FrancophonIA/ELRC3.0 huggingface dataset:
English: Silodyx is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Slovenian: Zdravilo Silodyx se uporablja za zdravljenje simptomov benigne hiperplazije prostate (BHP, povečana prostata) pri odraslih.
English: Silodyx has been compared with placebo (a dummy treatment) in three main studies involving over 1,800 men with BPH.
Slovenian: Zdravilo Silodyx so primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh glavnih študijah, ki so vključevale več kot 1 800 moških z BHP.
English: Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery.
Slovenian: Medoperacijski sindrom ohlapne šarenice (IFIS) se pojavi pri nekaterih bolnikih, ki jemljejo antagoniste adrenergičnih receptorjev, in lahko privede do zapletov med operacijo sive mrene.
English: When these receptors are activated, they cause the muscles controlling the flow of urine to contract.
Slovenian: Ko so ti receptorji aktivirani, povzročijo stiskanje mišic, ki nadzorujejo izločanje seča.
English: Silodyx silodosin
Slovenian: Silodyx silodozin
English: What is the risk associated with Silodyx?
Slovenian: Kakšna tveganja so povezana z zdravilom Silodyx?
English: Silodyx was more effective than placebo and as effective as tamsulosin at reducing symptoms of BPH.
Slovenian: Zdravilo Silodyx je bilo pri lajšanju simptomov BHP učinkovitejše od placeba in enako učinkovito kot tamsulozin.
English: Why has Silodyx been approved?
Slovenian: Zakaj je bilo zdravilo Silodyx odobreno?
English: IFIS is a condition that makes the iris floppy.
Slovenian: IFIS povzroči ohlapno šarenico.
English: How has Silodyx been studied?
Slovenian: Kako je bilo zdravilo Silodyx raziskano?
English: What is Silodyx used for?
Slovenian: Za kaj se zdravilo Silodyx uporablja?
English: What is Silodyx?
Slovenian: Kaj je zdravilo Silodyx?
English: How does Silodyx work?
Slovenian: Kako zdravilo Silodyx deluje?
English: How is Silodyx used?
Slovenian: Kako se zdravilo Silodyx uporablja?
English: MA (EU) Numbers
Slovenian: Številka (EU) dovoljenja za promet
English: ANNEX IV
Slovenian: DODATEK IV
English: • Conduct a drug utilisation study (DUS) to monitor the effectiveness of the risk minimisation measures.
Slovenian: • izvedba študije o uporabi zdravila za spremljanje učinkovitosti ukrepov za zmanjševanje tveganja.
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Slovenian: Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, zagotovijo, da imetniki dovoljenj za promet z zdravili izpolnijo naslednje pogoje:
English: The protocol and the timelines of the DUS should be provided to the RMS within one month of the commission decision concluding this referral procedure.
Slovenian: Protokol in časovni načrt študije je treba predložiti referenčni državi članici v enem mesecu po odločbi Komisije, s katero se zaključi ta napotitev;
English: • Shorten the PSUR cycle to an annual submission
Slovenian: • skrajšanje cikla PSUR na letno oddajo.
English: • Circulate the DHPC agreed upon with the CHMP, in accordance with the agreed communication plan.
Slovenian: • po dogovoru s CHMP razdeljevanje neposrednih obvestil za zdravstvene delavce v skladu s sprejetim komunikacijskim načrtom;
English: Sildenafil ratiopahrm EMA/432244/2013
Slovenian: Sildenafil ratiopharm EMA/432233/2013
English: The full EPAR for Sildenafil ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sildenafil ratiopharm je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for sildenafil.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo sildenafil.
English: What are the benefits and risks of sildenafil?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom sildenafil?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil ratiopharm on 23 December 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sildenafil ratiopharm, veljavno po vsej Evropski uniji, odobrila dne 23. decembra 2009.
English: For more information about treatment with sildenafil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom sildenafil preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Sildenafil ratiopharm is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a sufficiently hard penis (erection) for satisfactory sexual activity.
