natgillin/translations-raw huggingface dataset:
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").
• chest pain, discomfort, pressure, heaviness
• bolečina v prsnem košu, nelagodje, pritisk, občutek teže
• The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis).
• Uporabo kombiniranih hormonskih kontraceptivov so povezovali z večjim tveganjem za nastanek krvnih strdkov v venah (venska tromboza).
Inconsistent results on the risk of VTE with [Invented name] compared with CHCs that contain levonorgestrel have been found (with relative risk estimates ranging from no increase, RR=0.96, to an almost 2 fold increase, RR=1.90).
Ugotovili so neskladnost izsledkov o tveganjih za VTE z zdravilom [izmišljeno ime] v primerjavi s tveganjem pri kombiniranih hormonskih kontraceptivih, ki vsebujejo levonorgestrel (z ocenami relativnega tveganja, je bilo tveganje brez povečanja, RT = 0,96, do skoraj 2-kratnega povečanja, RT = 1,90).
• if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);
• če imate vi ali vaš bližnji sorodnik visoko raven maščob v krvi (holesterol ali trigliceridi);
• if you know you have a disorder affecting your blood clotting - for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• če veste, da imate bolezen, ki vpliva na strjevanje krvi, npr. pomanjkanje proteina C, pomanjkanje proteina S, pomanjkanje antitrombina III, faktor V Leiden ali antifosfolipidna protitelesa;
Particularly important in women with additional risk factors
To je pomembno predvsem pri ženskah, ki imajo še druge dejavnike tveganja.
• If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.
• Če krvni strdek potuje iz noge do pljuč, lahko povzroči pljučno embolijo.
If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to [invented name], please talk to your doctor.
Če se vam pojavi kateri koli neželeni učinek, predvsem če je resen ali trdovraten, ali če se vaše zdravje spremeni in menite, da je to lahko posledica zdravila [izmišljeno ime], se posvetujte z zdravnikom.
Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
Hipertrigliceridemija je povezana s povečanim tveganjem za razvoj pankreatitisa (vnetje trebušne slinavke);
• severe hypertension
• huda hipertenzija
• sudden confusion, trouble speaking or understanding;
• nenadna zmedenost, nerazločno govorjenje ali težave z razumevanjem;
• swelling and slight blue discolouration of an extremity; • severe pain in your stomach (acute abdomen)
• oteklina in nekoliko modrikasta okončina; • hude bolečine v želodcu (akutni abdomen)
Factors that increase your risk of a blood clot in an artery It is important to note that the risk of a heart attack or stroke from using [invented name] is very small but can increase:
Dejavniki, ki povečujejo vaše tveganje za nastanek krvnega strdka v arteriji Pomembno je povedati, da je tveganje za srčni infarkt ali možgansko kap zaradi uporabe zdravila [izmišljeno ime] zelo majhno, vendar se lahko poveča:
• if you have (or have ever had) a type of migraine called ‘migraine with aura';
• če imate (ali ste kdaj imeli) vrsto migrene, imenovano "migrena z avro";
in the arteries (referred to as an ‘arterial thrombosis', ‘arterial thromboembolism' or ATE).
v arterijah (imenujejo se "arterijska tromboza", "arterijska trombembolija" ali ATE).
Using a combined hormonal contraceptive such as [invented name] increases your risk of developing a blood clot compared with not using one.
Z uporabo kombiniranega hormonskega kontraceptiva, kot je zdravilo [izmišljeno ime], se vaše tveganje za nastanek krvnega strdka v primerjavi z ženskami, ki ga ne uporabljajo, poveča.
Risk of developing a blood clot in a year
Tveganje za nastanek krvnega strdka na leto
Temporary symptoms suggest the event is a transient ischaemic attack (TIA).
Začasni simptomi kažejo na tranzitorno ishemično atako (TIA).
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• če imate Crohnovo bolezen ali ulcerozni kolitis (kronično vnetno črevesno bolezen);
The increased risk of thromboembolism in pregnancy, and particularly the 6 week period of the puerperium, must be considered (for information on “Pregnancy and lactation” see section 4.6).
