne kadijo.
Submission of final study report 
Predložitev končnega poročila študije
Particularly important to consider if other risk factors also present. 
Posebej pomembno je upoštevati, če obstajajo še drugi dejavniki tveganja.
See also ‘General Notes' in section 2 above. 
Glejte tudi "Splošna opozorila" v poglavju 2 zgoraj.
Symptoms most commonly occur in one eye: 
Simptomi se najpogosteje pojavijo na enem očesu:
Available pharmacokinetic data are described in section 5.2. 
Razpoložljivi farmakokinetični podatki so opisani v poglavju 5.2.
If you want to delay your period 
Če želite preložiti menstruacijo
The following two options can be followed. 
Imate naslednji dve možnosti.
Particularly important in women with additional risk factors 
Posebno pomembno pri ženskah z dodatnimi dejavniki tveganja
• if you have just given birth you are at an increased risk of blood clots. 
• če ste pravkar rodili, imate večje tveganje za krvne strdke.
• VTE may be fatal in 1-2 % of cases. 
• VTE se lahko v 1-2 % primerov konča s smrtjo.
Synonyms or related conditions are not listed, but should be taken into account as well. 
Čeprav sopomenke ali sorodna stanja niso navedeni, jih je prav tako treba upoštevati.
About 5-7 out of 10,000 women 
Približno 5 do 7 od 10.000 žensk
Yellow tablets from the last (4 
Rumene tablete iz zadnje (4.)
• changes to menstrual periods (e.g. absence or irregularity) 
• spremembe menstruacije (npr. odsotnost ali nerednost)
In total 3,434 women, aged 18-50, were enrolled and completed 33,828 cycles. 
Vanje je bilo vključenih skupaj 3.434 žensk v starosti od 18 do 50 let, ki so zaključile skupaj 33.828 ciklusov.
Before you can begin taking Zoely, your doctor will ask you some questions about your personal health history and that of your close relatives. 
Preden lahko začnete jemati zdravilo Zoely, vam bo zdravnik postavil nekaj vprašanj o vašem zdravju v preteklosti in o zdravju vaših bližnjih sorodnikov.
However, it must be borne in mind that sex steroids can promote the growth of certain hormone-dependent tissues and tumours. 
Treba pa je upoštevati, da lahko spolni steroidni hormoni spodbujajo rast določenih hormonsko odvisnih tkiv in tumorjev.
HOW TO RECOGNISE A BLOOD CLOT 
KAKO PREPOZNATI KRVNI STRDEK
Therefore you should follow the rules given below. 
V tem primeru morate upoštevati spodnja pravila.
59452 LYS-LEZ-LANNOY France 
59452 LYS-LEZ-LANNOY Francija
Women who are not using a combined hormonal pill and are not pregnant 
Ženske, ki ne uporabljajo kombiniranih hormonskih tablet in niso noseče
Arterial thromboembolic events may be fatal. 
Arterijski trombembolični dogodki so lahko smrtni.
Combined hormonal contraceptives (CHCs) must not be used in the following conditions. 
Kombiniranih hormonskih kontraceptivov (CHC) se ne sme uporabljati pri naslednjih stanjih.
If you have more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be increased even more. 
Če imate več kot eno od teh stanj ali če je katero od njih posebej hudo, se lahko tveganje za nastanek krvnega strdka še bolj poveča.
If you have unexpected bleeding 
Če imate nepričakovano krvavitev
• increased warmth in the affected leg 
• večja toplota v prizadeti nogi,
The tablets should be returned to a pharmacy or disposed of in another safe way according to local requirements. 
Tablete je treba vrniti v lekarno ali jih odstraniti na kak drug varen način v skladu z lokalnimi zahtevami.
Genotoxicity and carcinogenicity studies were not conducted with the combination. 
Študije genotoksičnosti in kancerogenosti s to kombinacijo niso bile opravljene.
It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. 
Pomembno je, da zdravniku poveste, če kaj od naštetega velja za vas, tudi če ste negotovi.
In these situations it is advisable to discontinue use of the pill (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation. 
V takšnih okoliščinah je uporabo kontracepcijskih tablet priporočljivo prekiniti (v primeru elektivne operacije vsaj štiri tedne prej) in jo ponovno začeti šele dva tedna po popolni remobilizaciji.