Slovenian: Zdravilo Sildenafil ratiopharm se uporablja za zdravljenje erektilne disfunkcije (imenovane tudi impotenca) pri odraslih moških, kadar ne zmorejo doseči ali ohraniti dovolj čvrstega penisa (erekcije) za zadovoljivo spolno dejavnost.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for sildenafil.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The recommended dose of Sildenafil ratiopharm is 50 mg taken as needed about one hour before sexual activity.
Slovenian: Priporočeni odmerek zdravila Sildenafil ratiopharm je 50 mg, ki se vzame po potrebi približno eno uro pred spolnim odnosom.
English: liver function or severely reduced kidney function should start treatment with the 25-mg dose.
Slovenian: jeter ali močno zmanjšanim delovanjem ledvic morajo zdravljenje začeti s 25-miligramskim odmerkom.
English: Sexual stimulation is still needed to produce an erection.
Slovenian: Kljub temu je za erekcijo še vedno potrebno spolno vzburjenje.
English: This means that Sildenafil ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Viagra.
English: Because Sildenafil ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Slovenian: Ker je zdravilo Sildenafil ratiopharm generično zdravilo in je biološko enakovredno referenčnemu zdravilu, velja, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The CHMP concluded that, in accordance with EU requirements, Sildenafil ratiopharm has been shown to have comparable quality and to be bioequivalent to Viagra.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Sildenafil ratiopharm primerljivo raven kakovosti kot zdravilo Viagra ter da mu je biološko enakovredno.
English: Sildenafil ratiopharm is a ‘generic medicine'.
Slovenian: Sildenafil ratiopharm je „generično zdravilo“.
English: The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Slovenian: Odmerek zdravila se lahko glede na učinkovitost in neželene učinke poveča na največ 100 mg ali zmanjša na 25 mg. Bolniki z zmanjšanim delovanjem
English: The active ingredient in Sildenafil ratiopharm, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Slovenian: Zdravilna učinkovina v zdravilu Sildenafil ratiopharm, sildenafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
English: Other information about sildenafil
Slovenian: Druge informacije o zdravilu sildenafil:
English: Because Sildenafil ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Slovenian: Ker je zdravilo Sildenafil ratiopharm generično zdravilo, so bile študije na bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Viagra.
English: Sildenafil ratiopahrm sildenafil
Slovenian: Sildenafil ratiopharm sildenafil
English: What is sildenafil?
Slovenian: Kaj je sildenafil?
English: Sildenafil ratiopharm is a medicine that contains the active substance sildenafil.
Slovenian: Sildenafil ratiopharm je zdravilo, ki vsebuje zdravilno učinkovino sildenafil.
English: The Committee recommended that Sildenafil ratiopharm be given marketing authorisation.
Slovenian: Priporočil je, da se za zanj odobri dovoljenje za promet.
English: Why has sildenafil been approved?
Slovenian: Zakaj je bilo zdravilo sildenafil odobreno?
English: If Sildenafil ratiopharm is taken with food, the onset of activity may be delayed compared with taking Sildenafil ratiopharm without food.
Slovenian: Če se zdravilo Sildenafil ratiopharm zaužije sočasno s hrano, lahko začne delovati pozneje, kot če se zaužije brez nje.
English: By blocking the breakdown of cGMP, Sildenafil ratiopharm restores erectile function.
Slovenian: Zdravilo Sildenafil ratiopharm z zaviranjem razgradnje cGMP ponovno vzpostavi erektilno funkcijo.
English: How has sildenafil been studied?
Slovenian: Kako je bilo zdravilo sildenafil raziskano?
English: What is sildenafil used for?
Slovenian: Za kaj se zdravilo sildenafil uporablja?
English: How is sildenafil used?
Slovenian: Kako se zdravilo sildenafil uporablja?
English: How does sildenafil work?
Slovenian: Kako zdravilo sildenafil deluje?
English: Treatment with Abseamed is divided into two stages - correction and maintenance phase.
Slovenian: Zdravljenje z zdravilom Abseamed poteka v dveh fazah - korekcijska in vzdrževalna faza.
English: • a swollen face, lips, mouth, tongue or throat,
Slovenian: • otekanje obraza, ustnic, ust, jezika ali grla,
English: Your doctor will monitor your blood pressure regularly while you are using Abseamed.
Slovenian: Zdravnik bo redno nadziral vaš krvni tlak, medtem ko uporabljate zdravilo Abseamed.