Upoštevati je treba povečano tveganje za trombembolije med nosečnostjo in predvsem v 6-tedenskem obdobju po porodu (za informacije glede nosečnosti in dojenja glejte poglavje 4.6;).
In this case you could also have a higher risk of having a heart attack or stroke;
V tem primeru obstaja pri vas morda tudi večje tveganje za srčni infarkt ali možgansko kap;
If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).
Če se oceni, da je razmerje med koristmi in tveganji negativno, se kombiniranih hormonskih kontraceptivov ne sme predpisati (glejte poglavje 4.3).
Important things to know about combined hormonal contraceptives (CHCs):
Pomembne informacije, ki jih je treba vedeti o kombiniranih hormonskih kontraceptivih:
Prior to the initiation or reinstitution of [invented name] a complete medical history (including family history) should be taken and pregnancy must be ruled out.
Preden začne ženska uporabljati zdravilo [izmišljeno ime] ali pred njegovo ponovno uvedbo, se mora zdravnik seznaniti z njeno anamnezo (tudi z družinsko) in izključiti nosečnost.
If any of the conditions or risk factors mentioned below is present, the suitability of [invented name] should be discussed with the woman.
Če je prisotno katero od spodaj navedenih stanj ali dejavnikov tveganja, se je treba o primernosti zdravila [izmišljeno ime] pogovoriti z žensko.
Your doctor may decide that [invented name] needs to be stopped.
Vaš zdravnik se bo morda odločil, da z uporabo zdravila [izmišljeno ime] prenehate.
It is important to draw a woman's attention to the information on venous and arterial thrombosis, including the risk of [invented name] compared with other CHCs, the symptoms of VTE and ATE, the known risk factors and what to do in the event of a suspected thrombosis.
Pomembno je žensko opozoriti na informacije glede venske in arterijske tromboze, vključno s tveganjem zdravila [izmišljeno ime] v primerjavi z drugimi kombiniranimi hormonskimi kontraceptivi, simptomi VTE in ATE, znanimi dejavniki tveganja in kaj je treba storiti ob sumu na trombozo.
Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma
Dolgotrajna imobilizacija, večji kirurški posegi, vsak kirurški poseg na nogah ali v medenici, nevrološka operacija ali velika poškodba
• if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition.
• če imate zvišane ravni maščob v krvi (hipertrigliceridemijo) ali pozitivno družinsko anamnezo za to stanje.
After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
Po prvem letu se tveganje zmanjša, vendar pa je še vedno blago povečano v primerjavi z neuporabo kombiniranega hormonskega kontraceptiva.
HOW TO RECOGNISE A BLOOD CLOT Seek urgent medical attention if you notice any of the following signs or symptoms.
KAKO PREPOZNATI KRVNI STRDEK Če opazite katerega od naslednjih znakov ali simptomov, poiščite nujno medicinsko pomoč.
Products that contain levonorgestrel, norgestimate (including [invented name]) or norethisterone are associated with the lowest risk of VTE.
Zdravila, ki vsebujejo levonorgestrel, norgestimat (tudi zdravilo [izmišljeno ime]) ali noretisteron, so povezana z manjšim tveganjem za VTE.
• if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50).
• če je imel kdo od vaših bližnjih sorodnikov krvni strdek v nogi, pljučih ali drugem organu v mladih letih (npr. pri starosti manj kot 50 let).
About 9-12 out of 10,000 women
približno 9-12 od 10.000 žensk
• if you have any of the following diseases that may increase your risk of a clot in the arteries: - severe diabetes with blood vessel damage - very high blood pressure - a very high level of fat in the blood (cholesterol or triglycerides) - a condition known as hyperhomocysteinaemia
• če imate katero od naslednjih bolezni, ki lahko povečajo tveganje za nastanek strdkov v arterijah: - hudo sladkorno bolezen z zapleti na ožilju - zelo visok krvni tlak - zelo veliko koncentracijo maščob v krvi (holesterola ali trigliceridov) - stanje, znano kot hiperhomocisteinemija
If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold').
Če ste negotovi, se posvetujte z zdravnikom, saj je mogoče nekatere od teh simptomov, kot sta kašljanje ali zasoplost, zamenjati z bolj blagim stanjem, kot je okužba dihal (npr. prehlad).