English: Abseamed should not be used and discarded - if the liquid is coloured or you can see particles floating in it, - if the seal is broken, - if you know, or think that it may have been accidentally frozen, or - if there has been a refrigerator failure.
Slovenian: Zdravila Abseamed se ne sme uporabiti in ga je treba zavreči: - če je tekočina obarvana ali v njej vidite plavati delce, - če je tesnilo poškodovano, - če veste ali mislite, da je bila raztopina pomotoma zamrznjena ali - če hladilnik ni pravilno deloval.
English: Abseamed has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Abseamed nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Abseamed should be administered after the completion of the blood donation procedure.
Slovenian: Zdravilo Abseamed je treba uporabiti po tem, ko je postopek darovanja krvi končan.
English: • For adults and children Abseamed is given as an injection either into a vein (intravenously) or a tube that goes into a vein.
Slovenian: • Odraslim in otrokom se daje zdravilo Abseamed v obliki injekcije bodisi v veno (intravensko) ali s cevko, ki gre v veno.
English: Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, D-58638 Iserlohn, Germany
Slovenian: Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Nemčija
English: In controlled clinical studies, use of epoetin alfa and other ESAs have been associated with decreased locoregional tumour control or decreased overall survival:
Slovenian: V nadzorovanih kliničnih študijah je bila uporaba epoetina alfa in drugih ESA povezana z zmanjšanim lokoregionalnim nadzorom tumorjev ali zmanjšanim skupnim preživetjem:
English: If you visit a hospital, clinic or family doctor, tell them you are having Abseamed treatment.
Slovenian: Če obiščete bolnišnico, kliniko ali izbranega zdravnika, povejte, da se zdravite z zdravilom
English: The dose of Abseamed you receive is based on your body weight in kilograms.
Slovenian: Odmerek zdravila Abseamed, ki ga boste prejeli, je odvisen od vaše telesne mase v kilogramih.
English: Abseamed is given alone and not mixed with other liquids for injection.
Slovenian: Zdravilo Abseamed se daje samo in se ne meša z drugimi tekočinami za injiciranje.
English: Inject the Abseamed solution as you have been shown by your doctor.
Slovenian: Injicirajte raztopino zdravila Abseamed, kot vam je pokazal zdravnik.
English: When this access (via a vein or tube) is not readily available, your doctor may decide that Abseamed should be injected under the skin (subcutaneously).
Slovenian: Kadar takšen dostop (v veno ali cevko) ni takoj na razpolago, se vaš zdravnik lahko odloči, da je treba zdravilo Abseamed injicirati pod kožo (subkutano).
English: • Your doctor may initiate treatment with Abseamed if your haemoglobin is 10 g/dL or less.
Slovenian: • Vaš zdravnik lahko uvede zdravljenje z zdravilom Abseamed, ko je vaš hemoglobin 10 g/dl ali manj.
English: If you are a cancer patient, be aware that use of Abseamed may be associated with shorter survival and a higher death rate in head and neck, and metastatic breast cancer patients who are receiving chemotherapy.
Slovenian: Če ste bolnik z rakom, morate vedeti, da je uporaba zdravila Abseamed lahko povezana s krajšim preživetjem in večjimi stopnjami smrtnosti pri bolnikih z rakom v glavi in vratu ter metastatskim rakom dojke, ki prejemajo zdravljenje s kemoterapijo.
English: < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Ocena pogostnosti: zelo pogosti (≥ 1/10); 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), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: • If you are having dialysis treatment when you begin treatment with Abseamed, your dialysis regime may need to be adjusted.
Slovenian: • Če se zdravite z dializo, ko se začenjate zdraviti z zdravilom Abseamed, bo morda treba prilagoditi vaš režim dialize.
English: • Always use Abseamed exactly as instructed by your doctor or nurse.
Slovenian: • Zdravilo Abseamed vedno uporabljajte natančno po navodilih svojega zdravnika ali medicinske sestre.
English: During the maintenance phase, Abseamed can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Slovenian: Med vzdrževalno fazo se lahko zdravilo Abseamed daje bodisi 3-krat na teden ali v primeru subkutanega dajanja enkrat na teden ali enkrat na dva tedna.
English: You may still be able to use Abseamed, but discuss it with your doctor first:
Slovenian: Morda boste lahko še vedno uporabljali zdravilo Abseamed, vendar se najprej posvetujte s svojim zdravnikom:
English: If you forget to use Abseamed
Slovenian: Če ste pozabili uporabiti zdravilo Abseamed
English: Do not administer Abseamed by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Slovenian: Zdravila Abseamed ne dajajte v obliki intravenske infuzije ali v povezavi z drugimi raztopinami zdravil (glejte poglavje 6.6 za dodatne informacije).
English: In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Abseamed subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
Slovenian: Če zdravnik oceni, da lahko bolnik ali negovalec zdravilo Abseamed varno in učinkovito subkutano injicira sam, mu je treba dati navodila za pravilno odmerjanje in dajanje.
English: • You will usually continue Abseamed treatment for one month after the end of chemotherapy.
Slovenian: • Običajno boste zdravilo Abseamed dobivali še en mesec po končanem zdravljenju s kemoterapijo.
English: • If you do not respond adequately to Abseamed, your doctor will check your dose and will inform you if you need to change doses of Abseamed.
Slovenian: • Če se na zdravljenje z zdravilom Abseamed ne odzivate ustrezno, bo zdravnik preveril vaš odmerek in vas obvestil, če morate spremeniti odmerke zdravila Abseamed.
English: If Abseamed is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Slovenian: Če se zdravilo Abseamed injicira pod kožo (subkutano), se z eno injekcijo navadno ne injicira količina, večja kot en mililiter zdravila (1 ml).
English: For patients on peritoneal dialysis Abseamed may be given twice a week.
Slovenian: Bolniki na peritonealni dializi lahko dobivajo zdravilo Abseamed dvakrat na teden.
English: • Abseamed is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
Slovenian: • Zdravilo Abseamed se injicira v veno takoj po tem, ko darujete kri, 3 tedne pred kirurškim posegom.
English: • difficulty swallowing or breathing,
Slovenian: • težave s požiranjem ali dihanjem,
English: • if you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Abseamed).
Slovenian: • če so vam postavili diagnozo aplazija rdečih krvnih celic (kostni mozeg ne more tvoriti dovolj rdečih krvnih celic) po predhodnem zdravljenju s katerim koli zdravilom, ki spodbuja nastajanje rdečih krvnih celic (vključno z zdravilom Abseamed).
English: Because Abseamed stimulates the production of red blood cells, doctors can take more blood from these people.
Slovenian: Ker zdravilo Abseamed spodbuja nastajanje rdečih krvnih celic, lahko zdravnik od teh ljudi vzame več krvi.
English: Your doctor has carried out blood tests and decided you need Abseamed.
Slovenian: Vaš zdravnik je opravil krvne preiskave in odločil, da potrebujete zdravilo Abseamed.
English: In the 20-week study (n = 225), no significant difference was observed in the primary efficacy endpoint, i.e. the proportion of patients who required a RBC transfusion after Day 28 (62% of epoetin alfa patients versus 69% of standard therapy patients).
Slovenian: V 20-tedenski študiji (n = 225) niso opazili značilnih razlik v primarnem opazovanem dogodku učinkovitosti, tj. v deležu bolnikov, pri katerih je bila potrebna transfuzija RKC po 28. dnevu (62 % bolnikov z epoetinom alfa v primerjavi z 69 % bolnikov s standardnim zdravljenjem).
English: Your doctor will help you to decide if Abseamed is suitable for you.
Slovenian: Vaš zdravnik vam bo pomagal pri odločitvi, ali je zdravilo Abseamed za vas primerno.
English: While on Abseamed, some people need medicines to reduce the risk of blood clots.
Slovenian: Med uporabo zdravila Abseamed morajo nekatere osebe jemati zdravila za zmanjšanje tveganja za nastanek krvnih strdkov.
English: Later, your doctor may suggest that you or your caregiver learn how to inject Abseamed under the skin
Slovenian: Kasneje lahko zdravnik predlaga, da se vi ali vaš skrbnik naučite, kako si injicirati zdravilo Abseamed pod kožo (subkutano).
English: • The usual starting dose of Abseamed for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week.
Slovenian: • Običajni začetni odmerek zdravila Abseamed za odrasle in otroke je 50 mednarodnih enot (i.e.) na kilogram (/kg) telesne mase, trikrat na teden.
English: - Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Abseamed or any other erythropoietin (see section 4.4).
Slovenian: - Bolniki, pri katerih se po zdravljenju s katerim koli eritropoetinom razvije aplazija rdečih krvnih celic (PRCA - pure red cell aplasia), ne smejo dobivati zdravila Abseamed ali katerega koli drugega eritropoetina (glejte poglavje 4.4).
English: • Abseamed is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
Slovenian: • Zdravilo Abseamed se injicira pod kožo vsak teden tri tedne pred kirurškim posegom in na dan kirurškega posega.
English: Iron supplements and other blood stimulants may increase the effectiveness of Abseamed.
Slovenian: Dodatki železa in druga sredstva za spodbujanje tvorbe krvi lahko povečajo učinkovitost zdravila
English: Abseamed and other products that stimulate red cell production may increase the risk of developing blood clots in all patients.
Slovenian: Zdravilo Abseamed in druga zdravila, ki spodbujajo nastajanje rdečih krvnih celic, lahko povečajo tveganje za nastanek krvnih strdkov pri vseh bolnikih.
English: Abseamed may be given by injection:
Slovenian: Zdravilo Abseamed se lahko daje z injiciranjem:
English: Abseamed is indicated in adults in a predonation programme to increase the yield of autologous blood.
Slovenian: Zdravilo Abseamed je indicirano pri odraslih v preddonorskem programu za povečanje količine pridobljene avtologne krvi.
English: • If you are on a more extended dosing interval (greater than once weekly) of Abseamed, you may not maintain adequate haemoglobin levels and you may require an increase in Abseamed dose or frequency of administration.
Slovenian: • Če uporabljate daljši interval odmerjanja zdravila Abseamed (daljši kot enkrat tedensko), morda ne bo mogoče vzdrževati ustrezne ravni hemoglobina in bo treba odmerek ali pogostnost odmerjanja zdravila Abseamed povečati.
English: Abseamed can reduce the need for a blood transfusion.
Slovenian: Zdravilo Abseamed lahko zmanjša potrebo po transfuziji krvi.
English: Other medicines and Abseamed
Slovenian: Druga zdravila in zdravilo Abseamed
English: • Abseamed is given by injection under the skin.
Slovenian: • Zdravilo Abseamed se daje v obliki injekcije pod kožo.
English: Abseamed is a biosimilar medicinal product.
Slovenian: Zdravilo Abseamed je podobno biološko zdravilo.
English: • Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Abseamed treatment.
Slovenian: • Vaš zdravnik bo naročil krvne preiskave in po potrebi prilagodil odmerek, odvisno od odziva vaše anemije na zdravljenje z zdravilom Abseamed.
English: This section contains information on how to give yourself an injection of Abseamed.
Slovenian: To poglavje vsebuje navodila za to, kako morate sami sebi dajati injekcije zdravila Abseamed.
English: • Only use Abseamed if it has been stored correctly - see section 5, How to store Abseamed.
Slovenian: • Uporabljajte le pravilno shranjeno zdravilo Abseamed - glejte poglavje 5, Shranjevanje zdravila Abseamed.
English: Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Abseamed.
Slovenian: Zdravniku ali medicinski sestri takoj povejte, če ugotovite katerega koli od teh neželenih učinkov ali če med zdravljenjem z zdravilom Abseamed opazite druge neželene učinke.
English: Caution should be exercised with escalation of Abseamed doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Slovenian: Previdnost je potrebna pri stopnjevanju odmerkov zdravila Abseamed pri bolnikih s kronično ledvično odpovedjo, saj so morda višji kumulativni odmerki epoetina povezani s povečanim tveganjem za umrljivost, resne kardiovaskularne in cerebrovaskularne dogodke.
English: If signs and symptoms suggestive of these reactions appear, Abseamed should be withdrawn immediately and an alternative treatment considered.
Slovenian: Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravljenje z zdravilom Abseamed takoj prekiniti in razmisliti o drugi vrsti zdravljenja.